An Overview of EPA/FDA Jurisdiction of Food Contact Antimicrobial Products John Wood Sr. Director, Agency Relations Regulatory Affairs Ecolab Inc.
Antimicrobial Regulation: The Statutory Framework FIFRA Governs registration, labeling, sale, distribution, use and most other pesticide activities. Defines pest and pesticide. FFDCA Governs food additives. (Section 409) Governs pesticide chemical residues in food. (Section 408) FFCDA Amendments FQPA (1996) Changed risk assessment standard for pesticide chemical residue in food and moved jurisdiction for all pesticide uses to EPA: Narrowed food additives definition to exclude all pesticide chemicals-ffdca 201(s) Broadened pesticide chemical definition 201(q) ARTCA (1998) Established current division of FFDCA 408 and 409 and FIFRA jurisdiction for food-contact antimicrobials: reverted back to FDA jurisdiction of certain additives
Impact Of ARTCA On EPA/FDA Regulation of Food-Contact Antimicrobials Non-Pesticide Food Additive Regulated solely by FDA under FFDCA 409. (i.e. applied to processed food no longer in its raw state) Pesticide Chemical Residue Regulated solely by EPA under FFDCA 408. (i.e. hard surface food contact sanitizing solutions) Pesticide Food Additive Regulated by FDA under FFDCA 409 and EPA under FIFRA; EPA also may conduct FFDCA 408 risk assessment, based on interpretation of FIFRA 2(b)(b). (applied to raw agricultural commodities and processed fruits and vegetables)
Implications For The Antimicrobial Applicant Or Registrant Different uses of the same antimicrobial pesticide may be subject to: - different statutes or statutory provisions - different risk standards - different data requirements Same antimicrobial use may be subject to review and approval by both FDA and EPA (also could include USDA): - two agency approvals = two sets of regulatory procedures and opportunities for delay? - different risk standards - different data requirements - reviews by both EPA and FDA - potentially conflicting risk assessments
Implications For The Antimicrobial Applicant Or Registrant FQPA transferred sole jurisdiction for hard surface food contact sanitizers to FFDCA 408 and EPA. FQPA mandated risk assessment criteria for pesticide chemical residues in food regulated under FFDCA 408 (EPA): - additional 10X safety risk assessment - aggregate and cumulative risk assessment - exposure to infants and children ARTCA shifted regulation of residues of some antimicrobials to FDA as food additives without changing their status as pesticides requiring EPA registration.
Implications For The Antimicrobial Applicant Or Registrant EPA has interpreted FIFRA 2(bb) as requiring that pesticides with food use meet the FQPA (FFDCA 408) safety standard as a requirement for FIFRA registration even when a FDA food additive regulation under FFDCA 409 is necessary to mitigate the residues from adulterating food. The FFDCA 408 standard must be met even though no tolerance or exemption from tolerance is needed.
Key Definitions To Keep In Mind When Determining Regulatory Jurisdiction of EPA and FDA EPA s definition of a Pest at 40 CFR 152.5 EPA s definition of a Pesticide What is a Pesticide Chemical Residue Processed food definition Food processing facility definition Raw agricultural commodity (RAC) definition
What Is A Pest? In circumstances that make it deleterious to man or the environment: Any vertebrate animal other than man. Any invertebrate animal except: -any internal parasite of living man or other living animal Any plant growing where not wanted. Any fungus, bacterium, virus or other microorganism except: -those in or on living man or other living animal -those on or in processed food, beverages, processed animal feed, cosmetics, or drugs (but not in or on medical devices)
What Is A Pesticide? Any substance or mixture of substances intended for preventing, destroying, repelling or mitigating any pest.
What Is A Pesticide Chemical Residue? Residues of antimicrobials applied to or in water containing Raw Agricultural Commodities (RAC s) in the field, during transportation to or in a facility that is not a food processing facility. Residues of sanitizers used on permanent or semi-permanent foodcontact surfaces. Residues of antimicrobials from food-contact (treated) articles that make a pesticide claim to reduce microorganisms on the food-contact surface except for food packaging. Food that contains a Pesticide Chemical Residue is deemed to be adulterated unless EPA has issued a tolerance or exemption from food tolerance in 40 CFR that covers the specific use.
When Is An Antimicrobial A Pesticide And A Food Additive? Direct Food Additive Added directly to processed food, expected to become a component of food and exempt from definition of pesticide. EXAMPLE: Food Preservative Secondary Direct Food Additive May become a component of food and has a technical effect on food, also may be regulated by EPA as an antimicrobial pesticide. EXAMPLE: Processing aid used in food processing (i.e. Antimicrobial Fruit and vegetable treatments) Indirect Food Additive May become component of food from intended use; also may be regulated by EPA as an antimicrobial pesticide. EXAMPLE: Sanitizing solution used in processing water, paper mill slimicide -
What is a Processed food *Processed Food food subject to the activities of canning, freezing, cooking, pasteurization or homogenization, irradiation, milling, grinding, chopping, slicing, cutting or peeling. Note: Drying is considered processing unless the purpose is to facilitate transportation or shortage of the commodity to processing. *FDA-Antimicrobial Food Additives Guide July,1999
What is not considered a processed food The following activities do not constitute the processing of food: *Washing, waxing, coloring, hydro-cooling, refrigeration, shelling of nuts, ginning of cotton, and the removal of leaves, stems, and husks. *FDA-Antimicrobial Food Additives Guide July,1999
What is a food processing facility *Food processing facility facilities where food is subject to activities that constitute processing Includes meat and poultry slaughter facilities subject to the Federal Meat Inspection Act Egg washing or processing facilities subject to Egg Product Inspection Act provided eggs are treated in a manner that changes their status from a RAC to a processed food *FDA-Antimicrobial Food Additives
What is a food processing facility cont. *Food Processing Facility facilities where food is subject to activities that constitute processing. Harvested seafood storing, preparing, heading, eviscerating, shucking, holding 21 CFR 123.3(k)(1) Fish processing operations Commercial fishing vessels Retail food establishments *FDA-Antimicrobial Food Additives Guide July,1999
What Do I Need To Do? I AM SO CONFUSED!! Erg! Who regulates what?!! I want another job!! What types of clearances or registrations do I need?!! Do I need both a 408 and a 409 clearance under FFCDA?!!!
Key Considerations Which Determine Agency Jurisdiction And Regulatory Requirements Product Application (includes use site) Intended Technical Effect Product Claims (expressed or implied) i.e. reduces spoilage and decay organisms on the surfaces of raw fruits Sanitizes eating utensils
FDA s Antimicrobials Food Additives - Guidance July 1999 Clarifies in the wake of FQPA & ARTCA FDA s jurisdiction over antimicrobials that are used in or on food. Food related uses of antimicrobial products that are excluded from FDA s regulatory authority. Definition of processed food. Definition and clarification of food processing facility.
EPA/FDA Jurisdiction Table Antimicrobials Treatments (Food Use) Category Jurisdiction Requirement Carcass Slaughter FDA/USDA (FSIS) FFDCA 409 (meat & poultry) Seafood FDA FFDCA 409 (post harvest) Egg Washes FDA (for further processing) FFDCA 409 or EPA (No further processing) FFDCA 408 or EPA (for hatchlings) FFDCA 351 (animal drug)
EPA/FDA Jurisdiction Table Antimicrobials Treatments (Food Use) (con t) Category Jurisdiction Requirement Treatment of RAC s EPA Pesticide registration except in a food and FFDCA 408 processing facility Treatment of RAC s EPA/FDA Pesticide registration during transportation to or with FFDCA 408 standard 2(bb) in a food processing facility and FFDCA 409 Consumer treatment EPA Pesticide registration of RAC s with FFDCA 408 standard (2bb) Post harvest (in the EPA Pesticide registration field) treatment of RAC s and FFDCA 408
EPA/FDA Jurisdiction Table Antimicrobials Treatments (Food Use) (con t) Category Jurisdiction Requirement Treatment of process EPA/FDA Pesticide registration water in food with FFDCA 408 standard(2bb) processing facility and FFDCA 409 Use of process water FDA FFDCA 409 to deliver antimicrobial to processed food (No claims to reduce microbial count in process water) Treatment of FDA FFDCA 409 processed food
EPA/FDA Jurisdiction Table Antimicrobials Treatments (Food Use) (con t) Category Jurisdiction Requirement Hard surface food EPA Pesticide registration contact sanitizer (includes rinse aid/sanitizer) and FFDCA 408 Food packaging EPA/FDA Pesticide registration Materials with FFDCA 408 standard (2bb) (includes pulp and and FFDCA 409 paper mill slimicides) Food contact articles EPA/FDA Pesticide registration other than packaging with FFDCA 408 standard (2bb) (includes material and FFDCA 409 preservatives and pulp and paper mill slimicides) no effect on surface of article
EPA/FDA Jurisdiction Table Antimicrobials Treatments (Food Use) (con t) Category Jurisdiction Requirement Production of Food EPA Pesticide registration Contact articles other and FFDCA 408 than food packaging- with effect on surface of the article (a registered treated article ) Treatment of EPA/FDA Pesticide registration animal drinking and FFDCA 408 for safety (no intended effect on animals
EPA/FDA Jurisdiction Table Antimicrobials Treatments (Food Use) (con t) Category Jurisdiction Requirement Treatment of EPA (OPP) Pesticide registration human drinking water OR with 408 standard (2bb) (treatment for personal or emergency use) EPA (OPP)/ EPA (OW) OR FDA Pesticide registration with 408 standard (2bb) and SD (disinfection by-products) (treatments in public water systems) FFDCA 409 (bottled water)
Additional Sources of Information To Help FDA.gov Determining Regulatory Authority for Antimicrobial Substances Decision Tree for Determining whether any Particular Antimicrobial Intervention for Food is Regulated by the Environmental Protection Agency or the Food and Drug Administration Guidance for Industry: Antimicrobial Food Additives (July 1999) EPA.gov Pesticide Registration Manual Chapter 10 Other Federal or State Agency Requirements Antimicrobial Pesticides regulated by FDA and EPA EPA/FDA Memorandum of Understanding (MoU) Information Sharing between US EPA and Department of Health and Human Services (March 2015) Regulatory consultants
A word to the wise! Conduct Presubmission Meetings with the Regulatory Agencies Regulatory jurisdiction can be very complicated! Presubmission meetings with the Agencies will help to: Determine Accurate Regulatory Jurisdiction (EPA or FDA or EPA and FDA) Confirm necessary data requirements for both Agencies Helps to avoid misunderstandings during Agency technical reviews and unnecessary product registration delays Send presubmission meeting recap letter to each Agency and request confirmation of meeting minutes. For presubmission meetings you will need: Product formulation Proposed label claims Use sites Method of product application Outline of data requirements.
EPA and FDA Approvals Received!!!! You are not done yet. You may be required to register the product in all 50 states of the US. California Department of Pesticide Regulation Review of data submitted to Federal EPA and FDA. Process timeline (6-12 months) Can result in conflicting technical review conclusions Other US states Label and MSDS are required for state registration
QUESTIONS?