Volume 92 · 819
Public Law 95–396
To amend the Federal Insecticide, Fungicide, and Rodenticide Act, as amended.
Approved September 30, 1978
Statutory text
An Act
To amend the Federal Insecticide, Fungicide, and Rodenticide Act, as amended.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
definitions
Section 1.
Section 2 of the Federal Insecticide, Fungicide, and Rodenticide Act is amended by
—
adding at the end of subsection (e)(1) the following: “Any applicator who holds or applies registered pesticides, or use dilutions of registered pesticides consistent with section 2(ee) of this Act, only to provide a service of controlling pests without delivering any unapplied pesticide to any person so served is not deemed to be a seller or distributor of pesticides under this Act.”;
in subsection (e)(3), striking out “a certified” and inserting in lieu thereof “an”;
in subsection (q)(1), striking out the period at the end of clause (G), inserting “; or” in lieu thereof, and adding a new clause (H) as follows:
“(H) in the case of a pesticide not registered in accordance with section 3 of this Act and intended for export, the label
does not contain, in words prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or graphic matter in the labeling) as to render it likely to be noted by the ordinary individual under customary conditions of purchase and use, the following: ‘Not Registered for Use in the United States of America’.”;
in subsection (w), inserting “or active ingredient used in producing a pesticide” immediately after “or device” wherever that phrase appears therein;
adding at the end of subsection (w) the following: “The dilution by individuals of formulated pesticides for their own use and according to the directions on registered labels shall not of itself result in such individuals being included in the definition of ‘producer’ for the purposes of this Act.”;
in subsection (dd), inserting “or active ingredient used in producing a pesticide” immediately after “or device”; and
adding at the end thereof a new subsection (ee) as follows:
“(ee) To Use Any Registered Pesticide in a Manner Inconsistent With Its Labeling.—
The term ‘to use any registered pesticide in a manner inconsistent with its labeling’ means to use any registered pesticide in a manner not permitted by the labeling: Provided, That the term shall not include (1) applying a pesticide at any dosage, concentration, or frequency less than that specified on the labeling, (2) applying a pesticide against any target pest not specified on the labeling if the application is to the crop, animal, or site specified on the labeling, unless the Administrator has required that the labeling specifically state that the pesticide may be used only for the pests specified on the labeling after the Administrator has determined that the use of the pesticide against other pests would cause an unreasonable adverse effect on the environment, (3) employing any method of application not prohibited by the labeling, or (4) mixing a pesticide or pesticides with a fertilizer when such mixture is not prohibited by the labeling: Provided further, That the term also shall not include any use of a pesticide in conformance with section 5,18, or 24 of this Act, or any use of a pesticide in a manner that the Administrator determines to be consistent
Post, p. 835.
with the purposes of this Act: And provided further, That after March 31, 1979, the term shall not include the use of a pesticide for agricultural or forestry purposes at a dilution less than label dosage unless before or after that date the Administrator issues a regulation or advisory opinion consistent with the study provided for in section 27(b) of the Federal
Post, p. 841.
Pesticide Act of 1978, which regulation or advisory opinion specifically requires the use of definite amounts of dilution.”.
use of data to support registration; additional data to support existing registration
Sec. 2.
Section 3 of the Federal Insecticide, Fungicide, and Rodenticide
Act is amended by—
amending subsection (c)(1)(D) to read as follows:
“(D) except as otherwise provided in subsection (c)(2)(D) of this section, if requested by the Administrator, a full description of the tests made and the results thereof upon which the claims are based, or alternatively a citation to data that appear in the public literature or that previously had been submitted to the Administrator and that the Administrator may consider in accordance with the following provisions:
“(i) With respect to pesticides containing active ingredients that are initially registered under this Act after the date of enactment of the Federal Pesticide Act of 1978,
Ante, p. 819.
data submitted to support the application for the original registration of the pesticide, or an application for an amendment adding any new use to the registration and that pertains solely to such new use, shall not, without the written permission of the original data submitter, be considered by the Administrator to support an application by another person during a period of ten years following the date the Administrator first registers the pesticide: Provided, That such permission shall not be required in the case of defensive data;
“(ii) except as otherwise provided In subparagraph (D)(i) of this paragraph, with respect to data submitted after December 31, 1969, by an applicant or registrant to support an application for registration, experimental use permit, or amendment adding a new use to an existing registration, to support or maintain in effect an existing registration, or for reregistration, the Administrator may, without the permission of the original data submitter, consider any such item of data in support of an appli-cation by any other person (hereinafter in this subparagraph referred to as the ‘applicant’) within the fifteen-year period following the date the data were originally submitted only if the applicant has made an offer to compensate the original data submitter and submitted such offer to the Administrator accompanied by evidence of delivery to the original data submitter of the offer. The terms and amount of compensation, may be fixed by agreement between the original data submitter and the applicant, or, failing such agreement, binding arbitration under this subparagraph. If, at the end of ninety days after the date of delivery to the original data submitter of the offer to compensate, the original data submitter and the applicant have neither agreed on the amount and terms of compensation nor on a procedure for reaching an agreement on the amount and terms of compensation, either person may initiate binding arbitration proceedings by requesting the Federal Mediation and Conciliation Service to appoint an arbitrator from the roster of arbitrators maintained by such Service. The procedure and rules of the Service shall be applicable to the selection of such arbitrator and to such arbitration proceedings, and the findings and determination of the arbitrator shall be final and conclusive, and no official or court of the United States shall have power or jurisdiction to review any such findings and determination, except for fraud, misrepresentation, or other misconduct by one of the parties to the arbitration or the arbitrator where there is a verified complaint with supporting affidavits attesting to specific instances of such fraud, misrepresentation, or other misconduct. The parties to the arbitration shall share equally in the payment of the fee and expenses of the arbitrator. If the Administrator determines that an original data submitter has failed to participate in a procedure for reaching an agreement or in an arbitration proceeding as required by this subparagraph, or failed to comply with the terms of an agreement or arbitration decision concerning compensation under this subparagraph, the original data submitter shall forfeit the right to compensation for the use of the data in support of the application. Notwithstanding any other provision of this Act, if the Administrator determines that an applicant has failed to participate in a procedure for reaching an agreement or in an arbitration proceeding as required by this subparagraph, or failed to comply with the terms of an agreement or arbitration decision concerning compensation under this subparagraph, the Administrator shall deny the application or cancel the registration of the pesticide in support of which the data were used without further hearing. Before the Administrator takes action under either of the preceding two sentences, the Administrator shall furnish to the affected person, by certified mail, notice of intent to take action and allow fifteen days from the date of delivery of the notice for the affected person to respond. If a registration is denied or canceled under this subparagraph, the Administrator may make such order as the Administrator deems appropriate concerning the continued sale and use of existing stocks of such pesticide. Registration action by the Administrator shall not be delayed pending the fixing of compensation;
“(iii) after expiration of any period of exclusive use and any period for which compensation is required for the use of an item of data under subparagraphs (D)(i) and (D)(ii) of this paragraph, the Administrator may consider such item of data in support of an application by any other applicant without the permission of the original data submitter and without an offer haying been received to compensate the original data submitter for the use of such item of data;”; and
amending subsection (c)(2) by—
inserting “(A)” immediately after “(2)”;
inserting immediately after “kind of information” in the second sentence the following: “under subparagraph (B) of this paragraph,”;
striking out “subsection (c)(1)(D) of this section and” from the third sentence; and
adding at the end thereof a new subparagraph (B) as follows:
“(B) Addittonal data to support existing registration.—
“(i) If
Notification.
the Administrator determines that additional data are required to maintain in effect an existing registration of a pesticide, the Administrator shall notify all existing registrants of the pesticide to which the determination relates and provide a list of such registrants to any interested person.
“(ii) Each registrant of such pesticide shall provide evidence within ninety days after receipt of notification that it is taking appropriate steps to secure
Joint data development.
the additional data that are required. Two or more registrants may agree to develop jointly, or to share in the cost of developing, such data if they agree and advise the Administrator of their intent within ninety days after notification. Any registrant who agrees to share in the cost of producing the data shall be entitled to examine and rely upon such data in support of maintenance of such registration.
“(iii) If,
Arbitration.
at the end of sixty days after advising the Administrator of their agreement to develop jointly, or share in the cost of developing, data, the registrants have not further agreed on the terms of the data development arrangement or on a procedure for reaching such agreement, any of such registrants may initiate binding arbitration proceedings by requesting the Federal Mediation and Conciliation Service to appoint an arbitrator from the roster of arbitrators maintained by such Service. The procedure and rules of the Service shall be applicable to the selection of such arbitrator and to such arbitration proceedings, and the findings and determination of the arbitrator shall be final and conclusive, and no official or court of the United States shall have power or jurisdiction to review any such findings and determination, except for fraud, misrepresentation, or other misconduct by one of the parties to the arbitration or the arbitrator where there is a verified complaint with supporting affidavits attesting to specific instances of such fraud, misrepresentation, or other misconduct. All parties to the arbitration shall share
Payment of arbitrator.
equally in the payment of the fee and expenses of the arbitrator.
“(iv) Notwithstanding any other provision of this Act, if the Administrator determines that a registrant, within the time required by the Administrator, has failed to take appropriate steps to secure the data required under this subparagraph, to participate in a procedure for reaching agreement concerning a joint data development arrangement under this subparagraph or in an arbitration proceeding as required by this subparagraph, or to comply with the terms of an agreement or arbitration decision concerning a joint data development arrangement under this subparagraph, the Administrator may issue a notice of intent to suspend such registrant’s registration of the pesticide for which additional data is required. The Administrator may include in the notice of intent to suspend such provisions as the Administrator deems appropriate concerning the continued sale and use of existing stocks of such pesticide. Any suspension proposed under this subparagraph shall become final and effective at the end of thirty days from receipt by the registrant of the notice of intent to suspend, unless during that time a request for hearing is made by a person adversely affected by the notice or the registrant has satisfied the Administrator that the registrant has complied fully with the requirements that served as a basis for the notice of intent to suspend. If a hearing
Hearing.
is requested, a hearing shall be conducted under section 6(d) of this Act: Provided, That the only
matters for resolution at that hearing shall be whether the registrant has failed to take the action that served as the basis for the notice of intent to suspend the registration of the pesticide for which additional data is required, and whether the Administrator’s determination with respect to the disposition of existing stocks is consistent with this Act. If a hearing is held, a decision after completion of such hearing shall be final. Notwithstanding any other provision of this Act, a hearing shall be held and a determination made within seventy-five days after receipt of a request for such hearing. Any registra-tion suspended under this subparagraph shall be reinstated by the Administrator if the Administrator determines that the registrant has complied fully with the requirements that served as a basis for the suspension of the registration.
“(v) Any data submitted under this subparagraph shall be subject to the provisions of subsection (c)(1)(D) of this section. Whenever such data are submitted jointly by two or more registrants, an agent shall be agreed on at the time of the joint submission to handle any subsequent data compensation matters for the joint submitters of such data.”.
The amendment to section 3(c)(1)(D) of the Federal Insecticide,
Fungicide, and Rodenticide Act made by this section shall apply with respect to all applications for registration approved after the date of enactment of this Act.
minor use registrations
Sec. 3.
Section 3(c)(2)(A) of the Federal Insecticide, Fungicide, and
Ante, p. 820.
Rodenticide Act, as redesignated by section 2 of this Act, is further amended by inserting immediately after the second sentence the following: “The Administrator, in establishing standards for data requirements for the registration of pesticides with respect to minor uses, shall make such standards commensurate with the anticipated extent of use, pattern of use, and the level and degree of potential exposure of man and the environment to the pesticide. In the development of these standards, the Administrator shall consider the economic factors of potential national volume of use, extent of distribution, and the impact of the cost of meeting the requirements on the incentives for any potential registrant to undertake the development of the required data.”.
simplified registration procedures; exemption from requirements for submission of data
Sec. 4.
Section 3(c)(2) of the Federal Insecticide, Fungicide, and Rodenticide
Ante, p. 820.
Act is further amended by adding at the end thereof new subparagraphs (C) and (D) as follows:
“(C) Simplified procedures.—
Within nine months after the date of enactment of this subparagraph, the Administrator shall, by regulation, prescribe simplified procedures for the registration of pesticides, which shall include the provisions of subparagraph (D) of this paragraph.
“(D) Exemption.—
No applicant for registration of a pesticide who proposes to purchase a registered pesticide from another producer in order to formulate such purchased pesticide into an end-use product shall be required to—
“(i) submit or cite data pertaining to the safety of such purchased product; or
“(ii) offer to pay reasonable compensation otherwise required by paragraph (1)(D) of this subsection for the use of any such data.”.
waiver of data requirements pertaining to efficacy
Sec. 5.
Section 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide Act is amended by adding at the end thereof the following:
“In considering an application for the registration of a pesticide, the Administrator may waive data requirements pertaining to efficacy, in which event the Administrator may register the pesticide without determining that the pesticide’s composition is such as to warrant proposed claims of efficacy. If a pesticide is found to be efficacious by any State under section 24(c) of this Act, a presumption is
Post, p. 835.
established “that the Administrator shall waive data requirements pertaining to efficacy for use of the pesticide in such State.”.
registration under special circumstances; interim administrative review
Sec. 6.
Section 3(c) of the Federal Insecticide, Fungicide, and Rodenticide Act is amended by adding at the end thereof new paragraphs
(7) and (8) as follows:
“(7) Registration under special circumstances.—
Notwithstanding the provisions of subsection (c)(5) of this section—
“(A) The Administrator may conditionally register or amend the registration of a pesticide if the Administrator determines that (i) the pesticide and proposed use are identical or substantially similar to any currently registered pesticide and use thereof, or differ only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment, and (ii) approving the registration or amendment in the manner proposed by the applicant would not significantly increase the risk of any unreasonable adverse effect on the environment. An applicant seeking conditional registration or amended registration under this subparagraph shall submit such data as would be required to obtain registration of a similar pesticide under subsection (c)(5) of this section: Provided, That, if the applicant is unable to submit an item of data because it has not yet been generated, the Administrator may register or amend the registration of the pesticide under such conditions as will require the submission of such data not later than the time such data are required to be submitted with respect to similar pesticides already registered under this Act.
“(B) The Administrator may conditionally amend the registration of a pesticide to permit additional uses of such pesticide notwithstanding that data concerning the pesticide may be insufficient to support an unconditional amendment, if the Administrator determines that (i) the applicant has submitted satisfactory data pertaining to the proposed additional use, and (ii) amending the registration in the manner proposed by the applicant would not significantly increase the risk of any unreasonable adverse effect on the environment. Notwithstanding the foregoing provisions of this subparagraph, no registration of a pesticide may be amended to permit an additional use of such pesticide if “the Administrator has issued a notice stating that such pesticide, or any ingredient thereof, meets or exceeds risk criteria associated in whole or in part with human dietary exposure enumerated in regulations issued under this Act, and during the pendency of any risk-benefit evaluation initiated by such notice, if (I) the additional use of such pesticide involves a major food or feed crop, or (II) the additional use of such pesticide involves a minor food or feed crop and the Administrator determines, with the concurrence of the Secretary of Agriculture, there is available an effective alternative pesticide that does not meet or exceed such risk criteria. An applicant seeking amended registration under this subparagraph shall submit such data as would be required to obtain registration of a similar pesticide under subsection (c)(5) of this section: Provided, That, if the applicant is unable to submit an item of data (other than data pertaining to the proposed additional use) because it has not yet been generated, the Administrator may amend the registration under such conditions as will require the submission of such data not later than the time such data are required to be submitted with respect to similar pesticides already registered under this Act.
“(C) The Administrator may conditionally register a pesticide containing an active ingredient not contained in any currently registered pesticide for a period reasonably sufficient for the generation and submission of required data (which are lacking because a period reasonably sufficient for generation of the data has not elapsed since the Administrator first imposed the data requirement) on the condition that by the end of such period the Administrator receives such data and the data do not meet or exceed risk criteria enumerated in regulations issued under this Act, and on such other conditions as the Administrator may prescribe: Provided, That a conditional registration under this subparagraph shall be granted only if the Administrator determines that use of the pesticide during such period will not cause any unreasonable adverse effect on the environment, and that use of the pesticide is in the public interest.
“(8) Interim administrative review.—
Notwithstanding any other provision of this Act, the Administrator may not initiate a public interim administrative review process to develop a risk-benefit evaluation of the ingredients of a pesticide or any of its uses prior to initiating a formal action to cancel, suspend, or deny registration of such pesticide, required under this Act, unless such interim administrative process is based on a validated test or other significant evidence raising prudent concerns of unreasonable adverse
Notice of definitions.
Publication in Federal Register.
risk to man or to the environment. Notice of the definition of the terms ‘validated test’ and ‘other significant evidence’ as used herein shall be published by the Administrator in the Federal Register.”.
classification prior to reregistration; change in classification from restricted use to general use
Sec. 7.
Section 3(d) of the Federal Insecticide, Fungicide, and Rodenticide
Act is amended by—
inserting in paragraph (1)(A) immediately after the first sentence the following: “Pesticide uses may be classified by regula-tion on the initial classification, and registered pesticides may be classified prior to reregistration.”;
striking out “30 days” in paragraph (2) and inserting in lieu thereof “forty-five days”; and
adding a new paragraph (3) at the end thereof as follows:
“(3) Change in classification from restricted use to general use.—
The registrant of any pesticide with one or more uses classified for restricted use may petition the Administrator to change any such classification from restricted to general use. Such petition shall set out the basis for the registrant’s position that restricted use classification is unnecessary because classification of the pesticide for general use would not cause unreasonable adverse effects on the environment. The Administrator, within sixty days after receiving such petition, shall notify the registrant whether the petition has been granted or denied. Any denial shall contain an explanation therefor and any such denial shall be subject to judicial review under section 16 of this Act.”.
reregistration
Sec. 8.
Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act is amended by adding at the end thereof new subsection (g)
as follows:
“(g) Reregistration of Pesticides.—
The Administrator shall accomplish the reregistration of all pesticides in the most expeditious manner practicable: Provided, That, to the extent appropriate, any pesticide that results in a postharvest residue in or on food or feed crops shall be given priority in the reregistration process.”.
authority of administrator to certify applicators
Sec. 9.
Section 4(a) of the Federal Insecticide, Fungicide, and Rodenticide Act is amended by inserting in paragraph (1) immediately
after “(1) Federal certification.—” the following: “In any State for which a State plan for applicator certification has not been approved by the Administrator, the Administrator, in consultation with the Governor of such State, shall conduct a program for the certification of applicators of pesticides: Provided, That such program shall conform to the requirements imposed upon the States under the provisions of subsection (a)(2) of this section and shall not require private applicators to take any examination to establish competency in the use of pesticides. Prior to the implementation of the program, the Administrator shall publish in the Federal Register for review and comment a summary of the Federal plan for applicator certification and shall make generally available within the State copies of the plan. The Administrator shall hold public hearings at one or
Public hearings.
more locations within the State if so requested by the Governor of such State during the thirty days following publication of the Federal Register notice inviting comment on the Federal plan. The hearings shall be held within thirty days following receipt of the request from the Governor. In any State in which the Administrator conducts a certification program, the Administrator may require any person engaging in the commercial application, sale, offering for sale, holding for sale, or distribution of any pesticide one or more uses of which have been classified for restricted use to maintain such records and submit such reports concerning the commercial application, sale, or distribution of such pesticide as the Administrator may by regulation prescribe.”.
experimental use permits
Sec. 10.
Section 5 of the Federal Insecticide, Fungicide, and Rodenticide
Act is amended by—
amending subsection (a) to read as follows:
“(a) Issuance.—
Any person may apply to the Administrator for an experimental use permit for a pesticide. The Administrator shall review the application. After completion of the review, but not later than one hundred and twenty days after receipt of the application and all required supporting data, the Administrator shall either issue the permit or notify the applicant of the Administrator’s determination not to issue the permit and the reasons therefor. The applicant may correct the application or request a waiver of the conditions for such permit within thirty days of receipt by the applicant of such notification. The Administrator may issue an experimental use permit only if the Administrator determines that the applicant needs such permit in order to accumulate information necessary to register a pesticide under section 3 of this Act. An application for an experimental use permit may be filed at any time.”; and
in subsection (f), striking out the word “may” the first time it appears in the first sentence and inserting in lieu thereof “shall”.
alternative to cancellation
Sec. 11.
Section 6(b) of the Federal Insecticide, Fungicide, and Rodenticide
Act is amended by inserting in the last sentence immediately after “In taking any final action under this subsection, the Administrator” the following: “shall consider restricting a pesticide’s use or uses as an alternative to cancellation and shall fully explain the reasons for these restrictions, and”.
cancellation of conditional registration
Sec. 12.
Section 6 of the Federal Insecticide, Fungicide, and Rodenticide
Act is amended by redesignating subsection (e) as subsection (f) and inserting after subsection (d) a new subsection (e) as follows:
“(e) Conditional Registration.—
“(1) The
Notice.
Administrator shall issue a notice of intent to cancel a registration issued under section 3(c)(7) of this Act
Ante, p. 825.
if (A) the Administrator, at any time during the period provided for satisfaction of any condition imposed, determines that the registrant has failed to initiate and pursue appropriate action toward fulfilling any condition imposed, or (B) at the end of the period provided for satisfaction of any condition imposed, that condition has not been met: Provided, That the Administrator may permit the continued sale and use of existing stocks of a pesticide whose conditional registration has been canceled under this subsection to such extent, under such conditions, and for such uses as the Administrator may specify if the Administrator determines that such sale or use is not inconsistent with the purposes of this Act and will not have unreasonable adverse effects on the environment.
“(2) A cancellation proposed under this subsection shall become final and effective at the end of thirty days from receipt by the registrant of the notice of intent to cancel unless during that time a request for hearing is made by a person adversely affected by the notice. If a hearing is requested, a hearing shall be conducted under subsection (d) of this section: Provided, That the only matters for resolution at that hearing shall be whether the registrant has initiated and pursued appropriate action to comply with the condition or conditions within the time provided or whether the condition or conditions have been satisfied within the time provided, and whether the Administrator’s determination with respect to the disposition of existing stocks is consistent with this Act. A decision after completion of such hearing shall be final. Notwithstanding any other provision of this section, a hearing shall be held and a determination made within seventy-five days after receipt of a request for such hearing.”.
registration of establishments
Sec. 13.
Section 7 of the Federal Insecticide, Fungicide, and Rodenticide Act is amended by
—
in subsection (a), inserting “or active ingredient used in producing a pesticide subject to this Act” immediately after “any pesticide subject to this Act”;
in subsection (c)(1), inserting “and, if applicable, active ingredients used in producing pesticides” immediately after “pesticides”; and
in subsection (d), inserting “other than the names of the pesticides or active ingredients used in producing pesticides prouced, sold, or distributed at an establishment” immediately after “pursuant to subsection (c)”.
inspection of books and records
Sec. 14.
Section 8(b) of the Federal Insecticide, Fungicide, and Rodenticide Act is amended by adding at the end thereof the following:
“Before undertaking an inspection under this subsection, the officer or employee must present to the owner, operator, or agent in charge of the establishment or other place where pesticides or devices are held for distribution or sale, appropriate credentials and a written statement as to the reason for the inspection, including a statement as to whether a violation of the law is suspected. If no violation is suspected, an alternate and sufficient reason shall be given in writing. Each such inspection shall be commenced and completed with reasonable promptness.”.
trade secret amendments
Sec. 15.
Section 10 of the Federal Insecticide, Fungicide, and Rodenticide Act is amended by
—
in subsection (b), inserting immediately after “Notwithstanding any other provision of this Act” the following: “and subject to the limitations in subsections (d) and (e) of this section”; and
adding at the end thereof new subsections (d), (e), (f), and (g) as follows:
“(d) Limitations.—
“(1) All
Information, availability to public.
information concerning the objectives, methodology, results, or significance of any test or experiment performed on or with a registered or previously registered pesticide or its separate ingredients, impurities, or degradation products, and any information concerning the effects of such pesticide on any organism or the behavior of such pesticide in the environment, including, but not limited to, data on safety to fish and wildlife, humans and other mammals, plants, animals, and soil, and studies on persistence, translocation and fate in the environment, and metabolism, shall be available for disclosure to the public: Provided, That the use of such data for any registration purpose shall be governed
by section 3 of this Act: Provided further, That this paragraph does not authorize the disclosure of any information that—
“(A) discloses manufacturing or quality control processes,
“(B) discloses the details of any methods for testing, detecting, or measuring the quantity of any diberately added inert ingredient of a pesticide, or
“(C) discloses the identity or percentage quantity of any deliberately added inert ingredient of a pesticide,
unless the Administrator has first determined that disclosure is necessary to protect against an unreasonable risk of injury to health or the environment.
“(2) Information concerning production, distribution, sale, or inventories of a pesticide that is otherwise entitled to confidential treatment under subsection (b) of this section may be publicly disclosed in connection with a public proceeding to determine whether a pesticide, or any ingredient of a pesticide, causes unreasonable adverse effects on health or the environment, if the Administrator determines that such disclosure is necessary in the public interest.
“(3) if the Administrator proposes to disclose information described in clause (A), (B), or (C) of paragraph (1) or in paragraph (2) of this subsection, the Administrator shall notify by certified mail the submitter of such information of the intent to release such information. The Administrator may not release such information, without the submitter’s consent, until thirty days after the submitter has been furnished such notice: Provided, That where the Administrator finds that disclosure of information described in clause (A), (B), or (C) of paragraph (1) of this subsection is necessary to avoid or lessen an imminent and substantial risk of injury to the public health, the Administrator may set such shorter period of notice (but not less than ten days) and such method of notice as the Administrator finds appropriate. During such period the data submitter may institute an action in an appropriate district court to enjoin or limit the proposed disclosure. The court shall give expedited consideration to any such action. The court may enjoin disclosure, or limit the disclosure or the parties to whom disclosure shall be made, to the extent that—
“(A) in the case of information described m clause (A), (B), or (C) of paragraph (1) of this subsection, the proposed disclosure is not required to protect against an unreasonable risk of injury to health or the environment; or
“(B) in the case of information described in paragraph (2) of this subsection, the public interest in availability of the information in the public proceeding does not outweigh the interests in preserving the confidentiality of the information.
“(e) Disclosure to Contractors.—
Information otherwise protected from disclosure to the public under subsection (b) of this section may be disclosed to contractors with the United States and employees of such contractors if, in the opinion of the Administrator, such disclosure is necessary for the satisfactory performance by the contractor of a contract with the United States for the performance of work in connection with this Act and under such conditions as the Administrator may specify. The Administrator shall require as a condition to the disclosure of information under this subsection that the person receiving it take such security precautions respecting the information as the Administrator shall by regulation prescribe.
“(f) Penalty for Disclosure by Federal Employees.—
(1) Any officer or employee of the United States or former officer or employee of the United States who, by virtue of such employment or official position, has obtained possession of, or has access to, material the disclosure of which is prohibited by subsection (b) of this section, and who, knowing that disclosure of such material is prohibited by such subsection, willfully discloses the material in any manner to any person not entitled to receive it, shall be fined not more than $10,000 or imprisoned for not more than one year, or both. Section 1905 of title 18 of the United States Code shall not apply with respect to the publishing, divulging, disclosure, or making known of, or making available, information reported or otherwise obtained under this Act. Nothing in this Act shall preempt any civil remedy under State or Federal law for wrongful disclosure of trade secrets.
“(2) For the purposes of this section, any contractor with the United States who is furnished information as authorized by subsection (e) of this section, or any employee of any such contractor, shall be considered to be an employee of the United States.
“(g) Disclosure to Foreign and Multinational Pesticide Producers.—
(1) The Administrator shall not knowingly disclose information submitted by an applicant or registrant under this Act to any employee or agent of any business or other entity engaged in the production, sale, or distribution of pesticides in countries other than the United States or in addition to the United States or to any other person who intends to deliver such data to such foreign or multinational business or entity unless the applicant or registrant has consented to such disclosure. The Administrator shall require an affirmation from any person who intends to inspect data that such person does not seek access to the data for purposes of delivering it or offering it for sale to any such business or entity or its agents or employees and will not purposefully deliver or negligently cause the data to be delivered to such business or entity or its agents or employees. Notwithstanding any other provision of this subsection, the Administrator may disclose information to any person in connection with a public proceeding under law or regulation, subject to restrictions on the availability of information contained elsewhere in this Act, which information is relevant to a determination by the Administrator with respect to whether a pesticide, or any ingredient of a pesticide, causes unreasonable adverse effects on health or the environment.
“(2) The
Records.
Administrator shall maintain records of the names of persons to whom data are disclosed under this subsection and the persons or organizations they represent and shall inform the applicant or registrant of the names and affiliations of such persons.
“(3) Section 1001 of title 18 of the United States Code shall apply to any affirmation made under paragraph (1) of this subsection.”.
exemption from the unlawful acts provision
Sec. 16.
Section 12(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide
Act is amended by inserting immediately before the semicolon at the end of subparagraph (F) the following: “: Provided, That it shall not be unlawful to sell, under regulations issued by the Administrator, a restricted use pesticide to a person who is not a certified applicator for application by a certified applicator”.
civil penalties for certain applicators; procedure for determining the amount of civil penalties
Sec. 17.
Section 14(a) of the Federal Insecticide, Fungicide, and Rodenticide
Act is amended by—
inserting immediately before the period at the end of paragraph (2) the following: “: Provided, That any applicator not included under paragraph (1) of this subsection who holds or applies registered pesticides, or use dilutions of registered pesticides, only to provide a service of controlling pests without delivering any unapplied pesticide to any person so served, and who violates any provision of this Act may be assessed a civil penalty by the Administrator of not more than $500 for the first offense nor more than $1,000 for each subsequent offense”;
striking out the last sentence in paragraph (3);
redesignating paragraph (4) as paragraph (5); and
inserting after paragraph (3) a new paragraph (4) as follows:
“(4) Determination of penalty.—
In determining the amount of the penalty, the Administrator shall consider the appropriateness of such penalty to the size of the business of the person charged, the effect on the person’s ability to continue in business, and the gravity of the violation. Whenever the Administrator finds that the violation occurred despite the exercise of due care or did not cause significant harm to health or the environment, the Administrator may issue a warning in lieu of assessing a penalty.”.
pesticides and devices intended for export
Sec. 18.
Section 17 of the Federal Insecticide, Fungicide, and Rodenticide Act is amended by
—
amending subsection (a) to read as follows:
“(a) Pesticides and Devices Intended for Export.—
Notwithstanding any other provision of this Act, no pesticide or device or active ingredient used in producing a pesticide intended solely for export to any foreign country shall be deemed in violation of this Act—
“(1) when prepared or packed according to the specifications or directions of the foreign purchaser, except that producers of such pesticides and devices and active ingredients used in producing pesticides shall be subject to sections 2(p), 2(q)(1)(A), (C), (D), (E), (G), and (H), 2(q)(2)(A), (B), (C)(i) and (iii), and (D), 7, and 8 of this Act;
and
“(2) in the case of any pesticide other than a pesticide registered under section 3 or sold under section 6(a)(1) of
this Act, if, prior to export, the foreign purchaser has signed a statement acknowledging that the purchaser understands that such pesticide is not registered for use in the United States and cannot be sold in the United States under this Act. A copy of that statement shall be transmitted to an appropriate official of the government of the importing country.”; and
adding at the end of subsection (b) the following: “Such
Notification.
notification shall, upon request, include all information related to the cancellation or suspension of the registration of the pesticide and information concerning other pesticides that are registered under section 3 of this Act and that could be used in lieu of such pesticide.”.
The amendment made by subsection (a)(1) of this section shall
Effective date.
become effective one hundred and eighty days after the date of enactment of this Act.
disposal of pesticides
Sec. 19.
Section 19 of the Federal Insecticide, Fungicide, and Rodenticide Act is amended by adding at the end thereof a new subsection
(c) as follows:
“(c) Provisions for unused quantities.—
Notification of cancellation of any pesticide shall include specific provisions for the disposal of the unused quantities of such pesticide.”.
research and monitoring activities
Sec. 20.
Section 20 of the Federal Insecticide, Fungicide, and Rodenticide
Act is amended by—
in the first sentence of subsection (a), striking out all after the phrase “and he shall” down through the end of the sentence and inserting in lieu thereof the following: “conduct research into integrated pest management in coordination with the Secretary of Agriculture.”; and
amending subsection (c) to read as follows:
“(c) Monitoring.—
The Administrator shall undertake such monitoring activities, including, but not limited to monitoring in air, soil, water, man, plants, and animals, as may be necessary for the implementation of this Act and of the national pesticide monitoring plan. The Administrator shall establish procedures for the monitoring of man and animals and their environment for incidential pesticide exposure, including, but not limited to, the quantification of incidental human and environmental pesticide pollution and the secular trends thereof, and identification of the sources of contamination and their relationship to human and environmental effects. Such activities shall be carried out in cooperation with other Federal, State, and local agencies.”.
state cooperation, aid, and training
Sec. 21.
Section 23 of the Federal Insecticide, Fungicide, and Rodenticide
Act is amended to read as follows:
“SEC. 23. STATE COOPERATION, AID, AND TRAINING.
“(a) Cooperative Agreements.—
The Administrator may enter into cooperative agreements with States and Indian tribes—
“(1) to delegate to any State or Indian tribe the authority to cooperate in the enforcement of this Act through the use of its personnel or facilities, to train personnel of the State or Indian tribe to cooperate in the enforcement of this Act, and to assist States and Indian tribes in implementing cooperative enforcement programs through grants-in-aid; and
“(2) to assist States in developing and administering State programs, and Indian tribes that enter into cooperative agreements, to train and certify applicators consistent with the standards the Administrator prescribes.
Effective with the fiscal year beginning October 1, 1978, there are authorized to be appropriated annually such funds as may be necessary for the Administrator to provide through cooperative agreements an amount equal to 50 percent of the anticipated cost to each State or Indian tribe, as agreed to under such cooperative agreements, of conducting training and certification programs during such fiscal year. If funds sufficient to pay 50 percent of the costs for any year are not appropriated, the share of each State and Indian tribe shall be reduced in a like proportion in allocating available funds.
“(b) Contracts for Training.—
In addition, the Administrator may enter into contracts with Federal, State, or Indian tribal agencies for the purpose of encouraging the training of certified applicators.
“(c) Information and Education.—
The Administrator shall, in cooperation with the Secretary of Agriculture, use the services of the cooperative State extension services to inform and educate pesticide users about accepted uses and other regulations made under this Act.”.
pesticides formulated for distribution and use within a state
Sec. 22.
Section 24 of the Federal Insecticide, Fungicide, and Rodenticide Act is amended to read as follows:
“SEC. 24. AUTHORITY OF STATES.
“(a) A State may regulate the sale or use of any federally registered pesticide or device in the State, but only if and to the extent the regulation does not permit any sale or use prohibited by this Act.
“(b) Such State shall not impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under this Act.
“(c) (1) A State may provide registration for additional uses of federally registered pesticides formulated for distribution and use within that State to meet special local needs in accord with the purposes of this Act and if registration for such use has not previously been denied, disapproved, or canceled by the Administrator. Such registration shall be deemed registration under section 3 for all purposes
of this Act, but shall authorize distribution and use only within such State.
“(2) A registration issued by a State under this subsection shall not be effective for more than ninety days if disapproved by the Administrator within that period. Prior to disapproval, the Administrator shall, except as provided in paragraph (3) of this subsection, advise the State of the Administrator’s intention to disapprove and the reasons therefor, and provide the State time to respond. The Administrator shall not prohibit or disapprove a registration issued by a State under this subsection (A) on the basis of lack of essentiality of a pesticide or (B) except as provided in paragraph (3) of this subsection, if its composition and use patterns are similar to those of a federally registered pesticide.
“(3) In no instance may a State issue a registration for a food or feed use unless there exists a tolerance or exemption under the Federal Food, Drug, and Cosmetic Act that permits the residues of the pesticide
on the food or feed. If the Administrator determines that a registration issued by a State is inconsistent with the Federal Food, Drug, and Cosmetic Act, or the use of, a pesticide under a registration issued by a State constitutes an imminent hazard, the Administrator may immediately disapprove the registration.
“(4) If the Administrator finds, in accordance with standards set forth in regulations issued under section 25 of this Act, that a State
Post, p. 836.
is not capable of exercising adequate controls to assure that State registration under this section will be in accord with the purposes of this Act or has failed to exercise adequate controls, the Administrator may suspend the authority of the State to register pesticides until such time as the Administrator is satisfied that the State can and will exercise adequate controls. Prior to any such suspension, the Administrator shall advise the State of the Administrator’s intention to suspend and the reasons therefor and provide the State time to respond.”.
authority of administrator—regulations; scientific advisory panel
Sec. 23.
Section 25 of the Federal Insecticide, Fungicide, and Rodenticide
Act is amended by—
in subsection (a)(1), striking out the period at the end of the second sentence and adding the following: “and differences in environmental risk and the appropriate data for evaluating such risk between agricultural and nonagricultural pesticides.”;
adding
Publication in Federal Register.
at the end of subsection (a)(2)(B), the following: “In taking any final action under this subsection, the Administrator shall include among those factors to be taken into account the effect of the regulation on production and prices of agricultural commodities, retail food prices, and otherwise on the agricultural economy, and the Administrator shall publish in the Federal Register an analysis of such effect.”;
in subsection (d), striking out the third sentence and inserting in lieu thereof the following: “The Administrator shall also solicit from the advisory panel comments, evaluations, and recommendations for operating guidelines to improve the effectiveness and quality of scientific analyses made by personnel of the Environmental Protection Agency that lead to decisions by the Administrator
Publication in Federal Register.
in carrying out the provisions of this Act. The comments, evaluations, and recommendations of the advisory panel and the response of the Administrator shall be published in the Federal Register in the same manner as provided for publication of the comments of the Secretary of Agriculture under such sections. The chairman of the advisory panel, after consultation with the Administrator, may create temporary subpanels on specific projects to assist the full advisory panel in expediting and preparing its evaluations, comments, and recommendations.”; and
adding
Advisory panel, termination.
at the end of subsection (d) the following: “The advisory panel established under this subsection shall terminate September 30, 1981. In performing the functions assigned by this Act, the panel shall consult and coordinate its activities with the Science Advisory Board established under the Environmental Research, Development, and Demonstration Authorization Act of
1978.”.
state enforcement; identification of pests; cooperation with departivient of agricui,ture’s program; annual report
Sec. 24.
The Federal Insecticide, Fungicide, and Rodenticide Act is amended by—
redesignating sections 26 (severability) and 27 (authorization
for appropriations) as sections 30 and 31, respectively; and
inserting after section 25 new sections 26 through 29 as follows:
“SEC. 26. STATE PRIMARY ENFORCEMENT RESPONSIBILITY.
“(a) For the purposes of this Act, a State shall have primary enforcement responsibility for pesticide use violations during any period for which the Administrator determines that such State—
“(1) has adopted adecuate pesticide use laws and regulations; Provided, That the Administrator may not require a State to have pesticide use laws that are more stringent than this Act;
“(2) has adopted and is implementing adequate procedures for the enforcement of such State laws and regulations; and
“(3) will keep such records and make such reports showing compliance with paragraphs (1) and (2) of this subsection as the Administrator may require by regulation.
“(b) Notwithstanding the provisions of subsection (a) of this section, any State that enters into a cooperative agreement with the Administrator under section 23 of this Act for the enforcement of
Ante, p. 834.
pesticide use restrictions shall have the primary enforcement responsibility for pesticide use violations. Any State that has a plan approved by the Administrator in accordance with the requirements of section 4 of this Act that the Administrator determines meets the criteria set out
in subsection (a) of this section shall have the primary enforcement responsibility for pesticide use violations. The Administrator shall make such determinations with respect to State plans under section 4 of this Act in effect on the date of enactment of the Federal Pesticide Act of 1978 not later than six months after that date.
Ante, p. 819.
“(c) The Administrator shall have primary enforcement responsibility for those States that do not have primary enforcement responsibility under this Act. Notwithstanding the provisions of section 2(e)(1) of this Act, during any period when the Administrator has such enforcement responsibility, section 8(b) of this Act shall apply to the
Ante, p. 829.
books and records of commercial applicators and to any applicator who holds or applies pesticides, or use dilutions of pesticides, only to provide a service of controlling pests without delivering any unapplied pesticide to any person so served, and section 9(a) of this Act shall
apply to the establishment or other place where pesticides or devices are held for application by such persons with respect to pesticides or devices held for such application.
“SEC. 27. FAILURE BY THE STATE TO ASSURE ENFORCEMENT OF STATE PESTICIDE USE REGULATIONS.
“(a) Upon receipt of any complaint or other information alleging or indicating a significant violation of the pesticide use provisions of this Act, the Administrator shall refer the matter to the appropriate State officials for their investigation of the matter consistent with the requirements of this Act. If, within thirty days, the State has not commenced appropriate enforcement action, the Administrator may act upon the complaint or information to the extent authorized under this Act.
“(b) Whenever the Administrator determines that a State having primary enforcement responsibility for pesticide use violations is not carrying out (or cannot carry out due to the lack of adequate legal authority) such responsibility, the Administrator shall notify the State. Such notice shall specify those aspects of the administration of the State program that are determined to be inadequate. The State shall have ninety days after receipt of the notice to correct any deficiencies. If after that time the Administrator determines that the State program remains inadequate, the Administrator may rescind, in whole or in part, the State’s primary enforcement responsibility for pesticide use violations.
“(c) Neither section 26 of this Act nor this section shall limit the
Ante, p. 836.
authority of the Administrator to enforce this Act, where the Administrator determines that emergency conditions exist that require immediate action on the part of the Administrator and the State authority is unwilling or unable adequately to respond to the emergency.
“SEC. 28. IDENTIFICATION OF PESTS; COOPERATION WITH DEPARTMENT OF AGRICULTURE’S PROGRAM.
“The Administrator, in coordination with the Secretary of Agriculture, shall identify those pests that must be brought under control. The Administrator shall also coordinate and cooperate with the Secretary of Agriculture’s research and implementation programs to develop and improve the safe use and effectiveness of chemical, biological, and alternative methods to combat and control pests that reduce the quality and economical production and distribution of Agricultural products to domestic and foreign consumers.
“SEC. 29. ANNUAL REPORT.
“The Administrator shall submit an annual report to Congress before February 16 of each year and the first report shall be due February 15, 1979. The report shall include the total number of applications for conditional registration under sections 3(c)(7)(B) and 3(c)(7)(C)
Ante, p. 825.
of this Act that were filed during the immediately preceding fiscal year, and, with respect to those applications approved, the Administrator shall report the Administrator’s findings in each case, the conditions imposed and any modification of such conditions in each case, and the quantities produced of such pesticides.”.
authorization of appropriations
Sec. 25.
Section 31 of the Federal Insecticide, Fungicide, and Rodenticide
Act, as redesignated by section 24 of this Act, is amended by striking out “and for the period beginning October 1, 1976, and ending March 31, 1977, the sum of $23,600,000”, and inserting in lieu thereof the following: “and for the period beginning October 1, 1976, and ending September 30, 1977, the sum of $46,636,000, and for the period beginning October 1, 1977, and ending September 30, 1978, the sum of $54,500,000, and for the period beginning October 1, 1978, and ending September 30, 1979, such sums as may be necessary, but not in excess of $70,000,000”.
revision of fifra table of contents
Sec. 26.
Section 1(b) of the Federal Insecticide, Fungicide, and Rodenticide
Act is amended to read as follows:
“(b) Table of Contents.—
Studies
Sec. 27.
The Administrator of the Environmental Protection
Agency shall perform a study examining the feasibility of assessing and collecting fees from persons applying to register, or amend the registration of, pesticides to cover the costs incurred by the Environmental Protection Agency in processing such applications under the provisions of the Federal Insecticide, Fungicide, and Rodenticide Act. The Administrator shall complete this study and submit a report setting
Report to congressional committees.
forth the findings of the study and recommendations for the implementation of these findings to the Senate Committee on Agriculture, Nutrition, and Forestry and the House Committee on Agriculture, not later than nine months after the date of enactment of this Act.
The Administrator, in cooperation with the Secretary of Agriculture, and after consultation with appropriate State officials, shall review available scientific information dealing with issues involved in the methods of pesticide application, including, but not limited to, the advisability of ultra-low-volume methods of application, and shall recommend to the Senate Committee on Agriculture, Nutrition, and Forestry and the House Committee on Agriculture such changes as the Administrator may deem necessary in existing law relative to provisions of the Act pertaining to the use of a registered pesticide in a manner inconsistent with its labeling. The report shall be submitted as soon as practicable, but not later than six months after the date of enactment of this Act.
The Administrator shall submit an updated study examining the problems of minor uses of pesticides not specifically permitted by
Report to congressional committees.
labeling. The Administrator shall complete this study and submit a report setting forth the findings of the study and recommendations for the implementation of these findings to the Senate Committee on Agriculture, Nutrition, and Forestry and the House Committee on Apiculture, not later than nine months after the date of enactment of this Act.
effective dates
Sec. 28.
Section 4 of the Federal Environmental Pesticide Control Act
of 1972 is amended by—
in subsection (b), striking out the colon immediately after the second “thereunder” and all that follows down through the end of the subsection and substituting in lieu thereof a period;
in subsection (c), striking out paragraph (2), and redesignating paragraphs (3), (4), and (5) as (2), (3), and (4), respectively; and
in subsection (c)(3)(B), as redesignated, striking out “Within four years after the enactment of this Act each” and inserting in lieu thereof “Each”.
short title
Sec. 29.
This
Act may be cited as the “Federal Pesticide Act of 1978”.
Approved September 30, 1978.