II 116th CONGRESS 2d Session S. 4406 IN THE SENATE OF THE UNITED STATES August 4, 2020 Mr. Udall (for himself, Ms. Warren , Mr. Booker , and Mr. Sanders ) introduced the following bill; which was read twice and referred to the Committee on Agriculture, Nutrition, and Forestry A BILL To amend the Federal Insecticide, Fungicide, and Rodenticide Act to fully protect the safety of children and the environment, to remove dangerous pesticides from use, and for other purposes.

1. Short title This Act may be cited as the Protect America’s Children from Toxic Pesticides Act . 2. Findings Congress finds that— (1) the Environmental Protection Agency (referred to in this section as the EPA ) regularly fails to incorporate updated scientific understanding to protect human health and the environment from the harmful effects of pesticide products, as envisioned by the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U.S.C. 136 et seq.), resulting in the use of billions of pounds of pesticides every year that were approved based on outdated science; (2) the United States lags behind the European Union and other developed nations in protecting its people and its environment from toxic chemicals, allowing the use of 72 pesticides that have been banned or are being phased out in the European Union alone; (3) the EPA registers nearly 65 percent of pesticides through conditional registrations and frequently waives requirements to extend the use of conditional registrations prior to completion of comprehensive registration; (4) the EPA permits the continued sale of potentially dangerous stocks of pesticides after registration has been canceled or suspended; (5) the EPA uses emergency exemptions to keep pesticides on the market for years without undergoing a comprehensive registration process that would ensure the safe use of the pesticides; (6) the EPA is prohibited from requiring the disclosure of inert ingredients, even though inert ingredients can account for 99 percent of a pesticide product and include carcinogenic and toxic chemicals; (7) the International Agency for Research on Cancer, the specialized cancer agency of the World Health Organization, has assessed and ranked the carcinogenicity of hundreds of pesticides to ensure that the most up-to-date, rigorous scientific information is used to inform the world of the risks of pesticides; (8) scientists have repeatedly linked exposure to organophosphate pesticides to neurodevelopmental damage in children; (9) the United States Fish and Wildlife Service and the National Marine Fisheries Service have determined that organophosphate pesticides jeopardize the survival of 97 percent of endangered species; (10) neonicotinoid pesticides are contributing to the rapid decline of pollinators and the deterioration of pollinator health, including impaired foraging behavior and increased susceptibility to viruses, diseases, and parasites; (11) exposure to paraquat— (A) causes heart failure, kidney failure, liver failure, lung scarring, and damage to brain cells; and (B) greatly increases the risk of developing Parkinson’s disease; (12) local communities have been blocked by States from enacting pesticide restrictions to protect people and environment from toxic chemicals; and (13) farmworkers are— (A) disproportionately exposed to and harmed by pesticide use; and (B) afforded inadequate safeguards and far less protection than industrial workers. 3. Ending indefinite delays on review of dangerous pesticides (a) Definitions (1) In general Section 2 of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U.S.C. 136 ) is amended— (A) by striking subsection (z) and inserting the following: (z) Registration The term registration means the approval of an active ingredient or pesticide product under this Act— (1) that has not previously been registered under this Act; or (2) for a crop or use for which the active ingredient or pesticide has not previously been registered under this Act. ; (B) by redesignating subsections (aa) through (oo) as subsections (bb) through (pp), respectively; and (C) by inserting after subsection (z) the following: (aa) Registration review determination (1) In general The term registration review determination means the final decision to renew the registration of a pesticide product or active ingredient to authorize the use of the pesticide product or active ingredient— (A) for an additional 15-year period from the date of the previous registration, reregistration, or registration review determination, as applicable; and (B) in compliance with all applicable laws and regulations. (2) Exclusion The term registration review determination does not include any interim determination regarding the continued use of a pesticide product or active ingredient by the Administrator. . (2) Conforming amendments (A) Section 2(e)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U.S.C. 136(e)(1) ) is amended by striking subsection (ee) and inserting subsection (ff) . (B) Section 3(h)(3)(E) of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U.S.C. 136a(h)(3)(E) ) is amended by striking section 2(mm) and inserting section 2(nn) . (C) Section 33(b)(3) of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U.S.C. 136w–8(b)(3) ) is amended— (i) by striking §2(mm) each place it appears and inserting section 2(nn) ; and (ii) by striking Section 2(ll)(2) and inserting section 2(mm)(2) . (b) Suspension of dangerous pesticides on failure To complete registration review on time Section 4 of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U.S.C. 136a–1 ) is amended by adding at the end the following: (o) Suspension of dangerous pesticides on failure To complete registration review on time (1) Definition of dangerous pesticide In this subsection, the term dangerous pesticide means an active ingredient or pesticide product that may— (A) be carcinogenic; (B) be acutely toxic; (C) be an endocrine disruptor; (D) cause harm to a pregnant woman or a fetus; or (E) cause neurological or developmental harm. (2) Petitions to designate dangerous pesticides (A) In general An interested person may submit a petition under section 553(e) of title 5, United States Code, to designate an active ingredient or pesticide product as a dangerous pesticide under this subsection. (B) Review On receipt of a petition under subparagraph (A), the Administrator shall review the petitions submitted by interested persons under that subparagraph relating to that active ingredient or pesticide product to determine if the active ingredient or pesticide product may warrant designation as a dangerous pesticide. (3) Initial findings (A) In general Not later than 90 days after the receipt of a petition described in paragraph (2)(A), the Administrator shall make a finding as to whether the petition presents substantial scientific information indicating that the designation of the petitioned active ingredient or pesticide product as a dangerous pesticide may be warranted. (B) Failure to review petition If the Administrator fails make a finding on a petition by the date required under subparagraph (A), the active ingredient or pesticide product that is the subject of the petition shall be deemed to be a dangerous pesticide. (C) Full consideration of all science (i) In general In making a finding as to whether a petition provides substantial scientific information that an active ingredient or pesticide product may warrant designation as a dangerous pesticide under subparagraph (A), the Administrator shall fully consider all relevant— (I) epidemiological studies or information; (II) peer-reviewed literature; and (III) information or data provided by a Federal or State agency. (ii) Requirement The Administrator shall not discount or ignore information provided in a petition described in paragraph (2)(A) based on any criteria under part 152 or 160 of title 40, Code of Federal Regulations (or successor regulations), or any rule issued by the Administrator under docket number EPA–HQ–OA–2018–0259. (4) Suspensions of pesticide (A) In general Notwithstanding any other provision of law, on a finding under paragraph (3)(A) that an active ingredient or pesticide product may warrant designation as a dangerous pesticide, or on operation of paragraph (3)(B), the Administrator shall immediately suspend the registration of the active ingredient or pesticide product if a valid reregistration eligibility decision or registration review determination has not been made regarding the active ingredient or pesticide product during the 15-year period ending on the date of that finding or operation. (B) Duration The registration of an active ingredient or pesticide product suspended under subparagraph (A) shall remain suspended until such time as the Administrator makes a registration review determination in accordance with this section. (5) Existing stocks In accordance with section 6(a)(1), the Administrator shall not permit the continued sale and use of existing stocks of an active ingredient or pesticide product the registration of which has been suspended under paragraph (4). (6) Cancellation Notwithstanding any other provision of law, including section 6(b), if the Administrator fails to suspend the registration of an active ingredient or pesticide product that may warrant designation as a dangerous pesticide as required by this subsection by not later than 60 days after any deadline described in this subsection— (A) the registration of the active ingredient or pesticide product shall be immediately and permanently canceled by operation of law and without any further proceedings; and (B) in accordance with section 6(a)(1), the sale of existing stocks of the active ingredient or pesticide product shall be prohibited. (7) Citizen suits (A) In general Any person may bring a civil action against the Administrator where there is an alleged failure of the Administrator to comply with any provision of this subsection. (B) Reviewability An action under subparagraph (A) shall be reviewable in the district courts of the United States pursuant to section 16(a). (8) Inapplicability of IREDS Notwithstanding any other provision of law, an interim registration review decision or any other interim determination with respect to an active ingredient or pesticide product shall have no force or effect regarding any requirement of this subsection. . 4. Emergency review of pesticides banned in other nations Section 6 of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U.S.C. 136d ) is amended by adding at the end the following: (i) Suspension and expedited review of banned pesticides (1) Suspension of banned pesticides The Administrator shall immediately suspend the registration of any active ingredient or pesticide product that is— (A) banned or otherwise prohibited from entering the market by the European Union, 1 or more countries in the European Union, or Canada; and (B) registered for use within the United States. (2) Expedited review (A) In general The Administrator shall complete an expedited review of the justification and rationale for the ban of a pesticide by the European Union or a country described in paragraph (1)(A). (B) Notice and comment In carrying out an expedited review with respect to each pesticide under subparagraph (A), the Administrator shall provide notice and an opportunity for public comment. (3) Cancellation (A) In general Notwithstanding any other provision of law, including subsection (b), if the Administrator determines after a review under paragraph (2) that the pesticide under review may be dangerous in accordance with subparagraph (B), the registration that is suspended shall be canceled not later than 2 years after the date of completion of the review. (B) Determination of dangerous pesticide The Administrator shall determine that a pesticide under review under paragraph (2) may be dangerous if substantial information indicates that the pesticide may— (i) be carcinogenic; (ii) be acutely toxic; (iii) be an endocrine disruptor; (iv) cause harm to a pregnant woman or a fetus; or (v) cause neurological or developmental harm. (C) Full consideration of science (i) In general In determining whether a pesticide under review under paragraph (2) may be dangerous, the Administrator shall consider relevant evidence, including— (I) epidemiological data; (II) peer-reviewed literature; and (III) data generated by a State or Federal agency or an agency of a foreign government. (ii) Treatment of information Notwithstanding any requirements or criteria under parts 152 and 160 of title 40, Code of Federal Regulations (or successor regulations), or any rule issued by the Administrator under docket number EPA–HQ–OA–2018–0259, the Administrator shall not discount, otherwise ignore, or give disproportionately more or less weight to evidence described in clause (i). (D) Consideration of economic cost prohibited In determining whether a pesticide under review under paragraph (2) may be dangerous, the Administrator shall not consider any economic analysis of the benefits or costs of continuing to register the pesticide. (E) Public comment Prior to making a final determination under subparagraph (A), the Administrator shall provide a draft determination for not less than 90 days of public comment. (4) Citizen suits (A) In general Any person may bring a civil action against the Administrator where there is an alleged failure of the Administrator to comply with any provision of this subsection. (B) Reviewability An action under subparagraph (A) shall be reviewable in the district courts of the United States pursuant to section 16(a). . 5. Ensuring accountability in conditional registrations (a) In general Section 3(c)(7) of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U.S.C. 136a(c)(7) ) is amended by striking subparagraph (C) and inserting the following: (C) Time limits on conditional registrations (i) In general Notwithstanding any other provision of this subsection or section 6(e), the Administrator shall provide not longer than 2 years for the terms and requirements of any conditional registration under this paragraph to be met by the registrant. (ii) Cancellation The Administrator shall cancel a conditional registration under this paragraph unless the registrant fully complies with all conditions by the earlier of— (I) all deadlines established by the Administrator; and (II) 2 years after the effective date of the conditional registration. (iii) Existing conditional registrations Notwithstanding any other provision of law, as of the date of enactment of this clause, each outstanding conditional registration under this paragraph for which the registrant has not fulfilled all conditions of the conditional registration shall be canceled. (iv) Reports (I) In general Not later than December 31 of each calendar year, the Administrator shall submit to Congress an annual report describing the total number of conditional registrations under this paragraph that were registered during the immediately preceding fiscal year. (II) Contents A report under subclause (I) shall include a description of— (aa) each conditionally registered pesticide and the conditions imposed, including any modification of those conditions; and (bb) the quantity produced of each pesticide described in item (aa). . (b) Conforming amendment Section 6(e) of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U.S.C. 136d(e) ) is amended— (1) in paragraph (1), by striking the last sentence and inserting The Administrator shall not permit the continued sale and use of existing stocks of a pesticide the conditional registration of which has been canceled. ; and (2) in paragraph (2), in the third sentence, by striking , and whether the Administrator's determination with respect to the disposition of existing stocks is consistent with this Act . 6. Prohibition on the sale or use of existing stocks of suspended or canceled pesticides Section 6(a) of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U.S.C. 136d(a) ) is amended by striking the subsection designation and heading and all that follows through the period at the end of paragraph (1) and inserting the following: (a) Prohibition on the sale or use of existing stocks; information (1) Existing stocks The Administrator shall not permit the continued sale or use of existing stocks of a pesticide the registration of which is suspended or canceled under this section or section 3 or 4. . 7. Ending abuse of emergency exemptions Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U.S.C. 136p ) is amended— (1) in the first sentence, by striking The Administrator and inserting the following: (a) In general The Administrator ; (2) in subsection (a) (as so designated), in the second sentence, by striking The Administrator and inserting the following: (b) Consultation The Administrator ; and (3) by adding at the end the following: (c) Limitations on emergency exemptions Notwithstanding any other provision of law, the Administrator shall not grant an emergency exemption under subsection (a) for the same active ingredient or pesticide product in the same location for more than 2 years in any 10-year period. (d) Restrictions on unregistered pesticides The Administrator shall not grant an emergency exemption under subsection (a) to use an active ingredient or pesticide product that is not registered under section 3 for any use. (e) Restrictions on conditional pesticides The Administrator shall not grant an emergency exemption under subsection (a) for any active ingredient or pesticide product that is registered conditionally under section 3(c)(7)(A). . 8. Adding transparency for inert ingredients (a) Definition of ingredient statement Section 2(n) of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U.S.C. 136(n) ) is amended— (1) by redesignating paragraph (2) as paragraph (4); and (2) by striking paragraph (1) and inserting the following: (1) the name and percentage of each active ingredient in the pesticide product; (2) the name and percentage of each inert ingredient in the pesticide product; (3) if applicable, a statement that the pesticide product contains an inert ingredient determined by a State or Federal agency to be likely— (A) to be carcinogenic; (B) to be an endocrine disruptor; (C) to be highly toxic; (D) to cause harm to pregnant women or fetuses; or (E) to cause neurological or developmental harm; and . (b) Complete list of inert ingredients Section 3(c)(9) of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U.S.C. 136a(c)(9) ) is amended by adding at the end the following: (E) Complete list of inert ingredients Notwithstanding any other provision of law, the label or labeling required under this Act shall provide a complete list of inert ingredients. . (c) Conforming amendment Section 10(d) of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U.S.C. 136h(d) ) is amended— (1) in paragraph (1)— (A) in subparagraph (A), by adding or at the end; (B) in subparagraph (B), by striking or at the end; and (C) by striking subparagraph (C); and (2) in paragraph (3), by striking clause (A), (B), or (C) each place it appears and inserting subparagraph (A) or (B) . 9. Cancellation of registration of organophosphates Section 6 of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U.S.C. 136d ) (as amended by section 4) is amended by adding at the end the following: (j) Cancellation of registration of organophosphate pesticides (1) In general (A) Cancellation Effective on the date of enactment of this subsection— (i) all pesticides of the class organophosphate shall be deemed to generally cause unreasonable adverse effects to humans; and (ii) notwithstanding any other provision of law, including subsection (b), the registration of all uses of pesticides of the class organophosphate shall be immediately and permanently canceled by operation of law and without further proceedings. (B) Revocation of tolerances and exemptions Not later than 6 months after the date of enactment of this subsection, the Administrator shall, in accordance with section 408(b)(1)(B) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 346a(b)(1)(B) ), revoke any tolerance or exemption that allows the presence of an organophosphate, or any pesticide chemical residue that results from organophosphate use, in or on food. (2) Sale of existing stocks prohibited In accordance with subsection (a)(1), effective on the date of enactment of this subsection, the continued sale or use of existing stocks of pesticides of the class organophosphate shall be prohibited. (3) No future organophosphate registrations Effective on the date of enactment of this subsection, the Administrator may not register any pesticide of the class organophosphate under section 4. (4) Ineligibility for emergency use Notwithstanding any other provision of law, a pesticide canceled under this subsection shall not be eligible for use under section 18. . 10. Cancellation of registration of neonicotinoids Section 6 of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U.S.C. 136d ) (as amended by section 9) is amended by adding at the end the following: (k) Cancellation of registration of neonicotinoid pesticides (1) In general (A) Cancellation Effective on the date of enactment of this subsection— (i) all active ingredients and pesticide products containing 1 or more of the active ingredients imidacloprid, clothianidin, thiamethoxam, dinotefuran, acetamiprid, sulfoxaflor, and flupyradifurone (referred to in this subsection as neonicotinoid pesticides ) shall be deemed to generally cause unreasonable adverse effects to the environment; and (ii) notwithstanding any other provision of law, including subsection (b), the registration of all uses of neonicotinoid pesticides shall be immediately and permanently canceled by operation of law and without further proceedings. (B) Revocation of tolerances and exemptions Not later than 6 months after the date of enactment of this subsection, the Administrator shall, in accordance with section 408(b)(1)(B) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 346a(b)(1)(B) ), revoke any tolerance or exemption that allows the presence of a neonicotinoid pesticide, or any pesticide chemical residue that results from neonicotinoid pesticide use, in or on food. (2) Sale of existing stocks prohibited In accordance with subsection (a)(1), effective on the date of enactment of this subsection, the continued sale or use of existing stocks of neonicotinoid pesticides shall be prohibited. (3) No future neonicotinoid registrations Effective on the date of enactment of this subsection, the Administrator may not register any neonicotinoid pesticide under section 4. (4) Ineligibility for emergency use Notwithstanding any other provision of law, a pesticide canceled under this section shall not be eligible for use under section 18. . 11. Cancellation of registration of paraquat Section 6 of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U.S.C. 136d ) (as amended by section 10) is amended by adding at the end the following: (l) Cancellation of registration of paraquat (1) In general (A) Cancellation Effective on the date of enactment of this subsection— (i) paraquat shall be deemed to generally cause unreasonable adverse effects to humans; and (ii) notwithstanding any other provision of law, including subsection (b), the registration of all uses of paraquat shall be immediately and permanently canceled by operation of law and without further proceedings. (B) Revocation of tolerances and exemptions Not later than 6 months after the date of enactment of this subsection, the Administrator shall, in accordance with section 408(b)(1)(B) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 346a(b)(1)(B) ), revoke any tolerance or exemption that allows the presence of paraquat, or any pesticide chemical residue that results from paraquat use, in or on food. (2) Sale of existing stocks prohibited In accordance with subsection (a)(1), effective on the date of enactment of this subsection, the continued sale or use of existing stocks of paraquat shall be prohibited. (3) No future paraquat registrations Effective on the date of enactment of this subsection, the Administrator may not register any paraquat pesticide under section 4. (4) Ineligibility for emergency use Notwithstanding any other provision of law, a pesticide canceled under this section shall not be eligible for use under section 18. . 12. Empowering communities to protect themselves from pesticides (a) In general Section 24 of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U.S.C. 136v ) is amended— (1) in subsection (a)— (A) by inserting , or any political subdivision of a State, after A State ; and (B) by inserting or political subdivision after the State ; (2) by striking subsection (b); and (3) by redesignating subsection (c) as subsection (b). (b) Conforming amendment Section 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U.S.C. 136a(c)(5) ) is amended, in the fourth sentence of the undesignated matter following subparagraph (D), by striking 24(c) of this Act and inserting 24(b) . 13. Protecting farmworkers from dangerous pesticides (a) Language requirements for pesticide products Section 3(c)(9) of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U.S.C. 136a(c)(9) ) (as amended by section 8(b)) is amended by adding at the end the following: (F) Language requirements for pesticide products (i) In general The label for any pesticide product shall be printed in both English and Spanish. (ii) Other languages In a case in which information exists that a pesticide product is used in agriculture by more than 500 individual persons or applicators who speak the same language other than English or Spanish, the Administrator shall provide a translation of that label in the language used by those individuals on the website of the Environmental Protection Agency. (iii) Educational information The Administrator shall provide educational information to ensure that all users of a pesticide product are aware that information is available in alternate languages. . (b) Farmworker safety The Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U.S.C. 136 et seq.) is amended by adding at the end the following: 36. Farmworker safety (a) Definitions In this section: (1) Farmworker The term farmworker means an individual of any age that is employed in agriculture, including as a pesticide user or applicator, for any length of time, including migrant and seasonal employees, regardless of classification as a full-time, part-time, or contract employee. (2) Farmworker incident The term farmworker incident means exposure of a farmworker to an active ingredient, a pesticide product, a tank mixture of multiple pesticides, a metabolite, or a degradate that results in— (A) an illness or injury— (i) requiring medical attention or hospitalization of the farmworker; or (ii) that requires the farmworker to stop working temporarily or permanently; (B) a permanent disability or loss in function of the farmworker; or (C) death of the farmworker. (b) Mandatory duty To report (1) In general Whenever a farmworker incident occurs, the employer of each affected farmworker shall report the incident to the Administrator. (2) Online system (A) In general Not later than 60 days after the date of enactment of this section, the Administrator shall implement and deploy an online system to facilitate the reporting of farmworker incidents. (B) Requirements The online system under subparagraph (A) shall include, at a minimum, a description of, with respect to each farmworker incident— (i) the time and location; (ii) the name of each active ingredient and pesticide product involved; (iii) whether such a pesticide was applied in accordance with the label instructions; (iv) the harm that resulted to any affected farmworker; (v) the nature of any medical care that was sought by any affected farmworker; and (vi) any other pertinent information. (C) Anonymous reporting The Administrator shall ensure that the online system under subparagraph (A) allows for anonymous reporting to protect farmworkers from retaliation. (c) Penalties for failure To report (1) Civil penalties An employer described in subsection (b)(1) that fails to report a farmworker incident shall be fined $1,000 per day beginning on the 8th day after the farmworker incident occurs. (2) Criminal penalties An employer described in subsection (b)(1) that knowingly fails to report a farmworker incident, or that otherwise pressures or coerces a farmworker to not report a farmworker incident, shall be liable for a criminal penalty of up to $100,000, 6 months in prison, or both. (3) Rewards The Administrator shall implement a reward system that a provides monetary award of not less than $25,000 per person per farmworker incident that leads to the identification of 1 or more employers that have failed to report a farmworker incident. (4) Retaliation (A) In general Any person that takes punitive action against a farmworker or a person that reports a farmworker incident shall be liable for a criminal penalty of not more than $100,000, 6 months in prison, or both. (B) Immigration status No Federal agency shall take any action regarding the immigration legal status within the United States of a farmworker, including initiating removal proceedings or any other prosecution of the farmworker, based solely on any information derived from the reporting or investigation of a farmworker incident. (d) Preventing future harm to farmworkers (1) In general Not later than 15 days after the receipt of a report of a farmworker incident, the Administrator shall transmit a report prepared by the Administrator of the farmworker incident to— (A) the manufacturer of each involved pesticide product; and (B) the manufacturer of each involved active ingredient or ingredients. (2) Suspension Notwithstanding any other provision of law, if a farmworker incident results in the death of a farmworker, the pesticide product or active ingredient that caused the death shall be immediately suspended, pending the review required by this section. (3) Assessments (A) Pesticide product manufacturer Not later than 60 days after the receipt of a report of a farmworker incident, the manufacturer of the pesticide product shall provide to the Administrator an assessment of the farmworker incident, including whether any changes to the label of the pesticide product or active ingredient are warranted at the time of the assessment to avoid future farmworker incidents. (B) Assessment by active ingredient manufacturer Not later than 60 days after the receipt of a report of a farmworker incident, the manufacturer of each involved pesticide active ingredient shall provide to the Administrator an assessment of the farmworker incident, including whether any changes to the pesticide product or active ingredient are warranted at the time of the assessment to avoid future farmworker incidents. (4) Determinations by Administrator (A) Draft determination (i) In general Not later than the earlier of 90 days after the receipt of an assessment required by paragraph (3) and 180 days after the occurrence of the farmworker incident, the Administrator shall make a draft determination as to whether a change in the label of an involved pesticide product or active ingredient is warranted. (ii) Publication The Administrator shall publish a determination under clause (i) in the Federal Register for a period of 30 days for public notice and comment. (B) Final determination Not later than 30 days after the close of the public comment described in subparagraph (A)(ii), the Administrator shall— (i) make a final determination as to whether the label of the pesticide product should be changed; and (ii) publish that final determination in the Federal Register. (5) Cancellations (A) failure to change label Notwithstanding any other provision of law, including section 6(b), if the manufacturer of a pesticide product or active ingredient does not change the label of the applicable product in accordance with a final determination of the Administrator under paragraph (4)(B), the pesticide product or active ingredient shall be immediately and permanently canceled by operation of law and without further proceedings. (B) Cancellation for failure to comply Notwithstanding any other provision of law, including section 6(b), if the manufacturer of the pesticide product or active ingredient fails to comply with any applicable provision of this section, the active ingredient and all pesticide products containing the active ingredient shall be immediately and permanently canceled by operation of law and without further proceedings. (e) Accounting for farmworker incidents during registration review (1) In general Notwithstanding any other provision of law, if a pesticide product or active ingredient is responsible for not fewer than 10 farmworker incidents of any type, or not fewer than 3 farmworker incidents resulting in death, and the pesticide product or active ingredient has not received a final determination regarding a registration review during the preceding 15-year period, the Administrator shall immediately suspend the pesticide product or active ingredient until a final determination is made regarding the registration review of the pesticide. (2) Reports The Administrator shall— (A) include in a final determination regarding the registration review of a pesticide the registration of which is suspended under paragraph (1) a full and complete report describing each farmworker incident that has occurred during the period covered by the report; and (B) (i) require label changes to prevent farmworker incidents from occurring in the future; or (ii) explain why no label changes under clause (i) are warranted. (f) Citizen suits (1) In general Any person may bring a civil action against the Administrator where there is an alleged failure of the Administrator to comply with any provision of this section. (2) Reviewability An action under subparagraph (A) shall be reviewable in the district courts of the United States pursuant to section 16(a). .