Food Law

Accessibility


| Share

cGMPs & HACCP for Animal Food/Feed (proposed regulations)

.

Congress updated its direction to the FDA to develop and implement regulations overseeing the safety of food, except seafood, juice, meat, poultry and eggs.  This statute -- the FDA Food Safety Modernization Act (FSMA) -- was signed by the president in early January 2011 and requires that the remaining food processing business develop and implement a HACCP-based Food Safety Plan.  The underlying statutory authority is found at 21 U.S.C. 350g; one of the proposed regulation is copied below.

.

Subpart a General Provisions

§ 507.1 Applicability and status.

(a) The criteria and definitions in this part will apply in determining whether an animal food is adulterated:

(1) Within the meaning of section 402(a)(3) of the Federal Food, Drug, andCosmetic Act in that the food has been manufactured under such conditions that it is unfit for food; or

(2) Within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act in that the food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. The criteria and definitions in this part also apply in determining whether an animal food is in violation of section 361 of the Public Health Service Act (42 U.S.C. 264).

(b) The operation of a facility that manufactures, processes, packs, or holds animal food for sale in the United States if the owner, operator, or agent in charge of such facility is required to comply with and is not in compliance with section 418 of the Federal Food, Drug, and Cosmetic Act or subparts C, D, and F of this part and § 507.7 is a prohibited act under section 301(uu) of the Federal Food, Drug, and Cosmetic Act.

(c) Animal food covered by specific current good manufacturing practice regulations also is subject to the requirements of those regulations.

(d) Animal food for sale in the United States must be manufactured, processed, packed, and held in accordance with the requirements in this part, subject to the exemptions in § 507.5. If a facility is required to comply with subpart B of this part and is also required to comply with subpart B of part 117 of this chapter because the facility manufactures, processes, packs, or holds human food, then the facility may choose to comply with the requirements in subpart B of part 117, instead of subpart B of part 507, as to the manufacturing, processing, packing, and holding of animal food at that facility. If a facility is required to comply with subpart C of part 507 and is also required to comply with subpart C of part 117 of this chapter, then the facility may choose to comply with the requirements in subpart C of part 117 as to the manufacturing, processing, packing, and holding of animal food at the facility, instead of subpart C of part 507, so long as the food safety plan also addresses all hazards that are reasonably likely to occur in the animal food, including nutrient imbalances. In both instances, when applying the requirements of part 117 of this chapter to animal food, the term “food” in part 117 includes animal food.

 

§ 507.3 Definitions.

The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this part. The following definitions also apply:

  • Adequate means that which is needed to accomplish the intended purpose in keeping with good public health practice.
  • Affiliate means any facility that controls, is controlled by, or is under common control with another facility.
  • Animal food means food for animals other than man and includes pet food, animal feed, and raw materials and ingredients.
  • Batter means a semifluid substance, usually composed of flour and other ingredients, into which principal components of food are dipped or with which they are coated, or which may be used directly to form bakery foods.
  • Blanching, except for tree nuts and peanuts, means a prepackaging heat treatment of foodstuffs for a sufficient time and at a sufficient temperature to partially or completely inactivate the naturally occurring enzymes and to effect other physical or biochemical changes in the food.
  • Calendar day means every day shown on the calendar.
  • Critical control point means a point, step, or procedure in a food process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to an acceptable level.
  • Environmental pathogen means a microorganism that is of animal or human health significance and is capable of surviving and persisting within the manufacturing, processing, packing, or holding environment.
  • Facility means a domestic facility or a foreign facility that is required to register under section 415 of the Federal Food, Drug, and Cosmetic Act, in accordance with the requirements of 21 CFR part 1, subpart H.
  • Farm means farm as defined in § 1.227(b) of this chapter.
  • FDA means the Food and Drug Administration.
  • Food means food as defined in section 201(f) of the Federal Food, Drug, and Cosmetic Act and includes raw materials and ingredients.
  • Food-contact surfaces are those surfaces that contact animal food and those surfaces from which drainage, or other transfer, onto the food or onto surfaces that contact the food ordinarily occurs during the normal course of operations. “Food-contact surfaces” include food-contact surfaces of utensils and equipment.
  • Harvesting applies to farms and farm mixed-type facilities and means activities that are traditionally performed by farms for the purpose of removing raw agricultural commodities from the place they were grown or raised and preparing them for use as food. Harvesting is limited to activities performed on raw agricultural commodities on the farm on which they were grown or raised, or another farm under the same ownership. Harvesting does not include activities that transform a raw agricultural commodity, as defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act, into a processed food as defined in section 201(gg). Gathering, washing, trimming of outer leaves of, removing stems and husks from, sifting, filtering, threshing, shelling, and cooling raw agricultural commodities grown on a farm or another farm under the same ownership are examples of harvesting.
  • Hazard means any biological, chemical, physical, or radiological agent that is reasonably likely to cause illness or injury in animals or humans in the absence of its control.
  • Hazard reasonably likely to occur means a hazard for which a prudent person who manufactures, processes, packs, or holds food would establish controls because experience, illness data, scientific reports, or other information provides a basis to conclude that there is a reasonable possibility that the hazard will occur in the type of food being manufactured, processed, packed, or held in the absence of those controls.
  • Holding means storage of food. Holding facilities include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks. For farms and farm mixed-type facilities, holding also includes activities traditionally performed by farms for the safe or effective storage of raw agricultural commodities grown or raised on the same farm or another farm under the same ownership, but does not include activities that transform a raw agricultural commodity, as defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act, into a processed food as defined in section 201(gg).
  • Lot means the food produced during a period of time indicated by a specific code.
  • Manufacturing/processing means making food from one or more ingredients, or synthesizing, preparing, treating, modifying, or manipulating food, including food crops or ingredients. Examples of manufacturing/processing activities are cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling, or packaging. For farms and farm mixed-type facilities, manufacturing/processing does not include activities that are part of harvesting, packing, or holding.
  • Microorganisms means yeasts, molds, bacteria, viruses, protozoa, and microscopic parasites and includes species having animal or human health significance. The term “undesirable microorganisms” includes those microorganisms that are of animal or human health significance, that subject food to decomposition, that indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated.
  • Mixed-type facility means an establishment that engages in both activities that are exempt from registration under section 415 of the Federal Food, Drug, and Cosmetic Act and activities that require the establishment to be registered. An example of such a facility is a “farm mixed-type facility,” which is an establishment that grows and harvests crops or raises animals and may conduct other activities within the farm definition, but also conducts activities that require the establishment to be registered.
  • Monitor means to conduct a planned sequence of observations or measurements to assess whether a process, point, or procedure is under control and to produce an accurate record for use in verification.
  • Packaging (when used as a verb) means placing food into a container that directly contacts the food and that the consumer receives.
  • Packing means placing food into a container other than packaging the food. For farms and farm mixed-type facilities, packing also includes activities traditionally performed by farms to prepare raw agricultural commodities grown or raised on the same farm or another farm under the same ownership for storage and transport, but does not include activities that transform a raw agricultural commodity, as defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act, into a processed food as defined in section 201(gg).
  • Pest refers to any objectionable animals or insects including birds, rodents, flies, and larvae.
  • Plant means the building or establishment, or parts thereof, used for or in connection with the manufacturing, processing, packing, or holding of animal food.
  • Preventive controls means those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis.
  • Qualified end-user, with respect to an animal food, means the consumer of the food (where the term does not include a business); or a restaurant or retail food establishment (as those terms are defined in § 1.227(b) of this chapter) that:
  • Is located:
    • In the same State as the qualified facility that sold the food to such restaurant or retail food establishment; or
    • Not more than 275 miles from such facility; and
    • Is purchasing the food for sale directly to consumers at such restaurant or retail food establishment.
    • Qualified facility means (when including the sales by any subsidiary; affiliate; or subsidiaries or affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate) a facility that is a very small business as defined in this part, or a facility to which both of the following apply:
    • During the 3-year period preceding the applicable calendar year, the average annual monetary value of the animal food manufactured, processed, packed, or held at such facility that is sold directly to qualified end-users (as defined in this part) during such period exceeded the average annual monetary value of the animal food sold by such facility to all other purchasers; and
    • The average annual monetary value of all animal food sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation.
    • Qualified individual means a person who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA, or is otherwise qualified through job experience to develop and apply a food safety system.
    • Quality control operation means a planned and systematic procedure for taking all actions necessary to prevent food from being adulterated.
    • Reasonably foreseeable hazard means a potential biological, chemical, physical, or radiological hazard that may be associated with the facility, or the food.
    • Rework means clean, unadulterated food that has been removed from processing for reasons other than insanitary conditions or that has been successfully reconditioned by reprocessing and that is suitable for use as food.
    • Safe moisture level is a level of moisture low enough to prevent the growth of undesirable microorganisms in the finished product under the intended conditions of manufacturing, processing, packing, and holding. The safe moisture level for a food is related to its water activity (a w). An a w will be considered safe for a food if adequate data are available that demonstrate that the food at or below the given a w will not support the growth of undesirable microorganisms.
    • Sanitize means to adequately treat cleaned food-contact surfaces by a process that is effective in destroying vegetative cells of microorganisms of animal or human health significance, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for animals or humans.
    • Should is used to state recommended or advisory procedures or identify recommended equipment. Should denotes non-binding guidance.
    • Significantly minimize means to reduce to an acceptable level, including to eliminate.
    • Small business means, for purposes of this part, a business employing fewer than 500 persons.
    • Subsidiary means any company that is owned or controlled directly or indirectly by another company.
    • Validation means that element of verification focused on collecting and evaluating scientific and technical information to determine whether the food safety plan, when properly implemented, will effectively control the identified hazards.
    • Verification means those activities, other than monitoring, that establish the validity of the food safety plan and that the system is operating according to the plan.

Option 1 for Definition of “Very Small Business”

Very small business means, for purposes of this part, a business that has less than $500,000 in total annual sales of animal food, adjusted for inflation.

Option 2 for Definition of “Very Small Business”

Very small business means, for purposes of this part, a business that has less than $1,000,000 in total annual sales of animal food, adjusted for inflation.

Option 3 for Definition of “Very Small Business”

Very small business means, for purposes of this part, a business that has less than $2,500,000 in total annual sales of animal food, adjusted for inflation.

Water activity (a w) means a measure of the free moisture in a food and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.

 

§ 507.5 Exemptions.

(a) This part does not apply to establishments (including “farms” as defined in § 1.227(b) of this chapter) that are not required to register under section 415 of the Federal Food, Drug, and Cosmetic Act.

(b) Activities in animal food facilities that are regulated under, and are in compliance with, § 500.23 and part 113 of this chapter (Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers) are exempt from subpart C of part 507 only with respect to those microbiological hazards regulated under part 113. The facilities must comply with subparts C and F of this part regarding all other potential hazards and must comply with subparts A and B of this part.

(c) Subpart C of this part does not apply to activities of a facility that are subject to section 419 of the Federal Food, Drug, and Cosmetic Act (Standards for Produce Safety).

(d) Except as provided in subpart D of this part, qualified facilities are exempt from subpart C of this part if they comply with the requirements in § 507.7.

(e) Subpart C of this part does not apply to on-farm packing or holding of animal food by a small or very small business if the only packing and holding activities subject to section 418 of the Federal Food, Drug, and Cosmetic Act that the business conducts are the following low-risk packing or holding activity/animal food combinations on animal food not grown, raised, or consumed on that farm mixed-type facility or another farm or farm mixed-type facility under the same ownership:

(1) Conveying, weighing, sorting, culling, or grading (incidental to storing):

(i) Grain (e.g., barley, corn, rice, oat, sorghum, triticale, wheat);

(ii) Oilseed (e.g., cottonseed, linseed, rapeseed, soybean, sunflower);

(iii) Grain or oilseed byproducts;

(iv) Forage (e.g., hay or ensiled material); or

(v) Other plants or plant byproducts (e.g., almond, peanut, or soybean hulls, citrus, other fruit including culled fruit, potatoes, or other vegetables including culled vegetables).

(2) Storing:

(i) Dried grain;

(ii) Dried oilseed;

(iii) Byproducts of dried grain or dried oilseed;

(iv) Forage; or

(v) Other plants or plant byproducts.

(3) Packing:

(i) Grain;

(ii) Oilseed;

(iii) Grain or oilseed byproducts;

(iv) Forage; or

(v) Other plants or plant byproducts.

(4) Mixing (incidental to packing or storing):

(i) Grain, whole; or

(ii) Forage.

(f) Subpart C does not apply to on-farm low-risk manufacturing/processing activities conducted by a small or very small business if the only manufacturing/processing activities subject to section 418 of the Federal Food, Drug, and Cosmetic Act that the business conducts consists of the following:

(1) When conducted on a farm mixed-typed facility's own raw agriculture commodities as defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act, (those grown or raised on that farm mixed-type facility or another farm/farm mixed-typed facility under the same ownership) for distribution into commerce:

(i) Cracking, crimping, or flaking:

(A) Grain (e.g., barley, corn, rice, oat, sorghum, triticale, wheat);

(B) Oilseed (e.g., cotton seed, linseed, rapeseed, soybean, sunflower); or

(C) Grain or oilseed byproducts.

(ii) Crushing, grinding, milling, pulverizing, or dry rolling:

(A) Grain;

(B) Oilseed;

(C) Grain or oilseed byproducts;

(D) Forage (e.g., hay or ensiled material); or

(E) Other plants or plant byproducts (e.g., such as almond, peanut, or soybean hulls, citrus, other fruit including culled fruit, potatoes, or other vegetables including culled vegetables).

(iii) Making silage.

(iv) Chopping or shredding hay.

(v) Extracting (mechanical) or wet rolling:

(A) Grain; or

(B) Oilseed.

(2) When conducted on animal food other than the farm mixed-typed facility's own raw agriculture commodities for distribution into commerce:

(i) Cracking, crimping, flaking, or shelling:

(A) Grain (e.g., barley, corn, rice, oat, sorghum, triticale, wheat);

(B) Oilseed (e.g., cotton seed, linseed, rapeseed, soybean, sunflower); or

(C) Grain or oilseed byproducts.

(ii) Crushing, grinding, milling, pulverizing, or dry rolling:

(A) Grain;

(B) Oilseed;

(C) Grain or oilseed byproducts;

(D) Forage (e.g., hay or ensiled material); or

(E) Other plants or plant byproducts (e.g., such as almond, peanut, or soybean hulls, citrus, other fruit including culled fruit, potatoes, or other vegetables including culled vegetables).

(iii) Making silage.

(iv) Chopping or shredding hay.

(v) Extracting (mechanical) or wet rolling:

(A) Grain; or

(B) Oilseed.

(vi) Labeling:

(A) Grain whole; or

(B) Oilseed whole.

(vii) Sifting, separating, or sizing:

(A) Grain;

(B) Oilseed;

(C) Grain or oilseed byproducts; or

(D) Other plants or plant byproducts.

(g) Subpart C of this part does not apply to facilities that are solely engaged in the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing.

(h) Subpart B of this part does not apply to the holding or transportation of one or more raw agricultural commodities as defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act.

 

§ 507.7 Requirements that apply to a qualified facility.

(a) A qualified facility is exempt from subpart C of this part provided that for the calendar year in which it is to be considered a qualified facility, the facility has submitted to FDA documentation that:

(1) Demonstrates the facility is a qualified facility as defined in § 507.3. For the purpose of determining whether a facility satisfies the definition of qualified facility, the baseline year for calculating the adjustment for inflation is 2011; and

(2)

(i) Demonstrates the owner, operator, or agent in charge of the facility has identified the potential hazards associated with the animal food being manufactured, processed, packed, or held at the facility, is implementing preventive controls to address the hazards, and is monitoring the performance of the preventive controls to ensure that such controls are effective; or

(ii) Demonstrates the facility is in compliance with state, local, county, or other applicable non-Federal food safety law. This documentation may include inspection reports, certification by an appropriate agency (such as a State department of agriculture), or other documentation deemed appropriate by FDA.

(b) The documentation required by paragraph (a) of this section must be submitted to FDA by any one of the following means:

(1) To submit electronically, go to http://www.access.fda.gov and follow the instructions. This Web site is available from wherever the Internet is accessible, including libraries, copy centers, schools, and Internet cafes. FDA encourages electronic submission.

(2) To submit documents in a paper format or in an electronic format on a CD-ROM, mail these to the U.S. Food and Drug Administration, ATTN: Qualified Facility Coordinator, 10903 New Hampshire Ave., Silver Spring, MD 20993. We recommend that an owner, operator, or agent in charge of a facility submit by mail only if the facility does not have reasonable access to the Internet.

(c) The documentation required by paragraph (a) of this section must be:

(1) Submitted to FDA initially within 90 days of the applicable compliance date of this part; and

(2) Resubmitted at least every 2 years, or whenever there is a material change to the information described in paragraph (a) of this section. For the purpose of this section, a material change is one that changes whether or not a facility is a “qualified facility”.

(d) A qualified facility that does not submit documentation under paragraph (a)(2)(i) of this section must provide notification to consumers as to the name and complete business address (the street address, city, state, and ZIP code for domestic facilities, and comparable full address information for foreign facilities) of the facility where the animal food was manufactured or processed as follows:

(1) Such notification must appear in a prominent and conspicuous location on the label for animal food required to bear a package label under any other provision of the Federal Food, Drug, and Cosmetic Act.

(2) For animal food that is not required to bear a food packaging label, the notification must appear prominently and conspicuously, at the point of purchase, on a label, poster, sign, placard, or documents delivered contemporaneously with the food in the normal course of business, or in an electronic notice, in the case of Internet sales.

(e) A qualified facility must maintain those records relied upon to support the documentation required by § 507.7(a)(2). These records are subject to the requirements of subpart F of this part.

 

§ 507.10 Applicability of subpart C to a facility solely engaged in the storage of packaged animal food that is not exposed to the environment.

(a) Subpart C of this part does not apply to a facility solely engaged in the storage of packaged animal food that is not exposed to the environment and does not require time/temperature control to ensure the safety of the animal food.

(b) A facility solely engaged in the storage of packaged animal food that is not exposed to the environment but requires time/temperature control is subject to the modified requirements in § 507.48.

 

Subpart B Current Good Manufacturing Practice

 

§ 507.14 Personnel.

(a) Plant management must take all reasonable measures and precautions to ensure that:

(1) Any person who, by his own acknowledgement, by medical examination, or by supervisory observation, is shown to have, or appears to have any illness, open skin lesion, or other source of abnormal microbial contamination by which there is a reasonable possibility of animal food, animal food-contact surfaces, or animal food-packaging materials becoming contaminated, is excluded from any operations which may be expected to result in such contamination until the condition is resolved;

(2) Personnel have been instructed to report such health conditions to their supervisors;

(3) All persons working in direct contact with animal food, animal food-contact surfaces, and animal food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect against contamination of animal food. The methods for maintaining cleanliness include:

(i) Maintaining adequate personal cleanliness;

(ii) Washing hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work and at any other time when the hands may have become soiled or contaminated;

(iii) Removing all unsecured jewelry and other objects that might fall into animal food, equipment, or containers;

(iv) Storing clothing or other personal belongings in areas other than where animal food is exposed or where equipment or utensils are washed; and

(v) Taking any other necessary precautions to protect against contamination of animal food, animal food-contact surfaces, or animal food-packaging materials with microorganisms or foreign substances.

(b) Personnel responsible for identifying sanitation failures or animal food contamination should have a background of education or experience, or a combination thereof, to provide a level of competency necessary for production of clean and safe animal food. Animal food handlers and supervisors should receive appropriate training in proper food handling techniques and food-protection principles and should be informed of the danger of poor personal hygiene and unsanitary practices.

(c) Responsibility for ensuring compliance by all personnel with all requirements of this subpart must be clearly assigned to competent supervisory personnel.

 

§ 507.17 Plant and grounds.

(a) The grounds about an animal food plant under the control of the operator must be kept in a condition that will protect against the contamination of animal food. The methods for adequate maintenance of grounds must include:

(1) Properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the plant that may constitute an attractant, breeding place, or harborage for pests;

(2) Maintaining roads, yards, and parking lots so that they do not constitute a source of contamination in areas where animal food is exposed;

(3) Adequately draining areas that may contribute to contamination of animal food by seepage, foot-borne filth, or providing a breeding place for pests; and

(4) Treating and disposing of waste so that it does not constitute a source of contamination in areas where animal food is exposed. If the plant grounds are bordered by grounds not under the operator's control and not maintained in the manner described in paragraph (a)(1) through (a)(3) of this section, care must be exercised in the plant by inspection, extermination, or other means to exclude pests, dirt, and filth that may be a source of animal food contamination.

(b) The plant's buildings and structures must be suitable in size, construction, and design to facilitate maintenance and sanitary operations for animal food-production purposes (i.e., manufacturing, processing, packing, and holding). The plant must:

(1) Provide sufficient space for such placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe animal food.

(2) Permit the taking of proper precautions to reduce the potential for contamination of animal food, animal food-contact surfaces, or animal food-packaging materials with microorganisms, chemicals, filth, and other extraneous material. The potential for contamination may be reduced by adequate food safety controls and operating practices or effective design, including the separation of operations in which contamination is likely to occur, by one or more of the following means: Location, time, partition, air flow, enclosed systems, or other effective means.

(3) Permit the taking of proper precautions to protect animal food in outdoor bulk vessels by any effective means, including:

(i) Using protective coverings;

(ii) Controlling areas over and around the vessels to eliminate harborages for pests;

(iii) Checking on a regular basis for pests and pest infestation; and

(iv) Skimming fermentation vessels, as necessary.

(4) Be constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair; that drip or condensate from fixtures, ducts, and pipes does not contaminate animal food, animal food-contact surfaces, or animal food-packaging materials; and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating animal food, animal food-contact surfaces, or animal food-packaging materials.

(5) Provide adequate lighting in hand-washing areas, toilet rooms, areas where animal food is examined, processed, or stored, and areas where equipment or utensils are cleaned; and provide safety-type light bulbs, fixtures, and skylights, or other glass items suspended over exposed animal food in any step of preparation, or otherwise protect against animal food contamination in case of glass breakage.

(6) Provide adequate ventilation or control equipment to minimize odors and vapors (including steam and noxious fumes) in areas where they may contaminate animal food; and locate and operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating animal food, animal food-packaging materials, and animal food-contact surfaces.

(7) Provide, where necessary, adequate screening or other protection against pests.

 

§ 507.19 Sanitary operations.

(a) Buildings, fixtures, and other physical facilities of the plant must be maintained in a sanitary condition and must be kept in repair sufficient to prevent animal food from becoming adulterated. Cleaning and sanitizing of utensils and equipment must be conducted in a manner that protects against contamination of animal food, animal food-contact surfaces, or animal food-packaging materials.

(b) Cleaning compounds and sanitizing agents must be free from undesirable microorganisms and must be safe and adequate under the conditions of use. Compliance with this requirement may be verified by any effective means, including purchase of these substances under a supplier's guarantee or certification or examination of these substances for contamination.

(c) The following applies to toxic materials:

(1) Only the following toxic materials may be used or stored in a plant where animal food is processed or exposed:

(i) Those required to maintain clean and sanitary conditions;

(ii) Those necessary for use in laboratory testing procedures;

(iii) Those necessary for plant and equipment maintenance and operation; and

(iv) Those necessary for use in the plant's operations.

(2) Toxic cleaning compounds, sanitizing agents, and pesticide chemicals must be identified, held, and stored in a manner that protects against contamination of animal food, animal food-contact surfaces, or animal food-packaging materials.

(d) Effective measures must be taken to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against the contamination of animal food on the premises by pests. The use of insecticides or rodenticides is permitted only under precautions and restrictions that will protect against the contamination of animal food, animal food-contact surfaces, and animal food-packaging materials.

(e) All animal food-contact surfaces, including utensils and animal food-contact surfaces of equipment, must be cleaned as frequently as necessary to protect against contamination of animal food.

(1) Animal food-contact surfaces used for manufacturing, processing or holding low-moisture animal food must be in a clean, dry, sanitary condition at the time of use. When the surfaces are wet-cleaned, they must, when necessary, be sanitized and thoroughly dried before subsequent use.

(2) In wet processing, when cleaning is necessary to protect against the introduction of microorganisms into animal food, all animal food-contact surfaces must be cleaned and sanitized before use and after any interruption during which the animal food-contact surfaces may have become contaminated. Where equipment and utensils are used in a continuous production operation, the utensils and animal food-contact surfaces of the equipment must be cleaned and sanitized as necessary.

(3) Single-service articles (such as utensils intended for one-time use, paper cups, and paper towels) should be stored in appropriate containers and must be handled, dispensed, used, and disposed of in a manner that protects against contamination of animal food, animal food-contact surfaces, or animal food-packaging materials.

(f) Non-animal food-contact surfaces of equipment used in the operation of an animal food plant should be cleaned in a manner and as frequently as necessary to protect against contamination of animal food, animal food-contact surfaces, and animal food-packaging materials.

(g) Cleaned and sanitized portable equipment with animal food-contact surfaces and utensils should be stored in a location and manner that protects animal food-contact surfaces from contamination.

 

§ 507.20 Sanitary facilities and controls.

(a) The water supply must be sufficient for the operations intended and must be derived from an adequate source. Any water that contacts animal food, animal food-contact surfaces, or animal food-packaging materials must be safe and of adequate sanitary quality. Running water at a suitable temperature, and under pressure as needed, must be provided in all areas where required for the processing of animal food, for the cleaning of equipment, utensils, and animal food-packaging materials, or for employee sanitary facilities.

(b) Plumbing must be of adequate size and design and adequately installed and maintained to:

(1) Carry sufficient quantities of water to required locations throughout the plant;

(2) Properly convey sewage and liquid disposable waste from the plant;

(3) Avoid constituting a source of contamination to animal food, water supplies, equipment, or utensils or creating an unsanitary condition;

(4) Provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor; and

(5) Provide that there is not backflow from, or cross-connection between, piping systems that discharge waste water or sewage and piping systems that carry water for animal food or animal food manufacturing.

(c) Sewage must be disposed of through an adequate sewerage system or through other adequate means.

(d) Each plant must provide its employees with adequate, readily accessible toilet facilities. Toilet facilities must be kept clean and must not be a potential source of contamination of animal food, animal food-contact surfaces, or animal food-packaging materials.

(e) Each plant must provide hand-washing facilities designed to ensure that an employee's hands are not a source of contamination of animal food, animal food-contact surfaces, or animal food-packaging materials, by providing facilities that are adequate, convenient, and furnish running water at a suitable temperature.

(f) Rubbish must be conveyed, stored, and disposed of in a way to minimize the development of odor, minimize the potential for the waste becoming an attractant and harborage or breeding place for pests, and protect against contamination of animal food, animal food-contact surfaces, animal food-packaging materials, water supplies, and ground surfaces.

 

§ 507.22 Equipment and utensils.

(a)

(1) All plant equipment and utensils must be designed and of such material and workmanship to be adequately cleanable, and must be properly maintained;

(2) The design, construction, and use of equipment and utensils must preclude the adulteration of animal food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants;

(3) All equipment should be installed and maintained in such a way to facilitate the cleaning of the equipment and all adjacent spaces;

(4) Animal food-contact surfaces must be made of materials that resist corrosion when in contact with animal food;

(5) Animal food-contact surfaces must be made of nontoxic materials and designed to withstand the environment of their intended use and the action of animal food, and, if applicable, the action of cleaning compounds and sanitizing agents; and

(6) Animal food-contact surfaces must be maintained to protect animal food from being contaminated.

(b) Seams on animal food-contact surfaces must be maintained so as to minimize accumulation of food particles, dirt, and organic matter, and thus minimize the opportunity for growth of microorganisms.

(c) Equipment in the animal food manufacturing or handling area that does not come into contact with animal food must be constructed in such a way that it can be kept in a clean condition.

(d) Holding, conveying, and manufacturing systems, including gravimetric, pneumatic, closed, and automated systems, must be of a design and construction that enables them to be maintained in an appropriate sanitary condition.

(e) Each freezer and cold storage compartment used to store and hold animal food capable of supporting growth of microorganisms must be fitted with an indicating thermometer, temperature-measuring device, or temperature-recording device installed to show the temperature accurately within the compartment.

(f) Instruments and controls used for measuring, regulating, or recording temperatures, pH, a w, or other conditions that control or prevent the growth of undesirable microorganisms in animal food must be accurate and precise and adequately maintained, and adequate in number for their designated uses.

(g) Compressed air or other gases mechanically introduced into animal food or used to clean animal food-contact surfaces or equipment must be treated in such a way that animal food is not contaminated.

 

§ 507.25 Processes and controls.

(a) Plant management must ensure that:

(1) All operations in the manufacturing, processing, packing, and holding of animal food (including operations directed to receiving, inspecting, transporting, and segregating) are conducted in accordance with adequate sanitation principles;

(2) Containers holding animal food, raw materials, or ingredients are labeled to accurately identify the contents;

(3) The labeling for the finished animal food product contains the specific information and instructions needed so the food can be safely used for the intended animal species;

(4) Appropriate quality control operations are employed so that animal food-packaging materials are safe and suitable;

(5) The overall sanitation of the plant is under the supervision of one or more competent individuals assigned responsibility for this function;

(6) All reasonable precautions are taken so that production procedures do not contribute to contamination from any source;

(7) Chemical, microbial, or extraneous-material testing procedures are used where necessary to identify sanitation failures or possible animal food contamination; and

(8) All animal food that has become contaminated to the extent that it is adulterated is rejected, or if permissible, treated or processed to eliminate the contamination.

(b) Raw materials and ingredients:

(1) Must be inspected and segregated or otherwise handled as necessary to ensure that they are clean and suitable for processing into animal food and must be stored under conditions that will protect against contamination and minimize deterioration. In addition:

(i) Raw materials must be washed or cleaned as necessary to remove soil or other contamination;

(ii) Water used for washing, rinsing, or conveying animal food must be safe and of adequate sanitary quality;

(iii) Water may be reused for washing, rinsing, or conveying animal food if it does not increase the level of contamination of the animal food; and

(iv) Containers and carriers of raw materials should be inspected on receipt to ensure that their condition has not contributed to contamination or deterioration of animal food.

(2) Must not contain levels of microorganisms that may render the food injurious to the health of animals or humans, or they must be treated (e.g., heat) during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated;

(3) Susceptible to contamination with aflatoxin or other natural toxins must comply with current FDA regulations for poisonous or deleterious substances before these materials or ingredients are incorporated into finished animal food;

(4) Including rework, must be held in bulk, or in containers designed and constructed in a way that protects against contamination, and must be held at a temperature and relative humidity and in a manner that prevents the animal food from becoming adulterated. Material scheduled for rework must be identified as such;

(5) If frozen, must be kept frozen. If thawing is required prior to use, it must be done in a manner that prevents the raw materials and ingredients from becoming adulterated; and

(6) Whether liquid or dry, received and stored in bulk form must be held in a manner that protects against contamination.

(c) For the purposes of manufacturing operations, the following apply:

(1) Equipment, utensils, and finished animal food containers must be maintained in an acceptable condition through appropriate cleaning and sanitizing, as necessary. When necessary, equipment must be taken apart for thorough cleaning;

(2) All animal food manufacturing, processing, packing, and holding must be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms or for the contamination of animal food;

(3) Animal food that can support the rapid growth of undesirable microorganisms must be held at temperatures that will prevent the animal food from becoming adulterated during manufacturing, processing, packing, and holding;

(4) Measures taken to destroy or prevent the growth of undesirable microorganisms, such as sterilizing, irradiating, pasteurizing, cooking, freezing, refrigerating, controlling pH, or controlling a w, must be adequate under the conditions of manufacture, handling, and distribution to prevent animal food from being adulterated;

(5) Work-in-process and rework must be handled in a manner that protects against contamination and the growth of undesirable microorganisms;

(6) Effective measures must be taken to protect finished animal food from contamination by raw materials, ingredients, or refuse. When raw materials, ingredients, or refuse are unprotected, they must not be handled simultaneously in a receiving, loading, or shipping area if that handling could result in contaminated animal food. Animal food transported by conveyor must be protected against contamination as necessary;

(7) Equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or animal food must be constructed, handled, and maintained during manufacturing, processing, packing, or holding in a manner that protects against contamination of animal food;

(8) Effective measures must be taken to protect against the inclusion of metal or other extraneous material in animal food;

(9) Adulterated animal food, raw materials, and ingredients must be disposed of in a manner that protects against the contamination of other animal food or, if the adulterated animal food, raw materials, or ingredients are capable of being reconditioned, they must be reconditioned using a method that has been proven to be effective;

(10) Steps such as washing, peeling, trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, defatting, and forming must be performed in a way that protects animal food against contamination. Animal food should be protected from contaminants that may drip, drain, or be drawn into the animal food;

(11) Heat blanching, when required in the preparation of animal food, should be effected by heating the animal food to the required temperature, holding it at this temperature for the required time, and then either rapidly cooling the animal food or passing it to subsequent manufacturing without delay. Thermophilic growth and contamination in blanchers should be minimized by the use of adequate operating temperatures and by periodic cleaning;

(12) Batters, breading, sauces, gravies, dressings, and other similar preparations must be treated or maintained in such a manner that they are protected against contamination;

(13) Filling, assembling, packaging, and other operations must be performed in such a way that the animal food is protected against contamination and growth of undesirable microorganisms;

(14) Animal food, including dry mixes, nuts, intermediate moisture animal food, and dehydrated animal food, that relies on the control of a w for preventing the growth of undesirable microorganisms must be processed to and maintained at a safe moisture level;

(15) Animal food that relies principally on the control of pH for preventing the growth of undesirable microorganisms must be monitored and maintained at the appropriate pH; and

(16) When ice is used in contact with animal food, it must be made from water that is safe and of adequate sanitary quality, and must be used only if it has been manufactured in accordance with current good manufacturing practice as outlined in this part.

 

§ 507.28 Warehousing and distribution.

Storage and transportation of animal food must be conducted under conditions that will protect against biological, chemical, physical, and radiological contamination of animal food as well as against deterioration of the animal food and the container.

 

Subpart C Hazard Analysis and Risk Based Preventive Controls

 

§ 507.30 Requirement for a food safety plan.

(a) The owner, operator, or agent in charge of a facility must prepare, or have prepared, and implement a written food safety plan.

(b) The written food safety plan must be prepared by (or its preparation overseen by) a qualified individual.

(c) The written food safety plan must include:

(1) The hazard analysis as required by § 507.33;

(2) The preventive controls as required by § 507.36;

(3) The recall plan as required by § 507.38;

(4) The procedures and the frequency with which these procedures will be conducted for monitoring the performance of the preventive controls as required by § 507.39;

(5) The corrective action procedures as required by § 507.42; and

(6) The verification procedures and the frequency with which they will be performed as required by § 507.45.

 

§ 507.33 Hazard analysis.

(a) The owner, operator, or agent in charge of a facility must identify and evaluate known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed, or held at the facility to determine whether there are hazards that are reasonably likely to occur and develop a written hazard analysis.

(b) The hazard analysis must consider hazards that may occur naturally or may be unintentionally introduced including:

(1) Biological hazards, including microbiological hazards such as parasites, environmental pathogens, and other microorganisms of animal or human health significance;

(2) Chemical hazards, including substances such as pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives, and nutrient imbalances;

(3) Physical hazards; and

(4) Radiological hazards.

(c) The hazard analysis must contain an evaluation of the hazards identified in paragraph (b) of this section to determine whether the hazards are reasonably likely to occur, including an assessment of the severity of the illness or injury if the hazard were to occur.

(d) The hazard analysis must consider the effect of the following on the safety of the finished animal food:

(1) The formulation of the animal food;

(2) The condition, function, and design of the facility and equipment;

(3) Raw materials and ingredients;

(4) Transportation practices;

(5) Manufacturing/processing procedures;

(6) Packaging activities and labeling activities;

(7) Storage and distribution;

(8) Intended or reasonably foreseeable use;

(9) Sanitation, including employee hygiene; and

(10) Any other relevant factors.

 

§ 507.36 Preventive controls for hazards that are reasonably likely to occur.

For hazards identified in the hazard analysis as reasonably likely to occur:

(a) The owner, operator, or agent in charge of a facility must identify and implement preventive controls, including at critical control points, if any, to provide assurances that hazards identified in the hazard analysis as reasonably likely to occur will be significantly minimized or prevented and the animal food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act.

(b) Preventive controls must be written.

(c) Preventive controls must include, as appropriate to the facility and animal food:

(1) Parameters associated with the control of the hazard, such as parameters associated with heat processing, irradiating, and refrigerating animal foods; and

(2) The maximum or minimum value, or combination of values, to which any biological, chemical, physical, or radiological parameter must be controlled to significantly minimize or prevent a hazard that is reasonably likely to occur.

(d) Preventive controls must include, as appropriate:

(1) Process controls that include those procedures, practices, and processes performed on an animal food during manufacturing/processing that are employed to significantly minimize or prevent hazards that are reasonably likely to occur;

(2) Sanitation controls:

(i) Where necessary to significantly minimize or prevent hazards that are reasonably likely to occur, procedures for the:

(A) Cleanliness of animal food-contact surfaces, including animal food-contact surfaces of utensils and equipment; and

(B) Prevention of cross-contamination from insanitary objects and from personnel to animal food, animal food packaging material, and other animal food-contact surfaces and from raw product to processed product.

(ii) The owner, operator, or agent in charge must take action to correct, in a timely manner, conditions and practices that are not consistent with the procedures in paragraph (d)(2)(i)(A) or (d)(2)(i)(B) of this section.

(iii) The owner, operator, or agent in charge of the facility is not required to follow the corrective actions described in § 507.42(a) and (b) when the owner, operator, or agent in charge of a facility takes action, in accordance with paragraph (d)(2)(ii) of this section, to correct conditions and practices that are not consistent with the procedures in paragraph (d)(2)(i)(A) or (d)(2)(i)(B) of this section.

(iv) All corrective actions taken in accordance with paragraph (d)(2)(ii) of this section must be documented in records that are subject to verification in accordance with § 507.45(b)(2) and records review in accordance with § 507.45(c)(1)(i) and (c)(2).

(3) A recall plan as required by § 507.38; and

(4) Any other controls necessary to satisfy the requirements of paragraph (a) of this section.

(e)

(1) Except as provided by paragraph (e)(2) of this section, the preventive controls required under this section are subject to:

(i) Monitoring as required by § 507.39;

(ii) Corrective actions as required by § 507.42; and

(iii) Verification as required by § 507.45.

(2) The recall plan established in § 507.38 is not subject to the requirements of paragraph (e)(1) of this section.

 

§ 507.38 Recall plan for animal food with a hazard that is reasonably likely to occur.

(a) The owner, operator, or agent in charge of a facility must develop a written recall plan for animal food with a hazard that is reasonably likely to occur and assign responsibility for performing all actions in the plan.

(b) The written recall plan must include procedures for:

(1) Directly notifying direct consignees about the animal food being recalled, including how to return or dispose of the affected animal food;

(2) Notifying the public about any hazard presented by the animal food when appropriate to protect animal and human health;

(3) Conducting effectiveness checks (as described in part 7 of this chapter) to verify the recall has been carried out; and

(4) The proper disposition (e.g., destroying, reprocessing, or diverting to another use that would not present a safety concern) of the recalled animal food.

 

§ 507.39 Monitoring.

(a) The owner, operator, or agent in charge of a facility must establish and implement written procedures for monitoring the preventive controls. These procedures must include:

(1) What preventive controls will be monitored;

(2) Who will perform the monitoring;

(3) How the monitoring will be performed;

(4) What parameter will be measured, if applicable;

(5) Frequency with which the monitoring will be performed; and

(6) Any additional information needed to ensure appropriate monitoring of the preventive controls.

(b) The owner, operator, or agent in charge of a facility must monitor the preventive controls with sufficient frequency to provide assurance that the preventive controls are consistently performed.

(c) Monitoring of preventive controls in accordance with this section must be documented in records that are subject to verification in accordance with § 507.45(b)(1) and records review in accordance with § 507.45(c)(1)(i) and (c)(2).

 

§ 507.42 Corrective actions.

(a) The owner, operator, or agent in charge of a facility must establish and implement written corrective action procedures that must be taken if preventive controls are not properly implemented. The corrective active procedures must describe the steps to be taken to ensure:

(1) Appropriate action is taken to identify and correct a problem with implementation of a preventive control to reduce the likelihood that the problem will recur;

(2) All affected animal food is evaluated for safety; and

(3) All affected animal food is prevented from entering into commerce if the owner, operator, or agent in charge of the facility cannot ensure the affected animal food is not adulterated undersection 402 of the Federal Food, Drug, and Cosmetic Act.

(b) If a preventive control is not properly implemented and a specific corrective action procedure has not been established, or a preventive control is found to be ineffective, the owner, operator, or agent in charge of a facility must:

(1) Take corrective action to identify and correct the problem to reduce the likelihood that the problem will recur;

(2) Evaluate all affected animal food for safety;

(3) As necessary, prevent affected animal food from entering commerce as would be done following the corrective action procedure under paragraph (a)(3) of this section; and

(4) Reanalyze the food safety plan in accordance with § 507.45(e) to determine whether modification of the food safety plan is required.

(c) When corrective actions are taken, they must be documented in written records. These records are subject to verification in accordance with § 507.45(b)(2) and records review in accordance with § 507.45(c)(1)(i) and (c)(2).

 

§ 507.45 Verification.

(a) Except as provided by paragraph (a)(3) of this section, the owner, operator, or agent in charge of a facility must validate that the preventive controls identified and implemented in accordance with § 507.36 to control the hazards identified in the hazard analysis as reasonably likely to occur are adequate to do so. The validation of the preventive controls:

(1) Must be performed (or overseen) by a qualified individual:

(i) Prior to implementation of the food safety plan or, when necessary, during the first 6 weeks of production; and

(ii) Whenever a reanalysis of the food safety plan reveals the need to do so;

(2) Must include collecting and evaluating scientific and technical information (or, when such information is not available or is insufficient, conducting studies) to determine whether the preventive controls, when properly implemented, will effectively control the hazards that are reasonably likely to occur; and

(3) Need not address:

(i) The sanitation controls in § 507.36(d)(2); and

(ii) The recall plan in § 507.38.

(b) The owner, operator, or agent in charge of a facility must verify that:

(1) Monitoring is conducted as required by § 507.39;

(2) Appropriate decisions about corrective actions are being made as required by § 507.42;

(3) The preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards that are reasonably likely to occur; and

(4) The activities conducted must include, as appropriate to the facility and the animal food, calibration of process monitoring and verification instruments.

(c) The owner, operator, or agent in charge of a facility must verify that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards that are reasonably likely to occur by ensuring that a qualified individual is conducting (or overseeing):

(1) A review of the following records in the timeframe specified:

(i) Monitoring and corrective action records within 1 week after the records are made; and

(ii) Records of calibration of instruments within a reasonable time after the records are created.

(2) A review of the records in paragraphs (c)(1)(i) and (c)(1)(ii) of this section to ensure:

(i) The records are complete;

(ii) The activities reflected in the records occurred in accordance with the food safety plan;

(iii) The preventive controls are effective; and

(iv) Appropriate decisions were made about corrective actions.

(d) The owner, operator, or agent in charge of a facility must establish and implement written procedures, as appropriate to the facility and the animal food, for the frequency of calibrating process monitoring and verification instruments.

(e) The owner, operator, or agent in charge of a facility must:

(1) Conduct a reanalysis of the food safety plan:

(i) At least once every 3 years;

(ii) Whenever a significant change is made in the activities conducted at the facility operated by such owner, operator, or agent in charge if the change creates a reasonable potential for a new hazard or creates a significant increase in a previously identified hazard;

(iii) Whenever the owner, operator, or agent in charge becomes aware of new information about potential hazards associated with the animal food;

(iv) Whenever a preventive control is not properly implemented and a specific corrective action procedure has not been established;

(v) Whenever a preventive control is found to be ineffective; and

(vi) Whenever FDA requires a reanalysis in response to newly identified hazards and developments in scientific understanding.

(2) Complete the reanalysis and implement any additional preventive controls needed to address the hazard identified before the change in activities at the facility is operative or, when necessary, during the first 6 weeks of production;

(3) Revise the written food safety plan if a significant change is made, or document the basis for the conclusion that no additional or revised preventive controls are needed; and

(4) Ensure the reanalysis is performed (or overseen) by a qualified individual.

(f) All verification activities taken in accordance with this section must be documented in records.

 

§ 507.48 Modified requirements that apply to a facility solely engaged in the storage of packaged animal food that is not exposed to the environment.

(a) The owner, operator, or agent in charge of a facility solely engaged in the storage of packaged animal food that is not exposed to the environment must conduct the following activities for any such refrigerated packaged animal food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin formation by, microorganisms of animal or human health significance:

(1) Establish and implement temperature controls adequate to significantly minimize or prevent the growth of, or toxin formation by, microorganisms of animal or human health significance;

(2) Monitor the temperature controls with sufficient frequency to provide assurance they are consistently performed;

(3) Take appropriate corrective actions if there is a problem with the temperature controls for such refrigerated packaged animal food to:

(i) Correct the problem and reduce the likelihood that the problem will recur;

(ii) Evaluate all affected animal food for safety; and

(iii) Prevent the animal food from entering commerce, if the owner, operator, or agent in charge of the facility cannot ensure the affected animal food is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act;

(4) Verify that temperature controls are consistently implemented by:

(i) Calibrating temperature monitoring and recording devices;

(ii) Reviewing records of calibration within a reasonable time after the records are made; and

(iii) Reviewing records of monitoring and corrective actions taken to correct aproblem with the control of temperature within a week after the records are made;

(5) Establish and maintain the following records:

(i) Records documenting the monitoring of temperature controls for any such refrigerated packaged animal food;

(ii) Records of corrective actions taken when there is a problem with the control of temperature for any such refrigerated packaged animal food; and

(iii) Records documenting the verification activities.

(b) The records that a facility must establish and maintain under paragraph (a)(5) of this section are subject to the requirements of subpart F of this part.

 

§ 507.50 Requirements applicable to a qualified individual.

(a) One or more qualified individuals must do or oversee the following:

(1) Prepare the food safety plan (§ 507.30));

(2) Validate the preventive controls (§ 507.45(a));

(3) Conduct a review of records for implementation and effectiveness of preventive controls and appropriateness of corrective actions (§ 507.45(c));

(4) Perform a reanalysis of the food safety plan (§ 507.45(e)).

(b) To be qualified, an individual must have successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system. Job experience may qualify an individual to perform these functions if such experience has provided an individual with knowledge at least equivalent to that provided through the standardized curriculum. This individual may be, but is not required to be, an employee of the facility.

(c) All applicable training must be documented in records, including the date of the training, the type of training, and the person(s) trained.

 

§ 507.55 Records required for this subpart C.

(a) The owner, operator, or agent in charge of a facility must establish and maintain the following records:

(1) The written food safety plan, including the written hazard analysis, preventive controls, monitoring procedures, corrective action procedures, verification procedures, and recall plan;

(2) Records that document the monitoring of preventive controls;

(3) Records that document corrective actions;

(4) Records that document verification, including, as applicable, those related to:

(i) Validation;

(ii) Monitoring;

(iii) Corrective actions;

(iv) Calibration of process monitoring and verification instruments;

(v) Records review; and

(vi) Reanalysis; and

(5) Records that document applicable training for the qualified individual.

(b) The records that the owner, operator, or agent in charge of a facility must establish and maintain are subject to the requirements of subpart F of this part.

 

Subpart D Withdrawal of an Exemption Applicable to a Qualified Facility

 

§ 507.60 Circumstances that may lead FDA to withdraw an exemption applicable to a qualified facility.

FDA may withdraw the exemption applicable to a qualified facility under § 507.5(d):

(a) In the event of an active investigation of a foodborne illness outbreak that is directly linked to the qualified facility; or

(b) If FDA determines that it is necessary to protect the animal or human health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with the qualified facility that are material to the safety of the animal food manufactured, processed, packed, or held at such facility.

 

§ 507.62 Issuance of an order to withdraw an exemption applicable to a qualified facility.

(a) If FDA determines that an exemption applicable to a qualified facility under § 507.5(d) should be withdrawn, any officer or qualified employee of FDA may issue an order to withdraw the exemption.

(b) An FDA District Director in whose district the qualified facility is located (or, in the case of a foreign facility, the Director of the Division of Compliance in the Center for Veterinary Medicine), or an FDA official senior to such Director, must approve an order to withdraw the exemption.

(c) FDA must issue an order to withdraw the exemption to the owner, operator, or agent in charge of the facility.

(d) FDA must issue an order to withdraw the exemption in writing, signed and dated by the officer or qualified employee of FDA who is issuing the order.

 

§ 507.65 Contents of an order to withdraw an exemption applicable to a qualified facility.

An order to withdraw an exemption applicable to a qualified facility under § 507.5(d) must include the following information:

(a) The date of the order;

(b) The name, address, and location of the qualified facility;

(c) A brief, general statement of the reasons for the order, including information relevant to:

(1) An active investigation of a foodborne illness outbreak that is directly linked to the facility; or

(2) Conduct or conditions associated with a qualified facility that are material to the safety of the animal food manufactured, processed, packed, or held at such facility.

(d) A statement that the facility must comply with subpart C of this part on the date that is 60 calendar days after the date of the order;

(e) The text of section 418(l) of the Federal Food, Drug, and Cosmetic Act and of this subpart D;

(f) A statement that any informal hearing on an appeal of the order must be conducted as a regulatory hearing under part 16 of this chapter, with certain exceptions described in § 507.73;

(g) The mailing address, telephone number, email address, and facsimile number of the FDA district office and the name of the FDA District Director in whose district the facility is located (or, in the case of a foreign facility, the same information for the Director of the Division of Compliance in the Center for Veterinary Medicine); and

(h) The name and the title of the FDA representative who approved the order.

 

§ 507.67 Compliance with, or appeal of, an order to withdraw an exemption applicable to a qualified facility.

(a) The owner, operator, or agent in charge of a qualified facility that receives an order under § 507.60 to withdraw an exemption applicable to that facility under § 507.5(d) must either:

(1) Comply with applicable requirements of this part within 60 calendar days of the date of the order; or

(2) Appeal the order within 10 calendar days of the date of the order in accordance with the requirements of § 507.69.

(b) Submission of an appeal, including submission of a request for an informal hearing, will not operate to delay or stay any administrative action, including enforcement action by FDA, unless the Commissioner, as a matter of discretion, determines that delay or a stay is in the public interest.

(c) If the owner, operator, or agent in charge of the qualified facility appeals the order, and FDA confirms the order, the owner, operator, or agent in charge of the facility must comply with applicable requirements of this part within 60 calendar days of the date of the order.

 

§ 507.69 Procedure for submitting an appeal.

(a) To appeal an order to withdraw an exemption applicable to a qualified facility under § 507.5(d), the owner, operator, or agent in charge of the facility must:

(1) Submit the appeal in writing to the FDA District Director in whose district the facility is located (or, in the case of a foreign facility, the Director of the Division of Compliance in the Center for Veterinary Medicine), at the mailing address, email address, or facsimile number identified in the order within 10 calendar days of the date of the order;

(2) Respond with particularity to the facts and issues contained in the order, including any supporting documentation upon which the owner, operator, or agent in charge of the facility relies.

(b) In a written appeal of the order withdrawing an exemption provided under § 507.5(d), the owner, operator, or agent in charge of the facility may include a written request for an informal hearing as provided in § 507.71.

 

§ 507.71 Procedure for requesting an informal hearing.

(a) If the owner, operator, or agent in charge of the facility appeals the order, the owner, operator, or agent in charge of the facility:

(1) May request an informal hearing; and

(2) Must submit any request for an informal hearing together with its written appeal submitted in accordance with § 507.69 within 10 calendar days of the date of the order.

(b) A request for an informal hearing may be denied, in whole or in part, if the presiding officer determines that no genuine and substantial issue of material fact has been raised by the material submitted. If the presiding officer determines that a hearing is not justified, written notice of the determination will be given to the owner, operator, or agent in charge of the facility explaining the reason for the denial.

 

§ 507.73 Requirements applicable to an informal hearing.

If the owner, operator, or agent in charge of the facility requests an informal hearing, and FDA grants the request:

(a) The hearing will be held within 10 calendar days after the date the appeal is filed or, if applicable, within a timeframe agreed upon in writing by the owner, operator, or agent in charge of the facility and FDA.

(b) The presiding officer may require that a hearing conducted under this subpart be completed within 1 calendar day, as appropriate.

(c) FDA must conduct the hearing in accordance with part 16 of this chapter, except that:

(1) The order withdrawing an exemption under §§ 507.62 and 507.65, rather than the notice under § 16.22(a) of this chapter, provides notice of opportunity for a hearing under this section and is part of the administrative record of the regulatory hearing under § 16.80(a) of this chapter.

(2) A request for a hearing under this subpart must be addressed to the FDA District Director (or, in the case of a foreign facility, the Director of the Division of Compliance in the Center for Veterinary Medicine) as provided in the order withdrawing an exemption.

(3) Section 507.75, rather than § 16.42(a) of this chapter, describes the FDA employees who preside at hearings under this subpart.

(4) Section 16.60(e) and (f) of this chapter does not apply to a hearing under this subpart. The presiding officer must prepare a written report of the hearing. All written material presented at the hearing will be attached to the report. The presiding officer must include as part of the report of the hearing a finding on the credibility of witnesses (other than expert witnesses) whenever credibility is a material issue, and must include a proposed decision, with a statement of reasons. The hearing participant may review and comment on the presiding officer's report within 2 calendar days of issuance of the report. The presiding officer will then issue the final decision.

(5) Section 16.80(a)(4) of this chapter does not apply to a regulatory hearing under this subpart. The presiding officer's report of the hearing and any comments on the report by the hearing participant under § 507.73(c)(4) are part of the administrative record.

(6) No party shall have the right, under § 16.119 of this chapter to petition the Commissioner for reconsideration or a stay of the presiding officer's final decision.

(7) If FDA grants a request for an informal hearing on an appeal of an order withdrawing an exemption, the hearing must be conducted as a regulatory hearing under part 16 of this chapter, except that § 16.95(b) does not apply to a hearing under this subpart. With respect to a regulatory hearing under this subpart, the administrative record of the hearing specified in §§ 16.80(a)(1), (a)(2), (a)(3), and (a)(5), and 507.73(c)(5) constitutes the exclusive record for the presiding officer's final decision. For purposes of judicial review under § 10.45 of this chapter, the record of the administrative proceeding consists of the record of the hearing and the presiding officer's final decision.

 

§ 507.75 Presiding officer for an appeal and for an informal hearing.

The presiding officer for an appeal, and for an informal hearing, must be an FDA Regional Food and Drug Director or another FDA official senior to an FDA District Director.

 

§ 507.77 Timeframe for issuing a decision on an appeal.

(a) If the owner, operator, or agent in charge of a facility appeals the order without requesting a hearing, the presiding officer must issue a written report that includes a final decision confirming or revoking the withdrawal by the 10th calendar day after the appeal is filed.

(b) If the owner, operator, or agent in charge of a facility appeals the order and requests an informal hearing:

(1) If FDA grants the request for a hearing and the hearing is held, the presiding officer must provide a 2 calendar day opportunity for the hearing participants to review and submit comments on the report of the hearing under § 507.73(c)(4), and must issue a final decision within 10 calendar days after the hearing is held; or

(2) If FDA denies the request for a hearing, the presiding officer must issue a final decision on the appeal confirming or revoking the withdrawal within 10 calendar days after the date the appeal is filed.

 

§ 507.80 Revocation of an order to withdraw an exemption applicable to a qualified facility.

An order to withdraw an exemption applicable to a qualified facility under § 507.5(d) is revoked if:

(a) The owner, operator, or agent in charge of the facility appeals the order and requests an informal hearing, FDA grants the request for an informal hearing, and the presiding officer does not confirm the order within the 10 calendar days after the hearing, or issues a decision revoking the order within that time; or

(b) The owner, operator, or agent in charge of the facility appeals the order and requests an informal hearing, FDAdenies the request for an informal hearing, and FDA does not confirm the order within the 10 calendar days after the appeal is filed, or issues a decision revoking the order within that time; or

(c) The owner, operator, or agent in charge of the facility appeals the order without requesting an informal hearing, and FDA does not confirm the order within the 10 calendar days after the appeal is filed, or issues a decision revoking the order within that time.

 

§ 507.83 Final agency action.

Confirmation of a withdrawal order by the presiding officer is considered a final agency action for purposes of 5 U.S.C. 702.

 

Subpart E Reserved

 

Subpart F Requirements Applying to Records That Must Be Established and Maintained

 

§ 507.100 Records subject to the requirements of this subpart F.

(a) Except as provided by paragraphs (d) and (e) of this section, all records required by this part are subject to all requirements of this subpart F.

(b) Records required by this part are subject to the disclosure requirements under part 20 of this chapter.

(c) All records required by this part must be made promptly available to a duly authorized representative of the Secretary of Health and Human Services upon oral or written request.

(d) The requirements of § 507.106 apply only to the written food safety plan.

(e) The requirements of § 507.102(a)(2), (a)(4), and (a)(5) and (b) do not apply to the records required by § 507.7(e) pertaining to qualified facilities.

 

§ 507.102 General requirements applying to records.

(a) Records must:

(1) Be kept as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic records, which must be kept in accordance with part 11 of this chapter;

(2) Contain the actual values and observations obtained during monitoring;

(3) Be accurate, indelible, and legible;

(4) Be created concurrently with performance of the activity documented; and

(5) Be as detailed as necessary to provide history of work performed.

(b) All records must include:

(1) The name and location of the plant or facility;

(2) The date and time of the activity documented;

(3) The signature or initials of the person performing the activity; and

(4) Where appropriate, the identity of the product and the production code, if any.

 

§ 507.106 Additional requirements applying to the food safety plan.

The food safety plan must be signed and dated by the owner, operator, or agent in charge of the facility upon initial completion and upon any modification.

 

§ 507.108 Requirements for record retention.

(a) All records required by this part must be retained at the plant or facility for at least 2 years after the date they were prepared.

(b) Records that relate to the general adequacy of the equipment or processes being used by a facility, including the results of scientific studies and evaluations, must be retained at the facility for at least 2 years after their use is discontinued (e.g., because the facility has updated the written food safety plan (§ 507.30) or records that document validation of the written food safety plan (§ 507.45(a)).

(c) Except for the food safety plan, offsite storage of records is permitted after 6 months following the date that the record was made if such records can be retrieved and provided onsite within 24 hours of request for official review. The food safety plan must remain onsite. Electronic records are considered to be onsite if they are accessible from an onsite location.

(d) If the plant or facility is closed for a prolonged period, the records may be transferred to some other reasonably accessible location, but must be returned to the plant or facility within 24 hours for official review upon request.

Email David.Saxowsky@ndsu.edu

This material is intended for educational purposes only. It is not a substitute for competent legal counsel. Seek appropriate professional advice for answers to your specific questions.

This material is protected by U.S. copyright laws.

Creative Commons License
Feel free to use and share this content, but please do so under the conditions of our Creative Commons license and our Rules for Use. Thanks.