U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
December 2000

Guidance for Industry: Channels of Trade Policy for Commodities with Methyl Parathion Residues

This guidance represents FDA's current thinking on the channels of trade provision and how this provision relates to FDA-regulated products with methyl parathion residues. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such an approach satisfies the requirements of applicable statutes and regulations. The agency previously issued a draft guidance for public comment on June 2, 2000 (65 FR 35376), and is now issuing a final guidance for implementation in accordance with FDA's final rule on administrative practices and procedures for Good Guidance Practices (65 FR 56468; September 19, 2000).

Purpose

This final guidance applies to firms in the food production and processing industries who handlefood products that may contain residues of the pesticide chemical "methyl parathion." It is intended to present the Food and Drug Administration's (FDA's) policy on its planned enforcement approach for foods containing methyl parathion residues in accordance with the provision in §408(l)(5) (hereinafter the "channels of trade provision") 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)). As such, this guidance will assist firms in understanding the types of showing under §408(l)(5) of the FFDCA that FDA may find satisfactory, in accordance with its planned enforcement approach for such section.

The channels of trade provision⁽¹⁾ addresses the circumstances under which a food is not unsafe solely because of the presence of a pesticide chemical residue that has been revoked, suspended, or modified by the Environmental Protection Agency (EPA). When EPA takes an action, for example, that makes the use of a pesticide unlawful under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), or lowers or revokes the corresponding tolerance for that pesticide in food, such food that was lawfully treated with the pesticide 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 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 §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 policy for its planned approach to the enforcement of the channels of trade provision with respect to the pesticide chemical methyl parathion, and it is intended to assist firms in understanding the type of showing under §408(l)(5) that FDA may find satisfactory in accordance with its planned enforcement approach for such section. FDA has developed this guidance document because, as discussed below, as part of the tolerance reassessment process mandated by FQPA, EPA has canceled several registered food uses of methyl parathion, and has revoked the corresponding tolerances for this pesticide chemical in food. FDA anticipates that some foods bearing methyl parathion residues resulting from lawful application of this pesticide chemical will remain in channels of trade after the revocation of these applicable tolerances for methyl parathion. If FDA encounters such a food bearing a residue of methyl parathion, it intends to invoke the channels of trade provision of FQPA, consistent with its policy as set forth in this guidance document.

Background

Regulation of Pesticides

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 in the United States, EPA evaluates the pesticide and determines whether or not to grant a registration that permits its sale and use.

Before allowing the use of a pesticide on food crops, the EPA, under §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. Without a tolerance or exemption from a tolerance, food containing pesticide residues is considered adulterated under §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 tolerances in imported food and in domestically-produced food shipped in interstate commerce.

Impact of the Food Quality Protection Act (FQPA)

On August 3, 1996, FQPA was signed into law. This law, which amends both FIFRA and the FFDCA, established a new safety standard for pesticide residues in food, with an emphasis on protecting the health of infants and children. In accordance with FQPA, EPA is in the process of reassessing, under the new safety standard, the pesticide tolerances and exemptions that were in effect when the law was signed. If EPA makes a determination that a pesticide's tolerance level does not meet the safety standard set forth by FQPA, the registration for the pesticide may be canceled for all or some uses. In addition, the tolerances for that pesticide may be lowered or revoked for the corresponding food commodities. Under §408(l)(2) of the FFDCA, when the registration for a pesticide 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 such tolerance (or exemption in some cases) must be no later than 180 days after the date such cancellation becomes effective or 180 days after the date on which the use of the canceled pesticide becomes unlawful under the terms of the cancellation, whichever is later.

Tolerance Reassessment for Methyl Parathion

In a cancellation order published in the FEDERAL REGISTER of October 27, 1999, EPA canceled, effective on the same date, several registered food uses⁽²⁾ for the pesticide methyl parathion (64 FR 57877). The cancellation was precipitated by EPA's determination that methyl parathion could not meet the FQPA safety standard as the pesticide is currently registered. Under limitations on the use of existing stocks, the application of the pesticide on the crops specified became unlawful after December 31, 1999, and in a final rule published in the Federal Register on January 5, 2001 EPA revoked the pesticide tolerances for methyl parathion corresponding to the canceled food uses (66 FR 1242). EPA had proposed to revoke the same pesticide tolerances in a notice published in the Federal Register on June 2, 2000 (65 FR 35307).

Methyl Parathion Residues in Foods Resulting from Legal Application

When applied to food crops in accordance with the canceled uses, methyl parathion residues dissipate by chemical degradation in the treated food at varying rates depending upon the storage conditions for the food. FDA has evaluated information provided by EPA which estimates how long residues of methyl parathion are expected to remain in various foods (Ref. 1). Each estimate is a worst case scenario in that EPA assumed the pesticide was applied to the crop on the last day application was legal under FIFRA, i.e., December 31, 1999, and at the maximum level permitted by law. These estimates indicate the following:

Information provided to FDA by food industry associations indicates that certain processed foods (frozen, dried, and canned) may remain in channels of trade for up to 4 years after a product is harvested (Ref. 2 & 3). This fact, combined with EPA's residue dissipation estimates, indicates that detectable methyl parathion residues resulting from lawful application of this pesticide may be expected to remain in some foods (i.e., some frozen foods and some refrigerated foods) for certain intervals beyond the date of revocation of the applicable tolerance. While the maximum time required for residues to dissipate in foods stored under refrigerated conditions is estimated to be relatively short, i.e., no more than a year past the date the pesticide was last lawfully applied, methyl parathion residues are not expected to dissipate in frozen foods. Conceivably, frozen food products bearing methyl parathion residues resulting from lawful application could remain in the channels of trade beyond 3 years after the applicable tolerance revocation. FDA's policy for its enforcement of the channels of trade provision for any food found to bear residues⁽⁴⁾ of methyl parathion after the tolerance is revoked will be as follows⁽⁵⁾:

Period from the date of tolerance revocation through December 31, 2000

Excluding frozen foods, FDA believes that methyl parathion residues in foods (i.e., foods stored at ambient temperature and under refrigeration) resulting from lawful application will dissipate to non-detectable levels within one year of the last potentially lawful pesticide application, i.e., by no later than December 31, 2000. For foods that were subject to the former tolerance (including frozen foods) found from the date of tolerance revocation through December 31, 2000, to contain a methyl parathion residue that complies with the former tolerance, FDA intends to consider the presence of the residue (except in the circumstances noted in the following two paragraphs) to be a result of the lawful application of methyl parathion. Consequently, FDA, as a matter of its enforcement discretion, does not plan to deem such food to be adulterated under the channels of trade provision. Thus, FDA does not plan to ask the party responsible for such food to make a showing that such food in question meets the requirements of the channels of trade provision. Instead, the agency intends to consider the food to be in compliance with the channels of trade provision.

The first exception to the above is the circumstance in which FDA has information indicating that there is a reasonable possibility that a residue that is within the former tolerance found in food from the date of tolerance revocation through December 31, 2000, resulted from application of the pesticide to the crop after December 31, 1999, which constitutes an unlawful use of methyl parathion. Such information might be provided to FDA by another government agency that has jurisdiction over pesticide usage and that has concluded that an unlawful application of a pesticide to a food crop took place. In such a circumstance, FDA would not exercise its enforcement discretion as previously stated. Rather, FDA intends to ask the party responsible to show that the food complies with §408(l)(5) of the FFDCA 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 methyl parathion residue in the food resulted from application of the pesticide to the crop prior to January 1, 2000.

The second exception is the circumstance in which the food found to bear a residue of methyl parathion is derived from a crop that was necessarily grown in the year 2000, as indicated by its growing season and shelf-life. Based upon generally recognized agronomic practices (when crops are grown), and farm-to-market time requirements for agricultural commodities (shelf life), it is possible in certain instances to identify foods, e.g. certain items of fresh produce, that are the product of the current growing year. Food derived from any crop that is grown in the year 2000 cannot meet the requirements of the channels of trade provision, because application of methyl parathion to food crops became unlawful after December 31, 1999. Thus, if FDA encounters a residue of methyl parathion on any such food (e.g. fresh lettuce), that food would be subject to regulatory action.

January 1, 2001 to June 30, 2001, for Processed Foods

If, during the period from January 1, 2001 to June 30, 2001, FDA encounters any processed food (for which the tolerance has been revoked) bearing a detectable methyl parathion residue within the former tolerance, FDA intends to notify the responsible party of this finding, and to inform that party that if the food is expected to be in interstate commerce as of July 1, 2001, the firm should be prepared to make a showing to FDA that the food is within the scope of FDA's exercise of its enforcement discretion consistent with this guidance.⁽⁶⁾

January 1, 2001 and Beyond, for Raw Agricultural Commodities

Beginning on January 1, 2001, if FDA finds a detectable residue of methyl parathion on any raw agricultural commodity for which the tolerance has been revoked, FDA intends to ask the party responsible to show that the food is within the scope of FDA's exercise of its enforcement discretion set forth in this guidance 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 methyl parathion residue in the food resulted from application of the pesticide to the crop prior to January 1, 2000. As explained above, the agency believes that after December 31, 2000, detectable residues of methyl parathion resulting from legal application should no longer be present on raw agricultural commodities subject to EPA's 1999 cancellations, and therefore such a finding of methyl parathion on a raw agricultural commodity is likely to result in the food being subject to enforcement action.

July 1, 2001 and Beyond, for Processed Foods

Based on estimates provided to FDA by industry groups, we expect that processed foods derived from crops that may have been treated with methyl parathion may remain in the channels of trade for up to four years after the crop was harvested. For the period from July 1, 2001 until December 31, 2004, when FDA encounters any processed food bearing a detectable methyl parathion residue within the former tolerance, FDA plans to ask for documentation from the party responsible to show that the food was packed or processed prior to or on December 31, 2000. In such cases, FDA intends 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 such types of documentation. As explained above, the agency believes that after December 31, 2000, detectable residues of methyl parathion resulting from legal application should no longer be present in processed foods (for which the tolerance has been revoked) other than frozen foods, and therefore such a finding of methyl parathion on nonfrozen processed food, is likely to result in the food being subject to enforcement action.

In general, FDA anticipates that the party responsible will be able to provide appropriate documentation to the agency. Examples of documentation that may be appropriate for foods that are found to have methyl parathion residues within the former tolerance are provided in the next 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.

Examples of Documentation that May be Useful to Show Applicability of the Channels of Trade Provision

Documentation associated with packing codes

If a product's label bears a packing code and the firm supplies documentation that relates that code to a packing date on or before December 31, 2000, we plan to regard such documentation as indicating that the food was packed prior to or on December 31, 2000, unless it falls within one of the two exceptions discussed earlier. FDA plans to exercise enforcement discretion for such food packaged during the stated period when methyl parathion residues may be found on food that was lawfully treated under FIFRA.

Documentation associated with batch records, and inventory records

If a product's label bears a packing code and the firm supplies documentation that relates that code to a batch record indicating that the product was processed, e.g., formulated, on or before December 31, 2000, we plan to regard such documentation as indicating that the food was processed prior to such date, unless such food falls within one of the two exceptions discussed earlier. Batch records may also be combined with inventory records to demonstrate that the ingredients used to manufacture the food were purchased on or before December 31, 2000. FDA plans to exercise its enforcement discretion for such food processed during the stated period when methyl parathion residues may be found on food that was lawfully treated under FIFRA.

Policy for Multiple Ingredient Foods, e.g., Mixed Vegetables, Blended Juices.

If FDA finds a residue of methyl parathion in a multiple ingredient food, for which all ingredients are subject to the aforementioned EPA tolerance revocations, e.g., an apple-pear juice, to be within the scope of FDA's exercise of enforcement discretion under this guidance, the responsible party would need to demonstrate that at least one of the ingredients in the food could bear the methyl parathion residue at the level found as a result of a lawful application or use of this pesticide chemical. In the case of an apple-pear juice, such a demonstration could be accomplished by providing records showing that the finished product was packed prior to January 1, 2001, or if packing occurred after that date, a firm could provide records showing that at least one of the ingredients, e.g., the pear concentrate, was placed into frozen or near-frozen inventory⁽⁷⁾ prior to January 1, 2001, the time period during which residues of methyl parathion legally applied to pears in 1999 could still be present at the levels found in the juice. In such a case for an apple-pear juice for example, if the responsible party can make such a demonstration with respect to the pear concentrate ingredient, FDA does not intend to ask the responsible party to provide additional documentation showing that the apple concentrate used in the juice did not contain methyl parathion, even if the apple concentrate ingredient was not placed into frozen or near-frozen inventory prior to January 1, 2001.

If the amount of methyl parathion found in an apple-pear juice exceeded the level of the former tolerance for methyl parathion in one of the source commodities e.g., pears (based upon the percentage of pear juice in the blend), but did not exceed the cumulative amount that would have been lawful under both of the former tolerances e.g., apples and pears, the responsible party could not make the showing only with respect to the pear concentrate as provided in the previous paragraph. In such a case the responsible party should be prepared to make a showing with respect to both the pear and the apple concentrates to enable FDA to conclude that the food is within the scope of FDA's exercise of its discretion set forth in this guidance.

If FDA finds a residue of methyl parathion in a multiple ingredient food for which some ingredients are subject to the aforementioned EPA tolerance revocation, and other ingredients are subject to current tolerances for methyl parathion, e.g., apple-cranberry juice, FDA would not regard such a situation to fall under the channels of trade provision if the amount of methyl parathion in the juice is within the current tolerance, i.e., the tolerance for cranberries (based upon the percentage of cranberry juice in the blend), and thus, FDA does not intend to ask the responsible party to make a showing that the food is within the scope of FDA's exercise of its discretion set forth in this guidance.⁽⁸⁾

If the amount of methyl parathion found in an apple-cranberry juice exceeded the level of the current tolerance for methyl parathion in cranberries (based upon the percentage of cranberry juice in the blend), but did not exceed the cumulative amount that would have been lawful under the current and former tolerances e.g., for cranberries and apples, the responsible party should be prepared to make a showing with respect to the apple juice 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.

If FDA finds a residue of methyl parathion in a multiple ingredient food for which one or more ingredients are subject to the aforementioned EPA tolerance revocation, and the remaining ingredients are not subject to current or revoked tolerances for methyl parathion, the responsible party should be prepared to make a showing with respect to one or more of the ingredients that are subject to the EPA tolerance revocation to enable FDA to conclude that the food is within the scope of FDA's exercise of its enforcement discretion set forth in this guidance. FDA does not intend to ask the responsible party to provide additional documentation showing that the ingredients not subject to current or revoked tolerances did not contain methyl parathion.

Imported Foods

Upon the effective date of the revocation of the pesticide tolerances for methyl parathion, FDA intends to subject the importation of any food (for which the tolerance has been revoked) bearing a residue of methyl parathion that is within the former tolerance to the same enforcement approach as that set forth in this guidance document for domestic food. In the interest of fairness, FDA intends to exercise its enforcement discretion for the imported commodities for which EPA has revoked the tolerance for methyl parathion as follows:

1. During the period from the date of tolerance revocation through December 31, 2000, FDA intends to consider, as a matter of its enforcement discretion, the importation of a food (for which the tolerance has been revoked) bearing a methyl parathion residue that is within the former tolerance, and not subject to either of the two exceptions discussed earlier for domestic food, to be a result of the lawful application of methyl parathion. Consequently, FDA does not plan to deem such food to be adulterated under the channels of trade provision. Thus, FDA does not plan to ask the party responsible for such food to make a showing that such food in question is within the scope of FDA's exercise of its discretion set forth in this guidance. Instead, the agency intends to consider the food to be in compliance with the channels of trade provision.

2. During the period from the date of tolerance revocation through December 31, 2000, FDA intends to detain any food (for which the tolerance has been revoked) offered for import, bearing a residue of methyl parathion, if the food is subject to either of the two exceptions discussed earlier. For example, if the agency has information indicating that there is a reasonable possibility that a residue that is within the former tolerance resulted from application of the pesticide to the crop after December 31, 1999, which EPA would consider to be an unlawful application or use within the meaning of §408(l)(5) of the FFDCA, FDA intends to ask the party responsible to show that the food complies with §408(l)(5) of the FFDCA 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 methyl parathion residue in the food resulted from application of the pesticide to the crop prior to or on December 31, 1999.

   Further, FDA intends to detain any food (for which the tolerance has been revoked) offered for import, bearing a residue of methyl parathion, if the food was derived from a crop that was necessarily grown in the year 2000, as indicated by its growing season and shelf-life. Based upon generally recognized agronomic practices (when crops are grown), and farm to market time requirements for agricultural commodities (shelf life), it is possible in certain instances to identify foods, e.g., certain items of fresh produce such as fresh lettuce, that are the product of the current growing year in the country of origin.

3. After December 31, 2000, if FDA finds a methyl parathion residue, that is within the former tolerance, in any raw agricultural commodity (for which the tolerance has been revoked) offered for import, FDA does not intend to allow importation of that food, unless the party responsible can provide documentation to show that the food was packed or processed on or prior to December 31, 2000. In such cases, FDA intends to inform the responsible party that the food appears to be in violation of the FFDCA, and provide an opportunity for the party to respond and provide such types of documentation.
4. Between January 1, 2001 and June 30, 2001, if FDA encounters any processed food (containing an ingredient for which the tolerance has been revoked) offered for import that bears a detectable methyl parathion residue within the former tolerance, FDA does not intend to detain the entry but will notify the responsible party that as of July 1, 2001 the party should be prepared to make a showing to FDA that such food, bearing a detectable residue of methyl parathion when offered for import, is within the scope of FDA's exercise of its enforcement discretion set forth in this guidance.

   For the period from July 1, 2001 until 4 years from the date of this document, if FDA finds a methyl parathion residue in any processed food (containing an ingredient for which the tolerance has been revoked) offered for import, that is within the former tolerance, FDA intends to detain the entry. FDA intends to, as a matter of its enforcement discretion, consider releasing the entry only if the responsible party provides the same type of documentation that FDA would consider under this policy for domestic processed food, e.g., documentation that the product was packed or processed on or before December 31, 2000. As explained above, such a finding of methyl parathion on such a processed food, other than a frozen food, is likely to result in the food being subject to enforcement action.

References

1. EPA, 1999. Residue Dissipation Chart containing draft estimates of methyl parathion dissipation rates in commodities under various storage conditions.
2. American Frozen Food Institute, October 26, 1999. Letter to FDA estimating the amount of time frozen fruits and vegetables are likely to remain in commerce prior to being purchased by the consumer (i.e., how long they are to remain in the channels of trade).
3. National Food Processors Association, August 23, 1999. Letter to FDA estimating the amount of time processed foods are likely to remain in the channels of trade.

Notes

¹ The channels of trade provision (§408(l)(5) of the FFDCA) states the following:

² Under the EPA cancellation, treatment of the following foods with methyl parathion was prohibited after December 31, 1999: apples, artichokes, beets (greens alone), beets (with or without tops), broccoli, Brussels sprouts, carrots, cauliflower, celery, cherries, collards, grapes, kale, lentils, kohlrabi, lettuce, mustard green, nectarines, peaches, pears, plums (fresh prunes), rutabagas (with or without tops), rutabaga tops, spinach, succulent beans and peas, tomatoes, turnips (with or without tops), turnips greens, vegetables leafy Brassica (cole), and vetch.

³ "Non-detectable levels" assumes that the methyl parathion analysis is performed using the test methods for methyl parathion cited in FDA's 2000 compliance programs for pesticide residues in domestic and imported foods (i.e., "Pesticides and Industrial Chemicals in Domestic Foods" and "Pesticides and Industrial Chemicals in Imported Foods," available at www.cfsan.fda.gov under "Inspections, Compliance, Enforcement and Recalls"). The cited methods are in the FDA Pesticide Analytical Manual (PAM) I, Sections 302, 303 and 304, available at www.cfsan.fda.gov under "Pesticides and Chemical Contaminants." FDA intends to use these cited methods to determine whether any detectable methyl parathion residues are present in food.

⁴ FDA intends to follow this enforcement approach as long as the methods for methyl parathion analysis cited in FDA's compliance programs for pesticide residues in domestic and imported foods continue to be those currently cited, i.e., the methods currently in the FDA Pesticide Analytical Manual (PAM) I, Sections 302, 303 and 304 (see footnote 4 for information about the availability of these methods). If FDA changes the methods for methyl parathion analysis in these respective compliance programs, and such changes would have a material impact on the enforcement approach described in this document, (e.g., should FDA adopt a significantly more sensitive test method) FDA intends to provide additional guidance or modify this guidance.

⁵ Foods bearing residues of methyl parathion that are subject to existing tolerances for methyl parathion that were not revoked by EPA, e.g., cranberries, are not subject to the channels of trade provision, and thus, do not fall under this guidance.

⁶ FDA decided, based upon comments received to the draft guidance, to provide an additional six months, i.e., until July 1, 2001, before it intends to ask responsible parties to provide documentation to FDA on the applicability of the channels of trade provision to processed food containing detectable methyl parathion residues. This additional six months will allow the responsible parties adequate time to compile appropriate documentation.

⁷ It is a common practice in the juice industry to inventory juice concentrates at temperatures just above the freezing point for quality retention and product handling purposes. Available information, e.g., verbal communications with industry scientists, indicates that methyl parathion residues may persist for prolonged periods of time under such storage conditions.

⁸However, if FDA had other evidence indicating that the methyl parathion residue in such a food was due to the ingredient for which the tolerance had been revoked, e.g., the apple juice ingredient in this example, the responsible party should be prepared to make a showing with respect to the apple juice 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.

Hypertext updated by cjm/dms 2001-JAN-08