7 U.S.C. § 136a — Registration of pesticides

(a) Requirement of registration. No one in any state may sell or distribute a pesticide unless it is registered under this law. To prevent unreasonable harm to the environment, EPA's Administrator may make rules limiting the distribution, sale, or use of an unregistered pesticide in a state — but only if that pesticide is not already covered by an experimental use permit (section 136c) or an emergency exemption (section 136p). (b) Exemptions. An unregistered pesticide can still be transferred in two situations. First, if it moves from one registered facility to another registered facility run by the same producer, just to be packaged there or used as an ingredient in another pesticide made there. Second, if the transfer follows the rules of an experimental use permit. (c) Procedure for registration. This is the longest part of the section and covers how a pesticide gets registered. Paragraph (1), Statement required: Each applicant must file a statement with EPA giving (A) the applicant's name and address, plus the name of anyone else who will appear on the label; (B) the pesticide's name; (C) a complete copy of the label, every claim made for the product, and directions for use; (D) the complete formula; (E) a request that the pesticide be classified for general use, restricted use, or both; and (F) — unless paragraph (2)(D) says otherwise — if EPA asks, a full description of the tests behind the claims, or instead a citation to public data or data already on file with EPA. That last option comes with detailed rules about who can use whose data: Data submitted to support an original registration (for pesticides first registered after September 30, 1978) or an amendment adding a new use cannot be used by EPA to support someone else's application for 10 years after the pesticide is first registered, unless the original submitter gives written permission. "Defensive data" is an exception — it does not need permission. That 10-year exclusive period can grow by one extra year for every 3 minor uses registered after August 3, 1996, within 7 years of the period starting, up to 3 extra years total, but only if EPA, working with the Secretary of Agriculture, finds that there are not enough good alternative pesticides for that use, the alternatives pose bigger risks, the minor-use pesticide helps manage pest resistance, or it helps an integrated pest-management program. A minor use registered on an EPA-recognized "crop grouping" counts as one minor use for each representative crop with supporting data. The extension shrinks or ends if the registrant cancels the product, drops the minor uses that earned the extension, or is not actually selling it for those uses. For other data submitted after December 31, 1969, EPA may let it support someone else's application within 15 years of when it was submitted — but only if that other applicant first offers to pay the original submitter and shows EPA proof the offer was delivered. Payment terms come from an agreement between the two sides or, failing that, binding arbitration: after 90 days without agreement, either side may ask the Federal Mediation and Conciliation Service for an arbitrator. The arbitrator's decision is final and courts cannot review it, except for proven fraud, misrepresentation, or misconduct. Both sides split the arbitrator's fee. An original data submitter who refuses to take part in this process, or who ignores the resulting agreement or decision, loses the right to be paid. An applicant who refuses to take part, or ignores the agreement or decision, will have EPA deny or cancel the registration without a hearing — but EPA must first mail 15 days' notice and a chance to respond. EPA decides what happens to existing stock of a canceled pesticide, and a registration decision does not have to wait for compensation to be worked out. Once both the exclusive-use period and any compensation period end, EPA may use the data for anyone's application without permission or a payment offer. The extended exclusivity described above did not start until one year after August 3, 1996, unless the applicant was registering a brand-new active ingredient. For data submitted after August 3, 1996 to support a new minor use that does not already have exclusivity, that data gets its own 10-year exclusive-use protection if the registrant tells EPA, when requesting the new use, that they believe the earlier exclusive-use period has expired and that this data qualifies. If that minor-use registration is later voluntarily canceled, or the data ends up supporting a non-minor use, this special protection ends and the data instead follows the general 10-year rule above. Finally, (G): if the applicant wants the registration or amendment expedited, they must explain why, following the process set out in paragraph (10). Paragraph (2), Data in support of registration: (A) EPA must publish, and periodically update, guidelines on what data is needed to register a pesticide, and must give applicants enough time to gather any new kind of data it later requires. For minor uses, EPA's data standards must match the expected extent and pattern of use, the public-health and agricultural need, and the potential harm or benefit to people and the environment. EPA cannot require field residue data from a place where the pesticide will not be registered for that use, and must consider how the cost of meeting data rules affects a registrant's willingness to do the studies. Except where section 136h protects confidential information, EPA must make the registration data public within 30 days of registering a pesticide, along with any other science it considers relevant. (B) Additional data: if EPA decides an existing registration needs more data to stay in effect, it must notify every registrant of that pesticide and give a list of them to anyone interested. Each registrant then has 90 days to show it is taking steps to get the data. Two or more registrants may agree to share the cost, if they tell EPA within 90 days, and anyone who pays gets to use the resulting data. A registrant who does not comply faces a notice of intent to suspend its registration, following the process below. If registrants agree to share costs but cannot agree on the details within 60 days, any of them may start binding arbitration through the Federal Mediation and Conciliation Service, on the same terms described above — a final decision, split fees, and court review only for fraud or misconduct. Refusing to arbitrate also triggers suspension proceedings. Under the suspension process: if a registrant fails to get the needed data, fails to join the cost-sharing talks or arbitration, or ignores the resulting agreement or decision, EPA may send a notice of intent to suspend that registrant's registration, adding any conditions it wants about existing stock. The suspension becomes final in 30 days unless someone affected asks for a hearing, or the registrant proves it has fully complied. A hearing follows section 136d(d) procedures and decides only whether the registrant really failed to act and whether EPA's plan for existing stock is lawful; the hearing decision is final, and EPA must hold and finish the hearing within 75 days of the request. EPA must reinstate a suspended registration once the registrant complies. Data submitted under this part follows the same compensation rules described in paragraph (1); joint submitters must agree on one agent to handle compensation matters. On request, EPA must push back a minor-use residue-data deadline to match the deadline for the pesticide's other uses under section 136a–1, if data on those other food uses is being provided, the registrant supplies a schedule with checkpoints, the delay will not significantly slow EPA's reregistration schedule, and it will not meaningfully raise the risk of environmental harm. EPA must track progress on any extension it grants, and may revoke or change it in writing if the registrant falls behind or if the extension turns out to risk unreasonable harm — after which the data becomes due on EPA's original schedule. Separately, if a registrant will not commit to a specific minor use but is on time supporting the pesticide's other uses, EPA — on written request — must hold off enforcing the missing-data rule for that minor use until the deadline for the supported uses, unless the missing data raises a real health or environmental concern, in which case EPA can refuse the request. EPA must publish the request and the date the unsupported use will be voluntarily dropped, under section 136d(f)(1). EPA must track this extension too, and may revoke it in writing, set a new deletion date, and notify the public if the registrant falls behind or if continuing the minor use risks unreasonable environmental harm. If both a federal and a state regulator want data, EPA must, where practical, coordinate testing requirements so the registrant is not burdened twice, may make a cooperative agreement with a state to help, and — within a year of August 3, 1996 — had to build a process for catching and fixing future mismatches between federal and state data rules. (C) Within 9 months of September 30, 1978, EPA had to write simplified registration procedures that include the exemption in (D). (D) Exemption: an applicant who wants to buy an already-registered pesticide from another maker, just to mix it into their own product, does not have to submit or cite data about that purchased product, or offer to pay for using such data. (E) Minor use waiver: for a minor-use registration, EPA may skip normally required data if it can still tell how much extra risk the minor use adds, and that any such risk would not be unreasonable harm to the environment. Paragraph (3), Application: (A) EPA must review the data as fast as possible and either register the pesticide under paragraph (5) or tell the applicant it does not comply, under paragraph (6). (B) EPA must fast-track any application proposing a new or amended end-use product that is identical, substantially similar, or only trivially different (in ways that do not meaningfully raise risk) from an already-registered pesticide, or that amends a registration without needing new scientific review. For these, EPA must review the application for completeness and reject it if incomplete, decide within the set review time — or, if none is set, within 90 days of a complete application — whether to grant or deny it, and if it denies the application, explain the specific reasons in writing. (C) EPA must also fast-track any complete application proposing a brand-new active ingredient solely for minor uses, an amendment solely for minor uses, or "significant minor uses." "As expeditiously as possible" here means EPA should, as much as practical, finish reviewing all the data within 12 months, but a court cannot review EPA for missing that target. "Significant minor uses" means 3 or more minor uses proposed for every non-minor use, a minor use EPA thinks would replace one canceled in the last 5 years, or a minor use that would avoid the need for another emergency exemption under section 136p. (D) If a registrant asks for a minor-use data waiver under paragraph (2)(E) and EPA denies it, in whole or in part, the registrant gets the full original deadline for that data, starting from the date it receives EPA's denial. Paragraph (4), Notice of application: EPA must promptly publish in the Federal Register each application involving a new active ingredient or a changed use pattern, and give the public 30 days to comment. Paragraph (5), Approval of registration: EPA must register a pesticide if, considering any restrictions under subsection (d), it finds that (A) its makeup supports the claims made for it; (B) its label and other required materials meet the law's requirements; (C) it will do its job without unreasonable harm to the environment; and (D) used the normal, widely recognized way, it generally will not cause unreasonable environmental harm. EPA cannot deny registration just because the pesticide is not essential, and if two pesticides both qualify, EPA cannot favor one over the other. EPA may waive data about how well the pesticide works and register it without confirming those effectiveness claims; if a state finds the pesticide effective under section 136v(c), that creates a presumption EPA should waive that data for use in that state. Paragraph (6), Denial of registration: if EPA finds paragraph (5)'s requirements are not met, it must tell the applicant why, with the facts behind its decision, and give the applicant 30 days from the day after they get the notice to fix the problems — after which EPA may refuse to register the pesticide. If EPA refuses, it must again explain its reasons and promptly publish the denial and reasons in the Federal Register. The applicant — or, with the applicant's agreement, another interested person — then has the same remedies available under section 136d. Paragraph (7), Registration under special circumstances: even without fully meeting paragraph (5), (A) EPA may conditionally register or amend a registration if the pesticide and use are identical, substantially similar to, or only trivially different from an already-registered one, and approving it would not meaningfully raise environmental risk. The applicant must submit the data normally required; if some data does not exist yet, EPA can register the product on the condition that data arrives by the same deadline similar already-registered pesticides had. (B) EPA may conditionally amend a registration to add a use even with insufficient data, if the applicant submitted satisfactory data on that new use and the amendment would not meaningfully raise risk. But no amendment may add a use if EPA has already flagged the pesticide as meeting or exceeding dietary-exposure risk limits and a risk-benefit review of that flag is still pending — where the new use involves a major food or feed crop, or a minor food or feed crop for which USDA agrees a safer alternative pesticide exists. As with (A), the applicant must submit the usual data, with a deadline for anything not yet generated. (C) EPA may conditionally register a pesticide with a brand-new active ingredient for a period long enough to generate needed data that is missing only because not enough time has passed since EPA required it, on the condition that the data arrives by then and does not show risky results, plus any other conditions EPA sets. This kind of conditional registration requires EPA to find that using the pesticide during that period will not cause unreasonable environmental harm and is in the public interest. Paragraph (8), Interim administrative review: EPA cannot start a public interim review weighing a pesticide's risks and benefits before formally moving to cancel, suspend, or deny it, unless that review rests on a validated test or other significant evidence of real risk to people or the environment. EPA must publish in the Federal Register what "validated test" and "other significant evidence" mean. Paragraph (9), Labeling: (A) A registrant may add label information about an antimicrobial pesticide's effectiveness, composition, container, or similar facts — not about pesticidal claims — without violating this law, subject to (B) and (C). (B) That added information cannot be false or misleading, cannot conflict with anything the law or EPA requires, and must be backed up with evidence if EPA asks. (C) The registrant may add it if it notifies EPA in writing at least 60 days before selling the relabeled product, and EPA does not disapprove within 30 days of that notice; if EPA disapproves, it must explain why in writing; the registrant then cannot sell the product with the disapproved wording, but may object in writing within 30 days of the disapproval, and EPA's decision on that objection is final agency action. (D) The label for a diluted antimicrobial pesticide may carry different caution or protection instructions than the concentrate's label, if EPA finds enough data supports the diluted-use instructions and they give adequate protection. Paragraph (10), Expedited registration: within 1 year of August 3, 1996, EPA had to create, using public comment, procedures to speed up review of qualifying applications. Any application, biological or conventional, qualifies if its pesticide's use could reasonably be expected to reduce risk to human health, reduce risk to nontarget organisms, reduce contamination of groundwater, surface water, or other valued resources, or expand the use of integrated pest management. Within 30 days of getting an expedited-review request, EPA must say whether it is complete; if not, EPA may reject the expedited request or ask for more information. Paragraph (11), Interagency working group: "covered agency" means USDA, the Department of Commerce, the Department of the Interior, the Council on Environmental Quality, and EPA. EPA must set up a working group with representatives from each covered agency to recommend and carry out a strategy improving the Endangered Species Act consultation process (16 U.S.C. 1536) for pesticide registration and registration review. The group must analyze the relevant laws and case law framing that process; advise on how to define which agency actions need consultation and how to classify their effects; identify each agency's legal obligations and limits; review current consultation practices for problems and best practices; develop scientific and policy approaches to make consultation faster and more accurate — including ways to share data and coordinate analysis among the agencies, a streamlined way to sort actions by the type of consultation they need, clarity on what counts as the "best scientific and commercial data available," and ways EPA can better help Interior and Commerce meet their duties; and propose and put in place a strategy — through a memorandum of understanding, revised regulations, or another format — for lasting cooperation. The group must report to Congress on a set schedule: a progress report within 18 months of December 20, 2018; a results report on the recommendations and implementation plans within 1 year of that date; an implementation report within 1 year after that, describing how the recommendations were carried out, how much they improved consultation, and further recommendations; and then further reports every 180 days for 5 years after that. Each report must reflect every covered agency's perspective and note where they agree or disagree. The group must, as appropriate, consult industry and nonprofit stakeholders and weigh their differing views and interests. The federal advisory-committee rules in Chapter 10 of Title 5 do not apply to this group. Nothing in this paragraph overrides this law or the Endangered Species Act, including its section 7 consultation duty. (d) Classification of pesticides. Paragraph (1): when registering a pesticide, EPA must classify it as general use, restricted use, or both, if some uses fit one category and some the other. If it is split, the label directions for each use must be clearly separated, and EPA may require the packaging and labeling itself to look clearly different for restricted uses. Classification can happen by regulation, and already-registered pesticides can be reclassified before reregistration. EPA classifies a pesticide for general use if, used as directed or by common practice, it generally will not cause unreasonable environmental harm. EPA classifies it for restricted use if, used as directed or by common practice without more regulation, it may generally cause unreasonable harm — including to the person applying it. If that risk comes from acute skin or breathing danger to the applicator or others, the pesticide may only be applied by, or under the direct supervision of, a certified applicator. If the risk is broader environmental harm, the same certified-applicator rule applies, or other restrictions EPA sets by regulation — and such a regulation can be challenged in a federal court of appeals within 60 days of its final publication. Paragraph (2), Change in classification: if EPA decides a use must move from general to restricted to prevent unreasonable harm, it must notify the registrant at least 45 days before making the change and publish the proposed change in the Federal Register. The registrant — or, with the registrant's agreement, another interested person — may seek relief under section 136d(b). Paragraph (3), Change in classification from restricted use to general use: a registrant may petition EPA to reclassify a restricted use as general use, explaining why the restriction is unnecessary. EPA has 60 days to grant or deny the petition; a denial must explain why, and can be challenged in court under section 136n. (e) Products with same formulation and claims. Products made by the same person, with the same formula, the same label claims, and labels marking them as the same pesticide, may all be registered as a single pesticide. Additional names and labels are then added to that registration by supplemental statements. (f) Miscellaneous. Paragraph (1): if a pesticide's label or formula changes, its registration must be amended to match, as long as EPA finds the change does not violate the law. Paragraph (2): registering a product is never a legal defense for violating this law — but as long as no cancellation proceeding is underway, registration counts as evidence (not proof) that the pesticide, its label, and its packaging meet the registration rules. Paragraph (3): EPA may consult any other federal agency when considering a registration or application. Paragraph (4): a mixture of one or more registered nitrogen stabilizers with one or more fertilizer products is exempt from this section and from sections 136a–1, 136c, 136e, 136m, and 136o(a)(2), as long as the mixture carries the nitrogen stabilizer's required labeling, is mixed according to that labeling, and has no active ingredient besides the nitrogen stabilizer. Paragraph (5), Bilingual labeling: (A) subject to the exceptions below, by the applicable deadline, every registered pesticide product that ships must either carry the Spanish translation described in (G) on its container, or include a scannable link or other electronic way to reach that translation. As exceptions, an antimicrobial product may instead link to Spanish-language safety data sheets, and so may a non-restricted, non-agricultural product. (B) The deadlines are: 3 years after December 29, 2022 for restricted-use products; for non-restricted products, 3 years for agricultural products in Acute Toxicity Category I and 5 years for Category II; 4 years for antimicrobial and non-agricultural products in Category I and 6 years for Category II; and 8 years for every other pesticide product. (C) EPA must allow these translations or links to be added without prior notice to EPA (a "non-notification procedure" — a label change made without telling EPA first), must work with state pesticide agencies to roll this out as fast as possible, and the requirement applies to end-use product labels. After the initial deadlines, later updates to the translation guide must be worked into labels by the earlier of a set time after the update — 1 year for agricultural labels, 2 years for antimicrobial and non-agricultural labels — or the next time the label is changed and reshipped. EPA must tell registrants within 10 days of updating the guide. (D) Within 180 days of December 29, 2022, EPA had to seek stakeholder input on making this labeling accessible to farm workers. (E) Within 3 years of that date, EPA had to put a plan in place ensuring farm workers can access the bilingual labeling. (F) Within 2 years of that date, EPA had to build and publish a plan for tracking how well the bilingual labeling is being adopted. (G) The "Spanish Translation Guide" means the guide EPA issued in October 2019, as it stood on December 29, 2022, plus any later versions or amendments. (g) Registration review. Paragraph (1): pesticide registrations must be reviewed periodically, and EPA must set the review procedure by regulation. The first review of each pesticide, or "pesticide case" — one or more active ingredients and the products built on them — must finish by whichever is later: October 1, 2022, or 15 years after that pesticide's first new active ingredient was registered. Each later review must finish within 15 years of the one before it. No registration can be canceled through this review process except by following section 136d's procedures. After meeting with any non-government individuals about a registration review, EPA must — within 45 days of the meeting, or by the time it issues its review decision, whichever comes first — put the meeting's minutes, attendee list, and any exchanged documents in the public docket, except that EPA must identify but withhold any confidential business information protected under section 136h. None of this stops EPA from doing any other kind of pesticide review the law allows. Paragraph (2): EPA must use its data-demanding power from paragraph (c)(2)(B) whenever a registration review needs more data, and the data-submission, compensation, and exemption rules from paragraphs (c)(1), (c)(2)(B), and (c)(2)(D) apply to that data too. (h) Registration requirements for antimicrobial pesticides. Paragraph (1): EPA had to find and evaluate, as much as practical given the risk involved and the type of review needed, ways to shorten the review times that existed as of August 3, 1996 for antimicrobial pesticide applications — covering new antimicrobial active ingredients, new antimicrobial end-use products, substantially similar or identical antimicrobial pesticides, and amendments to antimicrobial registrations. Paragraph (2): each reform should aim for review periods, after a complete application, of no more than 540 days for a new active ingredient, 270 days for a new use of an already-registered active ingredient, 120 days for any other new product, 90 days for a substantially similar or identical product, 90 days for an amendment not needing scientific review, and 120 days for an amendment needing scientific review that is not otherwise listed. Paragraph (3), Implementation: within 270 days of August 3, 1996, EPA had to publish proposed rules aimed at those goals. The rules had to define the classes of antimicrobial products — disinfectants, sanitizers, preservatives, water treatment and paper-mill additives, and similar products — separate the types of review used, match review depth to actual risk and product type, keep antimicrobial products effective and meeting their performance claims, and set reliable process deadlines; EPA had to seek input from registrants and other affected parties while drafting them. Final rules were due within 240 days after the comment period closed. If a goal from paragraph (2) was not met, EPA must say which goal, explain why, describe what it did instead, and explain its next steps. The final rules had to consider a certification process for well-understood, manageable risks handled cost-effectively, consider letting approved outside labs certify as part of review, use all appropriate cost-effective review tools — expanded notification and non-notification procedures, revised review procedures, and resources for streamlined management — and clarify what makes an application "complete." This subsection does not change the deadlines or requirements for expedited review under paragraph (c)(3). If the final rules were not in effect 630 days after August 3, 1996, then until they took effect, review periods from a complete application defaulted to 2 years for a new active ingredient, 1 year for a new use of a registered ingredient, 180 days for other new products, 90 days for substantially similar or identical products, 90 days for amendments without scientific review, and 120 days for amendments with scientific review not otherwise listed. A wood-preservative product making a pesticidal claim listed in section 136(mm) gets reviewed on the same schedule as an antimicrobial application, matching its actual risk level, if it must meet the same data requirements as an antimicrobial wood preservative. EPA must tell an applicant whether its application is granted or denied by the last day of the applicable review period, unless the applicant and EPA agree to a later date; missing that deadline can be treated by a court as an agency action unlawfully withheld or unreasonably delayed. This notification duty does not apply to an antimicrobial application filed under paragraph (c)(3)(B) before 90 days after August 3, 1996, and courts cannot review EPA's failure to notify on an amendment needing scientific review within the applicable default or final-rule time period. Paragraph (4), Annual report: starting August 3, 1996 and continuing until the paragraph (2) goals are met, EPA must send Congress's House and Senate agriculture committees a report by March 1 each year, describing steps taken to reduce the backlog of pending applications, progress toward these reforms, and recommendations to improve antimicrobial-registration work.