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FDA Guidance Helps Clarify Jurisdiction Under the Federal Food, Drug and Cosmetic Act Over Residues of Antimicrobial Substances on Food

Date: Sep 13, 1999


Prior to passage of the Food Quality Protection Act (FQPA) of 1996, the division of jurisdiction over antimicrobials used in food-related applications between the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA), was governed by the provisions of the Federal Food, Drug and Cosmetic Act (FFDCA). FQPA modified FFDCA, and in the process transferred to EPA regulatory jurisdiction over several antimicrobial substances that had once been under FDA jurisdiction and made compliance with the new food safety criteria a requirement for pesticide registration.

In the two years after FQPA enactment, EPA and FDA held extensive discussions on their respective legal authorities pre- and post-FQPA. As a result, on October 9, 1998, the two agencies issued a joint notice of policy interpretation announcing their plans for implementing the jurisdictional shifts enacted two years before. See 63 Fed. Reg. 54532 (1998). The joint notice also outlined planned changes to the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) definition of "pest" to exclude more microorganisms as well as additional transfers of jurisdiction back to FDA under FFDCA section 201 (q) (3).

Subsequently, however, the agencies have decided that much of their transition plans have been rendered unnecessary by the Antimicrobial Regulation Technical Corrections Act (ARTCA), which President Clinton signed into law on October 30, 1998. See Antimicrobial Regulation Technical Corrections Act of 1998, Pub. L. No. 105-324, 112 Stat. 3035; see also Antimicrobial Regulation Technical Corrections Act Becomes Law; Jurisdictional Chaos Created by FQPA. ARTCA amended the FFDCA section 201 (q) (1) definition of "pesticide chemical." According to an EPA draft Federal Register notice dated December, 1998, ARTCA essentially accomplished EPA's and FDA's planned regulatory approach as set forth in the October 9, 1998 Federal Register notice, and the joint notice will be abandoned.

This position was confirmed on July 27, 1999, when FDA announced the availability of a guidance document intended to clarify FDAs jurisdiction over antimicrobials used in food or that may become a component of food as a result of their intended use. The document, Antimicrobial Food Additives  Guidance, also discusses the food-related uses of antimicrobial products that ARTCA excluded from FDAs regulatory authority. It describes, consistent with the interpretation set forth in the October 9, 1998 Federal Register Notice, EPAs jurisdiction over certain pesticide inert ingredients, and EPAs intent to transfer responsibility to FDA for certain inerts used as food-contact articles.

The guidance also defines certain terms, such as "processed food" and "food processing facility," that are important to the delineation of FDAs and EPAs regulatory authority. Briefly, processing alters the general state of a raw agricultural commodity (RAC), defined in FFDCA as "any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing," while non-processing operations merely isolate or separate the RAC from foreign objects or other parts of the plant. Therefore, RACs that have been canned, frozen, cooked, dried (unless the purpose for drying is to facilitate transportation or storage of the RAC prior to processing) pasteurized, homogenized, irradiated, milled, ground, chopped, sliced, cut, peeled, skinned, eviscerated, quartered, or harvested (e.g., seafood) are considered processed food. RACs that simply have been washed, colored, waxed, hydro-cooled, refrigerated, shelled (e.g., nuts), ginned (e.g., cotton), or have had their leaves, stems, or husks removed maintain their status as RACs.

A "food processing facility" is simply a facility where food is subject to activities that constitute processing. Included within this meaning are facilities where meat and poultry are slaughtered, where eggs are washed and treated such that they are changed from RACs to processed food, and where post-harvest activities are conducted on sea food. The term also includes commercial fishing vessels and retail food establishments.

An understanding of these definitions is important in determining whether EPA or FDA possesses regulatory jurisdiction over pesticides and their residues on food. The bottom line is that, for the foreseeable future, residues on food of antimicrobial products which require registration as pesticides will adulterate food unless: (1) an appropriate FDA status is established for the residue when the antimicrobial is used on a RAC in a food processing facility (defined at 3 in Table); or (2) an appropriate tolerance or exemption from tolerance is in place for a pesticide chemical in other uses. Microorganisms on processed foods continue to be exempt from the definition of "pest;" antimicrobials intended to affect such "non-pests" are not pesticides and still will only require FDA clearance.

The following table provides a summary of post-ARTCA EPA and FDA jurisdiction over pesticide products and their residue on food, as compared to the pre-FQPA jurisdictional allocation. Note that some products which have not previously required pesticide registration will now apparently be required to obtain registrations. This appears to be a consequence of EPA rethinking prior positions, since FQPA, per se, did not amend the definition of "pest" other than with respect to the use of liquid chemical sterilants on certain medical devices. The table is set up so that each cell contains two entries. The entry to the left of the "/" identifies the agency with jurisdiction for the antimicrobial product which moves in commerce. The entry to the right of the "/" identifies the agency with jurisdiction of any required pre-clearance of residues. If EPA has jurisdiction over the product, then the product is a pesticide and registration is required. If FDA has product jurisdiction, no preclearance of the specific product is required; any product which complies with applicable regulations such that its use will not cause food to be adulterated may be sold for such use in or on food as long as the product itself is not adulterated or misbranded.

Notes appear at the end of the table. © 1999 Keller and Heckman LLP. Permission granted to freely copy and distribute with attribution.

Cell entries refer to agency with jurisdiction for:

PESTICIDE PRODUCT/RESIDUE ON FOOD

Pre-FQPA

EPA's Post FQPA Interpretation!

Antimicrobial Regulation Technical Corrections Act (ARTCA)
(Amends the Definition of "Pesticide Chemical" but does not Amend EPA's
Definition of "Pest")

1. Ethylene and Propylene Oxides Applied to Food EPA/EPA EPA/EPA EPA/EPA
2. Antimicrobial Treatment for Edible Processed Foods
direct or through the claimed action of process water, treated surface, or food packaging material

(A food-contact surface is an unlikely delivery vehicle, but is included for completeness.)

FDA/FDA FDA/FDA FDA/FDA
3. Antimicrobial Treatment for Raw Agricultural Commodities (RACs) -
direct or through the claimed action of process water, treated surface, or food packaging material

(A food-contact surface is an unlikely delivery vehicle, but is included for completeness.)

OR

Antimicrobial Treatment for Process Waterregardless of whether the food contacted is RAC

(Residue on food relates to the edible food contacted by the treated process water, not the residues in the process water, per se.)

 

 

EPA/EPA
applied in the field, in the home, or in washing, waxing, fumigating, or packaging facilities

 

OR

 

FDA/FDA
applied in food processing facilities based on informal understanding between FDA and EPA

 

 

 

 

EPA/EPA

FQPA prompted EPA to terminate its deference to FDA regarding the use of antimicrobials on RACs in food processing facilities.

EPA/EPA
applied in the field; at a facility that is not a food processing facility (defined as a facility where processing other than washing, waxing, fumigating, or packing occurs); or applied during transportation between the field and a food processing facility. UNLESS&

EPA/FDA
&through the claimed action of a food packaging material
EPA/FDA
when in a food processing facility
EPA/EPA
in the home
4. Sanitizer for Food Packaging Surfaces (e.g. Hydrogen Peroxide) FDA/FDA EPA/EPA EPA/FDA
5. (a) "No Rinse" Sanitizer for (Non-packaging) Food-contact Surfaces

5.(b) Disinfectants Required to be Rinsed after Use on Food-contact Surfaces

(a) EPA/FDA
EPA registration requirement imposed by FDA regulation prior to EPA clarification that food-contact surfaces are not processed foods for purposes of the regulatory definition of pest.!

(b) EPA/None

 

EPA/EPA
EPA has announced that it intends to require all antimicrobials used on non-packaging food-contact surfaces to be registered on the basis of "No Rinse" use instructions.

 

EPA/EPA
EPA has announced that it intends to require all antimicrobials used on non-packaging food-contact surfaces to be registered on the basis of "no Rinse" use instructions.

6. Materials Preservative for Food Packaging Materials and Food-contact Equipment FDA*/FDA EPA/EPA EPA/FDA
7. Antimicrobial in Food Packaging which is Claimed to Reduce Microorganisms on Food Packaging Surfaces FDA*/FDA EPA/EPA EPA/FDA
8. Antimicrobial in Food-contact Articles which is Claimed to Reduce Microorganisms on the Surface of (Non-Packaging) Food-contact Articles EPA/???
Pesticides added to articles require registration but other components presumably defaulted to FDA. EPA did not consistently issue tolerances or exemptions from tolerance for the registered pesticide or other components.
EPA/EPA
Presumably, all components of such articles now require tolerances or exemptions from tolerance. No guidance or enforcement since enactment of FQPA, so interpretation is uncertain.
EPA/EPA
EPA intends to defer to FDA under 21 U.S.C.
§ 321 (q) (3) regarding the status of "inerts" that compose the structure of the articles.

    Shaded boxes indicate that different agencies would be responsible for product registration and food safety. However, EPA may still be required to apply FQPA safety criteria before registering products (even though FDA has cleared the safety of potential residues under section 409 of the Federal Food Drug and Cosmetic Act (21 U.S.C. § 348)). Section 2(bb) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) provides that "[t]he term "unreasonable adverse effects on the environment" means . . . (2) a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a) . . ." 7 U.S.C. § 136(bb). EPA cannot register a product that poses an unreasonable adverse effect on the environment. On October 9, 1998, EPA published a Federal Register Notice which would eliminate the need to apply the 408 criteria to residues already found to be safe under section 409 by expanding the circumstances under which microorganisms would be excluded from the definition of "pest." See 63 Fed. Reg. 54,532 (1998). Current indications are that this approach has been abandoned and the allocation of jurisdiction created by ARTCA will remain the law for the foreseeable future.

!     All changes in jurisdiction that EPA attributes to FQPA arguably result from EPA's non-codified decision to interpret the definition of the term "processed food" for purposes of its regulatory definition of the term "pest" more narrowly than the statutory definition of "processed food" contained in FQPA; presumably enforcement discretion will permit unregistered products to remain on the market in those situations where this interpretation requires registration of previously unregistered products. EPA has not spoken on this issue, nor has it initiated any enforcement actions against historical FDA regulated products that are now unregistered pesticides.

* Most products used for this purpose already have EPA registrations because they typically have uses that do not involve food contact.