21 U.S.C. § 346a — Tolerances and exemptions for pesticide chemical residues

(a) Requirement for a tolerance or exemption A pesticide chemical residue in or on food is legally "unsafe" — meaning it violates section 342(a)(2)(B) — unless one of two things is true: a legal limit, called a "tolerance," is in effect for that residue and the amount present is within that limit, or an official "exemption" from needing a tolerance is in effect. Here, "food" means either a raw farm product or a processed food. There are three exceptions. First, for processed food: if a tolerance exists for the raw farm product, a processed food made from it can have that residue without its own separate tolerance — as long as the pesticide was used following the tolerance rules, the residue was reduced as much as good manufacturing practice allows, and the amount in the processed food is no higher than the raw-product tolerance. If instead an exemption (not a tolerance) covers the raw product, the processed food made from it is automatically covered too. Second, for breakdown products: if a pesticide residue is present because it is a byproduct of a different pesticide chemical breaking down, that byproduct residue is not automatically unsafe, even without its own tolerance or exemption, if three things are true: the EPA Administrator has not found the byproduct poses a different or bigger health risk than the original chemical; either a tolerance covers the original chemical (and the combined amount of both substances doesn't exceed what the tolerance would allow if it were all the original chemical) or an exemption covers the original chemical; and that tolerance or exemption isn't written to apply only to specifically named substances or to exclude breakdown products. Third, while a tolerance or exemption is in effect for a food, that food is not considered "adulterated" under section 342(a)(1) just because it contains that residue. (b) Authority and standard for tolerances The EPA Administrator can issue rules to create, change, or cancel a tolerance, either after someone files a petition (see subsection (d)) or on the Administrator's own initiative (see subsection (e)). Here, "modify" does not include expanding a tolerance to cover more foods. The Administrator can set or keep a tolerance only if it is "safe" — meaning there is a reasonable certainty that no harm will result from all the combined exposure to that residue, from food and from any other reliable source. If a tolerance is not safe, the Administrator must change or cancel it. There is a special, narrower path for "eligible" pesticide residues — ones where the Administrator cannot identify a safe exposure level for at least one health effect (called a "nonthreshold effect"), so that risk must instead be estimated using quantitative risk assessment. For these residues, a tolerance may be kept or changed under this special path only if at least one of two "use" conditions is met (using the pesticide protects consumers from a bigger health risk than the residue itself, or using it is necessary to avoid seriously disrupting the food supply) and both of two "risk" conditions are met (the yearly risk from the nonthreshold effect is no more than 10 times the risk normally allowed, and the tolerance limits the lifetime risk to no more than twice what is normally allowed). Every five years, the Administrator must recheck, after public notice and comment, whether these conditions still hold; if they don't, the Administrator must issue a rule within 180 days to change or cancel the tolerance. Any tolerance kept under this special path must still meet the children's-safety rules described next. When setting, changing, keeping, or canceling any tolerance or exemption, the Administrator must specifically protect infants and children. The Administrator must assess risk using available information about children's eating patterns that could mean they get an unusually high dose, children's special vulnerability (including differences in the nervous system and risks from exposure before birth), and the combined effect of this residue together with other substances that work the same way in the body. The Administrator must then make sure there is a reasonable certainty of no harm to infants and children, and must publish a specific, separate finding about their safety. The Department of Health and Human Services and the Department of Agriculture must survey how much pesticide residue infants and children actually consume. For health effects that do have a known safe threshold, an extra 10-times safety margin must be applied for children, to account for gaps in the data and risks before and after birth — unless reliable data show a different margin is still safe for children. In making tolerance decisions, the Administrator must also weigh several other factors: how solid and complete the underlying scientific studies are; the type of toxic effects those studies found; how well those results predict actual risk to humans; people's real eating patterns, including specific groups of consumers; the combined effect of this residue with other similarly acting substances; total exposure to this residue and related substances from all tolerances and other non-work sources; how much sensitivity varies among different groups of consumers; whether the pesticide might act like natural estrogen or otherwise affect hormones; and safety factors that qualified scientific experts generally consider appropriate when using animal-testing data. The Administrator may also use data on anticipated or actual residue levels found in food, including data collected by the FDA, when making tolerance decisions. If the Administrator relies on that kind of data, the Administrator must require confirming data five years later, and periodically after that, to show the residue levels haven't gone above what was assumed. If that confirming data isn't provided, or doesn't confirm the assumption, the Administrator must issue a rule within 180 days to change or cancel the tolerance. When assessing long-term ("chronic") dietary risk, the Administrator may also consider data on the percent of a crop that is actually treated with the pesticide, including U.S. Department of Agriculture data — but only if the Administrator finds the data reliable and a valid basis for estimating exposure, finds it doesn't understate exposure for any at-risk group, finds that people in areas with high local use and consumption aren't exposed to more than the estimate assumes, and provides for periodically re-checking the estimate. A tolerance cannot be set or changed unless the Administrator, after consulting the Secretary (of Health and Human Services), determines there is a practical method to detect and measure the residue. A tolerance also cannot be set below the lowest level that method can actually detect. When setting a tolerance, the Administrator must check whether the Codex Alimentarius Commission (an international food-standards body) has set its own maximum residue level for the same pesticide. If the Administrator does not plan to adopt that Codex level, the Administrator must publish, for public comment, an explanation of why. (c) Authority and standard for exemptions The rules for exemptions from the tolerance requirement largely mirror the tolerance rules above. The Administrator can issue a rule creating, changing, or canceling an exemption, either by petition or on the Administrator's own initiative. The Administrator can set or keep an exemption only if it is "safe" by the same reasonable-certainty-of-no-harm standard used for tolerances, and must consider the same children's-safety and other factors listed in subsection (b)(2)(C) and (D). An exemption cannot be set or changed unless the Administrator, after consulting the Secretary, finds there is a practical detection method — or finds that no such method is needed, and states why. (d) Petition for a tolerance or exemption Anyone can file a petition asking the Administrator to establish, change, or cancel a tolerance or an exemption. A petition to create a new tolerance or exemption must include specific supporting data set by regulation, such as: a plain-language summary of the petition and its supporting data, along with the petitioner's agreement that the summary can be published; the pesticide chemical's identity and makeup; the recommended amount, timing, and method of using it; full reports on safety testing, including the methods used; full reports on how much residue is expected to remain in or on the food, including the testing methods; a practical detection method (or an explanation of why none is needed); a proposed tolerance level, if one is proposed; for processed foods, reports based on the actual processing methods used; information needed for the children's-safety finding; information on possible estrogen-like or other hormone effects; information about exposure from any tolerances or exemptions already granted for the same residue; practical methods for removing excess residue; and any other data the Administrator requires by regulation. A petitioner can point to data the Administrator already has instead of resubmitting it, and the Administrator may require product samples. For petitions to change or cancel an existing tolerance or exemption, the Administrator sets the required data by regulation. Once the Administrator decides a petition meets these requirements, the Administrator must publish a notice within 30 days. The notice must describe available detection methods (or explain why none is needed) and include the required plain-language summary. After fully considering the petition and all available information, the Administrator must do one of three things: issue a final rule (which can differ from what the petition asked for, without further notice or comment); issue a proposed rule under subsection (e) and later a final rule; or issue an order denying the petition. The Administrator must give priority to petitions proposing a tolerance or exemption for a pesticide that appears to pose a meaningfully lower health risk than pesticides already allowed for the same use. If a petition proposes such a lower-risk alternative to a tolerance that was kept in place under the special "eligible pesticide" path in subsection (b)(2)(B), the Administrator must finish acting on it within one year; and if the Administrator approves that safer alternative, the Administrator must then decide within 180 days whether the older, higher-risk tolerance still meets the conditions that let it stay in place, and if not, must move within another 180 days to change or cancel it. (e) Action on the Administrator's own initiative The Administrator can issue a rule establishing, changing, suspending, or canceling a tolerance or exemption, or setting general procedures for this section, without waiting for a petition. Before issuing a final rule this way, the Administrator must first propose it and allow at least 60 days for public comment — unless the Administrator finds good cause for a shorter comment period and explains that finding in the proposal. (f) Special data requirements If the Administrator decides more data is reasonably needed to justify keeping an existing tolerance or exemption, the Administrator can require it in one of three ways: through a notice under the pesticide-registration law (FIFRA); through a testing rule under the Toxic Substances Control Act; or through a Federal Register order — issued only after at least 60 days of public notice and comment — that identifies who must submit the data, describes what data is needed and why it couldn't be obtained the other two ways, describes required progress reports, and sets submission deadlines. The Administrator can later correct errors in such an order, and can require data on possible estrogen-like or other hormone effects. If the required data isn't submitted by the deadline, the Administrator can modify or cancel the tolerance or exemption by order. If that order is later challenged, the only question in that review is whether the data was submitted on time. (g) Effective date, objections, hearings, and administrative review A rule or order issued under subsection (d)(4), (e)(1), or (f)(2) takes effect when published, unless it says otherwise. The Administrator can pause its effect if objections are later filed. Within 60 days after such a rule or order is issued, anyone can file a written objection, spelling out exactly which parts they object to and why. If the rule responded to someone's petition, the Administrator must send that petitioner a copy of any objection filed by someone else. An objection can include a request for a public hearing. The Administrator must hold one if it's needed to resolve a real factual dispute raised by the objections. The official running the hearing can allow the parties to gather evidence from each other and, for good cause, can subpoena witnesses or documents; that official must follow federal court rules for protecting witnesses and can order reimbursement of a witness's reasonable costs. A subpoena that is contested can be enforced by a federal court. After hearing the parties' arguments, the Administrator must issue a final order explaining what was decided on each objection and describing any changes to the rule. If a hearing was held, factual findings must be based only on solid evidence from that hearing record, with detailed findings and reasoning. (h) Judicial review Anyone harmed by a rule issued under subsection (e)(1)(C), or by an order under subsection (f)(1)(C) or (g)(2)(C), or by the underlying rule such an order addresses, can ask a federal court of appeals to set it aside, within 60 days of publication, either in the circuit where they live or do business, or in the D.C. Circuit. The court receives the full administrative record and has exclusive authority to uphold or overturn the rule or order, in whole or in part. If the challenged order followed a public hearing, the Administrator's factual findings are upheld only if solid evidence in the whole record supports them. A party can ask the court to consider new evidence if it is important and there was good reason it wasn't presented earlier; the court can send that evidence back to the Administrator, who may then revise findings and the rule or order accordingly, and must file the revised version with the court. The court's final judgment can be appealed to the Supreme Court. Filing a court challenge does not, by itself, pause the rule or order — only a specific court order can do that. Any issue that could have been reviewed this way cannot be reviewed under any other law. (i) Confidentiality and use of data Data submitted to support a tolerance or exemption gets the same confidential treatment, and the same exclusive-use and compensation rights, as under the pesticide-registration law (FIFRA). That confidential data can still be shown, under security rules the Administrator sets, to authorized federal employees or contractors doing official work to protect public health. This confidentiality rule never blocks Congress, or its committees, from getting the data. Despite this confidentiality, the Administrator may still publish the required plain-language summaries of petitions and of the data behind a rule or order. (j) Status of previously issued regulations Older pesticide-residue regulations are folded into this section's framework. Regulations for raw farm products issued under the old section 346(a), based on hearings begun before January 1, 1953, count as if issued under this section, and can be changed, canceled, or reviewed the same way. Regulations that set tolerances for pesticide residues in processed food, issued under section 348 on or before August 3, 1996, count the same way. Tolerances and exemptions issued under this very section on or before August 3, 1996, simply stay in effect until changed or canceled, and are also subject to periodic review. For a substance that used to count as a "pesticide chemical" but no longer does (as of October 30, 1998): regulations that would otherwise be treated as issued under this section are instead treated as issued under section 348, and regulations that actually were issued under this section are likewise treated, going forward, as issued under section 348. (k) Transitional provision If, just before August 3, 1996, a pesticide's use on a particular food was already treated by the Administrator or the Secretary as "generally recognized as safe," or was treated by the Secretary as described in section 321(s)(4), then that residue automatically became exempt from needing a tolerance, as of August 3, 1996. The Administrator must issue a regulation identifying which substances this covers. Any such automatic exemption can later be changed or canceled the same way as an exemption issued under subsection (c). (l) Harmonization with action under other laws Where practical, the Administrator must coordinate any rule suspending or canceling a tolerance or exemption with related action under the pesticide-registration law (FIFRA). If the Administrator, acting under FIFRA, cancels every registration for a pesticide's use on a particular food — or requires those registrations to be changed to forbid that use — because of dietary health risk, the Administrator must then cancel any tolerance or exemption allowing that pesticide's residue on that food, using the procedures in subsection (e). This cancellation must take effect within 180 days after the FIFRA cancellation (or, if later, after that use actually becomes unlawful). Similarly, if the Administrator suspends every registration for a pesticide's use on a food because of dietary risk, the Administrator must suspend the matching tolerance or exemption within 60 days, again using subsection (e) procedures. That suspension lasts as long as the FIFRA suspension does; while suspended, the tolerance or exemption does not count as being "in effect." If the FIFRA suspension ends without canceling the registration, the Administrator must lift the matching suspension too. For pesticides whose registrations were suspended or canceled (including before August 3, 1996), if the Administrator finds that some residue will unavoidably persist in the environment and show up in food anyway, the Administrator may set a special "unavoidable residue" tolerance, considering both the usual safety factors in subsection (b)(2) and how unavoidable the residue actually is. The Administrator must review such a tolerance periodically and tighten it so it allows no more residue than is truly unavoidable. Even after a tolerance or exemption has been revoked, suspended, or changed, food is not automatically considered unsafe just because it contains that pesticide's residue, if the residue resulted from a pesticide application that was lawful under FIFRA at the time, and the residue does not exceed the level that was legal at that time. This protection does not apply if the Administrator has separately determined that eating the food, while it remains available for sale, would create an unreasonable dietary risk. If the Administrator grants an emergency-use exemption for a pesticide under FIFRA section 18, the Administrator must also set a matching tolerance or exemption for the resulting residue, and that tolerance or exemption must have an expiration date. The Administrator can do this without the usual notice-and-comment process. The Administrator had to issue regulations governing this process within 365 days of August 3, 1996, consistent with the normal safety standards in subsections (b)(2) and (c)(2) and with FIFRA section 18. (m) Fees The Administrator must set fees, by regulation, to cover the reasonable cost of running this section's programs over time. These fees can apply to filing a petition, to tolerance or exemption decisions, to filing objections, and to preparing the court record for judicial review. The Administrator's regulations can also allow fees to be waived or refunded when that is fair. Collected fees go into the Reregistration and Expedited Processing Fund created under FIFRA, and stay available to the Administrator without a yearly deadline to spend them. From December 29, 2022 through September 30, 2027, the Administrator may not collect any tolerance fees at all. (n) National uniformity of tolerances This subsection defines a "qualifying pesticide chemical residue" as a residue from a pesticide that was either first approved for that use in a registration issued on or after April 25, 1985, based on data meeting the modern FIFRA data standards in effect on that date, or approved for that use in a "reregistration eligibility determination" issued on or after August 3, 1996. A "qualifying Federal determination" is a tolerance or exemption for such a residue that either was issued under this section after August 3, 1996, and found by the Administrator to meet the usual safety standard, or was carried forward from an earlier law under subsection (j), or automatically exempted under subsection (k), and the Administrator has separately found that it meets the usual safety standard. The Administrator can only make that "meets the usual standard" finding for carried-forward tolerances through formal rulemaking, following the procedures in subsection (d) or (e), with at least 30 days of public comment; that finding can then be challenged the same way as other rules, under subsections (g) and (h). With limited exceptions (described below), a state or local government cannot set or enforce its own regulatory limit on a qualifying residue if a qualifying Federal determination already covers it — unless the state's limit is identical to the federal one. A state or local government counts as "enforcing" a limit if it tries to prohibit or penalize selling, processing, shipping, or otherwise handling a food because its pesticide residue is above some limit the state has set. A state can petition the Administrator for permission to set its own, non-identical limit on a qualifying residue. That petition must meet the Administrator's regulatory requirements and include supporting scientific data on the residue, on how much of the food is consumed in that state, and on human exposure within the state. The Administrator can grant this permission by order if the state's proposed limit is justified by real local conditions and would not make any food violate federal law. Instead of ruling on it directly, the Administrator can also choose to treat the state's petition as a regular petition, under subsection (d), to change the federal tolerance or exemption itself. Either kind of Administrator decision here can be challenged the same way as other rules, under subsections (g) and (h). If a state petition shows that eating the food, with that residue level, during the time it's likely to be sold, would pose an acute (short-term) public-health risk, it counts as an "urgent" petition. If the Administrator doesn't rule on an urgent petition within 30 days, the state may temporarily enforce its own limit until the Administrator's final decision. A state also cannot enforce any residue limit against food if, at the time the pesticide was applied, selling that food with that residue level was legal under both this federal law and that state's own law — unless the state can show that eating the food during its likely time on the market would create an unreasonable dietary health risk within that state. Nothing in this law stops a state or local government from requiring a food to carry a warning or other statement about the presence of a pesticide residue. (o) Consumer right to know Within 2 years of August 3, 1996, and every year after that, the Administrator, working with the Department of Agriculture and the Department of Health and Human Services, must publish — in language an ordinary reader can understand — and distribute to large grocery retailers for public display: a discussion of the risks and benefits of pesticide residues in food that consumers buy; a list of the actions taken under the special "eligible pesticide residue" path in subsection (b)(2)(B) that may leave residues posing an above-normal yearly or lifetime risk, and which foods are affected; and recommendations for how consumers can reduce their exposure while still eating a healthy diet, including foods that could reasonably substitute for the ones on that list. Grocers can choose how to display this information, and nothing stops them from adding more of their own. (p) Estrogenic substances screening program Within 2 years of August 3, 1996, the Administrator, working with the Department of Health and Human Services, had to develop a screening program — using scientifically validated tests and other relevant information — to check whether certain substances act like natural estrogen in humans, or have other hormone-related effects the Administrator chooses to include. Within 3 years, after public comment and review by a scientific advisory panel, the Administrator had to put that program into use. The Administrator must test every pesticide chemical under this program, and may also test other substances whose effects could add to a pesticide's effects, if a substantial number of people might be exposed to them. The Administrator can exempt a biological or other substance from this testing if it is not expected to act like estrogen in humans. The Administrator can order a registrant, manufacturer, or importer of a substance covered by this program to run the required tests and report the results, within a reasonable time the Administrator sets. The Administrator should try to avoid making companies duplicate the same test, should set up fair ways to share testing costs, and should protect confidential business information where necessary. If a registrant fails to comply with a testing order, the Administrator must issue a notice proposing to suspend that registrant's ability to sell or distribute the substance. That suspension becomes final 30 days after the registrant receives the notice, unless someone affected requests a hearing, or the Administrator finds the registrant has since fully complied. Any such hearing follows standard federal administrative-hearing rules, and the only question is whether the registrant complied with the order; the resulting decision counts as final agency action. The Administrator must lift a suspension once the registrant has fully complied. Anyone else (not a registrant) who fails to comply with a testing order faces the same penalties as under the Toxic Substances Control Act's enforcement section. If testing shows a substance does have a hormone-related effect on humans, the Administrator must take whatever appropriate action is available under any relevant law to protect public health. Within 4 years of August 3, 1996, the Administrator had to report to Congress on the program's findings, on what further testing is needed, and on any further action the Administrator recommends. (q) Schedule for review The Administrator must review every tolerance and exemption that was in effect the day before August 3, 1996, working as fast as reasonably possible: 33 percent of them within 3 years, 66 percent within 6 years, and 100 percent within 10 years. For each one reviewed, the Administrator must decide whether it still meets the usual safety standards, and if it doesn't, must issue a rule to change or cancel it by that review's deadline. In choosing which ones to review first, the Administrator must prioritize those that appear to pose the greatest risk to public health. Within 12 months of August 3, 1996, the Administrator had to publish the full review schedule. Deciding the order of review is not itself a formal rulemaking and cannot be challenged in court — but failing to actually meet the published schedule's deadlines can be challenged. (r) Temporary tolerance or exemption If someone holds an experimental permit for a pesticide under FIFRA, the Administrator may set a temporary tolerance or exemption for that pesticide's residue, covering the uses allowed under that permit — either at that person's request or on the Administrator's own initiative. The usual standards and procedures in subsections (b)(2), (c)(2), (d), and (e) apply to this temporary tolerance or exemption. (s) Savings clause Nothing in this section changes or overrides the Toxic Substances Control Act or the pesticide-registration law (FIFRA).