§ 381. Imports and exports

Footnotes

1. 1 So in original. Probably should be preceded by a comma.
2. 2 So in original. No par. (2) has been enacted.
3. 3 So in original. Probably should be preceded by “section”.

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1938

   Pub. L. 75–675 § 801 · 52 Stat. 1040

   Enacted · 21 U.S.C. § 381

   June 25, 1938, ch. 675, § 801, 52 Stat. 1058

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 801, 52 Stat. 1058

   Enacted provision · exact public law section
   Sec. 801. (a) The Secretary of the Treasury shall deliver to the Secretary of Agriculture, upon his request, samples of food, drugs, devices, and cosmetics which are being imported or offered for import into the United States, giving notice thereof to the owner or consignee, who may appear before the Secretary of Agriculture and Articles manufactured. etc., under insanitary conditions. have the right to introduce testimony. If it appears from the examination of such samples or otherwise that (1) such article has been manufactured, processed, or packed under insanitary conditions, or Sale forbidden in exporting, etc., country. Adulterated, misbranded, etc. Ante, p. 1052. Admission of narcotic drugs. (2) such article, is forbidden or restricted in sale in the country in which it was produced or from which it was exported, or (3) such article is adulterated, misbranded, or in violation of section 505, then such article shall be refused admission. This paragraph shall not be construed to prohibit the admission of narcotic drugs the importation of which is permitted under section 2 of the Act of May 42 Stat. 596. 21 U. S. C. § 173. Destruction of inadmissible articles; exception. 26, 1922, as amended (U. S. C., 1934 edition, title 21, sec. 173). (b) The Secretary of the Treasury shall refuse delivery to the consignee and shall cause the destruction of any such article refused admission, unless such article is exported by the consignee within three months from the date of notice of such refusal, under such regulations as the Secretary of the Treasury may prescribe: Provisos. Delivery pending examination. Provided, That the Secretary of the Treasury may deliver to the consignee any such article pending examination and decision in the Bond. matter on execution of a bond as liquidated damages for the amount of the full invoice value thereof together with the duty thereon and on refusing for any cause to return such article or any part thereof to the custody of the Secretary of the Treasury when demanded for the purpose of excluding it from the country or for any other purpose, such consignee shall forfeit the full amount of the bond as liquidated damages. (c) All charges for storage, cartage, and labor on any article which is refused admission or delivery shall be paid by the owner or consignee and in default of such payment shall constitute a lien against any future importations made by such owner or consignee. (d) A food, drug, device, or cosmetic intended for export shall not be deemed to be adulterated or misbranded under this Act if it (1) accords to the specifications of the foreign purchaser, (2) is not in conflict with the laws of the country to which it is intended for export, and (3) is labeled on the outside of the shipping package to show that it is intended for export. But if such article is sold or offered for sale in domestic commerce, this subsection shall not exempt it from any of the provisions of this Act.

2. 1949

   Public Law not identified

   Inserted · 21 U.S.C. § 381(a)

   Subsec. (a). Act Oct. 18, 1949, § 1, inserted before period at end of second sentence “, except as provided in subsection (b) of this section. The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury within ninety days of the notice of such refusal or within such additional time as may be permitted pursuant to such regulations”

   Unresolved: No Public Law or Statutes at Large citation in the Code source.

   Source evidence

   Code amendment note
   Subsec. (a). Act Oct. 18, 1949, § 1, inserted before period at end of second sentence “, except as provided in subsection (b) of this section. The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury within ninety days of the notice of such refusal or within such additional time as may be permitted pursuant to such regulations”.

3. 1949

   Public Law not identified

   Changed · 21 U.S.C. § 381(b)

   Subsec. (b). Act Oct. 18, 1949, § 2, provided for express statutory authority for the long-standing administrative practice of releasing imported articles that do not comply with the requirements of the law so that they may be relabeled or given appropriate treatment to bring them into compliance

   Unresolved: No Public Law or Statutes at Large citation in the Code source.

   Source evidence

   Code amendment note
   Subsec. (b). Act Oct. 18, 1949, § 2, provided for express statutory authority for the long-standing administrative practice of releasing imported articles that do not comply with the requirements of the law so that they may be relabeled or given appropriate treatment to bring them into compliance.

4. 1949

   Public Law not identified

   Changed · 21 U.S.C. § 381(c)

   Subsec. (c). Act Oct. 18, 1949, § 3, charged all costs, including salaries and travel and subsistence expenses of officers and employees, against importers

   Unresolved: No Public Law or Statutes at Large citation in the Code source.

   Source evidence

   Code amendment note
   Subsec. (c). Act Oct. 18, 1949, § 3, charged all costs, including salaries and travel and subsistence expenses of officers and employees, against importers.

5. 1962

   Drug Amendments of 1962

   Pub. L. 87–781 title III § 306 · 76 Stat. 780

   Inserted · 21 U.S.C. § 381(a)

   Pub. L. 87–781 inserted provisions requiring the Secretary of Health, Education, and Welfare to furnish the Secretary of the Treasury a list of establishments registered under section 360(i) of this title, and to request that samples of any drugs from any establishments not so registered be delivered to the Secretary of Health, Education, and Welfare, with notice of delivery to the consignee who may appear before the Secretary to testify

   Source evidence

   Code amendment note
   Subsec. (a). Pub. L. 87–781 inserted provisions requiring the Secretary of Health, Education, and Welfare to furnish the Secretary of the Treasury a list of establishments registered under section 360(i) of this title, and to request that samples of any drugs from any establishments not so registered be delivered to the Secretary of Health, Education, and Welfare, with notice of delivery to the consignee who may appear before the Secretary to testify.

   Enacted provision · exact public law section
   Sec. 306. samples of imported drugs Section 801 (a) of such Act (21 U.S.C. 381(a)) is amended by inserting, after the first sentence thereof, the following new sentence: “The Secretary of Health, Education, and Welfare shall furnish to the Secretary of the Treasury a list of establishments registered Ante, p. 795. pursuant to subsection (i) of section 510 and shall request that if any drugs manufactured, prepared, propagated, compounded, or processed in an establishment not so registered are imported or offered for import into the United States, samples of such drugs be delivered to the Secretary of Health, Education, and Welfare, with notice of such delivery to the owner or consignee, who may appear before the Secretary of Health, Education, and Welfare and have the right to introduce testimony.”

6. 1968

   Animal Drug Amendments of 1968

   Pub. L. 90–399 § 106 · 82 Stat. 342

   Changed · 21 U.S.C. § 381(d)

   Pub. L. 90–399 provided that nothing in subsec. (d) shall authorize the exportation of any new animal drug, or an animal feed bearing or containing a new animal drug, which is unsafe within the meaning of section 360b of this title

   Source evidence

   Code amendment note
   Subsec. (d). Pub. L. 90–399 provided that nothing in subsec. (d) shall authorize the exportation of any new animal drug, or an animal feed bearing or containing a new animal drug, which is unsafe within the meaning of section 360b of this title.

   Enacted provision · exact public law section
   Sec. 106. animal drugs for extort Section 801(d) of the Federal Food, Drug, and Cosmetic Act, as amended, is amended by adding at the end thereof the following: 52 Stat. 1058. 21 USC 381. “Nothing in this subsection shall authorize the exportation of any new animal drug, or an animal feed bearing or containing a new animal drug, which is unsafe within the meaning of section 512 of this Act.” Ante, p. 343.

7. 1970

   Controlled Substances Act

   Pub. L. 91–513 title II § 701(h) · 84 Stat. 1236

   1. Substituted · 21 U.S.C. § 381(a)

      Pub. L. 91–513 substituted “Clause (2) of the third sentence of this paragraph” for “This paragraph” in last sentence

   2. Substituted · 21 U.S.C. § 381(a)

      Pub. L. 91–513 substituted “the Controlled Substances Import and Export Act” for “section 173 of this title” in last sentence

   Source evidence

   Code amendment note
   Subsec. (a). Pub. L. 91–513 substituted “Clause (2) of the third sentence of this paragraph” for “This paragraph” and “the Controlled Substances Import and Export Act” for “section 173 of this title” in last sentence.

   Enacted provision · exact public law section
   (h) The last sentence of section 801 (a) of the Federal Food, Drug, 52 Stat. 1058. and Cosmetic Act (21 U.S.C. 381(a)) is amended (1) by striking out “This paragraph” and inserting in lieu thereof “Clause (2) of the third sentence of this paragraph,”, and (2) by striking out “section 2 of the Act of May 26, 1922, as amended (U.S.C. 1934, edition, title 21, sec. 173)” and inserting in lieu thereof “the Controlled Substances Import and Export Act”.

8. 1976

   Medical Device Amendments of 1976

   Pub. L. 94–295 · 90 Stat. 539

   Inserted · 21 U.S.C. § 381(a)

   Pub. L. 94–295, §§ 3(f)(2), 4(b)(3), expanded provisions requiring the Secretary of Health, Education, and Welfare to request that the Secretary of the Treasury deliver to the Secretary of Health, Education, and Welfare items imported or offered for import into the United States that were manufactured, prepared, propagated, compounded, or processed in non-registered establishments by extending the provisions to include devices imported or offered for import, and, in cl. (1), inserted reference to devices which were manufactured, packed, stored, or installed using methods, facilities, or controls not conforming to the requirements of section 360j(f) of this title

   Source evidence

   Code amendment note
   Subsec. (a). Pub. L. 94–295, §§ 3(f)(2), 4(b)(3), expanded provisions requiring the Secretary of Health, Education, and Welfare to request that the Secretary of the Treasury deliver to the Secretary of Health, Education, and Welfare items imported or offered for import into the United States that were manufactured, prepared, propagated, compounded, or processed in non-registered establishments by extending the provisions to include devices imported or offered for import, and, in cl. (1), inserted reference to devices which were manufactured, packed, stored, or installed using methods, facilities, or controls not conforming to the requirements of section 360j(f) of this title.

9. 1976

   Medical Device Amendments of 1976

   Pub. L. 94–295 § 3(f)(1) · 90 Stat. 539

   1. Amended · 21 U.S.C. § 381(d)

      Pub. L. 94–295, § 3(f)(1), designated existing provisions as par. (1)

   2. Added · 21 U.S.C. § 381(d)

      Pub. L. 94–295, § 3(f)(1), added par. (2)

   Source evidence

   Code amendment note
   Subsec. (d). Pub. L. 94–295, § 3(f)(1), designated existing provisions as par. (1) and added par. (2).

   Enacted provision · exact public law section
   (1) Section 801(d) is amended to read as follows: “(d) (1) A food, drug, device, or cosmetic intended for export shall not be deemed to be adulterated or misbranded under this Act if it— “(A) accords to the specifications of the foreign purchaser, “(B) is not in conflict with the laws of the country to which it is intended for export. “(C) is labeled on the outside of the shipping package that it is intended for export, and “(D) is not sold or offered for sale in domestic commerce. This paragraph does not authorize the exportation of any new animal drug, or an animal feed bearing or containing a new animal drug, 21 USC 360b. which is unsafe within the meaning of section 512. “(2) Paragraph (1) does not apply to any device— “(A) which does not comply with an applicable requirement Ante, p. 552. of section 514 or 515, “(B) which under section 520(g) is exempt from either such section, or “(C) which is a banned device under section 516, unless, in addition to the requirements of paragraph (1), the Secretary has determined that the exportation of the device is not contrary to public health and safety and has the approval of the country to which it is intended for export,.”.

10. 1988

    Prescription Drug Marketing Act of 1987

    Pub. L. 100–293 § 3 · 102 Stat. 95

    1. Added · 21 U.S.C. § 381(d); 21 U.S.C. § 381(e)

       Pub. L. 100–293 added subsec. (d)

    2. Redesignated · 21 U.S.C. § 381(d); 21 U.S.C. § 381(e)

       Pub. L. 100–293 redesignated former subsec. (d) as (e)

    Source evidence

    Code amendment note
    Subsecs. (d), (e). Pub. L. 100–293 added subsec. (d) and redesignated former subsec. (d) as (e).

    Enacted provision · exact public law section
    SEC. 3. REIMPORTATION. Section 801 (21 U.S.C. 381) is amended by redesignating subsection (d) as subsection (e) and by inserting after subsection (c) the following: “(d) (1) Except as provided in paragraph (2), no drug subject to section 503(b) which is manufactured in a State and exported may be imported into the United States unless the drug is imported by the person who manufactured the drug. “(2) The Secretary may authorize the importation of a drug the importation of which is prohibited by paragraph (1) if the drug is required for emergency medical care.”.

11. 1992

    Medical Device Amendments of 1992

    Pub. L. 102–300 § 6(b)(1) · 106 Stat. 238

    Substituted · 21 U.S.C. § 381(a); 21 U.S.C. § 381(b)

    Pub. L. 102–300, which directed the substitution of “Health and Human Services” for “Health, Education, and Welfare” wherever appearing, was executed in second sentence of subsec. (a), but could not be executed in first sentence of subsec. (a) or in subsec. (b) because such words did not appear. See 1993 Amendment note above and Transfer of Functions note below

    Source evidence

    Code amendment note
    Subsecs. (a), (b). Pub. L. 102–300, which directed the substitution of “Health and Human Services” for “Health, Education, and Welfare” wherever appearing, was executed in second sentence of subsec. (a), but could not be executed in first sentence of subsec. (a) or in subsec. (b) because such words did not appear. See 1993 Amendment note above and Transfer of Functions note below.

    Enacted provision · exact public law section
    (1) Subsections (c) and (d) of sections 201, subsections (a), (d), (h), (i), (1), (m), and (o) of section 408, subsections (a) and (b) of section 536, section 701(b), and subsections (a) and (b) of section 801 (21 U.S.C. 321 (c) and (d), 346a (a), (d), (h), (i), (1), (m), and (o), 360mm (a) and (b), 371(b), and 381 (a) and (b)) and section 351(c) of the Public Health Service Act (42 U.S.C. 262(c)) are each amended by striking out “Health, Education, and Welfare” each place it appears and inserting in lieu thereof “Health and Human Services”.

12. 1992

    Prescription Drug Amendments of 1992

    Pub. L. 102–353 § 5 · 106 Stat. 941

    Substituted · 21 U.S.C. § 381(d)(1)

    Pub. L. 102–353 substituted “manufacturer of” for “person who manufactured”

    Source evidence

    Code amendment note
    Subsec. (d)(1). Pub. L. 102–353 substituted “manufacturer of” for “person who manufactured”.

    Enacted provision · exact public law section
    SEC. 5. TECHNICAL AMENDMENT. Section 801(d)(1) (21 U.S.C. 381(d)(1)) is amended by striking out “person who manufactured” and inserting in lieu thereof “manufacturer of”.

13. 1993

    Nutrition Labeling and Education Act Amendments of 1993

    Pub. L. 103–80 § 3(dd)(1) · 107 Stat. 773

    Substituted · 21 U.S.C. § 381(a)

    Pub. L. 103–80, § 3(dd)(1), substituted “Health and Human Services” for “Agriculture” after “Secretary of” in two places in first sentence

    Source evidence

    Code amendment note
    Subsec. (a). Pub. L. 103–80, § 3(dd)(1), substituted “Health and Human Services” for “Agriculture” after “Secretary of” in two places in first sentence.

    Enacted provision · exact public law section
    SEC. 3. TECHNICAL AMENDMENTS TO FEDERAL FOOD, DRUG, AND COSMETIC ACT. (a) Reference.— Whenever in this section an amendment or repeal is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act (b) Section 201.— Paragraphs (w), (x), (y), (z), (aa), (bb), (cc), (dd), (ee), and (ff) of section 201 (21 U.S.C 321) are redesignated as paragraphs (v), (w), (x), (y), (z), (aa), (bb), (cc), (dd), and (ee) respectively. (c) Section 301.— Section 301 (21 U.S.C. 331) is amended— (1) in subsection (j), by striking out “721, or 708” and inserting in lieu thereof “708, or 721”; and (2) in subsection (s), by striking out “412(d)” and inserting in lieu thereof “412(e)”. (d) Section 302.— Section 302 (21 U.S.C. 332) is amended— (1) in subsection (a), by striking out “, and subject to” and all that follows through “381),”, and (2) in subsection (b), by striking out the second sentence. (e) Section 303.— Section 303 (21 U.S.C. 333) is amended by redesignating the second subsection (e) and subsection (f) as subsections (f) and (g), respectively. (f) Section 304.— Section 304 (21 U.S.C. 334) is amended— (1) in subsection (a)(1), by striking out “: Provided, however, That no” and inserting in lieu thereof a period and “No”, and (2) in subsection (d)(1)— (A) by striking out “: Provided, That after” and inserting in lieu thereof a period and “After”, (B) by striking out “: Provided, however, That the” and inserting in lieu thereof a period and “The”, (C) by striking out “: And provided further, That where” and inserting in lieu thereof a period and “Where”, and (D) by striking out “the foregoing proviso” and inserting in lieu thereof “the preceding sentence”. (g) Section 307.— Section 307(b)(3)(A) (21 U.S.C. 337(b)(3)(A)) is amended by striking out “Act” and inserting in lieu thereof “section”. (h) Section 401.— Section 401 (21 U.S.C. 341) is amended by striking out “and/or reasonable standards of fill of container: Provided, That no” and inserting in lieu thereof “or reasonable standards of fill of container. No”. (i) Section 402.— Section 402 (21 U.S.C. 342) is amended— (1) by striking out “; or” at the end of subparagraphs (1) and (2) of paragraph (a) and inserting in lieu thereof a period and by striking out “if it” at the beginning of subparagraph (3) of such paragraph and inserting in lieu thereof “If it”, (2) in paragraph (d)(1), by striking out “: Provided, That this clause” and inserting in lieu thereof “, except that this subparagraph”, and (3) in paragraph (d)(3), by striking out “: Provided, That this clause” and inserting in lieu thereof “, except that this subparagraph” and by striking out “: And provided further, That the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this clause” and inserting in lieu thereof “, except that the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this subparagraph”. (j) Section 403.— Section 403 (21 U.S.C. 343) is amended— (1) in paragraph (e), by striking out “: Provided, That” and inserting in lieu thereof “, except that”, (2) in paragraph (i), by striking out “, other than those sold as such” and inserting in lieu thereof “unless sold as spices, flavorings, or such colors” and by striking out “: Provided, That, to the extent” and inserting in lieu thereof a period and “To the extent”, (3) in paragraph (k), by striking out “: Provided, That” and inserting in lieu thereof “, except mat”, (4) in paragraph (l), by striking out “: Provided, however, That” and inserting in lieu thereof “, except that”, (5) in paragraph (r)(1)(B), by striking out “5(D)” and inserting in lieu thereof “(5)(D)”, and (6) in paragraph (r)(4)(B), by striking out “subsection” and inserting in lieu thereof “paragraph”. (k) Section 408.— Section 408 (21 U.S.C. 346a) is amended— (1) in subsection (a)(1), by striking out “Secretary of Health and Human Services” and inserting in lieu thereof “Administrator of the Environmental Protection Agency (hereinafter in this section referred to as the ‘Administrator’)”, (2) in subsection (d)(5), by striking out “section 7(c) of the Administrative Procedure Act (5 U.S.C., sec. 1006(c))” and inserting in lieu thereof “section 556(c) of title 5, United States Code”, (3) in subsection (1), by striking out “It the event” and inserting in lieu thereof “In the events”, (4) in subsection (n), by striking out “of the Federal Food, Drug, and Cosmetic Act”, (5) in subsection (o), by striking out “Secretary of Health and Human Services” each place it occurs and inserting in lieu thereof “Administrator”, and (6) by striking out “Secretary” each place it occurs except when followed by “of Agriculture” and inserting in lieu thereof “Administrator”. (l) Section 412.— Section 412(h) (21 U.S.C. 350a(h)) is amended by striking out “(c)(1)(B),” and inserting in lieu thereof “(e)(1)(B)”. (m) Section 502.— Section 502 (21 U.S.C. 352) is amended— (1) in paragraph (e)(3), by striking out “: Provided further, That” and inserting in lieu thereof “, except that”, (2) in paragraph (f), by striking out “: Provided, That” and inserting in lieu thereof “, except that”, (3) in paragraph (g), by striking out “: Provided, That the method” and inserting in lieu thereof a period and “The method” and by striking out “: Provided further, That,” and inserting in lieu thereof “, except that”, and (4) in paragraph (n), by striking out “: Provided, That” and inserting in lieu thereof “, except that”. (n) Section 505.— Section 505 (21 U.S.C. 355) is amended— (1) in subsection (j)(6)(A)— (A) by striking out “Secretry” in clause (ii) and inserting in lieu thereof “Secretary”, and (B) by inserting a comma after “Secretary” the first time it appears in clause (iii). (2) in subsection (k)(1), by striking out “: Provided, however, That regulations” and inserting in lieu thereof a period and “Regulations”. (o) Section 506.— Section 506(a) (21 U.S.C. 356(a)) is amended by striking out “Federal Security Administrator” and “Administrator” each place it appears and inserting in lieu thereof “Secretary”. (p) Section 507.— Section 507 (21 U.S.C. 357) is amended— (1) in subsection (a), by striking out “Federal Security Administrator” and “Administrator” each place it appears and inserting in lieu thereof “Secretary”, (2) in subsection (e)— (A) by striking out “section 507” each place it occurs and inserting in lieu thereof “this section”, (B) by striking out “or 507” and inserting in lieu thereof “or this section”, and (C) by striking out “: Provided, That, for purposes” and inserting in lieu thereof a period and “For purposes”, (3) in subsection (g)(1), by striking out “: Provided, however, That regulations” and inserting in lieu thereof a period and “Regulations”, and (4) in subsection (h), by striking out “507”. (q) Section 508.— Subsections (c) and (e) of section 508 (21 U.S.C. 358) are each amended by striking out “section 4 of the Administrative Procedure Act (5 U.S.C. 1003)” and inserting in lieu thereof “section 553 of title 5, United States Code”. (r) Section 512.— Section 512 (21 U.S.C. 360b) is amended— (1) in subsection (c)(2)(A)(ii), by inserting “in” after “provided”, (2) in subsection (c)(2)(F)(i), by striking out “(C)(iii)” and inserting in lieu thereof “(D)(iii)”, (3) in subsection (c)(2)(H), by striking out “subclause” the first time it appears and inserting in lieu thereof “subclauses”, (4) in subsection (d)(1), by striking out “subparagraphs (A) through (G)” and inserting in lieu thereof “subparagraphs (A) through (I)”, and (5) in subsection (n)(1)— (A) by striking out “201(w)” in subparagraphs (B)(ii)(I). and (C)(ii)(1) and inserting in lieu thereof “201(w)”, and (B) by striking out in the last sentence “(H)” and inserting in lieu thereof “(I)”. (s) Section 513.— Section 513(b)(3) (21 U.S.C 360c(b)(3)) is amended by striking out “5703(b)” and inserting in lieu thereof “5703”. (t) Section 515.— Section 515(c)(2)(A) (21 U.S.C. 360e(c)(2)(A)) is amended by striking out “refer such application”. (u) Section 519.— Section 519(a) (21 U.S.C. 360i(a)) is amended by striking out “paragraph (4)” and inserting in lieu thereof “paragraph (7)”; (v) Section 527.— Section 527(b) (21 U.S.C. 36Occ(b)) is amended— (1) by striking out “507„” and inserting in lieu thereof “507”, and (2) in paragraph (1), by striking out “The” and inserting in lieu thereof “the”. (w) Section 534.— Section 534(f)(2) (21 U.S.C. 360kk) is amended by striking out “this Act” and inserting in lieu thereof “the Public Health Service Act”. (x) Section 601.— Section 601(a) (21 U.S.C. 361) is amended by striking out “: Provided, That this” and inserting in lieu thereof “, except that this”. (y) Section 701.— Section 701 (21 U.S.C. 371) is amended— (1) in subsection (e)(1), by striking out the period after “Regulations)” the second time it occurs, and (2) in subsection (f)(4), by striking out “sections 239 and 240 of the Judicial Code, as amended” and inserting in lieu thereof “section 1254 of title 28, United States Code”. (z) Section 703.— Section 703 (21 U.S.C. 373) is amended— (1) by striking out “: Provided, That” and inserting in lieu thereof “, except that”, and (2) by striking out “: Provided further, That” and inserting in lieu thereof “, and except that”. (aa) Section 704.— Section 704(a)(1) (21 U.S.C. 374(a)(1)) is amended— (1) by striking out the semicolon after “materials” and inserting in lieu thereof a comma, and (2) by striking out “(j)” the first time it appears and inserting in lieu thereof “(k)”. (bb) Section 721.— Section 721(b)(5)(D) (21 U.S.C. 379e(b)(5)(D)) is amended by striking out “5703(b)” and inserting in lieu thereof “5703”. (cc) Section 801.— Section 801(b) (21 U.S.C. 381(b)) is amended— (1) by striking out “Administrator” the first time it occurs and inserting in lieu thereof “Secretary of Health and Human Services”, (2) by striking out “Administrator” the second and third time it occurs and inserting in lieu thereof “Secretary”, (3) by striking out “Administrator’s” and inserting in lieu thereof “Secretary’s”, and (4) by striking out “Federal Security Agency” and inserting in lieu thereof “Department of Health and Human Services”. (dd) Agriculture.— (1) Sections 201(c), 201(d), 701(b), and 801(a) (21 U.S.C. 321(c), 321(d), 371(b), and 381(a) are each amended by striking out “Agriculture” each place it appears and inserting in lieu thereof “Health and Human Services”. (2) Sections 702(c) and 706 (21 U.S.C. 372(c) and 376) are each amended by striking out “of Agriculture” each place it appears.

14. 1993

    Nutrition Labeling and Education Act Amendments of 1993

    Pub. L. 103–80 § 3(cc) · 107 Stat. 773

    1. Substituted · 21 U.S.C. § 381(b)

       Pub. L. 103–80, § 3(cc), substituted “Secretary of Health and Human Services” for “Administrator” after “designated by the”

    2. Substituted · 21 U.S.C. § 381(b)

       Pub. L. 103–80, § 3(cc), substituted “Secretary” for “Administrator” after “designated by the”

    3. Substituted · 21 U.S.C. § 381(b)

       Pub. L. 103–80, § 3(cc), substituted “Secretary’s” for “Administrator’s” after “designated by the”

    4. Substituted · 21 U.S.C. § 381(b)

       Pub. L. 103–80, § 3(cc), substituted “Department of Health and Human Services” for “Federal Security Agency” after “designated by the”

    Source evidence

    Code amendment note
    Subsec. (b). Pub. L. 103–80, § 3(cc), substituted “Secretary of Health and Human Services” for “Administrator” after “If it appears to the”, “Secretary” for “Administrator” after “provisions of this subsection, the”, “Secretary’s” for “Administrator’s” after “as may be specified in the”, “Department of Health and Human Services” for “Federal Security Agency”, and “Secretary” for “Administrator” after “designated by the”.

    Enacted provision · exact public law section
    SEC. 3. TECHNICAL AMENDMENTS TO FEDERAL FOOD, DRUG, AND COSMETIC ACT. (a) Reference.— Whenever in this section an amendment or repeal is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act (b) Section 201.— Paragraphs (w), (x), (y), (z), (aa), (bb), (cc), (dd), (ee), and (ff) of section 201 (21 U.S.C 321) are redesignated as paragraphs (v), (w), (x), (y), (z), (aa), (bb), (cc), (dd), and (ee) respectively. (c) Section 301.— Section 301 (21 U.S.C. 331) is amended— (1) in subsection (j), by striking out “721, or 708” and inserting in lieu thereof “708, or 721”; and (2) in subsection (s), by striking out “412(d)” and inserting in lieu thereof “412(e)”. (d) Section 302.— Section 302 (21 U.S.C. 332) is amended— (1) in subsection (a), by striking out “, and subject to” and all that follows through “381),”, and (2) in subsection (b), by striking out the second sentence. (e) Section 303.— Section 303 (21 U.S.C. 333) is amended by redesignating the second subsection (e) and subsection (f) as subsections (f) and (g), respectively. (f) Section 304.— Section 304 (21 U.S.C. 334) is amended— (1) in subsection (a)(1), by striking out “: Provided, however, That no” and inserting in lieu thereof a period and “No”, and (2) in subsection (d)(1)— (A) by striking out “: Provided, That after” and inserting in lieu thereof a period and “After”, (B) by striking out “: Provided, however, That the” and inserting in lieu thereof a period and “The”, (C) by striking out “: And provided further, That where” and inserting in lieu thereof a period and “Where”, and (D) by striking out “the foregoing proviso” and inserting in lieu thereof “the preceding sentence”. (g) Section 307.— Section 307(b)(3)(A) (21 U.S.C. 337(b)(3)(A)) is amended by striking out “Act” and inserting in lieu thereof “section”. (h) Section 401.— Section 401 (21 U.S.C. 341) is amended by striking out “and/or reasonable standards of fill of container: Provided, That no” and inserting in lieu thereof “or reasonable standards of fill of container. No”. (i) Section 402.— Section 402 (21 U.S.C. 342) is amended— (1) by striking out “; or” at the end of subparagraphs (1) and (2) of paragraph (a) and inserting in lieu thereof a period and by striking out “if it” at the beginning of subparagraph (3) of such paragraph and inserting in lieu thereof “If it”, (2) in paragraph (d)(1), by striking out “: Provided, That this clause” and inserting in lieu thereof “, except that this subparagraph”, and (3) in paragraph (d)(3), by striking out “: Provided, That this clause” and inserting in lieu thereof “, except that this subparagraph” and by striking out “: And provided further, That the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this clause” and inserting in lieu thereof “, except that the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this subparagraph”. (j) Section 403.— Section 403 (21 U.S.C. 343) is amended— (1) in paragraph (e), by striking out “: Provided, That” and inserting in lieu thereof “, except that”, (2) in paragraph (i), by striking out “, other than those sold as such” and inserting in lieu thereof “unless sold as spices, flavorings, or such colors” and by striking out “: Provided, That, to the extent” and inserting in lieu thereof a period and “To the extent”, (3) in paragraph (k), by striking out “: Provided, That” and inserting in lieu thereof “, except mat”, (4) in paragraph (l), by striking out “: Provided, however, That” and inserting in lieu thereof “, except that”, (5) in paragraph (r)(1)(B), by striking out “5(D)” and inserting in lieu thereof “(5)(D)”, and (6) in paragraph (r)(4)(B), by striking out “subsection” and inserting in lieu thereof “paragraph”. (k) Section 408.— Section 408 (21 U.S.C. 346a) is amended— (1) in subsection (a)(1), by striking out “Secretary of Health and Human Services” and inserting in lieu thereof “Administrator of the Environmental Protection Agency (hereinafter in this section referred to as the ‘Administrator’)”, (2) in subsection (d)(5), by striking out “section 7(c) of the Administrative Procedure Act (5 U.S.C., sec. 1006(c))” and inserting in lieu thereof “section 556(c) of title 5, United States Code”, (3) in subsection (1), by striking out “It the event” and inserting in lieu thereof “In the events”, (4) in subsection (n), by striking out “of the Federal Food, Drug, and Cosmetic Act”, (5) in subsection (o), by striking out “Secretary of Health and Human Services” each place it occurs and inserting in lieu thereof “Administrator”, and (6) by striking out “Secretary” each place it occurs except when followed by “of Agriculture” and inserting in lieu thereof “Administrator”. (l) Section 412.— Section 412(h) (21 U.S.C. 350a(h)) is amended by striking out “(c)(1)(B),” and inserting in lieu thereof “(e)(1)(B)”. (m) Section 502.— Section 502 (21 U.S.C. 352) is amended— (1) in paragraph (e)(3), by striking out “: Provided further, That” and inserting in lieu thereof “, except that”, (2) in paragraph (f), by striking out “: Provided, That” and inserting in lieu thereof “, except that”, (3) in paragraph (g), by striking out “: Provided, That the method” and inserting in lieu thereof a period and “The method” and by striking out “: Provided further, That,” and inserting in lieu thereof “, except that”, and (4) in paragraph (n), by striking out “: Provided, That” and inserting in lieu thereof “, except that”. (n) Section 505.— Section 505 (21 U.S.C. 355) is amended— (1) in subsection (j)(6)(A)— (A) by striking out “Secretry” in clause (ii) and inserting in lieu thereof “Secretary”, and (B) by inserting a comma after “Secretary” the first time it appears in clause (iii). (2) in subsection (k)(1), by striking out “: Provided, however, That regulations” and inserting in lieu thereof a period and “Regulations”. (o) Section 506.— Section 506(a) (21 U.S.C. 356(a)) is amended by striking out “Federal Security Administrator” and “Administrator” each place it appears and inserting in lieu thereof “Secretary”. (p) Section 507.— Section 507 (21 U.S.C. 357) is amended— (1) in subsection (a), by striking out “Federal Security Administrator” and “Administrator” each place it appears and inserting in lieu thereof “Secretary”, (2) in subsection (e)— (A) by striking out “section 507” each place it occurs and inserting in lieu thereof “this section”, (B) by striking out “or 507” and inserting in lieu thereof “or this section”, and (C) by striking out “: Provided, That, for purposes” and inserting in lieu thereof a period and “For purposes”, (3) in subsection (g)(1), by striking out “: Provided, however, That regulations” and inserting in lieu thereof a period and “Regulations”, and (4) in subsection (h), by striking out “507”. (q) Section 508.— Subsections (c) and (e) of section 508 (21 U.S.C. 358) are each amended by striking out “section 4 of the Administrative Procedure Act (5 U.S.C. 1003)” and inserting in lieu thereof “section 553 of title 5, United States Code”. (r) Section 512.— Section 512 (21 U.S.C. 360b) is amended— (1) in subsection (c)(2)(A)(ii), by inserting “in” after “provided”, (2) in subsection (c)(2)(F)(i), by striking out “(C)(iii)” and inserting in lieu thereof “(D)(iii)”, (3) in subsection (c)(2)(H), by striking out “subclause” the first time it appears and inserting in lieu thereof “subclauses”, (4) in subsection (d)(1), by striking out “subparagraphs (A) through (G)” and inserting in lieu thereof “subparagraphs (A) through (I)”, and (5) in subsection (n)(1)— (A) by striking out “201(w)” in subparagraphs (B)(ii)(I). and (C)(ii)(1) and inserting in lieu thereof “201(w)”, and (B) by striking out in the last sentence “(H)” and inserting in lieu thereof “(I)”. (s) Section 513.— Section 513(b)(3) (21 U.S.C 360c(b)(3)) is amended by striking out “5703(b)” and inserting in lieu thereof “5703”. (t) Section 515.— Section 515(c)(2)(A) (21 U.S.C. 360e(c)(2)(A)) is amended by striking out “refer such application”. (u) Section 519.— Section 519(a) (21 U.S.C. 360i(a)) is amended by striking out “paragraph (4)” and inserting in lieu thereof “paragraph (7)”; (v) Section 527.— Section 527(b) (21 U.S.C. 36Occ(b)) is amended— (1) by striking out “507„” and inserting in lieu thereof “507”, and (2) in paragraph (1), by striking out “The” and inserting in lieu thereof “the”. (w) Section 534.— Section 534(f)(2) (21 U.S.C. 360kk) is amended by striking out “this Act” and inserting in lieu thereof “the Public Health Service Act”. (x) Section 601.— Section 601(a) (21 U.S.C. 361) is amended by striking out “: Provided, That this” and inserting in lieu thereof “, except that this”. (y) Section 701.— Section 701 (21 U.S.C. 371) is amended— (1) in subsection (e)(1), by striking out the period after “Regulations)” the second time it occurs, and (2) in subsection (f)(4), by striking out “sections 239 and 240 of the Judicial Code, as amended” and inserting in lieu thereof “section 1254 of title 28, United States Code”. (z) Section 703.— Section 703 (21 U.S.C. 373) is amended— (1) by striking out “: Provided, That” and inserting in lieu thereof “, except that”, and (2) by striking out “: Provided further, That” and inserting in lieu thereof “, and except that”. (aa) Section 704.— Section 704(a)(1) (21 U.S.C. 374(a)(1)) is amended— (1) by striking out the semicolon after “materials” and inserting in lieu thereof a comma, and (2) by striking out “(j)” the first time it appears and inserting in lieu thereof “(k)”. (bb) Section 721.— Section 721(b)(5)(D) (21 U.S.C. 379e(b)(5)(D)) is amended by striking out “5703(b)” and inserting in lieu thereof “5703”. (cc) Section 801.— Section 801(b) (21 U.S.C. 381(b)) is amended— (1) by striking out “Administrator” the first time it occurs and inserting in lieu thereof “Secretary of Health and Human Services”, (2) by striking out “Administrator” the second and third time it occurs and inserting in lieu thereof “Secretary”, (3) by striking out “Administrator’s” and inserting in lieu thereof “Secretary’s”, and (4) by striking out “Federal Security Agency” and inserting in lieu thereof “Department of Health and Human Services”. (dd) Agriculture.— (1) Sections 201(c), 201(d), 701(b), and 801(a) (21 U.S.C. 321(c), 321(d), 371(b), and 381(a) are each amended by striking out “Agriculture” each place it appears and inserting in lieu thereof “Health and Human Services”. (2) Sections 702(c) and 706 (21 U.S.C. 372(c) and 376) are each amended by striking out “of Agriculture” each place it appears.

15. 1996

    Department of Commerce and Related Agencies Appropriations Act, 1996

    Pub. L. 104–134 § 2102(a)(1) · 110 Stat. 1321

    Added · 21 U.S.C. § 381(d)(3)

    Pub. L. 104–134, § 2102(a)(1), added par. (3)

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 104–134, § 2102(a)(1), added par. (3)

    Enacted provision · exact public law section
    SEC. 2102. SUPERINTENDENTS REPORT ON REFORMS. Not later than December 1, 1996, the Superintendent shall submit to the appropriate congressional committees, the Board of Education, the Mayor, the Consensus Commission, and the District of Columbia Council a report regarding the progress of the District of Columbia public schools toward achieving the goals of the long-term reform plan.

16. 1996

    Department of Commerce and Related Agencies Appropriations Act, 1996

    Pub. L. 104–134 § 2102(a)(1) · 110 Stat. 1321

    Added · 21 U.S.C. § 381(d)(4)

    Pub. L. 104–134, § 2102(a)(1), added par. (4)

    Source evidence

    Code amendment note
    Subsec. (d)(4). Pub. L. 104–134, § 2102(a)(1), added par. (4).

    Enacted provision · exact public law section
    SEC. 2102. SUPERINTENDENTS REPORT ON REFORMS. Not later than December 1, 1996, the Superintendent shall submit to the appropriate congressional committees, the Board of Education, the Mayor, the Consensus Commission, and the District of Columbia Council a report regarding the progress of the District of Columbia public schools toward achieving the goals of the long-term reform plan.

17. 1996

    Department of Commerce and Related Agencies Appropriations Act, 1996

    Pub. L. 104–134 § 2102(b)(1) · 110 Stat. 1321

    Struck · 21 U.S.C. § 381(e)(1)

    Pub. L. 104–134, § 2102(b)(1), struck out concluding provisions which read as follows: “This paragraph does not authorize the exportation of any new animal drug, or an animal feed bearing or containing a new animal drug, which is unsafe within the meaning of section 360b of this title.”

    Source evidence

    Code amendment note
    Subsec. (e)(1). Pub. L. 104–134, § 2102(b)(1), struck out concluding provisions which read as follows: “This paragraph does not authorize the exportation of any new animal drug, or an animal feed bearing or containing a new animal drug, which is unsafe within the meaning of section 360b of this title.”

    Enacted provision · exact public law section
    SEC. 2102. SUPERINTENDENTS REPORT ON REFORMS. Not later than December 1, 1996, the Superintendent shall submit to the appropriate congressional committees, the Board of Education, the Mayor, the Consensus Commission, and the District of Columbia Council a report regarding the progress of the District of Columbia public schools toward achieving the goals of the long-term reform plan.

18. 1996

    Department of Commerce and Related Agencies Appropriations Act, 1996

    Pub. L. 104–134 § 2102(b)(2) · 110 Stat. 1321

    1. Substituted · 21 U.S.C. § 381(e)(2)

       Pub. L. 104–134, § 2102(b)(2), in concluding provisions, substituted “either (i) the Secretary” for “the Secretary”

    2. Added · 21 U.S.C. § 381(e)(2)

       Pub. L. 104–134, § 2102(b)(2), in concluding provisions, added cl. (ii)

    Source evidence

    Code amendment note
    Subsec. (e)(2). Pub. L. 104–134, § 2102(b)(2), in concluding provisions, substituted “either (i) the Secretary” for “the Secretary” and added cl. (ii).

    Enacted provision · exact public law section
    SEC. 2102. SUPERINTENDENTS REPORT ON REFORMS. Not later than December 1, 1996, the Superintendent shall submit to the appropriate congressional committees, the Board of Education, the Mayor, the Consensus Commission, and the District of Columbia Council a report regarding the progress of the District of Columbia public schools toward achieving the goals of the long-term reform plan.

19. 1996

    Department of Commerce and Related Agencies Appropriations Act, 1996

    Pub. L. 104–134 § 2102(b)(3) · 110 Stat. 1321

    Added · 21 U.S.C. § 381(e)(3); 21 U.S.C. § 381(e)(4)

    Pub. L. 104–134, § 2102(b)(3), added pars. (3) and (4)

    Source evidence

    Code amendment note
    Subsec. (e)(3), (4). Pub. L. 104–134, § 2102(b)(3), added pars. (3) and (4).

    Enacted provision · exact public law section
    SEC. 2102. SUPERINTENDENTS REPORT ON REFORMS. Not later than December 1, 1996, the Superintendent shall submit to the appropriate congressional committees, the Board of Education, the Mayor, the Consensus Commission, and the District of Columbia Council a report regarding the progress of the District of Columbia public schools toward achieving the goals of the long-term reform plan.

20. 1996

    Department of Commerce and Related Agencies Appropriations Act, 1996

    Pub. L. 104–134 § 2102(c) · 110 Stat. 1321

    Added · 21 U.S.C. § 381(f)

    Pub. L. 104–134, § 2102(c), added subsec. (f)

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 104–134, § 2102(c), added subsec. (f).

    Enacted provision · exact public law section
    SEC. 2102. SUPERINTENDENTS REPORT ON REFORMS. Not later than December 1, 1996, the Superintendent shall submit to the appropriate congressional committees, the Board of Education, the Mayor, the Consensus Commission, and the District of Columbia Council a report regarding the progress of the District of Columbia public schools toward achieving the goals of the long-term reform plan.

21. 1996

    Pub. L. 104–180 § 603(a) · 110 Stat. 1569

    1. Substituted · 21 U.S.C. § 381(d)(3)

       Pub. L. 104–180, § 603(a), substituted “accessory of a device, or other article of device requiring further processing, which is ready” for “accessory of a device which is ready” in introductory provisions

    2. Inserted · 21 U.S.C. § 381(d)(3)

       Pub. L. 104–180, § 603(a), inserted “further processed by the initial owner or consignee, or” after “is intended to be” in subpar. (A)

    3. Inserted · 21 U.S.C. § 381(d)(3)

       Pub. L. 104–180, § 603(a), inserted “article,” after “part,” and “or further processed” after “incorporated” in subpar. (C)

    Source evidence

    Code amendment note
    Subsec. (d)(3). Pub. L. 104–180, § 603(a), substituted “accessory of a device, or other article of device requiring further processing, which is ready” for “accessory of a device which is ready” in introductory provisions, inserted “further processed by the initial owner or consignee, or” after “is intended to be” in subpar. (A), and inserted “article,” after “part,” and “or further processed” after “incorporated” in subpar. (C).

22. 1996

    Pub. L. 104–180 § 603(b) · 110 Stat. 1569

    Inserted · 21 U.S.C. § 381(f)

    Pub. L. 104–180, § 603(b), inserted “(other than insulin, an antibiotic drug, an animal drug, or a drug exported under section 382 of this title)” after “If a drug” in par. (1) and “A drug exported under section 382 of this title is exempt from this section.” at end of par. (2)

    Source evidence

    Code amendment note
    Subsec. (f). Pub. L. 104–180, § 603(b), inserted “(other than insulin, an antibiotic drug, an animal drug, or a drug exported under section 382 of this title)” after “If a drug” in par. (1) and “A drug exported under section 382 of this title is exempt from this section.” at end of par. (2).

23. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 title I § 125(a)(2)(D) · 111 Stat. 2296

    Inserted · 21 U.S.C. § 381(d)(1)

    Pub. L. 105–115 inserted “or composed wholly or partly of insulin” after “353(b) of this title”

    Source evidence

    Code amendment note
    Subsec. (d)(1). Pub. L. 105–115 inserted “or composed wholly or partly of insulin” after “353(b) of this title”.

    Enacted provision · exact public law section
    (D) Section 801(d)(1) (21 U.S.C. 381(d)(1)) is amended by inserting after “503(b)” the following: “or composed wholly or partly of insulin”.

24. 2000

    Pub. L. 106–387 § 1(a)(tVII)(s745)(c)(1) · 114 Stat. 1549

    Inserted · 21 U.S.C. § 381(d)(1)

    Pub. L. 106–387, § 1(a) [title VII, § 745(c)(1)], inserted “and section 384 of this title” after “paragraph (2)”

    Source evidence

    Code amendment note
    Subsec. (d)(1). Pub. L. 106–387, § 1(a) [title VII, § 745(c)(1)], inserted “and section 384 of this title” after “paragraph (2)”.

    Enacted provision · exact public law section
    (a) The provisions of H.R. 5426 of the 106th Congress, as introduced on October 6, 2000, are hereby enacted into law.

25. 2000

    Pub. L. 106–387 § 1(a)(tVII)(s746)(c) · 114 Stat. 1549

    Added · 21 U.S.C. § 381(g)

    Pub. L. 106–387, § 1(a) [title VII, § 746(c)], added subsec. (g)

    Source evidence

    Code amendment note
    Subsec. (g). Pub. L. 106–387, § 1(a) [title VII, § 746(c)], added subsec. (g).

    Enacted provision · exact public law section
    (a) The provisions of H.R. 5426 of the 106th Congress, as introduced on October 6, 2000, are hereby enacted into law.

26. 2002

    Public Health Security and Bioterrorism Preparedness and Response Act of 2002”

    Pub. L. 107–188 § 322(a) · 116 Stat. 594

    Amended · 21 U.S.C. § 381(d)(3)

    Pub. L. 107–188, § 322(a), amended par. (3) generally. Prior to amendment, par. (3) read as follows: “No component of a drug, no component part or accessory of a device, or other article of device requiring further processing, which is ready or suitable for use for health-related purposes, and no food additive, color additive, or dietary supplement, including a product in bulk form, shall be excluded from importation into the United States under subsection (a) of this section if—

    Source evidence

    Code amendment note
    Subsec. (d)(3). Pub. L. 107–188, § 322(a), amended par. (3) generally. Prior to amendment, par. (3) read as follows: “No component of a drug, no component part or accessory of a device, or other article of device requiring further processing, which is ready or suitable for use for health-related purposes, and no food additive, color additive, or dietary supplement, including a product in bulk form, shall be excluded from importation into the United States under subsection (a) of this section if—

    “(A) the importer of such article of a drug or device or importer of the food additive, color additive, or dietary supplement submits a statement to the Secretary, at the time of initial importation, that such article of a drug or device, food additive, color additive, or dietary supplement is intended to be further processed by the initial owner or consignee, or incorporated by the initial owner or consignee into a drug, biological product, device, food, food additive, color additive, or dietary supplement that will be exported by such owner or consignee from the United States in accordance with subsection (e) of this section or section 382 of this title or section 262(h) of title 42; “(B) the initial owner or consignee responsible for such imported article maintains records that identify the use of such imported article and upon request of the Secretary submits a report that provides an accounting of the exportation or the disposition of the imported article, including portions that have been destroyed, and the manner in which such person complied with the requirements of this paragraph; and “(C) any imported component, part, article, or accessory of a drug or device and any food additive, color additive, or dietary supplement not incorporated or further processed as described in subparagraph (A) is destroyed or exported by the owner or consignee.”

    Enacted provision · exact public law section
    (a) In General.— Section 801(d)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(d)(3)) is amended to read as follows: “(3) (A) Subject to subparagraph (B), no component of a drug, no component part or accessory of a device, or other article of device requiring further processing, which is ready or suitable for use for health-related purposes, and no article of a food additive, color additive, or dietary supplement, including a product in bulk form, shall be excluded from importation into the United States under subsection (a) if each of the following conditions is met: “(i) The importer of such article of a drug or device or importer of such article of a food additive, color additive, or dietary supplement submits to the Secretary, at the time of initial importation, a statement in accordance with the following: “(I) Such statement provides that such article is intended to be further processed by the initial owner or consignee, or incorporated by the initial owner or consignee, into a drug, biological product, device, food, food additive, color additive, or dietary supplement that will be exported by the initial owner or consignee from the United States in accordance with subsection (e) or section 802, or with section 351(h) of the Public Health Service Act. “(II) The statement identifies the manufacturer of such article and each processor, packer, distributor, or other entity that had possession of the article in the chain of possession of the article from the manufacturer to such importer of the article. “(III) The statement is accompanied by such certificates of analysis as are necessary to identify such article, unless the article is a device or is an article described in paragraph (4). “(ii) At the time of initial importation and before the delivery of such article to the importer or the initial owner or consignee, such owner or consignee executes a good and sufficient bond providing for the payment of such liquidated damages in the event of default as may be required pursuant to regulations of the Secretary of the Treasury. “(iii) Such article is used and exported by the initial owner or consignee in accordance with the intent described under clause (i)(I), except for any portions of the article that are destroyed. “(iv) The initial owner or consignee maintains records on Records. the use or destruction of such article or portions thereof, as the case may be, and submits to the Secretary any such records requested by the Secretary. “(v) Upon request of the Secretary, the initial owner or Reports. consignee submits a report that provides an accounting of the exportation or destruction of such article or portions thereof, and the manner in which such owner or consignee complied with the requirements of this subparagraph. “(B) Notwithstanding subparagraph (A), the Secretary may refuse admission to an article that otherwise would be imported into the United States under such subparagraph if the Secretary determines that there is credible evidence or information indicating that such article is not intended to be further processed by the initial owner or consignee, or incorporated by the initial owner or consignee, into a drug, biological product, device, food, food additive, color additive, or dietary supplement that will be exported by the initial owner or consignee from the United States in accordance with subsection (e) or section 802, or with section 351(h) of the Public Health Service Act. “(C) This section may not be construed as affecting the responsibility of the Secretary to ensure that articles imported into the United States under authority of subparagraph (A) meet each of the conditions established in such subparagraph for importation”.

27. 2002

    Public Health Security and Bioterrorism Preparedness and Response Act of 2002”

    Pub. L. 107–188 § 302(a) · 116 Stat. 594

    Added · 21 U.S.C. § 381(h)

    Pub. L. 107–188, § 302(a)–(c), added subsec. (h)

    Source evidence

    Code amendment note
    Subsec. (h). Pub. L. 107–188, § 302(a)–(c), added subsec. (h).

    Enacted provision · exact public law section
    (a) Increasing Inspections for Detection of Adulteration of Food.— Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended by adding at the end the following subsection: “(h) (1) The Secretary shall give high priority to increasing the number of inspections under this section for the purpose of enabling the Secretary to inspect food offered for import at ports of entry into the United States, with the greatest priority given to inspections to detect the intentional adulteration of food.”.

28. 2002

    Public Health Security and Bioterrorism Preparedness and Response Act of 2002”

    Pub. L. 107–188 § 302(d) · 116 Stat. 594

    Added · 21 U.S.C. § 381(i)

    Pub. L. 107–188, § 302(d), added subsec. (i)

    Source evidence

    Code amendment note
    Subsec. (i). Pub. L. 107–188, § 302(d), added subsec. (i).

    Enacted provision · exact public law section
    SEC. 302. PROTECTION AGAINST ADULTERATION OF FOOD. (a) Increasing Inspections for Detection of Adulteration of Food.— Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended by adding at the end the following subsection: “(h) (1) The Secretary shall give high priority to increasing the number of inspections under this section for the purpose of enabling the Secretary to inspect food offered for import at ports of entry into the United States, with the greatest priority given to inspections to detect the intentional adulteration of food.”. (b) Improvements to Information Management Systems.— Section 801(h) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a) of this section, is amended by adding at the end the following paragraph: “(2) The Secretary shall give high priority to making necessary improvements to the information management systems of the Food and Drug Administration that contain information related to foods imported or offered for import into the United States for purposes of improving the ability of the Secretary to allocate resources, detect the intentional adulteration of food, and facilitate the importation of food that is in compliance with this Act.”. (c) Linkages With Appropriate Public Entities.— Section 801(h) of the Federal Food, Drug, and Cosmetic Act, as amended by subsection (b) of this section, is amended by adding at the end the following paragraph: “(3) The Secretary shall improve linkages with other regulatory agencies of the Federal Government that share responsibility for food safety, and shall with respect to such safety improve linkages with the States and Indian tribes (as defined in section 4(e) of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 450b(e))).”. (b) Testing for Rapid Detection of Adulteration of Food.— Section 801 of the Federal Food, Drug, and Cosmetic Act, as amended by subsection (a) of this section, is amended by adding at the end the following: “(i) (1) For use in inspections of food under this section, the Secretary shall provide for research on the development of tests and sampling methodologies— “(A) whose purpose is to test food in order to rapidly detect the adulteration of the food, with the greatest priority given to detect the intentional adulteration of food; and “(B) whose results offer significant improvements over the available technology in terms of accuracy, timing, or costs. “(2) In providing for research under paragraph (1), the Secretary shall give priority to conducting research on the development of tests that are suitable for inspections of food at ports of entry into the United States. “(3) In providing for research under paragraph (1), the Secretary shall as appropriate coordinate with the Director of the Centers for Disease Control and Prevention, the Director of the National Institutes of Health, the Administrator of the Environmental Protection Agency, and the Secretary of Agriculture. “(4) The Secretary shall annually submit to the Committee Reports. on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate, a report describing the progress made in research under paragraph (1), including progress regarding paragraph (2).”. (e) Assessment of Threat of Intentional Adulteration of Food.— The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall ensure that, not later than six months after the date of the enactment of this Act— (1) the assessment that (as of such date of enactment) is being conducted on the threat of the intentional adulteration of food is completed; and (2) a report describing the findings of the assessment is Reports. submitted to the Committee on Energy and Commerce of the House of Representatives and to the Committee on Health, Education, Labor, and Pensions of the Senate. (f) Authorization of Appropriations.— For the purpose of carrying out this section and the amendments made by this section, there are authorized to be appropriated $100,000,000 for fiscal year 2002, and such sums as may be necessary for each of the fiscal years 2003 through 2006, in addition to other authorizations of appropriations that are available for such purpose.

29. 2002

    Public Health Security and Bioterrorism Preparedness and Response Act of 2002”

    Pub. L. 107–188 § 303(c) · 116 Stat. 594

    Added · 21 U.S.C. § 381(j)

    Pub. L. 107–188, § 303(c), added subsec. (j)

    Source evidence

    Code amendment note
    Subsec. (j). Pub. L. 107–188, § 303(c), added subsec. (j).

    Enacted provision · exact public law section
    (c) Temporary Holds at Ports of Entry.— Section 801 of the Federal Food, Drug, and Cosmetic Act, as amended by section 302(d)of this Act, is amended by adding at the end the following: 21 USC 381. “(j) (1) If an officer or qualified employee of the Food and Drug Administration has credible evidence or information indicating that an article of food presents a threat of serious adverse health consequences or death to humans or animals, and such officer or qualified employee is unable to inspect, examine, or investigate such article upon the article being offered for import at a port of entry into the United States, the officer or qualified employee shall request the Secretary of Treasury to hold the food at the port of entry for a reasonable period of time, not to exceed 24 hours, for the purpose of enabling the Secretary to inspect, examine, or investigate the article as appropriate. “(2) The Secretary shall request the Secretary of Treasury to remove an article held pursuant to paragraph (1) to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be. Subsection (b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. “(3) An officer or qualified employee of the Food and Drug Administration may make a request under paragraph (1) only if the Secretary or an official designated by the Secretary approves the request. An official may not be so designated unless the official is the director of the district under this Act in which the article involved is located, or is an official senior to such director. “(4) With respect to an article of food for which a request under paragraph (1) is made, the Secretary, promptly after the request is made, shall notify the State in which the port of entry involved is located that the request has been made, and as applicable, that such article is being held under this subsection.”.

30. 2002

    Public Health Security and Bioterrorism Preparedness and Response Act of 2002”

    Pub. L. 107–188 § 304(e) · 116 Stat. 594

    Added · 21 U.S.C. § 381(k)

    Pub. L. 107–188, § 304(e), added subsec. (k)

    Source evidence

    Code amendment note
    Subsec. (k). Pub. L. 107–188, § 304(e), added subsec. (k).

    Enacted provision · exact public law section
    (e) Importation by Debarred Persons.— Section 801 of the Federal Food, Drug, and Cosmetic Act, as amended by section 303(c) of this Act, is amended by adding at the end the following 21 USC 381. subsection: “(k) (1) If an article of food is being imported or offered for import into the United States, and the importer, owner, or consignee of the article is a person who has been debarred under section 306(b)(3), such article shall be held at the port of entry for the article, and may not be delivered to such person. Subsection (b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. The article shall be removed to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be. “(2) An article of food held under paragraph (1) may be delivered to a person who is not a debarred person under section 306(b)(3) if such person affirmatively establishes, at the expense of the person, that the article complies with the requirements of this Act, as determined by the Secretary.”.

31. 2002

    Public Health Security and Bioterrorism Preparedness and Response Act of 2002”

    Pub. L. 107–188 § 305(c) · 116 Stat. 594

    Added · 21 U.S.C. § 381(l)

    Pub. L. 107–188, § 305(c), added subsec. (l)

    Source evidence

    Code amendment note
    Subsec. (l). Pub. L. 107–188, § 305(c), added subsec. (l).

    Enacted provision · exact public law section
    (c) Importation; Failure to Register.— Section 801 of the Federal Food, Drug, and Cosmetic Act, as amended by section 21 USC 381. 304(e) of this Act, is amended by adding at the end the following subsection: “(l) (1) If an article of food is being imported or offered for import into the United States, and such article is from a foreign facility for which a registration has not been submitted to the Secretary under section 415, such article shall be held at the port of entry for the article, and may not be delivered to the importer, owner, or consignee of the article, until the foreign facility is so registered. Subsection (b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. The article shall be removed to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be.”.

32. 2002

    Public Health Security and Bioterrorism Preparedness and Response Act of 2002”

    Pub. L. 107–188 § 307(a) · 116 Stat. 594

    Added · 21 U.S.C. § 381(m)

    Pub. L. 107–188, § 307(a), added subsec. (m)

    Source evidence

    Code amendment note
    Subsec. (m). Pub. L. 107–188, § 307(a), added subsec. (m).

    Enacted provision · exact public law section
    (a) In General.— Section 801 of the Federal Food, Drug, and Cosmetic Act, as amended by section 305(c) of this Act, is amended by adding at the end the following subsection: “(m) (1) In the case of an article of food that is being imported or offered for import into the United States, the Secretary, after consultation with the Secretary of the Treasury, shall by regulation require, for the purpose of enabling such article to be inspected at ports of entry into the United States, the submission to the Secretary of a notice providing the identity of each of the following: The article; the manufacturer and shipper of the article; if known within the specified period of time that notice is required to be provided, the grower of the article; the country from which the article originates; the country from which the article is shipped; and the anticipated port of entry for the article. An article of food imported or offered for import without submission of such notice in accordance with the requirements under this paragraph shall be refused admission into the United States. Nothing in this section may be construed as a limitation on the port of entry for an article of food. “(2) (A) Regulations under paragraph (1) shall require that a notice under such paragraph be provided by a specified period of time in advance of the time of the importation of the article of food involved or the offering of the food for import, which period shall be no less than the minimum amount of time necessary for the Secretary to receive, review, and appropriately respond to such notification, but may not exceed five days. In determining the specified period of time required under this subparagraph, the Secretary may consider, but is not limited to consideration of, the effect on commerce of such period of time, the locations of the various ports of entry into the United States, the various modes of transportation, the types of food imported into the United States, and any other such consideration. Nothing in the preceding sentence may be construed as a limitation on the obligation of the Secretary to receive, review, and appropriately respond to any notice under paragraph (1). “(B) (i) If an article of food is being imported or offered for import into the United States and a notice under paragraph (1) is not provided in advance in accordance with the requirements under paragraph (1), such article shall be held at the port of entry for the article, and may not be delivered to the importer, owner, or consignee of the article, until such notice is submitted to the Secretary, and the Secretary examines the notice and determines that the notice is in accordance with the requirements under paragraph (1). Subsection (b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. The article shall be removed to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be. “(ii) In carrying out clause (i) with respect to an article of food, the Secretary shall determine whether there is in the possession of the Secretary any credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to humans or animals. “(3) (A) This subsection may not be construed as limiting the authority of the Secretary to obtain information under any other provision of this Act. “(B) This subsection may not be construed as authorizing the Secretary to impose any requirements with respect to a food to the extent that it is within the exclusive jurisdiction of the Secretary of Agriculture pursuant to the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).”.

33. 2002

    Public Health Security and Bioterrorism Preparedness and Response Act of 2002”

    Pub. L. 107–188 § 308(a) · 116 Stat. 594

    Added · 21 U.S.C. § 381(n)

    Pub. L. 107–188, § 308(a), added subsec. (n)

    Source evidence

    Code amendment note
    Subsec. (n). Pub. L. 107–188, § 308(a), added subsec. (n).

    Enacted provision · exact public law section
    (a) In General.— Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)), as amended by section 307(a) of this Act, is amended by adding at the end the following: “(n) (1) If a food has been refused admission under subsection (a), other than such a food that is required to be destroyed, the Secretary may require the owner or consignee of the food to affix to the container of the food a label that clearly and conspicuously bears the statement: ‘UNITED STATES: REFUSED ENTRY’. “(2) All expenses in connection with affixing a label under paragraph (1) shall be paid by the owner or consignee of the food involved, and in default of such payment, shall constitute a lien against future importations made by such owner or consignee. “(3) A requirement under paragraph (1) remains in effect until the Secretary determines that the food involved has been brought into compliance with this Act.”.

34. 2002

    Public Health Security and Bioterrorism Preparedness and Response Act of 2002”

    Pub. L. 107–188 § 321(b)(1) · 116 Stat. 594

    Added · 21 U.S.C. § 381(o)

    Pub. L. 107–188, § 321(b)(1), added subsec. (o)

    Source evidence

    Code amendment note
    Subsec. (o). Pub. L. 107–188, § 321(b)(1), added subsec. (o).

    Enacted provision · exact public law section
    (1) In general.— Section 801 of the Federal Food, Drug, and Cosmetic Act, as amended by section 308(a) of this Act, is amended by adding at the end the following subsection: “(o) If an article that is a drug or device is being imported or offered for import into the United States, and the importer, owner, or consignee of such article does not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of each establishment that with respect to such article is required under such section to register with the Secretary, the article may be refused admission. If the article is refused admission for failure to submit such a statement, the article shall be held at the port of entry for the article, and may not be delivered to the importer, owner, or consignee of the article, until such a statement is submitted to the Secretary. Subsection (b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. The article shall be removed to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be.”.

35. 2006

    Dietary Supplement and Nonprescription Drug Consumer Protection Act

    Pub. L. 109–462 § 5(a)(1) · 120 Stat. 3469

    Inserted · 21 U.S.C. § 381(a)

    Pub. L. 109–462, § 5(a)(1), inserted after third sentence “If such article is subject to a requirement under section 379aa or 379aa–1 of this title and if the Secretary has credible evidence or information indicating that the responsible person (as defined in such section 379aa or 379aa–1 of this title) has not complied with a requirement of such section 379aa or 379aa–1 of this title with respect to any such article, or has not allowed access to records described in such section 379aa or 379aa–1 of this title, then such article shall be refused admission, except as provided in subsection (b) of this section.”

    Source evidence

    Code amendment note
    Subsec. (a). Pub. L. 109–462, § 5(a)(1), inserted after third sentence “If such article is subject to a requirement under section 379aa or 379aa–1 of this title and if the Secretary has credible evidence or information indicating that the responsible person (as defined in such section 379aa or 379aa–1 of this title) has not complied with a requirement of such section 379aa or 379aa–1 of this title with respect to any such article, or has not allowed access to records described in such section 379aa or 379aa–1 of this title, then such article shall be refused admission, except as provided in subsection (b) of this section.”

    Enacted provision · exact public law section
    (1) in subsection (a), by inserting after the third sentence the following: “If such article is subject to a requirement under section 760 or 761 and if the Secretary has credible evidence or information indicating that the responsible person (as defined in such section 760 or 761) has not complied with a requirement of such section 760 or 761 with respect to any such article, or has not allowed access to records described in such section 760 or 761, then such article shall be refused admission, except as provided in subsection (b) of this section.”; and

36. 2006

    Dietary Supplement and Nonprescription Drug Consumer Protection Act

    Pub. L. 109–462 § 5(a)(2) · 120 Stat. 3469

    Inserted · 21 U.S.C. § 381(b)

    Pub. L. 109–462, § 5(a)(2), in second sentence, inserted “(1)” before “an article included”, “or (2) with respect to an article included within the provision of the fourth sentence of subsection (a), the responsible person (as defined in section 379aa or 379aa–1 of this title) can take action that would assure that the responsible person is in compliance with section 379aa or 379aa–1 of this title, as the case may be,” before “final determination”, and “, or, with respect to clause (2), the responsible person,” before “to perform”

    Source evidence

    Code amendment note
    Subsec. (b). Pub. L. 109–462, § 5(a)(2), in second sentence, inserted “(1)” before “an article included”, “or (2) with respect to an article included within the provision of the fourth sentence of subsection (a), the responsible person (as defined in section 379aa or 379aa–1 of this title) can take action that would assure that the responsible person is in compliance with section 379aa or 379aa–1 of this title, as the case may be,” before “final determination”, and “, or, with respect to clause (2), the responsible person,” before “to perform”.

    Enacted provision · exact public law section
    (2) in the second sentence of subsection (b)— (A) by inserting “(1)” before “an article included”; (B) by inserting before “final determination” the following: “or (2) with respect to an article included within the provision of the fourth sentence of subsection (a), the responsible person (as defined in section 760 or 761) can take action that would assure that the responsible person is in compliance with section 760 or 761, as the case may be,”; and (C) by inserting “, or, with respect to clause (2), the responsible person,” before “to perform”.

37. 2007

    Food and Drug Administration Amendments Act of 2007

    Pub. L. 110–85 title IX § 912(b)(2) · 121 Stat. 823

    Substituted · 21 U.S.C. § 381(a)

    Pub. L. 110–85 substituted “is adulterated, misbranded, or in violation of section 355 of this title, or prohibited from introduction or delivery for introduction into interstate commerce under section 331(ll) of this title,” for “is adulterated, misbranded, or in violation of section 355 of this title,”

    Source evidence

    Code amendment note
    Subsec. (a). Pub. L. 110–85 substituted “is adulterated, misbranded, or in violation of section 355 of this title, or prohibited from introduction or delivery for introduction into interstate commerce under section 331(ll) of this title,” for “is adulterated, misbranded, or in violation of section 355 of this title,”.

    Enacted provision · exact public law section
    (2) 21 USC 381. in section 801(a), by striking “is adulterated, misbranded, or in violation of section 505,” and inserting “is adulterated, misbranded, or in violation of section 505, or prohibited from introduction or delivery for introduction into interstate commerce under section 301(ll),”.

38. 2009

    Family Smoking Prevention and Tobacco Control Act

    Pub. L. 111–31 § 103 · 123 Stat. 1776

    Substituted · 21 U.S.C. § 381(a)

    Pub. L. 111–31, § 103(l)(1)(C), which directed substitution of “drugs, devices, or tobacco products” for “drugs or devices” wherever appearing, was executed by making the substitution for “drugs and devices” in two places in second sentence, to reflect the probable intent of Congress

    Source evidence

    Code amendment note
    Subsec. (a). Pub. L. 111–31, § 103(l)(1)(C), which directed substitution of “drugs, devices, or tobacco products” for “drugs or devices” wherever appearing, was executed by making the substitution for “drugs and devices” in two places in second sentence, to reflect the probable intent of Congress.

    Enacted provision · exact public law section
    SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GENERAL PROVISIONS. (a) Amendment of Federal Food, Drug, and Cosmetic Act.— Except as otherwise expressly provided, whenever in this section an amendment is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference is to a section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). (b) Section 301.— Section 301 (21 U.S.C. 331) is amended— (1) in subsection (a), by inserting “tobacco product,” after “device,”; (2) in subsection (b), by inserting “tobacco product,” after “device,”; (3) in subsection (c), by inserting “tobacco product,” after “device,”; (4) in subsection (e)— (A) by striking the period after “572(i)”; and (B) by striking “or 761 or the refusal to permit access to” and inserting “761, 909, or 920 or the refusal to permit access to”; (5) in subsection (g), by inserting “tobacco product,” after “device,”; (6) in subsection (h), by inserting “tobacco product,” after “device,”; (7) in subsection (j)— (A) by striking the period after “573”; and (B) by striking “708, or 721” and inserting “708, 721, 904, 905, 906, 907, 908, 909, or 920(b)”; (8) in subsection (k), by inserting “tobacco product,” after “device,”; (9) by striking subsection (p) and inserting the following: “(p) The failure to register in accordance with section 510 or 905, the failure to provide any information required by section 510(j), 510(k), 905(i), or 905(j), or the failure to provide a notice required by section 510(j)(2) or 905(i)(3).” ; (10) by striking subsection (q)(1) and inserting the following: “(q) (1) The failure or refusal— “(A) to comply with any requirement prescribed under section 518, 520(g), 903(b), 907, 908, or 915; “(B) to furnish any notification or other material or information required by or under section 519, 520(g), 904, 909, or 920; or “(C) to comply with a requirement under section 522 or 913.” ; (11) in subsection (q)(2), by striking “device,” and inserting “device or tobacco product,”; (12) in subsection (r), by inserting “or tobacco product” after the term “device” each time that such term appears; and (13) by adding at the end the following: “(oo) The sale of tobacco products in violation of a no-tobacco-sale order issued under section 303(f). “(pp) The introduction or delivery for introduction into interstate commerce of a tobacco product in violation of section 911. “(qq) (1) Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp (including tax stamp), tag, label, or other identification device upon any tobacco product or container or labeling thereof so as to render such tobacco product a counterfeit tobacco product. “(2) Making, selling, disposing of, or keeping in possession, control, or custody, or concealing any punch, die, plate, stone, or other item that is designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing upon any tobacco product or container or labeling thereof so as to render such tobacco product a counterfeit tobacco product. “(3) The doing of any act that causes a tobacco product to be a counterfeit tobacco product, or the sale or dispensing, or the holding for sale or dispensing, of a counterfeit tobacco product. “(rr) The charitable distribution of tobacco products. “(ss) The failure of a manufacturer or distributor to notify the Attorney General and the Secretary of the Treasury of their knowledge of tobacco products used in illicit trade. “(tt) Making any express or implied statement or representation directed to consumers with respect to a tobacco product, in a label or labeling or through the media or advertising, that either conveys, or misleads or would mislead consumers into believing, that— “(1) the product is approved by the Food and Drug Administration; “(2) the Food and Drug Administration deems the product to be safe for use by consumers; “(3) the product is endorsed by the Food and Drug Administration for use by consumers; or “(4) the product is safe or less harmful by virtue of— “(A) its regulation or inspection by the Food and Drug Administration; or “(B) its compliance with regulatory requirements set by the Food and Drug Administration; including any such statement or representation rendering the product misbranded under section 903.” . (c) Section 303.— Section 303(f) (21 U.S.C. 333(f)) is amended— (1) in paragraph (5)— (A) by striking “paragraph (1), (2), (3), or (4)” each place such appears and inserting “paragraph (1), (2), (3), (4), or (9)”; (B) in subparagraph (A)— (i) by striking “assessed” the first time it appears and inserting “assessed, or a no-tobacco-sale order may be imposed,”; and (ii) by striking “penalty” the second time it appears and inserting “penalty, or upon whom a no-tobacco-sale order is to be imposed,”; (C) in subparagraph (B)— (i) by inserting after “penalty,” the following: “or the period to be covered by a no-tobacco-sale order,”; and (ii) by adding at the end the following: “A no-tobacco-sale order permanently prohibiting an individual retail outlet from selling tobacco products shall include provisions that allow the outlet, after a specified period of time, to request that the Secretary compromise, modify, or terminate the order.”; and (D) by adding at the end the following: “(D) The Secretary may compromise, modify, or terminate, with or without conditions, any no-tobacco-sale order.” ; (2) in paragraph (6)— (A) by inserting “or the imposition of a no-tobacco-sale order” after the term “penalty” each place such term appears; and (B) by striking “issued.” and inserting “issued, or on which the no-tobacco-sale order was imposed, as the case may be.”; and (3) by adding at the end the following: “(8) If the Secretary finds that a person has committed repeated violations of restrictions promulgated under section 906(d) at a particular retail outlet then the Secretary may impose a no-tobacco-sale order on that person prohibiting the sale of tobacco products in that outlet. A no-tobacco-sale order may be imposed with a civil penalty under paragraph (1). Prior to the entry of a no-sale order under this paragraph, a person shall be entitled to a hearing pursuant to the procedures established through regulations of the Food and Drug Administration for assessing civil money penalties, including at a retailer’s request a hearing by telephone, or at the nearest regional or field office of the Food and Drug Administration, or at a Federal, State, or county facility within 100 miles from the location of the retail outlet, if such a facility is available. “(9) Civil Monetary Penalties for Violation of Tobacco Product Requirements.— “(A) In general.— Subject to subparagraph (B), any person who violates a requirement of this Act which relates to tobacco products shall be liable to the United States for a civil penalty in an amount not to exceed $15,000 for each such violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding. “(B) Enhanced penalties.— “(i) Any person who intentionally violates a requirement of section 902(5), 902(6), 904, 908(c), or 911(a), shall be subject to a civil monetary penalty of— “(I) not to exceed $250,000 per violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding; or “(II) in Notice. the case of a violation that continues after the Secretary provides written notice to such person, $250,000 for the first 30-day period (or any portion thereof) that the person continues to be in violation, and such amount shall double for every 30-day period thereafter that the violation continues, not to exceed $1,000,000 for any 30-day period, and not to exceed $10,000,000 for all such violations adjudicated in a single proceeding. “(ii) Any person who violates a requirement of section 911(g)(2)(C)(ii) or 911(i)(1), shall be subject to a civil monetary penalty of— “(I) not to exceed $250,000 per violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding; or “(II) in Notice. the case of a violation that continues after the Secretary provides written notice to such person, $250,000 for the first 30-day period (or any portion thereof) that the person continues to be in violation, and such amount shall double for every 30-day period thereafter that the violation continues, not to exceed $1,000,000 for any 30-day period, and not to exceed $10,000,000 for all such violations adjudicated in a single proceeding. “(iii) In determining the amount of a civil penalty under clause (i)(II) or (ii)(II), the Secretary shall take into consideration whether the person is making efforts toward correcting the violation of the requirements of the section for which such person is subject to such civil penalty.” . (d) Section 304.— Section 304 (21 U.S.C. 334) is amended— (1) in subsection (a)(2)— (A) by striking “and” before “(D)”; and (B) by striking “device.” and inserting the following: “device, and (E) Any adulterated or misbranded tobacco product.”; (2) in subsection (d)(1), by inserting “tobacco product,” after “device,”; (3) in subsection (g)(1), by inserting “or tobacco product” after the term “device” each place such term appears; and (4) in subsection (g)(2)(A), by inserting “or tobacco product” after “device”. (e) Section 505.— Section 505(n)(2) (21 U.S.C. 355(n)(2)) is amended by striking “section 904” and inserting “section 1004”. (f) Section 523.— Section 523(b)(2)(D) (21 U.S.C. 360m(b)(2)(D)) is amended by striking “section 903(g)” and inserting “section 1003(g)”. (g) Section 702.— Section 702(a)(1) (U.S.C. 372(a)(1)) 21 USC 372. is amended— (1) by striking “(a)(1)” and inserting “(a)(1)(A)”; and (2) by adding at the end the following: “(B) (i) For Contracts. Inter- governmental relations. a tobacco product, to the extent feasible, the Secretary shall contract with the States in accordance with this paragraph to carry out inspections of retailers within that State in connection with the enforcement of this Act. “(ii) The Secretary shall not enter into any contract under clause (i) with the government of any of the several States to exercise enforcement authority under this Act on Indian country without the express written consent of the Indian tribe involved.” . (h) Section 703.— Section 703 (21 U.S.C. 373) is amended— (1) by inserting “tobacco product,” after the term “device,” each place such term appears; and (2) by inserting “tobacco products,” after the term “devices,” each place such term appears. (i) Section 704.— Section 704 (21 U.S.C. 374) is amended— (1) in subsection (a)(1)— (A) by striking “devices, or cosmetics” each place it appears and inserting “devices, tobacco products, or cosmetics”; (B) by striking “or restricted devices” each place it appears and inserting “restricted devices, or tobacco products”; and (C) by striking “and devices and subject to” and all that follows through “other drugs or devices” and inserting “devices, and tobacco products and subject to reporting and inspection under regulations lawfully issued pursuant to section 505 (i) or (k), section 519, section 520(g), or chapter IX and data relating to other drugs, devices, or tobacco products”; (2) in subsection (b), by inserting “tobacco product,” after “device,”; and (3) in subsection (g)(13), by striking “section 903(g)” and inserting “section 1003(g)”. (j) Section 705.— Section 705(b) (21 U.S.C. 375(b)) is amended by inserting “tobacco products,” after “devices,”. (k) Section 709.— Section 709 (21 U.S.C. 379a) is amended by inserting “tobacco product,” after “device,”. (l) Section 801.— Section 801 (21 U.S.C. 381) is amended— (1) in subsection (a)— (A) by inserting “tobacco products,” after the term “devices,”; (B) by inserting “or section 905(h)” after “section 510”; and (C) by striking the term “drugs or devices” each time such term appears and inserting “drugs, devices, or tobacco products”; (2) in subsection (e)(1)— (A) by inserting “tobacco product” after “drug, device,”; and (B) by inserting “, and a tobacco product intended for export shall not be deemed to be in violation of section 906(e), 907, 911, or 920(a),” before “if it—”; and (3) by adding at the end the following: “(p) (1) Not Deadline. Reports. later than 36 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, and annually thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report regarding— “(A) the nature, extent, and destination of United States tobacco product exports that do not conform to tobacco product standards established pursuant to this Act; “(B) the public health implications of such exports, including any evidence of a negative public health impact; and “(C) recommendations or assessments of policy alternatives available to Congress and the executive branch to reduce any negative public health impact caused by such exports. “(2) The Requirements. Secretary is authorized to establish appropriate information disclosure requirements to carry out this subsection.” . (m) Section 1003.— Section 1003(d)(2)(C) (as redesignated by section 101(b)) 21 USC 393. is amended— (1) by striking “and” after “cosmetics,”; and (2) inserting “, and tobacco products” after “devices”. (n) Section 1009.— Section 1009(b) (as redesignated by section 101(b)) is 21 USC 399. amended by striking “section 908” and inserting “section 1008”. (o) Section 409 of the Federal Meat Inspection Act.— Section 409(a) of the Federal Meat Inspection Act (21 U.S.C. 679(a)) is amended by striking “section 902(b)” and inserting “section 1002(b)”. (p) Rule of Construction.— Nothing in this section is intended or shall be construed to expand, contract, or otherwise modify or amend the existing limitations on State government authority over tribal restricted fee or trust lands. (q) Guidance and Effective Dates.— (1) In general.— The Secretary of Health and Human Services shall issue guidance— (A) defining the term “repeated violation”, as used in section 303(f)(8) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(8)) as amended by subsection (c), as including at least 5 violations of particular requirements over a 36-month period at a particular retail outlet that constitute a repeated violation and providing for civil penalties in accordance with paragraph (2); (B) providing for timely and effective notice by certified or registered mail or personal delivery to the retailer of each alleged violation at a particular retail outlet prior to conducting a followup compliance check, such notice to be sent to the location specified on the retailer’s registration or to the retailer’s registered agent if the retailer has provider such agent information to the Food and Drug Administration prior to the violation; (C) providing for a hearing pursuant to the procedures established through regulations of the Food and Drug Administration for assessing civil money penalties, including at a retailer’s request a hearing by telephone or at the nearest regional or field office of the Food and Drug Administration, and providing for an expedited procedure for the administrative appeal of an alleged violation; (D) providing that a person may not be charged with a violation at a particular retail outlet unless the Secretary has provided notice to the retailer of all previous violations at that outlet; (E) establishing that civil money penalties for multiple violations shall increase from one violation to the next violation pursuant to paragraph (2) within the time periods provided for in such paragraph; (F) providing that good faith reliance on the presentation of a false government-issued photographic identification that contains a date of birth does not constitute a violation of any minimum age requirement for the sale of tobacco products if the retailer has taken effective steps to prevent such violations, including— (i) adopting and enforcing a written policy against sales to minors; (ii) informing its employees of all applicable laws; (iii) establishing disciplinary sanctions for employee noncompliance; and (iv) requiring its employees to verify age by way of photographic identification or electronic scanning device; and (G) providing for the Secretary, in determining whether to impose a no-tobacco-sale order and in determining whether to compromise, modify, or terminate such an order, to consider whether the retailer has taken effective steps to prevent violations of the minimum age requirements for the sale of tobacco products, including the steps listed in subparagraph (F). (2) Penalties for violations.— (A) In general.— The amount of the civil penalty to be applied for violations of restrictions promulgated under section 906(d), as described in paragraph (1), shall be as follows: (i) With respect to a retailer with an approved training program, the amount of the civil penalty shall not exceed— (I) in the case of the first violation, $0.00 together with the issuance of a warning letter to the retailer; (II) in the case of a second violation within a 12-month period, $250; (III) in the case of a third violation within a 24-month period, $500; (IV) in the case of a fourth violation within a 24-month period, $2,000; (V) in the case of a fifth violation within a 36-month period, $5,000; and (VI) in the case of a sixth or subsequent violation within a 48-month period, $10,000 as determined by the Secretary on a case-by-case basis. (ii) With respect to a retailer that does not have an approved training program, the amount of the civil penalty shall not exceed— (I) in the case of the first violation, $250; (II) in the case of a second violation within a 12-month period, $500; (III) in the case of a third violation within a 24-month period, $1,000; (IV) in the case of a fourth violation within a 24-month period, $2,000; (V) in the case of a fifth violation within a 36-month period, $5,000; and (VI) in the case of a sixth or subsequent violation within a 48-month period, $10,000 as determined by the Secretary on a case-by-case basis. (B) Training program.— For purposes of subparagraph (A), the term “approved training program” means a training program that complies with standards developed by the Food and Drug Administration for such programs. (C) Consideration of state penalties.— The Secretary shall coordinate with the States in enforcing the provisions of this Act and, for purposes of mitigating a civil penalty to be applied for a violation by a retailer of any restriction promulgated under section 906(d), shall consider the amount of any penalties paid by the retailer to a State for the same violation. (3) General effective date.— The amendments made by paragraphs (2), (3), and (4) of subsection (c) shall take effect upon the issuance of guidance described in paragraph (1) of this subsection. (4) Special effective date.— The amendment made by subsection (c)(1) shall take effect on the date of enactment of this Act. (5) Package label requirements.— The package label requirements of paragraphs (3) and (4) of section 903(a) of the Federal Food, Drug, and Cosmetic Act (as amended by this division) shall take effect on the date that is 12 months after the date of enactment of this Act. The package label requirements of paragraph (2) of such section 903(a) for cigarettes shall take effect on the date that is 15 months after the issuance of the regulations required by section 4(d) of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333), as amended by section 201 of this division. The package label requirements of paragraph (2) of such section 903(a) for tobacco products other than cigarettes shall take effect on the date that is 12 months after the date of enactment of this Act. The effective date shall be with respect to the date of manufacture, provided that, in any case, beginning 30 days after such effective date, a manufacturer shall not introduce into the domestic commerce of the United States any product, irrespective of the date of manufacture, that is not in conformance with section 903(a) (2), (3), and (4) and section 920(a) of the Federal Food, Drug, and Cosmetic Act. (6) Advertising requirements.— The advertising requirements of section 903(a)(8) of the Federal Food, Drug, and Cosmetic Act (as amended by this division) shall take effect on the date that is 12 months after the date of enactment of this Act.

39. 2009

    Family Smoking Prevention and Tobacco Control Act

    Pub. L. 111–31 § 103 · 123 Stat. 1776

    Inserted · 21 U.S.C. § 381(a)

    Pub. L. 111–31, § 103(l)(1)(A), (B), inserted “tobacco products,” after “devices,” in first sentence and “or section 387e(h)” after “section 360” in second sentence

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 111–31, § 103(l)(1)(A), (B), inserted “tobacco products,” after “devices,” in first sentence and “or section 387e(h)” after “section 360” in second sentence.

    Enacted provision · exact public law section
    SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GENERAL PROVISIONS. (a) Amendment of Federal Food, Drug, and Cosmetic Act.— Except as otherwise expressly provided, whenever in this section an amendment is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference is to a section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). (b) Section 301.— Section 301 (21 U.S.C. 331) is amended— (1) in subsection (a), by inserting “tobacco product,” after “device,”; (2) in subsection (b), by inserting “tobacco product,” after “device,”; (3) in subsection (c), by inserting “tobacco product,” after “device,”; (4) in subsection (e)— (A) by striking the period after “572(i)”; and (B) by striking “or 761 or the refusal to permit access to” and inserting “761, 909, or 920 or the refusal to permit access to”; (5) in subsection (g), by inserting “tobacco product,” after “device,”; (6) in subsection (h), by inserting “tobacco product,” after “device,”; (7) in subsection (j)— (A) by striking the period after “573”; and (B) by striking “708, or 721” and inserting “708, 721, 904, 905, 906, 907, 908, 909, or 920(b)”; (8) in subsection (k), by inserting “tobacco product,” after “device,”; (9) by striking subsection (p) and inserting the following: “(p) The failure to register in accordance with section 510 or 905, the failure to provide any information required by section 510(j), 510(k), 905(i), or 905(j), or the failure to provide a notice required by section 510(j)(2) or 905(i)(3).” ; (10) by striking subsection (q)(1) and inserting the following: “(q) (1) The failure or refusal— “(A) to comply with any requirement prescribed under section 518, 520(g), 903(b), 907, 908, or 915; “(B) to furnish any notification or other material or information required by or under section 519, 520(g), 904, 909, or 920; or “(C) to comply with a requirement under section 522 or 913.” ; (11) in subsection (q)(2), by striking “device,” and inserting “device or tobacco product,”; (12) in subsection (r), by inserting “or tobacco product” after the term “device” each time that such term appears; and (13) by adding at the end the following: “(oo) The sale of tobacco products in violation of a no-tobacco-sale order issued under section 303(f). “(pp) The introduction or delivery for introduction into interstate commerce of a tobacco product in violation of section 911. “(qq) (1) Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp (including tax stamp), tag, label, or other identification device upon any tobacco product or container or labeling thereof so as to render such tobacco product a counterfeit tobacco product. “(2) Making, selling, disposing of, or keeping in possession, control, or custody, or concealing any punch, die, plate, stone, or other item that is designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing upon any tobacco product or container or labeling thereof so as to render such tobacco product a counterfeit tobacco product. “(3) The doing of any act that causes a tobacco product to be a counterfeit tobacco product, or the sale or dispensing, or the holding for sale or dispensing, of a counterfeit tobacco product. “(rr) The charitable distribution of tobacco products. “(ss) The failure of a manufacturer or distributor to notify the Attorney General and the Secretary of the Treasury of their knowledge of tobacco products used in illicit trade. “(tt) Making any express or implied statement or representation directed to consumers with respect to a tobacco product, in a label or labeling or through the media or advertising, that either conveys, or misleads or would mislead consumers into believing, that— “(1) the product is approved by the Food and Drug Administration; “(2) the Food and Drug Administration deems the product to be safe for use by consumers; “(3) the product is endorsed by the Food and Drug Administration for use by consumers; or “(4) the product is safe or less harmful by virtue of— “(A) its regulation or inspection by the Food and Drug Administration; or “(B) its compliance with regulatory requirements set by the Food and Drug Administration; including any such statement or representation rendering the product misbranded under section 903.” . (c) Section 303.— Section 303(f) (21 U.S.C. 333(f)) is amended— (1) in paragraph (5)— (A) by striking “paragraph (1), (2), (3), or (4)” each place such appears and inserting “paragraph (1), (2), (3), (4), or (9)”; (B) in subparagraph (A)— (i) by striking “assessed” the first time it appears and inserting “assessed, or a no-tobacco-sale order may be imposed,”; and (ii) by striking “penalty” the second time it appears and inserting “penalty, or upon whom a no-tobacco-sale order is to be imposed,”; (C) in subparagraph (B)— (i) by inserting after “penalty,” the following: “or the period to be covered by a no-tobacco-sale order,”; and (ii) by adding at the end the following: “A no-tobacco-sale order permanently prohibiting an individual retail outlet from selling tobacco products shall include provisions that allow the outlet, after a specified period of time, to request that the Secretary compromise, modify, or terminate the order.”; and (D) by adding at the end the following: “(D) The Secretary may compromise, modify, or terminate, with or without conditions, any no-tobacco-sale order.” ; (2) in paragraph (6)— (A) by inserting “or the imposition of a no-tobacco-sale order” after the term “penalty” each place such term appears; and (B) by striking “issued.” and inserting “issued, or on which the no-tobacco-sale order was imposed, as the case may be.”; and (3) by adding at the end the following: “(8) If the Secretary finds that a person has committed repeated violations of restrictions promulgated under section 906(d) at a particular retail outlet then the Secretary may impose a no-tobacco-sale order on that person prohibiting the sale of tobacco products in that outlet. A no-tobacco-sale order may be imposed with a civil penalty under paragraph (1). Prior to the entry of a no-sale order under this paragraph, a person shall be entitled to a hearing pursuant to the procedures established through regulations of the Food and Drug Administration for assessing civil money penalties, including at a retailer’s request a hearing by telephone, or at the nearest regional or field office of the Food and Drug Administration, or at a Federal, State, or county facility within 100 miles from the location of the retail outlet, if such a facility is available. “(9) Civil Monetary Penalties for Violation of Tobacco Product Requirements.— “(A) In general.— Subject to subparagraph (B), any person who violates a requirement of this Act which relates to tobacco products shall be liable to the United States for a civil penalty in an amount not to exceed $15,000 for each such violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding. “(B) Enhanced penalties.— “(i) Any person who intentionally violates a requirement of section 902(5), 902(6), 904, 908(c), or 911(a), shall be subject to a civil monetary penalty of— “(I) not to exceed $250,000 per violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding; or “(II) in Notice. the case of a violation that continues after the Secretary provides written notice to such person, $250,000 for the first 30-day period (or any portion thereof) that the person continues to be in violation, and such amount shall double for every 30-day period thereafter that the violation continues, not to exceed $1,000,000 for any 30-day period, and not to exceed $10,000,000 for all such violations adjudicated in a single proceeding. “(ii) Any person who violates a requirement of section 911(g)(2)(C)(ii) or 911(i)(1), shall be subject to a civil monetary penalty of— “(I) not to exceed $250,000 per violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding; or “(II) in Notice. the case of a violation that continues after the Secretary provides written notice to such person, $250,000 for the first 30-day period (or any portion thereof) that the person continues to be in violation, and such amount shall double for every 30-day period thereafter that the violation continues, not to exceed $1,000,000 for any 30-day period, and not to exceed $10,000,000 for all such violations adjudicated in a single proceeding. “(iii) In determining the amount of a civil penalty under clause (i)(II) or (ii)(II), the Secretary shall take into consideration whether the person is making efforts toward correcting the violation of the requirements of the section for which such person is subject to such civil penalty.” . (d) Section 304.— Section 304 (21 U.S.C. 334) is amended— (1) in subsection (a)(2)— (A) by striking “and” before “(D)”; and (B) by striking “device.” and inserting the following: “device, and (E) Any adulterated or misbranded tobacco product.”; (2) in subsection (d)(1), by inserting “tobacco product,” after “device,”; (3) in subsection (g)(1), by inserting “or tobacco product” after the term “device” each place such term appears; and (4) in subsection (g)(2)(A), by inserting “or tobacco product” after “device”. (e) Section 505.— Section 505(n)(2) (21 U.S.C. 355(n)(2)) is amended by striking “section 904” and inserting “section 1004”. (f) Section 523.— Section 523(b)(2)(D) (21 U.S.C. 360m(b)(2)(D)) is amended by striking “section 903(g)” and inserting “section 1003(g)”. (g) Section 702.— Section 702(a)(1) (U.S.C. 372(a)(1)) 21 USC 372. is amended— (1) by striking “(a)(1)” and inserting “(a)(1)(A)”; and (2) by adding at the end the following: “(B) (i) For Contracts. Inter- governmental relations. a tobacco product, to the extent feasible, the Secretary shall contract with the States in accordance with this paragraph to carry out inspections of retailers within that State in connection with the enforcement of this Act. “(ii) The Secretary shall not enter into any contract under clause (i) with the government of any of the several States to exercise enforcement authority under this Act on Indian country without the express written consent of the Indian tribe involved.” . (h) Section 703.— Section 703 (21 U.S.C. 373) is amended— (1) by inserting “tobacco product,” after the term “device,” each place such term appears; and (2) by inserting “tobacco products,” after the term “devices,” each place such term appears. (i) Section 704.— Section 704 (21 U.S.C. 374) is amended— (1) in subsection (a)(1)— (A) by striking “devices, or cosmetics” each place it appears and inserting “devices, tobacco products, or cosmetics”; (B) by striking “or restricted devices” each place it appears and inserting “restricted devices, or tobacco products”; and (C) by striking “and devices and subject to” and all that follows through “other drugs or devices” and inserting “devices, and tobacco products and subject to reporting and inspection under regulations lawfully issued pursuant to section 505 (i) or (k), section 519, section 520(g), or chapter IX and data relating to other drugs, devices, or tobacco products”; (2) in subsection (b), by inserting “tobacco product,” after “device,”; and (3) in subsection (g)(13), by striking “section 903(g)” and inserting “section 1003(g)”. (j) Section 705.— Section 705(b) (21 U.S.C. 375(b)) is amended by inserting “tobacco products,” after “devices,”. (k) Section 709.— Section 709 (21 U.S.C. 379a) is amended by inserting “tobacco product,” after “device,”. (l) Section 801.— Section 801 (21 U.S.C. 381) is amended— (1) in subsection (a)— (A) by inserting “tobacco products,” after the term “devices,”; (B) by inserting “or section 905(h)” after “section 510”; and (C) by striking the term “drugs or devices” each time such term appears and inserting “drugs, devices, or tobacco products”; (2) in subsection (e)(1)— (A) by inserting “tobacco product” after “drug, device,”; and (B) by inserting “, and a tobacco product intended for export shall not be deemed to be in violation of section 906(e), 907, 911, or 920(a),” before “if it—”; and (3) by adding at the end the following: “(p) (1) Not Deadline. Reports. later than 36 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, and annually thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report regarding— “(A) the nature, extent, and destination of United States tobacco product exports that do not conform to tobacco product standards established pursuant to this Act; “(B) the public health implications of such exports, including any evidence of a negative public health impact; and “(C) recommendations or assessments of policy alternatives available to Congress and the executive branch to reduce any negative public health impact caused by such exports. “(2) The Requirements. Secretary is authorized to establish appropriate information disclosure requirements to carry out this subsection.” . (m) Section 1003.— Section 1003(d)(2)(C) (as redesignated by section 101(b)) 21 USC 393. is amended— (1) by striking “and” after “cosmetics,”; and (2) inserting “, and tobacco products” after “devices”. (n) Section 1009.— Section 1009(b) (as redesignated by section 101(b)) is 21 USC 399. amended by striking “section 908” and inserting “section 1008”. (o) Section 409 of the Federal Meat Inspection Act.— Section 409(a) of the Federal Meat Inspection Act (21 U.S.C. 679(a)) is amended by striking “section 902(b)” and inserting “section 1002(b)”. (p) Rule of Construction.— Nothing in this section is intended or shall be construed to expand, contract, or otherwise modify or amend the existing limitations on State government authority over tribal restricted fee or trust lands. (q) Guidance and Effective Dates.— (1) In general.— The Secretary of Health and Human Services shall issue guidance— (A) defining the term “repeated violation”, as used in section 303(f)(8) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(8)) as amended by subsection (c), as including at least 5 violations of particular requirements over a 36-month period at a particular retail outlet that constitute a repeated violation and providing for civil penalties in accordance with paragraph (2); (B) providing for timely and effective notice by certified or registered mail or personal delivery to the retailer of each alleged violation at a particular retail outlet prior to conducting a followup compliance check, such notice to be sent to the location specified on the retailer’s registration or to the retailer’s registered agent if the retailer has provider such agent information to the Food and Drug Administration prior to the violation; (C) providing for a hearing pursuant to the procedures established through regulations of the Food and Drug Administration for assessing civil money penalties, including at a retailer’s request a hearing by telephone or at the nearest regional or field office of the Food and Drug Administration, and providing for an expedited procedure for the administrative appeal of an alleged violation; (D) providing that a person may not be charged with a violation at a particular retail outlet unless the Secretary has provided notice to the retailer of all previous violations at that outlet; (E) establishing that civil money penalties for multiple violations shall increase from one violation to the next violation pursuant to paragraph (2) within the time periods provided for in such paragraph; (F) providing that good faith reliance on the presentation of a false government-issued photographic identification that contains a date of birth does not constitute a violation of any minimum age requirement for the sale of tobacco products if the retailer has taken effective steps to prevent such violations, including— (i) adopting and enforcing a written policy against sales to minors; (ii) informing its employees of all applicable laws; (iii) establishing disciplinary sanctions for employee noncompliance; and (iv) requiring its employees to verify age by way of photographic identification or electronic scanning device; and (G) providing for the Secretary, in determining whether to impose a no-tobacco-sale order and in determining whether to compromise, modify, or terminate such an order, to consider whether the retailer has taken effective steps to prevent violations of the minimum age requirements for the sale of tobacco products, including the steps listed in subparagraph (F). (2) Penalties for violations.— (A) In general.— The amount of the civil penalty to be applied for violations of restrictions promulgated under section 906(d), as described in paragraph (1), shall be as follows: (i) With respect to a retailer with an approved training program, the amount of the civil penalty shall not exceed— (I) in the case of the first violation, $0.00 together with the issuance of a warning letter to the retailer; (II) in the case of a second violation within a 12-month period, $250; (III) in the case of a third violation within a 24-month period, $500; (IV) in the case of a fourth violation within a 24-month period, $2,000; (V) in the case of a fifth violation within a 36-month period, $5,000; and (VI) in the case of a sixth or subsequent violation within a 48-month period, $10,000 as determined by the Secretary on a case-by-case basis. (ii) With respect to a retailer that does not have an approved training program, the amount of the civil penalty shall not exceed— (I) in the case of the first violation, $250; (II) in the case of a second violation within a 12-month period, $500; (III) in the case of a third violation within a 24-month period, $1,000; (IV) in the case of a fourth violation within a 24-month period, $2,000; (V) in the case of a fifth violation within a 36-month period, $5,000; and (VI) in the case of a sixth or subsequent violation within a 48-month period, $10,000 as determined by the Secretary on a case-by-case basis. (B) Training program.— For purposes of subparagraph (A), the term “approved training program” means a training program that complies with standards developed by the Food and Drug Administration for such programs. (C) Consideration of state penalties.— The Secretary shall coordinate with the States in enforcing the provisions of this Act and, for purposes of mitigating a civil penalty to be applied for a violation by a retailer of any restriction promulgated under section 906(d), shall consider the amount of any penalties paid by the retailer to a State for the same violation. (3) General effective date.— The amendments made by paragraphs (2), (3), and (4) of subsection (c) shall take effect upon the issuance of guidance described in paragraph (1) of this subsection. (4) Special effective date.— The amendment made by subsection (c)(1) shall take effect on the date of enactment of this Act. (5) Package label requirements.— The package label requirements of paragraphs (3) and (4) of section 903(a) of the Federal Food, Drug, and Cosmetic Act (as amended by this division) shall take effect on the date that is 12 months after the date of enactment of this Act. The package label requirements of paragraph (2) of such section 903(a) for cigarettes shall take effect on the date that is 15 months after the issuance of the regulations required by section 4(d) of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333), as amended by section 201 of this division. The package label requirements of paragraph (2) of such section 903(a) for tobacco products other than cigarettes shall take effect on the date that is 12 months after the date of enactment of this Act. The effective date shall be with respect to the date of manufacture, provided that, in any case, beginning 30 days after such effective date, a manufacturer shall not introduce into the domestic commerce of the United States any product, irrespective of the date of manufacture, that is not in conformance with section 903(a) (2), (3), and (4) and section 920(a) of the Federal Food, Drug, and Cosmetic Act. (6) Advertising requirements.— The advertising requirements of section 903(a)(8) of the Federal Food, Drug, and Cosmetic Act (as amended by this division) shall take effect on the date that is 12 months after the date of enactment of this Act.

40. 2009

    Family Smoking Prevention and Tobacco Control Act

    Pub. L. 111–31 § 103 · 123 Stat. 1776

    Inserted · 21 U.S.C. § 381(e)(1)

    Pub. L. 111–31, § 103(l)(2), in introductory provisions, inserted “tobacco product” after “drug, device,” and “, and a tobacco product intended for export shall not be deemed to be in violation of section 387f(e), 387g, 387k, or 387t(a) of this title,” after “chapter”

    Source evidence

    Code amendment note
    Subsec. (e)(1). Pub. L. 111–31, § 103(l)(2), in introductory provisions, inserted “tobacco product” after “drug, device,” and “, and a tobacco product intended for export shall not be deemed to be in violation of section 387f(e), 387g, 387k, or 387t(a) of this title,” after “chapter”.

    Enacted provision · exact public law section
    SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GENERAL PROVISIONS. (a) Amendment of Federal Food, Drug, and Cosmetic Act.— Except as otherwise expressly provided, whenever in this section an amendment is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference is to a section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). (b) Section 301.— Section 301 (21 U.S.C. 331) is amended— (1) in subsection (a), by inserting “tobacco product,” after “device,”; (2) in subsection (b), by inserting “tobacco product,” after “device,”; (3) in subsection (c), by inserting “tobacco product,” after “device,”; (4) in subsection (e)— (A) by striking the period after “572(i)”; and (B) by striking “or 761 or the refusal to permit access to” and inserting “761, 909, or 920 or the refusal to permit access to”; (5) in subsection (g), by inserting “tobacco product,” after “device,”; (6) in subsection (h), by inserting “tobacco product,” after “device,”; (7) in subsection (j)— (A) by striking the period after “573”; and (B) by striking “708, or 721” and inserting “708, 721, 904, 905, 906, 907, 908, 909, or 920(b)”; (8) in subsection (k), by inserting “tobacco product,” after “device,”; (9) by striking subsection (p) and inserting the following: “(p) The failure to register in accordance with section 510 or 905, the failure to provide any information required by section 510(j), 510(k), 905(i), or 905(j), or the failure to provide a notice required by section 510(j)(2) or 905(i)(3).” ; (10) by striking subsection (q)(1) and inserting the following: “(q) (1) The failure or refusal— “(A) to comply with any requirement prescribed under section 518, 520(g), 903(b), 907, 908, or 915; “(B) to furnish any notification or other material or information required by or under section 519, 520(g), 904, 909, or 920; or “(C) to comply with a requirement under section 522 or 913.” ; (11) in subsection (q)(2), by striking “device,” and inserting “device or tobacco product,”; (12) in subsection (r), by inserting “or tobacco product” after the term “device” each time that such term appears; and (13) by adding at the end the following: “(oo) The sale of tobacco products in violation of a no-tobacco-sale order issued under section 303(f). “(pp) The introduction or delivery for introduction into interstate commerce of a tobacco product in violation of section 911. “(qq) (1) Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp (including tax stamp), tag, label, or other identification device upon any tobacco product or container or labeling thereof so as to render such tobacco product a counterfeit tobacco product. “(2) Making, selling, disposing of, or keeping in possession, control, or custody, or concealing any punch, die, plate, stone, or other item that is designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing upon any tobacco product or container or labeling thereof so as to render such tobacco product a counterfeit tobacco product. “(3) The doing of any act that causes a tobacco product to be a counterfeit tobacco product, or the sale or dispensing, or the holding for sale or dispensing, of a counterfeit tobacco product. “(rr) The charitable distribution of tobacco products. “(ss) The failure of a manufacturer or distributor to notify the Attorney General and the Secretary of the Treasury of their knowledge of tobacco products used in illicit trade. “(tt) Making any express or implied statement or representation directed to consumers with respect to a tobacco product, in a label or labeling or through the media or advertising, that either conveys, or misleads or would mislead consumers into believing, that— “(1) the product is approved by the Food and Drug Administration; “(2) the Food and Drug Administration deems the product to be safe for use by consumers; “(3) the product is endorsed by the Food and Drug Administration for use by consumers; or “(4) the product is safe or less harmful by virtue of— “(A) its regulation or inspection by the Food and Drug Administration; or “(B) its compliance with regulatory requirements set by the Food and Drug Administration; including any such statement or representation rendering the product misbranded under section 903.” . (c) Section 303.— Section 303(f) (21 U.S.C. 333(f)) is amended— (1) in paragraph (5)— (A) by striking “paragraph (1), (2), (3), or (4)” each place such appears and inserting “paragraph (1), (2), (3), (4), or (9)”; (B) in subparagraph (A)— (i) by striking “assessed” the first time it appears and inserting “assessed, or a no-tobacco-sale order may be imposed,”; and (ii) by striking “penalty” the second time it appears and inserting “penalty, or upon whom a no-tobacco-sale order is to be imposed,”; (C) in subparagraph (B)— (i) by inserting after “penalty,” the following: “or the period to be covered by a no-tobacco-sale order,”; and (ii) by adding at the end the following: “A no-tobacco-sale order permanently prohibiting an individual retail outlet from selling tobacco products shall include provisions that allow the outlet, after a specified period of time, to request that the Secretary compromise, modify, or terminate the order.”; and (D) by adding at the end the following: “(D) The Secretary may compromise, modify, or terminate, with or without conditions, any no-tobacco-sale order.” ; (2) in paragraph (6)— (A) by inserting “or the imposition of a no-tobacco-sale order” after the term “penalty” each place such term appears; and (B) by striking “issued.” and inserting “issued, or on which the no-tobacco-sale order was imposed, as the case may be.”; and (3) by adding at the end the following: “(8) If the Secretary finds that a person has committed repeated violations of restrictions promulgated under section 906(d) at a particular retail outlet then the Secretary may impose a no-tobacco-sale order on that person prohibiting the sale of tobacco products in that outlet. A no-tobacco-sale order may be imposed with a civil penalty under paragraph (1). Prior to the entry of a no-sale order under this paragraph, a person shall be entitled to a hearing pursuant to the procedures established through regulations of the Food and Drug Administration for assessing civil money penalties, including at a retailer’s request a hearing by telephone, or at the nearest regional or field office of the Food and Drug Administration, or at a Federal, State, or county facility within 100 miles from the location of the retail outlet, if such a facility is available. “(9) Civil Monetary Penalties for Violation of Tobacco Product Requirements.— “(A) In general.— Subject to subparagraph (B), any person who violates a requirement of this Act which relates to tobacco products shall be liable to the United States for a civil penalty in an amount not to exceed $15,000 for each such violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding. “(B) Enhanced penalties.— “(i) Any person who intentionally violates a requirement of section 902(5), 902(6), 904, 908(c), or 911(a), shall be subject to a civil monetary penalty of— “(I) not to exceed $250,000 per violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding; or “(II) in Notice. the case of a violation that continues after the Secretary provides written notice to such person, $250,000 for the first 30-day period (or any portion thereof) that the person continues to be in violation, and such amount shall double for every 30-day period thereafter that the violation continues, not to exceed $1,000,000 for any 30-day period, and not to exceed $10,000,000 for all such violations adjudicated in a single proceeding. “(ii) Any person who violates a requirement of section 911(g)(2)(C)(ii) or 911(i)(1), shall be subject to a civil monetary penalty of— “(I) not to exceed $250,000 per violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding; or “(II) in Notice. the case of a violation that continues after the Secretary provides written notice to such person, $250,000 for the first 30-day period (or any portion thereof) that the person continues to be in violation, and such amount shall double for every 30-day period thereafter that the violation continues, not to exceed $1,000,000 for any 30-day period, and not to exceed $10,000,000 for all such violations adjudicated in a single proceeding. “(iii) In determining the amount of a civil penalty under clause (i)(II) or (ii)(II), the Secretary shall take into consideration whether the person is making efforts toward correcting the violation of the requirements of the section for which such person is subject to such civil penalty.” . (d) Section 304.— Section 304 (21 U.S.C. 334) is amended— (1) in subsection (a)(2)— (A) by striking “and” before “(D)”; and (B) by striking “device.” and inserting the following: “device, and (E) Any adulterated or misbranded tobacco product.”; (2) in subsection (d)(1), by inserting “tobacco product,” after “device,”; (3) in subsection (g)(1), by inserting “or tobacco product” after the term “device” each place such term appears; and (4) in subsection (g)(2)(A), by inserting “or tobacco product” after “device”. (e) Section 505.— Section 505(n)(2) (21 U.S.C. 355(n)(2)) is amended by striking “section 904” and inserting “section 1004”. (f) Section 523.— Section 523(b)(2)(D) (21 U.S.C. 360m(b)(2)(D)) is amended by striking “section 903(g)” and inserting “section 1003(g)”. (g) Section 702.— Section 702(a)(1) (U.S.C. 372(a)(1)) 21 USC 372. is amended— (1) by striking “(a)(1)” and inserting “(a)(1)(A)”; and (2) by adding at the end the following: “(B) (i) For Contracts. Inter- governmental relations. a tobacco product, to the extent feasible, the Secretary shall contract with the States in accordance with this paragraph to carry out inspections of retailers within that State in connection with the enforcement of this Act. “(ii) The Secretary shall not enter into any contract under clause (i) with the government of any of the several States to exercise enforcement authority under this Act on Indian country without the express written consent of the Indian tribe involved.” . (h) Section 703.— Section 703 (21 U.S.C. 373) is amended— (1) by inserting “tobacco product,” after the term “device,” each place such term appears; and (2) by inserting “tobacco products,” after the term “devices,” each place such term appears. (i) Section 704.— Section 704 (21 U.S.C. 374) is amended— (1) in subsection (a)(1)— (A) by striking “devices, or cosmetics” each place it appears and inserting “devices, tobacco products, or cosmetics”; (B) by striking “or restricted devices” each place it appears and inserting “restricted devices, or tobacco products”; and (C) by striking “and devices and subject to” and all that follows through “other drugs or devices” and inserting “devices, and tobacco products and subject to reporting and inspection under regulations lawfully issued pursuant to section 505 (i) or (k), section 519, section 520(g), or chapter IX and data relating to other drugs, devices, or tobacco products”; (2) in subsection (b), by inserting “tobacco product,” after “device,”; and (3) in subsection (g)(13), by striking “section 903(g)” and inserting “section 1003(g)”. (j) Section 705.— Section 705(b) (21 U.S.C. 375(b)) is amended by inserting “tobacco products,” after “devices,”. (k) Section 709.— Section 709 (21 U.S.C. 379a) is amended by inserting “tobacco product,” after “device,”. (l) Section 801.— Section 801 (21 U.S.C. 381) is amended— (1) in subsection (a)— (A) by inserting “tobacco products,” after the term “devices,”; (B) by inserting “or section 905(h)” after “section 510”; and (C) by striking the term “drugs or devices” each time such term appears and inserting “drugs, devices, or tobacco products”; (2) in subsection (e)(1)— (A) by inserting “tobacco product” after “drug, device,”; and (B) by inserting “, and a tobacco product intended for export shall not be deemed to be in violation of section 906(e), 907, 911, or 920(a),” before “if it—”; and (3) by adding at the end the following: “(p) (1) Not Deadline. Reports. later than 36 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, and annually thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report regarding— “(A) the nature, extent, and destination of United States tobacco product exports that do not conform to tobacco product standards established pursuant to this Act; “(B) the public health implications of such exports, including any evidence of a negative public health impact; and “(C) recommendations or assessments of policy alternatives available to Congress and the executive branch to reduce any negative public health impact caused by such exports. “(2) The Requirements. Secretary is authorized to establish appropriate information disclosure requirements to carry out this subsection.” . (m) Section 1003.— Section 1003(d)(2)(C) (as redesignated by section 101(b)) 21 USC 393. is amended— (1) by striking “and” after “cosmetics,”; and (2) inserting “, and tobacco products” after “devices”. (n) Section 1009.— Section 1009(b) (as redesignated by section 101(b)) is 21 USC 399. amended by striking “section 908” and inserting “section 1008”. (o) Section 409 of the Federal Meat Inspection Act.— Section 409(a) of the Federal Meat Inspection Act (21 U.S.C. 679(a)) is amended by striking “section 902(b)” and inserting “section 1002(b)”. (p) Rule of Construction.— Nothing in this section is intended or shall be construed to expand, contract, or otherwise modify or amend the existing limitations on State government authority over tribal restricted fee or trust lands. (q) Guidance and Effective Dates.— (1) In general.— The Secretary of Health and Human Services shall issue guidance— (A) defining the term “repeated violation”, as used in section 303(f)(8) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(8)) as amended by subsection (c), as including at least 5 violations of particular requirements over a 36-month period at a particular retail outlet that constitute a repeated violation and providing for civil penalties in accordance with paragraph (2); (B) providing for timely and effective notice by certified or registered mail or personal delivery to the retailer of each alleged violation at a particular retail outlet prior to conducting a followup compliance check, such notice to be sent to the location specified on the retailer’s registration or to the retailer’s registered agent if the retailer has provider such agent information to the Food and Drug Administration prior to the violation; (C) providing for a hearing pursuant to the procedures established through regulations of the Food and Drug Administration for assessing civil money penalties, including at a retailer’s request a hearing by telephone or at the nearest regional or field office of the Food and Drug Administration, and providing for an expedited procedure for the administrative appeal of an alleged violation; (D) providing that a person may not be charged with a violation at a particular retail outlet unless the Secretary has provided notice to the retailer of all previous violations at that outlet; (E) establishing that civil money penalties for multiple violations shall increase from one violation to the next violation pursuant to paragraph (2) within the time periods provided for in such paragraph; (F) providing that good faith reliance on the presentation of a false government-issued photographic identification that contains a date of birth does not constitute a violation of any minimum age requirement for the sale of tobacco products if the retailer has taken effective steps to prevent such violations, including— (i) adopting and enforcing a written policy against sales to minors; (ii) informing its employees of all applicable laws; (iii) establishing disciplinary sanctions for employee noncompliance; and (iv) requiring its employees to verify age by way of photographic identification or electronic scanning device; and (G) providing for the Secretary, in determining whether to impose a no-tobacco-sale order and in determining whether to compromise, modify, or terminate such an order, to consider whether the retailer has taken effective steps to prevent violations of the minimum age requirements for the sale of tobacco products, including the steps listed in subparagraph (F). (2) Penalties for violations.— (A) In general.— The amount of the civil penalty to be applied for violations of restrictions promulgated under section 906(d), as described in paragraph (1), shall be as follows: (i) With respect to a retailer with an approved training program, the amount of the civil penalty shall not exceed— (I) in the case of the first violation, $0.00 together with the issuance of a warning letter to the retailer; (II) in the case of a second violation within a 12-month period, $250; (III) in the case of a third violation within a 24-month period, $500; (IV) in the case of a fourth violation within a 24-month period, $2,000; (V) in the case of a fifth violation within a 36-month period, $5,000; and (VI) in the case of a sixth or subsequent violation within a 48-month period, $10,000 as determined by the Secretary on a case-by-case basis. (ii) With respect to a retailer that does not have an approved training program, the amount of the civil penalty shall not exceed— (I) in the case of the first violation, $250; (II) in the case of a second violation within a 12-month period, $500; (III) in the case of a third violation within a 24-month period, $1,000; (IV) in the case of a fourth violation within a 24-month period, $2,000; (V) in the case of a fifth violation within a 36-month period, $5,000; and (VI) in the case of a sixth or subsequent violation within a 48-month period, $10,000 as determined by the Secretary on a case-by-case basis. (B) Training program.— For purposes of subparagraph (A), the term “approved training program” means a training program that complies with standards developed by the Food and Drug Administration for such programs. (C) Consideration of state penalties.— The Secretary shall coordinate with the States in enforcing the provisions of this Act and, for purposes of mitigating a civil penalty to be applied for a violation by a retailer of any restriction promulgated under section 906(d), shall consider the amount of any penalties paid by the retailer to a State for the same violation. (3) General effective date.— The amendments made by paragraphs (2), (3), and (4) of subsection (c) shall take effect upon the issuance of guidance described in paragraph (1) of this subsection. (4) Special effective date.— The amendment made by subsection (c)(1) shall take effect on the date of enactment of this Act. (5) Package label requirements.— The package label requirements of paragraphs (3) and (4) of section 903(a) of the Federal Food, Drug, and Cosmetic Act (as amended by this division) shall take effect on the date that is 12 months after the date of enactment of this Act. The package label requirements of paragraph (2) of such section 903(a) for cigarettes shall take effect on the date that is 15 months after the issuance of the regulations required by section 4(d) of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333), as amended by section 201 of this division. The package label requirements of paragraph (2) of such section 903(a) for tobacco products other than cigarettes shall take effect on the date that is 12 months after the date of enactment of this Act. The effective date shall be with respect to the date of manufacture, provided that, in any case, beginning 30 days after such effective date, a manufacturer shall not introduce into the domestic commerce of the United States any product, irrespective of the date of manufacture, that is not in conformance with section 903(a) (2), (3), and (4) and section 920(a) of the Federal Food, Drug, and Cosmetic Act. (6) Advertising requirements.— The advertising requirements of section 903(a)(8) of the Federal Food, Drug, and Cosmetic Act (as amended by this division) shall take effect on the date that is 12 months after the date of enactment of this Act.

41. 2009

    Family Smoking Prevention and Tobacco Control Act

    Pub. L. 111–31 § 103 · 123 Stat. 1776

    Added · 21 U.S.C. § 381(p)

    Pub. L. 111–31, § 103(l)(3), added subsec. (p)

    Source evidence

    Code amendment note
    Subsec. (p). Pub. L. 111–31, § 103(l)(3), added subsec. (p).

    Enacted provision · exact public law section
    SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GENERAL PROVISIONS. (a) Amendment of Federal Food, Drug, and Cosmetic Act.— Except as otherwise expressly provided, whenever in this section an amendment is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference is to a section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). (b) Section 301.— Section 301 (21 U.S.C. 331) is amended— (1) in subsection (a), by inserting “tobacco product,” after “device,”; (2) in subsection (b), by inserting “tobacco product,” after “device,”; (3) in subsection (c), by inserting “tobacco product,” after “device,”; (4) in subsection (e)— (A) by striking the period after “572(i)”; and (B) by striking “or 761 or the refusal to permit access to” and inserting “761, 909, or 920 or the refusal to permit access to”; (5) in subsection (g), by inserting “tobacco product,” after “device,”; (6) in subsection (h), by inserting “tobacco product,” after “device,”; (7) in subsection (j)— (A) by striking the period after “573”; and (B) by striking “708, or 721” and inserting “708, 721, 904, 905, 906, 907, 908, 909, or 920(b)”; (8) in subsection (k), by inserting “tobacco product,” after “device,”; (9) by striking subsection (p) and inserting the following: “(p) The failure to register in accordance with section 510 or 905, the failure to provide any information required by section 510(j), 510(k), 905(i), or 905(j), or the failure to provide a notice required by section 510(j)(2) or 905(i)(3).” ; (10) by striking subsection (q)(1) and inserting the following: “(q) (1) The failure or refusal— “(A) to comply with any requirement prescribed under section 518, 520(g), 903(b), 907, 908, or 915; “(B) to furnish any notification or other material or information required by or under section 519, 520(g), 904, 909, or 920; or “(C) to comply with a requirement under section 522 or 913.” ; (11) in subsection (q)(2), by striking “device,” and inserting “device or tobacco product,”; (12) in subsection (r), by inserting “or tobacco product” after the term “device” each time that such term appears; and (13) by adding at the end the following: “(oo) The sale of tobacco products in violation of a no-tobacco-sale order issued under section 303(f). “(pp) The introduction or delivery for introduction into interstate commerce of a tobacco product in violation of section 911. “(qq) (1) Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp (including tax stamp), tag, label, or other identification device upon any tobacco product or container or labeling thereof so as to render such tobacco product a counterfeit tobacco product. “(2) Making, selling, disposing of, or keeping in possession, control, or custody, or concealing any punch, die, plate, stone, or other item that is designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing upon any tobacco product or container or labeling thereof so as to render such tobacco product a counterfeit tobacco product. “(3) The doing of any act that causes a tobacco product to be a counterfeit tobacco product, or the sale or dispensing, or the holding for sale or dispensing, of a counterfeit tobacco product. “(rr) The charitable distribution of tobacco products. “(ss) The failure of a manufacturer or distributor to notify the Attorney General and the Secretary of the Treasury of their knowledge of tobacco products used in illicit trade. “(tt) Making any express or implied statement or representation directed to consumers with respect to a tobacco product, in a label or labeling or through the media or advertising, that either conveys, or misleads or would mislead consumers into believing, that— “(1) the product is approved by the Food and Drug Administration; “(2) the Food and Drug Administration deems the product to be safe for use by consumers; “(3) the product is endorsed by the Food and Drug Administration for use by consumers; or “(4) the product is safe or less harmful by virtue of— “(A) its regulation or inspection by the Food and Drug Administration; or “(B) its compliance with regulatory requirements set by the Food and Drug Administration; including any such statement or representation rendering the product misbranded under section 903.” . (c) Section 303.— Section 303(f) (21 U.S.C. 333(f)) is amended— (1) in paragraph (5)— (A) by striking “paragraph (1), (2), (3), or (4)” each place such appears and inserting “paragraph (1), (2), (3), (4), or (9)”; (B) in subparagraph (A)— (i) by striking “assessed” the first time it appears and inserting “assessed, or a no-tobacco-sale order may be imposed,”; and (ii) by striking “penalty” the second time it appears and inserting “penalty, or upon whom a no-tobacco-sale order is to be imposed,”; (C) in subparagraph (B)— (i) by inserting after “penalty,” the following: “or the period to be covered by a no-tobacco-sale order,”; and (ii) by adding at the end the following: “A no-tobacco-sale order permanently prohibiting an individual retail outlet from selling tobacco products shall include provisions that allow the outlet, after a specified period of time, to request that the Secretary compromise, modify, or terminate the order.”; and (D) by adding at the end the following: “(D) The Secretary may compromise, modify, or terminate, with or without conditions, any no-tobacco-sale order.” ; (2) in paragraph (6)— (A) by inserting “or the imposition of a no-tobacco-sale order” after the term “penalty” each place such term appears; and (B) by striking “issued.” and inserting “issued, or on which the no-tobacco-sale order was imposed, as the case may be.”; and (3) by adding at the end the following: “(8) If the Secretary finds that a person has committed repeated violations of restrictions promulgated under section 906(d) at a particular retail outlet then the Secretary may impose a no-tobacco-sale order on that person prohibiting the sale of tobacco products in that outlet. A no-tobacco-sale order may be imposed with a civil penalty under paragraph (1). Prior to the entry of a no-sale order under this paragraph, a person shall be entitled to a hearing pursuant to the procedures established through regulations of the Food and Drug Administration for assessing civil money penalties, including at a retailer’s request a hearing by telephone, or at the nearest regional or field office of the Food and Drug Administration, or at a Federal, State, or county facility within 100 miles from the location of the retail outlet, if such a facility is available. “(9) Civil Monetary Penalties for Violation of Tobacco Product Requirements.— “(A) In general.— Subject to subparagraph (B), any person who violates a requirement of this Act which relates to tobacco products shall be liable to the United States for a civil penalty in an amount not to exceed $15,000 for each such violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding. “(B) Enhanced penalties.— “(i) Any person who intentionally violates a requirement of section 902(5), 902(6), 904, 908(c), or 911(a), shall be subject to a civil monetary penalty of— “(I) not to exceed $250,000 per violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding; or “(II) in Notice. the case of a violation that continues after the Secretary provides written notice to such person, $250,000 for the first 30-day period (or any portion thereof) that the person continues to be in violation, and such amount shall double for every 30-day period thereafter that the violation continues, not to exceed $1,000,000 for any 30-day period, and not to exceed $10,000,000 for all such violations adjudicated in a single proceeding. “(ii) Any person who violates a requirement of section 911(g)(2)(C)(ii) or 911(i)(1), shall be subject to a civil monetary penalty of— “(I) not to exceed $250,000 per violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding; or “(II) in Notice. the case of a violation that continues after the Secretary provides written notice to such person, $250,000 for the first 30-day period (or any portion thereof) that the person continues to be in violation, and such amount shall double for every 30-day period thereafter that the violation continues, not to exceed $1,000,000 for any 30-day period, and not to exceed $10,000,000 for all such violations adjudicated in a single proceeding. “(iii) In determining the amount of a civil penalty under clause (i)(II) or (ii)(II), the Secretary shall take into consideration whether the person is making efforts toward correcting the violation of the requirements of the section for which such person is subject to such civil penalty.” . (d) Section 304.— Section 304 (21 U.S.C. 334) is amended— (1) in subsection (a)(2)— (A) by striking “and” before “(D)”; and (B) by striking “device.” and inserting the following: “device, and (E) Any adulterated or misbranded tobacco product.”; (2) in subsection (d)(1), by inserting “tobacco product,” after “device,”; (3) in subsection (g)(1), by inserting “or tobacco product” after the term “device” each place such term appears; and (4) in subsection (g)(2)(A), by inserting “or tobacco product” after “device”. (e) Section 505.— Section 505(n)(2) (21 U.S.C. 355(n)(2)) is amended by striking “section 904” and inserting “section 1004”. (f) Section 523.— Section 523(b)(2)(D) (21 U.S.C. 360m(b)(2)(D)) is amended by striking “section 903(g)” and inserting “section 1003(g)”. (g) Section 702.— Section 702(a)(1) (U.S.C. 372(a)(1)) 21 USC 372. is amended— (1) by striking “(a)(1)” and inserting “(a)(1)(A)”; and (2) by adding at the end the following: “(B) (i) For Contracts. Inter- governmental relations. a tobacco product, to the extent feasible, the Secretary shall contract with the States in accordance with this paragraph to carry out inspections of retailers within that State in connection with the enforcement of this Act. “(ii) The Secretary shall not enter into any contract under clause (i) with the government of any of the several States to exercise enforcement authority under this Act on Indian country without the express written consent of the Indian tribe involved.” . (h) Section 703.— Section 703 (21 U.S.C. 373) is amended— (1) by inserting “tobacco product,” after the term “device,” each place such term appears; and (2) by inserting “tobacco products,” after the term “devices,” each place such term appears. (i) Section 704.— Section 704 (21 U.S.C. 374) is amended— (1) in subsection (a)(1)— (A) by striking “devices, or cosmetics” each place it appears and inserting “devices, tobacco products, or cosmetics”; (B) by striking “or restricted devices” each place it appears and inserting “restricted devices, or tobacco products”; and (C) by striking “and devices and subject to” and all that follows through “other drugs or devices” and inserting “devices, and tobacco products and subject to reporting and inspection under regulations lawfully issued pursuant to section 505 (i) or (k), section 519, section 520(g), or chapter IX and data relating to other drugs, devices, or tobacco products”; (2) in subsection (b), by inserting “tobacco product,” after “device,”; and (3) in subsection (g)(13), by striking “section 903(g)” and inserting “section 1003(g)”. (j) Section 705.— Section 705(b) (21 U.S.C. 375(b)) is amended by inserting “tobacco products,” after “devices,”. (k) Section 709.— Section 709 (21 U.S.C. 379a) is amended by inserting “tobacco product,” after “device,”. (l) Section 801.— Section 801 (21 U.S.C. 381) is amended— (1) in subsection (a)— (A) by inserting “tobacco products,” after the term “devices,”; (B) by inserting “or section 905(h)” after “section 510”; and (C) by striking the term “drugs or devices” each time such term appears and inserting “drugs, devices, or tobacco products”; (2) in subsection (e)(1)— (A) by inserting “tobacco product” after “drug, device,”; and (B) by inserting “, and a tobacco product intended for export shall not be deemed to be in violation of section 906(e), 907, 911, or 920(a),” before “if it—”; and (3) by adding at the end the following: “(p) (1) Not Deadline. Reports. later than 36 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, and annually thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report regarding— “(A) the nature, extent, and destination of United States tobacco product exports that do not conform to tobacco product standards established pursuant to this Act; “(B) the public health implications of such exports, including any evidence of a negative public health impact; and “(C) recommendations or assessments of policy alternatives available to Congress and the executive branch to reduce any negative public health impact caused by such exports. “(2) The Requirements. Secretary is authorized to establish appropriate information disclosure requirements to carry out this subsection.” . (m) Section 1003.— Section 1003(d)(2)(C) (as redesignated by section 101(b)) 21 USC 393. is amended— (1) by striking “and” after “cosmetics,”; and (2) inserting “, and tobacco products” after “devices”. (n) Section 1009.— Section 1009(b) (as redesignated by section 101(b)) is 21 USC 399. amended by striking “section 908” and inserting “section 1008”. (o) Section 409 of the Federal Meat Inspection Act.— Section 409(a) of the Federal Meat Inspection Act (21 U.S.C. 679(a)) is amended by striking “section 902(b)” and inserting “section 1002(b)”. (p) Rule of Construction.— Nothing in this section is intended or shall be construed to expand, contract, or otherwise modify or amend the existing limitations on State government authority over tribal restricted fee or trust lands. (q) Guidance and Effective Dates.— (1) In general.— The Secretary of Health and Human Services shall issue guidance— (A) defining the term “repeated violation”, as used in section 303(f)(8) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(8)) as amended by subsection (c), as including at least 5 violations of particular requirements over a 36-month period at a particular retail outlet that constitute a repeated violation and providing for civil penalties in accordance with paragraph (2); (B) providing for timely and effective notice by certified or registered mail or personal delivery to the retailer of each alleged violation at a particular retail outlet prior to conducting a followup compliance check, such notice to be sent to the location specified on the retailer’s registration or to the retailer’s registered agent if the retailer has provider such agent information to the Food and Drug Administration prior to the violation; (C) providing for a hearing pursuant to the procedures established through regulations of the Food and Drug Administration for assessing civil money penalties, including at a retailer’s request a hearing by telephone or at the nearest regional or field office of the Food and Drug Administration, and providing for an expedited procedure for the administrative appeal of an alleged violation; (D) providing that a person may not be charged with a violation at a particular retail outlet unless the Secretary has provided notice to the retailer of all previous violations at that outlet; (E) establishing that civil money penalties for multiple violations shall increase from one violation to the next violation pursuant to paragraph (2) within the time periods provided for in such paragraph; (F) providing that good faith reliance on the presentation of a false government-issued photographic identification that contains a date of birth does not constitute a violation of any minimum age requirement for the sale of tobacco products if the retailer has taken effective steps to prevent such violations, including— (i) adopting and enforcing a written policy against sales to minors; (ii) informing its employees of all applicable laws; (iii) establishing disciplinary sanctions for employee noncompliance; and (iv) requiring its employees to verify age by way of photographic identification or electronic scanning device; and (G) providing for the Secretary, in determining whether to impose a no-tobacco-sale order and in determining whether to compromise, modify, or terminate such an order, to consider whether the retailer has taken effective steps to prevent violations of the minimum age requirements for the sale of tobacco products, including the steps listed in subparagraph (F). (2) Penalties for violations.— (A) In general.— The amount of the civil penalty to be applied for violations of restrictions promulgated under section 906(d), as described in paragraph (1), shall be as follows: (i) With respect to a retailer with an approved training program, the amount of the civil penalty shall not exceed— (I) in the case of the first violation, $0.00 together with the issuance of a warning letter to the retailer; (II) in the case of a second violation within a 12-month period, $250; (III) in the case of a third violation within a 24-month period, $500; (IV) in the case of a fourth violation within a 24-month period, $2,000; (V) in the case of a fifth violation within a 36-month period, $5,000; and (VI) in the case of a sixth or subsequent violation within a 48-month period, $10,000 as determined by the Secretary on a case-by-case basis. (ii) With respect to a retailer that does not have an approved training program, the amount of the civil penalty shall not exceed— (I) in the case of the first violation, $250; (II) in the case of a second violation within a 12-month period, $500; (III) in the case of a third violation within a 24-month period, $1,000; (IV) in the case of a fourth violation within a 24-month period, $2,000; (V) in the case of a fifth violation within a 36-month period, $5,000; and (VI) in the case of a sixth or subsequent violation within a 48-month period, $10,000 as determined by the Secretary on a case-by-case basis. (B) Training program.— For purposes of subparagraph (A), the term “approved training program” means a training program that complies with standards developed by the Food and Drug Administration for such programs. (C) Consideration of state penalties.— The Secretary shall coordinate with the States in enforcing the provisions of this Act and, for purposes of mitigating a civil penalty to be applied for a violation by a retailer of any restriction promulgated under section 906(d), shall consider the amount of any penalties paid by the retailer to a State for the same violation. (3) General effective date.— The amendments made by paragraphs (2), (3), and (4) of subsection (c) shall take effect upon the issuance of guidance described in paragraph (1) of this subsection. (4) Special effective date.— The amendment made by subsection (c)(1) shall take effect on the date of enactment of this Act. (5) Package label requirements.— The package label requirements of paragraphs (3) and (4) of section 903(a) of the Federal Food, Drug, and Cosmetic Act (as amended by this division) shall take effect on the date that is 12 months after the date of enactment of this Act. The package label requirements of paragraph (2) of such section 903(a) for cigarettes shall take effect on the date that is 15 months after the issuance of the regulations required by section 4(d) of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333), as amended by section 201 of this division. The package label requirements of paragraph (2) of such section 903(a) for tobacco products other than cigarettes shall take effect on the date that is 12 months after the date of enactment of this Act. The effective date shall be with respect to the date of manufacture, provided that, in any case, beginning 30 days after such effective date, a manufacturer shall not introduce into the domestic commerce of the United States any product, irrespective of the date of manufacture, that is not in conformance with section 903(a) (2), (3), and (4) and section 920(a) of the Federal Food, Drug, and Cosmetic Act. (6) Advertising requirements.— The advertising requirements of section 903(a)(8) of the Federal Food, Drug, and Cosmetic Act (as amended by this division) shall take effect on the date that is 12 months after the date of enactment of this Act.

42. 2011

    FDA Food Safety Modernization Act

    Pub. L. 111–353 § 301(c) · 124 Stat. 3885

    Inserted · 21 U.S.C. § 381(a)

    Pub. L. 111–353, § 301(c), inserted “or the importer (as defined in section 384a of this title) is in violation of such section 384a of this title” after “or in violation of section 355 of this title”

    Source evidence

    Code amendment note
    Subsec. (a). Pub. L. 111–353, § 301(c), inserted “or the importer (as defined in section 384a of this title) is in violation of such section 384a of this title” after “or in violation of section 355 of this title”.

    Enacted provision · exact public law section
    (c) Imports.— Section 801(a) (21 U.S.C. 381(a)) is amended by adding “or the importer (as defined in section 805) is in violation of such section 805” after “or in violation of section 505”.

43. 2011

    FDA Food Safety Modernization Act

    Pub. L. 111–353 title I · 124 Stat. 3885

    1. Inserted · 21 U.S.C. § 381(a)

       Pub. L. 111–353, §§ 204(j)(2), 303(a), inserted “or (4) the recordkeeping requirements under section 2223 of this title (other than the requirements under subsection (f) of such section) have not been complied with regarding such article,” in the third sentence before “then such article shall be refused admission”

    2. Inserted · 21 U.S.C. § 381(a)

       Pub. L. 111–353, §§ 204(j)(2), 303(a), inserted after the third sentence “With respect to an article of food, if importation of such food is subject to, but not compliant with, the requirement under subsection (q) that such food be accompanied by a certification or other assurance that the food meets applicable requirements of this chapter, then such article shall be refused admission.”

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 111–353, §§ 204(j)(2), 303(a), inserted “or (4) the recordkeeping requirements under section 2223 of this title (other than the requirements under subsection (f) of such section) have not been complied with regarding such article,” in the third sentence before “then such article shall be refused admission” and inserted after the third sentence “With respect to an article of food, if importation of such food is subject to, but not compliant with, the requirement under subsection (q) that such food be accompanied by a certification or other assurance that the food meets applicable requirements of this chapter, then such article shall be refused admission.”

    Enacted provision · exact public law
    TITLE I— IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS SEC. 101. INSPECTIONS OF RECORDS. (a) In General.— Section 414(a) (21 U.S.C. 350c(a)) is amended— (1) by striking the heading and all that follows through “of food is” and inserting the following: “ Records Inspection .— “(1) Adulterated food.— If the Secretary has a reasonable belief that an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, is” ; (2) by inserting “, and to any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner,” after “relating to such article”; (3) by striking the last sentence; and (4) by inserting at the end the following: “(2) Use of or exposure to food of concern.— If the Secretary believes that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such article shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such article and to any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, that are needed to assist the Secretary in determining whether there is a reasonable probability that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals. “(3) Application.— The requirement under paragraphs (1) and (2) applies to all records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of such article maintained by or on behalf of such person in any format (including paper and electronic formats) and at any location.” . (b) Conforming Amendment.— Section 704(a)(1)(B) (21 U.S.C. 374(a)(1)(B)) is amended by striking “section 414 when” and all that follows through “subject to” and inserting “section 414, when the standard for records inspection under paragraph (1) or (2) of section 414(a) applies, subject to”. SEC. 102. REGISTRATION OF FOOD FACILITIES. (a) Updating of Food Category Regulations; Biennial Registration Renewal.— Section 415(a) (21 U.S.C. 350d(a)) is amended— (1) in paragraph (2), by— (A) striking “conducts business and” and inserting “conducts business, the e-mail address for the contact person of the facility or, in the case of a foreign facility, the United States agent for the facility, and”; and (B) inserting “, or any other food categories as determined appropriate by the Secretary, including by guidance” after “Code of Federal Regulations”; (2) by redesignating paragraphs (3) and (4) as paragraphs (4) and (5), respectively; and (3) by inserting after paragraph (2) the following: “(3) Biennial registration renewal.— During the period beginning on October 1 and ending on December 31 of each even-numbered year, a registrant that has submitted a registration under paragraph (1) shall submit to the Secretary a renewal registration containing the information described in paragraph (2). The Secretary shall provide for an abbreviated registration renewal process for any registrant that has not had any changes to such information since the registrant submitted the preceding registration or registration renewal for the facility involved.” . (b) Suspension of Registration.— (1) In general.— Section 415 (21 U.S.C. 350d) is amended— (A) in subsection (a)(2), by inserting after the first sentence the following: “The registration shall contain an assurance that the Secretary will be permitted to inspect such facility at the times and in the manner permitted by this Act.”; (B) by redesignating subsections (b) and (c) as subsections (c) and (d), respectively; and (C) by inserting after subsection (a) the following: “(b) Suspension of Registration.— “(1) In general.— If the Secretary determines that food manufactured, processed, packed, received, or held by a facility registered under this section has a reasonable probability of causing serious adverse health consequences or death to humans or animals, the Secretary may by order suspend the registration of a facility— “(A) that created, caused, or was otherwise responsible for such reasonable probability; or “(B) (i) that knew of, or had reason to know of, such reasonable probability; and “(ii) packed, received, or held such food. “(2) Hearing on suspension.— The Secretary shall provide the registrant subject to an order under paragraph (1) with an opportunity for an informal hearing, to be held as soon as possible but not later than 2 business days after the issuance of the order or such other time period, as agreed upon by the Secretary and the registrant, on the actions required for reinstatement of registration and why the registration that is subject to suspension should be reinstated. The Secretary shall reinstate a registration if the Secretary determines, based on evidence presented, that adequate grounds do not exist to continue the suspension of the registration. “(3) Post-hearing corrective action plan; vacating of order.— “(A) Corrective action plan.— If, after providing opportunity for an informal hearing under paragraph (2), the Secretary determines that the suspension of registration remains necessary, the Secretary shall require the registrant to submit a corrective action plan to demonstrate how the registrant plans to correct the conditions found by the Secretary. Deadline. The Secretary shall review such plan not later than 14 days after the submission of the corrective action plan or such other time period as determined by the Secretary. “(B) Vacating of order.— Upon a determination by the Secretary that adequate grounds do not exist to continue the suspension actions required by the order, or that such actions should be modified, the Secretary shall promptly vacate the order and reinstate the registration of the facility subject to the order or modify the order, as appropriate. “(4) Effect of suspension.— If the registration of a facility is suspended under this subsection, no person shall import or export food into the United States from such facility, offer to import or export food into the United States from such facility, or otherwise introduce food from such facility into interstate or intrastate commerce in the United States. “(5) Regulations.— “(A) In general.— The Secretary shall promulgate regulations to implement this subsection. The Secretary may promulgate such regulations on an interim final basis. “(B) Registration requirement.— The Secretary may require that registration under this section be submitted in an electronic format. Such requirement may not take effect before the date that is 5 years after the date of enactment of the FDA Food Safety Modernization Act. “(6) Application date.— Facilities shall be subject to the requirements of this subsection beginning on the earlier of— “(A) the date on which the Secretary issues regulations under paragraph (5); or “(B) 180 days after the date of enactment of the FDA Food Safety Modernization Act. “(7) No delegation.— The authority conferred by this subsection to issue an order to suspend a registration or vacate an order of suspension shall not be delegated to any officer or employee other than the Commissioner.” . (2) Small entity compliance policy guide.— Not later than 180 days after the issuance of the regulations promulgated under section 415(b)(5) of the Federal Food, Drug, and Cosmetic Act (as added by this section), the Secretary shall issue a small entity compliance policy guide setting forth in plain language the requirements of such regulations to assist small entities in complying with registration requirements and other activities required under such section. (3) Imported food.— Section 801(l) (21 U.S.C. 381(l)) is amended by inserting “(or for which a registration has been suspended under such section)” after “section 415”. (c) Clarification of Intent.— (1) Retail food establishment.— The Secretary shall amend the definition of the term “retail food establishment” in section in 1.227(b)(11) of title 21, Code of Federal Regulations to clarify that, in determining the primary function of an establishment or a retail food establishment under such section, the sale of food products directly to consumers by such establishment and the sale of food directly to consumers by such retail food establishment include— (A) the sale of such food products or food directly to consumers by such establishment at a roadside stand or farmers’ market where such stand or market is located other than where the food was manufactured or processed; (B) the sale and distribution of such food through a community supported agriculture program; and (C) the sale and distribution of such food at any other such direct sales platform as determined by the Secretary. (2) Definitions.— For purposes of paragraph (1)— (A) the term “community supported agriculture program” has the same meaning given the term “community supported agriculture (CSA) program” in section 249.2 of title 7, Code of Federal Regulations (or any successor regulation); and (B) the term “consumer” does not include a business. (d) Conforming Amendments.— (1) Section 301(d) (21 U.S.C. 331(d)) is amended by inserting “415,” after “404,”. (2) Section 415(d), as redesignated by subsection (b), 21 USC 350d. is amended by adding at the end before the period “for a facility to be registered, except with respect to the reinstatement of a registration that is suspended under subsection (b)”. SEC. 103. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS. (a) In General.— Chapter IV (21 U.S.C. 341 et seq.) is amended by adding at the end the following: “SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS. “(a) In General.— The owner, operator, or agent in charge of a facility shall, in accordance with this section, evaluate the hazards that could affect food manufactured, processed, packed, or held by such facility, identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards and provide assurances that such food is not adulterated under section 402 or misbranded under section 403(w), monitor the performance of those controls, and maintain records of this monitoring as a matter of routine practice. “(b) Hazard Analysis.— The owner, operator, or agent in charge of a facility shall— “(1) identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility, including— “(A) biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives; and “(B) hazards that occur naturally, or may be unintentionally introduced; and “(2) identify and evaluate hazards that may be intentionally introduced, including by acts of terrorism; and “(3) develop a written analysis of the hazards. “(c) Preventive Controls.— The owner, operator, or agent in charge of a facility shall identify and implement preventive controls, including at critical control points, if any, to provide assurances that— “(1) hazards identified in the hazard analysis conducted under subsection (b)(1) will be significantly minimized or prevented; “(2) any hazards identified in the hazard analysis conducted under subsection (b)(2) will be significantly minimized or prevented and addressed, consistent with section 420, as applicable; and “(3) the food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 or misbranded under section 403(w). “(d) Monitoring of Effectiveness.— The owner, operator, or agent in charge of a facility shall monitor the effectiveness of the preventive controls implemented under subsection (c) to provide assurances that the outcomes described in subsection (c) shall be achieved. “(e) Corrective Actions.— The owner, operator, or agent in charge of a facility shall establish procedures to ensure that, if the preventive controls implemented under subsection (c) are not properly implemented or are found to be ineffective— “(1) appropriate action is taken to reduce the likelihood of recurrence of the implementation failure; “(2) all affected food is evaluated for safety; and “(3) all affected food is prevented from entering into commerce if the owner, operator or agent in charge of such facility cannot ensure that the affected food is not adulterated under section 402 or misbranded under section 403(w). “(f) Verification.— The owner, operator, or agent in charge of a facility shall verify that— “(1) the preventive controls implemented under subsection (c) are adequate to control the hazards identified under subsection (b); “(2) the owner, operator, or agent is conducting monitoring in accordance with subsection (d); “(3) the owner, operator, or agent is making appropriate decisions about corrective actions taken under subsection (e); “(4) the preventive controls implemented under subsection (c) are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means; and “(5) there is documented, periodic reanalysis of the plan under subsection (i) to ensure that the plan is still relevant to the raw materials, conditions and processes in the facility, and new and emerging threats. “(g) Recordkeeping.— The owner, operator, or agent in charge of a facility shall maintain, for not less than 2 years, records documenting the monitoring of the preventive controls implemented under subsection (c), instances of nonconformance material to food safety, the results of testing and other appropriate means of verification under subsection (f)(4), instances when corrective actions were implemented, and the efficacy of preventive controls and corrective actions. “(h) Written Plan and Documentation.— The owner, operator, or agent in charge of a facility shall prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of this section, including analyzing the hazards under subsection (b) and identifying the preventive controls adopted under subsection (c) to address those hazards. Such written plan, together with the documentation described in subsection (g), shall be made promptly available to a duly authorized representative of the Secretary upon oral or written request. “(i) Requirement To Reanalyze.— The owner, operator, or agent in charge of a facility shall conduct a reanalysis under subsection (b) whenever a significant change is made in the activities conducted at a facility operated by such owner, operator, or agent if the change creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard or not less frequently than once every 3 years, whichever is earlier. Such reanalysis shall be completed and additional preventive controls needed to address the hazard identified, if any, shall be implemented before the change in activities at the facility is operative. Such owner, operator, or agent shall revise the written plan required under subsection (h) if such a significant change is made or document the basis for the conclusion that no additional or revised preventive controls are needed. The Secretary may require a reanalysis under this section to respond to new hazards and developments in scientific understanding, including, as appropriate, results from the Department of Homeland Security biological, chemical, radiological, or other terrorism risk assessment. “(j) Exemption for Seafood, Juice, and Low-acid Canned Food Facilities Subject to HACCP.— “(1) In general.— This section shall not apply to a facility if the owner, operator, or agent in charge of such facility is required to comply with, and is in compliance with, 1 of the following standards and regulations with respect to such facility: “(A) The Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration. “(B) The Juice Hazard Analysis Critical Control Points Program of the Food and Drug Administration. “(C) The Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards of the Food and Drug Administration (or any successor standards). “(2) Applicability.— The exemption under paragraph (1)(C) shall apply only with respect to microbiological hazards that are regulated under the standards for Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers under part 113 of chapter 21, Code of Federal Regulations (or any successor regulations). “(k) Exception for Activities of Facilities Subject to Section 419.— This section shall not apply to activities of a facility that are subject to section 419. “(l) Modified Requirements for Qualified Facilities.— “(1) Qualified facilities.— “(A) In general.— A facility is a qualified facility for purposes of this subsection if the facility meets the conditions under subparagraph (B) or (C). “(B) Very small business.— A facility is a qualified facility under this subparagraph— “(i) if the facility, including any subsidiary or affiliate of the facility, is, collectively, a very small business (as defined in the regulations promulgated under subsection (n)); and “(ii) in the case where the facility is a subsidiary or affiliate of an entity, if such subsidiaries or affiliates, are, collectively, a very small business (as so defined). “(C) Limited annual monetary value of sales.— “(i) In general.— A facility is a qualified facility under this subparagraph if clause (ii) applies— “(I) to the facility, including any subsidiary or affiliate of the facility, collectively; and “(II) to the subsidiaries or affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate. “(ii) Average annual monetary value.— This clause applies if— “(I) during the 3-year period preceding the applicable calendar year, the average annual monetary value of the food manufactured, processed, packed, or held at such facility (or the collective average annual monetary value of such food at any subsidiary or affiliate, as described in clause (i)) that is sold directly to qualified end-users during such period exceeded the average annual monetary value of the food manufactured, processed, packed, or held at such facility (or the collective average annual monetary value of such food at any subsidiary or affiliate, as so described) sold by such facility (or collectively by any such subsidiary or affiliate) to all other purchasers during such period; and “(II) the average annual monetary value of all food sold by such facility (or the collective average annual monetary value of such food sold by any subsidiary or affiliate, as described in clause (i)) during such period was less than $500,000, adjusted for inflation. “(2) Exemption.— A qualified facility— “(A) shall not be subject to the requirements under subsections (a) through (i) and subsection (n) in an applicable calendar year; and “(B) shall submit to the Secretary— “(i) (I) documentation that demonstrates that the owner, operator, or agent in charge of the facility has identified potential hazards associated with the food being produced, is implementing preventive controls to address the hazards, and is monitoring the preventive controls to ensure that such controls are effective; or “(II) documentation (which may include licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency (such as a State department of agriculture), or other evidence of oversight), as specified by the Secretary, that the facility is in compliance with State, local, county, or other applicable non-Federal food safety law; and “(ii) documentation, as specified by the Secretary in a guidance document issued not later than 1 year after the date of enactment of this section, that the facility is a qualified facility under paragraph (1)(B) or (1)(C). “(3) Withdrawal; rule of construction.— “(A) In general.— In the event of an active investigation of a foodborne illness outbreak that is directly linked to a qualified facility subject to an exemption under this subsection, or if the Secretary determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with a qualified facility that are material to the safety of the food manufactured, processed, packed, or held at such facility, the Secretary may withdraw the exemption provided to such facility under this subsection. “(B) Rule of construction.— Nothing in this subsection shall be construed to expand or limit the inspection authority of the Secretary. “(4) Definitions.— In this subsection: “(A) Affiliate.— The term ‘affiliate’ means any facility that controls, is controlled by, or is under common control with another facility. “(B) Qualified end-user.— The term ‘qualified end-user’, with respect to a food, means— “(i) the consumer of the food; or “(ii) a restaurant or retail food establishment (as those terms are defined by the Secretary for purposes of section 415) that— “(I) is located— “(aa) in the same State as the qualified facility that sold the food to such restaurant or establishment; or “(bb) not more than 275 miles from such facility; and “(II) is purchasing the food for sale directly to consumers at such restaurant or retail food establishment. “(C) Consumer.— For purposes of subparagraph (B), the term ‘consumer’ does not include a business. “(D) Subsidiary.— The term ‘subsidiary’ means any company which is owned or controlled directly or indirectly by another company. “(5) Study.— “(A) In general.— The Secretary, in consultation with the Secretary of Agriculture, shall conduct a study of the food processing sector regulated by the Secretary to determine— “(i) the distribution of food production by type and size of operation, including monetary value of food sold; “(ii) the proportion of food produced by each type and size of operation; “(iii) the number and types of food facilities co-located on farms, including the number and proportion by commodity and by manufacturing or processing activity; “(iv) the incidence of foodborne illness originating from each size and type of operation and the type of food facilities for which no reported or known hazard exists; and “(v) the effect on foodborne illness risk associated with commingling, processing, transporting, and storing food and raw agricultural commodities, including differences in risk based on the scale and duration of such activities. “(B) Size.— The results of the study conducted under subparagraph (A) shall include the information necessary to enable the Secretary to define the terms ‘small business’ and ‘very small business’, for purposes of promulgating the regulation under subsection (n). In defining such terms, the Secretary shall include consideration of harvestable acres, income, the number of employees, and the volume of food harvested. “(C) Submission of report.— Not later than 18 months after the date of enactment the FDA Food Safety Modernization Act, the Secretary shall submit to Congress a report that describes the results of the study conducted under subparagraph (A). “(6) No preemption.— Nothing in this subsection preempts State, local, county, or other non-Federal law regarding the safe production of food. Compliance with this subsection shall not relieve any person from liability at common law or under State statutory law. “(7) Notification to consumers.— “(A) In general.— A qualified facility that is exempt from the requirements under subsections (a) through (i) and subsection (n) and does not prepare documentation under paragraph (2)(B)(i)(I) shall— “(i) with respect to a food for which a food packaging label is required by the Secretary under any other provision of this Act, include prominently and conspicuously on such label the name and business address of the facility where the food was manufactured or processed; or “(ii) with respect to a food for which a food packaging label is not required by the Secretary under any other provisions of this Act, prominently and conspicuously display, at the point of purchase, the name and business address of the facility where the food was manufactured or processed, on a label, poster, sign, placard, or documents delivered contemporaneously with the food in the normal course of business, or, in the case of Internet sales, in an electronic notice. “(B) No additional label.— Subparagraph (A) does not provide authority to the Secretary to require a label that is in addition to any label required under any other provision of this Act. “(m) Authority With Respect to Certain Facilities.— The Secretary may, by regulation, exempt or modify the requirements for compliance under this section with respect to facilities that are solely engaged in the production of food for animals other than man, the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing, or the storage of packaged foods that are not exposed to the environment. “(n) Regulations.— “(1) In general.— Not later than 18 months after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall promulgate regulations— “(A) to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls under this section; and “(B) to define, for purposes of this section, the terms ‘small business’ and ‘very small business’, taking into consideration the study described in subsection (l)(5). “(2) Coordination.— In promulgating the regulations under paragraph (1)(A), with regard to hazards that may be intentionally introduced, including by acts of terrorism, the Secretary shall coordinate with the Secretary of Homeland Security, as appropriate. “(3) Content.— The regulations promulgated under paragraph (1)(A) shall— “(A) provide sufficient flexibility to be practicable for all sizes and types of facilities, including small businesses such as a small food processing facility co-located on a farm; “(B) comply with chapter 35 of title 44, United States Code (commonly known as the ‘Paperwork Reduction Act’), with special attention to minimizing the burden (as defined in section 3502(2) of such Act) on the facility, and collection of information (as defined in section 3502(3) of such Act), associated with such regulations; “(C) acknowledge differences in risk and minimize, as appropriate, the number of separate standards that apply to separate foods; and “(D) not require a facility to hire a consultant or other third party to identify, implement, certify, or audit preventative controls, except in the case of negotiated enforcement resolutions that may require such a consultant or third party. “(4) Rule of construction.— Nothing in this subsection shall be construed to provide the Secretary with the authority to prescribe specific technologies, practices, or critical controls for an individual facility. “(5) Review.— In promulgating the regulations under paragraph (1)(A), the Secretary shall review regulatory hazard analysis and preventive control programs in existence on the date of enactment of the FDA Food Safety Modernization Act, including the Grade ‘A’ Pasteurized Milk Ordinance to ensure that such regulations are consistent, to the extent practicable, with applicable domestic and internationally-recognized standards in existence on such date. “(o) Definitions.— For purposes of this section: “(1) Critical control point.— The term ‘critical control point’ means a point, step, or procedure in a food process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to an acceptable level. “(2) Facility.— The term ‘facility’ means a domestic facility or a foreign facility that is required to register under section 415. “(3) Preventive controls.— The term ‘preventive controls’ means those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis conducted under subsection (b) and that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis. Those procedures, practices, and processes may include the following: “(A) Sanitation procedures for food contact surfaces and utensils and food-contact surfaces of equipment. “(B) Supervisor, manager, and employee hygiene training. “(C) An environmental monitoring program to verify the effectiveness of pathogen controls in processes where a food is exposed to a potential contaminant in the environment. “(D) A food allergen control program. “(E) A recall plan. “(F) Current Good Manufacturing Practices (cGMPs) under part 110 of title 21, Code of Federal Regulations (or any successor regulations). “(G) Supplier verification activities that relate to the safety of food.” . (b) Guidance Document.— The Secretary shall issue a guidance document related to the regulations promulgated under subsection (b)(1) with respect to the hazard analysis and preventive controls under section 418 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)). (c) Rulemaking.— (1) Proposed rulemaking.— (A) In general.— Not later than 9 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this subsection as the “Secretary”) shall publish a notice of proposed rulemaking in the Federal Register to promulgate regulations with respect to— (i) activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership for purposes of section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), as amended by this Act; and (ii) activities that constitute on-farm manufacturing or processing of food that is not consumed on that farm or on another farm under common ownership for purposes of such section 415. (B) Clarification.— The rulemaking described under subparagraph (A) shall enhance the implementation of such section 415 and clarify the activities that are included as part of the definition of the term “facility” under such section 415. Nothing in this Act authorizes the Secretary to modify the definition of the term “facility” under such section. (C) Science-based risk analysis.— In promulgating regulations under subparagraph (A), the Secretary shall conduct a science-based risk analysis of— (i) specific types of on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership, as such packing and holding relates to specific foods; and (ii) specific on-farm manufacturing and processing activities as such activities relate to specific foods that are not consumed on that farm or on another farm under common ownership. (D) Authority with respect to certain facilities.— (i) In general.— In promulgating the regulations under subparagraph (A), the Secretary shall consider the results of the science-based risk analysis conducted under subparagraph (C), and shall exempt certain facilities from the requirements in section 418 of the Federal Food, Drug, and Cosmetic Act (as added by this section), including hazard analysis and preventive controls, and the mandatory inspection frequency in section 421 of such Act (as added by section 201), or modify the requirements in such sections 418 or 421, as the Secretary determines appropriate, if such facilities are engaged only in specific types of on-farm manufacturing, processing, packing, or holding activities that the Secretary determines to be low risk involving specific foods the Secretary determines to be low risk. (ii) Limitation.— The exemptions or modifications under clause (i) shall not include an exemption from the requirement to register under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), as amended by this Act, if applicable, and shall apply only to small businesses and very small businesses, as defined in the regulation promulgated under section 418(n) of the Federal Food, Drug, and Cosmetic Act (as added under subsection (a)). (2) Final regulations.— Not later than 9 months after the close of the comment period for the proposed rulemaking under paragraph (1), the Secretary shall adopt final rules with respect to— (A) activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership for purposes of section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), as amended by this Act; (B) activities that constitute on-farm manufacturing or processing of food that is not consumed on that farm or on another farm under common ownership for purposes of such section 415; and (C) the requirements under sections 418 and 421 of the Federal Food, Drug, and Cosmetic Act, as added by this Act, from which the Secretary may issue exemptions or modifications of the requirements for certain types of facilities. (d) Small Entity Compliance Policy Guide.— Not later than 180 days after the issuance of the regulations promulgated under subsection (n) of section 418 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)), the Secretary shall issue a small entity compliance policy guide setting forth in plain language the requirements of such section 418 and this section to assist small entities in complying with the hazard analysis and other activities required under such section 418 and this section. (e) Prohibited Acts.— Section 301 (21 U.S.C. 331) is amended by adding at the end the following: “(uu) The operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with section 418.” . (f) No Effect on HACCP Authorities.— Nothing in the amendments made by this section limits the authority of the Secretary under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health Service Act (42 U.S.C. 201 et seq.) to revise, issue, or enforce Hazard Analysis Critical Control programs and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards. (g) Dietary Supplements.— Nothing in the amendments made by this section shall apply to any facility with regard to the manufacturing, processing, packing, or holding of a dietary supplement that is in compliance with the requirements of sections 402(g)(2) and 761 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(g)(2), 379aa–1). (h) Updating Guidance Relating to Fish and Fisheries Products Hazards and Controls.— The Secretary shall, not later than 180 days after the date of enactment of this Act, update the Fish and Fisheries Products Hazards and Control Guidance to take into account advances in technology that have occurred since the previous publication of such Guidance by the Secretary. (i) Effective Dates.— (1) General rule.— The amendments made by this section shall take effect 18 months after the date of enactment of this Act. (2) Flexibility for small businesses.— Notwithstanding paragraph (1)— (A) the amendments made by this section shall apply to a small business (as defined in the regulations promulgated under section 418(n) of the Federal Food, Drug, and Cosmetic Act (as added by this section)) beginning on the date that is 6 months after the effective date of such regulations; and (B) the amendments made by this section shall apply to a very small business (as defined in such regulations) beginning on the date that is 18 months after the effective date of such regulations. SEC. 104. PERFORMANCE STANDARDS. (a) In General.— The Secretary shall, in coordination with the Secretary of Agriculture, not less frequently than every 2 years, review and evaluate relevant health data and other relevant information, including from toxicological and epidemiological studies and analyses, current Good Manufacturing Practices issued by the Secretary relating to food, and relevant recommendations of relevant advisory committees, including the Food Advisory Committee, to determine the most significant foodborne contaminants. (b) Guidance Documents and Regulations.— Based on the review and evaluation conducted under subsection (a), and when appropriate to reduce the risk of serious illness or death to humans or animals or to prevent adulteration of the food under section 402 of the Federal Food, Drug, or Cosmetic Act (21 U.S.C. 342) or to prevent the spread by food of communicable disease under section 361 of the Public Health Service Act (42 U.S.C. 264), the Secretary shall issue contaminant-specific and science-based guidance documents, including guidance documents regarding action levels, or regulations. Such guidance, including guidance regarding action levels, or regulations— (1) shall apply to products or product classes; (2) shall, where appropriate, differentiate between food for human consumption and food intended for consumption by animals other than humans; and (3) shall not be written to be facility-specific. (c) No Duplication of Efforts.— The Secretary shall coordinate with the Secretary of Agriculture to avoid issuing duplicative guidance on the same contaminants. (d) Review.— The Secretary shall periodically review and revise, as appropriate, the guidance documents, including guidance documents regarding action levels, or regulations promulgated under this section. SEC. 105. STANDARDS FOR PRODUCE SAFETY. (a) In General.— Chapter IV (21 U.S.C. 341 et seq.), as amended by section 103, is amended by adding at the end the following: “SEC. 419. STANDARDS FOR PRODUCE SAFETY. “(a) Proposed Rulemaking.— “(1) In general.— “(A) Rulemaking.— Not later than 1 year after the date of enactment of the FDA Food Safety Modernization Act, the Secretary, in coordination with the Secretary of Agriculture and representatives of State departments of agriculture (including with regard to the national organic program established under the Organic Foods Production Act of 1990), and in consultation with the Secretary of Homeland Security, shall publish a notice of proposed rulemaking to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death. “(B) Determination by secretary.— With respect to small businesses and very small businesses (as such terms are defined in the regulation promulgated under subparagraph (A)) that produce and harvest those types of fruits and vegetables that are raw agricultural commodities that the Secretary has determined are low risk and do not present a risk of serious adverse health consequences or death, the Secretary may determine not to include production and harvesting of such fruits and vegetables in such rulemaking, or may modify the applicable requirements of regulations promulgated pursuant to this section. “(2) Public input.— During the comment period on the notice of proposed rulemaking under paragraph (1), the Secretary shall conduct not less than 3 public meetings in diverse geographical areas of the United States to provide persons in different regions an opportunity to comment. “(3) Content.— The proposed rulemaking under paragraph (1) shall— “(A) provide sufficient flexibility to be applicable to various types of entities engaged in the production and harvesting of fruits and vegetables that are raw agricultural commodities, including small businesses and entities that sell directly to consumers, and be appropriate to the scale and diversity of the production and harvesting of such commodities; “(B) include, with respect to growing, harvesting, sorting, packing, and storage operations, science-based minimum standards related to soil amendments, hygiene, packaging, temperature controls, animals in the growing area, and water; “(C) consider hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism; “(D) take into consideration, consistent with ensuring enforceable public health protection, conservation and environmental practice standards and policies established by Federal natural resource conservation, wildlife conservation, and environmental agencies; “(E) in the case of production that is certified organic, not include any requirements that conflict with or duplicate the requirements of the national organic program established under the Organic Foods Production Act of 1990, while providing the same level of public health protection as the requirements under guidance documents, including guidance documents regarding action levels, and regulations under the FDA Food Safety Modernization Act; and “(F) define, for purposes of this section, the terms ‘small business’ and ‘very small business’. “(4) Prioritization.— The Secretary shall prioritize the implementation of the regulations under this section for specific fruits and vegetables that are raw agricultural commodities based on known risks which may include a history and severity of foodborne illness outbreaks. “(b) Final Regulation.— “(1) In general.— Not later than 1 year after the close of the comment period for the proposed rulemaking under subsection (a), the Secretary shall adopt a final regulation to provide for minimum science-based standards for those types of fruits and vegetables, including specific mixes or categories of fruits or vegetables, that are raw agricultural commodities, based on known safety risks, which may include a history of foodborne illness outbreaks. “(2) Final regulation.— The final regulation shall— “(A) provide for coordination of education and enforcement activities by State and local officials, as designated by the Governors of the respective States or the appropriate elected State official as recognized by State statute; and “(B) include a description of the variance process under subsection (c) and the types of permissible variances the Secretary may grant. “(3) Flexibility for small businesses.— Notwithstanding paragraph (1)— “(A) the regulations promulgated under this section shall apply to a small business (as defined in the regulation promulgated under subsection (a)(1)) after the date that is 1 year after the effective date of the final regulation under paragraph (1); and “(B) the regulations promulgated under this section shall apply to a very small business (as defined in the regulation promulgated under subsection (a)(1)) after the date that is 2 years after the effective date of the final regulation under paragraph (1). “(c) Criteria.— “(1) In general.— The regulations adopted under subsection (b) shall— “(A) set forth those procedures, processes, and practices that the Secretary determines to minimize the risk of serious adverse health consequences or death, including procedures, processes, and practices that the Secretary determines to be reasonably necessary to prevent the introduction of known or reasonably foreseeable biological, chemical, and physical hazards, including hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism, into fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities and to provide reasonable assurances that the produce is not adulterated under section 402; “(B) provide sufficient flexibility to be practicable for all sizes and types of businesses, including small businesses such as a small food processing facility co-located on a farm; “(C) comply with chapter 35 of title 44, United States Code (commonly known as the ‘Paperwork Reduction Act’), with special attention to minimizing the burden (as defined in section 3502(2) of such Act) on the business, and collection of information (as defined in section 3502(3) of such Act), associated with such regulations; “(D) acknowledge differences in risk and minimize, as appropriate, the number of separate standards that apply to separate foods; and “(E) not require a business to hire a consultant or other third party to identify, implement, certify, compliance with these procedures, processes, and practices, except in the case of negotiated enforcement resolutions that may require such a consultant or third party; and “(F) permit States and foreign countries from which food is imported into the United States to request from the Secretary variances from the requirements of the regulations, subject to paragraph (2), where the State or foreign country determines that the variance is necessary in light of local growing conditions and that the procedures, processes, and practices to be followed under the variance are reasonably likely to ensure that the produce is not adulterated under section 402 and to provide the same level of public health protection as the requirements of the regulations adopted under subsection (b). “(2) Variances.— “(A) Requests for variances.— A State or foreign country from which food is imported into the United States may in writing request a variance from the Secretary. Such request shall describe the variance requested and present information demonstrating that the variance does not increase the likelihood that the food for which the variance is requested will be adulterated under section 402, and that the variance provides the same level of public health protection as the requirements of the regulations adopted under subsection (b). The Secretary shall review such requests in a reasonable timeframe. “(B) Approval of variances.— The Secretary may approve a variance in whole or in part, as appropriate, and may specify the scope of applicability of a variance to other similarly situated persons. “(C) Denial of variances.— The Secretary may deny a variance request if the Secretary determines that such variance is not reasonably likely to ensure that the food is not adulterated under section 402 and is not reasonably likely to provide the same level of public health protection as the requirements of the regulation adopted under subsection (b). Notification. The Secretary shall notify the person requesting such variance of the reasons for the denial. “(D) Modification or revocation of a variance.— The Secretary, after notice and an opportunity for a hearing, may modify or revoke a variance if the Secretary determines that such variance is not reasonably likely to ensure that the food is not adulterated under section 402 and is not reasonably likely to provide the same level of public health protection as the requirements of the regulations adopted under subsection (b). “(d) Enforcement.— The Secretary may coordinate with the Secretary of Agriculture and, as appropriate, shall contract and coordinate with the agency or department designated by the Governor of each State to perform activities to ensure compliance with this section. “(e) Guidance.— “(1) In general.— Not later than 1 year after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall publish, after consultation with the Secretary of Agriculture, representatives of State departments of agriculture, farmer representatives, and various types of entities engaged in the production and harvesting or importing of fruits and vegetables that are raw agricultural commodities, including small businesses, updated good agricultural practices and guidance for the safe production and harvesting of specific types of fresh produce under this section. “(2) Public meetings.— The Secretary shall conduct not fewer than 3 public meetings in diverse geographical areas of the United States as part of an effort to conduct education and outreach regarding the guidance described in paragraph (1) for persons in different regions who are involved in the production and harvesting of fruits and vegetables that are raw agricultural commodities, including persons that sell directly to consumers and farmer representatives, and for importers of fruits and vegetables that are raw agricultural commodities. “(3) Paperwork reduction.— The Secretary shall ensure that any updated guidance under this section will— “(A) provide sufficient flexibility to be practicable for all sizes and types of facilities, including small businesses such as a small food processing facility co-located on a farm; and “(B) acknowledge differences in risk and minimize, as appropriate, the number of separate standards that apply to separate foods. “(f) Exemption for Direct Farm Marketing.— “(1) In general.— A farm shall be exempt from the requirements under this section in a calendar year if— “(A) during the previous 3-year period, the average annual monetary value of the food sold by such farm directly to qualified end-users during such period exceeded the average annual monetary value of the food sold by such farm to all other buyers during such period; and “(B) the average annual monetary value of all food sold during such period was less than $500,000, adjusted for inflation. “(2) Notification to consumers.— “(A) In general.— A farm that is exempt from the requirements under this section shall— “(i) with respect to a food for which a food packaging label is required by the Secretary under any other provision of this Act, include prominently and conspicuously on such label the name and business address of the farm where the produce was grown; or “(ii) with respect to a food for which a food packaging label is not required by the Secretary under any other provision of this Act, prominently and conspicuously display, at the point of purchase, the name and business address of the farm where the produce was grown, on a label, poster, sign, placard, or documents delivered contemporaneously with the food in the normal course of business, or, in the case of Internet sales, in an electronic notice. “(B) No additional label.— Subparagraph (A) does not provide authority to the Secretary to require a label that is in addition to any label required under any other provision of this Act. “(3) Withdrawal; rule of construction.— “(A) In general.— In the event of an active investigation of a foodborne illness outbreak that is directly linked to a farm subject to an exemption under this subsection, or if the Secretary determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with a farm that are material to the safety of the food produced or harvested at such farm, the Secretary may withdraw the exemption provided to such farm under this subsection. “(B) Rule of construction.— Nothing in this subsection shall be construed to expand or limit the inspection authority of the Secretary. “(4) Definitions.— “(A) Qualified end-user.— In this subsection, the term ‘qualified end-user’, with respect to a food means— “(i) the consumer of the food; or “(ii) a restaurant or retail food establishment (as those terms are defined by the Secretary for purposes of section 415) that is located— “(I) in the same State as the farm that produced the food; or “(II) not more than 275 miles from such farm. “(B) Consumer.— For purposes of subparagraph (A), the term ‘consumer’ does not include a business. “(5) No preemption.— Nothing in this subsection preempts State, local, county, or other non-Federal law regarding the safe production, harvesting, holding, transportation, and sale of fresh fruits and vegetables. Compliance with this subsection shall not relieve any person from liability at common law or under State statutory law. “(6) Limitation of effect.— Nothing in this subsection shall prevent the Secretary from exercising any authority granted in the other sections of this Act. “(g) Clarification.— This section shall not apply to produce that is produced by an individual for personal consumption. “(h) Exception for Activities of Facilities Subject to Section 418.— This section shall not apply to activities of a facility that are subject to section 418.” . (b) Small Entity Compliance Policy Guide.— Not later than 180 days after the issuance of regulations under section 419 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)), the Secretary of Health and Human Services shall issue a small entity compliance policy guide setting forth in plain language the requirements of such section 419 and to assist small entities in complying with standards for safe production and harvesting and other activities required under such section. (c) Prohibited Acts.— Section 301 (21 U.S.C. 331), as amended by section 103, is amended by adding at the end the following: “(vv) The failure to comply with the requirements under section 419.” . (d) No Effect on HACCP Authorities.— Nothing in the amendments made by this section limits the authority of the Secretary under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health Service Act (42 U.S.C. 201 et seq.) to revise, issue, or enforce product and category-specific regulations, such as the Seafood Hazard Analysis Critical Controls Points Program, the Juice Hazard Analysis Critical Control Program, and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards. SEC. 106. PROTECTION AGAINST INTENTIONAL ADULTERATION. (a) In General.— Chapter IV (21 U.S.C. 341 et seq.), as amended by section 105, is amended by adding at the end the following: “SEC. 420. PROTECTION AGAINST INTENTIONAL ADULTERATION. “(a) Determinations.— “(1) In general.— The Secretary shall— “(A) conduct a vulnerability assessment of the food system, including by consideration of the Department of Homeland Security biological, chemical, radiological, or other terrorism risk assessments; “(B) consider the best available understanding of uncertainties, risks, costs, and benefits associated with guarding against intentional adulteration of food at vulnerable points; and “(C) determine the types of science-based mitigation strategies or measures that are necessary to protect against the intentional adulteration of food. “(2) Limited distribution.— In the interest of national security, the Secretary, in consultation with the Secretary of Homeland Security, may determine the time, manner, and form in which determinations made under paragraph (1) are made publicly available. “(b) Regulations.— Not later than 18 months after the date of enactment of the FDA Food Safety Modernization Act, the Secretary, in coordination with the Secretary of Homeland Security and in consultation with the Secretary of Agriculture, shall promulgate regulations to protect against the intentional adulteration of food subject to this Act. Such regulations shall— “(1) specify how a person shall assess whether the person is required to implement mitigation strategies or measures intended to protect against the intentional adulteration of food; and “(2) specify appropriate science-based mitigation strategies or measures to prepare and protect the food supply chain at specific vulnerable points, as appropriate. “(c) Applicability.— Regulations promulgated under subsection (b) shall apply only to food for which there is a high risk of intentional contamination, as determined by the Secretary, in consultation with the Secretary of Homeland Security, under subsection (a), that could cause serious adverse health consequences or death to humans or animals and shall include those foods— “(1) for which the Secretary has identified clear vulnerabilities (including short shelf-life or susceptibility to intentional contamination at critical control points); and “(2) in bulk or batch form, prior to being packaged for the final consumer. “(d) Exception.— This section shall not apply to farms, except for those that produce milk. “(e) Definition.— For purposes of this section, the term ‘farm’ has the meaning given that term in section 1.227 of title 21, Code of Federal Regulations (or any successor regulation).” . (b) Guidance Documents.— (1) In general.— Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with the Secretary of Homeland Security and the Secretary of Agriculture, shall issue guidance documents related to protection against the intentional adulteration of food, including mitigation strategies or measures to guard against such adulteration as required under section 420 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a). (2) Content.— The guidance documents issued under paragraph (1) shall— (A) include a model assessment for a person to use under subsection (b)(1) of section 420 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a); (B) include examples of mitigation strategies or measures described in subsection (b)(2) of such section; and (C) specify situations in which the examples of mitigation strategies or measures described in subsection (b)(2) of such section are appropriate. (3) Limited distribution.— In the interest of national security, the Secretary of Health and Human Services, in consultation with the Secretary of Homeland Security, may determine the time, manner, and form in which the guidance documents issued under paragraph (1) are made public, including by releasing such documents to targeted audiences. (c) Periodic Review.— The Secretary of Health and Human Services shall periodically review and, as appropriate, update the regulations under section 420(b) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), and the guidance documents under subsection (b). (d) Prohibited Acts.— Section 301 (21 U.S.C. 331 et seq.), as amended by section 105, is amended by adding at the end the following: “(ww) The failure to comply with section 420.” . SEC. 107. AUTHORITY TO COLLECT FEES. (a) Fees for Reinspection, Recall, and Importation Activities.— Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is amended by adding at the end the following: “PART 6— FEES RELATED TO FOOD “SEC. 743. AUTHORITY TO COLLECT AND USE FEES. “(a) In General.— “(1) Purpose and authority.— For fiscal year 2010 and each subsequent fiscal year, the Secretary shall, in accordance with this section, assess and collect fees from— “(A) the responsible party for each domestic facility (as defined in section 415(b)) and the United States agent for each foreign facility subject to a reinspection in such fiscal year, to cover reinspection-related costs for such year; “(B) the responsible party for a domestic facility (as defined in section 415(b)) and an importer who does not comply with a recall order under section 423 or under section 412(f) in such fiscal year, to cover food recall activities associated with such order performed by the Secretary, including technical assistance, follow-up effectiveness checks, and public notifications, for such year; “(C) each importer participating in the voluntary qualified importer program under section 806 in such year, to cover the administrative costs of such program for such year; and “(D) each importer subject to a reinspection in such fiscal year, to cover reinspection-related costs for such year. “(2) Definitions.— For purposes of this section— “(A) the term ‘reinspection’ means— “(i) with respect to domestic facilities (as defined in section 415(b)), 1 or more inspections conducted under section 704 subsequent to an inspection conducted under such provision which identified noncompliance materially related to a food safety requirement of this Act, specifically to determine whether compliance has been achieved to the Secretary’s satisfaction; and “(ii) with respect to importers, 1 or more examinations conducted under section 801 subsequent to an examination conducted under such provision which identified noncompliance materially related to a food safety requirement of this Act, specifically to determine whether compliance has been achieved to the Secretary’s satisfaction; “(B) the term ‘reinspection-related costs’ means all expenses, including administrative expenses, incurred in connection with— “(i) arranging, conducting, and evaluating the results of reinspections; and “(ii) assessing and collecting reinspection fees under this section; and “(C) the term ‘responsible party’ has the meaning given such term in section 417(a)(1). “(b) Establishment of Fees.— “(1) In general.— Subject to subsections (c) and (d), the Secretary shall establish the fees to be collected under this section for each fiscal year specified in subsection (a)(1), based on the methodology described under paragraph (2), and shall publish such fees in a Federal Register notice not later than 60 days before the start of each such year. “(2) Fee methodology.— “(A) Fees.— Fees amounts established for collection— “(i) under subparagraph (A) of subsection (a)(1) for a fiscal year shall be based on the Secretary’s estimate of 100 percent of the costs of the reinspection-related activities (including by type or level of reinspection activity, as the Secretary determines applicable) described in such subparagraph (A) for such year; “(ii) under subparagraph (B) of subsection (a)(1) for a fiscal year shall be based on the Secretary’s estimate of 100 percent of the costs of the activities described in such subparagraph (B) for such year; “(iii) under subparagraph (C) of subsection (a)(1) for a fiscal year shall be based on the Secretary’s estimate of 100 percent of the costs of the activities described in such subparagraph (C) for such year; and “(iv) under subparagraph (D) of subsection (a)(1) for a fiscal year shall be based on the Secretary’s estimate of 100 percent of the costs of the activities described in such subparagraph (D) for such year. “(B) Other considerations.— “(i) Voluntary qualified importer program.— In establishing the fee amounts under subparagraph (A)(iii) for a fiscal year, the Secretary shall provide for the number of importers who have submitted to the Secretary a notice under section 806(c) informing the Secretary of the intent of such importer to participate in the program under section 806 in such fiscal year. “(II) Recoupment.— In establishing the fee amounts under subparagraph (A)(iii) for the first 5 fiscal years after the date of enactment of this section, the Secretary shall include in such fee a reasonable surcharge that provides a recoupment of the costs expended by the Secretary to establish and implement the first year of the program under section 806. “(ii) Crediting of fees.— In establishing the fee amounts under subparagraph (A) for a fiscal year, the Secretary shall provide for the crediting of fees from the previous year to the next year if the Secretary overestimated the amount of fees needed to carry out such activities, and consider the need to account for any adjustment of fees and such other factors as the Secretary determines appropriate. “(iii) Published guidelines.— Not later than 180 days after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall publish in the Federal Register a proposed set of guidelines in consideration of the burden of fee amounts on small business. Such consideration may include reduced fee amounts for small businesses. The Secretary shall provide for a period of public comment on such guidelines. The Secretary shall adjust the fee schedule for small businesses subject to such fees only through notice and comment rulemaking. “(3) Use of fees.— The Secretary shall make all of the fees collected pursuant to clause (i), (ii), (iii), and (iv) of paragraph (2)(A) available solely to pay for the costs referred to in such clause (i), (ii), (iii), and (iv) of paragraph (2)(A), respectively. “(c) Limitations.— “(1) In general.— Fees under subsection (a) shall be refunded for a fiscal year beginning after fiscal year 2010 unless the amount of the total appropriations for food safety activities at the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) is equal to or greater than the amount of appropriations for food safety activities at the Food and Drug Administration for fiscal year 2009 (excluding the amount of fees appropriated for such fiscal year), multiplied by the adjustment factor under paragraph (3). “(2) Authority.— If— “(A) the Secretary does not assess fees under subsection (a) for a portion of a fiscal year because paragraph (1) applies; and “(B) at a later date in such fiscal year, such paragraph (1) ceases to apply, the Secretary may assess and collect such fees under subsection (a), without any modification to the rate of such fees, notwithstanding the provisions of subsection (a) relating to the date fees are to be paid. “(3) Adjustment factor.— “(A) In general.— The adjustment factor described in paragraph (1) shall be the total percentage change that occurred in the Consumer Price Index for all urban consumers (all items; United States city average) for the 12-month period ending June 30 preceding the fiscal year, but in no case shall such adjustment factor be negative. “(B) Compounded basis.— The adjustment under subparagraph (A) made each fiscal year shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2009. “(4) Limitation on amount of certain fees.— “(A) In general.— Notwithstanding any other provision of this section and subject to subparagraph (B), the Secretary may not collect fees in a fiscal year such that the amount collected— “(i) under subparagraph (B) of subsection (a)(1) exceeds $20,000,000; and “(ii) under subparagraphs (A) and (D) of subsection (a)(1) exceeds $25,000,000 combined. “(B) Exception.— If a domestic facility (as defined in section 415(b)) or an importer becomes subject to a fee described in subparagraph (A), (B), or (D) of subsection (a)(1) after the maximum amount of fees has been collected by the Secretary under subparagraph (A), the Secretary may collect a fee from such facility or importer. “(d) Crediting and Availability of Fees.— Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the purpose of paying the operating expenses of the Food and Drug Administration employees and contractors performing activities associated with these food safety fees. “(e) Collection of Fees.— “(1) In general.— The Secretary shall specify in the Federal Register notice described in subsection (b)(1) the time and manner in which fees assessed under this section shall be collected. “(2) Collection of unpaid fees.— In any case where the Secretary does not receive payment of a fee assessed under this section within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to provisions of subchapter II of chapter 37 of title 31, United States Code. “(f) Annual Report to Congress.— Not later than 120 days after each fiscal year for which fees are assessed under this section, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to include a description of fees assessed and collected for each such year and a summary description of the entities paying such fees and the types of business in which such entities engage. “(g) Authorization of Appropriations.— For fiscal year 2010 and each fiscal year thereafter, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted or otherwise affected under the other provisions of this section.” . (b) Export Certification Fees for Foods and Animal Feed.— (1) Authority for export certifications for food, including animal feed.— Section 801(e)(4)(A) (21 U.S.C. 381(e)(4)(A)) is amended— (A) in the matter preceding clause (i), by striking “a drug” and inserting “a food, drug”; (B) in clause (i) by striking “exported drug” and inserting “exported food, drug”; and (C) in clause (ii) by striking “the drug” each place it appears and inserting “the food, drug”. (2) Clarification of certification.— Section 801(e)(4) (21 U.S.C. 381(e)(4)) is amended by inserting after subparagraph (B) the following new subparagraph: “(C) For purposes of this paragraph, a certification by the Secretary shall be made on such basis, and in such form (including a publicly available listing) as the Secretary determines appropriate.” . (3) Limitations on the use and amount of fees.— Paragraph (4) of section 801(e) (21 U.S.C. 381(e)) is amended by adding at the end the following: “(D) With regard to fees pursuant to subparagraph (B) in connection with written export certifications for food: “(i) Such fees shall be collected and available solely for the costs of the Food and Drug Administration associated with issuing such certifications. “(ii) Such fees may not be retained in an amount that exceeds such costs for the respective fiscal year.” SEC. 108. NATIONAL AGRICULTURE AND FOOD DEFENSE STRATEGY. (a) Development and Submission of Strategy.— (1) In general.— Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services and the Secretary of Agriculture, in coordination with the Secretary of Homeland Security, shall prepare and transmit to the relevant committees of Congress, and make publicly available on the Internet Web sites of the Department of Health and Human Services and the Department of Agriculture, the National Agriculture and Food Defense Strategy. (2) Implementation plan.— The strategy shall include an implementation plan for use by the Secretaries described under paragraph (1) in carrying out the strategy. (3) Research.— The strategy shall include a coordinated research agenda for use by the Secretaries described under paragraph (1) in conducting research to support the goals and activities described in paragraphs (1) and (2) of subsection (b). (4) Revisions.— Not later than 4 years after the date on which the strategy is submitted to the relevant committees of Congress under paragraph (1), and not less frequently than every 4 years thereafter, the Secretary of Health and Human Services and the Secretary of Agriculture, in coordination with the Secretary of Homeland Security, shall revise and submit to the relevant committees of Congress the strategy. (5) Consistency with existing plans.— The strategy described in paragraph (1) shall be consistent with— (A) the National Incident Management System; (B) the National Response Framework; (C) the National Infrastructure Protection Plan; (D) the National Preparedness Goals; and (E) other relevant national strategies. (b) Components.— (1) In general.— The strategy shall include a description of the process to be used by the Department of Health and Human Services, the Department of Agriculture, and the Department of Homeland Security— (A) to achieve each goal described in paragraph (2); and (B) to evaluate the progress made by Federal, State, local, and tribal governments towards the achievement of each goal described in paragraph (2). (2) Goals.— The strategy shall include a description of the process to be used by the Department of Health and Human Services, the Department of Agriculture, and the Department of Homeland Security to achieve the following goals: (A) Preparedness goal.— Enhance the preparedness of the agriculture and food system by— (i) conducting vulnerability assessments of the agriculture and food system; (ii) mitigating vulnerabilities of the system; (iii) improving communication and training relating to the system; (iv) developing and conducting exercises to test decontamination and disposal plans; (v) developing modeling tools to improve event consequence assessment and decision support; and (vi) preparing risk communication tools and enhancing public awareness through outreach. (B) Detection goal.— Improve agriculture and food system detection capabilities by— (i) identifying contamination in food products at the earliest possible time; and (ii) conducting surveillance to prevent the spread of diseases. (C) Emergency response goal.— Ensure an efficient response to agriculture and food emergencies by— (i) immediately investigating animal disease outbreaks and suspected food contamination; (ii) preventing additional human illnesses; (iii) organizing, training, and equipping animal, plant, and food emergency response teams of— (I) the Federal Government; and (II) State, local, and tribal governments; (iv) designing, developing, and evaluating training and exercises carried out under agriculture and food defense plans; and (v) ensuring consistent and organized risk communication to the public by— (I) the Federal Government; (II) State, local, and tribal governments; and (III) the private sector. (D) Recovery goal.— Secure agriculture and food production after an agriculture or food emergency by— (i) working with the private sector to develop business recovery plans to rapidly resume agriculture, food production, and international trade; (ii) conducting exercises of the plans described in subparagraph (C) with the goal of long-term recovery results; (iii) rapidly removing, and effectively disposing of— (I) contaminated agriculture and food products; and (II) infected plants and animals; and (iv) decontaminating and restoring areas affected by an agriculture or food emergency. (3) Evaluation.— The Secretary, in coordination with the Secretary of Agriculture and the Secretary of Homeland Security, shall— (A) develop metrics to measure progress for the evaluation process described in paragraph (1)(B); and (B) report on the progress measured in subparagraph (A) as part of the National Agriculture and Food Defense strategy described in subsection (a)(1). (c) Limited Distribution.— In the interest of national security, the Secretary of Health and Human Services and the Secretary of Agriculture, in coordination with the Secretary of Homeland Security, may determine the manner and format in which the National Agriculture and Food Defense strategy established under this section is made publicly available on the Internet Web sites of the Department of Health and Human Services, the Department of Homeland Security, and the Department of Agriculture, as described in subsection (a)(1). SEC. 109. FOOD AND AGRICULTURE COORDINATING COUNCILS.   The Secretary of Homeland Security, in coordination with the Secretary of Health and Human Services and the Secretary of Agriculture, shall within 180 days of enactment of this Act, and annually thereafter, submit to the relevant committees of Congress, and make publicly available on the Internet Web site of the Department of Homeland Security, a report on the activities of the Food and Agriculture Government Coordinating Council and the Food and Agriculture Sector Coordinating Council, including the progress of such Councils on— (1) facilitating partnerships between public and private entities to help coordinate and enhance the protection of the agriculture and food system of the United States; (2) providing for the regular and timely interchange of information between each council relating to the security of the agriculture and food system (including intelligence information); (3) identifying best practices and methods for improving the coordination among Federal, State, local, and private sector preparedness and response plans for agriculture and food defense; and (4) recommending methods by which to protect the economy and the public health of the United States from the effects of— (A) animal or plant disease outbreaks; (B) food contamination; and (C) natural disasters affecting agriculture and food. SEC. 110. BUILDING DOMESTIC CAPACITY. (a) In General.— (1) Initial report.— The Secretary, in coordination with the Secretary of Agriculture and the Secretary of Homeland Security, shall, not later than 2 years after the date of enactment of this Act, submit to Congress a comprehensive report that identifies programs and practices that are intended to promote the safety and supply chain security of food and to prevent outbreaks of foodborne illness and other food-related hazards that can be addressed through preventive activities. Such report shall include a description of the following: (A) Analysis of the need for further regulations or guidance to industry. (B) Outreach to food industry sectors, including through the Food and Agriculture Coordinating Councils referred to in section 109, to identify potential sources of emerging threats to the safety and security of the food supply and preventive strategies to address those threats. (C) Systems to ensure the prompt distribution to the food industry of information and technical assistance concerning preventive strategies. (D) Communication systems to ensure that information about specific threats to the safety and security of the food supply are rapidly and effectively disseminated. (E) Surveillance systems and laboratory networks to rapidly detect and respond to foodborne illness outbreaks and other food-related hazards, including how such systems and networks are integrated. (F) Outreach, education, and training provided to States and local governments to build State and local food safety and food defense capabilities, including progress implementing strategies developed under sections 108 and 205. (G) The estimated resources needed to effectively implement the programs and practices identified in the report developed in this section over a 5-year period. (H) The impact of requirements under this Act (including amendments made by this Act) on certified organic farms and facilities (as defined in section 415 (21 U.S.C. 350d). (I) Specific efforts taken pursuant to the agreements authorized under section 421(c) of the Federal Food, Drug, and Cosmetic Act (as added by section 201), together with, as necessary, a description of any additional authorities necessary to improve seafood safety. (2) Biennial reports.— On a biennial basis following the submission of the report under paragraph (1), the Secretary shall submit to Congress a report that— (A) reviews previous food safety programs and practices; (B) outlines the success of those programs and practices; (C) identifies future programs and practices; and (D) includes information related to any matter described in subparagraphs (A) through (H) of paragraph (1), as necessary. (b) Risk-based Activities.— The report developed under subsection (a)(1) shall describe methods that seek to ensure that resources available to the Secretary for food safety-related activities are directed at those actions most likely to reduce risks from food, including the use of preventive strategies and allocation of inspection resources. The Secretary shall promptly undertake those risk-based actions that are identified during the development of the report as likely to contribute to the safety and security of the food supply. (c) Capability for Laboratory Analyses; Research.— The report developed under subsection (a)(1) shall provide a description of methods to increase capacity to undertake analyses of food samples promptly after collection, to identify new and rapid analytical techniques, including commercially-available techniques that can be employed at ports of entry and by Food Emergency Response Network laboratories, and to provide for well-equipped and staffed laboratory facilities and progress toward laboratory accreditation under section 422 of the Federal Food, Drug, and Cosmetic Act (as added by section 202). (d) Information Technology.— The report developed under subsection (a)(1) shall include a description of such information technology systems as may be needed to identify risks and receive data from multiple sources, including foreign governments, State, local, and tribal governments, other Federal agencies, the food industry, laboratories, laboratory networks, and consumers. The information technology systems that the Secretary describes shall also provide for the integration of the facility registration system under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), and the prior notice system under section 801(m) of such Act (21 U.S.C. 381(m)) with other information technology systems that are used by the Federal Government for the processing of food offered for import into the United States. (e) Automated Risk Assessment.— The report developed under subsection (a)(1) shall include a description of progress toward developing and improving an automated risk assessment system for food safety surveillance and allocation of resources. (f) Traceback and Surveillance Report.— The Secretary shall include in the report developed under subsection (a)(1) an analysis of the Food and Drug Administration’s performance in foodborne illness outbreaks during the 5-year period preceding the date of enactment of this Act involving fruits and vegetables that are raw agricultural commodities (as defined in section 201(r) (21 U.S.C. 321(r)) and recommendations for enhanced surveillance, outbreak response, and traceability. Such findings and recommendations shall address communication and coordination with the public, industry, and State and local governments, as such communication and coordination relates to outbreak identification and traceback. (g) Biennial Food Safety and Food Defense Research Plan.— The Secretary, the Secretary of Agriculture, and the Secretary of Homeland Security shall, on a biennial basis, submit to Congress a joint food safety and food defense research plan which may include studying the long-term health effects of foodborne illness. Such biennial plan shall include a list and description of projects conducted during the previous 2-year period and the plan for projects to be conducted during the subsequent 2-year period. (h) Effectiveness of Programs Administered by the Department of Health and Human Services.— (1) In general.— To determine whether existing Federal programs administered by the Department of Health and Human Services are effective in achieving the stated goals of such programs, the Secretary shall, beginning not later than 1 year after the date of enactment of this Act— (A) conduct an annual evaluation of each program of such Department to determine the effectiveness of each such program in achieving legislated intent, purposes, and objectives; and (B) submit to Congress a report concerning such evaluation. (2) Content.— The report described under paragraph (1)(B) shall— (A) include conclusions concerning the reasons that such existing programs have proven successful or not successful and what factors contributed to such conclusions; (B) include recommendations for consolidation and elimination to reduce duplication and inefficiencies in such programs at such Department as identified during the evaluation conduct under this subsection; and (C) be made publicly available in a publication entitled “Guide to the U.S. Department of Health and Human Services Programs”. (i) Unique Identification Numbers.— (1) In general.— Not later than 1 year after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall conduct a study regarding the need for, and challenges associated with, development and implementation of a program that requires a unique identification number for each food facility registered with the Secretary and, as appropriate, each broker that imports food into the United States. Such study shall include an evaluation of the costs associated with development and implementation of such a system, and make recommendations about what new authorities, if any, would be necessary to develop and implement such a system. (2) Report.— Not later than 15 months after the date of enactment of this Act, the Secretary shall submit to Congress a report that describes the findings of the study conducted under paragraph (1) and that includes any recommendations determined appropriate by the Secretary. SEC. 111. SANITARY TRANSPORTATION OF FOOD. (a) In General.— Not later than 18 months after the date of enactment of this Act, the Secretary shall promulgate regulations described in section 416(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350e(b)). (b) Food Transportation Study.— The Secretary, acting through the Commissioner of Food and Drugs, shall conduct a study of the transportation of food for consumption in the United States, including transportation by air, that includes an examination of the unique needs of rural and frontier areas with regard to the delivery of safe food. SEC. 112. FOOD ALLERGY AND ANAPHYLAXIS MANAGEMENT. (a) Definitions.— In this section: (1) Early childhood education program.— The term “early childhood education program” means— (A) a Head Start program or an Early Head Start program carried out under the Head Start Act (42 U.S.C. 9831 et seq.); (B) a State licensed or regulated child care program or school; or (C) a State prekindergarten program that serves children from birth through kindergarten. (2) ESEA definitions.— The terms “local educational agency”, “secondary school”, “elementary school”, and “parent” have the meanings given the terms in section 9101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801). (3) School.— The term “school” includes public— (A) kindergartens; (B) elementary schools; and (C) secondary schools. (4) Secretary.— The term “Secretary” means the Secretary of Health and Human Services. (b) Establishment of Voluntary Food Allergy and Anaphylaxis Management Guidelines.— (1) Establishment.— (A) In general.— Not later than 1 year after the date of enactment of this Act, the Secretary, in consultation with the Secretary of Education, shall— (i) develop guidelines to be used on a voluntary basis to develop plans for individuals to manage the risk of food allergy and anaphylaxis in schools and early childhood education programs; and (ii) make such guidelines available to local educational agencies, schools, early childhood education programs, and other interested entities and individuals to be implemented on a voluntary basis only. (B) Applicability of ferpa.— Each plan described in subparagraph (A) that is developed for an individual shall be considered an education record for the purpose of section 444 of the General Education Provisions Act (commonly referred to as the “Family Educational Rights and Privacy Act of 1974”) (20 U.S.C. 1232g). (2) Contents.— The voluntary guidelines developed by the Secretary under paragraph (1) shall address each of the following and may be updated as the Secretary determines necessary: (A) Parental obligation to provide the school or early childhood education program, prior to the start of every school year, with— (i) documentation from their child’s physician or nurse— (I) supporting a diagnosis of food allergy, and any risk of anaphylaxis, if applicable; (II) identifying any food to which the child is allergic; (III) describing, if appropriate, any prior history of anaphylaxis; (IV) listing any medication prescribed for the child for the treatment of anaphylaxis; (V) detailing emergency treatment procedures in the event of a reaction; (VI) listing the signs and symptoms of a reaction; and (VII) assessing the child’s readiness for self-administration of prescription medication; and (ii) a list of substitute meals that may be offered to the child by school or early childhood education program food service personnel. (B) The creation and maintenance of an individual plan for food allergy management, in consultation with the parent, tailored to the needs of each child with a documented risk for anaphylaxis, including any procedures for the self-administration of medication by such children in instances where— (i) the children are capable of self-administering medication; and (ii) such administration is not prohibited by State law. (C) Communication strategies between individual schools or early childhood education programs and providers of emergency medical services, including appropriate instructions for emergency medical response. (D) Strategies to reduce the risk of exposure to anaphylactic causative agents in classrooms and common school or early childhood education program areas such as cafeterias. (E) The dissemination of general information on life-threatening food allergies to school or early childhood education program staff, parents, and children. (F) Food allergy management training of school or early childhood education program personnel who regularly come into contact with children with life-threatening food allergies. (G) The authorization and training of school or early childhood education program personnel to administer epinephrine when the nurse is not immediately available. (H) The timely accessibility of epinephrine by school or early childhood education program personnel when the nurse is not immediately available. (I) The creation of a plan contained in each individual plan for food allergy management that addresses the appropriate response to an incident of anaphylaxis of a child while such child is engaged in extracurricular programs of a school or early childhood education program, such as non-academic outings and field trips, before- and after-school programs or before- and after-early child education program programs, and school-sponsored or early childhood education program-sponsored programs held on weekends. (J) Maintenance of information for each administration of epinephrine to a child at risk for anaphylaxis and prompt notification to parents. (K) Other elements the Secretary determines necessary for the management of food allergies and anaphylaxis in schools and early childhood education programs. (3) Relation to state law.— Nothing in this section or the guidelines developed by the Secretary under paragraph (1) shall be construed to preempt State law, including any State law regarding whether students at risk for anaphylaxis may self-administer medication. (c) School-based Food Allergy Management Grants.— (1) In general.— The Secretary may award grants to local educational agencies to assist such agencies with implementing voluntary food allergy and anaphylaxis management guidelines described in subsection (b). (2) Application.— (A) In general.— To be eligible to receive a grant under this subsection, a local educational agency shall submit an application to the Secretary at such time, in such manner, and including such information as the Secretary may reasonably require. (B) Contents.— Each application submitted under subparagraph (A) shall include— (i) an assurance that the local educational agency has developed plans in accordance with the food allergy and anaphylaxis management guidelines described in subsection (b); (ii) a description of the activities to be funded by the grant in carrying out the food allergy and anaphylaxis management guidelines, including— (I) how the guidelines will be carried out at individual schools served by the local educational agency; (II) how the local educational agency will inform parents and students of the guidelines in place; (III) how school nurses, teachers, administrators, and other school-based staff will be made aware of, and given training on, when applicable, the guidelines in place; and (IV) any other activities that the Secretary determines appropriate; (iii) an itemization of how grant funds received under this subsection will be expended; (iv) a description of how adoption of the guidelines and implementation of grant activities will be monitored; and (v) an agreement by the local educational agency to report information required by the Secretary to conduct evaluations under this subsection. (3) Use of funds.— Each local educational agency that receives a grant under this subsection may use the grant funds for the following: (A) Purchase of materials and supplies, including limited medical supplies such as epinephrine and disposable wet wipes, to support carrying out the food allergy and anaphylaxis management guidelines described in subsection (b). (B) In partnership with local health departments, school nurse, teacher, and personnel training for food allergy management. (C) Programs that educate students as to the presence of, and policies and procedures in place related to, food allergies and anaphylactic shock. (D) Outreach to parents. (E) Any other activities consistent with the guidelines described in subsection (b). (4) Duration of awards.— The Secretary may award grants under this subsection for a period of not more than 2 years. In the event the Secretary conducts a program evaluation under this subsection, funding in the second year of the grant, where applicable, shall be contingent on a successful program evaluation by the Secretary after the first year. (5) Limitation on grant funding.— The Secretary may not provide grant funding to a local educational agency under this subsection after such local educational agency has received 2 years of grant funding under this subsection. (6) Maximum amount of annual awards.— A grant awarded under this subsection may not be made in an amount that is more than $50,000 annually. (7) Priority.— In awarding grants under this subsection, the Secretary shall give priority to local educational agencies with the highest percentages of children who are counted under section 1124(c) of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 6333(c)). (8) Matching funds.— (A) In general.— The Secretary may not award a grant under this subsection unless the local educational agency agrees that, with respect to the costs to be incurred by such local educational agency in carrying out the grant activities, the local educational agency shall make available (directly or through donations from public or private entities) non-Federal funds toward such costs in an amount equal to not less than 25 percent of the amount of the grant. (B) Determination of amount of non-federal contribution.— Non-Federal funds required under subparagraph (A) may be cash or in kind, including plant, equipment, or services. Amounts provided by the Federal Government, and any portion of any service subsidized by the Federal Government, may not be included in determining the amount of such non-Federal funds. (9) Administrative funds.— A local educational agency that receives a grant under this subsection may use not more than 2 percent of the grant amount for administrative costs related to carrying out this subsection. (10) Progress and evaluations.— At the completion of the grant period referred to in paragraph (4), a local educational agency shall provide the Secretary with information on how grant funds were spent and the status of implementation of the food allergy and anaphylaxis management guidelines described in subsection (b). (11) Supplement, not supplant.— Grant funds received under this subsection shall be used to supplement, and not supplant, non-Federal funds and any other Federal funds available to carry out the activities described in this subsection. (12) Authorization of appropriations.— There is authorized to be appropriated to carry out this subsection $30,000,000 for fiscal year 2011 and such sums as may be necessary for each of the 4 succeeding fiscal years. (d) Voluntary Nature of Guidelines.— (1) In general.— The food allergy and anaphylaxis management guidelines developed by the Secretary under subsection (b) are voluntary. Nothing in this section or the guidelines developed by the Secretary under subsection (b) shall be construed to require a local educational agency to implement such guidelines. (2) Exception.— Notwithstanding paragraph (1), the Secretary may enforce an agreement by a local educational agency to implement food allergy and anaphylaxis management guidelines as a condition of the receipt of a grant under subsection (c). SEC. 113. NEW DIETARY INGREDIENTS. (a) In General.— Section 413 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350b) is amended— (1) by redesignating subsection (c) as subsection (d); and (2) by inserting after subsection (b) the following: “(c) Notification.— “(1) In general.— If the Secretary determines that the information in a new dietary ingredient notification submitted under this section for an article purported to be a new dietary ingredient is inadequate to establish that a dietary supplement containing such article will reasonably be expected to be safe because the article may be, or may contain, an anabolic steroid or an analogue of an anabolic steroid, the Secretary shall notify the Drug Enforcement Administration of such determination. Such notification by the Secretary shall include, at a minimum, the name of the dietary supplement or article, the name of the person or persons who marketed the product or made the submission of information regarding the article to the Secretary under this section, and any contact information for such person or persons that the Secretary has. “(2) Definitions.— For purposes of this subsection— “(A) the term ‘anabolic steroid’ has the meaning given such term in section 102(41) of the Controlled Substances Act; and “(B) the term ‘analogue of an anabolic steroid’ means a substance whose chemical structure is substantially similar to the chemical structure of an anabolic steroid.” . (b) Guidance.— Not later than 180 days after the date of enactment of this Act, the Secretary shall publish guidance that clarifies when a dietary supplement ingredient is a new dietary ingredient, when the manufacturer or distributor of a dietary ingredient or dietary supplement should provide the Secretary with information as described in section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act, the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing the identify of a new dietary ingredient. SEC. 114. REQUIREMENT FOR GUIDANCE RELATING TO POST HARVEST PROCESSING OF RAW OYSTERS. (a) In General.— Not later than 90 days prior to the issuance of any guidance, regulation, or suggested amendment by the Food and Drug Administration to the National Shellfish Sanitation Program’s Model Ordinance, or the issuance of any guidance or regulation by the Food and Drug Administration relating to the Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration (parts 123 and 1240 of title 21, Code of Federal Regulations (or any successor regulations), where such guidance, regulation or suggested amendment relates to post harvest processing for raw oysters, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report which shall include— (1) an assessment of how post harvest processing or other equivalent controls feasibly may be implemented in the fastest, safest, and most economical manner; (2) the projected public health benefits of any proposed post harvest processing; (3) the projected costs of compliance with such post harvest processing measures; (4) the impact post harvest processing is expected to have on the sales, cost, and availability of raw oysters; (5) criteria for ensuring post harvest processing standards will be applied equally to shellfish imported from all nations of origin; (6) an evaluation of alternative measures to prevent, eliminate, or reduce to an acceptable level the occurrence of foodborne illness; and (7) the extent to which the Food and Drug Administration has consulted with the States and other regulatory agencies, as appropriate, with regard to post harvest processing measures. (b) Limitation.— Subsection (a) shall not apply to the guidance described in section 103(h). (c) Review and Evaluation.— Not later than 30 days after the Secretary issues a proposed regulation or guidance described in subsection (a), the Comptroller General of the United States shall— (1) review and evaluate the report described in (a) and report to Congress on the findings of the estimates and analysis in the report; (2) compare such proposed regulation or guidance to similar regulations or guidance with respect to other regulated foods, including a comparison of risks the Secretary may find associated with seafood and the instances of those risks in such other regulated foods; and (3) evaluate the impact of post harvest processing on the competitiveness of the domestic oyster industry in the United States and in international markets. (d) Waiver.— The requirement of preparing a report under subsection (a) shall be waived if the Secretary issues a guidance that is adopted as a consensus agreement between Federal and State regulators and the oyster industry, acting through the Interstate Shellfish Sanitation Conference. (e) Public Access.— Any report prepared under this section shall be made available to the public. SEC. 115. PORT SHOPPING.    Notification. Until the date on which the Secretary promulgates a final rule that implements the amendments made by section 308 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, (Public Law 107–188), the Secretary shall notify the Secretary of Homeland Security of all instances in which the Secretary refuses to admit a food into the United States under section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) so that the Secretary of Homeland Security, acting through the Commissioner of Customs and Border Protection, may prevent food refused admittance into the United States by a United States port of entry from being admitted by another United States port of entry, through the notification of other such United States ports of entry. SEC. 116. ALCOHOL-RELATED FACILITIES. (a) In General.— Except as provided by sections 102, 206, 207, 302, 304, 402, 403, and 404 of this Act, and the amendments made by such sections, nothing in this Act, or the amendments made by this Act, shall be construed to apply to a facility that— (1) under the Federal Alcohol Administration Act (27 U.S.C. 201 et seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986 (26 U.S.C. 5001 et seq.) is required to obtain a permit or to register with the Secretary of the Treasury as a condition of doing business in the United States; and (2) under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) is required to register as a facility because such facility is engaged in manufacturing, processing, packing, or holding 1 or more alcoholic beverages, with respect to the activities of such facility that relate to the manufacturing, processing, packing, or holding of alcoholic beverages. (b) Limited Receipt and Distribution of Non-alcohol Food.— Subsection (a) shall not apply to a facility engaged in the receipt and distribution of any non-alcohol food, except that such paragraph shall apply to a facility described in such paragraph that receives and distributes non-alcohol food, provided such food is received and distributed— (1) in a prepackaged form that prevents any direct human contact with such food; and (2) in amounts that constitute not more than 5 percent of the overall sales of such facility, as determined by the Secretary of the Treasury. (c) Rule of Construction.— Except as provided in subsections (a) and (b), this section shall not be construed to exempt any food, other than alcoholic beverages, as defined in section 214 of the Federal Alcohol Administration Act (27 U.S.C. 214), from the requirements of this Act (including the amendments made by this Act).

44. 2011

    FDA Food Safety Modernization Act

    Pub. L. 111–353 § 303(c) · 124 Stat. 3885

    Substituted · 21 U.S.C. § 381(b)

    Pub. L. 111–353, § 303(c), substituted “with respect to an article described in subsection (a) relating to the requirements of sections 379aa or 379aa–1 of this title,” for “with respect to an article included within the provision of the fourth sentence of subsection (a)” in second sentence

    Source evidence

    Code amendment note
    Subsec. (b). Pub. L. 111–353, § 303(c), substituted “with respect to an article described in subsection (a) relating to the requirements of sections 379aa or 379aa–1 of this title,” for “with respect to an article included within the provision of the fourth sentence of subsection (a)” in second sentence.

    Enacted provision · exact public law section
    (c) Conforming Technical Amendment.— Section 801(b) (21 U.S.C. 381(b)) is amended in the second sentence by striking “with respect to an article included within the provision of the fourth sentence of subsection (a)” and inserting “with respect to an article described in subsection (a) relating to the requirements of sections 760 or 761,”.

45. 2011

    FDA Food Safety Modernization Act

    Pub. L. 111–353 § 107(b)(1)(A) · 124 Stat. 3885

    Substituted · 21 U.S.C. § 381(e)(4)(A)

    Pub. L. 111–353, § 107(b)(1)(A), substituted “a food, drug” for “a drug” in introductory provisions

    Source evidence

    Code amendment note
    Subsec. (e)(4)(A). Pub. L. 111–353, § 107(b)(1)(A), substituted “a food, drug” for “a drug” in introductory provisions.

    Enacted provision · exact public law section
    (A) in the matter preceding clause (i), by striking “a drug” and inserting “a food, drug”;

46. 2011

    FDA Food Safety Modernization Act

    Pub. L. 111–353 § 107(b)(1)(B) · 124 Stat. 3885

    Substituted · 21 U.S.C. § 381(e)(4)(A)(i)

    Pub. L. 111–353, § 107(b)(1)(B), substituted “exported food, drug” for “exported drug”

    Source evidence

    Code amendment note
    Subsec. (e)(4)(A)(i). Pub. L. 111–353, § 107(b)(1)(B), substituted “exported food, drug” for “exported drug”.

    Enacted provision · exact public law section
    (B) in clause (i) by striking “exported drug” and inserting “exported food, drug”; and

47. 2011

    FDA Food Safety Modernization Act

    Pub. L. 111–353 § 107(b)(1)(C) · 124 Stat. 3885

    Substituted · 21 U.S.C. § 381(e)(4)(A)(ii)

    Pub. L. 111–353, § 107(b)(1)(C), substituted “the food, drug” for “the drug” in two places

    Source evidence

    Code amendment note
    Subsec. (e)(4)(A)(ii). Pub. L. 111–353, § 107(b)(1)(C), substituted “the food, drug” for “the drug” in two places.

    Enacted provision · exact public law section
    (C) in clause (ii) by striking “the drug” each place it appears and inserting “the food, drug”.

48. 2011

    FDA Food Safety Modernization Act

    Pub. L. 111–353 § 107(b)(2) · 124 Stat. 3885

    Added · 21 U.S.C. § 381(e)(4)(C)

    Pub. L. 111–353, § 107(b)(2), added subpar. (C)

    Source evidence

    Code amendment note
    Subsec. (e)(4)(C). Pub. L. 111–353, § 107(b)(2), added subpar. (C).

    Enacted provision · exact public law section
    (2) Clarification of certification.— Section 801(e)(4) (21 U.S.C. 381(e)(4)) is amended by inserting after subparagraph (B) the following new subparagraph: “(C) For purposes of this paragraph, a certification by the Secretary shall be made on such basis, and in such form (including a publicly available listing) as the Secretary determines appropriate.” .

49. 2011

    FDA Food Safety Modernization Act

    Pub. L. 111–353 § 107(b)(3) · 124 Stat. 3885

    Added · 21 U.S.C. § 381(e)(4)(D)

    Pub. L. 111–353, § 107(b)(3), added subpar. (D)

    Source evidence

    Code amendment note
    Subsec. (e)(4)(D). Pub. L. 111–353, § 107(b)(3), added subpar. (D).

    Enacted provision · exact public law section
    (3) Limitations on the use and amount of fees.— Paragraph (4) of section 801(e) (21 U.S.C. 381(e)) is amended by adding at the end the following: “(D) With regard to fees pursuant to subparagraph (B) in connection with written export certifications for food: “(i) Such fees shall be collected and available solely for the costs of the Food and Drug Administration associated with issuing such certifications. “(ii) Such fees may not be retained in an amount that exceeds such costs for the respective fiscal year.”

50. 2011

    FDA Food Safety Modernization Act

    Pub. L. 111–353 § 102(b)(3) · 124 Stat. 3885

    Inserted · 21 U.S.C. § 381(l)

    Pub. L. 111–353, § 102(b)(3), inserted “(or for which a registration has been suspended under such section)” after “section 350d of this title”

    Source evidence

    Code amendment note
    Subsec. (l). Pub. L. 111–353, § 102(b)(3), inserted “(or for which a registration has been suspended under such section)” after “section 350d of this title”.

    Enacted provision · exact public law section
    (3) Imported food.— Section 801(l) (21 U.S.C. 381(l)) is amended by inserting “(or for which a registration has been suspended under such section)” after “section 415”.

51. 2011

    FDA Food Safety Modernization Act

    Pub. L. 111–353 § 304(a) · 124 Stat. 3885

    Inserted · 21 U.S.C. § 381(m)(1)

    Pub. L. 111–353, § 304(a), inserted “any country to which the article has been refused entry;” after “the country from which the article is shipped;”

    Source evidence

    Code amendment note
    Subsec. (m)(1). Pub. L. 111–353, § 304(a), inserted “any country to which the article has been refused entry;” after “the country from which the article is shipped;”.

    Enacted provision · exact public law section
    (a) In General.— Section 801(m)(1) (21 U.S.C. 381(m)(1)) is amended by inserting “any country to which the article has been refused entry;” after “the country from which the article is shipped;”.

52. 2011

    FDA Food Safety Modernization Act

    Pub. L. 111–353 § 303(b) · 124 Stat. 3885

    Added · 21 U.S.C. § 381(q)

    Pub. L. 111–353, § 303(b), added subsec. (q)

    Source evidence

    Code amendment note
    Subsec. (q). Pub. L. 111–353, § 303(b), added subsec. (q).

    Enacted provision · exact public law section
    (b) Addition of Certification Requirement.— Section 801 (21 U.S.C. 381) is amended by adding at the end the following new subsection: “(q) Certifications Concerning Imported Foods.— “(1) In general.— The Secretary may require, as a condition of granting admission to an article of food imported or offered for import into the United States, that an entity described in paragraph (3) provide a certification, or such other assurances as the Secretary determines appropriate, that the article of food complies with applicable requirements of this Act. Such certification or assurances may be provided in the form of shipment-specific certificates, a listing of certified facilities that manufacture, process, pack, or hold such food, or in such other form as the Secretary may specify. “(2) Factors to be considered in requiring certification.— The Secretary shall base the determination that an article of food is required to have a certification described in paragraph (1) on the risk of the food, including— “(A) known safety risks associated with the food; “(B) known food safety risks associated with the country, territory, or region of origin of the food; “(C) a finding by the Secretary, supported by scientific, risk-based evidence, that— “(i) the food safety programs, systems, and standards in the country, territory, or region of origin of the food are inadequate to ensure that the article of food is as safe as a similar article of food that is manufactured, processed, packed, or held in the United States in accordance with the requirements of this Act; and “(ii) the certification would assist the Secretary in determining whether to refuse or admit the article of food under subsection (a); and “(D) information submitted to the Secretary in accordance with the process established in paragraph (7). “(3) Certifying entities.— For purposes of paragraph (1), entities that shall provide the certification or assurances described in such paragraph are— “(A) an agency or a representative of the government of the country from which the article of food at issue originated, as designated by the Secretary; or “(B) such other persons or entities accredited pursuant to section 808 to provide such certification or assurance. “(4) Renewal and refusal of certifications.— The Secretary may— “(A) require that any certification or other assurance provided by an entity specified in paragraph (2) be renewed by such entity at such times as the Secretary determines appropriate; and “(B) refuse to accept any certification or assurance if the Secretary determines that such certification or assurance is not valid or reliable. “(5) Electronic submission.— The Secretary shall provide for the electronic submission of certifications under this subsection. “(6) False statements.— Any statement or representation made by an entity described in paragraph (2) to the Secretary shall be subject to section 1001 of title 18, United States Code. “(7) Assessment of food safety programs, systems, and standards.— If the Secretary determines that the food safety programs, systems, and standards in a foreign region, country, or territory are inadequate to ensure that an article of food is as safe as a similar article of food that is manufactured, processed, packed, or held in the United States in accordance with the requirements of this Act, the Secretary shall, to the extent practicable, identify such inadequacies and establish a process by which the foreign region, country, or territory may inform the Secretary of improvements made to such food safety program, system, or standard and demonstrate that those controls are adequate to ensure that an article of food is as safe as a similar article of food that is manufactured, processed, packed, or held in the United States in accordance with the requirements of this Act.” .

53. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 708(b) · 126 Stat. 993

    Inserted · 21 U.S.C. § 381(a)

    Pub. L. 112–144, § 708(b), inserted “The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug under the sixth sentence of this subsection. The regulations shall provide that prior to destruction, appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug. Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c). Such process may be combined with the notice and opportunity to appear before the Secretary and introduce testimony, as described in the first sentence of this subsection, as long as appropriate notice is provided to the owner or consignee.” after “described under subsection (b)..”

    Source evidence

    Code amendment note
    Subsec. (a). Pub. L. 112–144, § 708(b), inserted “The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug under the sixth sentence of this subsection. The regulations shall provide that prior to destruction, appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug. Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c). Such process may be combined with the notice and opportunity to appear before the Secretary and introduce testimony, as described in the first sentence of this subsection, as long as appropriate notice is provided to the owner or consignee.” after “described under subsection (b)..”

    Enacted provision · exact public law section
    (b) Notice.— Subsection (a) of section 801 (21 U.S.C. 381), as amended by subsection (a), is further amended by inserting after the sixth sentence the following: “The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug under the sixth sentence of this subsection. The regulations shall provide that prior to destruction, appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug. Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c). Such process may be combined with the notice and opportunity to appear before the Secretary and introduce testimony, as described in the first sentence of this subsection, as long as appropriate notice is provided to the owner or consignee.”.

54. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 708(a) · 126 Stat. 993

    Inserted · 21 U.S.C. § 381(a)

    Pub. L. 112–144, § 708(a), inserted “, except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug refused admission under this section, if such drug is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 1498(a)(1) of title 19 and was not brought into compliance as described under subsection (b).” after “pursuant to such regulations”

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 112–144, § 708(a), inserted “, except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug refused admission under this section, if such drug is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 1498(a)(1) of title 19 and was not brought into compliance as described under subsection (b).” after “pursuant to such regulations”.

    Enacted provision · exact public law section
    (a) In General.— The sixth sentence of section 801(a) (21 U.S.C. 381(a)) is amended by inserting before the period at the end the following: “, except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug refused admission under this section, if such drug is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 498(a)(1) of the Tariff Act of 1930 (19 U.S.C. 1498(a)(1)) and was not brought into compliance as described under subsection (b).”.

55. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 713(1) · 126 Stat. 993

    Struck · 21 U.S.C. § 381(o)

    Pub. L. 112–144, § 713(1), struck out “drug or” after “If an article that is a”

    Source evidence

    Code amendment note
    Subsec. (o). Pub. L. 112–144, § 713(1), struck out “drug or” after “If an article that is a”.

    Enacted provision · exact public law section
    (1) in subsection (o), by striking “drug or”; and

56. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 713(2) · 126 Stat. 993

    Added · 21 U.S.C. § 381(r)

    Pub. L. 112–144, § 713(2), added subsec. (r)

    Source evidence

    Code amendment note
    Subsec. (r). Pub. L. 112–144, § 713(2), added subsec. (r).

    Enacted provision · exact public law section
    (2) by adding at the end the following: “(r) (1) The Secretary may require, pursuant to the regulations promulgated under paragraph (4)(A), as a condition of granting admission to a drug imported or offered for import into the United States, that the importer electronically submit information demonstrating that the drug complies with applicable requirements of this Act. “(2) The information described under paragraph (1) may include— “(A) information demonstrating the regulatory status of the drug, such as the new drug application, abbreviated new drug application, or investigational new drug or drug master file number; “(B) facility information, such as proof of registration and the unique facility identifier; “(C) indication of compliance with current good manufacturing practice, testing results, certifications relating to satisfactory inspections, and compliance with the country of export regulations; and “(D) any other information deemed necessary and appropriate by the Secretary to assess compliance of the article being offered for import. “(3) Information requirements referred to in paragraph (2)(C) may, at the discretion of the Secretary, be satisfied— “(A) through representation by a foreign government, if an inspection is conducted by a foreign government using standards and practices as determined appropriate by the Secretary; “(B) through representation by a foreign government or an agency of a foreign government recognized under section 809; or “(C) other appropriate documentation or evidence as described by the Secretary. “(4) (A) Deadlines. Regulations. Not later than 18 months after the date of enactment of the Food and Drug Administration Safety and Innovation Act, the Secretary shall adopt final regulations implementing this subsection. Such requirements shall be appropriate for the type of import, such as whether the drug is for import into the United States for use in preclinical research or in a clinical investigation under an investigational new drug exemption under 505(i). “(B) In promulgating the regulations under subparagraph (A), the Secretary— “(i) may, as appropriate, take into account differences among importers and types of imports, and, based on the level of risk posed by the imported drug, provide for expedited clearance for those importers that volunteer to participate in partnership programs for highly compliant companies and pass a review of internal controls, including sourcing of foreign manufacturing inputs, and plant inspections; and “(ii) shall— “(I) Notice. issue a notice of proposed rulemaking that includes the proposed regulation; “(II) Time period. provide a period of not less than 60 days for comments on the proposed regulation; and “(III) Publication. publish the final regulation not less than 30 days before the effective date of the regulation. “(C) Notwithstanding any other provision of law, the Secretary shall promulgate regulations implementing this subsection only as described in subparagraph (B).” .

57. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 714(b) · 126 Stat. 993

    Added · 21 U.S.C. § 381(s)

    Pub. L. 112–144, § 714(b), added subsec. (s)

    Source evidence

    Code amendment note
    Subsec. (s). Pub. L. 112–144, § 714(b), added subsec. (s).

    Enacted provision · exact public law section
    (b) Registration.— Section 801 (21 U.S.C. 381), as amended by section 713 of this Act, is further amended by adding at the end the following: “(s) Registration of Commercial Importers.— “(1) Registration.— The Secretary shall require a commercial importer of drugs— “(A) to be registered with the Secretary in a form and manner specified by the Secretary; and “(B) subject to paragraph (4), to submit, at the time of registration, a unique identifier for the principal place of business for which the importer is required to register under this subsection. “(2) Regulations.— “(A) In general.— The Secretary, in consultation with the Secretary of Homeland Security acting through U.S. Customs and Border Protection, shall promulgate regulations to establish good importer practices that specify the measures an importer shall take to ensure imported drugs are in compliance with the requirements of this Act and the Public Health Service Act. “(B) Procedure.— In promulgating a regulation under subparagraph (A), the Secretary shall— “(i) Notice. issue a notice of proposed rulemaking that includes the proposed regulation; “(ii) Time period. provide a period of not less than 60 days for comments on the proposed regulation; and “(iii) Publication. publish the final regulation not less than 30 days before the regulation’s effective date. “(C) Restrictions.— Notwithstanding any other provision of Federal law, in implementing this subsection, the Secretary shall only promulgate regulations as described in subparagraph (B). “(3) Discontinuance of registration.— The Secretary shall discontinue the registration of any commercial importer of drugs that fails to comply with the regulations promulgated under this subsection. “(4) Unique facility identifier.— The Secretary shall specify the unique facility identifier system that shall be used by registrants under paragraph (1). Applicability. The requirement to include a unique facility identifier in a registration under paragraph (1) shall not apply until the date that the identifier system is specified by the Secretary under the preceding sentence. “(5) Exemptions.— The Secretary, by notice in the Federal Register, may establish exemptions from the requirements of this subsection.” .

58. 2016

    21st Century Cures Act

    Pub. L. 114–255 div. A title III § 3101(a)(2)(W)(i) · 130 Stat. 1033

    Added · 21 U.S.C. § 381(s)(2)(D)

    Pub. L. 114–255 added subpar. (D)

    Source evidence

    Code amendment note
    Subsec. (s)(2)(D). Pub. L. 114–255 added subpar. (D).

    Enacted provision · exact public law section
    (i) Amendment.— Section 801(s)(2) (21 U.S.C. 381(s)(2)) is amended by adding at the end the following: “(D) Effective date.— In establishing the effective date of the regulations under subparagraph (A), the Secretary shall, in consultation with the Secretary of Homeland Security acting through U.S. Customs and Border Protection, as determined appropriate by the Secretary of Health and Human Services, provide a reasonable period of time for an importer of a drug to comply with good importer practices, taking into account differences among importers and types of imports, including based on the level of risk posed by the imported product.” .

59. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 604(a) · 131 Stat. 1005

    1. Amended · 21 U.S.C. § 381(d)(1)

       Pub. L. 115–52, § 604(a), designated existing provisions as subpar. (A)

    2. Added · 21 U.S.C. § 381(d)(1)

       Pub. L. 115–52, § 604(a), added subpar. (B)

    Source evidence

    Code amendment note
    Subsec. (d)(1). Pub. L. 115–52, § 604(a), designated existing provisions as subpar. (A) and added subpar. (B).

    Enacted provision · exact public law section
    (a) Diverted Drugs.— Paragraph (1) of section 801(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(d)) is amended— (1) by striking “(d)(1) Except as” and inserting “(d)(1)(A) Except as”; and (2) by adding at the end the following: “(B) Except as authorized by the Secretary in the case of a drug that appears on the drug shortage list under section 506E or in the case of importation pursuant to section 804, no drug that is subject to section 503(b)(1) may be imported into the United States for commercial use if such drug is manufactured outside the United States, unless the manufacturer has authorized the drug to be marketed in the United States and has caused the drug to be labeled to be marketed in the United States.” .

60. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 704(2) · 131 Stat. 1005

    Changed · 21 U.S.C. § 381(e)(4)(C); 21 U.S.C. § 381(e)(4)(D)

    Pub. L. 115–52, § 704(2), realigned margins

    Source evidence

    Code amendment note
    Subsec. (e)(4)(C), (D). Pub. L. 115–52, § 704(2), realigned margins.

    Enacted provision · exact public law section
    (2) by moving the margins of subparagraphs (C) and (D) 4 ems to the left.

61. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 704(1) · 131 Stat. 1005

    Added · 21 U.S.C. § 381(e)(4)(E)

    Pub. L. 115–52, § 704(1), added subpar. (E)

    Source evidence

    Code amendment note
    Subsec. (e)(4)(E). Pub. L. 115–52, § 704(1), added subpar. (E).

    Enacted provision · exact public law section
    (1) by adding at the end the following: “(E) (i) (I) If the Secretary denies a request for certification under subparagraph (A)(ii) with respect to a device manufactured in an establishment (foreign or domestic) registered under section 510, the Secretary shall provide in writing to the person seeking such certification the basis for such denial, and specifically identify the finding upon which such denial is based. “(II) If the denial of a request as described in subclause (I) is based on grounds other than an injunction proceeding pursuant to section 302, seizure action pursuant to section 304, or a recall designated Class I or Class II pursuant to part 7, title 21, Code of Federal Regulations, and is based on the facility being out of compliance with part 820 of title 21, Code of Federal Regulations, the Secretary shall provide a substantive summary of the specific grounds for noncompliance identified by the Secretary. “(III) With respect to a device manufactured in an establishment that has received a report under section 704(b), the Secretary shall not deny a request for certification as described in subclause (I) with respect to a device based solely on the issuance of that report if the owner, operator, or agent in charge of such establishment has agreed to a plan of correction in response to such report. “(ii) (I) The Secretary shall provide a process for a person who is denied a certification as described in clause (i)(I) to request a review that conforms to the standards of section 517A(b). “(II) Notwithstanding any previous review conducted pursuant to subclause (I), a person who has been denied a certification as described in clause (i)(I) may at any time request a review in order to present new information relating to actions taken by such person to address the reasons identified by the Secretary for the denial of certification, including evidence that corrective actions are being or have been implemented to address grounds for noncompliance identified by the Secretary. “(III) Not later than 1 year after the date of enactment of the FDA Reauthorization Act of 2017, the Secretary shall issue guidance providing for a process to carry out this subparagraph. Not later than 1 year after the close of the comment period for such guidance, the Secretary shall issue final guidance. “(iii) (I) Subject to subclause (II), this subparagraph applies to requests for certification on behalf of any device establishment registered under section 510, whether the establishment is located inside or outside of the United States, and regardless of whether such devices are to be exported from the United States. “(II) If an establishment described in subclause (I) is not located within the United States and does not demonstrate that the devices manufactured, prepared, propagated, compounded, or processed at such establishment are to be exported from the United States, this subparagraph shall apply only if— “(aa) the establishment has been inspected by the Secretary within 3 years of the date of the request; or “(bb) the establishment participates in an audit program in which the United States participates or the United States recognizes, an audit under such program has been conducted, and the findings of such audit are provided to the Secretary within 3 years of the date of the request.” ; and

62. 2018

    Stop Illicit Drug Importation Act of 2018

    Pub. L. 115–271 § 3022(c)(2) · 132 Stat. 3894

    1. Inserted · 21 U.S.C. § 381(a)

       Pub. L. 115–271, § 3022(c)(2), (3), inserted “If it appears from the examination of such samples or otherwise that the article is a counterfeit drug, such article shall be refused admission.” after third sentence

    2. Substituted · 21 U.S.C. § 381(a)

       Pub. L. 115–271, § 3022(c)(2), (3), substituted “Neither clause (2) nor clause (5) of the third sentence of this subsection shall be construed to prohibit the admission of narcotic drugs, the importation of which is permitted under the Controlled Substances Import and Export Act.” for “Clause (2) of the third sentence of this paragraph shall not be construed to prohibit the admission of narcotic drugs the importation of which is permitted under the Controlled Substances Import and Export Act.”

    Source evidence

    Code amendment note
    Subsec. (a). Pub. L. 115–271, § 3022(c)(2), (3), inserted “If it appears from the examination of such samples or otherwise that the article is a counterfeit drug, such article shall be refused admission.” after third sentence, and substituted “Neither clause (2) nor clause (5) of the third sentence of this subsection shall be construed to prohibit the admission of narcotic drugs, the importation of which is permitted under the Controlled Substances Import and Export Act.” for “Clause (2) of the third sentence of this paragraph shall not be construed to prohibit the admission of narcotic drugs the importation of which is permitted under the Controlled Substances Import and Export Act.”

    Enacted provision · exact public law section
    (2) by inserting “If it appears from the examination of such samples or otherwise that the article is a counterfeit drug, such article shall be refused admission.” before “With respect to an article of food, if importation”; and

63. 2018

    Stop Illicit Drug Importation Act of 2018

    Pub. L. 115–271 § 3022(c)(1) · 132 Stat. 3894

    Substituted · 21 U.S.C. § 381(a)

    Pub. L. 115–271, § 3022(c)(1), which directed substitution of “or (5) such article is being imported or offered for import in violation of section 331(cc) of this title, then any such article described in any of clauses (1) through (5) shall be refused admission” for “, then such article shall be refused admission”, was executed by making the substitution only in the third sentence, to reflect the probable intent of Congress

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 115–271, § 3022(c)(1), which directed substitution of “or (5) such article is being imported or offered for import in violation of section 331(cc) of this title, then any such article described in any of clauses (1) through (5) shall be refused admission” for “, then such article shall be refused admission”, was executed by making the substitution only in the third sentence, to reflect the probable intent of Congress.

    Enacted provision · exact public law section
    (1) by striking “, then such article shall be refused admission” inserting “or (5) such article is being imported or offered for import in violation of section 301(cc), then any such article described in any of clauses (1) through (5) shall be refused admission”;

64. 2018

    Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act

    Pub. L. 115–271 § 3012(c) · 132 Stat. 3894

    Inserted · 21 U.S.C. § 381(a)

    Pub. L. 115–271, § 3012(c), inserted “, or is a controlled substance subject to an order under section 360bbb–8d of this title” before “or (4)” in third sentence

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 115–271, § 3012(c), inserted “, or is a controlled substance subject to an order under section 360bbb–8d of this title” before “or (4)” in third sentence.

    Enacted provision · exact public law section
    (c) Controlled Substances Subject to Refusal.— The third sentence of section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended by inserting “, or is a controlled substance subject to an order under section 569D” before “, or (4)”.

65. 2018

    Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act

    Pub. L. 115–271 § 3013 · 132 Stat. 3894

    Added · 21 U.S.C. § 381(t)

    Pub. L. 115–271, § 3013, added subsec. (t)

    Source evidence

    Code amendment note
    Subsec. (t). Pub. L. 115–271, § 3013, added subsec. (t).

    Enacted provision · exact public law section
    SEC. 3013. SINGLE SOURCE PATTERN OF IMPORTED ILLEGAL DRUGS.   Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381), as amended by section 3012, is further amended by adding at the end the following: “(t) Single Source Pattern of Imported Illegal Drugs.— If the Secretary determines that a person subject to debarment as a result of engaging in a pattern of importing or offering for import controlled substances or drugs as described in section 306(b)(3)(D), and such pattern is identified by the Secretary as being offered for import from the same manufacturer, distributor, or importer, the Secretary may by order determine all drugs being offered for import from such person as adulterated or misbranded, unless such person can provide evidence otherwise.” .

66. 2018

    Stop Illicit Drug Importation Act of 2018

    Pub. L. 115–271 § 3022(d) · 132 Stat. 3894

    Added · 21 U.S.C. § 381(u)

    Pub. L. 115–271, § 3022(d), added subsec. (u)

    Source evidence

    Code amendment note
    Subsec. (u). Pub. L. 115–271, § 3022(d), added subsec. (u).

    Enacted provision · exact public law section
    (d) Certain Illicit Articles.— Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381), as amended, is amended by adding at the end the following— “(u) Illicit Articles Containing Active Pharmaceutical Ingredients.— “(1) In general.— For purposes of this section, an article that is being imported or offered for import into the United States may be treated by the Secretary as a drug if the article— “(A) is not— “(i) accompanied by an electronic import entry for such article submitted using an authorized electronic data interchange system; and “(ii) designated in such a system as an article regulated by the Secretary (which may include regulation as a drug, a device, a dietary supplement, or other product that is regulated under this Act); and “(B) is an ingredient that presents significant public health concern and is, or contains— “(i) an active ingredient in a drug— “(I) that is approved under section 505 or licensed under section 351 of the Public Health Service Act; or “(II) for which— “(aa) an investigational use exemption has been authorized under section 505(i) of this Act or section 351(a) of the Public Health Service Act; and “(bb) a substantial clinical investigation has been instituted, and such investigation has been made public; or “(ii) a substance that has a chemical structure that is substantially similar to the chemical structure of an active ingredient in a drug or biological product described in subclause (I) or (II) of clause (i). “(2) Effect.— This subsection shall not be construed to bear upon any determination of whether an article is a drug within the meaning of section 201(g), other than for the purposes described in paragraph (1).” .

67. 2020

    Coronavirus Aid, Relief, and Economic Security Act

    Pub. L. 116–136 div. A title III § 3856(a) · 134 Stat. 281

    Substituted · 21 U.S.C. § 381(e)(4)(E)(iii)

    Pub. L. 116–136 substituted “paragraph” for “subparagraph” in subcls. (I) and (II)

    Source evidence

    Code amendment note
    Subsec. (e)(4)(E)(iii). Pub. L. 116–136 substituted “paragraph” for “subparagraph” in subcls. (I) and (II).

    Enacted provision · exact public law section
    (a) Imports and Exports.— Section 801(e)(4)(E)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(e)(4)(E)(iii)) is amended by striking “subparagraph” each place such term appears and inserting “paragraph”.

68. 2021

    Safeguarding Therapeutics Act

    Pub. L. 116–304 § 2(a) · 134 Stat. 4915

    1. Inserted · 21 U.S.C. § 381(a)

       Pub. L. 116–304 inserted “or counterfeit device” after “counterfeit drug” in fourth sentence

    2. Substituted · 21 U.S.C. § 381(a)

       Pub. L. 116–304 substituted “The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within 90 days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations, except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug or device refused admission under this section, if such drug or device is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 1498(a)(1) of title 19) and was not brought into compliance as described under subsection (b). The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug or device under the seventh sentence of this subsection. The regulations shall provide that prior to destruction, appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug or device. Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug or device, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug or device after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c).” for “The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within ninety days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations, except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug refused admission under this section, if such drug is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 1498(a)(1) of title 19) and was not brought into compliance as described under subsection (b).. The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug under the sixth sentence of this subsection. The regulations shall provide that prior to destruction, appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug. Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c).”

    Source evidence

    Code amendment note
    Subsec. (a). Pub. L. 116–304 inserted “or counterfeit device” after “counterfeit drug” in fourth sentence, and substituted “The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within 90 days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations, except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug or device refused admission under this section, if such drug or device is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 1498(a)(1) of title 19) and was not brought into compliance as described under subsection (b). The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug or device under the seventh sentence of this subsection. The regulations shall provide that prior to destruction, appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug or device. Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug or device, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug or device after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c).” for “The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within ninety days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations, except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug refused admission under this section, if such drug is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 1498(a)(1) of title 19) and was not brought into compliance as described under subsection (b).. The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug under the sixth sentence of this subsection. The regulations shall provide that prior to destruction, appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug. Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c).”

    Enacted provision · exact public law section
    (a) In General.— Section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended— (1) in the fourth sentence, by inserting “or counterfeit device” after “counterfeit drug”; and (2) by striking “The Secretary of the Treasury shall cause the destruction of” and all that follows through “liable for costs pursuant to subsection (c).” and inserting the following: “The Regulations. Deadline. Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within 90 days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations, except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug or device refused admission under this section, if such drug or device is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 498(a)(1) of the Tariff Act of 1930 (19 U.S.C. 1498(a)(1))) and was not brought into compliance as described under subsection (b). Regulations. The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug or device under the seventh sentence of this subsection. The regulations shall provide that prior to destruction, appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug or device. Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug or device, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug or device after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c).”.

69. 2022

    Modernization of Cosmetics Regulation Act of 2022

    Pub. L. 117–328 § 3503(a)(4)(C) · 136 Stat. 4459

    1. Substituted · 21 U.S.C. § 381(a)

       Pub. L. 117–328, § 3503(a)(4)(C), substituted “under section 364a, 379aa, or 379aa–1 of this title” for “under section 379aa or 379aa–1 of this title”

    2. Substituted · 21 U.S.C. § 381(a)

       Pub. L. 117–328, § 3503(a)(4)(C), substituted “defined in section 364, 379aa, or 379aa–1 of this title” for “defined in such section 379aa or 379aa–1 of this title”

    3. Substituted · 21 U.S.C. § 381(a)

       Pub. L. 117–328, § 3503(a)(4)(C), substituted “of such section 364a, 379aa, or 379aa–1 of this title” for “of such section 379aa or 379aa–1 of this title”

    4. Substituted · 21 U.S.C. § 381(a)

       Pub. L. 117–328, § 3503(a)(4)(C), substituted “described in such section 364a, 379aa, or 379aa–1 of this title” for “described in such section 379aa or 379aa–1 of this title”

    Source evidence

    Code amendment note
    Subsec. (a). Pub. L. 117–328, § 3503(a)(4)(C), substituted “under section 364a, 379aa, or 379aa–1 of this title” for “under section 379aa or 379aa–1 of this title”, “defined in section 364, 379aa, or 379aa–1 of this title” for “defined in such section 379aa or 379aa–1 of this title”, “of such section 364a, 379aa, or 379aa–1 of this title” for “of such section 379aa or 379aa–1 of this title”, and “described in such section 364a, 379aa, or 379aa–1 of this title” for “described in such section 379aa or 379aa–1 of this title”.

    Enacted provision · exact public law section
    (C) in section 801(a) (21 U.S.C. 381(a))— (i) by striking “under section 760 or 761” and inserting “under section 605, 760, or 761”; (ii) by striking “defined in such section 760 or 761” and inserting “defined in section 604, 760, or 761”; (iii) by striking “of such section 760 or 761” and inserting “of such section 605, 760, or 761”; and (iv) by striking “described in such section 760 or 761” and inserting “described in such section 605, 760, or 761”; and

    Effective date note
    Amendment by section 3503(a)(4)(C), (D) of Pub. L. 117–328 effective on the date that is 1 year after Dec. 29, 2022, see section 3503(b)(1) of Pub. L. 117–328, set out as a note under section 331 of this title.

70. 2022

    Modernization of Cosmetics Regulation Act of 2022

    Pub. L. 117–328 § 3503(a)(4)(D) · 136 Stat. 4459

    1. Substituted · 21 U.S.C. § 381(b)

       Pub. L. 117–328, § 3503(a)(4)(D), substituted “requirements of section 364a, 379aa, or 379aa–1 of this title” for “requirements of sections 379aa or 379aa–1 of this title,”

    2. Substituted · 21 U.S.C. § 381(b)

       Pub. L. 117–328, § 3503(a)(4)(D), substituted “as defined in section 364, 379aa, or 379aa–1 of this title” for “defined in section 379aa or 379aa–1 of this title”

    3. Substituted · 21 U.S.C. § 381(b)

       Pub. L. 117–328, § 3503(a)(4)(D), substituted “with section 364a, 379aa, or 379aa–1 of this title” for “with section 379aa or 379aa–1 of this title”

    Source evidence

    Code amendment note
    Subsec. (b). Pub. L. 117–328, § 3503(a)(4)(D), substituted “requirements of section 364a, 379aa, or 379aa–1 of this title” for “requirements of sections 379aa or 379aa–1 of this title,”, “as defined in section 364, 379aa, or 379aa–1 of this title” for “defined in section 379aa or 379aa–1 of this title”, and “with section 364a, 379aa, or 379aa–1 of this title” for “with section 379aa or 379aa–1 of this title”.

    Enacted provision · exact public law section
    (D) in section 801(b) (21 U.S.C. 381(b))— (i) by striking “requirements of sections 760 or 761,” and inserting “requirements of section 605, 760, or 761”; (ii) by striking “as defined in section 760 or 761” and inserting “as defined in section 604, 760, or 761”; and (iii) by striking “with section 760 or 761” and inserting “with section 605, 760, or 761”.

    Effective date note
    Amendment by section 3503(a)(4)(C), (D) of Pub. L. 117–328 effective on the date that is 1 year after Dec. 29, 2022, see section 3503(b)(1) of Pub. L. 117–328, set out as a note under section 331 of this title.

71. 2022

    Food and Drug Omnibus Reform Act of 2022

    Pub. L. 117–328 § 3304(1) · 136 Stat. 4459

    Struck · 21 U.S.C. § 381(e)(4)(E)(iii)

    Pub. L. 117–328, § 3304(1), struck out cl. (iii) which applied to requests for certification on behalf of any device establishment registered under section 360 of this title, whether the establishment is located inside or outside of the United States, and regardless of whether such devices are to be exported from the United States

    Source evidence

    Code amendment note
    Subsec. (e)(4)(E)(iii). Pub. L. 117–328, § 3304(1), struck out cl. (iii) which applied to requests for certification on behalf of any device establishment registered under section 360 of this title, whether the establishment is located inside or outside of the United States, and regardless of whether such devices are to be exported from the United States.

    Enacted provision · exact public law section
    (1) in subparagraph (E), by striking clause (iii); and

    Effective date note
    Amendment by section 3503(a)(4)(C), (D) of Pub. L. 117–328 effective on the date that is 1 year after Dec. 29, 2022, see section 3503(b)(1) of Pub. L. 117–328, set out as a note under section 331 of this title.

72. 2022

    Food and Drug Omnibus Reform Act of 2022

    Pub. L. 117–328 § 3304(2) · 136 Stat. 4459

    Added · 21 U.S.C. § 381(e)(4)(F)

    Pub. L. 117–328, § 3304(2), added subpar. (F)

    Source evidence

    Code amendment note
    Subsec. (e)(4)(F). Pub. L. 117–328, § 3304(2), added subpar. (F).

    Enacted provision · exact public law section
    (2) by adding at the end the following: “(F) (i) This paragraph applies to requests for certification under this subparagraph of a device manufactured by a device establishment located outside of the United States that is registered under section 510, if the device is listed pursuant to section 510(j), the device has been cleared, approved, or is not required to submit a premarket report pursuant to subsection (l) or (m) of section 510, and the device is imported or offered for import into the United States. “(ii) The Secretary shall issue the certification as described in clause (iii) if the device or devices for which certification is requested under this subparagraph meet the applicable requirements of this Act. “(iii) (I) Fees. A certification for a device described in clause (i) shall be subject to the fee described in subparagraph (B). “(II) Notwithstanding subparagraph (C), a certification for a device described in clause (i) shall address and include the same material information as a ‘Certificate to Foreign Government’ and shall have a document title including the words ‘Certificate to Foreign Government’. “(iv) Applicability. The requirements and procedures of subparagraph (E) shall apply to a denial of a certification under this subparagraph.” .

    Effective date note
    Amendment by section 3503(a)(4)(C), (D) of Pub. L. 117–328 effective on the date that is 1 year after Dec. 29, 2022, see section 3503(b)(1) of Pub. L. 117–328, set out as a note under section 331 of this title.

73. 2025

    Pub. L. 119–37 div. B title VII § 772(d) · 139 Stat. 556

    Substituted · 21 U.S.C. § 381(a)

    Pub. L. 119–37 substituted “drug, device, or tobacco product” for “drug or device” wherever appearing

    Unresolved: Pub. L. 119–37 was not found in the local Statutes at Large index.

    Source evidence

    Code amendment note
    Subsec. (a). Pub. L. 119–37 substituted “drug, device, or tobacco product” for “drug or device” wherever appearing.

80 of 91 references resolved to an enrolled provision · 7 partial · 4 unresolved