Title 7 — Agriculture

Chapter 6 — Insecticides and Environmental Pesticide Control

§ 136a. Registration of pesticides

Statutory text

Requirement of registration

Except as provided by this subchapter, no person in any State may distribute or sell to any person any pesticide that is not registered under this subchapter. To the extent necessary to prevent unreasonable adverse effects on the environment, the Administrator may by regulation limit the distribution, sale, or use in any State of any pesticide that is not registered under this subchapter and that is not the subject of an experimental use permit under section 136c of this title or an emergency exemption under section 136p of this title.

Exemptions

A pesticide which is not registered with the Administrator may be transferred if—

the transfer is from one registered establishment to another registered establishment operated by the same producer solely for packaging at the second establishment or for use as a constituent part of another pesticide produced at the second establishment; or

the transfer is pursuant to and in accordance with the requirements of an experimental use permit.

Procedure for registration

Statement required

Each applicant for registration of a pesticide shall file with the Administrator a statement which includes—

the name and address of the applicant and of any other person whose name will appear on the labeling;

the name of the pesticide;

a complete copy of the labeling of the pesticide, a statement of all claims to be made for it, and any directions for its use;

the complete formula of the pesticide;

a request that the pesticide be classified for general use or for restricted use, or for both; and

except as otherwise provided in paragraph (2)(D), 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:

With respect to pesticides containing active ingredients that are initially registered under this subchapter after September 30, 1978, 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, except that such permission shall not be required in the case of defensive data.

The period of exclusive data use provided under clause (i) shall be extended 1 additional year for each 3 minor uses registered after August 3, 1996, and within 7 years of the commencement of the exclusive use period, up to a total of 3 additional years for all minor uses registered by the Administrator if the Administrator, in consultation with the Secretary of Agriculture, determines that, based on information provided by an applicant for registration or a registrant, that—

there are insufficient efficacious alternative registered pesticides available for the use;

the alternatives to the minor use pesticide pose greater risks to the environment or human health;

the minor use pesticide plays or will play a significant part in managing pest resistance; or

the minor use pesticide plays or will play a significant part in an integrated pest management program.

The registration of a pesticide for a minor use on a crop grouping established by the Administrator shall be considered for purposes of this clause 1 minor use for each representative crop for which data are provided in the crop grouping. Any additional exclusive use period under this clause shall be modified as appropriate or terminated if the registrant voluntarily cancels the product or deletes from the registration the minor uses which formed the basis for the extension of the additional exclusive use period or if the Administrator determines that the registrant is not actually marketing the product for such minor uses.

Except as otherwise provided in clause (i), 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 application 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 subchapter, 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.

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 clauses (i), (ii), and (iii), 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 having been received to compensate the original data submitter for the use of such item of data.

The period of exclusive use provided under clause (ii) shall not take effect until 1 year after August 3, 1996, except where an applicant or registrant is applying for the registration of a pesticide containing an active ingredient not previously registered.

With respect to data submitted after August 3, 1996, by an applicant or registrant to support an amendment adding a new use to an existing registration that does not retain any period of exclusive use, if such data relates solely to a minor use of a pesticide, such data shall not, without the written permission of the original data submitter, be considered by the Administrator to support an application for a minor use by another person during the period of 10 years following the date of submission of such data. The applicant or registrant at the time the new minor use is requested shall notify the Administrator that to the best of their knowledge the exclusive use period for the pesticide has expired and that the data pertaining solely to the minor use of a pesticide is eligible for the provisions of this paragraph. If the minor use registration which is supported by data submitted pursuant to this subsection is voluntarily canceled or if such data are subsequently used to support a nonminor use, the data shall no longer be subject to the exclusive use provisions of this clause but shall instead be considered by the Administrator in accordance with the provisions of clause (i), as appropriate.

If the applicant is requesting that the registration or amendment to the registration of a pesticide be expedited, an explanation of the basis for the request must be submitted, in accordance with paragraph (10) of this subsection.

Data in support of registration

In general

The Administrator shall publish guidelines specifying the kinds of information which will be required to support the registration of a pesticide and shall revise such guidelines from time to time. If thereafter the Administrator requires any additional kind of information under subparagraph (B) of this paragraph, the Administrator shall permit sufficient time for applicants to obtain such additional information. 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, the public health and agricultural need for such minor use, and the level and degree of potential beneficial or adverse effects on man and the environment. The Administrator shall not require a person to submit, in relation to a registration or reregistration of a pesticide for minor agricultural use under this subchapter, any field residue data from a geographic area where the pesticide will not be registered for such use. 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. Except as provided by section 136h of this title, within 30 days after the Administrator registers a pesticide under this subchapter the Administrator shall make available to the public the data called for in the registration statement together with such other scientific information as the Administrator deems relevant to the Administrator’s decision.

Additional data

If 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.

Each registrant of such pesticide shall provide evidence within ninety days after receipt of notification that it is taking appropriate steps to secure 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. The Administrator shall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures prescribed by clause (iv) if a registrant fails to comply with this clause.

If, 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 equally in the payment of the fee and expenses of the arbitrator. The Administrator shall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures prescribed by clause (iv) if a registrant fails to comply with this clause.

Notwithstanding any other provision of this subchapter, 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 is requested, a hearing shall be conducted under section 136d(d) of this title. 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 subchapter. If a hearing is held, a decision after completion of such hearing shall be final. Notwithstanding any other provision of this subchapter, a hearing shall be held and a determination made within seventy-five days after receipt of a request for such hearing. Any registration 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.

Any data submitted under this subparagraph shall be subject to the provisions of paragraph (1)(D). 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.

Upon the request of a registrant the Administrator shall, in the case of a minor use, extend the deadline for the production of residue chemistry data under this subparagraph for data required solely to support that minor use until the final deadline for submission of data under section 136a–1 of this title for the other uses of the pesticide established as of August 3, 1996, if—

the data to support other uses of the pesticide on a food are being provided;

the registrant, in submitting a request for such an extension, provides a schedule, including interim dates to measure progress, to assure that the data production will be completed before the expiration of the extension period;

the Administrator has determined that such extension will not significantly delay the Administrator’s schedule for issuing a reregistration eligibility determination required under section 136a–1 of this title; and

the Administrator has determined that based on existing data, such extension would not significantly increase the risk of any unreasonable adverse effect on the environment. If the Administrator grants an extension under this clause, the Administrator shall monitor the development of the data and shall ensure that the registrant is meeting the schedule for the production of the data. If the Administrator determines that the registrant is not meeting or has not met the schedule for the production of such data, the Administrator may proceed in accordance with clause (iv) regarding the continued registration of the affected products with the minor use and shall inform the public of such action. Notwithstanding the provisions of this clause, the Administrator may take action to modify or revoke the extension under this clause if the Administrator determines that the extension for the minor use may cause an unreasonable adverse effect on the environment. In such circumstance, the Administrator shall provide, in writing to the registrant, a notice revoking the extension of time for submission of data. Such data shall instead be due in accordance with the date established by the Administrator for the submission of the data.

If the registrant does not commit to support a specific minor use of the pesticide, but is supporting and providing data in a timely and adequate fashion to support uses of the pesticide on a food, or if all uses of the pesticide are nonfood uses and the registrant does not commit to support a specific minor use of the pesticide but is supporting and providing data in a timely and adequate fashion to support other nonfood uses of the pesticide, the Administrator, at the written request of the registrant, shall not take any action pursuant to this clause in regard to such unsupported minor use until the final deadline established as of August 3, 1996, for the submission of data under section 136a–1 of this title for the supported uses identified pursuant to this clause unless the Administrator determines that the absence of the data is significant enough to cause human health or environmental concerns. On the basis of such determination, the Administrator may refuse the request for extension by the registrant. Upon receipt of the request from the registrant, the Administrator shall publish in the Federal Register a notice of the receipt of the request and the effective date upon which the uses not being supported will be voluntarily deleted from the registration pursuant to section 136d(f)(1) of this title. If the Administrator grants an extension under this clause, the Administrator shall monitor the development of the data for the uses being supported and shall ensure that the registrant is meeting the schedule for the production of such data. If the Administrator determines that the registrant is not meeting or has not met the schedule for the production of such data, the Administrator may proceed in accordance with clause (iv) of this subparagraph regarding the continued registration of the affected products with the minor and other uses and shall inform the public of such action in accordance with section 136d(f)(2) of this title. Notwithstanding the provisions of this clause, the Administrator may deny, modify, or revoke the temporary extension under this subparagraph if the Administrator determines that the continuation of the minor use may cause an unreasonable adverse effect on the environment. In the event of modification or revocation, the Administrator shall provide, in writing, to the registrant a notice revoking the temporary extension and establish a new effective date by which the minor use shall be deleted from the registration.

If data required to support registration of a pesticide under subparagraph (A) is requested by a Federal or State regulatory authority, the Administrator shall, to the extent practicable, coordinate data requirements, test protocols, timetables, and standards of review and reduce burdens and redundancy caused to the registrant by multiple requirements on the registrant.

The Administrator may enter into a cooperative agreement with a State to carry out subclause (I).

Not later than 1 year after August 3, 1996, the Administrator shall develop a process to identify and assist in alleviating future disparities between Federal and State data requirements.

Simplified procedures

Within nine months after September 30, 1978, the Administrator shall, by regulation, prescribe simplified procedures for the registration of pesticides, which shall include the provisions of subparagraph (D) of this paragraph.

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 the pesticide that is the subject of the application shall be required to—

submit or cite data pertaining to such purchased product; or

offer to pay reasonable compensation otherwise required by paragraph (1)(D) of this subsection for the use of any such data.

Minor use waiver

In handling the registration of a pesticide for a minor use, the Administrator may waive otherwise applicable data requirements if the Administrator determines that the absence of such data will not prevent the Administrator from determining—

the incremental risk presented by the minor use of the pesticide; and

that such risk, if any, would not be an unreasonable adverse effect on the environment.

Application

In general

The Administrator shall review the data after receipt of the application and shall, as expeditiously as possible, either register the pesticide in accordance with paragraph (5), or notify the applicant of the Administrator’s determination that it does not comply with the provisions of the subchapter in accordance with paragraph (6).

Identical or substantially similar

The Administrator shall, as expeditiously as possible, review and act on any application received by the Administrator that—

proposes the initial or amended registration of an end-use pesticide that, if registered as proposed, would be identical or substantially similar in composition and labeling to a currently-registered pesticide identified in the application, or that would differ in composition and labeling from such currently-registered pesticide only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment; or

proposes an amendment to the registration of a registered pesticide that does not require scientific review of data.

In expediting the review of an application for an action described in clause (i), the Administrator shall—

review the application in accordance with section 136w–8(f)(4)(B) of this title and, if the application is found to be incomplete, reject the application;

not later than the applicable decision review time established pursuant to section 136w–8(f)(4)(B) of this title, or, if no review time is established, not later than 90 days after receiving a complete application, notify the registrant if the application has been granted or denied; and

if the application is denied, notify the registrant in writing of the specific reasons for the denial of the application.

Minor use registration

The Administrator shall, as expeditiously as possible, review and act on any complete application—

that proposes the initial registration of a new pesticide active ingredient if the active ingredient is proposed to be registered solely for minor uses, or proposes a registration amendment solely for minor uses to an existing registration; or

for a registration or a registration amendment that proposes significant minor uses.

For the purposes of clause (i)—

the term “as expeditiously as possible” means that the Administrator shall, to the greatest extent practicable, complete a review and evaluation of all data, submitted with a complete application, within 12 months after the submission of the complete application, and the failure of the Administrator to complete such a review and evaluation under clause (i) shall not be subject to judicial review; and

the term “significant minor uses” means 3 or more minor uses proposed for every nonminor use, a minor use that would, in the judgment of the Administrator, serve as a replacement for any use which has been canceled in the 5 years preceding the receipt of the application, or a minor use that in the opinion of the Administrator would avoid the reissuance of an emergency exemption under section 136p of this title for that minor use.

Adequate time for submission of minor use data

If a registrant makes a request for a minor use waiver, regarding data required by the Administrator, pursuant to paragraph (2)(E), and if the Administrator denies in whole or in part such data waiver request, the registrant shall have a full-time period for providing such data. For purposes of this subparagraph, the term “full-time period” means the time period originally established by the Administrator for submission of such data, beginning with the date of receipt by the registrant of the Administrator’s notice of denial.

Notice of application

The Administrator shall publish in the Federal Register, promptly after receipt of the statement and other data required pursuant to paragraphs (1) and (2), a notice of each application for registration of any pesticide if it contains any new active ingredient or if it would entail a changed use pattern. The notice shall provide for a period of 30 days in which any Federal agency or any other interested person may comment.

Approval of registration

The Administrator shall register a pesticide if the Administrator determines that, when considered with any restrictions imposed under subsection (d)—

its composition is such as to warrant the proposed claims for it;

its labeling and other material required to be submitted comply with the requirements of this subchapter;

it will perform its intended function without unreasonable adverse effects on the environment; and

when used in accordance with widespread and commonly recognized practice it will not generally cause unreasonable adverse effects on the environment.

The Administrator shall not make any lack of essentiality a criterion for denying registration of any pesticide. Where two pesticides meet the requirements of this paragraph, one should not be registered in preference to the other. 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 136v(c) of this title, a presumption is established that the Administrator shall waive data requirements pertaining to efficacy for use of the pesticide in such State.

Denial of registration

If the Administrator determines that the requirements of paragraph (5) for registration are not satisfied, the Administrator shall notify the applicant for registration of the Administrator’s determination and of the Administrator’s reasons (including the factual basis) therefor, and that, unless the applicant corrects the conditions and notifies the Administrator thereof during the 30-day period beginning with the day after the date on which the applicant receives the notice, the Administrator may refuse to register the pesticide. Whenever the Administrator refuses to register a pesticide, the Administrator shall notify the applicant of the Administrator’s decision and of the Administrator’s reasons (including the factual basis) therefor. The Administrator shall promptly publish in the Federal Register notice of such denial of registration and the reasons therefor. Upon such notification, the applicant for registration or other interested person with the concurrence of the applicant shall have the same remedies as provided for in section 136d of this title.

Registration under special circumstances

Notwithstanding the provisions of paragraph (5)—

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 paragraph (5). 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 subchapter.

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 subchapter, 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 paragraph (5). 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 subchapter.

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 subchapter, and on such other conditions as the Administrator may prescribe. 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.

Interim administrative review

Notwithstanding any other provision of this subchapter, 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 subchapter, unless such interim administrative process is based on a validated test or other significant evidence raising prudent concerns of unreasonable adverse 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.

Labeling

Additional statements

Subject to subparagraphs (B) and (C), it shall not be a violation of this subchapter for a registrant to modify the labeling of an antimicrobial pesticide product to include relevant information on product efficacy, product composition, container composition or design, or other characteristics that do not relate to any pesticidal claim or pesticidal activity.

Requirements

Proposed labeling information under subparagraph (A) shall not be false or misleading, shall not conflict with or detract from any statement required by law or the Administrator as a condition of registration, and shall be substantiated on the request of the Administrator.

Notification and disapproval

Notification

A registration may be modified under subparagraph (A) if—

the registrant notifies the Administrator in writing not later than 60 days prior to distribution or sale of a product bearing the modified labeling; and

the Administrator does not disapprove of the modification under clause (ii).

Disapproval

Not later than 30 days after receipt of a notification under clause (i), the Administrator may disapprove the modification by sending the registrant notification in writing stating that the proposed language is not acceptable and stating the reasons why the Administrator finds the proposed modification unacceptable.

Restriction on sale

A registrant may not sell or distribute a product bearing a disapproved modification.

Objection

A registrant may file an objection in writing to a disapproval under clause (ii) not later than 30 days after receipt of notification of the disapproval.

Final action

A decision by the Administrator following receipt and consideration of an objection filed under clause (iv) shall be considered a final agency action.

Use dilution

The label or labeling required under this subchapter for an antimicrobial pesticide that is or may be diluted for use may have a different statement of caution or protective measures for use of the recommended diluted solution of the pesticide than for use of a concentrate of the pesticide if the Administrator determines that—

adequate data have been submitted to support the statement proposed for the diluted solution uses; and

the label or labeling provides adequate protection for exposure to the diluted solution of the pesticide.

Expedited registration of pesticides

Not later than 1 year after August 3, 1996, the Administrator shall, utilizing public comment, develop procedures and guidelines, and expedite the review of an application for registration of a pesticide or an amendment to a registration that satisfies such guidelines.

Any application for registration or an amendment, including biological and conventional pesticides, will be considered for expedited review under this paragraph. An application for registration or an amendment shall qualify for expedited review if use of the pesticide proposed by the application may reasonably be expected to accomplish 1 or more of the following:

Reduce the risks of pesticides to human health.

Reduce the risks of pesticides to nontarget organisms.

Reduce the potential for contamination of groundwater, surface water, or other valued environmental resources.

Broaden the adoption of integrated pest management strategies, or make such strategies more available or more effective.

The Administrator, not later than 30 days after receipt of an application for expedited review, shall notify the applicant whether the application is complete. If it is found to be incomplete, the Administrator may either reject the request for expedited review or ask the applicant for additional information to satisfy the guidelines developed under subparagraph (A).

Interagency working group

Definition of covered agency

In this paragraph, the term “covered agency” means any of the following:

The Department of Agriculture.

The Department of Commerce.

The Department of the Interior.

The Council on Environmental Quality.

The Environmental Protection Agency.

Establishment

The Administrator shall establish an interagency working group, to be comprised of representatives from each covered agency, to provide recommendations regarding, and to implement a strategy for improving, the consultation process required under section 7 of the Endangered Species Act of 1973 (16 U.S.C. 1536) for pesticide registration and registration review.

Duties

The interagency working group established under subparagraph (B) shall—

analyze relevant Federal law (including regulations) and case law for purposes of providing an outline of the legal and regulatory framework for the consultation process referred to in that subparagraph, including—

requirements under this subchapter and the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.);

Federal case law regarding the intersection of this subchapter and the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.); and

Federal regulations relating to the pesticide consultation process;

provide advice regarding methods of—

defining the scope of actions of the covered agencies that are subject to the consultation requirement referred to in subparagraph (B); and

properly identifying and classifying effects of actions of the covered agencies with respect to that consultation requirement;

identify the obligations and limitations under Federal law of each covered agency for purposes of providing a legal and regulatory framework for developing the recommendations referred to in subparagraph (B);

review practices for the consultation referred to in subparagraph (B) to identify problem areas, areas for improvement, and best practices for conducting that consultation among the covered agencies;

develop scientific and policy approaches to increase the accuracy and timeliness of the process for that consultation, in accordance with requirements of this subchapter and the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.), including—

processes to efficiently share data and coordinate analyses among the Department of Agriculture, the Department of Commerce, the Department of the Interior, and the Environmental Protection Agency;

a streamlined process for identifying which actions require no consultation, informal consultation, or formal consultation;

an approach that will provide clarity with respect to what constitutes the best scientific and commercial data available in the fields of pesticide use and ecological risk assessment, pursuant to section 7(a)(2) of the Endangered Species Act of 1973 (16 U.S.C. 1536(a)(2)); and

approaches that enable the Environmental Protection Agency to better assist the Department of the Interior and the Department of Commerce in carrying out obligations under that section in a timely and efficient manner; and

propose and implement a strategy to implement approaches to consultations under the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.) and document that strategy in a memorandum of understanding, revised regulations, or another appropriate format to promote durable cooperation among the covered agencies.

Reports

Progress reports

In general

Not later than 18 months after December 20, 2018, the Administrator, in coordination with the head of each other covered agency, shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report describing the progress of the working group in developing the recommendations under subparagraph (B).

Requirements

The report under this clause shall—

reflect the perspectives of each covered agency; and

identify areas of new consensus and continuing topics of disagreement and debate.

Results

In general

Not later than 1 year after December 20, 2018, the Administrator, in coordination with the head of each other covered agency, shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report describing—

the recommendations developed under subparagraph (B); and

plans for implementation of those recommendations.

Requirements

The report under this clause shall—

reflect the perspectives of each covered agency; and

identify areas of consensus and continuing topics of disagreement and debate, if any.

Implementation

Not later than 1 year after the date of submission of the report under clause (i), the Administrator, in coordination with the head of each other covered agency, shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report describing—

the implementation of the recommendations referred to in that clause;

the extent to which that implementation improved the consultation process referred to in subparagraph (B); and

any additional recommendations for improvements to the process described in subparagraph (B).

Other reports

Not later than the date that is 180 days after the date of submission of the report under clause (iii), and not less frequently than once every 180 days thereafter during the 5-year period beginning on that date, the Administrator, in coordination with the head of each other covered agency, shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report describing—

the implementation of the recommendations referred to in that clause;

the extent to which that implementation improved the consultation process referred to in subparagraph (B); and

any additional recommendations for improvements to the process described in subparagraph (B).

Consultation with private sector

In carrying out the duties under this paragraph, the working group shall, as appropriate—

consult with, representatives of interested industry stakeholders and nongovernmental organizations; and

take into consideration factors, such as actual and potential differences in interest between, and the views of, those stakeholders and organizations.

Chapter 10 of title 5

Chapter 10 of title 5 shall not apply to the working group established under this paragraph.

Savings clause

Nothing in this paragraph supersedes any provision of—

this subchapter; or

the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.), including the requirements under section 7 of that Act (16 U.S.C. 1536).

Classification of pesticides

Classification for general use, restricted use, or both

As a part of the registration of a pesticide the Administrator shall classify it as being for general use or for restricted use. If the Administrator determines that some of the uses for which the pesticide is registered should be for general use and that other uses for which it is registered should be for restricted use, the Administrator shall classify it for both general use and restricted use. Pesticide uses may be classified by regulation on the initial classification, and registered pesticides may be classified prior to reregistration. If some of the uses of the pesticide are classified for general use, and other uses are classified for restricted use, the directions relating to its general uses shall be clearly separated and distinguished from those directions relating to its restricted uses. The Administrator may require that its packaging and labeling for restricted uses shall be clearly distinguishable from its packaging and labeling for general uses.

If the Administrator determines that the pesticide, when applied in accordance with its directions for use, warnings and cautions and for the uses for which it is registered, or for one or more of such uses, or in accordance with a widespread and commonly recognized practice, will not generally cause unreasonable adverse effects on the environment, the Administrator will classify the pesticide, or the particular use or uses of the pesticide to which the determination applies, for general use.

If the Administrator determines that the pesticide, when applied in accordance with its directions for use, warnings and cautions and for the uses for which it is registered, or for one or more of such uses, or in accordance with a widespread and commonly recognized practice, may generally cause, without additional regulatory restrictions, unreasonable adverse effects on the environment, including injury to the applicator, the Administrator shall classify the pesticide, or the particular use or uses to which the determination applies, for restricted use:

If the Administrator classifies a pesticide, or one or more uses of such pesticide, for restricted use because of a determination that the acute dermal or inhalation toxicity of the pesticide presents a hazard to the applicator or other persons, the pesticide shall be applied for any use to which the restricted classification applies only by or under the direct supervision of a certified applicator.

If the Administrator classifies a pesticide, or one or more uses of such pesticide, for restricted use because of a determination that its use without additional regulatory restriction may cause unreasonable adverse effects on the environment, the pesticide shall be applied for any use to which the determination applies only by or under the direct supervision of a certified applicator, or subject to such other restrictions as the Administrator may provide by regulation. Any such regulation shall be reviewable in the appropriate court of appeals upon petition of a person adversely affected filed within 60 days of the publication of the regulation in final form.

Change in classification

If the Administrator determines that a change in the classification of any use of a pesticide from general use to restricted use is necessary to prevent unreasonable adverse effects on the environment, the Administrator shall notify the registrant of such pesticide of such determination at least forty-five days before making the change and shall publish the proposed change in the Federal Register. The registrant, or other interested person with the concurrence of the registrant, may seek relief from such determination under section 136d(b) of this title.

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 136n of this title.

Products with same formulation and claims

Products which have the same formulation, are manufactured by the same person, the labeling of which contains the same claims, and the labels of which bear a designation identifying the product as the same pesticide may be registered as a single pesticide; and additional names and labels shall be added to the registration by supplemental statements.

Miscellaneous

Effect of change of labeling or formulation

If the labeling or formulation for a pesticide is changed, the registration shall be amended to reflect such change if the Administrator determines that the change will not violate any provision of this subchapter.

Registration not a defense

In no event shall registration of an article be construed as a defense for the commission of any offense under this subchapter. As long as no cancellation proceedings are in effect registration of a pesticide shall be prima facie evidence that the pesticide, its labeling and packaging comply with the registration provisions of the subchapter.

Authority to consult other Federal agencies

In connection with consideration of any registration or application for registration under this section, the Administrator may consult with any other Federal agency.

Mixtures of nitrogen stabilizers and fertilizer products

Any mixture or other combination of—

1 or more nitrogen stabilizers registered under this subchapter; and

1 or more fertilizer products,

shall not be subject to the provisions of this section or sections 136a–1, 136c, 136e, 136m, and 136o(a)(2) of this title if the mixture or other combination is accompanied by the labeling required under this subchapter for the nitrogen stabilizer contained in the mixture or other combination, the mixture or combination is mixed or combined in accordance with such labeling, and the mixture or combination does not contain any active ingredient other than the nitrogen stabilizer.

Bilingual labeling

Requirement

In general

Subject to clause (ii), not later than the applicable deadline described in subparagraph (B), each registered pesticide product released for shipment shall include—

the translation of the parts of the labeling contained in the Spanish Translation Guide described in subparagraph (G) on the product container; or

a link to such translation via scannable technology or other electronic methods readily accessible on the product label.

Exceptions

Notwithstanding clause (i)—

an antimicrobial pesticide product may, in lieu of including a translation or a link under clause (i), provide a link to the safety data sheets in Spanish via scannable technology or other electronic methods readily accessible on the product label; or

a non-agricultural pesticide product that is not classified by the Administrator as restricted use under subsection (d)(1)(A) may, in lieu of including a translation or a link under clause (i), provide a link to the safety data sheets in Spanish via scannable technology or other electronic methods readily accessible on the product label.

Deadlines for bilingual labeling

Pesticide products classified as restricted use

In the case of pesticide products classified by the Administrator as restricted use under subsection (d)(1)(A), the deadline specified in this subparagraph is the date that is 3 years following December 29, 2022.

Pesticide products not classified as restricted use

In the case of pesticide products not classified by the Administrator as restricted use under subsection (d)(1)(A), the deadline specified in this subparagraph shall be as follows:

Agricultural

Acute Toxicity Category I

For agricultural pesticides classified as Acute Toxicity Category I, the date that is 3 years after December 29, 2022.

Acute Toxicity Category II

For agricultural pesticides classified as Acute Toxicity Category II, the date that is 5 years after December 29, 2022.

Antimicrobial and non-agricultural

Acute Toxicity Category I

For antimicrobial and non-agricultural pesticide products classified as Acute Toxicity Category I, the date that is 4 years after December 29, 2022.

Acute Toxicity Category II

For antimicrobial and non-agricultural pesticide products classified as Acute Toxicity Category II, the date that is 6 years after December 29, 2022.

Other pesticide products

With respect to pesticide products not described in subclause (I) or (II), the date that is 8 years after December 29, 2022.

Implementation

Non-notification

In general

In carrying out this paragraph, the Administrator shall allow translations of the parts of the label of a pesticide contained in the Spanish Translation Guide described in subparagraph (G) and scannable technology or other electronic methods to be added using non-notification procedures.

Non-notification procedure defined

In this clause, the term “non-notification procedure” refers to a procedure under which a change may be made to a pesticide label without notifying the Administrator.

Cooperation and consultation

In carrying out this paragraph, the Administrator shall cooperate and consult with State lead agencies for pesticide regulation for the purpose of implementing bilingual labeling as provided in this paragraph as expeditiously as possible.

End use labeling

The labeling requirements of this paragraph shall apply to end use product labels.

Incorporation timeframe

After initial translation deadlines provided in subparagraph (B), updates to the Spanish Translation Guide described in subparagraph (G) shall be incorporated into labeling on the earlier of—

in the case of agricultural use pesticide labels, as determined by the Administrator—

1 year after the date of publication of the updated Spanish Label Translation Guide described in subparagraph (G); or

the released for shipment date specified on the EPA Stamped Approved Label after the pesticide label is next changed or amended following the date of publication of the updated Spanish Label Translation Guide described in subparagraph (G); and

in the case of antimicrobial and non-agricultural use pesticide labels, as determined by the Administrator—

2 years after the date of publication of the updated Spanish Label Translation Guide described in subparagraph (G); or

Notification of updates to the Spanish Translation Guide for Pesticide Labeling

Not later than 10 days after updating the Spanish Translation Guide described in subparagraph (G), the Administrator shall notify registrants of the update to such guide.

Accessibility of bilingual labeling for farm workers

Not later than 180 days after December 29, 2022, to the maximum extent practicable, the Administrator shall seek stakeholder input on ways to make bilingual labeling required under this paragraph accessible to farm workers.

Plan

Not later than 3 years after December 29, 2022, the Administrator shall implement a plan to ensure that farm workers have access to the bilingual labeling required under this paragraph.

Reporting

Not later than 2 years after December 29, 2022, the Administrator shall develop and implement, and make publicly available, a plan for tracking the adoption of the bilingual labeling required under this paragraph.

Spanish Translation Guide described

The Spanish Translation Guide described in this subparagraph is the Spanish Translation Guide for Pesticide Labeling issued in October 2019, as in effect on December 29, 2022, and any successor guides or amendments to such guide.

Registration review

General rule

Periodic review

In general

The registrations of pesticides are to be periodically reviewed.

Regulations

In accordance with this subparagraph, the Administrator shall by regulation establish a procedure for accomplishing the periodic review of registrations.

Initial registration review

The Administrator shall complete the registration review of each pesticide or pesticide case, which may be composed of 1 or more active ingredients and the products associated with the active ingredients, not later than the later of—

October 1, 2022; or

the date that is 15 years after the date on which the first pesticide containing a new active ingredient is registered.

Subsequent registration review

Not later than 15 years after the date on which the initial registration review is completed under clause (iii) and each 15 years thereafter, the Administrator shall complete a subsequent registration review for each pesticide or pesticide case.

Cancellation

No registration shall be canceled as a result of the registration review process unless the Administrator follows the procedures and substantive requirements of section 136d of this title.

Docketing

In general

Subject to clause (ii), after meeting with 1 or more individuals that are not government employees to discuss matters relating to a registration review, the Administrator shall place in the docket minutes of the meeting, a list of attendees, and any documents exchanged at the meeting, not later than the earlier of—

the date that is 45 days after the meeting; or

the date of issuance of the registration review decision.

Protected information

The Administrator shall identify, but not include in the docket, any confidential business information the disclosure of which is prohibited by section 136h of this title.

Limitation

Nothing in this subsection shall prohibit the Administrator from undertaking any other review of a pesticide pursuant to this subchapter.

Data

Submission required

The Administrator shall use the authority in subsection (c)(2)(B) to require the submission of data when such data are necessary for a registration review.

Data submission, compensation, and exemption

For purposes of this subsection, the provisions of subsections (c)(1), (c)(2)(B), and (c)(2)(D) shall be utilized for and be applicable to any data required for registration review.

Registration requirements for antimicrobial pesticides

Evaluation of process

To the maximum extent practicable consistent with the degrees of risk presented by an antimicrobial pesticide and the type of review appropriate to evaluate the risks, the Administrator shall identify and evaluate reforms to the antimicrobial registration process that would reduce review periods existing as of August 3, 1996, for antimicrobial pesticide product registration applications and applications for amended registration of antimicrobial pesticide products, including—

new antimicrobial active ingredients;

new antimicrobial end-use products;

substantially similar or identical antimicrobial pesticides; and

amendments to antimicrobial pesticide registrations.

Review time period reduction goal

Each reform identified under paragraph (1) shall be designed to achieve the goal of reducing the review period following submission of a complete application, consistent with the degree of risk, to a period of not more than—

540 days for a new antimicrobial active ingredient pesticide registration;

270 days for a new antimicrobial use of a registered active ingredient;

120 days for any other new antimicrobial product;

90 days for a substantially similar or identical antimicrobial product;

90 days for an amendment to an antimicrobial registration that does not require scientific review of data; and

120 days for an amendment to an antimicrobial registration that requires scientific review of data and that is not otherwise described in this paragraph.

Implementation

Proposed rulemaking

Issuance

Not later than 270 days after August 3, 1996, the Administrator shall publish in the Federal Register proposed regulations to accelerate and improve the review of antimicrobial pesticide products designed to implement, to the extent practicable, the goals set forth in paragraph (2).

Requirements

Proposed regulations issued under clause (i) shall—

define the various classes of antimicrobial use patterns, including household, industrial, and institutional disinfectants and sanitizing pesticides, preservatives, water treatment, and pulp and paper mill additives, and other such products intended to disinfect, sanitize, reduce, or mitigate growth or development of microbiological organisms, or protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime;

differentiate the types of review undertaken for antimicrobial pesticides;

conform the degree and type of review to the risks and benefits presented by antimicrobial pesticides and the function of review under this subchapter, considering the use patterns of the product, toxicity, expected exposure, and product type;

ensure that the registration process is sufficient to maintain antimicrobial pesticide efficacy and that antimicrobial pesticide products continue to meet product performance standards and effectiveness levels for each type of label claim made; and

implement effective and reliable deadlines for process management.

Comments

In developing the proposed regulations, the Administrator shall solicit the views from registrants and other affected parties to maximize the effectiveness of the rule development process.

Final regulations

Issuance

The Administrator shall issue final regulations not later than 240 days after the close of the comment period for the proposed regulations.

Failure to meet goal

If a goal described in paragraph (2) is not met by the final regulations, the Administrator shall identify the goal, explain why the goal was not attained, describe the element of the regulations included instead, and identify future steps to attain the goal.

Requirements

In issuing final regulations, the Administrator shall—

consider the establishment of a certification process for regulatory actions involving risks that can be responsibly managed, consistent with the degree of risk, in the most cost-efficient manner;

consider the establishment of a certification process by approved laboratories as an adjunct to the review process;

use all appropriate and cost-effective review mechanisms, including—

expanded use of notification and non-notification procedures;

revised procedures for application review; and

allocation of appropriate resources to ensure streamlined management of antimicrobial pesticide registrations; and

clarify criteria for determination of the completeness of an application.

Expedited review

This subsection does not affect the requirements or extend the deadlines or review periods contained in subsection (c)(3).

Alternative review periods

If the final regulations to carry out this paragraph are not effective 630 days after August 3, 1996, until the final regulations become effective, the review period, beginning on the date of receipt by the Agency of a complete application, shall be—

2 years for a new antimicrobial active ingredient pesticide registration;

1 year for a new antimicrobial use of a registered active ingredient;

180 days for any other new antimicrobial product;

90 days for a substantially similar or identical antimicrobial product;

90 days for an amendment to an antimicrobial registration that does not require scientific review of data; and

120 days for an amendment to an antimicrobial registration that requires scientific review of data and that is not otherwise described in this subparagraph.

Wood preservatives

An application for the registration, or for an amendment to the registration, of a wood preservative product for which a claim of pesticidal activity listed in section 136(mm) of this title is made (regardless of any other pesticidal claim that is made with respect to the product) shall be reviewed by the Administrator within the same period as that established under this paragraph for an antimicrobial pesticide product application, consistent with the degree of risk posed by the use of the wood preservative product, if the application requires the applicant to satisfy the same data requirements as are required to support an application for a wood preservative product that is an antimicrobial pesticide.

Notification

In general

Subject to clause (iii), the Administrator shall notify an applicant whether an application has been granted or denied not later than the final day of the appropriate review period under this paragraph, unless the applicant and the Administrator agree to a later date.

Final decision

If the Administrator fails to notify an applicant within the period of time required under clause (i), the failure shall be considered an agency action unlawfully withheld or unreasonably delayed for purposes of judicial review under chapter 7 of title 5.

Exemption

This subparagraph does not apply to an application for an antimicrobial pesticide that is filed under subsection (c)(3)(B) prior to 90 days after August 3, 1996.

Limitation

Notwithstanding clause (ii), the failure of the Administrator to notify an applicant for an amendment to a registration for an antimicrobial pesticide shall not be judicially reviewable in a Federal or State court if the amendment requires scientific review of data within—

the time period specified in subparagraph (D)(vi), in the absence of a final regulation under subparagraph (B); or

the time period specified in paragraph (2)(F), if adopted in a final regulation under subparagraph (B).

Annual report

Submission

Beginning on August 3, 1996, and ending on the date that the goals under paragraph (2) are achieved, the Administrator shall, not later than March 1 of each year, prepare and submit an annual report to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate.

Requirements

A report submitted under subparagraph (A) shall include a description of—

measures taken to reduce the backlog of pending registration applications;

progress toward achieving reforms under this subsection; and

recommendations to improve the activities of the Agency pertaining to antimicrobial registrations.

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.

1947
Federal Environ mental Pesticide Control Act of 1972
Pub. L. 92–516 § 2 · 86 Stat. 973
Enacted · 7 U.S.C. § 136a
June 25, 1947, ch. 125, § 3, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 979
Source evidence
Code source credit
June 25, 1947, ch. 125, § 3, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 979
Enacted provision · exact public law section
Sec. 2. amendments to federal insecticide, fungicide, and rodenticide act The Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135 et seq.) is amended to read as follows: 61 Stat. 163; 78 Stat. 190. “SECTION 1. SHORT TITLE AND TABLE OF CONTENTS. “(a) Short Title.— This Act may be cited as the ‘Federal Insecticide, Fungicide, and Rodenticide Act’. “(b) Table of Contents.— “Section 1. Short title and table of contents. “(a) Short title. “(b) Table of contents. “Sec. 2. Definitions. “(a) Active ingredient. “(b) Administrator. “(c) Adulterated. “(d) Animal. “(e) Certified applicator, etc. “(1) Certified applicator. “(2) Private applicator. “(3) Commercial applicator. “(4) Under the direct supervision and control of a certified applicator. “(f) Defoliant. “(g) Desiccant. “(h) Device. “(1) District court. “(j) Environment. “(k) Fungus. “(l) Imminent hazard. “(m) Inert ingredient. “(n) Ingredient statement. “(o) Insect. “(p) Label and labeling. “(1) Label. “(2) Labeling. “(q) Misbranded. “(r) Nematode. “(s) Person. “(t) Pest “(u) Pesticide. “(v) Plant regulator. “(w) Producer and produce. “(x) Protect health and the environment. “(y) Registrant. “(z) Registration. “(aa) State. “(bb) Unreasonable adverse effects on the environment. “(cc) Weed. “(dd) Establishment. “Sec. 3. Registration of pesticides. “(a) Requirement. “(b) Exemptions. “(c) Procedure for registration. “(1) Statement required. “(2) Data in support of registration. “(3) Time for acting with respect to application. “(4) Notice of application. “(5) Approval of registration. “(6) Denial of registration. “(d) Classification of pesticides. “(1) Classification for general use, restricted use, or both. “(2) Change in classification. “(e) Products with same formulation and claims. “(f) Miscellaneous. “(1) Effect of change of labeling or formulation. “(2) Registration not a defense. “(3) Authority to consult other Federal agencies. “Sec. 4. Use of restricted use pesticide; certified applicators. “(a) Certification procedure. “(1) Federal certification. “(2) State certification. “(b) State plans. “Sec. 5. Experimental use permits. “(a) Issuance. “(b) Temporary tolerance level. “(c) Use under permit “(d) Studies. “(e) Revocation. “Sec. 6. Administrative review; suspension. “(a) Cancellation after five years. “(1) Procedure. “(2) Information. “(b) Cancellation and change in classification. “(c) Suspension. “(1) Order. “(2) Expedite hearing. “(3) Emergency order. “(4) Judicial review. “(d) Public hearings and scientific review. “(e) Judicial review. “Sec. 7. Registration of establishments. “(a) Requirement. “(b) Registration. “(c) Information required. “(d) Confidently records and information. “Sec. 8. Books and records. “(a) Requirement “(b) Inspection. “Sec. 9. Inspection of establishments, etc. “(a) In general. “(b) Warrants. “(c) Enforcement. “(1) Certification of facts to Attorney General. “(2) Notice not required. “(3) Warning notices. “Sec. 10. Protection of trade secrets, etc. “(a) In general. “(b) Disclosure. “Sec. 11. Standards applicable to pesticide applicators. “(a) In general. “(b) Separate standards. “Sec. 12. Unlawful acts. “(a) In general. “(b) Exemptions. “Sec. 13. Stop sale, use, removal, and seizure. “(a) Stop sale, etc., orders. “(b) Seizure. “(c) Disposition after condemnation. “(d) Court costs, etc. “Sec. 14. Penalties. “(a) Civil penalties. “(1) In general. “(2) Private pesticide applicator. “(3) Hearing. “(4) References to Attorney General. “(b) Criminal penalties. “(1) In general. “(2) Private pesticide applicator. “(3) Disclosure of information. “(4) Acts of officers, agents, etc. “Sec. 15. Indemnities. “(a) Requirement “(b) Amount of payment. “(1) In general. “(2) Special rule. “Sec. 16. Administrative procedure; judicial review. “(a) District court review. “(b) Review by Court of Appeals. “(c) Jurisdiction of district courts. “(d) Notice of judgments. “Sec. 17. Imports and exports. “(a) Pesticides and devices intended for export. “(b) Cancellation notices furnished to foreign governments. “(c) Importation of pesticides and devices. “(d) Cooperation in international efforts. “(e) Regulations. “Sec. 18. Exemption of Federal agencies. “Sec. 19. Disposal and transportation. “(a) Procedures. “(b) Advice to Secretary of Transportation. “Sec. 20. Research and monitoring. “(a) Research. “(b) National monitoring plan. “(e) Monitoring. “Sec. 21. Solicitation of public comments; notice of public hearings. “Sec. 22. Delegation and cooperation. “Sec. 23. State cooperation, aid, and training. “(a) Cooperative agreements. “(b) Contracts for training. “Sec. 24. Authority of States, “Sec. 25. Authority of Administrator. “(a) Regulations. “(b) Exemption of pesticides. “(c) Other authority. “Sec. 26. Severability. “Sec. 27. Authorization for appropriations. “SEC. 2. DEFINITIONS. “For purposes of this Act— “(a) Active Ingredient.— The term ‘active ingredient’ means— “(1) in the case of a pesticide other than a plant regulator, defoliant, or desiccant, an ingredient which will prevent, destroy, repel, or mitigate any pest; “(2) in the case of a plant regulator, an ingredient which, through physiological action, will accelerate or retard the rate of growth or rate of maturation or otherwise alter the behavior of ornamental or crop plants or the product thereof; “(3) in the case of a defoliant, an ingredient which will cause the leaves or foliage to drop from a plant; and “(4) in the case of a desiccant, an ingredient which will artificially accelerate the drying of plant tissue. “(b) Administrator.— The term ‘Administrator’ means the Administrator of the Environmental Protection Agency. “(c) Adulterated.— The term ‘adulterated’ applies to any pesticide if: “(1) its strength or purity falls below the professed standard of quality as expressed on its labeling under which it is sold; “(2) any substance has been substituted wholly or in part for the pesticide; or “(3) any valuable constituent of the pesticide has been wholly or in part abstracted. “(d) Animal.— The term ‘animal’ means all vertebrate and invertebrate species, including but not limited to man and other mammals, birds, fish, and shellfish. “(e) Certified Applicator, Etc.— “(1) Certified applicator.— The term ‘certified applicator’ means any individual who is certified under section 4 as authorized to use or supervise the use of any pesticide which is classified for restricted use. “(2) Private applicator.— The term ‘private applicator’ means a certified applicator who uses or supervises the use of any pesticide which is classified for restricted use for purposes of producing any agricultural commodity on property owned or rented by him or his employer or (if applied without compensation other than trading of personal services between producers of agricultural commodities) on the property of another person. “(3) Commercial applicator.— The term ‘commercial applicator’ means a certified applicator (whether or not he is a private applicator with respect to some uses) who uses or supervises the use of any pesticide which is classified for restricted use for any purpose or on any property other than as provided by paragraph (2). “(4) Under the direct supervision of a certified applicator.— Unless otherwise prescribed by its labeling, a pesticide shall be considered to be applied under the direct supervision of a certified applicator if it is applied by a competent person acting under the instructions and control of a certified applicator who is available if and when needed, even though such certified applicator is not physically present at the time and place the pesticide is applied. “(f) Defoliant.— The term ‘defoliant’ means any substance or mixture of substances intended for causing the leaves or foliage to drop from a plant, with or without causing abscission. “(g) Desigcant.— The term ‘desiccant’ means any substance or mixture of substances intended for artificially accelerating the drying of plant tissue. “(h) Device.— The term ‘device’ means any instrument or contrivance (other than a firearm) which is intended for trapping, destroying, repelling, or mitigating any pest or any other form of plant or animal life (other than man and other than bacteria, virus, or other microorganism on or in living man or other living animals); but not including equipment used for the application of pesticides when sold separately therefrom. “(i) District Court.— The term ‘district court’ means a United States district court, the District Court of Guam, the District Court of the Virgin Islands, and the highest court, of American Samoa. “(j) Environment.— The term ‘environment’ includes water, air, land, and all plants and man and other animals living therein, and the interrelationships which exist among these. “(k) Fungus.— The term ‘fungus’ means any non-chlorophyll-bearing thallophyte (that is, any non-chlorophyll-bearing plant of a lower order than mosses and liverworts), as for example, rust, smut, mildew, mold, yeast, and bacteria, except those on or in living man or other animals and those on or in processed food, beverages, or pharmaceuticals. “(l) Imminent Hazard.— The term ‘imminent hazard’ means a situation which exists when the continued use of a pesticide during the tune required for cancellation proceeding would be likely to result in unreasonable adverse effects on the environment or will involve unreasonable hazard to the survival of a species declared endangered 83 Stat. 275. 16 USC 668cc–1. by the Secretary of the Interior under Public Law 91–135. “(m) Inert Ingredient.— The term ‘inert ingredient’ means an ingredient which is not active. “(n) Ingredient Statement.— The term ‘ingredient statement’ means a statement which contains— “(1) the name and percentage of each active ingredient, and the total percentage of all inert ingredients, in the pesticide; and “(2) if the pesticide contains arsenic in any form, a statement of the percentages of total and water soluble arsenic, calculated as elementary arsenic. “(o) Insect.— The term ‘insect’ means any of the numerous small invertebrate animals generally having the body more or less obviously segmented, for the most part belonging to the class insecta, comprising six-legged, usually winged forms, as for example, beetles, bugs, bees, flies, and to other allied classes of arthropods whose members are wingless and usually have more than six legs, as for example, spiders, mites, ticks, centipedes, and wood lice. “(p) Label and Labeling.— “(1) Label.— The term ‘label’ means the written, printed, or graphic matter on, or attached to, the pesticide or device or any of its containers or wrappers. “(2) Labeling.— The term ‘labeling’ means all labels and all other written, printed, or graphic matter— “(A) accompanying the pesticide or device at any time; or “(B) to which reference is made on the label or in literature accompanying the pesticide or device, except to current official publications of the Environmental Protection Agency, the United States Departments of Agriculture and Interior, the Department of Health, Education, and Welfare, State experiment stations. State agricultural colleges, and other similar Federal or State institutions or agencies authorized by law to conduct research in the field of pesticides. “(q) Misbranded.— “(1) A pesticide is misbranded if— “(A) its labeling bears any statement, design, or graphic representation relative thereto or to its ingredients which is false or misleading in any particular; “(B) it is contained in a package or other container or wrapping which does not conform to the standards established by the Administrator pursuant to section 25(c)(3); “(C) it is an imitation of, or is offered for sale under the name of, another pesticide; “(D) its label does not bear the registration number assigned under section 7 to each establishment in which it was produced; “(E) any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or graphic matter in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use; “(F) the labeling accompanying it does not contain directions for use. which are necessary for effecting the purpose for which the product is intended and if complied with, together with any requirements imposed under section 3(d) of this Act, are adequate to protect health and the environment; “(G) the label does not contain a warning or caution statement which may be necessary and if complied with, together with any requirements imposed under section 3(d) of this Act, is adequate to protect health and the environment. “(2) A pesticide is misbranded if— “(A) the label does not bear an ingredient statement on that part of the immediate container (and on the outside container or wrapper of the retail package, if there be one, through which the ingredient statement on the immediate container cannot be clearly read) which is presented or dis-played under customary conditions of purchase, except that a pesticide is not misbranded under this subparagraph if: “(i) the size of form of the immediate container, or the outside container or wrapper of the retail package, makes it impracticable to place the ingredient statement on the part winch is presented or displayed under customary conditions of purchase; and “(ii) the ingredient statement appears prominently on another part of the immediate container, or outside container or wrapper, permitted by the Administrator; “(B) the labeling does not contain a statement of the use classification under which the product is registered; “(C) there is not affixed to its container, and to the outside container or wrapper of the retail package, if there be one, through which the required information on the immediate container cannot be clearly read, a label bearing— “(i) the name and address of the producer, registrant, or person for whom produced; “(ii) the name, brand, or trademark under which the pesticide is sold; “(iii) the net weight or measure of the content: Provided, That the Administrator may permit reasonable variations; and “(v) when required by regulation of the Administrator to effectuate the purposes of this Act, the registration number assigned to the pesticide under this Act, and the use classification; and “(D) the pesticide contains any substance or substances in quantities highly toxic to man, unless the label shall bear, in addition to any other matter required by this Act— “(i) the skull and crossbones; “(ii) the word ‘poison’ prominently in red on a background of distinctly contrasting color; and “(iii) a statement of a practical treatment (first aid or otherwise) in case of poisoning by the pesticide. “(r) Nematode.— The term ‘nematode’ means invertebrate animals of the phylum nemathelminthes and class nematoda, that is, unsegmented round worms with elongated, fusiform, or sad ike bodies covered with cuticle, and inhabiting soil, water, plants, or plant parts; may also be called nemos or eelworms. “(s) Person.— The term ‘person’ means any individual, partnership, association, corporation, or any organized group of persons whether incorporated or not. “(t) Pest.— The term ‘pest’ means (1) any insect, rodent, nematode, fungus, weed, or (2) any other form of terrestrial or aquatic plant or animal life or virus, bacteria, or other micro-organism (except viruses, bacteria, or other microorganisms on or in living man or other living animals) which the Administrator declares to be a pest under section 25(c)(1), “(u) Pesticide.— The term ‘pesticide’ means (1) any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, and (2) any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant. “(v) Plant Regulator.— The term ‘plant regulator’ means any substance or mixture of substances intended, through physiological action, for accelerating or retarding the rate of growth or rate of maturation, or for otherwise altering the behavior of plants or the produce thereof, but shall not include substances to the extent that they are intended as plant nutrients, trace elements, nutritional chemicals, plant inoculants, and soil amendments. Also, the term ‘plant regulator’ shall not be required to include any of such of those nutrient mixtures or soil amendments as are commonly known as vitaminhormone horticultural products, intended for improvement, maintenance, survival, health, and propagation of plants, and as are not for pest destruction and are non toxic, non poisonous in the undiluted packaged concentration. “(w) Producer and Produce.— The term ‘producer’ means the person who manufactures, prepares, compounds, propagates, or processes any pesticide or device. The term ‘produce’ means to manufacture, prepare, compound, propagate, or process any pesticide or device. “(x) Protect Health and the Environment.— The terms ‘protect health and the environment’ and ‘protection of health and the environment’ mean protection against, any unreasonable adverse effects on the environment. “(y) Registrant.— The term ‘registrant’ means a person who has registered any pesticide pursuant to the provisions of this Act. “(z) Registration.— The term ‘registration’ includes reregistration. “(aa) State.— The term ‘State’ means a State, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Trust Territory of the Pacific Islands, and American Samoa. “(bb) Unreasonable Adverse Effects on the Environment.— The term ‘unreasonable adverse effects on the environment’ means any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide. “(cc) Weed.— The term ‘weed’ means any plant which grows where not wanted. “(dd) Establishment.— The term ‘establishment’ means any place where a pesticide or device is produced, or held, for distribution or sale. “SEC. 3. REGISTRATION OF PESTICIDES. “(a) Requirement.— Except as otherwise provided by this Act, no person in any State may distribute, sell, offer for sale, hold for sale, ship, deliver for shipment, or receive and (having so received) deliver or offer to deliver, to any person any pesticide which is not registered with the Administrator. “(b) Exemptions.— A pesticide which is not registered with the Administrator may be transferred if— “(1) the transfer is from one registered establishment to another registered establishment operated by the same producer solely for packaging at the second establishment or for use as a constituent part of another pesticide produced at the second establishment; or “(2) the transfer is pursuant to and in accordance with the requirements of an experimental use permit. “(c) Procedure for Registration.— (1) Statement required.— Each applicant for registration of a pesticide shall file with the Administrator a statement which includes— “(A) the name and address of the applicant and of any other person whose name will appear on the labeling; “(B) the name of the pesticide; “(C) a complete copy of the labeling of the pesticide, a statement of all claims to be made for it, and any directions for its use; “(D) if requested by the Administrator, a full description of the tests made and the results thereof upon which the claims are based, except that data submitted in support of an application shall not, without permission of the applicant, be considered by the Administrator in support of any other application for registration unless such other applicant shall have first offered to pay reasonable compensation for producing the test data to be relied upon and such data is not protected from disclosure by section 10(b). If the parties cannot agree on the amount and method of payment, the Administrator shall make such determination and may fix such other terms and conditions as may be reasonable under the circumstances. The Administrator’s determination shall be made on the record after notice and opportunity for hearing. If the owner of the test data does not agree with said determination, he may, within thirty days, take an appeal to the federal district court for the district in which he resides with respect to either the amount of the payment or the terms of payment, or both. In no event shall the amount of payment determined by the court be less than that determined by the Administrator; “(E) the complete formula of the pesticide; and “(F) a request that the pesticide be classified for general use, for restricted use, or for both. “(2) Data in support of registration.— The Administrator shall publish guidelines specifying the kinds of information which will be required to support the registration of a pesticide and shall revise such guidelines from time to time. If thereafter he requires any additional kind of information he shall permit sufficient time for applicants to obtain such additional information. Except as provided by subsection (c)(1)(D) of this section and section 10, within 30 days after the Administrator registers a pesticide under this Act he shall make available to the public the data called for in the registration statement together with such other scientific information as he deems relevant to his decision. “(3) Time for acting with respect to application.— The Administrator shall review the data after receipt of the application and shall, as expeditiously as possible, either register the pesticide in accordance with paragraph (5), or notify the applicant of his determination that it does not comply with the provisions of the Act in accordance with paragraph (6). “(4) Notice of application.— The Administrator shall publish in the Federal Register, promptly after receipt of the statement and other data required pursuant to paragraphs (1) and (2), a notice of each application for registration of any pesticide if it contains any new active ingredient or if it would entail a changed use pattern. The notice shall provide for a period of 30 days in which any Federal agency or any other interested person may comment. “(5) Approval of registration.— The Administrator shall register a pesticide if he determines that, when considered with any restrictions imposed under subsection (d)— “(A) its composition is such as to warrant the proposed claims for it; “(B) its labeling and other material required to be submitted comply with the requirements of this Act; “(C) it will perform its intended function without unreasonable adverse effects on the environment: and “(D) when used in accordance with widespread and commonly recognized practice it will not generally cause unreasonable adverse effects on the environment. The Administrator shall not make any lack of essentiality a criterion for denying registration of any pesticide. Where two pesticides meet the requirements of this paragraph, one should not be registered in preference to the other. “(6) Denial of registration.— If the Administrator determines that the requirements of paragraph (5) for registration are not satisfied, he shall notify the applicant for registration of his determination and of his reasons (including the factual basis) therefor, and that, unless the applicant corrects the conditions and notifies the Administrator thereof during the 30-day period beginning with the day after the date on which the applicant receives the notice, the Administrator may refuse, to register the pesticide. Whenever the Administrator refuses to register a pesticide, he shall notify the applicant of his decision and of his reasons (including the factual basis) therefor. The Administrator Publication in Federal Register. shall promptly publish in the Federal Register notice of such denial of registration and the reasons therefor. Upon such notification, the applicant for registration or other interested person with the concurrence of the applicant shall have the same remedies as provided for in section 6. “(d) Classification of Pesticides.— “(1) Classification foe general use, restricted use, or both.— “(A) As a part of the registration of a pesticide the Administrator shall classify it as being for general use or for restricted use, provided that if the Administrator determines that some of the uses for which the pesticide is registered should be for general use and that other uses for which it is registered should be for restricted use, lie shall classify it for both general use and restricted use. If some of the uses of the pesticide are classified for general use and other uses are classified for restricted use, the directions relating to its general uses shall be clearly separated and distinguished from those directions relating to its restricted uses: Provided, however, That the Administrator may require that its packaging and labeling for restricted uses shall be clearly distinguishable from its packaging and labeling for general uses. “(B) If the Administrator determines that the pesticide, when applied in accordance with its directions for use, warnings and cautions and for the uses for which it is registered, or for one or more of such uses, or in accordance with a wide-spread and commonly recognized practice, will not generally cause unreasonable adverse effects on the environment, he will classify the pesticide, or the particular use or uses of the pesticide to which the determination applies, for general use. “(C) If the Administrator determines that the pesticide, when applied in accordance with its directions for use warnings and cautions and for the uses for which it is registered, or for one or more of such uses, or in accordance with a wide-spread and commonly recognized practice, may generally cause, without additional regulatory restrictions, unreasonable adverse effects on the environment, including injury to the applicator, he shall classify the pesticide, or the particular use or uses to which the determination applies, for restricted use: “(i) If the Administrator classifies a pesticide, or one or more, uses of such pesticide, for restricted use because of a determination that the acute dermal or inhalation toxicity of the pesticide presents a hazard to the applicator or other persons, the pesticide shall be applied for any use to which the restricted classification applies only by or under the direct supervision of a certified applicator. “(ii) If the Administrator classifies a pesticide, or one or more uses of such pesticide, for restricted use because of a determination that its use without additional regulatory restriction may cause unreasonable adverse effects on the environment, the pesticide shall be applied for any use to which the determination applies only by or under the direct supervision of a certified applicator, or subject to such other restrictions as the Administrator may provide by regulation. Any such regulation shall be reviewable in the appropriate court of appeals upon petition of a person adversely affected filed within 60 days of the publication of the regulation in final form. “(2) Change in classification.— If the Administrator determines that a change in the classification of any use of a pesticide from general use to restricted use is necessary to prevent unreasonable adverse effects on the environment, he shall notify the registrant of such pesticide of such determination at least. 30 days before making the change and shall publish the proposed change in the Federal Register. The registrant, or other interested person with the concurrence of the registrant, may seek relief from such determination under section 6(b). “(e) Products With Same Formulation and Claims.— Products which have the same formulation, are manufactured by the same person, the labeling of which contains the same claims, and the labels of which bear a designation identifying the product as the same pesticide may be registered as a single pesticide; and additional names and labels shall be added to the registration by supplemental statements. “(f) Miscellaneous.— “(1) Effect of change of labeling or formulation.— If the labeling or formulation for a pesticide is changed, the registration shall be amended to reflect such change if the Administrator determines that the change will not violate any provision of this Act, “(2) Registration not a defense.— In no event shall registration of an article be construed as a defense for the commission of any offense under this Act: Provided, That as long as no cancellation proceedings are in effect registration of a pesticide shall be prima facie evidence that the pesticide, its labeling and packaging comply with the registration provisions of the Act. “(3) Authority to consult other federal agencies.— In connection with consideration of any registration or application for registration under this section, the Administrator may consult with any other Federal agency. “SEC. 4. USE OF RESTRICTED USE PESTICIDES; CERTIFIED APPLICATORS. “(a) Certification Procedure.— “(1) Federal certification.— Subject to paragraph (2), the Standards. Administrator shall prescribe standards for the certification of applicators of pesticides. Such standards shall provide that to be certified, an individual must be determined to be competent with respect to the use and handling of pesticides, or to the use and handling of the pesticide or class of pesticides covered by such individual’s certification. “(2) State certification.— If any State, at any time, desires to certify applicators of pesticides, the Governor of such State shall submit a State plan for such purpose. The Administrator shall approve the plan submitted by any State, or any modification thereof, if such plan in his judgment— “(A) designates a State agency as the agency responsible for administering the plan throughout the State; “(B) contains satisfactory assurances that such agency has or will have the legal authority and qualified personnel necessary to carry out the plan; “(C) gives satisfactory assurances that the State will devote adequate funds to the administration of the plan; “(D) provides that the State agency will make such reports to the Administrator in such form and containing such information as the Administrator may from time to time require; and “(E) contains satisfactory assurances that. State standards for the certification of applicators of pesticides conform with those standards prescribed by the Administrator under paragraph (1). Any State certification program under this section shall be maintained in accordance with the State plan approved under this section. “(b) State Plans.— If the Administrator rejects a plan submitted Hearing. under this paragraph, he shall afford the State submitting the plan due notice and opportunity for hearing before so doing. If the Administrator approves a plan submitted under this paragraph, then such State shall certify applicators of pesticides with respect to such State. Whenever the Administrator determines that a State is not administering the certification program in accordance with the plan approved under this section, he shall so notify the State and provide for a hearing at the request of the State, and, if appropriate corrective action is not taken within a reasonable time, not to exceed ninety days, the Administrator shall withdraw approval of such plan. “SEC. 5. EXPERIMENTAL USE PERMITS. “(a) Issuance.— Any person may apply to the Administrator for an experimental use permit for a pesticide. The Administrator may issue an experimental use permit if he determines that the applicant needs such permit in order to accumulate information necessary to register a pesticide under section 3. An application for an experimental use permit may be filed at the time of or before or after an application for registration is filed. “(b) Temporary Tolerance Level.— If the Administrator determines that the use of a pesticide may reasonably be expected to result in any residue on or in food or feed, he may establish a temporary tolerance level for the residue of the pesticide before issuing the experimental use permit. “(e) Use Under Permit.— Use of a pesticide under an experimental use permit shall be under the supervision of the Administrator, and shall be subject to such terms and conditions and be for such period of time as the Administrator may prescribe in the permit. “(d) Studies.— When any experimental use permit is issued for a pesticide containing any chemical or combination of chemicals which has not been included in any previously registered pesticide, the Administrator may specify that studies be conducted to detect whether the use of the pesticide under the permit may cause unreasonable adverse effects on the environment. All results of such studies shall be reported to the Administrator before such pesticide may be registered under section 3. “(e) Revocation.— The Administrator may revoke any experimental use permit, at any time, if he finds that, its terms or conditions are being violated, or that its terms and conditions are inadequate to avoid unreasonable adverse effects on the environment “(f) State Issuance of Permits.— Notwithstanding the foregoing provisions of this section, the Administrator may, under such terms and conditions as he may by regulations prescribe, authorize any State to issue an experimental use permit for a pesticide. All provisions of section 4 relating to State plans shall apply with equal force to a State plan for the issuance of experimental use permits under this section. “SEC. 6. ADMINISTRATIVE REVIEW; SUSPENSION. “(a) Cancellation After Five Years.— “(1) Procedure.— The Administrator shall cancel the registration of any pesticide at the end of the five-year period which begins on the date of its registration (or at the end of any five-year period thereafter) unless the registrant, or other interested person with the concurrence of the registrant, before the end of such period, requests in accordance with regulations prescribed by the Administrator that the registration be continued in effect: Provided, That the Administrator may permit the continued sale and use of existing stocks of a pesticide whose registration is canceled under this subsection or subsection (b) to such extent, under such conditions, and for such uses as he may specify if lie determines that such sale or use is not inconsistent with the purposes of this Act and will not have unreasonable adverse effects on the Publication in Federal Register. environment. The Administrator shall publish in the Federal Register, at least 30 days prior to the expiration of such five-year period, notice that the registration will be canceled if the registrant or other interested person with the concurrence of the registrant does not request that the registration be continued in effect. “(2) Information.— If at any time after the registration of a pesticide the registrant has additional factual information regarding unreasonable adverse effects on the environment of the pesticide, he shall submit such information to the Administrator. “(b) Cancellation and Change in Classification.— If it appears to the Administrator that a pesticide or its labeling or other material required to be submitted does not comply with the provisions of this Act or, when used in accordance with widespread and commonly recognized practice, generally causes unreasonable adverse effects on the environment, the Administrator may issue a notice of his intent either— “(1) to cancel its registration or to change its classification together with the reasons (including the factual basis) for his action, or “(2) to hold a hearing to determine whether or not its registration Hearing. should be canceled or its classification changed. Such notice shall be sent to the registrant and made public. The proposed action shall become final and effective at the end of 30 days from receipt by the registrant, or publication, of a notice issued under paragraph (1), whichever occurs later, unless within that time either (i) the registrant makes the necessary corrections, if possible, or (ii) a request for a hearing is made by a person adversely affected by the notice. In the event a hearing is held pursuant to such a request or to the Administrator’s determination under paragraph (2), a decision pertaining to registration or classification issued after completion of such hearing shall be final. “(c) Suspension.— “(1) Order.— If the Administrator determines that action is necessary to prevent an imminent hazard during the time required for cancellation or change in classification proceedings, he may, by order, suspend the registration of the pesticide immediately. No order of suspension may be issued unless the Administrator has issued or at the same time issues notice of his intention to cancel the registration or change the classification of the pesticide. “Except as provided in paragraph (3), the Administrator shall notify the registrant prior to issuing any suspension order. Such notice shall include findings pertaining to the question of ‘imminent hazard’. The registrant, shall then have an opportunity, in accordance with the provisions of paragraph (2), for an expedited hearing before the Agency on the question of whether an imminent hazard exists. “(2) Expedite hearing.— If no request for a hearing is submitted to the Agency within five days of the registrant’s receipt of the notification provided for by paragraph (1), the suspension order may be issued and shall take effect and shall not be reviewable by a court. If a hearing is requested, it shall commence within five days of the receipt of the request, for such hearing unless the registrant and the Agency agree that it shall commence at a later time. The hearing shall be held in accordance with the provisions of subchapter II of title 5 of the United States Code, 80 Stat. 381; 81 Stat. 54. 5 USC 551. except that the presiding officer need not be a certified hearing examiner. The presiding officer shall have ten days from the conclusion of the presentation of evidence to submit recommended findings and conclusions to the Administrator, who shall then have seven days to render a final order on the issue of suspension. “(3) Emergency order.— Whenever the Administrator determines that an emergency exists that does not permit him to hold a hearing before suspending, he may issue a suspension order in advance of notification to the registrant. In that case, paragraph (2) shall apply except that (i) the order of suspension shall be in effect pending the expeditious completion of the remedies provided by that paragraph and the issuance of a final order on suspension, and (ii) no party other than the registrant and the Agency shall participate except that any person adversely affected may file briefs within the time allotted by the Agency’s rules. Any person so filing briefs shall be considered a party to such proceeding for the purposes of section 16(b), “(4) Judicial review.— A final order on the question of suspension following a hearing shall be reviewable in accordance with Section 16 of this Act, notwithstanding the fact that any related cancellation proceedings have not been completed. Petitions to review orders on the issue of suspension shall be advanced on the docket of the courts of appeals. Any order of suspension entered prior to a hearing before the Administrator shall be subject to immediate review in an action by the registrant or other interested person with the concurrence of the registrant in an appropriate district court, solely to determine whether the order of suspension was arbitrary, capricious or an abuse of discretion, or whether the order was issued in accordance with the procedures established by law. The effect of any order of the court will be only to stay the effectiveness of the suspension order, pending the Administrator’s final decision with respect to cancellation or change in classification. This action may be maintained simultaneously with any administrative review proceeding under this section. The commencement of proceedings under this paragraph shall not operate as a stay of order, unless ordered by the court. “(d) Public Hearings and Scientific Review.— In the event a hearing is requested pursuant to subsection (b) or determined upon by the Administrator pursuant to subsection (b), such hearing shall lie held after due notice for the purpose of receiving evidence relevant and material to the issues raised, by the objections filed by the applicant or other interested parties, or to the issues stated by the Administrator; if the hearing is called by the Administrator rather Subpena. than by the filing of objections. Upon a showing of relevance and reasonable scope of evidence sought by any party to a public hearing, the Hearing Examiner shall issue a subpena to compel testimony or production of documents from any person. The Hearing Examiner shall 28 USC app. be guided by the principles of the Federal Rules of Civil Procedure in making any order for the protection of the witness or the content of documents produced and shall order the payment of reasonable fees and expenses as a condition to requiring testimony of the witness. On contest, the subpena may be enforced by an appropriate United States district court in accordance with the principles stated herein. Upon the request of any party to a public hearing and when in the Hearing Examiners judgment it is necessary or desirable, the Hearing Examiner shall at any time before the hearing record is closed refer to a Committee of the National Academy of Sciences the relevant questions of scientific fact involved in the public hearing. No member of any committee of the National Academy of Sciences established to carry out the functions of this section shall have a financial or other conflict of interest with respect to any matter considered by such committee. Report. The Committee of the National Academy of Sciences shall report in writing to the Hearing Examiner within 60 days after such referral on these questions of scientific fact. The report shall be made public and shall he considered as part of the hearing record. The Administrator shall enter into appropriate arrangements with the National Academy of Sciences to assure an objective and competent scientific review of the questions presented to Committees of the Academy and to provide such other scientific advisory services as may be required by the Administrator for carrying out the purposes of this Act. As soon as practicable after completion of the hearing (including the report of the Academy) but not later than 90 days thereafter, the Administrator shall evaluate the data and reports before him and issue an order either revoking his notice of intention issued pursuant to this section, or shall issue an order either canceling the registration, changing the classification, denying the registration, or requiring modification of the labeling or packaging of the article. Such order shall be based only on substantial evidence of record of such hearing and shall set forth detailed findings of fact upon which the order is based. “(e) Judicial Review.— Final orders of the Administrator under this section shall be subject to judicial review pursuant to section 16. “SEC. 7. REGISTRATION OF ESTABLISHMENTS. “(a) Requirement.— No person shall produce any pesticide subject to this Act in any State unless the establishment in which it. is produced is registered with the Administrator. The application for registration of any establishment shall include the name and address of the establishment and of the producer who operates such establishment. “(b) Registration.— Whenever the Administrator receives an application under subsection (a), he shall register the establishment and assign it an establishment number. “(c) Information Required.— “(1) Any producer operating an establishment registered under this section shall inform the Administrator within 30 days after it is registered of the types and amounts of pesticides— “(A) which he is currently producing; “(B) which he has produced during the past year; and “(C) which he has sold or distributed during the past year. The information required by this paragraph shall be kept current and submitted to the Administrator annually as required under such regulations as the Administrator may prescribe. “(2) Any such producer shall, upon the request of the Administrator for the purpose of issuing a stop sale order pursuant to section 13, inf own him of the name and address of any recipient of any pesticide produced in any registered establishment which he operates. “(d) Confidential Records and Information.— Any information submitted to the Administrator pursuant to subsection (c) shall be considered confidential and shall be subject to the provisions of section 10. “SEC. 8. BOOKS AND RECORDS. “(a) Requirements.— The Administrator may prescribe, regulations Regulations. requiring producers to maintain such records with respect to their operations and the pesticides and devices produced as he determines are necessary for the effective enforcement of this Act. No records required under this subsection shall extend to financial data, sales data other than shipment data, pricing data, personnel data, and research data (other than data relating to registered pesticides or to a pesticide for which an application for registration has been filed). “(b) Inspection.— For the purposes of enforcing the provisions of this Act, any producer, distributor, carrier, dealer, or any other person who sells or offers for sale, delivers or offers for delivery any pesticide or device subject to this Act, shall, upon request of any officer or employee of the Environmental Protection Agency or of any State or political subdivision, duly designated by the Administrator, furnish or permit such person at all reasonable times to have access to, and to copy: (1), a11 records showing the delivery, movement, or holding of such pesticide or device, including the quantity, the date of shipment and receipt, and the name of the consignor and consignee; or (2) in the event of the inability of any person to produce records containing such information, all other records and information relating to such delivery, movement, or holding of the pesticide or device. Any inspection with respect to any records and information referred to in this subsection snail not extend to financial data, sales data other than shipment data, pricing data, personnel data, and research data (other than data relating to registered pesticides or to a pesticide for which an application for registration has been filed). “SEC. 9. INSPECTION OF ESTABLISHMENTS, ETC. “(a) In General.— For purposes of enforcing the provisions of this Act, officers or employees duly designated by the Administrator are authorized to enter at reasonable times, any establishment or other place where pesticides or devices are held for distribution or sale for the purpose of inspecting and obtaining samples of any pesticides or devices, packaged, labeled, and released for shipment, and samples of any containers or labeling for such pesticides or devices. Before undertaking such inspection, the officers or employees 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. If the officer or employee obtains any samples, prior to leaving the premises, he shall give to the owner, operator, or agent in charge a receipt describing the samples obtained and, if requested, a portion of each such sample equal in volume or weight to the portion retained. If an analysis is made of such samples, a copy of the results of such analysis shall be furnished promptly to the owner, operator, or agent in charge. “(b) Warrants.— For purposes of enforcing the provisions of this Act and upon a showing to an officer or court of competent jurisdiction that there is reason to believe that the provisions of this Act have been violated, officers or employees duly designated by the Administrator are empowered to obtain and to execute warrants authorizing— “(1) entry for the purpose of this section; “(2) inspection and reproduction of all records showing the quantity, date of shipment, and the name of consignor and consignee of any pesticide or device found in the establishment which is adulterated, misbranded, not registered (in the case of a pesticide) or otherwise in violation of this Act and in the event of the inability of any person to produce records containing such information, all other records and information relating to such delivery, movement, or holding of the pesticide or device; and “(3) the seizure of any pesticide or device which is in violation of this Act. “(c) Enforcement.— “(1) Certification of facts to attorney general.— The examination of pesticides or devices shall be made in the. Environmental Protection Agency or elsewhere as the Administrator may designate for the purpose of determining from such examinations whether they comply with the requirements of this Act. If it shall appear from any such examination that they fail to comply with the requirements of this Act, the Administrator shall cause notice to be given to the person against whom criminal or civil proceedings are contemplated. Any person so notified shall be given an opportunity to present Ins views, either orally or in writing, with regard to such contemplated proceedings, and if in the opinion of the Administrator it appears that the provisions of this Act have been violated by such person, then the Administrator shall certify the facts to the Attorney General, with a copy of the results of the analysis or the examination of such pesticide for the institution of a criminal proceeding pursuant to section 14(b) or a civil proceeding under section 14(a), when the Administrator determines that such action will be sufficient to effectuate the purposes of this Act. “(2) Notice not required.— The notice of contemplated proceedings and opportunity to present views set forth in this subsection are not prerequisites to the institution of any proceeding by the Attorney General. “(3) Warning notices.— Nothing in this Act. shall be construed as requiring the Administrator to institute proceedings for prosecution of minor violations of this Act whenever he believes that the public interest will be adequately served by a suitable written notice of warning. “SEC. 10. PROTECTION OF TRADE SECRETS AND OTHER INFORMATION. “(a) In General.— In submitting data required by this Act, the applicant may (1) clearly mark any portions thereof which in his opinion are trade secrets or commercial or financial information and (2) submit such marked material separately from other material required to be submitted under this Act. “(b) Disclosure.— Notwithstanding any other provision of this Act, the Administrator shall not make public information which m his judgment contains or relates to trade secrets or commercial or financial information obtained from a person and privileged or confidential, except that, when necessary to carry out the prolusions of this Act, information relating to formulas of products acquired by authorization of this Act may be revealed to any Federal agency consulted and may be revealed at a public hearing or in findings of fact issued by the Administrator. “(c) Disputes.— If the Administrator proposes to release for inspection information which the applicant or registrant believes to be protected from disclosure under subsection (b), he shall notify the applicant or registrant, in writing, by certified mail. The Administrator shall not thereafter make available for inspection such data until thirty days after receipt of the notice by the applicant or registrant. During this period, the applicant or registrant may institute an action in an appropriate district court for a declaratory judgment as to whether such information is subject to protection under subsection (b). “SEC. 11. STANDARDS APPLICABLE TO PESTICIDE APPLICATORS. “(a) In General.— No regulations prescribed by the Administrator for carrying out the provisions of this Act shall require any private applicator to maintain any records or file any reports or other documents. “(b) Separate Standards.— When establishing or approving standards for licensing or certification, the Administrator shall establish separate standards for commercial and private applicators. “SEC. 12. UNLAWFUL ACTS. “(a) In General.— “(1) Except as provided by subsection (b), it shall be unlawful for any person in any State to distribute, sell, offer for sale, hold for sale, ship, deliver for shipment, or receive and (having so received) deliver or offer to deliver, to any person— “(A) any pesticide which is not registered under section 3, except as provided by section 6(a)(1); “(B) any registered pesticide if any claims made for it as a part of its distribution or sale substantially differ from any claims made for it as a part of the statement required in connection with its registration under section 3; “(C) any registered pesticide the composition of which differs at the time of its distribution or sale from its composition as described in the statement required in connection with its registration under section 3; “(D) any pesticide which has not been colored or discolored pursuant to the provisions of section 25(c)(5); “(E) any pesticide which is adulterated or misbranded; or “(F) any device which is misbranded. “(2) It shall be unlawful for any person— “(A) to detach, alter, deface, or destroy, in whole or in part, any labeling required under this Act; “(B) to refuse to keep any records required pursuant to section 8, or to refuse to allow the inspection of any records or establishment pursuant to section 8 or 9, or to refuse to allow an officer or employee of the Environmental Protection Agency to take a sample of any pesticide pursuant to section 9; “(C) to give a guaranty or undertaking provided for in subsection (b) which is false in any particular, except that a person who receives and relies upon a guaranty authorized under subsection (b) may give a guaranty to the same effect, which guaranty shall contain, in addition to his own name and address, the name and address of the person residing in the United States from whom he received the guaranty or undertaking; “(D) to use for his own advantage or to reveal, other than to the Administrator, or officials or employees of the Environmental Protection Agency or other Federal executive agencies, or to the courts, or to physicians, pharmacists, and other qualified persons, needing such information for the performance of their duties, in accordance with such directions as the Administrator may prescribe, any information acquired by authority of this Act which is confidential under this Act; “(E) who is a registrant, wholesaler, dealer, retailer, or other distributor to advertise a product registered under this Act for restricted use without giving the classification of the product assigned to it under section 3; “(F) to make available for use, or to use, any registered pesticide classified for restricted use for some or all purposes other than in accordance with section 3(d) and any regulations thereunder; “(G) to use any registered pesticide in a manner inconsistent with its labeling; “(H) to use any pesticide which is under an experimental use permit contrary to the provisions of such permit; “(I) to violate any order issued under section 13; “(J) to violate any suspension order issued under section 6; “(K) to violate any cancellation of registration of a pesticide under section 6, except as provided by section 6(a)(1); “(L) who is a producer to violate any of the provisions of section 7; “(M) to knowingly falsify all or part of any application for registration, application for experimental use permit, any information submitted to the .Administrator pursuant to section 7, any records required to lie maintained pursuant to section 8, any report, filed under this Act, or any information marked as confidential and submitted to the Administrator under any provision of this Act; “(N) who is a registrant, wholesaler, dealer, retailer, or other distributor to fail to file reports required by this Act; “(O) to add any substance to, or take any substance from, any pesticide in a manner that may defeat the purpose of this Act; or “(P) to use any pesticide in tests on human beings unless such human beings (i) are. fully informed of the nature and purposes of the test and of any physical and mental health consequences which are reasonably foreseeable therefrom, and (ii) freely volunteer to participate in the test. “(b) Exemptions.— The penalties provided for a violation of paragraph (1) of subsection (a) shall not apply to— “(1) any person who establishes a guaranty signed by, and containing the name and address of, the registrant or person residing in the United States from whom he purchased or received in good faith the pesticide in the same unbroken package, to the effect that the pesticide was lawfully registered at the time of sale and delivery to him. and that it complies with the other requirements of this Act. and in such case the guarantor shall be subject to the penalties which would otherwise attach to the person holding the guaranty under the provisions of this Act; “(2) any carrier while lawfully shipping, transporting, or delivering for shipment any pesticide or device, if such carrier upon request of any officer or employee duly designated by the Administrator shall permit such officer or employee to copy all of its records concerning such pesticide or device; “(3) any public official while engaged in the performance of his official duties; “(4) any person using or possessing any pesticide as provided by an experimental use permit in effect with respect to such pesticide and such use or possession; or “(5) any person who ships a substance or mixture of substances being put through tests in which the purpose is only to determine its value for pesticide purposes or to determine its toxicity or other properties and from which the user does not expect, to receive any benefit in pest control from its use. “SEC. 13. STOP SALE, USE, REMOVAL, AND SEIZURE. “(a) Stop Sale, Etc., Orders.— Whenever any pesticide or device is found by the Administrator in any State and there is reason to believe on the basis of inspection or tests that such pesticide or device is in violation of any of the provisions of this Act, or that such pesticide or device has been or is intended to be distributed or sold in violation of any such provisions, or when the registration of the pesticide has been canceled by a final order or has been suspended, the Administrator may issue a written or printed ‘stop sale, use, or removal’ order to any person who owns, controls, or has custody of such pesticide or device, and after receipt of such order no person shall sell, use, or remove the pesticide or device described in the order except in accordance with the provisions of the order. “(b) Seizure.— Any pesticide or device that is being transported or, having been transported, remains unsold or in original unbroken packages, or that is sold or offered for sale in any State, or that is imported from a foreign country, shall be liable to be proceeded against in any district court in the district where it is found and seized for confiscation by a process in rem for condemnation if— “(1) in the case of a pesticide— “(A) it is adulterated or misbranded; “(B) it is not registered pursuant to the provisions of section 3; “(C) its labeling fails to bear the information required by this Act; “(D) it is not colored or discolored and such coloring or discoloring is required under this Act; or “(E) any of the claims made for it or any of the directions for its use differ in substance from the representations made in connection with its registration; “(2) in the case of a device, it is misbranded; or “(3) in the case of a pesticide or device, when used in accordance with the requirements imposed under this Act and as directed by the labeling, it nevertheless causes unreasonable adverse effects on the environment. In the case of a plant regulator, defoliant, or desiccant, used in accordance with the label claims and recommendations, physical or physiological effects on plants or parts thereof shall not be deemed to be injury, when such effects are the purpose for which the plant regulator, defoliant, or desiccant was applied. “(c) Disposition After Condemnation.— If the pesticide or device is condemned it shall, after entry of the decree, be disposed of by destruction or sale as the court may direct and the proceeds, if sold, less the court costs, shall be paid into the Treasury of the United States, but the pesticide or device shall not lie sold contrary to the provisions of this Act or the laws of the jurisdiction in which it is sold: Provided, That upon payment of the costs of the condemnation proceedings and the execution and delivery of a good and sufficient bond conditioned that the pesticide or device shall not be sold or otherwise disposed of contrary to the provisions of the Act or the laws of any jurisdiction in which sold, the court may direct that such pesticide or device be delivered to the owner thereof. The proceedings of such condemnation cases shall con from, as near as may be to the proceedings in admiralty, except that either party may demand trial by jury of any issue of fact joined in any case, and all such proceedings shall be at the suit of and in the name of the United States. “(d) Court Costs, Etc.— When a decree of condemnation is entered against the pesticide or device, court costs and fees, storage, and other proper expenses shall be awarded against the person, if any, intervening as claimant of the pesticide or device. “SEC. 14. PENALTIES. “(a) Civil Penalties.— “(1) In General.— Any registrant, commercial applicator, wholesaler, dealer, retailer, or other distributor who violates any provision of this Act may be assessed a civil penalty by the Administrator of not more than $5,000 for each offense. “(2) Private Applicator.— Any private applicator or other person not included in paragraph (1) who violates any provision of this Act subsequent to receiving a written warning from the Administrator or following a citation for a prior violation, may be assessed a civil penalty by the Administrator of not more than $1,000 for each offense. “(3) Hearing.— No civil penalty shall be assessed unless the person charged shall have been given notice and opportunity for a hearing on such charge in the county, parish, or incorporated city of the residence of the person charged. 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. “(4) References to Attorney General.— In case, of inability to collect such civil penalty or failure of any person to pay all, or such portion of such civil penalty as the Administrator may determine, the Administrator shall refer the matter to the Attorney General, who shall recover such amount by action in the appropriate United States district court. “(b) Criminal Penalties.— “(1) In general.— Any registrant, commercial applicator, wholesaler, dealer, retailer, or other distributor who knowingly violates any provision of this Act shall be guilty of a misdemeanor and shall on conviction be fined not more than $25,000, or imprisoned for not more than one year, or both. “(2) Private applicator.— Any private applicator or other person not included in paragraph (1) who knowingly violates any provision of this Act shall be guilty of a misdemeanor and shall on conviction be fined not more than $1,000, or imprisoned for not more than 30 days, or both. “(3) Disclosure of information.— Any person, who, with intent to defraud, uses or reveals information relative to formulas of products acquired under the authority of section 3, shall be fined not more than $10,000, or imprisoned for not more than three yea is, or both. “(4) Acts of officers, agents, etc.— When construing and enforcing the provisions of this Act, the act, omission, or failure of any officer, agent, or other person acting for or employed by any person shall in every case be also deemed to be the act, omission, or failure of such person as well as that of the person employed. “SEC. 15. INDEMNITIES. “(a) Requirement.— If— “(1) the Administrator notifies a registrant that he has suspended the registration of a pesticide because such action is necessary to prevent an imminent hazard; “(2) the registration of the pesticide is canceled as a result of a final determination that the use of such pesticide will create an imminent hazard; and “(3) any person who owned any quantify of such pesticide immediately before the notice to the registrant under paragraph (1) suffered losses by reason of suspension or cancellation of the registration, the Administrator shall make an indemnity payment to such person, unless the Administrator finds that such person (i) had knowledge of facts which, in themselves, would have shown that such pesticide did not meet the requirements of section 3(c)(5) for registration, and (ii) continued thereafter to produce such pesticide without giving timely notice of such facts to the Administrator. “(b) Amount of Payment.— “(1) In general.— The amount of the idemnity payment under subsection (a) to any person shall be determined on the basis of the cost of the pesticide owned by such person immediately before the notice to the registrant referred to in subsection (a)(1); except that in no event shall an indemnity payment to any person exceed the fair market value of the pesticide owned by such person immediately before the notice referred to in subsection (a)(1). “(2) Special rule.— Notwithstanding any other provision of this Act, the Administrator may provide a reasonable time for use or other disposal of such pesticide. In determining the quantity of any pesticide for which indemnity shall be paid under this subsection, proper adjustment shall be made for any pesticide used or otherwise disposed of by such owner. “SEC. 16. ADMINISTRATIVE PROCEDURE; JUDICIAL REVIEW. “(a) District Court Review.— Except as is otherwise provided in this Act, Agency refusals to cancel or suspend registrations or change classifications not following a hearing and other final Agency actions not committed to Agency discretion by Jaw are judicially reviewable in the district courts. “(b) Review by Court of Appeals.— In the case of actual controversy as to the validity of any order issued by the Administrator following a public hearing, any person who will be adversely affected by such order and who had been a party to the proceedings may obtain judicial review by filing in the United States court of appeal for the circuit wherein such person resides or has a place of business, within 60 days after the entry of such order, a petition praying that the order be set aside in whole or in part. A copy of the petition shall be forthwith transmitted by the clerk of the court to the Administrator or any officer designated by him for that purpose, and thereupon the Administrator shall file in the court the record of the proceedings on which he based his order, as provided in section 2112 of title 28, United States 72 stat. 941; 80 Stat. 1323. Code. Upon the filing of such petition the court shall have exclusive jurisdiction to affirm or set aside the order complained of in whole or in part. The court shall consider all evidence of record. The order of the Administrator shall lie sustained if it is supported by substantial evidence when considered on the record as a whole. The judgment of the court affirming or setting aside, in whole or in part, any order under this section shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in section 62 Stat. 928. 1254 of title 28 of the United States Code. The commencement of proceedings under this section shall not, unless specifically ordered by the court to the contrary, operate as a stay of an order. The court shall advance on the docket and expedite the disposition of all cases filed therein pursuant to this section, “(c) Jurisdiction of District Courts.— The district courts of the United States are vested with jurisdiction specifically to enforce, and to prevent and restrain violations of this Act. “(d) Notice of Judgments.— The Administrator shall, by publication in such manner as he may prescribe, give notice of all judgments entered in actions instituted under the authority of this Art. “SEC. 17. IMPORTS AND EXPORTS. “(a) Pesticides and Devices Intended for Export.— Notwithstanding any other provision of this Act, no pesticide or device shall be deemed in violation of this Act when intended solely for export to any foreign country and prepared or packed according to the specifications or directions of the foreign purchaser, except that producers of such pesticides and devices shall be subject to section 8 of this Act. (b) Cancellation Notices Furnished to Foreign Governments.— Whenever a registration, or a cancellation or suspension of the registration of a pesticide becomes effective, or ceases to be effective, the Administrator shall transmit through the State Department notification thereof to the governments of other countries and to appropriate international agencies. “(c) Importation of Pesticides and Devices.— The Secretary of the Treasury shall notify the Administrator of the arrival of pesticides and devices and shall deliver to the Administrator, upon his request, samples of pesticides or devices which are being imported into the United States, giving notice to the owner or consignee, who may appear before the Administrator and have the right to introduce testimony. If it appears from the examination of a sample that it is adulterated, or misbranded or otherwise violates the provisions set forth in this Act, or is otherwise injurious to health or the environment, the pesticide or device may be refused admission, and the Secretary of the Treasury shall refuse delivery to the consignee and shall cause the destruction of any pesticide or device refused delivery which shall not be exported by the consignee within 90 days from the date of notice of such refusal under such regulations as the Secretary of the Treasury may prescribe: Provided, That the Secretary of the Treasury may deliver to the consignee such pesticide or device pending examination and decision in the matter on execution of bond for the amount of the full invoice value of such pesticide or device, together with the duty thereon, and on refusal to return such pesticide or device for any cause to the custody of the Secretary of the Treasury, when demanded, for the purpose of excluding them from the country, or for any other purpose, said consignee shall forfeit the full amount of said bond: And provided further, That all charges for storage, cartage, and labor on pesticides or devices which are 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 importation made by such owner or consignee. “(d) Cooperation in International Efforts.— The Administrator shall, in cooperation with the Department of State and any other appropriate Federal agency, participate and cooperate in any international efforts to develop improved pesticide research and regulations. “(e) Regulations.— The Secretary of the, Treasury, in consultation with the Administrator, shall prescribe regulations for the enforcement of subsection (c) of this section. “SEC. 18. EXEMPTION OF FEDERAL AGENCIES, “The Administrator may, at his discretion, exempt any Federal or State agency from any provision of this Act if he determines that emergency conditions exist which require such exemption. “SEC. 19. DISPOSAL AND TRANSPORTATION. “(a) Procedures.— The Administrator shall, after consultation with Regulations. other interested Federal agencies, establish procedures and regula-tions for the disposal or storage of packages and containers of pesticides and for disposal or storage of excess amounts of such pesticides, and accept at convenient locations for safe disposal a pesticide the registration of which is canceled under section 6(c) if requested by the owner of the pesticide. “(b) Advice to Secretary of Transportation.— The Administrator shall provide advice and assistance to the Secretary of Transportation with respect to his functions relating to the transportation of hazardous materials under the Department of Transportation Act (49 80 Stat. 944. 74 stat. 808; 79 Stat. 285. 72 Stat. 775; 85 Stat. 481. U.S.C. 1657), the Transportation of Explosives Act (18 U.S.C. 831–835), the Federal Aviation Act of 1958 (49 U.S.C. 1421–1430, 1472 H), and the Hazardous Cargo Act (46 U.S.C. 170, 375, 416). “SEC. 20. RESEARCH AND MONITORING. “(a) Research.— The Administrator shall undertake research, including research by grant or contract with other Federal agencies, universities, or others as may be necessary to carry out the purposes of this Act, and he shall give priority to research to develop biologically integrated alternatives for pest control. The Administrator shall also take care to insure that such research does not duplicate research being undertaken by any other Federal agency. “(b) National Monitoring Plan.— The Administrator shall formulate and periodically revise, in cooperation with other Federal, State, or local agencies, a national plan for monitoring pesticides. “(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. Such activities shall be carried out in cooperation with other Federal, State, and local agencies. “SEC. 21. SOLICITATION OF COMMENTS; NOTICE OF PUBLIC HEARINGS. “(a) The Administrator, before publishing regulations under this Act, shall solicit the views of the Secretary of Agriculture. “(b) In addition to any other authority relating to public hearings and solicitation of views, in connection with the suspension or cancellation of a pesticide registration or any other actions authorized under this Act, the Administrator may, at his discretion, solicit the views of all interested persons, either orally or in writing, and seek such advice from scientists, farmers, farm organizations, and other qualified persons as he deems proper. “(c) In connection with all public hearings under this Act the Administrator shall publish timely notice of such hearings in the Federal Register. “SEC. 22. DELEGATION AND COOPERATION. “(a) Delegation.— All authority vested in the Administrator by virtue of the provisions of this Act may with like force and effect be executed by such employees of the Environmental Protection Agency as the Administrator may designate for the purpose. “(b) Cooperation.— The Administrator shall cooperate with the Department of Agriculture, any other Federal agency, and any appropriate agency of any State or any political subdivision thereof, in carrying out the provisions of this Act, and in securing uniformity of regulations. “SEC. 23. STATE COOPERATION, AID, AND TRAINING. “(a) Cooperative Agreements.— The Administrator is authorized to enter into cooperative agreements with States— “(1) to delegate to any State the authority to cooperate in the enforcement of the Act through the use of its personnel or facilities, to train personnel of the State to cooperate in the enforcement of this Act, and to assist. States in implementing cooperative enforcement, programs through grants-in-aid; and “(2) to assist State, agencies in developing and administering State programs for training and certification of applicators consistent with the standards which he prescribes. “(b) Contracts for Training.— In addition, the Administrator is authorized to enter into contracts with Federal or State agencies for the purpose of encouraging the training of certified applicators. “(c) The Administrator may, in cooperation with the Secretary of Agriculture, utilize the services of the Cooperative State Extension Services for informing farmers of accepted uses and other regulations made pursuant to this Act, “SEC. 24. AUTHORITY OF STATES. “(a) A State may regulate the sale or use of any 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 and packaging in addition to or different from those required pursuant to this Act; and “(c) a State may provide registration for pesticides formulated for distribution and use within that State to meet special local needs if t hat State is certified by the Administrator as capable of exercising adequate controls to assure that such registration will be 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 and shall not be effective for more than 90 days if disapproved by the Administrator within that period. “SEC. 25. AUTHORITY OF ADMINISTRATOR. “(a) Regulations.— The Administrator is authorized to prescribe regulations to carry out the provisions of this Act. Such regulations shall take into account the difference in concept and usage between various classes of pesticides. “(b) Exemption of Pesticides.— The Administrator may exempt from the requirements of this Act by regulation any pesticide which he determines either (1) to lie adequately regulated by another Federal agency, or (2) to be of a character which is unnecessary to be subject to this Act in order to carry out the purposes of this Act. “(c) Other Authority.— The Administrator, after notice and opportunity for hearing, is authorized— “(1) to declare a pest any form of plant or animal life (other than man and other than bacteria, virus, and other micro-organisms on or in living man or other living animals) which is injurious to health or the environment: “(2) to determine any pesticide which contains any substance or substances in quantities highly toxic to man; “(3) to establish standards (which shall be consistent with those established under the authority of the Poison Prevention Packaging Act (Public Law 91–601)) with respect to the package, 84 Stat. 1670. 15 USC 1471 note. container, or wrapping in which a pesticide or device is enclosed for use or consumption, in order to protect children and adults from serious injury or illness resulting from accidental ingestion “(4) contact with pesticides or devices regulated by this Act as well as to accomplish the other purposes of this Act; “(5) to specify those classes of devices which shall be subject to any provision of paragraph 2(q)(1) or section 7 of this Act upon his determination that application of such provision is necessary to effectuate the purposes of this Act; “(6) to prescribe regulations requiring any pesticide to be colored or discolored if he determines that such requirement is feasible and is necessary for the protection of health and the environment; and “(7) to determine and establish suitable names to be used in the ingredient statement. “SEC. 26. SEVERABILITY. “If any provision of this Act or the application thereof to any person or circumstance is held invalid, the invalidity shall not affect other provisions or applications of tins Act which can lie given effect without regard to the invalid provision or application, and to this end the provisions of this Act are severable. “SEC. 27. AUTHORIZATION FOR APPROPRIATIONS. “There is authorized to be appropriated such sums as may be necessary to carry out the provisions of this Act for each of the fiscal years ending June 30, 1973, June 30, 1974, and June 30, 1975. The amounts authorized to be appropriated for any fiscal year ending after June 30, 1975, shall be the sums hereafter provided by law.”
1975
Pub. L. 94–140 § 12 · 89 Stat. 751
1. Inserted · 7 U.S.C. § 136a(c)(1)(D)
  Pub. L. 94–140 inserted exception relating to test data submitted on or after January 1, 1970, in support of application
2. Inserted · 7 U.S.C. § 136a(c)(1)(D)
  Pub. L. 94–140 inserted provision that compensation for producing test data shall apply to all applications submitted on or after October 21, 1972, and provision relating to delay of registration pending determination of reasonable compensation
3. Struck · 7 U.S.C. § 136a(c)(1)(D)
  Pub. L. 94–140 struck out requirement that payment determined by court not be less than amount determined by Administrator
4. Substituted · 7 U.S.C. § 136a(c)(1)(D)
  Pub. L. 94–140 substituted “If either party” for “If the owner of the test data”
Source evidence
Code amendment note
Subsec. (c)(1)(D). Pub. L. 94–140 inserted exception relating to test data submitted on or after January 1, 1970, in support of application, inserted provision that compensation for producing test data shall apply to all applications submitted on or after October 21, 1972, and provision relating to delay of registration pending determination of reasonable compensation, struck out requirement that payment determined by court not be less than amount determined by Administrator, and substituted “If either party” for “If the owner of the test data”.
Enacted provision · exact public law section
Sec. 12. Section 3(c) (1) (D) of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended, is amended to read as follows: 7 USC 136a. Test data. “(D) if requested by the Administrator, a full description of the tests made and the results thereof upon which the claims are based, except that data submitted on or after January 1, 1970, in support of an application shall not, without permission of the applicant, be considered by the Administrator in support of any other application for registration unless such other applicant shall have first offered to pay reasonable compensation for producing the test data to be relied upon and such data is not protected from disclosure by section 10(b). This provision with regard to compensation 7 USC 136h. for producing the test data to be relied upon shall apply with respect to all applications for registration or reregistration submitted on or after October 21, 1972. If the parties cannot agree on the amount and method of payment, the Administrator shall make such determination and may fix such other terms and conditions as may be reasonable under the circumstances. The Administrator’s Notice and hearing. Appeal. determination shall be made on the record after notice and opportunity for hearing. If either party does not agree with said determination, he may, within thirty days, take an appeal to the Federal district court for the district in which he resides with respect to either the amount of the payment or the terms of payment, or both. Registration shall not be delayed pending the determination of reasonable compensation between the applicants, by the Administrator or by the court.”.
1978
Federal Pesticide Act of 1978
Pub. L. 95–396 § 2(a)(1) · 92 Stat. 819
1. Added · 7 U.S.C. § 136a(c)(1)(D)
  Pub. L. 95–396, § 2(a)(1), added subpar. (D)
2. Struck · 7 U.S.C. § 136a(c)(1)(D)
  Pub. L. 95–396, § 2(a)(1), struck out provisions which required the applicant for registration of a pesticide to file with the Administrator a statement containing “if requested by the Administrator, a full description of the tests made and the results thereof upon which the claims are based, except that data submitted on or after January 1, 1970, in support of an application shall not, without permission of the applicant, be considered by the Administrator in support of any other application for registration unless such other applicant shall have first offered to pay reasonable compensation for producing the test data to be relied upon and such data is not protected from disclosure by section 136h(b) of this title. This provision with regard to compensation for producing the test data to be relied upon shall apply with respect to all applications for registration or reregistration submitted on or after October 21, 1972. If the parties cannot agree on the amount and method of payment, the Administrator shall make such determination and may fix such other terms and conditions as may be reasonable under the circumstances. The Administrator’s determination shall be made on the record after notice and opportunity for hearing. If either party does not agree with said determination, he may, within thirty days, take an appeal to the Federal district court for the district in which he resides with respect to either the amount of the payment or the terms of payment, or both. Registration shall not be delayed pending the determination of reasonable compensation between the applicants, by the Administrator or by the court.”
Source evidence
Code amendment note
Subsec. (c)(1)(D). Pub. L. 95–396, § 2(a)(1), added subpar. (D), and struck out provisions which required the applicant for registration of a pesticide to file with the Administrator a statement containing “if requested by the Administrator, a full description of the tests made and the results thereof upon which the claims are based, except that data submitted on or after January 1, 1970, in support of an application shall not, without permission of the applicant, be considered by the Administrator in support of any other application for registration unless such other applicant shall have first offered to pay reasonable compensation for producing the test data to be relied upon and such data is not protected from disclosure by section 136h(b) of this title. This provision with regard to compensation for producing the test data to be relied upon shall apply with respect to all applications for registration or reregistration submitted on or after October 21, 1972. If the parties cannot agree on the amount and method of payment, the Administrator shall make such determination and may fix such other terms and conditions as may be reasonable under the circumstances. The Administrator’s determination shall be made on the record after notice and opportunity for hearing. If either party does not agree with said determination, he may, within thirty days, take an appeal to the Federal district court for the district in which he resides with respect to either the amount of the payment or the terms of payment, or both. Registration shall not be delayed pending the determination of reasonable compensation between the applicants, by the Administrator or by the court.”.
Enacted provision · exact public law section
(1) 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
1978
Federal Pesticide Act of 1978
Pub. L. 95–396 · 92 Stat. 819
1. Amended · 7 U.S.C. § 136a(c)(2)
  Pub. L. 95–396, §§ 2(a)(2)(A)–(D), 3, 4, designated existing provisions as subpar. (A)
2. Inserted · 7 U.S.C. § 136a(c)(2)
  Pub. L. 95–396, §§ 2(a)(2)(A)–(D), 3, 4, inserted in second sentence “under subparagraph (B) of this paragraph” after “kind of information”
3. Struck · 7 U.S.C. § 136a(c)(2)
  Pub. L. 95–396, §§ 2(a)(2)(A)–(D), 3, 4, struck out from introductory text of third sentence “subsection (c)(1)(D) of this section and” after “Except as provided by”
4. Inserted · 7 U.S.C. § 136a(c)(2)
  Pub. L. 95–396, §§ 2(a)(2)(A)–(D), 3, 4, inserted provisions relating to establishment of standards for data requirements for registration of pesticides with respect to minor uses and consideration of economic factors in development of standards and cost of development
5. Added · 7 U.S.C. § 136a(c)(2)
  Pub. L. 95–396, §§ 2(a)(2)(A)–(D), 3, 4, added subpars. (B) to (D)
Source evidence
Code amendment note
Subsec. (c)(2). Pub. L. 95–396, §§ 2(a)(2)(A)–(D), 3, 4, designated existing provisions as subpar. (A), inserted in second sentence “under subparagraph (B) of this paragraph” after “kind of information”, struck out from introductory text of third sentence “subsection (c)(1)(D) of this section and” after “Except as provided by”, and inserted provisions relating to establishment of standards for data requirements for registration of pesticides with respect to minor uses and consideration of economic factors in development of standards and cost of development, and added subpars. (B) to (D).
1978
Federal Pesticide Act of 1978
Pub. L. 95–396 § 5 · 92 Stat. 819
Changed · 7 U.S.C. § 136a(c)(5)
Pub. L. 95–396, § 5, provided for waiver of data requirements pertaining to efficacy
Source evidence
Code amendment note
Subsec. (c)(5). Pub. L. 95–396, § 5, provided for waiver of data requirements pertaining to efficacy.
Enacted provision · exact public law section
Sec. 5. Section 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide Act is amended by adding at the end thereof the following: 7 USC 136a. “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.”.
1978
Federal Pesticide Act of 1978
Pub. L. 95–396 § 6 · 92 Stat. 819
Added · 7 U.S.C. § 136a(c)(7); 7 U.S.C. § 136a(c)(8)
Pub. L. 95–396, § 6, added pars. (7) and (8)
Source evidence
Code amendment note
Subsec. (c)(7), (8). Pub. L. 95–396, § 6, added pars. (7) and (8).
Enacted provision · exact public law section
Sec. 6. Section 3(c) of the Federal Insecticide, Fungicide, and Rodenticide Act is amended by adding at the end thereof new paragraphs 7 USC 136a. (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.”.
1978
Federal Pesticide Act of 1978
Pub. L. 95–396 § 7(1) · 92 Stat. 819
Changed · 7 U.S.C. § 136a(d)(1)(A)
Pub. L. 95–396, § 7(1), authorized classification of pesticide uses by regulation on the initial classification and registered pesticides prior to reregistration
Source evidence
Code amendment note
Subsec. (d)(1)(A). Pub. L. 95–396, § 7(1), authorized classification of pesticide uses by regulation on the initial classification and registered pesticides prior to reregistration.
Enacted provision · exact public law section
(1) 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.”;
1978
Federal Pesticide Act of 1978
Pub. L. 95–396 § 7(2) · 92 Stat. 819
Substituted · 7 U.S.C. § 136a(d)(2)
Pub. L. 95–396, § 7(2), substituted “forty-five days” for “30 days”
Source evidence
Code amendment note
Subsec. (d)(2). Pub. L. 95–396, § 7(2), substituted “forty-five days” for “30 days”.
Enacted provision · exact public law section
(2) striking out “30 days” in paragraph (2) and inserting in lieu thereof “forty-five days”; and
1978
Federal Pesticide Act of 1978
Pub. L. 95–396 § 7(3) · 92 Stat. 819
Added · 7 U.S.C. § 136a(d)(3)
Pub. L. 95–396, § 7(3), added par. (3)
Source evidence
Code amendment note
Subsec. (d)(3). Pub. L. 95–396, § 7(3), added par. (3).
Enacted provision · exact public law section
(3) 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.”.
1978
Federal Pesticide Act of 1978
Pub. L. 95–396 § 8 · 92 Stat. 819
Added · 7 U.S.C. § 136a(g)
Pub. L. 95–396, § 8, added subsec. (g)
Source evidence
Code amendment note
Subsec. (g). Pub. L. 95–396, § 8, added subsec. (g).
Enacted provision · exact public law section
Sec. 8. Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act is amended by adding at the end thereof new subsection (g) 7 USC 136a. 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.”.
1988
Federal Insecticide, Fungicide, and Rodenticide Act Amendments of 1988
Pub. L. 100–532 § 601(b)(1) · 102 Stat. 2654
1. Substituted · 7 U.S.C. § 136a(a)
  Pub. L. 100–532, § 601(b)(1), substituted “Requirement of registration” for “Requirement” in heading
2. Amended · 7 U.S.C. § 136a(a)
  Pub. L. 100–532, § 601(b)(1), amended text generally. Prior to amendment, text read as follows: “Except as otherwise provided by this subchapter, no person in any State may distribute, sell, offer for sale, hold for sale, ship, deliver for shipment, or receive and (having so received) deliver or offer to deliver, to any person any pesticide which is not registered with the Administrator.”
Source evidence
Code amendment note
Subsec. (a). Pub. L. 100–532, § 601(b)(1), substituted “Requirement of registration” for “Requirement” in heading and amended text generally. Prior to amendment, text read as follows: “Except as otherwise provided by this subchapter, no person in any State may distribute, sell, offer for sale, hold for sale, ship, deliver for shipment, or receive and (having so received) deliver or offer to deliver, to any person any pesticide which is not registered with the Administrator.”
Enacted provision · exact public law section
(1) Registration of pesticides.— Subsection (a) of section 3 (7 U.S.C. 136a(a)) is amended to read as follows: “(a) Requirement of Registration.— Except as provided by this Act, no person Environmental protection. in any State may distribute or sell to any person any pesticide that is not registered under this Act. To the extent necessary to prevent unreasonable adverse effects on the environment, the Administrator may by regulation limit the distribution, sale, or use in any State of any pesticide that is not registered under this Act and that is not the subject of an experimental use permit under section 5 or an emergency exemption under section 18.”.
1988
Federal Insecticide, Fungicide, and Rodenticide Act Amendments of 1988
Pub. L. 100–532 § 801(b)(1) · 102 Stat. 2654
1. Substituted · 7 U.S.C. § 136a(c)(1)(D)
  Pub. L. 100–532, § 801(b)(1)–(4), in introductory provisions, substituted “paragraph (2)(D)” for “subsection (c)(2)(D) of this section”, in cl. (i)
2. Substituted · 7 U.S.C. § 136a(c)(1)(D)
  Pub. L. 100–532, § 801(b)(1)–(4), in introductory provisions, substituted “(i) with” for “(i) With” in cl. (ii)
3. Substituted · 7 U.S.C. § 136a(c)(1)(D)
  Pub. L. 100–532, § 801(b)(1)–(4), in introductory provisions, substituted “, except that” for “: Provided, That” in cl. (ii)
4. Substituted · 7 U.S.C. § 136a(c)(1)(D)
  Pub. L. 100–532, § 801(b)(1)–(4), in introductory provisions, substituted “clause (i)” for “subparagraph (D)(i) of this paragraph”, and in cl. (iii)
5. Substituted · 7 U.S.C. § 136a(c)(1)(D)
  Pub. L. 100–532, § 801(b)(1)–(4), in introductory provisions, substituted “clauses (i) and (ii)” for “subparagraphs (D)(i) and (D)(ii) of this paragraph”
Source evidence
Code amendment note
Subsec. (c)(1)(D). Pub. L. 100–532, § 801(b)(1)–(4), in introductory provisions, substituted “paragraph (2)(D)” for “subsection (c)(2)(D) of this section”, in cl. (i), substituted “(i) with” for “(i) With” and “, except that” for “: Provided, That”, in cl. (ii), substituted “clause (i)” for “subparagraph (D)(i) of this paragraph”, and in cl. (iii), substituted “clauses (i) and (ii)” for “subparagraphs (D)(i) and (D)(ii) of this paragraph”.
Enacted provision · exact public law section
(1) in subsection (c)(1)(D), by striking out “subsection (c)(2)(D) of this section” and inserting in lieu thereof “paragraph (2)(D)”;
1988
Federal Insecticide, Fungicide, and Rodenticide Act Amendments of 1988
Pub. L. 100–532 § 801(b)(5)(A) · 102 Stat. 2654
Substituted · 7 U.S.C. § 136a(c)(2)(A)
Pub. L. 100–532, § 801(b)(5)(A), (B), substituted “(2) Data in support of registration.—
Source evidence
Code amendment note
Subsec. (c)(2)(A). Pub. L. 100–532, § 801(b)(5)(A), (B), substituted “(2) Data in support of registration.—
“(A) The” for “(2)(A) Data in support of registration.—The”, and directed that subpar. (A) be aligned with left margin of subsec. (d)(1)(A) of this section.
Enacted provision · exact public law section
(A) by striking out “(2)(A) Data in support of registration.—The” and inserting in lieu thereof the following: “(2) Data in support of registration.— “(A) The”;
1988
Federal Insecticide, Fungicide, and Rodenticide Act Amendments of 1988
Pub. L. 100–532 title I · 102 Stat. 2654
1. Substituted · 7 U.S.C. § 136a(c)(2)(B)
  Pub. L. 100–532, §§ 102(b)(1), 801(b)(5)(C)–(F), substituted “(B)(i) If” for “(B) Additional data to support existing registration.—(i) If”, directed that cls. (ii) to (v) be aligned with left margin of subpar. (A), in cls. (ii) and (iii)
2. Inserted · 7 U.S.C. § 136a(c)(2)(B)
  Pub. L. 100–532, §§ 102(b)(1), 801(b)(5)(C)–(F), inserted “The Administrator shall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures prescribed by clause (iv) if a registrant fails to comply with this clause.”, in cl. (iv)
3. Substituted · 7 U.S.C. § 136a(c)(2)(B)
  Pub. L. 100–532, §§ 102(b)(1), 801(b)(5)(C)–(F), substituted “title. The only” for “title: Provided, that the only”, and in cl. (v)
4. Substituted · 7 U.S.C. § 136a(c)(2)(B)
  Pub. L. 100–532, §§ 102(b)(1), 801(b)(5)(C)–(F), substituted “paragraph (1)(D)” for “subsection (c)(1)(D) of this section”
Source evidence
Code amendment note
Subsec. (c)(2)(B). Pub. L. 100–532, §§ 102(b)(1), 801(b)(5)(C)–(F), substituted “(B)(i) If” for “(B) Additional data to support existing registration.—(i) If”, directed that cls. (ii) to (v) be aligned with left margin of subpar. (A), in cls. (ii) and (iii), inserted “The Administrator shall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures prescribed by clause (iv) if a registrant fails to comply with this clause.”, in cl. (iv), substituted “title. The only” for “title: Provided, that the only”, and in cl. (v), substituted “paragraph (1)(D)” for “subsection (c)(1)(D) of this section”.
Enacted provision · exact public law
TITLE I— REGISTRATION SEC. 101. DEFINITION OF OUTSTANDING DATA REQUIREMENT. Section 2 (7 U.S.C. 136) is amended by adding at the end thereof the following new subsection: “(ff) Outstanding Data Requirement.— “(1) In general.— The term ‘outstanding data requirement’ means a requirement for any study, information, or data that is necessary to make a determination under section 3(c)(5) and which study, information, or data— “(A) has not been submitted to the Administrator; or “(B) if submitted to the Administrator, the Administrator has determined must be resubmitted because it is not valid, complete, or adequate to make a determination under section 3(c)(5) and the regulations and guidelines issued under such section. “(2) Factors.— In making a determination under paragraph (1)(B) respecting a study, the Administrator shall examine, at a minimum, relevant protocols, documentation of the conduct and analysis of the study, and the results of the study to determine whether the study and the results of the study fulfill the data requirement for which the study was submitted to the Administrator.”. SEC. 102. REREGISTRATION OF REGISTERED PESTICIDES. (a) Amendment.— The Act is amended by inserting after section 3 (7 U.S.C. 136a) the following new section: “SEC. 3A. REREGISTRATION OF REGISTERED PESTICIDES. “(a) General Rule.— The Administrator shall reregister, in accordance with this section, each registered pesticide containing any active ingredient contained in any pesticide first registered before November 1, 1984, except for any pesticide as to which the Administrator has determined, after November 1, 1984, and before the effective date of this section, that— “(1) there are no outstanding data requirements; and “(2) the requirements of section 3(c)(5) have been satisfied. “(b) Reregistration Phases.— Reregistrations of pesticides under this section shall be carried out in the following phases: “(1) The first phase shall include the listing under subsection (c) of the active ingredients of the pesticides that will be reregistered. “(2) The second phase shall include the submission to the Administrator under subsection (d) of notices by registrants respecting their intention to seek reregistration, identification by registrants of missing and inadequate data for such pesticides, and commitments by registrants to replace such missing or inadequate data within the applicable time period. “(3) The third phase shall include submission to the Administrator by registrants of the information required under subsection (e). “(4) The fourth phase shall include an independent, initial review by the Administrator under subsection (l) of submissions under phases two and three, identification of outstanding data requirements, and the issuance, as necessary, of requests for additional data. “(5) The fifth phase shall include the review by the Administrator under subsection (g) of data submitted for reregistration and appropriate regulatory action by the Administrator. “(c) Phase One.— “(1) Priority for reregistration.— For purposes of the reregistration of the pesticides described in subsection (a), the Administrator shall list the active ingredients of pesticides and shall give priority to, among others, active ingredients (other than active ingredients for which registration standards have been issued before the effective date of this section) that— “(A) are in use on or in food or feed and may result in postharvest residues; “(B) may result in residues of potential toxicological concern in potable ground water, edible fish, or shellfish; “(C) have been determined by the Administrator before the effective date of this section to have significant outstanding data requirements; or “(D) are used on crops, including in greenhouses and nurseries, where worker exposure is most likely to occur. “(2) Reregistration lists.— For purposes of reregistration under this section, the Administrator shall by order— “(A) not later than 70 days after the effective date of this section, list pesticide active ingredients for which registration standards have been issued before such effective date; “(B) not later than 4 months after such effective date, list the first 150 pesticide active ingredients, as determined under paragraph (1); “(C) not later than 7 months after such effective date, list the second 150 pesticide active ingredients, as determined under paragraph (1); and “(D) not later than 10 months after such effective date, list the remainder of the pesticide active ingredients, as determined under paragraph (1). Each list shall be published in the Federal Register. “(3) Judicial review.— The content of a list issued by the Administrator under paragraph (2) shall not be subject to judicial review. “(4) Notice to registrants.— On the publication of a list of pesticide active ingredients under paragraph (2), the Administrator shall send by certified mail to the registrants of the pesticides containing such active ingredients a notice of the time by which the registrants are to notify the Administrator under subsection (d) whether the registrants intend to seek or not to seek reregistration of such pesticides. “(d) Phase Two.— “(1) In general.— The registrant of a pesticide that contains an active ingredient listed under subparagraph (B), (C), or (D) of subsection (c)(2) shall submit to the Administrator, within the time period prescribed by paragraph (4), the notice described in paragraph (2) and any information, commitment, or offer described in paragraph (3). “(2) Notice of intent to seek or not to seek reregistration.— “(A) The registrant of a pesticide containing an active Mail. ingredient listed under subparagraph (B), (C), or (D) of subsection (c)(2) shall notify the Administrator by certified mail whether the registrant intends to seek or does not intend to seek reregistration of the pesticide. “(B) If a registrant submits a notice under subparagraph Federal Register, publication. (A) of an intention not to seek reregistration of a pesticide, the Administrator shall publish a notice in the Federal Register stating that such a notice has been submitted. “(3) Missing or inadequate data.— Each registrant of a pesticide that contains an active ingredient listed under subparagraph (B), (C), or (D) of subsection (c)(2) and for which the registrant submitted a notice under paragraph (2) of an intention to seek reregistration of such pesticide shall submit to the Administrator— “(A) in accordance with regulations issued by the Administrator under section 3, an identification of— “(i) all data that are required by regulation to support the registration of the pesticide with respect to such active ingredient; “(ii) data that were submitted by the registrant previously in support of the registration of the pesticide that are inadequate to meet such regulations; and “(iii) data identified under clause (i) that have not been submitted to the Administrator; and “(B) either— “(i) a commitment to replace the data identified under subparagraph (A)(ii) and submit the data identified under subparagraph (A)(iii) within the applicable time period prescribed by paragraph (4)(B), or “(ii) an offer to share in the cost to be incurred by a person who has made a commitment under clause (i) to replace or submit the data and an offer to submit to arbitration as described by section 3(c)(2)(B) with regard to such cost sharing. For purposes of a submission by a registrant under subparagraph (A)(ii), data are inadequate if the data are derived from a study with respect to which the registrant is unable to make the certification prescribed by subsection (e)(1)(G) that the registrant possesses or has access to the raw data used in or generated by such study. For purposes of a submission by a registrant under such subparagraph, data shall be considered to be inadequate if the data are derived from a study submitted before January 1, 1970, unless it is demonstrated to the satisfaction of the Administrator that such data should be considered to support the registration of the pesticide that is to be reregistered. “(4) Time periods.— “(A) A submission under paragraph (2) or (3) shall be made— “(i) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(B), not later than 3 months after the date of publication of the listing of such active ingredient; “(ii) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(C), not later than 3 months after the date of publication of the listing of such active ingredient; and “(iii) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(D), not later than 3 months after the date of publication of the listing of such active ingredient. On application, the Administrator may extend a time period prescribed by this subparagraph if the Administrator determines that factors beyond the control of the registrant prevent the registrant from complying with such period. “(B) A registrant shall submit data in accordance with a commitment entered into under paragraph (3)(B) within a reasonable period of time, as determined by the Administrator, but not more than 48 months after the date the registrant submitted the commitment The Administrator, on application of a registrant may extend the period prescribed by the preceding sentence by no more than 2 years if extraordinary circumstances beyond the control of the registrant prevent the registrant from submitting data within such prescribed period. “(5) Cancellation and removal— “(A) If the registrant of a pesticide does not submit a notice under paragraph (2) or (3) within the time prescribed by paragraph (4)(A), the Administrator shall issue a notice of intent to cancel the registration of such registrant for such pesticide and shall publish the notice in the Federal Register and allow 60 days for the submission of comments on the notice. On expiration of such 60 days, the Administrator, by order and without a hearing, may cancel the registration or take such other action, including extension of applicable time periods, as may be necessary to enable reregistration of such pesticide by another person. “(B) (i) If— “(I) no registrant of a pesticide containing an active ingredient listed under subsection (c)(2) notifies the Administrator under paragraph (2) that the registrant intends to seek reregistration of any pesticide containing that active ingredient; ‘(II) no such registrant complies with paragraph (3)(A) or “(III) no such registrant makes a commitment under paragraph (3)(B) to replace or submit all data described in clauses (ii) and (iii) of paragraph (3)(A); Federal Register, publication. the Administrator shall publish in the Federal Register a notice of intent to remove the active ingredient from the list established under subsection (c)(2) and a notice of intent to cancel the registrations of all pesticides containing such active ingredient and shall provide 60 days for comment on such notice. “(ii) After the 60-day period has expired, the Administrator, by order, may cancel any such registration without hearing, except that the Administrator shall not cancel a registration under this subparagraph if— “(I) during the comment period a person acquires the rights of the registrant in that registration; “(II) during the comment period that person furnishes a notice of intent to reregister the pesticide in accordance with paragraph (2); and “(III) not later than 120 days after the publication of the notice under this subparagraph, that person has complied with paragraph (3) and the fee prescribed by subsection (i)(1) has been paid. “(6) Suspensions and penalties.— The Administrator shall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures prescribed by section 3(c)(2)(B)(iv) if the Administrator determines that (A) progress is insufficient to ensure the submission of the data required for such pesticide under a commitment made under paragraph (3)(B) within the time period prescribed by paragraph (4)(B) or (B) the registrant has not submitted such data to the Administrator within such time period. “(e) Phase Three.— “(1) Information about studies.— Each registrant of a pesticide that contains an active ingredient listed under subparagraph (B), (C), or (D) of subsection (c)(2) who has submitted a notice under subsection (d)(2) of an intent to seek the reregistration of such pesticide shall submit, in accordance with the guidelines issued under paragraph (4), to the Administrator— “(A) a summary of each study concerning the active ingredient previously submitted by the registrant in support of the registration of a pesticide containing such active ingredient and considered by the registrant to be adequate to meet the requirements of section 3 and the regulations issued under such section; “(B) a summary of each study concerning the active ingredient previously submitted by the registrant in support of the registration of a pesticide containing such active ingredient that may not comply with the requirements of section 3 and the regulations issued under such section but which the registrant asserts should be deemed to comply with such requirements and regulations; “(C) a reformat of the data from each study summarized under subparagraph (A) or (B) by the registrant concerning chronic dosing, oncogenicity, reproductive effects, mutagenicity, neurotoxicity, teratogenicity, or residue chemistry of the active ingredient that were submitted to the Administrator before January 1, 1982; “(D) where data described in subparagraph (C) are not required for the active ingredient by regulations issued under section 3, a reformat of acute and subchronic dosing data submitted by the registrant to the Administrator before January 1, 1982, that the registrant considers to be adequate to meet the requirements of section 3 and the regulations issued under such section; “(E) an identification of data that are required to be submitted to the Administrator under section 6(a)(2) indicating an adverse effect of the pesticide; “(F) an identification of any other information available that in the view of the registrant supports the registration; “(G) a certification that the registrant or the Administrator possesses or has access to the raw data used in or generated by the studies that the registrant summarized under subparagraph (A) or (B); “(H) either— “(i) a commitment to submit data to fill each outstanding data requirement identified by the registrant; or “(ii) an offer to share in the cost of developing such data to be incurred by a person who has made a commitment under clause (i) to submit such data, and an offer to submit to arbitration as described by section 3(c)(2)(B) with regard to such cost sharing; and “(I) evidence of compliance with section 3(c)(1)(D)(ii) and regulations issued thereunder with regard to previously submitted data as if the registrant were now seeking the original registration of the pesticide. A registrant who submits a certification under subparagraph (G) that is false shall be considered to have violated this Act and shall be subject to the penalties prescribed by section 14. “(2) Time periods.— “(A) The information required by paragraph (1) shall be submitted to the Administrator— “(i) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(B), not later than 12 months after the date of publication of the listing of such active ingredient; “(ii) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(C), not later than 12 months after the date of publication of the listing of such active ingredient; and “(iii) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(D), not later than 12 months after the date of publication of the listing of such active ingredient. “(B) A registrant shall submit data in accordance with a commitment entered into under paragraph (1)(H) within a reasonable period of time, as determined by the Administrator, but not more than 48 months after the date the registrant submitted the commitment under such paragraph. The Administrator, on application of a registrant, may extend the period prescribed by the preceding sentence by no more than 2 years if extraordinary circumstances beyond the control of the registrant prevent the registrant from submitting data within such prescribed period. “(3) Cancellation.— “(A) If the registrant of a pesticide fails to submit the information required by paragraph (1) within the time prescribed by paragraph (2), the Administrator, by order and without hearing, shall cancel the registration of such pesticide. “(B) (i) If the registrant of a pesticide submits the information required by paragraph (1) within the time prescribed by paragraph (2) and such information does not conform to the guidelines for submissions established by the Adminis-trator, the Administrator shall determine whether the registrant made a good faith attempt to conform its submission to such guidelines. “(ii) If the Administrator determines that the registrant made a good faith attempt to conform its submission to such guidelines, the Administrator shall provide the registrant a reasonable period of time to make any necessary changes or corrections. “(iii) (I) If the Administrator determines that the registrant did not make a good faith attempt to conform its submission to such guidelines, the Administrator may issue a notice of intent to cancel the registration. Such a notice Mail. shall be sent to the registrant by certified mail. “(II) The registration shall be canceled without a hearing or further notice at the end of 30 days after receipt by the registrant of the notice unless during that time a request for a hearing is made by the registrant. “(III) If a hearing is requested, a hearing shall be conducted under section 6(d), except that the only matter for resolution at the hearing shall be whether the registrant made a good faith attempt to conform its submission to such guidelines. The hearing shall be held and a determination made within 75 days after receipt of a request for hearing. “(4) Guidelines.— “(A) Not later than 1 year after the effective date of this section, the Administrator, by order, shall issue guidelines to be followed by registrants in— “(i) summarizing studies; “(ii) reformatting studies; “(iii) identifying adverse information; and “(iv) identifying studies that have been submitted previously that may not meet the requirements of section 3 or regulations issued under such section, under paragraph (1). “(B) Guidelines issued under, subparagraph (A) shall not be subject to judicial review. “(5) Monitoring.— The Administrator shall monitor the progress of registrants in acquiring and submitting the data required under paragraph (1). “(f) Phase Four.— “(1) Independent review and identification of outstanding data requirements.— “(A) The Administrator shall review the submissions of all registrants of pesticides containing a particular active ingredient under subsections (d)(3) and (e)(1) to determine if such submissions identified all the data that are missing or inadequate for such active ingredient. To assist the review of the Administrator under this subparagraph, the Administrator may require a registrant seeking reregistration to submit complete copies of studies summarized under subsection (e)(i). “(B) The Administrator shall independently identify and Federal Register, publication. publish in the Federal Register the outstanding data requirements for each active ingredient that is listed under subparagraph (B), (C), or (D) of subsection (c)(2) and that is contained in a pesticide to be reregistered under this sec-tion. The Administrator, at the same time, shall issue a notice under section 3(c)(2)(B) for the submission of the additional data that are required to meet such requirements. “(2) Time periods.— “(A) The Administrator shall take the action required by paragraph (1)— “(i) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(B), not later than 18 months after the date of the listing of such active ingredient; “(ii) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(C), not later than 24 months after the date of the listing of such active ingredient; and “(iii) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(D), not later than 33 months after the date of the listing of such active ingredient. “(B) If the Administrator issues a notice to a registrant under paragraph (1)(B) for the submission of additional data, the registrant shall submit such data within a reasonable period of time, as determined by the Administrator, but not to exceed 48 months after the issuance of such notice. The Administrator, on application of a registrant, may extend the period prescribed by the preceding sentence by no more than 2 years if extraordinary circumstances beyond the control of the registrant prevent the registrant from submitting data within such prescribed period. “(3) Suspensions and penalties.— The Administrator shall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures prescribed by section 3(c)(2)(B)9iv) if the Administrator determines that (A) tests necessary to fill an outstanding data requirement for such pesticide have not been initiated within 1 year after the issuance of a notice under paragraph (1)(B), or (B) progress is insufficient to ensure submission of the data referred to in clause (A) within the time period prescribed by paragraph (2)(B) or the required data have not been submitted to the Administrator within such time period. “(g) Phase Five.— “(1) Data review.— The Administrator shall conduct a thorough examination of all data submitted under this section concerning an active ingredient listed under subsection (c)(2) and of all other available data found by the Administrator to be relevant. “(2) Reregistration and other actions.— “(A) Within 1 year after the submission of all data concerning an active ingredient of a pesticide under subsection (f), the Administrator shall determine whether pesticides containing such active ingredient are eligible for reregistration. For extraordinary circumstances, the Administrator may extend such period for not more than 1 additional year. “(B) Before reregistering a pesticide, the Administrator shall obtain any needed product-specific data regarding the pesticide by use of section 3(c)(2)(B) and shall review such data within 90 days after its submission. The Administrator shall require that data under this subparagraph be submitted to the Administrator not later than 8 months after a determination of eligibility under subparagraph (A) has been made for each active ingredient of the pesticide, unless the Administrator determines that a longer period is required for the generation of the data. “(C) After conducting the review required by paragraph (1) for each active ingredient of a pesticide and the review required by subparagraph (B) of this paragraph, the Administrator shall determine whether to reregister a pesticide by determining whether such pesticide meets the requirements of section 3(c)(5). If the Administrator determines that a pesticide is eligible to be reregistered, the Administrator shall reregister such pesticide within 6 months after the submission of the data concerning such pesticide under subparagraph (B). “(D) If after conducting a review under paragraph (1) or subparagraph (B) of this paragraph the Administrator determines that a pesticide should not be reregistered, the Administrator shall take appropriate regulatory action. “(h) Compensation of Data Submitter.— If data that are submitted by a registrant under subsection (d), (e), (f), or (g) are used to support the application of another person under section 3, the registrant who submitted such data shall be entitled to compensation for the use of such data as prescribed by section 3(c)(1)(D). In determining the amount of such compensation, the fees paid by the registrant under this section shall be taken into account. “(i) Fees.— “(1) Initial fee for food or feed use pesticide active ingredients.— The registrants of pesticides that contain an active ingredient that is listed under subparagraph (B), (C), or (D) of subsection (c)(2) and that is an active ingredient of any pesticide registered for a major food or feed use shall collectively pay a fee of $50,000 on submission of information under paragraphs (2) and (3) of subsection (d) for such ingredient. “(2) Final fee for food or feed use pesticide active ingredients.— “(A) The registrants of pesticides that contain an active ingredient that is listed under subparagraph (B), (C), or (D) of subsection (c)(2) and that is an active ingredient of any pesticide registered for a major food or feed use shall collectively pay a fee of $100,000— “(i) on submission of information for such ingredient under subsection (e)(1) if data are reformatted under subsection (e)(1)(C); or “(ii) on submission of data for such ingredient under subsection (e)(2)(B) if data are not reformatted under subsection (e)(1)(C). “(B) The registrants of pesticides that contain an active ingredient that is listed under subsection (c)(2)(A) and that is an active ingredient of any pesticide registered for a major food or feed use shall collectively pay a fee of $150,000 at such time as the Administrator shall prescribe. “(3) Fees for other pesticide active ingredients.— “(A) The registrants of pesticides that contain an active ingredient that is listed under subparagraph (B), (C), or (D) of subsection (c)(2) and that is not an active ingredient of any pesticide registered for a major food or feed use shall collectively pay fees in amounts determined by the Administrator. Such fees may not be less than one-half of, nor greater than, the fees required by paragraphs (1) and (2). A registrant shall pay such fees at the times corresponding to the times fees prescribed by paragraphs (1) and (2) are to be paid. “(B) The registrants of pesticides that contain an active ingredient that is listed under subsection (c)(2)(A) and that is not an active ingredient of any pesticide that is registered for a major food or feed use shall collectively pay a fee of not more than $100,000 and not less them $50,000 at such time as the Administrator shall prescribe. “(4) Reduction or waiver of fees for minor use and other pesticides.— “(A) An active ingredient that is contained only in pesticides that are registered solely for agricultural or nonagricultural minor uses, or a pesticide the value or volume of use of which is small, shall be exempt from the fees prescribed by paragraph (3). “(B) An antimicrobial active ingredient, the production level of which does not exceed 1,000,000 pounds per year, shall be exempt from the fees prescribed by paragraph (3). For purposes of this subparagraph, the term ’antimicrobial active ingredient’ means any active ingredient that is contained only in pesticides that are not registered for any food or feed use and that are— “(i) sanitizers intended to reduce the number of living bacteria or viable virus particles on inanimate surface or in water or air; “(ii) bacteriostats intended to inhibit the growth of bacteria in the presence of moisture; “(iii) disinfectants intended to destroy or irreversibly inactivate bacteria, fungi, or viruses on surfaces or inanimate objects; “(iv) sterilizers intended to destroy viruses and all living bacteria, fungi, and their spores on inanimate surfaces; or “(v) fungicides or fungistats. “(C) (i) Notwithstanding any other provision of this subsection, in the case of a small business registrant of a pesticide, the registrant shall pay a fee for the reregistration of each active ingredient of the pesticide that does not exceed an amount determined in accordance with this subparagraph. “(ii) If during the 3-year period prior to reregistration the average annual gross revenue of the registrant from pesticides containing such active ingredient is— “(I) less than $5,000,000, the registrant shall pay 0.5 percent of such revenue; “(II) $5,000,000 or more but less than $10,000,000, the registrant shall pay 1 percent of such revenue; or “(III) $10,000,000 or more, the registrant shall pay 1.5 percent of such revenue, but not more than $150,000. “(iii) For the purpose of this subparagraph, a small business registrant is a corporation, partnership, or unincorporated business that— “(I) has 150 or fewer employees; and “(II) during the 3-year period prior to reregistration, had an average annual gross revenue from chemicals that did not exceed $40,000,000. “(5) Maintenance fee.— “(A) Subject to other provisions of this paragraph, each registrant of a pesticide shall pay an annual fee by March 1 of each year of— “(i) in the case of a registrant holding not more than 50 pesticide registrations, $425 for each registration; and “(ii) in the case of a registrant holding more than 50 pesticide registrations— “(I) $425 for each registration up to 50 registrations; and “(II) $100 for each registration over 50 registrations, except that no fee shall be charged for more than 200 registrations held by any registrant. “(B) The amount of each fee prescribed under subparagraph (A) shall be adjusted by the Administrator to a level that will result in the collection under this paragraph of, to the extent practicable, an aggregate amount of $14,000,000 each fiscal year. “(C) (i) The maximum annual fee payable by a registrant under clause (i) of subparagraph (A) (as adjusted under subparagraph (B)) shall be $20,000. “(ii) The maximum annual fee payable by a registrant under clause (ii) of subparagraph (A) (as adjusted under subparagraph (B)) shall be $35,000. “(D) If any fee prescribed by this paragraph with respect to the registration of a pesticide is not paid by a registrant by the time prescribed, the Administrator, by order and without hearing, may cancel the registration. “(E) The authority provided under this paragraph shall Termination date. terminate on September 30, 1997. “(6) Other fees.— During the period beginning on the date of enactment of this section and ending on September 30, 1997, the Administrator may not levy any other fees for the registration of a pesticide under this Act except as provided in paragraphs (1) through (5). “(7) Apportionment.— “(A) If two or more registrants are required to pay any fee prescribed by paragraph (1), (2), or (3) with respect to a particular active ingredient, the fees for such active ingredient shall be apportioned among such registrants on the basis of the market share in United States sales of the active ingredient for the 3 calendar years preceding the date of payment of such fee, except that— “(i) small business registrants that produce the active Small business. ingredient shall pay fees in accordance with paragraph (4)(C); and “(ii) registrants who have no market share but who choose to reregister a pesticide containing such active ingredient shall pay the lesser of— “(I) 15 percent of the reregistration fee; or “(II) a proportionate amount of such fee based on the lowest percentage market share held by any registrant active in the marketplace. In no event shall registrants who have no market share but who choose to reregister a pesticide containing such active ingredient collectively pay more than 25 percent of the total active ingredient reregistration fee. “(B) The Administrator, by order, may require any registrant to submit such reports as the Administrator determines to be necessary to allow the Administrator to determine and apportion fees under this subsection or to determine the registrant’s eligibility for a reduction or waiver of a fee. “(C) If any such report is not submitted by a registrant after receiving notice of such report requirement, or if any fee prescribed by this subsection (other than paragraph (5)) for an active ingredient is not paid by a registrant to the Administrator by the time prescribed under this subsection, the Administrator, by order and without hearing, may cancel each registration held by such registrant of a pesticide containing the active ingredient with respect to which the fee is imposed. The Administrator shall reapportion the fee among the remaining registrants and notify the registrants that the registrants are required to pay to the Administrator any unpaid balance of the fee within 30 days after receipt of such notice. “(j) Exemption of Certain Registrants.— The requirements of subsections (d), (e), (f), and (i) (other than subsection (i)(5)) regarding data concerning an active ingredient and fees for review of such data shall not apply to any person who is the registrant of a pesticide to the extent that, under section 3(c)(2)(D), the person would not be required to submit or cite such data to obtain an initial registration of such pesticide. “(k) Reregistration and Expedited Processing Fund.— “(1) Establishment.— There shall be established in the Treasury of the United States a reregistration and expedited processing fund. “(2) Source and use.— All fees collected by the Administrator under subsection (i) shall be deposited into the fund and shall be available to the Administrator, without fiscal year limitation, to carry out reregistration and expedited processing of similar applications. “(3) Expedited processing of similar applications.— “(A) The Administrator shall use each fiscal year not more than $2,000,000 of the amounts in the fund to obtain sufficient personnel and resources to assure the expedited processing and review of any application that— “(i) proposes the initial or amended registration of an end-use pesticide that, if registered as proposed, would be identical or substantially similar in composition and labeling to a currently-registered pesticide identified in the application, or that would differ in composition and labeling from any such currently-registered pesticide only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment; or “(ii) proposes an amendment to the registration of a registered pesticide that does not require scientific review of data. “(B) Any amounts made available under subparagraph (A) shall be used to obtain sufficient personnel and resources to carry out the activities described in such subparagraph that are in addition to the personnel and resources available to carry out such activities on the date of enactment of this section. “(4) Unused funds.— Money in the fund not currently needed to carry out this section shall be— “(A) maintained on hand or on deposit; “(B) invested in obligations of the United States or guaranteed thereby; or “(C) invested in obligations, participations, or other instruments that are lawful investments for fiduciary, trust, or public funds. “(5) Accounting.— The Administrator shall— “(A) provide an annual accounting of the fees collected and disbursed from the fund; and “(B) take all steps necessary to ensure that expenditures from such fund are used only to carry out this section. “(l) Judicial Review.— Any failure of the Administrator to take any action required by this section shall be subject to judicial review under the procedures prescribed by section 16(b).”. (b) Conforming Amendment.— (1) Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B)) is amended by adding at the end of clauses (ii) and (iii) the following: “The Administrator shall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures prescribed by clause (iv) if a registrant fails to comply with this clause.” (2) Section 3(c)(2)(D) (7 U.S.C. 136a(c)(2)(D)) is amended— (A) in the matter preceding clause (i), by striking out “an end use product” and inserting in lieu thereof “the pesticide that is the subject of the application”; and (B) in clause (i), by striking out “the safety of”. SEC. 103. EXPEDITED REGISTRATION OF SIMILAR APPLICATIONS. Section 3(c)(3) (7 U.S.C. 136a(c)(3)) is amended— (1) by striking out “Application.—The Administrator” and inserting in lieu thereof “Application.— “(A) The Administrator”; and (2) by adding at the end thereof the following new subparagraph: “(B) (i) The Administrator shall, as expeditiously as possible, review and act on any application received by the Administrator that— “(I) proposes the initial or amended registration of an end-use pesticide that, if registered as proposed, would be identical or substantially similar in composition and labeling to a currently-registered pesticide identified in the application, or that would differ in composition and labeling from such currently-registered pesticide only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment; or “(II) proposes an amendment to the registration of a registered pesticide that does not require scientific review of data. “(ii) In expediting the review of an application for an action described in clause (i), the Administrator shall— “(I) within 45 days after receiving the application, notify the registrant whether or not the application is complete and, if the application is found to be incomplete, reject the application; “(II) within 90 days after receiving a complete application, notify the registrant if the application has been granted or denied; and “(III) if the application is denied, notify the registrant in writing of the specific reasons for the denial of the application.”.
1988
Federal Insecticide, Fungicide, and Rodenticide Act Amendments of 1988
Pub. L. 100–532 § 801(b)(5)(G) · 102 Stat. 2654
Struck · 7 U.S.C. § 136a(c)(2)(C)
Pub. L. 100–532, § 801(b)(5)(G), (H), struck out “Simplified procedures” after “(C)” and directed that text be aligned with left margin of subpar. (A)
Source evidence
Code amendment note
Subsec. (c)(2)(C). Pub. L. 100–532, § 801(b)(5)(G), (H), struck out “Simplified procedures” after “(C)” and directed that text be aligned with left margin of subpar. (A).
Enacted provision · exact public law section
(G) in subparagraph (C), by striking out “Simplified procedures.—”; and
1988
Federal Insecticide, Fungicide, and Rodenticide Act Amendments of 1988
Pub. L. 100–532 § 102(b)(2)(A) · 102 Stat. 2654
Substituted · 7 U.S.C. § 136a(c)(2)(D)
Pub. L. 100–532, § 102(b)(2)(A), and Pub. L. 102–237, § 1006(c), substituted “the pesticide that is the subject of the application” for “an end-use product”
Source evidence
Code amendment note
Subsec. (c)(2)(D). Pub. L. 100–532, § 102(b)(2)(A), and Pub. L. 102–237, § 1006(c), substituted “the pesticide that is the subject of the application” for “an end-use product”.
Enacted provision · exact public law section
(A) in the matter preceding clause (i), by striking out “an end use product” and inserting in lieu thereof “the pesticide that is the subject of the application”; and
1988
Federal Insecticide, Fungicide, and Rodenticide Act Amendments of 1988
Pub. L. 100–532 § 102(b)(2)(B) · 102 Stat. 2654
Struck · 7 U.S.C. § 136a(c)(2)(D)(i)
Pub. L. 100–532, § 102(b)(2)(B), struck out “the safety of” after “data pertaining to”
Source evidence
Code amendment note
Subsec. (c)(2)(D)(i). Pub. L. 100–532, § 102(b)(2)(B), struck out “the safety of” after “data pertaining to”.
Enacted provision · exact public law section
(B) in clause (i), by striking out “the safety of”.
1988
Federal Insecticide, Fungicide, and Rodenticide Act Amendments of 1988
Pub. L. 100–532 § 103 · 102 Stat. 2654
1. Substituted · 7 U.S.C. § 136a(c)(3)
  Pub. L. 100–532, § 103, substituted “(A) The Administrator” for “The Administrator”
2. Added · 7 U.S.C. § 136a(c)(3)
  Pub. L. 100–532, § 103, added subpar. (B)
Source evidence
Code amendment note
Subsec. (c)(3). Pub. L. 100–532, § 103, substituted “(A) The Administrator” for “The Administrator” and added subpar. (B).
Enacted provision · exact public law section
SEC. 103. EXPEDITED REGISTRATION OF SIMILAR APPLICATIONS. Section 3(c)(3) (7 U.S.C. 136a(c)(3)) is amended— (1) by striking out “Application.—The Administrator” and inserting in lieu thereof “Application.— “(A) The Administrator”; and (2) by adding at the end thereof the following new subparagraph: “(B) (i) The Administrator shall, as expeditiously as possible, review and act on any application received by the Administrator that— “(I) proposes the initial or amended registration of an end-use pesticide that, if registered as proposed, would be identical or substantially similar in composition and labeling to a currently-registered pesticide identified in the application, or that would differ in composition and labeling from such currently-registered pesticide only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment; or “(II) proposes an amendment to the registration of a registered pesticide that does not require scientific review of data. “(ii) In expediting the review of an application for an action described in clause (i), the Administrator shall— “(I) within 45 days after receiving the application, notify the registrant whether or not the application is complete and, if the application is found to be incomplete, reject the application; “(II) within 90 days after receiving a complete application, notify the registrant if the application has been granted or denied; and “(III) if the application is denied, notify the registrant in writing of the specific reasons for the denial of the application.”.
1988
Federal Insecticide, Fungicide, and Rodenticide Act Amendments of 1988
Pub. L. 100–532 § 801(b)(6) · 102 Stat. 2654
1. Substituted · 7 U.S.C. § 136a(c)(7)
  Pub. L. 100–532, § 801(b)(6), in introductory provisions, substituted “paragraph (5)” for “subsection (c)(5) of this section”, in subpars. (A) and (B)
2. Substituted · 7 U.S.C. § 136a(c)(7)
  Pub. L. 100–532, § 801(b)(6), in introductory provisions, substituted “paragraph (5). If” for “subsection (c)(5) of this section: Provided, That, if”, and in subpar. (C)
3. Substituted · 7 U.S.C. § 136a(c)(7)
  Pub. L. 100–532, § 801(b)(6), in introductory provisions, substituted “prescribe. A” for “prescribe: Provided, that a”
Source evidence
Code amendment note
Subsec. (c)(7). Pub. L. 100–532, § 801(b)(6), in introductory provisions, substituted “paragraph (5)” for “subsection (c)(5) of this section”, in subpars. (A) and (B), substituted “paragraph (5). If” for “subsection (c)(5) of this section: Provided, That, if”, and in subpar. (C), substituted “prescribe. A” for “prescribe: Provided, that a”.
Enacted provision · exact public law section
(6) in subsection (c)(7)— (A) by striking out “subsection (c)(5) of this section” each place it appears and inserting in lieu thereof “paragraph (5)”; (B) in the second sentence of subparagraph (A), by striking out “: Provided, That, if” and inserting in lieu thereof a period and “If”; (C) in subparagraph (B), by striking out “: Provided, That, if” and inserting in lieu thereof a period and “If”; and (D) in subparagraph (C), by striking out “: Provided, That a” and inserting in lieu thereof a period and “A”;
1988
Federal Insecticide, Fungicide, and Rodenticide Act Amendments of 1988
Pub. L. 100–532 § 801(b)(7) · 102 Stat. 2654
1. Substituted · 7 U.S.C. § 136a(d)(1)(A)
  Pub. L. 100–532, § 801(b)(7), substituted “restricted use. If” for “restricted use, provided that if”
2. Substituted · 7 U.S.C. § 136a(d)(1)(A)
  Pub. L. 100–532, § 801(b)(7), substituted “restricted uses. The Administrator” for “restricted uses: Provided, however, That the Administrator”
Source evidence
Code amendment note
Subsec. (d)(1)(A). Pub. L. 100–532, § 801(b)(7), substituted “restricted use. If” for “restricted use, provided that if” and “restricted uses. The Administrator” for “restricted uses: Provided, however, That the Administrator”.
Enacted provision · exact public law section
(7) in subsection (d)(1)(A)— (A) in the first sentence, by striking out “, provided that if” and inserting in lieu thereof a period and “If”; (B) in the last sentence, by striking out “: Provided, however, That the” and inserting in lieu thereof a period and “The”;
1988
Federal Insecticide, Fungicide, and Rodenticide Act Amendments of 1988
Pub. L. 100–532 § 801(b)(8) · 102 Stat. 2654
Substituted · 7 U.S.C. § 136a(f)(2)
Pub. L. 100–532, § 801(b)(8), substituted “this subchapter. As” for “this subchapter: Provided, That as”
Source evidence
Code amendment note
Subsec. (f)(2). Pub. L. 100–532, § 801(b)(8), substituted “this subchapter. As” for “this subchapter: Provided, That as”.
Enacted provision · exact public law section
(8) in subsection (f)(2), by striking out “: Provided, That as” and inserting in lieu thereof a period and “As”; and
1988
Federal Insecticide, Fungicide, and Rodenticide Act Amendments of 1988
Pub. L. 100–532 § 801(b)(9) · 102 Stat. 2654
Struck · 7 U.S.C. § 136a(g)
Pub. L. 100–532, § 801(b)(9), struck out subsec. (g) which read as follows: “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.”
Source evidence
Code amendment note
Subsec. (g). Pub. L. 100–532, § 801(b)(9), struck out subsec. (g) which read as follows: “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.”
Enacted provision · exact public law section
(9) by striking out subsection (g).
1990
Conservation Program Improvements Act
Pub. L. 101–624 title XIV § 1492 · 104 Stat. 3359
Inserted · 7 U.S.C. § 136a(c)(2)(A)
Pub. L. 101–624 inserted after third sentence “The Administrator shall not require a person to submit, in relation to a registration or reregistration of a pesticide for minor agricultural use under this subchapter, any field residue data from a geographic area where the pesticide will not be registered for such use.”
Source evidence
Code amendment note
Subsec. (c)(2)(A). Pub. L. 101–624 inserted after third sentence “The Administrator shall not require a person to submit, in relation to a registration or reregistration of a pesticide for minor agricultural use under this subchapter, any field residue data from a geographic area where the pesticide will not be registered for such use.”
Enacted provision · exact public law section
SEC. 1492. DATA IN SUPPORT OF REGISTRATION. Section 3(c)(2)(A) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a(c)(2)(A)) is amended by inserting after the third sentence the following new sentence: “The Administrator shall not require a person to submit, in relation to a registration or reregistration of a pesticide for minor agricultural use under this Act, any field residue data from a geographic area where the pesticide will not be registered for such use”.
1991
Pub. L. 102–237 § 1006(a)(3)(B) · 105 Stat. 1818
1. Added · 7 U.S.C. § 136a(c)(1)(D)
  Pub. L. 102–237, § 1006(a)(3)(B), (C), added subpar. (D)
2. Redesignated · 7 U.S.C. § 136a(c)(1)(D)
  Pub. L. 102–237, § 1006(a)(3)(B), (C), redesignated former subpar. (D) as (F)
Source evidence
Code amendment note
Subsec. (c)(1)(D). Pub. L. 102–237, § 1006(a)(3)(B), (C), added subpar. (D) and redesignated former subpar. (D) as (F).
Enacted provision · exact public law section
(B) by redesignating subparagraph (D) as subparagraph (F);
1991
Pub. L. 102–237 § 1006(a)(3)(A) · 105 Stat. 1818
1. Added · 7 U.S.C. § 136a(c)(1)(E)
  Pub. L. 102–237, § 1006(a)(3)(A), (C), added subpar. (E)
2. Struck · 7 U.S.C. § 136a(c)(1)(E)
  Pub. L. 102–237, § 1006(a)(3)(A), (C), struck out former subpar. (E) which read as follows: “the complete formula of the pesticide; and”
Source evidence
Code amendment note
Subsec. (c)(1)(E). Pub. L. 102–237, § 1006(a)(3)(A), (C), added subpar. (E) and struck out former subpar. (E) which read as follows: “the complete formula of the pesticide; and”.
Enacted provision · exact public law section
(A) by striking subparagraphs (E) and (F);
1991
Pub. L. 102–237 § 1006(a)(3)(A) · 105 Stat. 1818
1. Redesignated · 7 U.S.C. § 136a(c)(1)(F)
  Pub. L. 102–237, § 1006(a)(3)(A), (B), (D), redesignated former subpar. (D) as (F), in cl. (i) substituted “With” for “with” and a period for semicolon at end, in cl. (ii) substituted “Except” for “except” and a period for semicolon at end, in cl. (iii) substituted “After” for “after” and a period for semicolon at end
2. Struck · 7 U.S.C. § 136a(c)(1)(F)
  Pub. L. 102–237, § 1006(a)(3)(A), (B), (D), struck out former subpar. (F) which read as follows: “a request that the pesticide be classified for general use, for restricted use, or for both.”
Source evidence
Code amendment note
Subsec. (c)(1)(F). Pub. L. 102–237, § 1006(a)(3)(A), (B), (D), redesignated former subpar. (D) as (F), in cl. (i) substituted “With” for “with” and a period for semicolon at end, in cl. (ii) substituted “Except” for “except” and a period for semicolon at end, in cl. (iii) substituted “After” for “after” and a period for semicolon at end, and struck out former subpar. (F) which read as follows: “a request that the pesticide be classified for general use, for restricted use, or for both.”
Enacted provision · exact public law section
(A) by striking subparagraphs (E) and (F);
1991
Pub. L. 102–237 § 1006(b)(1) · 105 Stat. 1818
1. Substituted · 7 U.S.C. § 136a(c)(2)(A)
  Pub. L. 102–237, § 1006(b)(1), (2), substituted “the Administrator” for “he” before “requires”, “shall permit”, “shall make”, and “deems”
2. Substituted · 7 U.S.C. § 136a(c)(2)(A)
  Pub. L. 102–237, § 1006(b)(1), (2), substituted “the Administrator’s” for “his”
Source evidence
Code amendment note
Subsec. (c)(2)(A). Pub. L. 102–237, § 1006(b)(1), (2), substituted “the Administrator” for “he” before “requires”, “shall permit”, “shall make”, and “deems”, and substituted “the Administrator’s” for “his”.
Enacted provision · exact public law section
(1) Such Act is amended by striking “he” each place it appears in sections 3(c)(2)(A), 3(c)(5), 3(c)(6), 3(d)(1)(A), 3(d)(1)(B), 3(d)(1)(C), 3(d)(2), 5(b), 5(e), 5(f), 6(a)(1), 6(b), 6(c)(1), 6(c)(3), 70?), 8(a), 9(c)(3), 10(c), 11(b), 16(b), 16(d), 18, 20(a), 21(b), 25(a)(3), 25(b), 25(c)(5), and 25(d) (7 U.S.C. 136a(c)(2)(A), 136a(c)(5), 136a(c)(6), 136a(d)(l)(A), 136a(d)(l)(B), 136a(d)(1)(C), 136a(d)(2), 136c(b), 136c(e), 136c(f), 136d(a)(l), 136d(b), 136d(c)(l), 136d(c)(3), 136e(b), 136f(a), 136g(c)(3), 136h(c), 136i(b), 136n(b), 136n(d), 136p, 136r(a), 136s(b), 136w(a)(3), 136w(b), 136w(c)(5), and 136w(d)) and inserting “the Administrator”.
1991
Pub. L. 102–237 § 1006(c) · 105 Stat. 1818
Changed · 7 U.S.C. § 136a(c)(2)(D)
Pub. L. 102–237, § 1006(c), clarified amendment made by Pub. L. 100–532, § 102(b)(2)(A). See 1988 Amendment note below
Source evidence
Code amendment note
Subsec. (c)(2)(D). Pub. L. 102–237, § 1006(c), clarified amendment made by Pub. L. 100–532, § 102(b)(2)(A). See 1988 Amendment note below.
Enacted provision · exact public law section
(c) Unexecutable Amendment.— The phrase sought to be struck in section 102(b)(2)(A) of the Federal Insecticide, Fungicide, and Rodenticide Act Amendments of 1988 (Public Law 100–532; 102 Stat. 2667) shall be deemed to be “an end-use product”. 7 USC 136a.
1991
Pub. L. 102–237 § 1006(b)(2) · 105 Stat. 1818
Substituted · 7 U.S.C. § 136a(c)(3)(A)
Pub. L. 102–237, § 1006(b)(2), substituted “the Administrator’s” for “his”
Source evidence
Code amendment note
Subsec. (c)(3)(A). Pub. L. 102–237, § 1006(b)(2), substituted “the Administrator’s” for “his”.
Enacted provision · exact public law section
(2) Such Act is amended by striking “his” each place it appears in sections 3(c)(2)(A), 3(c)(3)(A), 3(c)(6), 6(b), 6(c)(1), 6(d), l0(b), 11(a)(2), 16(b), 17(c), 18, 21(b), and 25(c)(4) (7 U.S.C. 136a(c)(2)(A), 136a(c)(3)(A), 136a(c)(6), 136d(b), 136d(c)(l), 136d(d), 136h(b), 136i(a)(2), 136n(b), 136o(c), 136p, 136sa)), and 136w(c)(4)) and inserting “the Administrator’s”.
1991
Pub. L. 102–237 § 1006(b)(1) · 105 Stat. 1818
Substituted · 7 U.S.C. § 136a(c)(5)
Pub. L. 102–237, § 1006(b)(1), substituted “the Administrator” for “he” before “determines”
Source evidence
Code amendment note
Subsec. (c)(5). Pub. L. 102–237, § 1006(b)(1), substituted “the Administrator” for “he” before “determines”.
Enacted provision · exact public law section
(1) Such Act is amended by striking “he” each place it appears in sections 3(c)(2)(A), 3(c)(5), 3(c)(6), 3(d)(1)(A), 3(d)(1)(B), 3(d)(1)(C), 3(d)(2), 5(b), 5(e), 5(f), 6(a)(1), 6(b), 6(c)(1), 6(c)(3), 70?), 8(a), 9(c)(3), 10(c), 11(b), 16(b), 16(d), 18, 20(a), 21(b), 25(a)(3), 25(b), 25(c)(5), and 25(d) (7 U.S.C. 136a(c)(2)(A), 136a(c)(5), 136a(c)(6), 136a(d)(l)(A), 136a(d)(l)(B), 136a(d)(1)(C), 136a(d)(2), 136c(b), 136c(e), 136c(f), 136d(a)(l), 136d(b), 136d(c)(l), 136d(c)(3), 136e(b), 136f(a), 136g(c)(3), 136h(c), 136i(b), 136n(b), 136n(d), 136p, 136r(a), 136s(b), 136w(a)(3), 136w(b), 136w(c)(5), and 136w(d)) and inserting “the Administrator”.
1991
Pub. L. 102–237 § 1006(b)(1) · 105 Stat. 1818
1. Substituted · 7 U.S.C. § 136a(c)(6)
  Pub. L. 102–237, § 1006(b)(1), (2), substituted “the Administrator” for “he” in four places
2. Substituted · 7 U.S.C. § 136a(c)(6)
  Pub. L. 102–237, § 1006(b)(1), (2), substituted “the Administrator’s” for “his” in four places
Source evidence
Code amendment note
Subsec. (c)(6). Pub. L. 102–237, § 1006(b)(1), (2), substituted “the Administrator” for “he” before “shall notify” in two places and “the Administrator’s” for “his” in four places.
Enacted provision · exact public law section
(1) Such Act is amended by striking “he” each place it appears in sections 3(c)(2)(A), 3(c)(5), 3(c)(6), 3(d)(1)(A), 3(d)(1)(B), 3(d)(1)(C), 3(d)(2), 5(b), 5(e), 5(f), 6(a)(1), 6(b), 6(c)(1), 6(c)(3), 70?), 8(a), 9(c)(3), 10(c), 11(b), 16(b), 16(d), 18, 20(a), 21(b), 25(a)(3), 25(b), 25(c)(5), and 25(d) (7 U.S.C. 136a(c)(2)(A), 136a(c)(5), 136a(c)(6), 136a(d)(l)(A), 136a(d)(l)(B), 136a(d)(1)(C), 136a(d)(2), 136c(b), 136c(e), 136c(f), 136d(a)(l), 136d(b), 136d(c)(l), 136d(c)(3), 136e(b), 136f(a), 136g(c)(3), 136h(c), 136i(b), 136n(b), 136n(d), 136p, 136r(a), 136s(b), 136w(a)(3), 136w(b), 136w(c)(5), and 136w(d)) and inserting “the Administrator”.
1991
Pub. L. 102–237 § 1006(b)(1) · 105 Stat. 1818
Substituted · 7 U.S.C. § 136a(d)(1)
Pub. L. 102–237, § 1006(b)(1), substituted “the Administrator” for “he” before “shall classify it for both” in subpar. (A), before “will classify” in subpar. (B), and before “shall classify” in subpar. (C)
Source evidence
Code amendment note
Subsec. (d)(1). Pub. L. 102–237, § 1006(b)(1), substituted “the Administrator” for “he” before “shall classify it for both” in subpar. (A), before “will classify” in subpar. (B), and before “shall classify” in subpar. (C).
Enacted provision · exact public law section
(1) Such Act is amended by striking “he” each place it appears in sections 3(c)(2)(A), 3(c)(5), 3(c)(6), 3(d)(1)(A), 3(d)(1)(B), 3(d)(1)(C), 3(d)(2), 5(b), 5(e), 5(f), 6(a)(1), 6(b), 6(c)(1), 6(c)(3), 70?), 8(a), 9(c)(3), 10(c), 11(b), 16(b), 16(d), 18, 20(a), 21(b), 25(a)(3), 25(b), 25(c)(5), and 25(d) (7 U.S.C. 136a(c)(2)(A), 136a(c)(5), 136a(c)(6), 136a(d)(l)(A), 136a(d)(l)(B), 136a(d)(1)(C), 136a(d)(2), 136c(b), 136c(e), 136c(f), 136d(a)(l), 136d(b), 136d(c)(l), 136d(c)(3), 136e(b), 136f(a), 136g(c)(3), 136h(c), 136i(b), 136n(b), 136n(d), 136p, 136r(a), 136s(b), 136w(a)(3), 136w(b), 136w(c)(5), and 136w(d)) and inserting “the Administrator”.
1991
Pub. L. 102–237 § 1006(b)(1) · 105 Stat. 1818
Substituted · 7 U.S.C. § 136a(d)(2)
Pub. L. 102–237, § 1006(b)(1), substituted “the Administrator” for “he” before “shall notify”
Source evidence
Code amendment note
Subsec. (d)(2). Pub. L. 102–237, § 1006(b)(1), substituted “the Administrator” for “he” before “shall notify”.
Enacted provision · exact public law section
(1) Such Act is amended by striking “he” each place it appears in sections 3(c)(2)(A), 3(c)(5), 3(c)(6), 3(d)(1)(A), 3(d)(1)(B), 3(d)(1)(C), 3(d)(2), 5(b), 5(e), 5(f), 6(a)(1), 6(b), 6(c)(1), 6(c)(3), 70?), 8(a), 9(c)(3), 10(c), 11(b), 16(b), 16(d), 18, 20(a), 21(b), 25(a)(3), 25(b), 25(c)(5), and 25(d) (7 U.S.C. 136a(c)(2)(A), 136a(c)(5), 136a(c)(6), 136a(d)(l)(A), 136a(d)(l)(B), 136a(d)(1)(C), 136a(d)(2), 136c(b), 136c(e), 136c(f), 136d(a)(l), 136d(b), 136d(c)(l), 136d(c)(3), 136e(b), 136f(a), 136g(c)(3), 136h(c), 136i(b), 136n(b), 136n(d), 136p, 136r(a), 136s(b), 136w(a)(3), 136w(b), 136w(c)(5), and 136w(d)) and inserting “the Administrator”.
1996
Food Quality Protection Act of 1996
Pub. L. 104–170 § 210(b) · 110 Stat. 1489
1. Added · 7 U.S.C. § 136a(c)(1)(F)(ii)(vi)
  Pub. L. 104–170, § 210(b), added cls. (ii), (v), and (vi)
2. Redesignated · 7 U.S.C. § 136a(c)(1)(F)(ii)(vi)
  Pub. L. 104–170, § 210(b), redesignated former cls. (ii) and (iii) as (iii) and (iv), respectively, and in cl. (iv) substituted “(i), (ii), and (iii)” for “(i) and (ii)”
Source evidence
Code amendment note
Subsec. (c)(1)(F)(ii) to (vi). Pub. L. 104–170, § 210(b), added cls. (ii), (v), and (vi), redesignated former cls. (ii) and (iii) as (iii) and (iv), respectively, and in cl. (iv) substituted “(i), (ii), and (iii)” for “(i) and (ii)”.
Enacted provision · exact public law section
(b) Exclusive Use of Minor Use Pesticides.— Section 3(c)(1)(F) (7 U.S.C. 136a(c)(l)(F)) is amended— (1) by redesignating clauses (ii) and (iii) as clauses (iii) and (iv), respectively; and (2) by inserting after clause (i) the following: “(ii) The period of exclusive data use provided under clause (i) shall be extended 1 additional year for each 3 minor uses registered after the date of enactment of this clause and within 7 years of the commencement of the exclusive use period, up to a total of 3 additional years for all minor uses registered by the Administrator if the Administrator, in consultation with the Secretary of Agriculture, determines that, based on information provided by an applicant for registration or a registrant, that— “(I) there are insufficient efficacious alternative registered pesticides available for the use; “(II) the alternatives to the minor use pesticide pose greater risks to the environment or human health; “(III) the minor use pesticide plays or will play a significant part in managing pest resistance; or “(IV) the minor use pesticide plays or will play a significant part in an integrated pest management program. The registration of a pesticide for a minor use on a crop grouping established by the Administrator shall be considered for purposes of this clause 1 minor use for each representative crop for which data are provided in the crop grouping. Any additional exclusive use period under this clause shall be modified as appropriate or terminated if the registrant voluntarily cancels the product or deletes from the registration the minor uses which formed the basis for the extension of the additional exclusive use period or if the Administrator determines that the registrant is not actually marketing the product for such minor uses.”; (3) in clause (iv), as amended by paragraph (1), by striking “and (ii)” and inserting “, (ii), and (iii)”; and (4) at the end of the section, as amended by paragraph (1), by adding the following: “(v) The period of exclusive use provided under clause (ii) shall not take effect until 1 year after enactment of this clause, except where an applicant or registrant is applying for the registration of a pesticide containing an active ingredient not previously registered. “(vi) With respect to data submitted after the date of enactment of this clause by an applicant or registrant to support an amendment adding a new use to an existing registration that does not retain any period of exclusive use, if such data relates solely to a minor use of a pesticide, such data shall not, without the written permission of the original data submitter, be considered by the Administrator to support an application for a minor use by another person during the period of 10 years following the date of submission of such data. The applicant or registrant at the time Notification. the new minor use is requested shall notify the Administrator that to the best of their knowledge the exclusive use period for the pesticide has expired and that the data pertaining solely to the minor use of a pesticide is eligible for the provisions of this paragraph. If the minor use registration which is supported by data submitted pursuant to this subsection is voluntarily canceled or if such data are subsequently used to support a nonminor use, the data shall no longer be subject to the exclusive use provisions of this clause but shall instead be considered by the Administrator in accordance with the provisions of clause (i), as appropriate.”.
1996
Food Quality Protection Act of 1996
Pub. L. 104–170 § 250(1) · 110 Stat. 1489
Added · 7 U.S.C. § 136a(c)(1)(G)
Pub. L. 104–170, § 250(1), added subpar. (G)
Source evidence
Code amendment note
Subsec. (c)(1)(G). Pub. L. 104–170, § 250(1), added subpar. (G).
Enacted provision · exact public law section
(1) by adding at the end of paragraph (1) the following: “(G) If the applicant is requesting that the registration or amendment to the registration of a pesticide be expedited, an explanation of the basis for the request must be submitted, in accordance with paragraph (10) of this subsection."; and
1996
Food Quality Protection Act of 1996
Pub. L. 104–170 title I · 110 Stat. 1489
1. Inserted · 7 U.S.C. § 136a(c)(2)(A)
  Pub. L. 104–170, §§ 210(d)(1), 231, inserted heading
2. Inserted · 7 U.S.C. § 136a(c)(2)(A)
  Pub. L. 104–170, §§ 210(d)(1), 231, inserted “the public health and agricultural need for such minor use,” after “pattern of use,”
3. Substituted · 7 U.S.C. § 136a(c)(2)(A)
  Pub. L. 104–170, §§ 210(d)(1), 231, substituted “potential beneficial or adverse effects on man and the environment” for “potential exposure of man and the environment to the pesticide”
Source evidence
Code amendment note
Subsec. (c)(2)(A). Pub. L. 104–170, §§ 210(d)(1), 231, inserted heading, inserted “the public health and agricultural need for such minor use,” after “pattern of use,”, and substituted “potential beneficial or adverse effects on man and the environment” for “potential exposure of man and the environment to the pesticide”.
Enacted provision · exact public law
TITLE I— SUSPENSION-APPLICATORS SEC. 101. REFERENCE. Whenever in this title 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 Insecticide, Fungicide, and Rodenticide Act. Subtitle A— Suspension SEC. 102. SUSPENSION. (a) Section 6(c)(1).— The second sentence of section 6(c)(1) (7 U.S.C. 136d(c)(l)) is amended to read: “Except as provided in paragraph (3), no order of suspension may be issued under this subsection unless the Administrator has issued, or at the same time issues, a notice of intention to cancel the registration or change the classification of the pesticide under subsection (b).”. (b) Section 6(C)(3).— Section 6(c)(3) (7 U.S.C. 136d(c)(3)) is amended— (1) by inserting after the first sentence the following new sentence: “The Administrator may issue an emergency order under this paragraph before issuing a notice of intention to cancel the registration or change the classification of the pesticide under subsection (b) and the Administrator shall proceed to issue the notice under subsection (b) within 90 days of issuing an emergency order. If the Administrator does not issue a notice under subsection (b) within 90 days of issuing an emergency order, the emergency order shall expire.”; and (2) by striking “In that case” and inserting “In the case of an emergency order”. SEC. 103. TOLERANCE REEVALUATION AS PART OF REREGISTRATION. Section 4(g)(2) (7 U.S.C. 136a–l(g)(2)) is amended by adding at the end the following: “(E) As soon as the Administrator has sufficient information with respect to the dietary risk of a particular active ingredient, but in any event no later than the time the Administrator makes a determination under subparagraph (C) or (D) with respect to pesticides containing a particular active ingredient, the Administrator shall— “(i) reassess each associated tolerance and exemption from the requirement for a tolerance issued under section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a); “(ii) determine whether such tolerance or exemption meets the requirements of that Act; “(iii) determine whether additional tolerances or exemptions should be issued; “(iv) publish in the Federal Register a notice setting forth the determinations made under this clause; and “(v) commence promptly such proceedings under this Act and section 408 of the Federal Food, Drug, and Cosmetic Act as are warranted by such determinations.”. SEC. 104. SCIENTIFIC ADVISORY PANEL. Section 25(d) (7 U.S.C. 136w(d)) is amended— (1) in the first sentence, by striking “The Administrator shall” and inserting: “(1) In general.— The Administrator shall’; and (2) by adding at the end the following: “(2) Science review board.— There is established a Science Review Board to consist of 60 scientists who shall be available to the Scientific Advisory Panel to assist in reviews conducted by the Panel. Members of the Board shall be selected in the same manner as members of temporary subpanels created under paragraph (1). Members of the Board shall be compensated in the same manner as members of the Panel.”. SEC. 105. NITROGEN STABILIZER. (a) Section 2.— Section 2 (7 U.S.C. 136) is amended— (1) in subsection (a)— (A) in paragraph (1) by striking “or” after “defoliant,” and inserting “, or nitrogen stabilizer” after “desiccant”; (B) at the end of paragraph (3) by striking “and”; (C) at the end of paragraph (4) by striking the period and inserting “; and”; and (D) at the end by adding the following: “(5) in the case of a nitrogen stabilizer, an ingredient which will prevent or hinder the process of nitrification, denitrification, ammonia volatilization, or urease production through action affecting soil bacteria.”; (2) in subsection (u), by striking “and” before “(2)” and by inserting “and (3) any nitrogen stabilizer,” after “desiccant,”; and (3) at the end by adding the following: “(hh) Nitrogen Stabilizer.— The term ‘nitrogen stabilizer’ means any substance or mixture of substances intended for preventing or hindering the process of nitrification, denitrification, ammonia volatilization, or urease production through action upon soil bacteria. Such term shall not include— “(1) dicyandiamide; “(2) ammonium thiosulfate; or “(3) any substance or mixture of substances.— “(A) that was not registered pursuant to section 3 prior to January 1, 1992; and “(B) that was in commercial agronomic use prior to January 1, 1992, with respect to which after January 1, 1992, the distributor or seller of the substance or mixture has made no specific claim of prevention or hindering of the process of nitrification, denitrification, ammonia volatilization urease production regardless of the actual use or purpose for, or future use or purpose for, the substance or mixture. Statements made in materials required to be submitted to any State legislative or regulatory authority, or required by such authority to be included in the labeling or other literature accompanying any such substance or mixture shall not be deemed a specific claim within the meaning of this subsection.”. (b) Section 3(f).— Section 3(f) (7 U.S.C. 136a(f)) is amended by adding at the end the following: “(4) Mixtures of nitrogen stabilizers and fertilizer products.— Any mixture or other combination of— “(A) 1 or more nitrogen stabilizers registered under this Act; and “(B) 1 or more fertilizer products, shall not be subject to the provisions of this section or sections 4, 5, 7, 15, and 17(a)(2) if the mixture or other combination is accompanied by the labeling required under this Act for the nitrogen stabilizer contained in the mixture or other combination, the mixture or combination is mixed or combined in accordance with such labeling, and the mixture or combination does not contain any active ingredient other than the nitrogen stabilizer.”. SEC. 106. PERIODIC REGISTRATION REVIEW. (a) Section 6.— Section 6 (7 U.S.C. 136d) is amended— (1) in subsection (a), by striking the heading and inserting the following: “(a) Existing Stocks and Information.— “; and (2) by amending paragraph (1) of subsection (a) to read as follows: “(1) Existing stocks.— The Administrator may permit the continued sale and use of existing stocks of a pesticide whose registration is suspended or canceled under this section, or section 3 or 4, to such extent, under such conditions, and for such uses as the Administrator determines that such sale or use is not inconsistent with the purposes of this Act.”. (b) Section 3.— Section 3 (7 U.S.C. 136a) is amended by adding at the end the following: “(g) Registration Review.— “(1) (A) General rule.— The registrations of pesticides are to be periodically reviewed. The Administrator shall by regula- Regulations. tion establish a procedure for accomplishing the periodic review of registrations. The goal of these regulations shall be a review of a pesticide’s registration every 15 years. No registration shall be canceled as a result of the registration review process unless the Administrator follows the procedures and substantive requirements of section 6. “(B) Limitation.— Nothing in this subsection shall prohibit the Administrator from undertaking any other review of a pesticide pursuant to this Act. “(2) (A) Data.— The Administrator shall use the authority in subsection (c)(2)(B) to require the submission of data when such data are necessary for a registration review. “(B) Data submission, compensation, and exemption.— For purposes of this subsection, the provisions of subsections (c)(1), (c)(2)(B), and (c)(2)(D) shall be utilized for and be applicable to any data required for registration review.”. Subtitle B— Training for Maintenance Applicators and Service Technicians SEC. 120. MAINTENANCE APPLICATORS AND SERVICE TECHNICIANS DEFINITIONS. Section 2 (7 U.S.C. 136), as amended by section 106, is amended by adding at the end the following: “(jj) Maintenance Applicator.— The term ‘maintenance applicator’ means any individual who, in the principal course of such individual’s employment, uses, or supervises the use of, a pesticide not classified for restricted use (other than a ready to use consumer products pesticide); for the purpose of providing structural pest control or lawn pest control including janitors, general maintenance personnel, sanitation personnel, and grounds maintenance personnel. The term ‘maintenance applicator’ does not include private applicators as defined in section 2(e)(2); individuals who use antimicrobial pesticides, sanitizers or disinfectants; individuals employed by Federal, State, and local governments or any political subdivisions thereof, or individuals who use pesticides not classified for restricted use in or around their homes, boats, sod farms, nurseries, greenhouses, or other noncommercial property. “(kk) Service Technician.— The term ‘service technician’ means any individual who uses or supervises the use of pesticides (other than a ready to use consumer products pesticide) for the purpose of providing structural pest control or lawn pest control on the property of another for a fee. The term ‘service technician’ does not include individuals who use antimicrobial pesticides, sanitizers or disinfectants; or who otherwise apply ready to use consumer products pesticides.”. SEC. 121. MINIMUM REQUIREMENTS FOR TRAINING OF MAINTENANCE APPLICATORS AND SERVICE TECHNICIANS. The Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) is amended— (1) by redesignating sections 30 and 31 as sections 33 and 34, respectively; and (2) by adding after section 29 the following: “SEC. 30. MINIMUM REQUIREMENTS FOR TRAINING OF MAINTENANCE APPLICATORS AND SERVICE TECHNICIANS. “Each State may establish minimum requirements for training of maintenance applicators and service technicians. Such training may include instruction in the safe and effective handling and use of pesticides in accordance with the Environmental Protection Agency approved labeling, and instruction in integrated pest management techniques. The authority of the Administrator with respect to minimum requirements for training of maintenance applicators and service technicians shall be limited to ensuring that each State understands the provisions of this section.”.
1996
Food Quality Protection Act of 1996
Pub. L. 104–170 § 210(d)(2) · 110 Stat. 1489
Inserted · 7 U.S.C. § 136a(c)(2)(B)
Pub. L. 104–170, § 210(d)(2), inserted heading
Source evidence
Code amendment note
Subsec. (c)(2)(B). Pub. L. 104–170, § 210(d)(2), inserted heading.
Enacted provision · exact public law section
(2) by inserting “Additional data.—” after “(B)”;
1996
Food Quality Protection Act of 1996
Pub. L. 104–170 § 210(c)(1) · 110 Stat. 1489
Added · 7 U.S.C. § 136a(c)(2)(B)(vi)
Pub. L. 104–170, § 210(c)(1), added cl. (vi)
Source evidence
Code amendment note
Subsec. (c)(2)(B)(vi). Pub. L. 104–170, § 210(c)(1), added cl. (vi).
Enacted provision · exact public law section
(1) Data call-in.— Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B)) is amended by adding at the end the following: “(vi) Upon the request of a registrant the Administrator shall, in the case of a minor use, extend the deadline for the production of residue chemistry data under this subparagraph for data required solely to support that minor use until the final deadline for submission of data under section 4 for the other uses of the pesticide established as of the date of enactment of the Food Quality Protection Act of 1996, if— “(I) the data to support other uses of the pesticide on a food are being provided; “(II) the registrant, in submitting a request for such an extension, provides a schedule, including interim dates to measure progress, to assure that the data production will be completed before the expiration of the extension period; “(III) the Administrator has determined that such extension will not significantly delay the Administrator’s schedule for issuing a reregistration eligibility determination required under section 4; and “(IV) the Administrator has determined that based on existing data, such extension would not significantly increase the risk of any unreasonable adverse effect on the environment. If the Administrator grants an extension under this subclause, the Administrator shall monitor the development of the data and shall ensure that the registrant is meeting the schedule for the production of the data. If the Administrator determines that the registrant is not meeting or has not met the schedule for the production of such data, the Administrator may proceed in accordance with subclause (iv) regarding the continued registration of the affected products with the minor use and shall inform the public of such action. Notwithstanding the provisions of this subclause, the Administrator may take action to modify or revoke the extension under this subclause if the Administrator determines that the extension for the minor use may cause an unreasonable adverse effect on the environment. In such circumstance, the Notice. Administrator shall provide, in writing to the reg-istrant, a notice revoking the extension of time for submission of data. Such data shall instead be due in accordance with the date established by the Administrator for the submission of the data.”.
1996
Food Quality Protection Act of 1996
Pub. L. 104–170 § 210(f)(2) · 110 Stat. 1489
Added · 7 U.S.C. § 136a(c)(2)(B)(vii)
Pub. L. 104–170, § 210(f)(2), added cl. (vii)
Source evidence
Code amendment note
Subsec. (c)(2)(B)(vii). Pub. L. 104–170, § 210(f)(2), added cl. (vii).
Enacted provision · exact public law section
(2) Data.— Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B)), as amended by subsection (c)(1), is further amended by adding at the end the following: “(vii) If the registrant does not commit to support a specific minor use of the pesticide, but is supporting and providing data in a timely and adequate fashion to support uses of the pesticide on a food, or if all uses of the pesticide are nonfood uses and the registrant does not commit to support a specific minor use of the pesticide but is supporting and providing data in a timely and adequate fashion to support other nonfood uses of the pesticide, the Administrator, at the written request of the registrant, shall not take any action pursuant to this clause in regard to such unsupported minor use until the final deadline established as of the date of enactment of the Food Quality Protection Act of 1996, for the submission of data under section 4 for the supported uses identified pursuant to this clause unless the Administrator determines that the absence of the data is significant enough to cause human health or environmental concerns. On the basis of such determination, the Administrator may refuse the request Federal Register, publication. for extension by the registrant. Upon receipt of the request from the registrant, the Administrator shall publish in the Federal Register a notice of the receipt of the request and the effective date upon which the uses not being supported will be voluntarily deleted from the registration pursuant to section 6(f)(1)- If the Administrator grants an extension under this clause, the Administrator shall monitor the development of the data for the uses being supported and shall ensure that the registrant is meeting the schedule for the production of such data. If the Administrator determines that the registrant is not meeting or has not met the schedule for the production of such data, the Administrator may proceed in accordance with clause (iv) of this subparagraph regarding the continued registration of the affected products with the minor and other uses and shall inform the public of such action in accordance with section 6(f)(2). Notwithstanding the provisions of this clause, the Administrator may deny, modify, or revoke the temporary extension under this subparagraph if the Administrator determines that the continuation of the minor use may cause an unreasonable adverse effect Notice. on the environment. In the event of modification or revocation, the Administrator shall provide, in writing, to the registrant a notice revoking the temporary extension and establish a new effective date by which the minor use shall be deleted from the registration.”.
1996
Food Quality Protection Act of 1996
Pub. L. 104–170 § 222 · 110 Stat. 1489
Added · 7 U.S.C. § 136a(c)(2)(B)(viii)
Pub. L. 104–170, § 222, added cl. (viii)
Source evidence
Code amendment note
Subsec. (c)(2)(B)(viii). Pub. L. 104–170, § 222, added cl. (viii).
Enacted provision · exact public law section
SEC. 222. FEDERAL AND STATE DATA COORDINATION. Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B)), as amended by section 210(f)(2), is amended by adding at the end the following: “(viii) (I) If data required to support registration of a pesticide under subparagraph (A) is requested by a Federal or State regulatory authority, the Administrator shall, to the extent practicable, coordinate data requirements, test Protocols, timetables, and standards of review and reduce burdens and redundancy caused to the registrant by multiple requirements on the registrant. “(II) The Administrator may enter into a cooperative agreement with a State to carry out subclause (I). “(III) Not later than 1 year after the date of enactment of this clause, the Administrator shall develop a process to identify and assist in alleviating future disparities between Federal and State data requirements.”.
1996
Food Quality Protection Act of 1996
Pub. L. 104–170 § 210(d)(3) · 110 Stat. 1489
Inserted · 7 U.S.C. § 136a(c)(2)(C)
Pub. L. 104–170, § 210(d)(3), inserted heading
Source evidence
Code amendment note
Subsec. (c)(2)(C). Pub. L. 104–170, § 210(d)(3), inserted heading.
Enacted provision · exact public law section
(3) by inserting “Simplified procedures.—” after “(C)”; and
1996
Food Quality Protection Act of 1996
Pub. L. 104–170 § 210(d)(4) · 110 Stat. 1489
Added · 7 U.S.C. § 136a(c)(2)(E)
Pub. L. 104–170, § 210(d)(4), added subpar. (E)
Source evidence
Code amendment note
Subsec. (c)(2)(E). Pub. L. 104–170, § 210(d)(4), added subpar. (E).
Enacted provision · exact public law section
(4) by adding at the end the following: “(E) Minor use waiver.— In handling the registration of a pesticide for a minor use, the Administrator may waive otherwise applicable data requirements if the Administrator determines that the absence of such data will not prevent the Administrator from determining— “(i) the incremental risk presented by the minor use of the pesticide; and “(ii) that such risk, if any, would not be an unreasonable adverse effect on the environment.”.
1996
Food Quality Protection Act of 1996
Pub. L. 104–170 § 210(e)(1) · 110 Stat. 1489
Inserted · 7 U.S.C. § 136a(c)(3)(A); 7 U.S.C. § 136a(c)(3)(B)
Pub. L. 104–170, § 210(e)(1), (2), inserted headings
Source evidence
Code amendment note
Subsec. (c)(3)(A), (B). Pub. L. 104–170, § 210(e)(1), (2), inserted headings.
Enacted provision · exact public law section
(1) by inserting after “(A)” the following: “In general.—”;
1996
Food Quality Protection Act of 1996
Pub. L. 104–170 § 210(e)(3) · 110 Stat. 1489
Added · 7 U.S.C. § 136a(c)(3)(C); 7 U.S.C. § 136a(c)(3)(D)
Pub. L. 104–170, § 210(e)(3), added subpars. (C) and (D)
Source evidence
Code amendment note
Subsec. (c)(3)(C), (D). Pub. L. 104–170, § 210(e)(3), added subpars. (C) and (D).
Enacted provision · exact public law section
(3) by adding at the end the following: “(C) Minor use registration.— “(i) The Administrator shall, as expeditiously as Review. possible, review and act on any complete application— “(I) that proposes the initial registration of a new pesticide active ingredient if the active ingredient is proposed to be registered solely for minor uses, or proposes a registration amendment solely for minor uses to an existing registration; or “(II) for a registration or a registration amendment that proposes significant minor uses, “(ii) For the purposes of clause (i)— “(I) the term ‘as expeditiously as possible’ means that the Administrator shall, to the greatest extent practicable, complete a review and evaluation of all data, submitted with a complete application, within 12 months after the submission of the complete application, and the failure of the Administrator to complete such a review and evaluation under clause (i) shall not be subject to judicial review; and “(II) the term ‘significant minor uses’ means 3 or more minor uses proposed for every nonminor use, a minor use that would, in the judgment of the Administrator, serve as a replacement for any use which has been canceled in the 5 years preceding the receipt of the application, or a minor use that in the opinion of the Administrator would avoid the reissuance of an emergency exemption under section 18 for that minor use. “(D) Adequate time for submission of minor use data.— If a registrant makes a request for a minor use waiver, regarding data required by the Administrator, pursuant to paragraph (2)(E), and if the Administrator denies in whole or in part such data waiver request, the registrant shall have a full-time period for providing such data. For purposes of this subparagraph, the term ‘fulltime period’ means the time period originally established by the Administrator for submission of such data, beginning with the date of receipt by the registrant of the Administrator’s notice of denial.”.
1996
Food Quality Protection Act of 1996
Pub. L. 104–170 § 223 · 110 Stat. 1489
Added · 7 U.S.C. § 136a(c)(9)
Pub. L. 104–170, § 223, added par. (9)
Source evidence
Code amendment note
Subsec. (c)(9). Pub. L. 104–170, § 223, added par. (9).
Enacted provision · exact public law section
SEC. 223. LABEL AND LABELING. Section 3(c) (7 U.S.C. 136a(c)) is amended by adding at the end the following: “(9) Labeling.— “(A) Additional statements.— Subject to subparagraphs (B) and (C), it shall not be a violation of this Act for a registrant to modify the labeling of an antimicrobial pesticide product to include relevant information on product efficacy, product composition, container composition or design, or other characteristics that do not relate to any pesticidal claim or pesticidal activity. “(B) Requirements.— Proposed labeling information under subparagraph (A) shall not be false or misleading, shall not conflict with or detract from any statement required by law or the Administrator as a condition of registration, and shall be substantiated on the request of the Administrator. “(C) Notification and disapproval.— “(i) Notification.— A registration may be modified under subclause (A) if— “(I) the registrant notifies the Administrator in writing not later than 60 days prior to distribution or sale of a product bearing the modified labeling; and “(II) the Administrator does not disapprove of the modification under clause (ii). “(ii) Disapproval.— Not later than 30 days after receipt of a notification under clause (i), the Administrator may disapprove the modification by sending the registrant notification in writing stating that the proposed language is not acceptable and stating the reasons why the Administrator finds the proposed modification unacceptable. “(iii) Restriction on sale.— A registrant may not sell or distribute a product bearing a disapproved modification. “(iv) Objection.— A registrant may file an objection in writing to a disapproval under clause (ii) not later than 30 days after receipt of notification of the disapproval. “(v) Final action.— A decision by the Administrator following receipt and consideration of an objection filed under clause (iv) shall be considered a final agency action. “(D) Use dilution.— The label or labeling required under this Act for an antimicrobial pesticide that is or may be diluted for use may have a different statement of caution or protective measures for use of the recommended diluted solution of the pesticide than for use of a concentrate of the pesticide if the Administrator determines that— “(i) adequate data have been submitted to support the statement proposed for the diluted solution uses; and “(ii) the label or labeling provides adequate protection for exposure to the diluted solution of the pesticide.”.
1996
Food Quality Protection Act of 1996
Pub. L. 104–170 § 250(2) · 110 Stat. 1489
Added · 7 U.S.C. § 136a(c)(10)
Pub. L. 104–170, § 250(2), added par. (10)
Source evidence
Code amendment note
Subsec. (c)(10). Pub. L. 104–170, § 250(2), added par. (10).
Enacted provision · exact public law section
(2) by adding at the end the following: “(10) Expedited registration of pesticides.— “(A) Not later than 1 year after the date of enactment Guidelines. of this paragraph, the Administrator shall, utilizing public comment, develop procedures and guidelines, and expedite the review of an application for registration of a pesticide or an amendment to a registration that satisfies such guidelines. “(B) Any application for registration or an amendment, including biological and conventional pesticides, will be considered for expedited review under this paragraph. An application for registration or an amendment shall qualify for expedited review if use of the pesticide proposed by the application may reasonably be expected to accomplish 1 or more of the following: “(i) Reduce the risks of pesticides to human health, “(ii) Reduce the risks of pesticides to nontarget organisms. “(iii) Reduce the potential for contamination of groundwater, surface water, or other valued environmental resources. “(iv) Broaden the adoption of integrated pest management strategies, or make such strategies more available or more effective. “(C) The Administrator, not later than 30 days after Notification. receipt of an application for expedited review, shall notify the applicant whether the application is complete. If it is found to be incomplete, the Administrator may either reject the request for expedited review or ask the applicant for additional information to satisfy the guidelines developed under subparagraph (A).”.
1996
Food Quality Protection Act of 1996
Pub. L. 104–170 § 105(b) · 110 Stat. 1489
Added · 7 U.S.C. § 136a(f)(4)
Pub. L. 104–170, § 105(b), added par. (4)
Source evidence
Code amendment note
Subsec. (f)(4). Pub. L. 104–170, § 105(b), added par. (4).
Enacted provision · exact public law section
(b) Section 3(f).— Section 3(f) (7 U.S.C. 136a(f)) is amended by adding at the end the following: “(4) Mixtures of nitrogen stabilizers and fertilizer products.— Any mixture or other combination of— “(A) 1 or more nitrogen stabilizers registered under this Act; and “(B) 1 or more fertilizer products, shall not be subject to the provisions of this section or sections 4, 5, 7, 15, and 17(a)(2) if the mixture or other combination is accompanied by the labeling required under this Act for the nitrogen stabilizer contained in the mixture or other combination, the mixture or combination is mixed or combined in accordance with such labeling, and the mixture or combination does not contain any active ingredient other than the nitrogen stabilizer.”.
1996
Food Quality Protection Act of 1996
Pub. L. 104–170 § 106(b) · 110 Stat. 1489
Added · 7 U.S.C. § 136a(g)
Pub. L. 104–170, § 106(b), added subsec. (g)
Source evidence
Code amendment note
Subsec. (g). Pub. L. 104–170, § 106(b), added subsec. (g).
Enacted provision · exact public law section
(b) Section 3.— Section 3 (7 U.S.C. 136a) is amended by adding at the end the following: “(g) Registration Review.— “(1) (A) General rule.— The registrations of pesticides are to be periodically reviewed. The Administrator shall by regula- Regulations. tion establish a procedure for accomplishing the periodic review of registrations. The goal of these regulations shall be a review of a pesticide’s registration every 15 years. No registration shall be canceled as a result of the registration review process unless the Administrator follows the procedures and substantive requirements of section 6. “(B) Limitation.— Nothing in this subsection shall prohibit the Administrator from undertaking any other review of a pesticide pursuant to this Act. “(2) (A) Data.— The Administrator shall use the authority in subsection (c)(2)(B) to require the submission of data when such data are necessary for a registration review. “(B) Data submission, compensation, and exemption.— For purposes of this subsection, the provisions of subsections (c)(1), (c)(2)(B), and (c)(2)(D) shall be utilized for and be applicable to any data required for registration review.”.
1996
Food Quality Protection Act of 1996
Pub. L. 104–170 § 224 · 110 Stat. 1489
Added · 7 U.S.C. § 136a(h)
Pub. L. 104–170, § 224, added subsec. (h)
Source evidence
Code amendment note
Subsec. (h). Pub. L. 104–170, § 224, added subsec. (h).
Enacted provision · exact public law section
SEC. 224. REGISTRATION REQUIREMENTS FOR ANTIMICROBIAL PESTICIDES. Section 3 (7 U.S.C. 136a), as amended by section 106(b), is further amended by adding at the end the following: “(h) Registration Requirements for Antimicrobial Pesticides.— “(1) Evaluation of process.— To the maximum extent practicable consistent with the degrees of risk presented by an antimicrobial pesticide and the type of review appropriate to evaluate the risks, the Administrator shall identify and evaluate reforms to the antimicrobial registration process that would reduce review periods existing as of the date of enactment of this subsection for antimicrobial pesticide product registration applications and applications for amended registration of antimicrobial pesticide products, including— “(A) new antimicrobial active ingredients; “(B) new antimicrobial end-use products; “(C) substantially similar or identical antimicrobial pesticides; and “(D) amendments to antimicrobial pesticide registrations. “(2) Review time period reduction goal.— Each reform identified under paragraph (1) shall be designed to achieve the goal of reducing the review period following submission of a complete application, consistent with the degree of risk, to a period of not more than— “(A) 540 days for a new antimicrobial active ingredient pesticide registration; “(B) 270 days for a new antimicrobial use of a registered active ingredient; “(C) 120 days for any other new antimicrobial product; “(D) 90 days for a substantially similar or identical antimicrobial product; “(E) 90 days for an amendment to an antimicrobial registration that does not require scientific review of data; and “(F) 90 to 180 days for an amendment to an antimicrobial registration that requires scientific review of data and that is not otherwise described in this paragraph. “(3) Implementation.— “(A) Proposed rulemaking.— “(i) Issuance.— Not later than 270 days after the Federal Register, publication. date of enactment of this subsection, the Administrator publication, shall publish in the Federal Register proposed regulations to accelerate and improve the review of antimicrobial pesticide products designed to implement, to the extent practicable, the goals set forth in paragraph (2). “(ii) Requirements.— Proposed regulations issued under clause (i) shall— “(I) define the various classes of antimicrobial use patterns, including household, industrial, and institutional disinfectants and sanitizing pesticides, preservatives, water treatment, and pulp and paper mill additives, and other such products intended to disinfect, sanitize, reduce, or mitigate growth or development of microbiological organisms, or protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime; “(II) differentiate the types of review undertaken for antimicrobial pesticides; “(III) conform the degree and type of review to the risks and benefits presented by antimicrobial pesticides and the function of review under this Act, considering the use patterns of the product, toxicity, expected exposure, and product type; “(IV) ensure that the registration process is sufficient to maintain antimicrobial pesticide efficacy and that antimicrobial pesticide products continue to meet product performance standards and effectiveness levels for each type of label claim made; and “(V) implement effective and reliable deadlines for process management. “(iii) Comments.— In developing the proposed regulations, the Administrator shall solicit the views from registrants and other affected parties to maximize the effectiveness of the rule development process. “(B) Final regulations.— “(i) Issuance.— The Administrator shall issue final regulations not later than 240 days after the close of the comment period for the proposed regulations. “(ii) Failure to meet goal.— If a goal described in paragraph (2) is not met by the final regulations, the Administrator shall identify the goal, explain why the goal was not attained, describe the element of the regulations included instead, and identify future steps to attain the goal. “(iii) Requirements.— In issuing final regulations, the Administrator shall— “(I) consider the establishment of a certification process for regulatory actions involving risks that can be responsibly managed, consistent with the degree of risk, in the most cost-efficient manner; “(II) consider the establishment of a certification process by approved laboratories as an adjunct to the review process; “(III) use all appropriate and cost-effective review mechanisms, including— “(aa) expanded use of notification and nonnotification procedures; “(bb) revised procedures for application review; and “(cc) allocation of appropriate resources to ensure streamlined management of antimicrobial pesticide registrations; and “(IV) clarify criteria for determination of the completeness of an application. “(C) Expedited review.— This subsection does not affect the requirements or extend the deadlines or review periods contained in subsection (c)(3). “(D) Alternative review periods.— If the final regulations to carry out this paragraph are not effective 630 days after the date of enactment of this subsection, until the final regulations become effective, the review period, beginning on the date of receipt by the Agency of a complete application, shall be— “(i) 2 years for a new antimicrobial active ingredient pesticide registration; “(ii) 1 year for a new antimicrobial use of a registered active ingredient; “(iii) 180 days for any other new antimicrobial product; “(iv) 90 days for a substantially similar or identical antimicrobial product; “(v) 90 days for an amendment to an antimicrobial registration that does not require scientific review of data; and “(vi) 240 days for an amendment to an antimicrobial registration that requires scientific review of data and that is not otherwise described in this subparagraph. “(E) Wood preservatives.— An application for the registration, or for an amendment to the registration, of a wood preservative product for which a claim of pesticidal activity listed in section 2(mm) is made (regardless of any other pesticidal claim that is made with respect to the product) shall be reviewed by the Administrator within the same period as that established under this paragraph for an antimicrobial pesticide product application, consistent with the degree of risk posed by the use of the wood preservative product, if the application requires the applicant to satisfy the same data requirements as are required to support an application for a wood preservative product that is an antimicrobial pesticide. “(F) Notification.— “(i) In general.— Subject to clause (iii), the Administrator shall notify an applicant whether an application has been granted or denied not later than the final day of the appropriate review period under this paragraph, unless the applicant and the Administrator agree to a later date. “(ii) Final decision.— If the Administrator fails to notify an applicant within the period of time required under clause (i), the failure shall be considered an agency action unlawfully withheld or unreasonably delayed for purposes of judicial review under chapter 7 of title 5, United States Code. “(iii) Exemption.— This subparagraph does not apply to an application for an antimicrobial pesticide that is filed under subsection (c)(3)(B) prior to 90 days after the date of enactment of this subsection. “(4) Annual report.— “(A) Submission.— Beginning on the date of enactment of this subsection and ending on the date that the goals under paragraph (2) are achieved, the Administrator shall, not later than March 1 of each year, prepare and submit an annual report to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate. “(B) Requirements.— A report submitted under subparagraph (A) shall include a description of— “(i) measures taken to reduce the backlog of pending registration applications; “(ii) progress toward achieving reforms under this subsection; and “(iii) recommendations to improve the activities of the Agency pertaining to antimicrobial registrations.”.
2004
Foreign Operations, Export Financing, and Related Programs Appropriations Act, 2004
Pub. L. 108–199 § 501(b)(1) · 118 Stat. 3
Substituted · 7 U.S.C. § 136a(h)(2)(F)
Pub. L. 108–199, § 501(b)(1), substituted “120 days” for “90 to 180 days”
Source evidence
Code amendment note
Subsec. (h)(2)(F). Pub. L. 108–199, § 501(b)(1), substituted “120 days” for “90 to 180 days”.
Enacted provision · exact public law section
(b) For purposes of this section, “international financial institutions” are: the International Bank for Reconstruction and Development, the Inter-American Development Bank, the Asian Development Bank, the Asian Development Fund, the African Development Bank, the African Development Fund, the International Monetary Fund, the North American Development Bank, and the European Bank for Reconstruction and Development.
2004
Foreign Operations, Export Financing, and Related Programs Appropriations Act, 2004
Pub. L. 108–199 § 501(b)(2)(A) · 118 Stat. 3
Substituted · 7 U.S.C. § 136a(h)(3)(D)(vi)
Pub. L. 108–199, § 501(b)(2)(A), substituted “120 days” for “240 days”
Source evidence
Code amendment note
Subsec. (h)(3)(D)(vi). Pub. L. 108–199, § 501(b)(2)(A), substituted “120 days” for “240 days”.
Enacted provision · exact public law section
(b) For purposes of this section, “international financial institutions” are: the International Bank for Reconstruction and Development, the Inter-American Development Bank, the Asian Development Bank, the Asian Development Fund, the African Development Bank, the African Development Fund, the International Monetary Fund, the North American Development Bank, and the European Bank for Reconstruction and Development.
2004
Foreign Operations, Export Financing, and Related Programs Appropriations Act, 2004
Pub. L. 108–199 § 501(b)(2)(B) · 118 Stat. 3
Added · 7 U.S.C. § 136a(h)(3)(F)(iv)
Pub. L. 108–199, § 501(b)(2)(B), added cl. (iv)
Source evidence
Code amendment note
Subsec. (h)(3)(F)(iv). Pub. L. 108–199, § 501(b)(2)(B), added cl. (iv).
Enacted provision · exact public law section
(b) For purposes of this section, “international financial institutions” are: the International Bank for Reconstruction and Development, the Inter-American Development Bank, the Asian Development Bank, the Asian Development Fund, the African Development Bank, the African Development Fund, the International Monetary Fund, the North American Development Bank, and the European Bank for Reconstruction and Development.
2007
Pesticide Registration Improvement Renewal Act
Pub. L. 110–94 § 2(1) · 121 Stat. 1000
Substituted · 7 U.S.C. § 136a(c)(3)(B)(ii)(I)
Pub. L. 110–94, § 2(1), substituted “review the application in accordance with section 136w–8(f)(4)(B) of this title and,” for “within 45 days after receiving the application, notify the registrant whether or not the application is complete and,”
Source evidence
Code amendment note
Subsec. (c)(3)(B)(ii)(I). Pub. L. 110–94, § 2(1), substituted “review the application in accordance with section 136w–8(f)(4)(B) of this title and,” for “within 45 days after receiving the application, notify the registrant whether or not the application is complete and,”.
Enacted provision · exact public law section
(1) in subparagraph (I), by striking “within 45 days” and all that follows through “and,” and inserting “review the application in accordance with section 33(f)(4)(B) and,”; and
Effective date note
Pub. L. 110–94, § 6, Oct. 9, 2007, 121 Stat. 1007, provided that: “This Act [see Short Title of 2007 Amendment note set out under section 136 of this title] and the amendments made by this Act take effect on October 1, 2007.”
2007
Pesticide Registration Improvement Renewal Act
Pub. L. 110–94 § 2(2) · 121 Stat. 1000
Substituted · 7 U.S.C. § 136a(c)(3)(B)(ii)(II)
Pub. L. 110–94, § 2(2), substituted “not later than the applicable decision review time established pursuant to section 136w–8(f)(4)(B) of this title, or, if no review time is established, not later than” for “within”
Source evidence
Code amendment note
Subsec. (c)(3)(B)(ii)(II). Pub. L. 110–94, § 2(2), substituted “not later than the applicable decision review time established pursuant to section 136w–8(f)(4)(B) of this title, or, if no review time is established, not later than” for “within”.
Enacted provision · exact public law section
(2) in subparagraph (II), by striking “within” and inserting “not later than the applicable decision review time established pursuant to section 33(f)(4)(B), or, if no review time is established, not later than”.
Effective date note
Pub. L. 110–94, § 6, Oct. 9, 2007, 121 Stat. 1007, provided that: “This Act [see Short Title of 2007 Amendment note set out under section 136 of this title] and the amendments made by this Act take effect on October 1, 2007.”
2007
Pesticide Registration Improvement Renewal Act
Pub. L. 110–94 § 3(1) · 121 Stat. 1000
1. Amended · 7 U.S.C. § 136a(g)(1)(A)
  Pub. L. 110–94, § 3(1), designated first sentence as cl. (i)
2. Inserted · 7 U.S.C. § 136a(g)(1)(A)
  Pub. L. 110–94, § 3(1), inserted heading
3. Amended · 7 U.S.C. § 136a(g)(1)(A)
  Pub. L. 110–94, § 3(1), designated second sentence as cl. (ii)
4. Substituted · 7 U.S.C. § 136a(g)(1)(A)
  Pub. L. 110–94, § 3(1), substituted “In accordance with this subparagraph, the Administrator” for “The Administrator”
5. Added · 7 U.S.C. § 136a(g)(1)(A)
  Pub. L. 110–94, § 3(1), added cls. (iii) and (iv)
6. Amended · 7 U.S.C. § 136a(g)(1)(A)
  Pub. L. 110–94, § 3(1), designated fourth sentence as cl. (v)
7. Struck · 7 U.S.C. § 136a(g)(1)(A)
  Pub. L. 110–94, § 3(1), struck out third sentence which read as follows: “The goal of these regulations shall be a review of a pesticide’s registration every 15 years.”
Source evidence
Code amendment note
Subsec. (g)(1)(A). Pub. L. 110–94, § 3(1), designated first sentence as cl. (i) and inserted heading, designated second sentence as cl. (ii), inserted heading, and substituted “In accordance with this subparagraph, the Administrator” for “The Administrator”, added cls. (iii) and (iv), designated fourth sentence as cl. (v) and inserted heading, and struck out third sentence which read as follows: “The goal of these regulations shall be a review of a pesticide’s registration every 15 years.”
Enacted provision · exact public law section
(1) in subparagraph (A)— (A) in the first sentence, by striking “The registrations” and inserting the following: “(i) In general.— The registrations” ; (B) in the second sentence, by striking “The Administrator” and inserting the following: “(ii) Regulations.— In accordance with this subparagraph, the Administrator” ; and (C) by striking “The goal” and all that follows through “No registration” and inserting the following: “(iii) Initial registration review.— The Administrator shall complete the registration review of each pesticide or pesticide case, which may be composed of 1 or more active ingredients and the products associated with the active ingredients, not later than the later of— “(I) October 1, 2022; or “(II) the date that is 15 years after the date on which the first pesticide containing a new active ingredient is registered. “(iv) Subsequent registration review.— Not later than 15 years after the date on which the initial registration review is completed under clause (iii) and each 15 years thereafter, the Administrator shall complete a subsequent registration review for each pesticide or pesticide case. “(v) Cancellation.— No registration” ;
Effective date note
Pub. L. 110–94, § 6, Oct. 9, 2007, 121 Stat. 1007, provided that: “This Act [see Short Title of 2007 Amendment note set out under section 136 of this title] and the amendments made by this Act take effect on October 1, 2007.”
2007
Pesticide Registration Improvement Renewal Act
Pub. L. 110–94 § 3(2) · 121 Stat. 1000
1. Added · 7 U.S.C. § 136a(g)(1)(B); 7 U.S.C. § 136a(g)(1)(C)
  Pub. L. 110–94, § 3(2), (3), added subpar. (B)
2. Redesignated · 7 U.S.C. § 136a(g)(1)(B); 7 U.S.C. § 136a(g)(1)(C)
  Pub. L. 110–94, § 3(2), (3), redesignated former subpar. (B) as (C)
Source evidence
Code amendment note
Subsec. (g)(1)(B), (C). Pub. L. 110–94, § 3(2), (3), added subpar. (B) and redesignated former subpar. (B) as (C).
Enacted provision · exact public law section
(2) by redesignating subparagraph (B) as subparagraph (C); and
Effective date note
Pub. L. 110–94, § 6, Oct. 9, 2007, 121 Stat. 1007, provided that: “This Act [see Short Title of 2007 Amendment note set out under section 136 of this title] and the amendments made by this Act take effect on October 1, 2007.”
2018
Agriculture Improvement Act of 2018
Pub. L. 115–334 title X § 10115 · 132 Stat. 4490
Added · 7 U.S.C. § 136a(c)(11)
Pub. L. 115–334 added par. (11)
Source evidence
Code amendment note
Subsec. (c)(11). Pub. L. 115–334 added par. (11).
Enacted provision · exact public law section
SEC. 10115. FIFRA INTERAGENCY WORKING GROUP. Section 3(c) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 13a(c)) is amended by adding at the end the following: “(11) Interagency working group.— “(A) Definition of covered agency.— In this paragraph, the term ‘covered agency’ means any of the following: “(i) The Department of Agriculture. “(ii) The Department of Commerce. “(iii) The Department of the Interior. “(iv) The Council on Environmental Quality. “(v) The Environmental Protection Agency. “(B) Establishment.— The Administrator shall establish an interagency working group, to be comprised of representatives from each covered agency, to provide recommendations regarding, and to implement a strategy for improving, the consultation process required under section 7 of the Endangered Species Act of 1973 (16 U.S.C. 1536) for pesticide registration and registration review. “(C) Duties.— The interagency working group established under subparagraph (B) shall— “(i) analyze relevant Federal law (including regulations) and case law for purposes of providing an outline of the legal and regulatory framework for the consultation process referred to in that subparagraph, including— “(I) requirements under this Act and the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.); “(II) Federal case law regarding the intersection of this Act and the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.); and “(III) Federal regulations relating to the pesticide consultation process; “(ii) provide advice regarding methods of— “(I) defining the scope of actions of the covered agencies that are subject to the consultation requirement referred to in subparagraph (B); and “(II) properly identifying and classifying effects of actions of the covered agencies with respect to that consultation requirement; “(iii) identify the obligations and limitations under Federal law of each covered agency for purposes of providing a legal and regulatory framework for developing the recommendations referred to in subparagraph (B); “(iv) review practices for the consultation referred to in subparagraph (B) to identify problem areas, areas for improvement, and best practices for conducting that consultation among the covered agencies; “(v) develop scientific and policy approaches to increase the accuracy and timeliness of the process for that consultation, in accordance with requirements of this Act and the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.), including— “(I) processes to efficiently share data and coordinate analyses among the Department of Agriculture, the Department of Commerce, the Department of the Interior, and the Environmental Protection Agency; “(II) a streamlined process for identifying which actions require no consultation, informal consultation, or formal consultation; “(III) an approach that will provide clarity with respect to what constitutes the best scientific and commercial data available in the fields of pesticide use and ecological risk assessment, pursuant to section 7(a)(2) of the Endangered Species Act of 1973 (16 U.S.C. 1536(a)(2)); and “(IV) approaches that enable the Environmental Protection Agency to better assist the Department of the Interior and the Department of Commerce in carrying out obligations under that section in a timely and efficient manner; and “(vi) propose and implement a strategy to implement approaches to consultations under the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.) and document that strategy in a memorandum of understanding, revised regulations, or another appropriate format to promote durable cooperation among the covered agencies. “(D) Reports.— “(i) Progress reports.— “(I) In general.— Not later than 18 months after the date of enactment of this paragraph, the Administrator, in coordination with the head of each other covered agency, shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report describing the progress of the working group in developing the recommendations under subparagraph (B). “(II) Requirements.— The report under this clause shall— “(aa) reflect the perspectives of each covered agency; and “(bb) identify areas of new consensus and continuing topics of disagreement and debate. “(ii) Results.— “(I) In general.— Not later than 1 year after the date of enactment of this paragraph, the Administrator, in coordination with the head of each other covered agency, shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report describing— “(aa) the recommendations developed under subparagraph (B); and “(bb) plans for implementation of those recommendations. “(II) Requirements.— The report under this clause shall— “(aa) reflect the perspectives of each covered agency; and “(bb) identify areas of consensus and continuing topics of disagreement and debate, if any. “(iii) Implementation.— Not later than 1 year after the date of submission of the report under clause (i), the Administrator, in coordination with the head of each other covered agency, shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report describing— “(I) the implementation of the recommendations referred to in that clause; “(II) the extent to which that implementation improved the consultation process referred to in subparagraph (B); and “(III) any additional recommendations for improvements to the process described in subparagraph (B). “(iv) Other reports.— Not later than the date that is 180 days after the date of submission of the report under clause (iii), and not less frequently than once every 180 days thereafter during the 5-year period beginning on that date, the Administrator, in coordination with the head of each other covered agency, shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report describing— “(I) the implementation of the recommendations referred to in that clause; “(II) the extent to which that implementation improved the consultation process referred to in subparagraph (B); and “(III) any additional recommendations for improvements to the process described in subparagraph (B). “(E) Consultation with private sector.— In carrying out the duties under this paragraph, the working group shall, as appropriate— “(i) consult with, representatives of interested industry stakeholders and nongovernmental organizations; and “(ii) take into consideration factors, such as actual and potential differences in interest between, and the views of, those stakeholders and organizations. “(F) Federal advisory committee act.— The Federal Advisory Committee Act (5 U.S.C. App.) shall not apply to the working group established under this paragraph. “(G) Savings clause.— Nothing in this paragraph supersedes any provision of— “(i) this Act; or “(ii) the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.), including the requirements under section 7 of that Act (16 U.S.C. 1536).” .
2022
Pub. L. 117–286 § 4(a)(21) · 136 Stat. 4196
1. Substituted · 7 U.S.C. § 136a(c)(11)(F)
  Pub. L. 117–286 substituted “Chapter 10 of title 5” for “Federal Advisory Committee Act” in text
2. Substituted · 7 U.S.C. § 136a(c)(11)(F)
  Pub. L. 117–286 substituted “Chapter 10 of title 5” for “The Federal Advisory Committee Act (5 U.S.C. App.)” in text
Source evidence
Code amendment note
Subsec. (c)(11)(F). Pub. L. 117–286 substituted “Chapter 10 of title 5” for “Federal Advisory Committee Act” in heading and “Chapter 10 of title 5” for “The Federal Advisory Committee Act (5 U.S.C. App.)” in text.
Enacted provision · exact public law section
(21) Section 3(c)(11)(F) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a(c)(11)(F)) is amended— (A) in the subparagraph heading, by striking “Federal advisory committee act” and inserting “Chapter 10 of title 5, united states code”; and (B) in text, by striking “The Federal Advisory Committee Act (5 U.S.C. App.)” and inserting “Chapter 10 of title 5, United States Code,”.
2022
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023
Pub. L. 117–328 div. HH title VI § 702 · 136 Stat. 4459
Added · 7 U.S.C. § 136a(f)(5)
Pub. L. 117–328 added par. (5)
Source evidence
Code amendment note
Subsec. (f)(5). Pub. L. 117–328 added par. (5).
Enacted provision · exact public law section
Sec. 702. Notwithstanding any other provision of this Act, the Secretary of Agriculture may transfer unobligated balances of discretionary funds appropriated by this Act or any other available unobligated discretionary balances that are remaining available of the Department of Agriculture to the Working Capital Fund for the acquisition of property, plant and equipment and for the improvement, delivery, and implementation of Department financial, and administrative information technology services, and other support systems necessary for the delivery of financial, administrative, and information technology services, including cloud adoption and migration, of primary benefit to the agencies of the Department of Agriculture, such transferred funds to remain available until expended: Provided, That none of the funds made available by this Act or any other Act shall be transferred to the Working Capital Fund without the prior approval of the agency administrator: Provided further, That none of the funds transferred to the Working Capital Fund pursuant to this section shall be available for obligation without written notification to and the prior approval of the Committees on Appropriations of both Houses of Congress: Provided further, That none of the funds appropriated by this Act or made available to the Department’s Working Capital Fund shall be available for obligation or expenditure to make any changes to the Department’s National Finance Center without written notification to and prior approval of the Committees on Appropriations of both Houses of Congress as required by section 716 of this Act: Provided further, That none of the funds appropriated by this Act or made available to the Department’s Working Capital Fund shall be available for obligation or expenditure to initiate, plan, develop, implement, or make any changes to remove or relocate any systems, missions, personnel, or functions of the offices of the Chief Financial Officer and the Chief Information Officer, co-located with or from the National Finance Center prior to written notification to and prior approval of the Committee on Appropriations of both Houses of Congress and in accordance with the requirements of section 716 of this Act: Provided further, That the National Finance Center Information Technology Services Division personnel and data center management responsibilities, and control of any functions, missions, and systems for current and future human resources management and integrated personnel and payroll systems (PPS) and functions provided by the Chief Financial Officer and the Chief Information Officer shall remain in the National Finance Center and under the management responsibility and administrative control of the National Finance Center: Provided further, That the Secretary of Agriculture and the offices of the Chief Financial Officer shall actively market to existing and new Departments and other government agencies National Finance Center shared services including, but not limited to, payroll, financial management, and human capital shared services and allow the National Finance Center to perform technology upgrades: Provided further, That of annual income amounts in the Working Capital Fund of the Department of Agriculture attributable to the amounts in excess of the true costs of the shared services provided by the National Finance Center and budgeted for the National Finance Center, the Secretary shall reserve not more than 4 percent for the replacement or acquisition of capital equipment, including equipment for the improvement, delivery, and implementation of financial, administrative, and information technology services, and other systems of the National Finance Center or to pay any unforeseen, extraordinary cost of the National Finance Center: Provided further, That none of the amounts reserved shall be available for obligation unless the Secretary submits written notification of the obligation to the Committees on Appropriations of both Houses of Congress: Provided further, Determination. That the limitations on the obligation of funds pending notification to Congressional Committees shall not apply to any obligation that, as determined by the Secretary, is necessary to respond to a declared state of emergency that significantly impacts the operations of the National Finance Center; or to evacuate employees of the National Finance Center to a safe haven to continue operations of the National Finance Center.

83 of 95 references resolved to an enrolled provision · 12 partial

Editorial Notes

References in Text

The Endangered Species Act of 1973, referred to in subsec. (c)(11)(C)(i)(I), (II), (v), (vi), (G)(ii), is Pub. L. 93–205, Dec. 28, 1973, 87 Stat. 884, which is classified generally to chapter 35 (§ 1531 et seq.) of Title 16, Conservation. For complete classification of this Act to the Code, see Short Title note set out under section 1531 of Title 16 and Tables.

Prior Provisions

A prior section 3 of act June 25, 1947, was classified to section 135a of this title prior to amendment of act June 25, 1947, by Pub. L. 92–516.

Amendments1975–2022 · 10 rounds

2022

Subsec. (c)(11)(F). Pub. L. 117–286 substituted “Chapter 10 of title 5” for “Federal Advisory Committee Act” in heading and “Chapter 10 of title 5” for “The Federal Advisory Committee Act (5 U.S.C. App.)” in text.

Subsec. (f)(5). Pub. L. 117–328 added par. (5).

2018

Subsec. (c)(11). Pub. L. 115–334 added par. (11).

2007

Subsec. (c)(3)(B)(ii)(I). Pub. L. 110–94, § 2(1), substituted “review the application in accordance with section 136w–8(f)(4)(B) of this title and,” for “within 45 days after receiving the application, notify the registrant whether or not the application is complete and,”.

Subsec. (c)(3)(B)(ii)(II). Pub. L. 110–94, § 2(2), substituted “not later than the applicable decision review time established pursuant to section 136w–8(f)(4)(B) of this title, or, if no review time is established, not later than” for “within”.

Subsec. (g)(1)(A). Pub. L. 110–94, § 3(1), designated first sentence as cl. (i) and inserted heading, designated second sentence as cl. (ii), inserted heading, and substituted “In accordance with this subparagraph, the Administrator” for “The Administrator”, added cls. (iii) and (iv), designated fourth sentence as cl. (v) and inserted heading, and struck out third sentence which read as follows: “The goal of these regulations shall be a review of a pesticide’s registration every 15 years.”

Subsec. (g)(1)(B), (C). Pub. L. 110–94, § 3(2), (3), added subpar. (B) and redesignated former subpar. (B) as (C).

2004

Subsec. (h)(2)(F). Pub. L. 108–199, § 501(b)(1), substituted “120 days” for “90 to 180 days”.

Subsec. (h)(3)(D)(vi). Pub. L. 108–199, § 501(b)(2)(A), substituted “120 days” for “240 days”.

Subsec. (h)(3)(F)(iv). Pub. L. 108–199, § 501(b)(2)(B), added cl. (iv).

1996

Subsec. (c)(1)(F)(ii) to (vi). Pub. L. 104–170, § 210(b), added cls. (ii), (v), and (vi), redesignated former cls. (ii) and (iii) as (iii) and (iv), respectively, and in cl. (iv) substituted “(i), (ii), and (iii)” for “(i) and (ii)”.

Subsec. (c)(1)(G). Pub. L. 104–170, § 250(1), added subpar. (G).

Subsec. (c)(2)(A). Pub. L. 104–170, §§ 210(d)(1), 231, inserted heading, inserted “the public health and agricultural need for such minor use,” after “pattern of use,”, and substituted “potential beneficial or adverse effects on man and the environment” for “potential exposure of man and the environment to the pesticide”.

Subsec. (c)(2)(B). Pub. L. 104–170, § 210(d)(2), inserted heading.

Subsec. (c)(2)(B)(vi). Pub. L. 104–170, § 210(c)(1), added cl. (vi).

Subsec. (c)(2)(B)(vii). Pub. L. 104–170, § 210(f)(2), added cl. (vii).

Subsec. (c)(2)(B)(viii). Pub. L. 104–170, § 222, added cl. (viii).

Subsec. (c)(2)(C). Pub. L. 104–170, § 210(d)(3), inserted heading.

Subsec. (c)(2)(E). Pub. L. 104–170, § 210(d)(4), added subpar. (E).

Subsec. (c)(3)(A), (B). Pub. L. 104–170, § 210(e)(1), (2), inserted headings.

Subsec. (c)(3)(C), (D). Pub. L. 104–170, § 210(e)(3), added subpars. (C) and (D).

Subsec. (c)(9). Pub. L. 104–170, § 223, added par. (9).

Subsec. (c)(10). Pub. L. 104–170, § 250(2), added par. (10).

Subsec. (f)(4). Pub. L. 104–170, § 105(b), added par. (4).

Subsec. (g). Pub. L. 104–170, § 106(b), added subsec. (g).

Subsec. (h). Pub. L. 104–170, § 224, added subsec. (h).

1991

Subsec. (c)(1)(D). Pub. L. 102–237, § 1006(a)(3)(B), (C), added subpar. (D) and redesignated former subpar. (D) as (F).

Subsec. (c)(1)(E). Pub. L. 102–237, § 1006(a)(3)(A), (C), added subpar. (E) and struck out former subpar. (E) which read as follows: “the complete formula of the pesticide; and”.

Subsec. (c)(1)(F). Pub. L. 102–237, § 1006(a)(3)(A), (B), (D), redesignated former subpar. (D) as (F), in cl. (i) substituted “With” for “with” and a period for semicolon at end, in cl. (ii) substituted “Except” for “except” and a period for semicolon at end, in cl. (iii) substituted “After” for “after” and a period for semicolon at end, and struck out former subpar. (F) which read as follows: “a request that the pesticide be classified for general use, for restricted use, or for both.”

Subsec. (c)(2)(A). Pub. L. 102–237, § 1006(b)(1), (2), substituted “the Administrator” for “he” before “requires”, “shall permit”, “shall make”, and “deems”, and substituted “the Administrator’s” for “his”.

Subsec. (c)(2)(D). Pub. L. 102–237, § 1006(c), clarified amendment made by Pub. L. 100–532, § 102(b)(2)(A). See 1988 Amendment note below.

Subsec. (c)(3)(A). Pub. L. 102–237, § 1006(b)(2), substituted “the Administrator’s” for “his”.

Subsec. (c)(5). Pub. L. 102–237, § 1006(b)(1), substituted “the Administrator” for “he” before “determines”.

Subsec. (c)(6). Pub. L. 102–237, § 1006(b)(1), (2), substituted “the Administrator” for “he” before “shall notify” in two places and “the Administrator’s” for “his” in four places.

Subsec. (d)(1). Pub. L. 102–237, § 1006(b)(1), substituted “the Administrator” for “he” before “shall classify it for both” in subpar. (A), before “will classify” in subpar. (B), and before “shall classify” in subpar. (C).

Subsec. (d)(2). Pub. L. 102–237, § 1006(b)(1), substituted “the Administrator” for “he” before “shall notify”.

1990

Subsec. (c)(2)(A). Pub. L. 101–624 inserted after third sentence “The Administrator shall not require a person to submit, in relation to a registration or reregistration of a pesticide for minor agricultural use under this subchapter, any field residue data from a geographic area where the pesticide will not be registered for such use.”

1988

Subsec. (a). Pub. L. 100–532, § 601(b)(1), substituted “Requirement of registration” for “Requirement” in heading and amended text generally. Prior to amendment, text read as follows: “Except as otherwise provided by this subchapter, no person in any State may distribute, sell, offer for sale, hold for sale, ship, deliver for shipment, or receive and (having so received) deliver or offer to deliver, to any person any pesticide which is not registered with the Administrator.”

Subsec. (c)(1)(D). Pub. L. 100–532, § 801(b)(1)–(4), in introductory provisions, substituted “paragraph (2)(D)” for “subsection (c)(2)(D) of this section”, in cl. (i), substituted “(i) with” for “(i) With” and “, except that” for “: Provided, That”, in cl. (ii), substituted “clause (i)” for “subparagraph (D)(i) of this paragraph”, and in cl. (iii), substituted “clauses (i) and (ii)” for “subparagraphs (D)(i) and (D)(ii) of this paragraph”.

Subsec. (c)(2)(A). Pub. L. 100–532, § 801(b)(5)(A), (B), substituted “(2) Data in support of registration.—

“(A) The”

for “(2)(A) Data in support of registration.—The”, and directed that subpar. (A) be aligned with left margin of subsec. (d)(1)(A) of this section.

Subsec. (c)(2)(B). Pub. L. 100–532, §§ 102(b)(1), 801(b)(5)(C)–(F), substituted “(B)(i) If” for “(B) Additional data to support existing registration.—(i) If”, directed that cls. (ii) to (v) be aligned with left margin of subpar. (A), in cls. (ii) and (iii), inserted “The Administrator shall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures prescribed by clause (iv) if a registrant fails to comply with this clause.”, in cl. (iv), substituted “title. The only” for “title: Provided, that the only”, and in cl. (v), substituted “paragraph (1)(D)” for “subsection (c)(1)(D) of this section”.

Subsec. (c)(2)(C). Pub. L. 100–532, § 801(b)(5)(G), (H), struck out “Simplified procedures” after “(C)” and directed that text be aligned with left margin of subpar. (A).

Subsec. (c)(2)(D). Pub. L. 100–532, § 102(b)(2)(A), and Pub. L. 102–237, § 1006(c), substituted “the pesticide that is the subject of the application” for “an end-use product”.

Subsec. (c)(2)(D)(i). Pub. L. 100–532, § 102(b)(2)(B), struck out “the safety of” after “data pertaining to”.

Subsec. (c)(3). Pub. L. 100–532, § 103, substituted “(A) The Administrator” for “The Administrator” and added subpar. (B).

Subsec. (c)(7). Pub. L. 100–532, § 801(b)(6), in introductory provisions, substituted “paragraph (5)” for “subsection (c)(5) of this section”, in subpars. (A) and (B), substituted “paragraph (5). If” for “subsection (c)(5) of this section: Provided, That, if”, and in subpar. (C), substituted “prescribe. A” for “prescribe: Provided, that a”.

Subsec. (d)(1)(A). Pub. L. 100–532, § 801(b)(7), substituted “restricted use. If” for “restricted use, provided that if” and “restricted uses. The Administrator” for “restricted uses: Provided, however, That the Administrator”.

Subsec. (f)(2). Pub. L. 100–532, § 801(b)(8), substituted “this subchapter. As” for “this subchapter: Provided, That as”.

Subsec. (g). Pub. L. 100–532, § 801(b)(9), struck out subsec. (g) which read as follows: “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.”

1978

Subsec. (c)(1)(D). Pub. L. 95–396, § 2(a)(1), added subpar. (D), and struck out provisions which required the applicant for registration of a pesticide to file with the Administrator a statement containing “if requested by the Administrator, a full description of the tests made and the results thereof upon which the claims are based, except that data submitted on or after January 1, 1970, in support of an application shall not, without permission of the applicant, be considered by the Administrator in support of any other application for registration unless such other applicant shall have first offered to pay reasonable compensation for producing the test data to be relied upon and such data is not protected from disclosure by section 136h(b) of this title. This provision with regard to compensation for producing the test data to be relied upon shall apply with respect to all applications for registration or reregistration submitted on or after October 21, 1972. If the parties cannot agree on the amount and method of payment, the Administrator shall make such determination and may fix such other terms and conditions as may be reasonable under the circumstances. The Administrator’s determination shall be made on the record after notice and opportunity for hearing. If either party does not agree with said determination, he may, within thirty days, take an appeal to the Federal district court for the district in which he resides with respect to either the amount of the payment or the terms of payment, or both. Registration shall not be delayed pending the determination of reasonable compensation between the applicants, by the Administrator or by the court.”.

Subsec. (c)(2). Pub. L. 95–396, §§ 2(a)(2)(A)–(D), 3, 4, designated existing provisions as subpar. (A), inserted in second sentence “under subparagraph (B) of this paragraph” after “kind of information”, struck out from introductory text of third sentence “subsection (c)(1)(D) of this section and” after “Except as provided by”, and inserted provisions relating to establishment of standards for data requirements for registration of pesticides with respect to minor uses and consideration of economic factors in development of standards and cost of development, and added subpars. (B) to (D).

Subsec. (c)(5). Pub. L. 95–396, § 5, provided for waiver of data requirements pertaining to efficacy.

Subsec. (c)(7), (8). Pub. L. 95–396, § 6, added pars. (7) and (8).

Subsec. (d)(1)(A). Pub. L. 95–396, § 7(1), authorized classification of pesticide uses by regulation on the initial classification and registered pesticides prior to reregistration.

Subsec. (d)(2). Pub. L. 95–396, § 7(2), substituted “forty-five days” for “30 days”.

Subsec. (d)(3). Pub. L. 95–396, § 7(3), added par. (3).

Subsec. (g). Pub. L. 95–396, § 8, added subsec. (g).

1975

Subsec. (c)(1)(D). Pub. L. 94–140 inserted exception relating to test data submitted on or after January 1, 1970, in support of application, inserted provision that compensation for producing test data shall apply to all applications submitted on or after October 21, 1972, and provision relating to delay of registration pending determination of reasonable compensation, struck out requirement that payment determined by court not be less than amount determined by Administrator, and substituted “If either party” for “If the owner of the test data”.

Statutory Notes and Related Subsidiaries

Effective Date of 2007 Amendment

Pub. L. 110–94, § 6, Oct. 9, 2007, 121 Stat. 1007, provided that: “This Act [see Short Title of 2007 Amendment note set out under section 136 of this title] and the amendments made by this Act take effect on October 1, 2007.”

Effective Date of 2004 Amendment

Pub. L. 108–199, div. G, title V, § 501(h), Jan. 23, 2004, 118 Stat. 434, provided that: “Except as otherwise provided in this section [enacting section 136w–8 of this title, amending this section and sections 136a–1, 136x, and 136y of this title, and enacting provisions set out as notes under sections 136 of this title and section 346a of Title 21, Food and Drugs] and the amendments made by this section, this section and the amendments made by this section take effect on the date that is 60 days after the date of enactment of this Act [Jan. 23, 2004].”

Effective Date of 1988 Amendment

Amendment by Pub. L. 100–532 effective on expiration of 60 days after Oct. 25, 1988, see section 901 of Pub. L. 100–532, set out as a note under section 136 of this title.

Effective Date of 1978 Amendment

Pub. L. 95–396, § 2(b), Sept. 30, 1978, 92 Stat. 824, provided that: “The amendment to section 3(c)(1)(D) of the Federal Insecticide, Fungicide, and Rodenticide Act [subsec. (c)(1)(D) of this section] made by [subsec. (a)(1) of] this section shall apply with respect to all applications for registration approved after the date of enactment of this Act [Sept. 30, 1978].”

Effective Date

For effective date of section, see section 4 of Pub. L. 92–516, set out as a note under section 136 of this title.

Registration Review Deadline Extension

Pub. L. 117–328, div. HH, title VI, § 711, Dec. 29, 2022, 136 Stat. 6083, provided that:

“(a)
In General.—
Notwithstanding section 3(g)(1)(A)(iii)(I) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a(g)(1)(A)(iii)(I)), the Administrator of the Environmental Protection Agency (referred to in this section as the ‘Administrator’) shall complete the initial registration review of each pesticide or pesticide case covered by that section not later than October 1, 2026.
#
“(b)
Interim Registration Review Decision Requirements.—
“(1)
Definition of covered interim registration review decision.—
In this subsection, the term ‘covered interim registration review decision’ means an interim registration review decision—
“(A)
that is associated with an initial registration review described in subsection (a);
#
“(B)
that is noticed in the Federal Register during the period beginning on the date of enactment of this Act [Dec. 29, 2022] and ending on October 1, 2026; and
#
“(C)
for which the Administrator has not, as of the date on which the decision is noticed in the Federal Register, made effects determinations or completed any necessary consultation under section 7(a)(2) of the Endangered Species Act of 1973 (16 U.S.C. 1536(a)(2)).
#
#
“(2)
Requirements.—
Any covered interim registration review decision shall include, where applicable, measures to reduce the effects of the applicable pesticide on—
“(A)
species listed under the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.); or
#
“(B)
any designated critical habitat.
#
#
“(3)
Consultation.—
In developing measures described in paragraph (2), the Administrator shall take into account the input received from the Secretary of Agriculture and other members of the interagency working group established under section 3(c)(11) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a(c)(11)).”
#
#

Biological Pesticide Handling Study

Pub. L. 101–624, title XIV, § 1498, Nov. 28, 1990, 104 Stat. 3631, provided that the National Academy of Sciences would conduct a study of the biological control programs and registration procedures utilized by the Food and Drug Administration, the Animal and Plant Health Inspection Service, and the Environmental Protection Agency, and within 1 year after completion of the study, develop and implement a common process for reviewing and approving biological control applications submitted to such agencies and offices based on the study conducted, the recommendation of the National Academy of Sciences, and other public comment.

Education, Study, and Report

Pub. L. 100–478, title I, § 1010, Oct. 7, 1988, 102 Stat. 2313, provided that:

“(a)
Education.—
The Administrator of the Environmental Protection Agency in cooperation with the Secretary of Agriculture and the Secretary of the Interior, promptly upon enactment of this Act [Oct. 7, 1988], shall conduct a program to inform and educate fully persons engaged in agricultural food and fiber commodity production of any proposed pesticide labeling program or requirements that may be imposed by the Administrator in compliance with the Endangered Species Act [of 1973] (16 U.S.C. 1531 et seq.). The Administrator also shall provide the public with notice of, and opportunity for comment on, the elements of any such program and requirements based on compliance with the Endangered Species Act [of 1973], including (but not limited to) an identification of any pesticides affected by the program; an explanation of the restriction or prohibition on the user or applicator of any such pesticide; an identification of those geographic areas affected by any pesticide restriction or prohibition; an identification of the effects of any restricted or prohibited pesticide on endangered or threatened species; and an identification of the endangered or threatened species along with a general description of the geographic areas in which such species are located wherein the application of a pesticide will be restricted, prohibited, or its use otherwise limited, unless the Secretary of the Interior determines that the disclosure of such information may create a substantial risk of harm to such species or its habitat.
#
“(b)
Study.—
The Administrator of the Environmental Protection Agency, jointly with the Secretary of Agriculture and the Secretary of the Interior, shall conduct a study to identify reasonable and prudent means available to the Administrator to implement the endangered species pesticides labeling program which would comply with the Endangered Species Act of 1973, as amended, and which would allow persons to continue production of agricultural food and fiber commodities. Such study shall include investigation by the Administrator of the best available methods to develop maps and the best available alternatives to mapping as means of identifying those circumstances in which use of pesticides may be restricted; identification of alternatives to prohibitions on pesticide use, including, but not limited to, alternative pesticides and application methods and other agricultural practices which can be used in lieu of any pesticides whose use may be restricted by the labeling program; examination of methods to improve coordination among the Environmental Protection Agency, Department of Agriculture, and Department of the Interior in administration of the labeling program; and analysis of the means of implementing the endangered species pesticides labeling program or alternatives to such a program, if any, to promote the conservation of endangered or threatened species and to minimize the impacts to persons engaged in agricultural food and fiber commodity production and other affected pesticide users and applicators.
#
“(c)
Report.—
The Administrator of the Environmental Protection Agency in cooperation with the Secretary of Agriculture and the Secretary of the Interior shall submit a report within one year of the date of enactment of this Act [Oct. 7, 1988], presenting the results of the study conducted pursuant to subsection (b) of this section to the Committee on Merchant Marine and Fisheries and the Committee on Agriculture of the United States House of Representatives, and the Committee on Environment and Public Works and the Committee on Agriculture, Nutrition, and Forestry of the United States Senate.”
#

Credits

1947–2022 · 12 acts

1947June 25, 1947, ch. 125, § 3, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 979
1975amended Pub. L. 94–140, § 12, Nov. 28, 1975, 89 Stat. 755
1978Pub. L. 95–396, §§ 2(a), 3–8, Sept. 30, 1978, 92 Stat. 820, 824–827
1988Pub. L. 100–532, title I, §§ 102(b), 103, title VI, § 601(b)(1), title VIII, § 801(b), Oct. 25, 1988, 102 Stat. 2667, 2677, 2680
1990Pub. L. 101–624, title XIV, § 1492, Nov. 28, 1990, 104 Stat. 3628
1991Pub. L. 102–237, title X, § 1006(a)(3), (b)(1), (2), (c), Dec. 13, 1991, 105 Stat. 1894–1896
1996Pub. L. 104–170, title I, §§ 105(b), 106(b), title II, §§ 210(b), (c)(1), (d), (e), (f)(2), 222–224, 231, 250, Aug. 3, 1996, 110 Stat. 1491, 1494–1497, 1499, 1503, 1504, 1508, 1510
2004Pub. L. 108–199, div. G, title V, § 501(b), Jan. 23, 2004, 118 Stat. 419
2007Pub. L. 110–94, §§ 2, 3, Oct. 9, 2007, 121 Stat. 1000
2018Pub. L. 115–334, title X, § 10115, Dec. 20, 2018, 132 Stat. 4914
2022Pub. L. 117–286, § 4(a)(21), Dec. 27, 2022, 136 Stat. 4307
2022Pub. L. 117–328, div. HH, title VI, § 702, Dec. 29, 2022, 136 Stat. 5996.

Show as published

(June 25, 1947, ch. 125, § 3, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 979; amended Pub. L. 94–140, § 12, Nov. 28, 1975, 89 Stat. 755; Pub. L. 95–396, §§ 2(a), 3–8, Sept. 30, 1978, 92 Stat. 820, 824–827; Pub. L. 100–532, title I, §§ 102(b), 103, title VI, § 601(b)(1), title VIII, § 801(b), Oct. 25, 1988, 102 Stat. 2667, 2677, 2680; Pub. L. 101–624, title XIV, § 1492, Nov. 28, 1990, 104 Stat. 3628; Pub. L. 102–237, title X, § 1006(a)(3), (b)(1), (2), (c), Dec. 13, 1991, 105 Stat. 1894–1896; Pub. L. 104–170, title I, §§ 105(b), 106(b), title II, §§ 210(b), (c)(1), (d), (e), (f)(2), 222–224, 231, 250, Aug. 3, 1996, 110 Stat. 1491, 1494–1497, 1499, 1503, 1504, 1508, 1510; Pub. L. 108–199, div. G, title V, § 501(b), Jan. 23, 2004, 118 Stat. 419; Pub. L. 110–94, §§ 2, 3, Oct. 9, 2007, 121 Stat. 1000; Pub. L. 115–334, title X, § 10115, Dec. 20, 2018, 132 Stat. 4914; Pub. L. 117–286, § 4(a)(21), Dec. 27, 2022, 136 Stat. 4307; Pub. L. 117–328, div. HH, title VI, § 702, Dec. 29, 2022, 136 Stat. 5996.)