7 U.S.C. § 136a–1 — Reregistration of registered pesticides

(a) General rule The EPA must re-review, or "reregister," every pesticide that was first registered before November 1, 1984, as long as it contains an active ingredient from that older pesticide. There's one exception: if the EPA already decided, sometime after November 1, 1984, but before this law's effective date, that a pesticide had no missing data and met the requirements in section 136a(c)(5), that pesticide does not need to be reregistered. (b) Reregistration phases Reregistration happens in five phases. Phase one is the EPA listing which active ingredients will be reregistered. Phase two is registrants telling the EPA whether they want reregistration, identifying missing or bad data, and promising to fill the gaps. Phase three is registrants sending the EPA the actual information required. Phase four is the EPA's own independent review of what registrants submitted, figuring out what data is still missing, and asking for it. Phase five is the EPA reviewing all the submitted data and deciding what to do about each pesticide. (c) Phase one (1) Priority for reregistration: When deciding which active ingredients to review first, the EPA must give priority to ingredients that: (A) are used on food or feed and could leave residue after harvest; (B) could leave residue that worries toxicologists in drinking water, fish, or shellfish; (C) the EPA already decided, before this law's effective date, have a lot of missing data; or (D) are used on crops — including in greenhouses and nurseries — where farm workers are most likely to be exposed. Ingredients that already have registration standards issued before the effective date don't get this priority treatment. (2) Reregistration lists: The EPA must publish four lists in the Federal Register, on a schedule: within 70 days, list ingredients that already have registration standards; within 4 months, list the first 150 priority ingredients; within 7 months, list the next 150; within 10 months, list everything else. (3) Judicial review: Courts cannot review what the EPA puts on these lists. (4) Notice to registrants: Once a list is published, the EPA must mail each registrant, by certified mail, notice of the deadline for telling the EPA whether they want to reregister. (d) Phase two (1) In general: If your pesticide's active ingredient was listed under (c)(2)(B), (C), or (D), you must send the EPA — by the deadline in paragraph (4) — the notice described below and any required data information or promises. (2) Notice of intent: You must tell the EPA, by certified mail, whether you want to reregister. If you say no, the EPA publishes that fact in the Federal Register. (3) Missing or inadequate data: If you said yes, you must also send the EPA: an identification of all data your registration is required to have, which of your previously submitted data doesn't meet current requirements, and which required data you haven't submitted at all. Then you must either (i) promise to replace bad data and submit missing data by the deadline in paragraph (4)(B), or (ii) offer to split the cost with whoever agreed to do that work, and agree to arbitration over the cost-split if needed. Data counts as "inadequate" if you can't certify you have access to the raw data behind it, or if it came from a study submitted before January 1, 1970 — unless you can convince the EPA the old data is still good enough. (4) Time periods: (A) Your notice or data identification (from paragraphs (2) and (3)) is due within 3 months of when your ingredient's listing was published, no matter which subsection ((c)(2)(B), (C), or (D)) it was listed under. The EPA may extend this if factors outside your control kept you from meeting it. (B) If you promised to submit data, you generally have up to 48 months from your promise to actually submit it; the EPA can extend that by up to 2 more years for extraordinary circumstances outside your control. For a "minor use" — a use with a small market — the EPA must extend your residue-chemistry data deadline to match the deadline for the pesticide's other uses, if: (i) you're still providing the data for those other uses; (ii) you give the EPA a schedule showing how you'll finish on time; (iii) the EPA decides this won't delay the eligibility decision; and (iv) the EPA decides it won't meaningfully raise the risk of environmental harm. If the EPA grants this extension, it must track your progress. If you fall behind, the EPA can move to suspend or cancel your registration for the minor use, and must tell the public. The EPA can also revoke this extension in writing, at any time, if it decides the extension itself risks unreasonable environmental harm — and it must then set a new, earlier deadline. (5) Cancellation and removal: (A) If you miss the deadline in (4)(A) entirely, the EPA must propose to cancel your registration, publish that in the Federal Register, and take comments for 60 days. After that, the EPA can cancel by order, without a hearing, or take another action — like extending deadlines — to let someone else reregister the pesticide instead. (B) If nobody registered for a given active ingredient files any notice of intent, or nobody identifies their missing data, or nobody promises to fix it, the EPA must propose in the Federal Register to drop that ingredient from the list entirely and cancel every registration that uses it, with a 60-day comment period. After that period, the EPA can cancel those registrations by order, without a hearing — unless, during the comment period, someone new bought the registration rights, filed their own notice of intent to reregister, and then — within 120 days of the EPA's notice — actually complied with the data requirements and paid the required fee. (6) Suspensions and penalties: The EPA must move to suspend a registration if a registrant isn't making enough progress on a data-submission promise, or misses the deadline entirely. But if a registrant isn't supporting one specific minor use, while still properly supporting the pesticide's food uses (or its other nonfood uses, if the whole pesticide is nonfood), the EPA — on the registrant's written request — must hold off acting against that unsupported minor use, until the final overall deadline, unless the missing data raises real health or environmental concerns; if so, the EPA can refuse the request. The EPA must publish the request and the date the unsupported use will be voluntarily dropped. If the EPA grants this pause, it must keep monitoring the supported uses' progress, and can still act if that progress lags. The EPA can also cancel or shrink this pause, in writing, if continuing the minor use risks environmental harm, and must then set a new deletion date. (e) Phase three (1) Information about studies: If you're seeking reregistration, you must send the EPA, following its guidelines: (A) a summary of each of your past studies that you believe already meets current requirements; (B) a summary of each past study you believe should count even though it might not technically meet current requirements; (C) for studies about chronic dosing, cancer risk, reproductive harm, mutation risk, nerve damage, birth defects, or pesticide residue that you submitted before January 1, 1982 — a reformatted version of that data; (D) if that kind of data isn't required for your ingredient, a reformatted version of your pre-1982 short-term dosing data that you consider adequate; (E) identification of data you're required to submit under section 136d(a)(2) showing the pesticide has some adverse effect; (F) any other information you think supports the registration; (G) a certification that you or the EPA has access to the raw data behind your summarized studies; (H) either a promise to fill every data gap you identified, or an offer to split that cost with the person who's filling it and go to arbitration over the split if needed; and (I) proof you've complied with section 136a(c)(1)(D)(ii) and its regulations for your old data, as if you were registering the pesticide for the first time. Falsely certifying under (G) counts as violating this law, punishable under section 136l. (2) Time periods: (A) All this information is due 12 months after your ingredient's listing is published, regardless of which subsection it was listed under. (B) Data you promised to submit is generally due within 48 months of your promise, extendable by up to 2 more years for extraordinary circumstances — with the same minor-use extension rules, monitoring duties, and revocation power described above in (d)(4)(B). (3) Cancellation: (A) If you miss the 12-month deadline, the EPA must cancel your registration by order, without a hearing — subject to the same minor-use carve-out, request process, monitoring duty, and revocation power described in (d)(6). (B) If you submit on time but your submission doesn't follow the EPA's guidelines, the EPA decides whether you made a good-faith effort. If you did, you get a reasonable extra time to fix it. If you didn't, the EPA can move to cancel by certified mail; the registration is canceled after 30 days unless you request a hearing, and if you do, the hearing (held under section 136d(d)) is only about whether your effort was good-faith, and must be decided within 75 days. (4) Guidelines: (A) Within 1 year of this section's effective date, the EPA must issue guidelines, by order, for summarizing studies, reformatting studies, flagging adverse information, and identifying past studies that might not meet current requirements. (B) Courts cannot review these guidelines. (5) Monitoring: The EPA must track how registrants are doing at gathering and submitting this data. (f) Phase four (1) Independent review: (A) The EPA reviews everyone's phase-two and phase-three submissions for a given active ingredient, to check whether they caught every piece of missing or bad data — and can require a registrant to hand over full copies of summarized studies to help with that review. (B) The EPA must independently figure out and publish, in the Federal Register, what data is still missing for each priority active ingredient, and at the same time issue a formal notice under section 136a(c)(2)(B) requiring registrants to submit it. (2) Time periods: (A) The EPA must do this within 18 months of listing for (c)(2)(B) ingredients, 24 months for (c)(2)(C) ingredients, and 33 months for (c)(2)(D) ingredients. (B) Once the EPA issues that data request, registrants generally have up to 48 months to comply, again extendable by up to 2 years for extraordinary circumstances, with the same minor-use extension process, monitoring duty, and revocation power as in (d)(4)(B). (3) Suspensions and penalties: The EPA must move to suspend a registration if required tests haven't even started within a year of the data request, or if progress is too slow, or if the data was never submitted on time — subject to the same minor-use carve-out and process described in (d)(6). (g) Phase five (1) Data review: The EPA must thoroughly examine all the submitted data for a listed active ingredient, plus any other relevant data it can find. (2) Reregistration and other actions: (A) The EPA must decide whether each active ingredient is eligible for reregistration — by the tolerance-reassessment deadline in the Food, Drug, and Cosmetic Act for ingredients that need food tolerances, and by October 3, 2008, for every other ingredient. (B) Before actually reregistering a specific pesticide product, the EPA must get any needed product-specific data and review it within 90 days of receiving it; that data is generally due within 8 months of the ingredient's eligibility decision, unless the EPA decides more time is needed to generate it — and in extraordinary circumstances, the EPA can allow up to 2 extra years. (C) After finishing both reviews, the EPA decides whether the pesticide meets the requirements of section 136a(c)(5); if it's eligible, the EPA must reregister it within 6 months of getting the product-specific data. (D) If the EPA instead decides not to reregister a pesticide, it must take appropriate regulatory action as quickly as possible. (E) As soon as the EPA has enough dietary-risk information about an active ingredient — and no later than its (C) or (D) decision — it must reassess every related food tolerance and exemption, decide whether each one still meets the Food, Drug, and Cosmetic Act, decide whether new tolerances are needed, publish its findings in the Federal Register, and start whatever follow-up proceedings those findings call for. (h) Compensation of data submitter If a registrant's submitted data ends up helping someone else's registration application, the registrant who supplied the data is entitled to compensation, figured under section 136a(c)(1)(D). The fees that registrant already paid under this section count toward that compensation amount. (i) Fees (1) Maintenance fee: (A) Every registrant must pay an annual fee, due January 15, for each registration — but nobody pays for more than 200 registrations. (B) For a pesticide registered for a minor agricultural use, the EPA can reduce or waive this fee if charging it would significantly cut the pesticide's availability. (C) The EPA must adjust these fees so they collect, on average, about $31,000,000 a year for fiscal years 2019–2022, and $42,000,000 a year for 2023–2027. (D) The most any single registrant pays per year is capped: $129,400 (2019–2022) or $172,000 (2023–2027) for someone with 50 or fewer registrations, and $207,000 (2019–2022) or $277,200 (2023–2027) for someone with more than 50. (E) Small businesses get lower caps: $79,100/$105,000 for 50-or-fewer registrations, and $136,800/$184,800 for more than 50, across the same two periods. A "small business" is a corporation, partnership, or unincorporated business with 500 or fewer employees whose average yearly global pesticide revenue, over the prior 3 years, was $60,000,000 or less; affiliated businesses (companies that control each other, through ownership, shared management, shared facilities, or shared employees) must combine their revenue for this test. (F) A "qualified small business entity" — 500 or fewer employees, $10,000,000 or less in average yearly revenue from all sources, and 5 or fewer registrations — gets 25% of its first registration's fee waived, unless the EPA decides the business was set up or manipulated just to qualify for that waiver. (G) For 2023–2027, the EPA must spend up to $7,500,000 a year of the collected fees on grants for training and educating farm workers about pesticide safety, developing new training materials, and finding better ways to deliver that training — going to organizations experienced in farm-worker training or materials, including community-based nonprofits (with up to $1,800,000 of unspent 2025–2027 money reserved for those), plus up to $1,200,000 in 2023–2024 for certain existing agreements; organizations may apply jointly as a partnership if they designate who's accountable. (H) Similarly, up to $2,500,000 a year for 2023–2027 goes to nonprofit grants training health-care providers to recognize and treat pesticide-related illness, again allowing partnership applications. (I) Up to $500,000 a year for 2023–2027 funds partnership grants. (J) Up to $500,000 a year for 2023–2027 funds the pesticide safety education program. (K) Up to $1,750,000 a year for 2023–2027 funds grants to nonprofits providing technical assistance to organizations applying for the (G) and (H) grants — covering help with the application process, drafting, and compliance — and if no suitable organization applies, the EPA provides that assistance itself; the EPA must also gather open, fair input from farm-worker and clinician trainers when designing these grant programs. (L) The EPA must exempt a "public health pesticide" from this fee entirely if, after consulting the Secretary of Health and Human Services, it decides the pesticide doesn't earn enough money to justify the fee. (M) If a registrant doesn't pay a required fee on time, the EPA can cancel the registration by order, without a hearing. (N) This whole fee authority expires September 30, 2027. (2) Other fees: Between December 29, 2022, and September 30, 2029, the EPA generally cannot charge any other registration-related fees beyond what's in paragraph (1) and section 136w–8. (j) Exemption of certain registrants The data and fee requirements in (d), (e), (f), and (i) (except (i)(1)) don't apply to a registrant if, under section 136a(c)(2)(D), that registrant wouldn't have had to submit or cite that data to get an initial registration in the first place. (k) Reregistration and expedited processing fund (1) Establishment: The law creates a Treasury fund called the Reregistration and Expedited Processing Fund. (2) Source and use: (A) All fees collected under subsection (i) go into this fund, available to the EPA without a fiscal-year time limit — even during a government shutdown — to cover the costs of reregistration, expedited processing, registration review under section 136a(g) (including Endangered Species Act reviews), tracking review decisions, and improving the EPA's tracking systems. Before spending this money, the EPA must adopt cost-accounting rules approved by the Government Accountability Office and its own Inspector General, make sure the money is spent only on these purposes, and keep personnel and facility costs in line with the agency's normal averages. (B) The EPA must also finish reviewing unreviewed reregistration studies on the schedule set under subsection (l)(2), and can hire outside help, chosen through a normal competitive process, to review required studies. (3) Review of registrant submissions not covered by section 136w–8(b)(3)(B): (A) This covers any registrant submission about a registration that isn't already covered by that section's fee table. (B) For 2023–2027, the EPA must spend about one-eighth of the fund on getting enough staff and resources to meet the deadlines in a specific 1998 EPA notice (PR 98-10) and in section 136a(c)(3)(B) and (h). (4) Public health performance standards for antimicrobial pesticide devices: For 2023–2027, the EPA can spend up to $500,000 a year of the fund developing efficacy test methods for antimicrobial devices that make public-health claims. (5) Good laboratory practices inspections: For 2023–2027, the EPA can spend up to $500,000 a year improving its lab-inspection and data-audit compliance program, and must give each inspected lab a preliminary summary of what the inspection found within 60 days. (6) Agency training and staff: For 2023–2027, the EPA can spend up to $500,000 a year training its own employees — on scientific, technical, and administrative skills, aligning with agency goals, improving processes and efficiency, promoting consistent decisions, and educating registrants — and, within a year of December 29, 2022, must set up a competitive grant program with colleges (non-land-grant agriculture colleges, land-grant colleges, or 1994 Institutions) to build that training. (7) Vector expedited review vouchers: (A) For 2023–2027, up to $500,000 a year funds a Vector Expedited Review Voucher program. (B) The program lets the EPA, through the Office of Pesticide Programs (set up within a year of December 29, 2022), issue vouchers to applicants who successfully register new, insecticide-resistance-fighting mosquito-control products meeting a detailed list of conditions — proven efficacy against resistant mosquitoes, a novel mechanism, targeting specific named mosquito-borne diseases, a public global-access plan, meeting vector-control guidelines, being accessible in the U.S. and disease-prone countries, meeting normal safety requirements, supporting integrated pest management, and not already being registered or recently approved elsewhere for the same use. A voucher entitles its holder — who can sell or transfer it any number of times — to expedited review of one different pesticide application; to redeem it, the holder must notify the EPA at least 90 days ahead and pay the normal registration service fee. Redeeming a voucher speeds up review by set amounts — from 2 months up to 6 months, depending on the application category. Repurposed agricultural active ingredients can qualify too, if the EPA decides there's a real public-health benefit. Starting in 2028, the EPA must review and recommend changes to the program's rules and which vectors it covers, after getting input from registrants and health groups. The EPA must report every year, by September 30, on how many vouchers were sought, issued, and redeemed, and how much time redeeming them actually saved. (C) Any of this money left unspent at year's end can go to other authorized fund purposes. (8) Pesticide surveillance program: For 2023–2027, up to $500,000 a year supports an interagency agreement with NIOSH for a pesticide illness-tracking program, aiming to add more participating states — especially ones with many agricultural workers — and improve their reporting. (9) Unused funds: Money not currently needed must be kept on hand, invested in U.S. government obligations, or invested in other lawful fiduciary or trust investments. (10) Accounting and performance: The EPA must make sure fee money is spent only on the purposes listed above and on the goals set under subsection (l). The fund counts as an EPA accounting component under federal law, and the required annual audit must cover these fees, the matching appropriated funds, and whether the EPA is meeting its performance goals — including reviewing whether overhead and cost allocations are reasonable. The Inspector General runs this audit and reports it to the Administrator and to the House and Senate Agriculture Committees; the audit itself is paid for out of these fees. (l) Performance measures and goals Every year, the EPA must publish performance measures and goals in the Federal Register, covering: (1) how many products were reregistered, canceled, or amended; the status of reregistration; data requests issued by active ingredient; progress reducing unreviewed studies; the status of reassessed tolerances; and how many (k)(3) applications were approved or denied; (2) the upcoming schedule of reregistration decisions for the current and next fiscal year; and (3) when the EPA expects to finish all reregistrations under this section. (m) Judicial review If the EPA fails to take any action this section requires, that failure can be challenged in court under the procedures in section 136n(b). (n) Authorization of funds to develop public health data (1) "Secretary" means the Secretary of Health and Human Services, acting through the Public Health Service. (2) For a pesticide registered for public-health uses like vector control, the EPA — at a registrant's or interested person's request, or on its own — may consult the Secretary before suspending or canceling that registration. (3) After consulting the Secretary, the EPA decides whether the public-health benefits of the pesticide are big enough to justify the Secretary committing to run or arrange the studies needed to keep it registered. (4) If the EPA decides that commitment is justified, it must notify the Secretary and, if needed, extend the data-submission deadline. (5) The Secretary must arrange for those studies — through Public Health Service research, grants, contracts, or cooperative agreements with qualified organizations. (6) The Secretary can fund these studies using money authorized under this section, the Public Health Service Act, or other authority, and must tell the House and Senate Appropriations Committees how much money is needed. (7) Congress authorized $12,000,000 for fiscal year 1997, and whatever amount is necessary for later years.