Federal Food, Drug, and Cosmetic Act, United States

April 15, 2011, 11:40 am
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Mrs. Winslow's soothing syrup was one of many suppsed 'remedies' widely available before FFDCA. It contained the opiate morphine.

The Federal Food, Drug, and Cosmetic Act (FFDCA), is one of two major federal pesticide statutes which the U.S. Environmental Protection Agency (EPA)  is responsible for implementing. FFDCA limits pesticide residues on food in interstate commerce (including imports).The other major statute is the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which governs the sale and use of pesticide products within the United States.

Pesticides are broadly defined in FIFRA Section 2(u) as chemicals and other products used to kill, repel, or control pests. Familiar examples include pesticides used to kill insects and weeds that can reduce the yield, and sometimes harm the quality, of agricultural crops, ornamental plants, forests, wooden structures, and also pastures. But the broad definition of “pesticide” in FIFRA also applies to products with less familiar “pesticidal uses.” For example, substances used to control mold, mildew, algae, and other nuisance growths on equipment, in surface water, or on stored grains are pesticides. The term also applies to disinfectants and sterilizing agents, animal repellents, rat poison, and many other substances. EPA estimates that, as of late 2006, there are about 18,000 pesticide products currently in use. These all are regulated under FIFRA, but approximately 5,800 pesticide products used in food production also are regulated under the FFDCA, as discussed below.

Ingredients in pesticide products are categorized as active or inert. Active ingredients are those that are intended to control the pest, while inert ingredients are used to deliver the active ingredients effectively to the pest. Inert ingredients often are solvents or surfactants and often comprise the bulk of the pesticide product. Some inerts are known to be toxic, and some are known to be harmless, but EPA lists most in the category “inerts of unknown toxicity.”

For the approximately 600 or more pesticides (i.e., active ingredients) registered for use in food production, the FFDCA Section 408 authorizes EPA to establish maximum allowable residue levels (called tolerances) that ensure that human exposure to the pesticide ingredients in food and animal feed will be “safe”.36 A “safe” tolerance is defined as a level at which there is “a reasonable certainty of no harm” from the exposure. Under FFDCA, foods with a residue of a pesticide ingredient for which there is no tolerance established, or with a residue level exceeding an established tolerance limit, are declared “unsafe” and “adulterated”; such foods cannot be sold in interstate commerce or imported to the United States. Pesticides may not be registered under FIFRA for use on food unless tolerances (or exemptions) have been established under the FFDCA.

History of FFDCA

The original Federal Food, Drug, and Cosmetic Act of 1938 (FFDCA) established the structure of the current law. With respect to food safety, it required the Food and Drug Administration (then a part of the U.S. Department of Agriculture) to set maximum residue levels (tolerances) for unavoidable poisonous substances in food. Congress acted to protect consumers from pesticide residues on food in 1954 by adding a new Section 408 to the FFDCA. It directed FDA to set residue tolerances for all pesticides in raw agricultural commodities. Congress expanded the requirement for tolerances in the Food Additives Amendment of 1958, which added Section 409, directing FDA to set tolerances for food additives, including pesticide residues in processed foods. Section 409 also forbade the addition to food of any additive (including pesticide residue), if it was found to be a potential cancer-causing agent. This provision is referred to as the Delaney Clause.

In 1970, authority to establish tolerances for pesticide residues was transferred to the newly formed EPA. FDA (now in the Department of Health and Human Services) retained responsibility for enforcement of tolerances in food that is imported or sold across state boundaries.

In 1996, Congress substantially revised requirements for pesticide residue tolerance setting in the Food Quality Protection Act (FQPA). The FQPA redefined terms so that pesticide residues in processed foods were no longer regulated as food additives, and therefore no longer were subject to the Delaney Clause. The FQPA also established a new safety standard of a “reasonable certainty of no harm” from exposure to pesticides. See Table 21 for a listing of current pesticidesrelated provisions in the FFDCA.

The Act of July 22, 1954, authorized such sums as may be necessary to carry out this FFDCA section (21 U.S.C. 346b).

Table 1. Federal Food, Drug, and Cosmetic Act, Section 408, and Amendments
(codified generally at 21 U.S.C. 321-346a)
Year Act Public Law Number
1938    Federal Food, Drug, and Cosmetic Act Act of June 25, 1938
1954    Federal Food, Drug, and Cosmetic Act Amendments Act of July 22, 1954
1954    Food Additive Amendments of 1958 (including the Delaney Clause) P.L. 85-929
1996    Food Quality Protection Act of 1996 P.L. 104-170

Registration of Pesticide Products

When pesticide manufacturers apply to register a pesticide active ingredient, pesticide product, or a new use of a registered pesticide under FIFRA Section 3, EPA requires them to submit scientific data on toxicity and behavior in the environment. EPA may require data from any combination of more than 100 different tests, depending on the potential toxicity of active and inert ingredients and degree of exposure. To register a pesticide use on food, EPA also requires applicants to identify analytical methods that can be used to test food for residues of active ingredients, certain inert ingredients, and their breakdown products and to determine the amount of residue that could remain on crops, as well as on (or in) food products, assuming that the pesticide product is applied according to the manufacturers’ recommended rates and methods.

Based on the data submitted, EPA determines whether and under what conditions the proposed pesticide use would present an unreasonable risk to human health or the environment. If the pesticide is proposed for use on a food crop, EPA also determines whether a “safe” level of pesticide residue, called a “tolerance,” can be established under the Federal Food, Drug, and Cosmetic Act. A tolerance must be established before a pesticide registration may be granted for use on food crops. If registration is granted, the agency specifies the approved uses and conditions of use, including safe methods of pesticide storage and disposal, which the registrant must explain on the product label. FIFRA requires that federal regulations for pesticide labels preempt state, local, and tribal regulations. Use of a pesticide product in a manner inconsistent with its label is prohibited.

EPA may classify and register a pesticide product for general or for restricted use. Products known as “restricted-use pesticides” are those judged to be more dangerous to the applicator or to the environment. Such pesticides can be applied only by people who have been trained and certified. Individual states and Indian tribes generally are responsible for training and certifying pesticide applicators.

FIFRA Section 3 also allows “conditional,” temporary registrations if (1) the proposed pesticide ingredients and uses are substantially similar to currently registered products and will not create additional significant environmental risks; (2) an amendment is proposed for additional uses of a registered pesticide, and sufficient data are submitted indicating that there is no significant additional risk; or (3) data requirements for a new active ingredient require more time to generate than normally allowed, and use of the pesticide during the period will not cause any unreasonable adverse effect on the environment and will be in the public interest.

Tolerance Setting

Any person who has registered a pesticide may petition EPA proposing establishment of a tolerance or an exemption for that pesticide to permit its use on food-related crops. (That is, use on food crops, animal feed crops, or food products directly (e.g., grains, fruits, or vegetables after harvest).)  Tolerance petitions must include information about pesticide application rates, measured concentrations of pesticide residues on the food after the pesticide has been applied according to directions on its label, and safety of pesticide use on food crops. The FFDCA requires EPA to respond to each petition by establishing a tolerance or exempting the pesticide from the requirement. If the pesticide will not leave residues above an established safe level, EPA will register the pesticide for use on that food product and set the tolerance level by issuing a regulation. EPA tolerances for pesticide residues preempt state and local restrictions on food, if the state and local restrictions are based on lower residue levels. States may petition for an exception if the EPA-set residue level threatens public health.

The FFDCA, Section 408, as amended, requires EPA to assess safety in terms of total exposure to the pesticide (that is, to the concentration of pesticide allowed by the tolerance, together with all other dietary and non-food exposures for which there is reliable information) as well as to other pesticides that have the same toxic effects on people. No quantitative standard of safety is established by law, but the House Committee on Commerce (now the Committee on Energy and Commerce) noted in its report on the bill that became the FQPA that EPA should continue setting standards to ensure safety as it had in the past:

... the Committee expects that a tolerance will provide a ‘reasonable certainty of no harm’ if the Administrator determines that the aggregate exposure to the pesticide chemical residue will be lower by an ample margin of safety than the level at which the pesticide chemical residue will not cause or contribute to any known or anticipated harm to human health. The Committee further expects, based on discussions with the Environmental Protection Agency, that the Administrator will interpret an ample margin of safety to be a 100-fold safety factor applied to the scientifically determined ‘no observable effect’ level when data are extrapolated from animal studies. (U.S. House, Committee on Commerce, Food Quality Protection Act of 1996, H.Rept. 104-669, part 2, 104th Congress, 2nd sess., 1996, p. 6.)

In determining a safe level, the FFDCA directs EPA to take into account many factors, including available information on dietary exposure to pesticides among infants and children. FQPA strictly limited the nature and influence of benefits considered in tolerance setting under Section 408 of the FFDCA. As amended, Section 408 allows EPA to maintain or modify existing tolerances (but not to establish new tolerances) at higher than “safe” residue levels only if the pesticide use avoids other greater risks to consumers, or is necessary to avoid significant disruption in domestic production of an adequate, wholesome, and economical food supply. Such higher tolerance levels may be set only for pesticides that are potential carcinogens (or have some other health effect) for which there is no known level of exposure at which no harm is anticipated (known as a nonthreshold effect).

The higher tolerance level allowed for such pesticide residues must be “safe” for infants and children, as well as with respect to health effects for which there is a known threshold (that is, a level below which exposure is known to be harmless). The higher cancer (or other non-threshold) risk posed by the tolerance on an annual basis may not be more than 10 times the risk at a “safe” level of exposure and not more than twice the risk of a “safe” level over a lifetime. For non-threshold effects, the House Commerce Committee provided additional guidance for establishing a level of residue that should be considered “safe.”

In the case of a nonthreshold effect which can be assessed through quantitative risk assessment, such as a cancer effect, the Committee expects, based on its understanding of current EPA practice, that a tolerance will be considered to provide a ‘reasonable certainty of no harm’ if any increase in lifetime risk, based on quantitative risk assessment using conservative assumptions, will be no greater than ‘negligible.’ It is the Committee’s understanding that, under current EPA practice, ... EPA interprets a negligible risk to be a one-in-a-million lifetime risk. The Committee expects the Administrator to continue to follow this interpretation.39

The “safe” standard applies to both raw and processed foods, and requires EPA to consider cumulative and aggregate exposure to pesticides in food, drinking water, air, and consumer products. Congress directed EPA to reevaluate all existing tolerances against this standard before August 2006.

FFDCA directs the FDA in the Department of Health and Human Services and USDA to monitor pesticide residue levels in food in interstate commerce and to enforce tolerances through their food inspection programs. USDA is responsible for inspecting meat and poultry; FDA inspects all other foods. States also may monitor pesticide residues in food sold within their jurisdictions.

FIFRA-FFDCA Coordination

EPA has long coordinated pesticide registrations for food uses under FIFRA with tolerance setting under the FFDCA. The Food Quality Protection Act of 1996 (FQPA; P.L. 104-170) codified this policy. Thus, if EPA revokes a residue tolerance under FFDCA, it cancels the FIFRA pesticide registration for that food use. Similarly, if a pesticide registration for use on a food crop is canceled, EPA also cancels the residue tolerance for food. However, just as FIFRA allows continued use of remaining pesticide stocks after a registration is canceled, FFDCA allows continued commerce in commodities legally treated with a pesticide. Thus, EPA does not immediately revoke the tolerance for the pesticide residue when it cancels the corresponding registration.

Public Disclosure, Exclusive Use, and Trade Secrets

FIFRA Section 3 directs EPA to make the data submitted by the applicant for pesticide registration publicly available within 30 days after a registration is granted. However, applicants may claim certain data are protected as trade secrets under FIFRA, Section 10. If EPA agrees that the data are protected, the agency must withhold those data from the public, unless the data pertain to the health effects or environmental fate or effects of the pesticide ingredients. Information may be protected if it qualifies as a trade secret and reveals (1) manufacturing processes; (2) details of methods for testing, detecting, or measuring amounts of inert ingredients; or (3) the identity or percentage quantity of inert ingredients.

Companies sometimes seek to register a product based upon the registration of similar products, relying upon the data provided by the original registrant that are publicly released. This is allowed. However, Section 3 of FIFRA provides for a 10-year period of “exclusive use” by the registrant of data submitted in support of an original registration or a new use. In addition, an applicant who submits any new data in support of a registration is entitled to compensation for the cost of data development by any subsequent applicant who supports an application with that data within 15 years of its submission. If compensation is not jointly agreed upon by the registrant and applicant, binding arbitration can be invoked.

Reregistration

Most pesticides currently registered in the United States are older pesticides and were not subject to modern safety reviews when first registered. Amendments to FIFRA in 1972 directed EPA to “reregister” approximately 35,000 older products, in order to assess their safety in light of current standards. The task of reregistering older pesticides has been streamlined by reviewing groupings of products having the same active ingredients, on a generic instead of individual product basis.

For food-use pesticides, EPA evaluated a pesticide’s eligibility for reregistration at the same time the agency reassessed the tolerance for that pesticide under the FFDCA. The FQPA required EPA to reassess pesticides posing the greatest risks first. Many of the 35,000 pesticide products were not reviewed and their registrations were canceled, because registrants did not request reregistration. At least 14,000 products are no longer in use. Nevertheless, the task for registrants and EPA was immense and costly.

To accelerate the process of reregistration, Congress, in 1988 amendments to FIFRA, imposed a 10-year reregistration schedule. To help pay for the additional costs of the accelerated process, Congress directed EPA to require registrants to pay reregistration and annual registration maintenance fees on pesticide ingredients and products. The 1996 amendments to FIFRA extended EPA’s authority to collect maintenance fees through FY2001. Exemptions from, or reductions in, fees were allowed for minor-use pesticides, public health pesticides, and small business registrants. Congress extended authority for fees annually through appropriations legislation after FY2001, until the omnibus appropriations legislation signed January 23, 2004 (P.L. 108-199), modified the types and amounts of fees that EPA could collect, potentially through FY2008.

The 2004 FIFRA amendments (PRIA) reauthorized collection of annual “maintenance” fees to support registration, designated a portion of those fees for the review of inert ingredients, and extended the deadline for completion of reregistration. PRIA directed EPA to complete Reregistration Eligibility Decisions (REDs) for pesticides with food uses/tolerances by August 3, 2006, and to complete REDs for all remaining non-food use pesticides by October 3, 2008. The reregistration process will continue for several years after that date, as explained on the EPA reregistration website:

After EPA has issued a RED and declared a pesticide eligible for reregistration, individual end-use products that contain the pesticide active ingredient still must be reregistered. Through this concluding part of the process, known as “product reregistration,” the Agency makes sure that the risk reduction measures called for in REDs are reflected on individual pesticide product labels. In some cases, the Agency uses Memoranda of Agreement or other measures to include risk reduction measures on pesticide labels sooner, before product reregistration is completed. EPA plans to complete the last product reregistration decisions several years after the last REDs are signed. (See EPA. Pesticide Reregistration Facts. October 26, 2006.)

EPA authority for administering these fees would have expired at the end of FY2008, but it was extended by the Pesticide Registration Improvement Renewal Act, or PRIA2 (P.L. 110-94), enacted October 9, 2007, effective retroactively to the beginning of FY2008 through FY2012.

PRIA2 also made some technical revisions, primarily modifications to the fee payment process and an expansion of the range of categories of pesticide registration (licensing) activities subject to fees.

Special Review

EPA continues to evaluate the safety of pesticides after they are registered as new information becomes available. FIFRA requires registrants to report promptly any new evidence of adverse effects from pesticide exposure. If evidence indicates that a registered pesticide may pose an unreasonable risk, EPA may initiate a special review of available information to reevaluate the risks and benefits of each registered use. FIFRA also authorizes EPA to require registrants to conduct new studies to fill gaps in scientific understanding to assist risk assessments. As a result of a special review EPA may conclude that registration is adequate, needs amendment, or should be canceled.

Canceling or Suspending a Registration

If a special review or reregistration evaluation finds that a registered use may cause “unreasonable adverse effects,” EPA may amend or cancel the registration. (Registrations also may be canceled under other conditions, for example, if data are not submitted in response to EPA’s request for additional information to maintain a registration, or if a registrant fails to pay the maintenance fee.)  FIFRA also allows registrants to request cancellation or amendment of a registration to terminate selected pesticide uses. Requesting voluntary cancellation sometimes reflects a registrant’s conclusion that the cost of additional studies is not worth the expected benefit (that is, profit) from sales if the registration would be maintained.

If a registration is canceled for one or more uses of a pesticide, FIFRA does not permit it to be sold or distributed for those uses in the United States, although for a specified period of time, U.S. farmers may use remaining stocks, and commerce may continue for commodities that were legally treated with the pesticide. FIFRA allows registrants to appeal an EPA decision to cancel a registration. An appeal initiates a lengthy review process during which the product may continue to be marketed. However, if there is threat of an “imminent hazard” during the time required to cancel a registration, FIFRA authorizes EPA to suspend registration. Suspension orders, which also may be appealed, stop sales and use of the pesticide. In the event of suspension and cancellation, FIFRA Section 15 directs EPA to request an appropriation from Congress to compensate anyone who owned any of the pesticide and suffered any loss due to the suspension or cancellation. The registrant of the suspended and canceled product is responsible, however, for all of the transportation and disposal costs, and most storage costs.

Use of Unregistered Pesticides

FIFRA also allows for unregistered use of pesticide products in special circumstances. Section 5 allows experimental use permits for purposes of research and to collect data needed to register a pesticide. Section 18 allows “emergency exemptions” from the provisions of FIFRA to be granted to federal or state agencies, for example, if there is a virulent outbreak of a disease that cannot be controlled by registered products. In addition, Section 24(c) permits states to allow additional uses of a federally registered product to meet “special local needs.”

Enforcement

Generally, EPA has the authority to enforce FIFRA requirements. However, FIFRA Section 26 gives primary enforcement authority for pesticide use under FIFRA to states that have adequate enforcement procedures, laws, and regulations, including inspection authority. EPA is authorized by Section 27 to rescind a state’s primary enforcement responsibility if it is not being carried out.

FIFRA Section 11 authorizes EPA to form cooperative agreements with states, giving them the responsibility for training and certifying applicators of restricted use pesticides. States also may initially review and give preliminary approval to applications for emergency exemptions and special local needs registrations, (although under some conditions FIFRA allows EPA later to deny state-approved applications).

Section 9 authorizes inspections by EPA and authorized state officials of pesticide products where they are stored for distribution or sale. Section 13 authorizes EPA to issue orders to stop sales and to seize supplies of pesticide products. Civil and criminal penalties for violations of FIFRA are established in Section 14, while Section 15 provides indemnity payments for end users, distributors, and dealers of pesticides when registrations are suspended and canceled.

Federal district courts are authorized in Section 16 to review EPA final actions and omissions when action is not discretionary. People adversely affected by an EPA order may file for judicial review of the order following a hearing. But, FIFRA does not authorize citizen suits against violators.

Export of Unregistered Pesticides

FIFRA does not give EPA the authority to regulate domestic production for export of unregistered pesticides, even if U.S. registration has been canceled for health or environmental reasons. However, FIFRA does require exporters to prepare or pack pesticides as specified by the purchaser and in accord with some of the FIFRA labeling provisions. For example, exporters must translate warning information into the language of the destination. FIFRA also requires exporters of unregistered pesticides to obtain the purchaser’s signature on a statement acknowledging that the pesticide is unregistered and cannot be sold in the United States. EPA is required to notify governments of other countries and international agencies whenever a registration, cancellation, or suspension of any pesticide becomes or ceases to be effective in the United States.

Note: This article was extracted from from the Congressional Research Service Report RL30798, Environmental Laws: Summaries of Major Statutes Administered by the Environmental Protection Agency by David M. Bearden, Claudia Copeland, Linda Luther, James E. McCarthy, Linda-Jo Schierow, and Mary Tiemann (October 8, 2010).

Further reading

  • Bergeson, Lynn L. FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act). Basic Practice Series. American Bar Association. 2000. 150 p.
  • U.S. Library of Congress, Congressional Research Service. Pesticide Legislation: Food Quality Protection Act of 1996 (P.L. 104-170). CRS Report 96-759 ENR. Washington, DC. Sept. 11, 1998. 31

 

Disclaimer: This article is taken wholly from, or contains information that was originally published by, the Congressional Research Service. Topic editors and authors for the Encyclopedia of Earth may have edited its content or added new information. The use of information from the Congressional Research Service should not be construed as support for or endorsement by that organization for any new information added by EoE personnel, or for any editing of the original content.

Note: The first version of this article was drawn from material prepared for the Congressional Research Service by Linda Schierow.

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Citation

(2011). Federal Food, Drug, and Cosmetic Act, United States. Retrieved from http://www.eoearth.org/view/article/51cbedc77896bb431f693de2

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