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May 2005
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For questions regarding this document, contact Michael E. Kashtock at the Center for Food Safety and Applied Nutrition (CFSAN) at (Tel) 301-436-2022, (Fax) 301-436-2651, or email michael.kashtock@fda.hhs.gov.
Additional copies are available from:
Office of Plant and Dairy Foods
Center for Food Safety and Applied Nutrition
Food and Drug Administration: 5100 Paint Branch Parkway
College Park, MD 20740
http://www.cfsan.fda.gov/guidance.html
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
May 2005
This guidance applies to firms in the food production and processing industries that handle food products that may contain residues of certain pesticide chemicals, for which tolerances have been revoked, suspended, or modified by the Environmental Protection Agency (EPA) under the provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act (FQPA) of 1996 (Pub. L. No. 104-170 (1996)). In particular, this guidance addresses food that may contain residues of pesticide chemicals for which the aforementioned EPA tolerance action occurred pursuant to the requirements of section 408(l)(2) of the FFDCA as amended by the FQPA.(2) It is intended to present the Food and Drug Administration's (FDA) general policy on its planned enforcement approach for foods containing such residues (i.e., for which the EPA tolerance action occurred pursuant to the requirements of section 408(l)(2) of the FFDCA as amended by the FQPA) in accordance with the provision in section 408(l)(5) (hereinafter the "channels of trade provision") of the FFDCA, as amended by the FQPA. This guidance will assist firms in understanding the types of showing under section 408(l)(5) of the FFDCA that FDA may find satisfactory, in accordance with its planned enforcement approach for the channels of trade provision.(3)
The channels of trade provision(4) addresses the circumstances under which a food is not unsafe solely because of the presence of a pesticide chemical residue whose tolerance (or exemption therefrom) has been revoked, suspended, or modified by EPA. When EPA takes an action, for example, that makes the use of a pesticide chemical unlawful under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), or lowers or revokes the corresponding tolerance for that pesticide chemical in food, food that was lawfully treated with the pesticide chemical and contains a pesticide chemical residue that does not exceed the previous tolerance, may not have cleared the channels of trade (e.g., may still be in interstate commerce) by the time the revocation or new lower tolerance level takes effect. Such food could be found by FDA to contain a residue of the revoked pesticide chemical or contain an amount of residue that exceeds the new lower tolerance. FDA would normally deem such food to be in violation of the law by virtue of it bearing an illegal pesticide residue. The food would be subject to FDA enforcement action as an "adulterated food" under section 402(a)(2)(B) of the FFDCA. However, the "channels of trade" provision provides an exception to such a finding by FDA provided that certain criteria are met.
This guidance document presents FDA's general policy for its planned approach to the enforcement of the channels of trade provision with respect to affected pesticide chemicals for which tolerances have been either revoked, suspended, or modified pursuant to section 408(l)(2), i.e., after EPA has cancelled the corresponding registration due in whole or part to dietary risk in humans. This guidance is intended to assist firms in understanding the type of showing under section 408(l)(5) of the FFDCA that FDA may find satisfactory in accordance with its planned enforcement approach. Firms should use this guidance document for this purpose except for situations in which the particular pesticide residue is one for which FDA has issued a Level 1 guidance document specifically for that pesticide chemical, e.g., methyl parathion and vinclozolin. FDA has developed this guidance document because, as explained below, it expects EPA to revoke, suspend, or modify the tolerances for several pesticide chemicals on various food commodities pursuant to the requirement of section 408(l)(2) of the FFDCA, as amended by the FQPA. FDA anticipates that some foods bearing such pesticide chemical residues resulting from both lawful domestic and foreign application or use will remain in the channels of trade or be introduced into U.S. commerce after the tolerance revocations, suspensions, or modifications become effective. If FDA encounters such a food, it intends to proceed consistent with the policy set forth in this guidance document.
This guidance document does not address enforcement of the channels of trade provision for residues of pesticide chemicals in food for which tolerances were revoked, suspended, or modified by EPA, but for which the EPA tolerance action was not required pursuant to section 408(l)(2), i.e., tolerance actions not stemming from cancellation of a corresponding registration due to dietary risk considerations. For example, EPA may revoke the tolerances for a pesticide chemical in food because the registrant has requested that its registration be cancelled due to the cessation of its production. EPA's policy is to allow time for food that may bear residues of such pesticide chemicals to clear the channels of trade prior to acting to revoke, suspend, or modify the tolerance. As such, FDA believes that it is not likely to find such pesticide chemical residues in food following the EPA tolerance action. For these reasons, FDA is not providing guidance for such situations. However, should FDA find a residue of such a pesticide chemical in a food for which the applicable tolerance has been revoked, suspended, or modified apart from any consideration stemming from dietary risk to humans, the holders of the food are entitled under the channels of trade provision to make a showing that the residue is present as a result of a lawful application or use of the pesticide chemical. FDA intends to handle any such situations on a case-by-case basis.
This guidance document has been developed for situations involving the potential application of the channels of trade provision to human food and not animal feed. Any matter that might arise involving the potential application of the channels of trade provision to animal feed would be handled by FDA's Center for Veterinary Medicine (CVM). To date, CVM has not developed guidance on this matter, and would currently handle any such situation on a case-by-case basis.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations unless specific regulatory or statutory requirements are cited. The use of the word "should" in Agency guidances means that something is suggested or recommended, but not required.
Pesticides are widely used to treat fruits, vegetables, grains, and other foods, and may be present in small amounts, as residues, after treatments. Before a pesticide may be sold or distributed in the United States, EPA evaluates the pesticide and determines whether to grant a registration that permits its sale and distribution.
Before allowing the use of a pesticide chemical on food crops, the EPA, under section 408 of the FFDCA, establishes a tolerance (maximum residue level), which is the amount of residue allowed to remain in or on each treated food commodity, or it establishes an exemption from the requirement of a tolerance for the pesticide chemical. Without a tolerance or exemption from a tolerance, food containing a pesticide chemical residue is considered adulterated under section 402(a)(2)(B) of the FFDCA and may not be introduced or delivered for introduction into interstate commerce (which includes importation into the U.S.). With the exception of meat, poultry, and certain egg products, for which the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) is responsible, FDA is charged with enforcing pesticide chemical tolerances in imported food and in domestically-produced food shipped in interstate commerce.
On August 3, 1996, the FQPA was signed into law. This law, which amends both FIFRA and the FFDCA, established a new safety standard for pesticide chemical residues in food, with an emphasis on protecting the health of infants and children. In accordance with the FQPA, EPA is in the process of reassessing, under the new safety standard, the pesticide chemical tolerances and exemptions that were in effect when the law was signed. If EPA makes a determination that a pesticide chemical's tolerance level does not meet the safety standard set forth by the FQPA, the registration for the pesticide chemical may be canceled for all or some uses. In addition, the tolerances for that pesticide chemical may be lowered or revoked for the corresponding food commodities. As noted above, under section 408(l)(2) of the FFDCA, when the registration for a pesticide chemical is canceled or modified due in whole or in part to dietary risks to humans posed by residues of that pesticide chemical on food, the effective date for the revocation of the tolerance (or exemption in some cases) must be no later than 180 days after the date the cancellation becomes effective or 180 days after the date on which the use of the canceled pesticide chemical becomes unlawful under the terms of the cancellation, whichever is later.
In order to avoid possible regulatory action against a food containing a residue of a pesticide chemical that is subject to the channels of trade provision, the party responsible for the food must, under section 408(l)(5) of the FFDCA, demonstrate that the residue is present as a result of a lawful application or use of the pesticide chemical and that the residue does not exceed a level that was authorized at the time of that application or use.
The following four examples illustrate FDA's planned enforcement approach for single ingredient foods.
FDA may determine for a certain period of time following an EPA action, such as revoking, suspending, or modifying a pesticide chemical tolerance, that it is a reasonable exercise of FDA's enforcement discretion to consider that a residue of that pesticide chemical found by FDA in a specific food, that is within the former tolerance, is the result of the lawful application or use of the pesticide chemical on the food. In such cases, FDA does not intend to ask the responsible party to make a showing to demonstrate that the residue is present as a result of a lawful application or use of the pesticide chemical, and does not intend to take regulatory action against the food on the basis of the presence of the pesticide chemical residue.(6)
If fresh carrots were found to contain a residue of pesticide chemical XYZ after October 1, 2005, in that instance it would appear, based upon the degradation rate of the pesticide chemical, that the application of the pesticide chemical to the carrots was made after the last lawful use date, i.e., after January 1, 2005, and the carrots would be subject to possible regulatory action. While the party responsible for the carrots would have the right under the law to make a showing that the residue is present as a result of a lawful application or use of the pesticide chemical, FDA does not expect that the responsible party would be able to make such a showing because no residues of lawfully applied pesticide chemical XYZ on fresh carrots would be expected to be detectable after October 1, 2005, based upon the degradation rate of the pesticide chemical.
If fresh carrots were found by FDA to contain a residue of pesticide chemical ABC after January 1, 2006, in that instance it would appear, based upon the last expected date of sale for fresh carrots lawfully treated with pesticide chemical ABC, that the application of the pesticide chemical to the carrots was made after the last lawful use date, i.e., after January 1, 2005, and the carrots would be subject to possible regulatory action. While the party responsible for the carrots would have the right under the law to make a showing that the residue is present as a result of a lawful application or use of the pesticide chemical, FDA does not expect that the responsible party would be able to make such a showing because no residues of lawfully applied pesticide chemical ABC on fresh carrots would be expected to be found after January 1, 2006.
There are two general exceptions to the circumstances in examples 1 and 2 in this section under which FDA does not intend to typically consider that a pesticide residue found in a specific food, that is within the former tolerance, is the result of the lawful application or use of the pesticide chemical on the food. The first exception is the circumstance in which FDA has information indicating that there is a reasonable possibility that the residue resulted from an unlawful application or use of the pesticide chemical, e.g., an application of pesticide chemical XYZ to carrots after January 1, 2005, in example 1 above. Such information might be provided to FDA by another government agency with jurisdiction over pesticide usage that has concluded that an unlawful application or use of a pesticide chemical on a food crop took place. In such a circumstance, FDA does not intend to exercise its enforcement discretion as previously stated. Rather, FDA intends to ask the party responsible to show that the food complies with the channels of trade provision in order to avoid regulatory action against the food. In such cases, FDA plans to inform the responsible party that the food may be in violation of the FFDCA, and provide an opportunity for the party to respond and provide documentation demonstrating that the residue in the food resulted from a lawful application or use of the pesticide chemical on the food.
The second exception is the circumstance in which the food found to bear a residue of a given pesticide chemical is derived from a crop that was necessarily grown after the last lawful use date for that pesticide chemical on that food, as indicated by factors such as the growing season and shelf-life of the food in question. Based upon generally recognized agronomic principles (when crops are grown), and farm-to-market time requirements for agricultural commodities (shelf life), it is possible in certain instances to identify foods, such as certain items of fresh produce, that are grown after a certain date, (after the last lawful use date of a pesticide chemical). Food derived from any crop that is grown after the last lawful use date for a pesticide chemical on that food cannot meet the requirements of the channels of trade provision for residues of that pesticide chemical, because the application or use of the pesticide chemical on that food was unlawful. Thus, if FDA encounters a residue of such a pesticide chemical on any such food, FDA intends to subject that food to possible regulatory action.
In some cases, FDA may be unable to exercise enforcement discretion concerning the presence of a pesticide chemical residue without asking the responsible party to make a showing to demonstrate that the residue is present as a result of a lawful application or use of the pesticide chemical. The following two examples are illustrative.
The following five examples illustrate FDA's planned enforcement approach for multiple ingredient foods.
In the interest of fairness, FDA intends to subject the importation of any food bearing a residue (within the former tolerance) of a pesticide chemical for which a tolerance has been revoked, suspended, or modified to the same enforcement approach as that set forth in this guidance document for a domestic food.
The following three examples illustrate how FDA intends to exercise its enforcement discretion for the imported commodities as illustrated in the following three examples:
FDA intends to afford firms the opportunity to make a showing through the last date that FDA anticipates that food made from lawfully treated commodities will remain in the channels of trade. For certain processed foods, i.e., frozen, dried, and canned foods, this date will generally be 4 years from the time the treated crop is harvested.(10)
FDA also advises firms that they may include in showings, data on a pesticide chemical's degradation, its last application date, or the time period that a food remains in commerce, etc., that are different from the data that FDA used in establishing its enforcement policy concerning a specific pesticide chemical residue in food. FDA will evaluate the data presented by the firm on its own merit, and will not deem the food to be adulterated if the showing of the firm meets the requirements of the channels of trade provision, even if such showing does not on its face satisfy the parameters of FDA's enforcement policy for that pesticide chemical/food combination.
It should be noted that the opportunity to make a showing under the channels of trade provision is not provided under the FFDCA for food bearing pesticide chemical residues that are not potentially subject to the channels of trade provision, such as when the residue of a revoked pesticide chemical in a food exceeds the prior tolerance for the food or when a residue of a pesticide chemical is found in a food for which no tolerance ever existed.
FDA intends to consider the following factors in determining the showing dates:
For each pesticide chemical that is to be the subject of an EPA tolerance revocation, suspension, or modification pursuant to section 408(l)(2) of the FFDCA, FDA intends to publish on our website, as a Level 2 guidance, the showing dates we intend to use for affected food commodities with a residue of that pesticide chemical. At the same time, we intend to also publish on our website, as part of the Level 2 guidance, any other determinations we have made about residues of the pesticide chemical, such as time periods during which we intend to consider that a pesticide chemical residue found in a food is the result of lawful application or use and thus needs no showing. In addition, when appropriate, we intend to publish as part of the Level 2 guidance, the last date that we anticipate that lawfully treated commodities, fresh and processed, would remain in the channels of trade. We intend to post the Level 2 guidance on the FDA pesticides website (http://www.cfsan.fda.gov/~lrd/pestadd.html) in conjunction with EPA's proposed action concerning the pesticide chemical. EPA's proposal will generally refer readers to this website to view the applicable Level 2 guidance. Under our Good Guidance Practices regulation in 21 CFR 10.115, persons may comment on the guidance document at any time and, as appropriate, FDA will revise the document in response to the comments. Should EPA's final action differ from its proposal in a way that impacts the guidance, FDA intends to revise the guidance document as appropriate.
In general, for foods containing residues of pesticide chemicals for which tolerances have been revoked, suspended, or modified under the FFDCA, either in domestic commerce or offered for import, FDA anticipates that the party responsible will be able to provide appropriate documentation to the agency in the event that such food bears a residue of the pesticide chemical that is within the former tolerance for that food, consistent with the principles set forth in this guidance. Examples of documentation that may be appropriate for foods that are found to have residues of such pesticide chemicals within the former tolerance are provided in this section. We are not suggesting that firms maintain a certain set list of documents where anything less or different would likely be considered unacceptable. We are leaving it to each firm's discretion to maintain appropriate documentation to demonstrate that the food is subject to the channels of trade provision. Listed below are some examples of types of documentation that FDA may find acceptable for demonstrating that a food meets the requirements of the channels of trade provision:
(1) This guidance has been prepared by the Division of Plant Product Safety in the Center for Food Safety and Applied Nutrition (CFSAN) at the U.S. Food and Drug Administration.
(2) §408(l)(2) of the FFDCA) states the following:
REVOCATION OF TOLERANCE OR EXEMPTION FOLLOWING CANCELLATION OF ASSOCIATED REGISTRATIONS.--If the Administrator, acting under the Federal Insecticide, Fungicide, and Rodenticide Act, cancels the registration of each pesticide that contains a particular pesticide chemical and that is labeled for use on a particular food, or requires that the registration of each such pesticide be modified to prohibit its use in connection with the production, storage, or transportation of such food, due in whole or in part to dietary risks to humans posed by residues of that pesticide chemical on that food, the Administrator shall revoke any tolerance or exemption that allows the presence of the pesticide chemical, or any pesticide chemical residue that results from its use, in or on that food. Subsection (e) shall apply to actions taken under this paragraph. A revocation under this paragraph shall become effective not later than 180 days after--
- (A) the date by which each such cancellation of a registration has become effective; or
- (B) the date on which the use of the canceled pesticide becomes unlawful under the terms of the cancellation, whichever is later.
(3) This is a Level 1 guidance under FDA's Good Guidance Practices regulation in 21 CFR 10.115. It is a generic guidance that FDA believes will be applicable to most pesticide chemicals that EPA will address pursuant to the requirements of section 408(l)(2) of the FFDCA as amended by the FQPA. However, FDA may elect to publish a Level 1 guidance for a specific pesticide chemical in conjunction with a future EPA tolerance action if FDA determines that the generic approach in this guidance does not adequately address the pesticide chemical. Although the need for a separate Level 1 guidance for a particular pesticide chemical is expected to be rare, when necessary, FDA will issue such guidance in accordance with its Good Guidance Practices regulation in conjunction with the EPA action on the tolerance.
(4) The channels of trade provision (§408(l)(5) of the FFDCA) states the following:
PESTICIDE RESIDUES RESULTING FROM LAWFUL APPLICATION OF PESTICIDE.-Notwithstanding any other provision of this Act, if a tolerance or exemption for a pesticide chemical residue in or on a food has been revoked, suspended, or modified under this section, an article of that food shall not be deemed unsafe solely because of the presence of such pesticide chemical residue in or on such food if it is shown to the satisfaction of the Secretary that-unless, in the case of any tolerance or exemption revoked, suspended, or modified under this subsection or subsection (d) or (e), the Administrator has issued a determination that consumption of the legally treated food during the period of its likely availability in commerce will pose an unreasonable dietary risk.
- (A) the residue is present as the result of an application or use of a pesticide at a time and in a manner that was lawful under the Federal Insecticide, Fungicide, and Rodenticide Act; and
- (B) the residue does not exceed a level that was authorized at the time of that application or use to be present on the food under a tolerance, exemption, food additive regulation, or other sanction then in effect under this Act;
(5) FDA intends in its enforcement approach to use the methods for pesticide analysis cited in FDA's compliance programs for pesticide residues in domestic and imported foods. The currently cited methods are those in the FDA Pesticide Analytical Manual (PAM) I, Sections 302, 303 and 304. The methods are available at www.cfsan.fda.gov under "Pesticides and Chemical Contaminants."
(6) As explained later in this guidance, FDA would determine in a Level 2 guidance document for any given pesticide tolerance revocation, suspension, or modification, what period of time FDA believes may be reasonable for the FDA to consider the presence of a pesticide chemical residue in a food to not be subject to a showing under § 408(l)(5) of the FFDCA.
(7) Although the examples in this guidance concern pesticide chemicals that are applied to food, e.g., by growers, the approaches in the examples would also be applicable to any pesticide chemical for which a tolerance was formerly in effect permitting residues in food resulting from uses in which the food was not directly treated, e.g., a revoked tolerance for residues of a pesticide chemical in food resulting from the application of the pesticide to cracks and crevices in food storage facilities.
(8) The approaches in examples 1 and 2 are generally applicable to other foods that are stored for various periods of time, such as grains and processed foods. Depending upon the food, FDA would consider its maximum storage period and the degradation rate for the pesticide chemical in determining the time period during which the food generally would not be considered adulterated solely because of the presence of the pesticide chemical residue.
(9) However, if FDA had other evidence indicating that the residue of pesticide ABC in the fruit salad was due to the ingredient for which the tolerance had been revoked, e.g., strawberries, the responsible party should be prepared to make a showing with respect to the strawberry ingredient to enable FDA to conclude that the food is within the scope of FDA's exercise of its discretion set forth in this guidance.
(10) Based upon information referenced in the guidance document entitled "Channels of Trade Policy for Commodities with Methyl Parathion Residues," the availability of which was announced in the Federal Register on January 5, 2001 (66 FR 1247), certain processed foods (frozen, dried and canned) may remain in the channels of trade for up to 4 years after the crop is harvested.
This document supercedes Guidance for Industry: Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency (July 22, 2003)