Antimicrobial Regulation Technical Corrections Act Becomes Law; Jurisdictional Chaos Created by FQPA Also Addressed in a Joint FDA/EPA Policy Statement

Date: Oct 24, 2000

Congress and two federal agencies have taken the first steps toward resolving some of the jurisdictional chaos created by the passage of the Food Quality Protection Act (FQPA) of 1996 related to antimicrobials used on food and food contact surfaces. The immediate effect, however, is to create more complications.

The Antimicrobial Regulation Technical Corrections Act (ARTCA) of 1998 (P.L. 105-324, 112 Stat. 3035) was signed by President Clinton on October 30, 1998. Just prior to the passage of the law, the Environmental Protection Agency (EPA) and Food and Drug Administration (FDA) jointly issued a notice of policy interpretation on October 9, 1998, announcing their plans for implementing the jurisdictional shifts enacted two years ago (63 Fed. Reg. 54532). Much of the agencies' transition plans are rendered unnecessary by ARTCA.

Nonetheless, EPA and FDA plan to have the final word regarding jurisdictional allocations for antimicrobials in food-related uses. In addition to a transition plan, the joint notice outlines planned changes to the definition of "pest" to exclude more microorganisms and additional transfers of jurisdiction back to FDA under section 201(q)(3) of the Federal Food, Drug, and Cosmetic Act (FFDCA). The effect of the planned changes will be to restore more completely the pre-FQPA division of jurisdiction and supersede the unintended impacts of FQPA, thereby rendering most of ARTCA unnecessary. Alternatively, some view ARTCA as making the planned rulemaking unnecessary, notwithstanding the complications it creates. [Ed. EPA subsequently abandoned the joint notice. EPA took the position that Congress had acted through ARTCA and no further action was necessary—we continue to disagree-1999]

Statutory Technical Corrections

Prior to FQPA, the term "pesticide chemical" was defined as a substance intended to control pests that was used in the production, storage, or transportation of raw agricultural commodities (RACs); the safety of pesticide chemical residues was regulated by EPA under section 408 of the FFDCA. Pesticide residues on processed foods were excluded from the "pesticide chemical" definition and were regulated by FDA as food additives under section 409 of FFDCA. Pesticide residues were transformed from pesticide chemicals to food additives upon processing of food. This transformation prevented the approval of some pesticides on some crops because the residues on processed food could not pass muster under the safety standard for food additives.

FQPA redefined "pesticide chemical" to mean any pesticide, including active and inert ingredients; it no longer is limited to pesticide residues on RACs. A corresponding change was made to the definition of "food additive" to exclude pesticide chemical residues on raw or processed food. This change, which gave EPA sole jurisdiction over all pesticide residues on food, was intended to eliminate the conflict that arises when two different safety standards are applicable to a particular pesticide residue, depending upon the type of food in which it resides.

Unfortunately, FQPA did not completely eliminate the need to distinguish between RACs and processed foods. The distinction persists in the definition of "pest." By regulation, EPA has long defined "pest" to exclude microorganisms (viruses, bacteria, etc.) on, among other things, processed foods and beverages (referred to here as processed foods). Residues of antimicrobials used to control microorganisms on processed foods are not pesticide chemicals because microorganisms on them are not pests; the products that kill the microorganisms, therefore, are not pesticides; and the residues of such antimicrobial products, therefore, are not pesticide chemical residues. Consequently, both before and after FQPA, FDA regulates the use of antimicrobials on processed foods.

With FQPA's expanded definition of "pesticide chemical," however, EPA asserted jurisdiction over the use of antimicrobials in areas that FDA had previously regulated (either by statute or by custom and practice) or where a custom of dual jurisdiction had arisen without any clear statutory basis: antimicrobials used inside a processing facility on RACs (particularly in process water), food packaging materials, and other food contact articles. Consequently, a number of food additive petitions that were pending at FDA when FQPA was passed were put on hold while the two agencies sorted out the new allocation of jurisdiction.

The food and packaging industries objected to the transfer of jurisdiction for many antimicrobials from FDA to EPA. Industry believes that the pre-FQPA jurisdiction allocations were more efficient, less time-consuming, less expensive, and an equally safe approach to regulating the use of antimicrobials in food and food-related applications.

The jurisdictional confusion was an unintended consequence of the definitional changes made by FQPA. After two years—with most pending antimicrobial food additive petitions still languishing before FDA—ARTCA corrects some of the unintended results of FQPA.

    • ARTCA amends the definition of "pesticide chemical" to exclude residues of antimicrobials in the following situations so that regulatory jurisdiction for the safety of these residues reverts to FDA:

      • Residues of antimicrobial pesticides used directly on RACs or in process water that contacts RACs are subject to FDA's food additives rules under section 409 of FFDCA if the use occurs in a food processing facility. A food processing facility is defined as a facility that includes operations other than washing, waxing, fumigating, and packing.

      • Residues of antimicrobial pesticides used in or on food packaging materials are subject to FDA's food additive rules under section 409 of FFDCA.

      • While jurisdiction for the safety of antimicrobial residues for the above uses shifts to FDA, the products intended for these uses are still pesticides and, as such, must be registered with EPA. (Prior to FQPA, many of these products were registered with EPA as pesticides because they had both FDA- and EPA-regulated uses.)

    • Residues of antimicrobials used on RACs in the home, in the field, in a facility other than a food processing (OTFP) facility; used in process water in the field or at an OTFP facility; or used while transporting RACs from the field to an OTFP facility remain subject to EPA regulatory jurisdiction as pesticide chemicals under section 408 of FFDCA. Products intended for such use are pesticides.

    • ARTCA defines "pesticide chemical" to include antimicrobials used on permanent or semi-permanent food contact surfaces (other than packaging), and antimicrobials used in a permanent or semi-permanent food contact surface (other than packaging) where the antimicrobial is intended to have an ongoing effect on the food contact surface.

    • ARTCA defines ethylene oxide and propylene oxide as pesticides whenever they are used on food and, therefore, always subject to EPA jurisdiction—even when used to kill microorganisms on processed food.

    • Transition rules included in ARTCA provide that approvals granted by either EPA or FDA for antimicrobials for food-related uses remain valid, even if jurisdictional authority to grant those approvals has been changed by ARTCA.

Policy Interpretation and Regulatory Fixes

Just prior to passage of ARTCA, EPA and FDA jointly published a notice of policy interpretation (63 Fed. Reg. 54532, October 9, 1998) explaining how petitions previously filed with FDA will be transferred to EPA and how to file new petitions with EPA. This portion of the notice is superseded by ARTCA.

The policy interpretation also announces EPA's intention to propose an amendment to the definition of "pest" (40 CFR 152.5(d)) to provide three new exclusions: (1) microorganisms in a food processing facility on RACs or process water that contacts RACs; (2) microorganisms in or on food packaging or materials used to produce such packaging; and (3) microorganisms in materials used in the production of food-contact articles. These exclusions would have the same effect as the exclusions from the definition of "pesticide chemical" in ARTCA. By excluding microorganisms in these specific cases from the definition of "pest," FDA would assume sole jurisdiction over antimicrobials for these uses. FDA's food additive procedures would apply to the residues on food, and there would be no need to obtain an EPA pesticide registration for the antimicrobial product.

Microorganisms on food contact surfaces (other than packaging) are regarded as pests. If an antimicrobial is impregnated into a food contact article in order to have an ongoing effect on the microorganisms on the surface, then the article is a pesticide. The inert ingredients of these articles will be excepted from the definition of "pesticide chemical" on a case-by-case basis so as not to duplicate FDA's clearance of the components of the article per se.

More Unintended Consequences

By changing the definition of "pesticide chemical," ARTCA creates several situations where antimicrobial residues need to be cleared by FDA under section 409 of FFDCA and need to be reviewed by EPA under section 408 of FFDCA. Prior to ARTCA but after FQPA, antimicrobials on RACs in food processing facilities and in or on food contact materials (including food packaging) were subject to the new FQPA safety criteria in section 408 of FFDCA. Post-ARTCA, these antimicrobials are still pesticides—subject to EPA product registration requirements—but in some case the residues on food are no longer pesticide chemicals by statutory definition. Therefore, such residues are, by default, food additives subject to FDA's standards under section 409 of FFDCA. However, until EPA amends its definition of "pest," antimicrobials on RACs in food processing facilities and in packaging and other uses affected by ARTCA are still subject, indirectly, to the FQPA criteria in section 408 of FFDCA. The section 408 standard continues to be relevant because FQPA amended the registration criteria in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to prohibit EPA from registering a pesticide that yields residues in food that do not meet the safety criteria in section 408 of FFDCA. Therefore, even though certain foods containing antimicrobial residues would not be adulterated as long as any necessary food additive regulations under section 409 of FFDCA are in place, the pesticide product that leads to the residues would not be eligible to be registered by EPA unless the residues meet the FFDCA section 408 safety criteria as well.

As noted above, FQPA was intended to eliminate the problems created when two different safety standards apply to a particular pesticide residue, depending on whether the food in which it appeared was raw or processed. Ironically, ARTCA recreates a similar redundancy. This time the different requirements of sections 408 and 409 both apply to antimicrobials used (1) on RACs in a food processing facility; (2) in process water that contacts RACs in a food processing facility; (3) in or on food packaging materials; and (4) in food contact surfaces where no ongoing antimicrobial effect is intended.

Since the criteria for performing safety evaluations are different under sections 408 and 409, it is possible that an antimicrobial could be approved under one standard but fail to gain approval under the other. This is a conflict waiting to happen that will be avoided if EPA moves forward with its planned rulemaking.