21 U.S.C. § 379e — Listing and certification of color additives for foods, drugs, devices, and cosmetics

(a) A color additive counts as "unsafe" for food, drugs, devices, or cosmetics unless certain rules are followed. There must be a rule (issued under part (b)) that lists this additive for this exact use, including any safety conditions attached — and on top of that, either the additive must come from a batch that was certified for this use under part (c), or the Secretary must have excused this use from needing certification. Instead of all that, the additive and its use can be covered by an exemption granted under part (f). As long as these listing, certification, or exemption rules are being followed, an article isn't automatically "adulterated" just because it contains the additive — that's true for food, and also for cosmetics other than hair dye. This section only covers color additives used on devices if the additive touches a person's or animal's body for a significant amount of time, and the Secretary can write regulations spelling out exactly which device uses count. (b) This part explains how the Secretary lists which color additives are allowed. The Secretary must issue regulations separately listing safe color additives for food, for drugs and devices, and for cosmetics. A color additive can be listed for general use in one of those categories if the Secretary finds it's safe for that broad use. If the evidence only supports a narrower use, or if that's all that's being requested, the Secretary can list it only for that narrower use. Whenever needed to keep a use safe, the listing regulation must set conditions — like a maximum allowed amount (called a "tolerance limitation"), rules for how the additive can be added to a product, and labeling or packaging requirements. The Secretary can't list an additive for a use unless the evidence shows that use, under the listed conditions, is safe. One exception: an additive counts as safe for general food use automatically while the Secretary has a separate, published finding that it's exempt from being called a "food additive" because qualified experts generally recognize it as safe. When deciding if a proposed use is safe, the Secretary must weigh several things: how much people will likely eat, drink, or otherwise be exposed to, from the additive itself and from anything it creates when used; whether the additive builds up in the diet along with similar substances; safety standards that experts consider appropriate for judging animal test data; and whether good, workable testing methods exist to identify and measure the pure additive, its impurities, the additive in the finished product, and anything it creates in that product. There's a strict cancer rule. If a color additive is found — after appropriate testing — to cause cancer in people or animals when swallowed, it must be ruled unsafe and can never be listed for any use that leads to swallowing any of it. If it's found to cause cancer through other kinds of exposure, it must be ruled unsafe and can't be listed for any use that doesn't involve swallowing it either. There's one carve-out: the swallowing rule doesn't block using the additive as an ingredient in animal feed, if the Secretary finds that, used and fed the way the label says, it won't hurt the animals, and if tests find no trace of it left in any edible part of the animal after slaughter. People affected by a listing decision can ask for extra scientific review. In any case about issuing, changing, or canceling a listing rule, a petitioner or anyone else who'd be hurt by the Secretary's proposal or order can ask — generally before or within 30 days after the Secretary's order — that the matter be sent to an advisory committee for study, when it involves the kind of scientific judgment covered by the cancer rules above. The Secretary can also send it to the committee on their own initiative. The person who asked, and FDA staff, can both consult with the committee. Within 60 days of the referral (or 90 if the committee needs more time), the committee must give the Secretary a full report and recommendations, including its underlying data and reasoning, and a copy goes to whoever asked for the referral. Within 30 days after that, having considered everything, the Secretary must issue an order — confirming or changing any earlier order, or ruling on the original petition if there wasn't one yet. If the Secretary is trying to remove a color additive from the list because of the cancer rules, and someone has asked for committee review, the Secretary generally can't act until the committee reports back and the Secretary has considered it — unless there's an emergency. The advisory committee itself is picked by the National Academy of Sciences, choosing qualified experts with varied backgrounds; if the Academy won't or can't do this, the Secretary picks the members instead. The Secretary decides how big the committee is. Members get paid for their time — capped at the daily rate for a top federal pay grade (GS-18) — plus travel costs, but they aren't treated as regular federal employees for pay and appointment purposes. The Secretary must give the committee clerical help and set the rules for how it operates. The Secretary also can't list an additive if the evidence shows the listing would let people be deceived, or would otherwise cause a product to be mislabeled or adulterated under this law. If a maximum-amount limit ("tolerance") is needed to keep a use safe, the Secretary can't list the additive unless the evidence shows that, kept under a safe limit, it would still do its intended job — and any limit the Secretary sets can't be higher than what's actually needed to do that job. Finally, if the total amount of a color additive (or related additives) that people would likely eat or apply to their bodies, across all its proposed uses, isn't shown to be safe, the Secretary must decide which uses to allow, or how to split up the total safe amount among competing uses. Safety always comes first, but the Secretary can also weigh how much each use matters to the marketability of the products and the industries that depend on it, how much of the additive each use and its amount would actually add up to, and whether other color additives are available and safe for the same jobs. (c) The Secretary must also make rules for certifying batches of listed color additives — checking them (with or without safe filler substances) to confirm they meet the requirements. The Secretary can excuse a particular additive, listing, or use from needing this certification if it's not necessary to protect public health. One case is automatic: if a food use is already treated as safe because of the exemption finding described in part (b), that use doesn't need certification either. (d) Rules for issuing, changing, or cancelling these regulations generally follow the standard procedure used elsewhere in this law (in section 371(e), (f), and (g)), including for court review — with some special rules here. If the case starts with a petition, the Secretary must publicly announce it within 30 days, and must issue a ruling within 90 days of the petition being filed (unless it's already gone to an advisory committee) — though the Secretary can extend that to up to 180 days total by telling the petitioner in writing before the 90 days are up. Any advisory committee's report, data, and reasoning become part of the official hearing record if relevant, and the committee must send a member to testify about its report at a hearing if the Secretary, the petitioner, or the hearing officer asks — though other committee members can testify too. A Secretary's post-hearing decision must meet the same standard as decisions on food additives under section 348(f)(2). And courts reviewing these decisions use the same review standard used for food additive decisions under section 348(g)(2) and (3). (e) The Secretary can only list and certify color additives after collecting fees, set out in regulations, big enough to pay for running that service properly. (f) The Secretary must also write rules — without going through the special procedure in part (d) — exempting any color additive or specific use, and any product containing it, from this section's requirements, as long as it's meant only for testing by qualified experts and the Secretary believes that's fine for public health.