FSMA: ANIMAL FOOD FINAL RULE

FSMA: ANIMAL FOOD FINAL RULE
Richard Sellers Sr. Vice President, Public Policy & Education American Feed Industry Association

Food Safety Modernization Act
Signed into law Jan. 4, 2011 Proposed rule published Oct. 29, 2014 Supplemental proposed rule published Sept. 29, 2014 Final rule published Sept. 17, 2015 First compliance date for large firms and CGMPs, Sept. 19, 2016

Two sets of rules were finalized: CGMPs (FD&C Act) and Hazard Analysis Preventive Controls (FSMA) CGMPs All animal food facilities required to register under the Bioterrorism Act must comply, “farms” are exempt, meaning those feed mills feeding animals owned by the feed mill owner and land owned by the same Medicated feed facilities must still comply with 21 CFR part 225 for medicated feed CGMPs and also FSMA rule

Total annualized costs are est. $ million/year; AFIA says nearly $1 billion According to FDA, cost reductions should come from: can keep electronic records (Part 11 exempt), use of existing history or past records (as in supply chain management), flexibility (“where appropriate) However, very likely the costs are substantially higher than FDA’s estimates Hazard analysis alone is very costly for each facility

Who’s covered? Facilities that manufacture, process, pack or hold animals food and required to register with FDA under Bioterrorism Act (every even-numbered year) Exemptions Farms – as defined in § 1.227 Qualified facilities (very unlikely for animal food) Animal food = food for animals other than man and includes pet food, animal feed and raw materials and ingredients

The Feel Good List: CGMP revisions – more appropriate to animal food, but still not perfect Flexibility throughout (where applicable to the animal food or facility) Phase-in of compliance dates 21 CFR Part 11 exemption for electronic records and signatures No remote access to records

Concerns/Interesting Twists: If CGMPs are handling hazards – how you must treat them – like Preventive Controls? Supply-chain program – very detailed and new Recall plan – only for animal food with hazards requiring a preventive control Cost Interpretation – to be a continuing issue Training – what constitutes training and experience – likely it’s up to the plant and FDA has to show otherwise

What do you need to do at your plant? Create CGMPs Perform a hazard analysis Determine what hazards need controlling, if any Determine if all your hazards can be controlled by CGMPs, which AFIA believes is true for feed mills Develop your Animal Food Facility Safety Plan Have it reviewed and authorized by your preventive controls qualified individual (PCQI) Create a supply-chain management plan Create and maintain the records under your plan

Part 507—Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls Subpart A—General Provisions Subpart B—Current Good Manufacturing Practice Subpart C—Hazard Analysis and Risk-Based Preventive Controls Subpart D—Withdrawal of a Qualified Facility Exemption Subpart E—Supply-Chain Program Subpart F—Requirements Applying to Records That Must Be Established and Maintained

Definitions Facility vs. Plant
Hazard or Hazard requiring a preventive control or Known or reasonably foreseeable hazard Affiliate, subsidiary, and full-time equivalent employee Manufacturing/processing Qualified auditor Supplier, receiving facility, supply-chain-applied control Facility = domestic or foreign facility required to register Plant = building or structure, or parts thereof, used for or in connection with manufacturing, processing, packing or holding animal food

Definitions Qualified individual means a person who has the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold safe animal food as appropriate to the individual’s assigned duties. A qualified individual may be, but is not required to be, an employee of the establishment. Preventive controls qualified individual means a qualified individual 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. § – Qualifications of individuals who manufacture, process, pack or hold animal food § – Requirements of PCQI or qualified auditor

CGMPs: Are they new? International:
Codex Animal Production and Health Manual of Good Practices PAS 222: Prerequisite Programs for Food Safety in the Manufacturing of Food and Feed for Animals Domestic: 21 CFR, Part 225: medicated feed CGMPs AAFCO Model Good Manufacturing Practice Regulations Third party programs, such as Safe Feed/Safe Food Certification Program

Add one more: FSMA CGMPs: Are they new? International:
Codex Animal Production and Health Manual of Good Practices PAS 222: Prerequisite Programs for Food Safety in the Manufacturing of Food and Feed for Animals Domestic: 21 CFR, Part 225: medicated feed CGMPs AAFCO Model Good Manufacturing Practice Regulations Third party programs, such as Safe Feed/Safe Food Add one more: FSMA

CGMPs: Is there value? Overall FSMA goal: prevention
CGMPs provide foundation for standards, some say pre-requisite programs …but only if they are appropriate So which are they?

Subpart B: CGMPs What could have been?
Progress between the original and the supplemental rules Ex: Removed provision excluding a person with any illness from all plant operations Added “where necessary” or “as appropriate” Removed some overly specific rules, such as screenings for pest management

Subpart B: CGMPs What could have been?
“prevent contamination” “protect against contamination” “prevent from becoming contaminated” “prevent from becoming adulterated” From FDA: We recognize that it may not always be possible to prevent contamination of animal food. Therefore, we have changed the regulatory text throughout subpart B to stress that the goal of the regulations is to ‘‘protect against’’ or ‘‘minimize’’ the contamination of animal food.

Subpart B: CGMPs Section Headings
§ Personnel. § Plant and grounds. § Sanitation. § Water supply and plumbing. § Equipment and utensils. § Plant operations. § Holding and distribution. § Holding and distribution of human food by-products for use as animal food.

Subpart B: CGMPs § 507.14 Personnel
“Management … must take reasonable measures and precautions to ensure that all persons … conform to hygienic practices to the extent necessary to protect against the contamination of animal food.” Considerable difference between feed mill and pet food facility Washing hands: “We recognize that there may be some situations where hand washing facilities are not readily available. The use of waterless hand cleaners (including hand sanitizers) may be adequate under these circumstances.” Remove jewelry, store clothing (etc.) away from animal food. “Protect against” replaced “Prevent”

Subpart B: CGMPs § 507.17 Plant and grounds
“The grounds around…must be kept in a condition that will protect against the contamination of animal food” “The plant must be suitable in size, construction, and design to facilitate cleaning, maintenance, and pest control to reduce the potential for contamination of animal food…” “The plant must protect animal food stored outdoors in bulk from contamination by any effective means”

§ 507.17 Plant and grounds, continued
Subpart B: CGMPs § Plant and grounds, continued AFIA is concerned with the use of “Designed” and “Constructed” FDA said “we agree that one way to manage dripping and condensation is through maintenance or repair to the plumbing or structure, and do not intend that existing plants must be redesigned or reconstructed.” Cutting weeds and grass Provide adequate space between walls & equipment Provide ventilation where appropriate and necessary Use shatter resistant glass over exposed animal food Outdoor storage

Subpart B: CGMPs § 507.19 Sanitation
“Sanitation” vs. “Housekeeping & Cleaning” “… the plant must be kept clean and in good repair to prevent animal food from becoming adulterated.” “Animal food-contact and noncontact surfaces of utensils and equipment must be cleaned and maintained … and stored as necessary to protect against the contamination… When necessary, equipment must be disassembled for thorough cleaning.” *Note the flexibility

§ 507.19 Sanitation, continued
Subpart B: CGMPs § Sanitation, continued “In wet processing of animal food, when cleaning and sanitizing is necessary to protect against the introduction of undesirable microorganisms into animal food” Big fix from the supplemental: Storage of toxic materials FDA added:(3) Other toxic materials (such as fertilizers and pesticides not included in paragraph (d)(1) of this section) must be stored in an area of the plant where animal food is not manufactured, processed, or exposed. AFIA believes perhaps a cage can be constructed if not possible to completely remove the items.

§ 507.20 Water supply and plumbing
Subpart B: CGMPs § Water supply and plumbing Water supply must be adequate; Plumbing must be adequate; Sewage and liquid waste must be disposed of adequately; and plants must provide adequate toilet & handwashing facilities * Adequate? Are there any mills lacking this? “We understand that there may be an exception where toilet facilities are not inside a plant, but we believe it is important that toilet facilities are available near the plant for employee use” “We understand that there may not be running water in every plant … in some cases hand-washing facilities might consist of waterless hand cleaners” Adequate = that which is needed to accomplish the intended purpose in keeping with good public (human and animal) health practices.

§ 507.22 Equipment and utensils
“All plant equipment and utensils, including equipment and utensils that do not come in contact with animal food, must be designed and constructed of such material and workmanship to be adequately cleanable, and must be properly maintained” Food grade lubricants Fitted with an accurate temperature-measuring device “we do not intend the establishment to use a continuous monitoring device or temperature recording device.” Specifics on contact surfaces, controlling/preventing undesirable microorganism growth, compress air/gas

Subpart B: CGMPs § 507.25 Plant operations
Identifying food vs. identifying containers in (a)(2) “(a)(4) The overall cleanliness of the plant is under the supervision of one or more competent individuals assigned responsibility for this function” “(a)(6) Chemical, microbial, or extraneous-material testing procedures are used where necessary to identify sanitation failures or possible animal food contamination” FDA says: this provision provides flexibility for management to determine when testing is required by providing that testing be used ‘‘where necessary.’’

§ 507.25 Plant operations, continued
Subpart B: CGMPs § Plant operations, continued Examination of raw materials and shipping containers According to FDA: “An examination of raw materials and other ingredients may include basic activities such as a simple visual examination of the product (e.g., looking for broken bags), or performing a chemical or microbial analysis” “We do not intend that every load of grain received must be tested before it can be used. We intend for ‘‘evaluation’’ to be broad and flexible enough to consider any information that allows the plant to use the raw materials and other ingredients in a manner that does not result in harm to humans or animals.”

§ 507.25 Plant operations, continued
Subpart B: CGMPs § Plant operations, continued Examples: Raw materials susceptible to contamination with mycotoxins FDA says: “An evaluation could be based on a general review of the weather conditions during the growing season and whether it could result in mycotoxins.” Raw materials must be cleaned as necessary to minimize soil? “ We have revised the regulatory text to remove the words ‘‘soil or other’’ from the requirement.” Too many specifics: rework, pH, ice, undesirable microorganisms, and deterioration

§ 507.27 Holding and distribution
Subpart B: CGMPs § Holding and distribution “(a) Animal food held for distribution must be held under conditions that will protect against contamination and minimize deterioration” Quality vs. safety “(b) The labeling for the animal food product ready for distribution must contain, when applicable, information and instructions for safely using the animal food product for the intended animal species.” Moved from plant operations, still concerning Big improvement on affixed labels for products in the plant

Subpart B: CGMPs § Holding & distribution of human food by-products for use as animal food Facilities implementing human food CGMPs do not need separate PCs or CGMPs except to prevent physical/chemical contamination for holding/distribution of by-product If further processing (drying, for example) the by-product, however, then must comply with animal food CGMPs and PCs. “Animal food” or “human food by-products for use as animal food”

Subpart B: CGMPs § Holding & distribution of human food by-products for use as animal food, continued Added “as necessary” for cleaning of containers and equipment FDA notes this “may not require cleaning after each use” Examining shipping containers/bulk vehicles prior to use “This examination could include viewing the shipping container or vehicle to observe whether there are any unusual residues in it that may contaminate the animal food, or it could be simply knowing what the shipping container or vehicle had previously been used for and because of that, whether the container needed to be cleaned prior to use. We do not expect a plant or facility to examine the shipping container or bulk vehicle when a customer transports the animal food or arranges for a third-party to pick up the animal food” – 80 FR at 56237

Subpart C: Hazard Analysis and Risk-Based Preventive Controls
§ Food Safety Plan Preventive Controls Qualified Individual(s) must: Prepare and implement a written food safety plan Hazard analysis as required by § (a)(2); Preventive controls as required by § (b); Supply-chain program as required by Subpart E; Recall plan as required by § (a)(1); Procedures for monitoring the implementation of preventive controls as required by § (a)(1); Corrective action procedures as required by § (a)(1); and Verification procedures as required by § (b).

Identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control Based on experience, illness data, scientific reports and other information For each type of animal food manufactured, processed, packed or held at the facility Must be written regardless of outcome—quite complex and comprehensive

Biological, chemical (radiological) or physical hazards must be considered Naturally occurring, unintentionally introduced or intentionally introduced for economic gain For any known or reasonably foreseeable hazard identified - assess severity and probability; exposure to environmental pathogens § (d) – 10 factors that must be considered for their effect on the safety of the finished animal food

Identify and implement preventive controls to provide assurance that any hazards requiring a preventive control will be significantly minimized or prevented and animal food not adulterated Can be CCPs or other controls Must be written Process controls Sanitation controls Supply-chain controls Recall plan Other controls

§ Circumstances…not required to implement a preventive control Manufacturer/processor – not required to implement a PC when: Determine and document type of animal food could not be consumed without application of an appropriate control Your customers will control the hazard Disclose in documents the animal food is “not processed to control [identified hazard]” Obtain annual written assurance from customer (as detailed for specific customer circumstance – in (a)(2)(ii); (a)(3)(ii); or (a)(4)(ii) Lots of documentation and many scenarios in this section

§ Recall plan § Preventive controls management components § Monitoring § Corrective actions and corrections § Verification § Validation § Verification of implementation and effectiveness § Reanalysis § Modified requirements that apply to a facility solely engaged in storage of unexposed packaged animal food (time/temp)

Subpart E – Supply-Chain Program
The intent with Subpart E: clarify the supply-chain program requirements for domestic suppliers. § Requirement to establish and implement a supply-chain program. § General requirements applicable to a supply-chain program. § Responsibilities of the receiving facility. § Using approved suppliers. § Determining appropriate supplier verification activities (including determining the frequency of conducting the activity). § Conducting supplier verification activities for raw materials and other ingredients. § On-site audit.

§ Requirement to establish and implement a supply-chain program. (a)(1) Receiving facility must establish and implement a risk-based supply- chain program for those raw materials and other ingredients for which the receiving facility has identified a hazard requiring a supply chain- applied control. “supply chain-applied control” = a preventive control for a hazard in a raw material or other ingredient when the hazard in the raw material or other ingredient is controlled before its receipt. Distributors, brokers, and aggregators may determine, conduct, and document appropriate supplier verification activities as a service to the receiving facility, but the rule specifies that only a receiving facility can approve suppliers. (a)(2) A receiving facility that is an importer and is compliant with the FSVP requirements need not conduct supplier verification activities for that raw material or other ingredient.

§ Requirement to establish and implement a supply-chain program. The Supply-Chain Program must be written. When a supply-chain applied control is applied by an entity other than the receiving facility, the receiving facility must verify the applied control or obtain verification. Growing, harvesting, or packing activities.

§ General requirements applicable to a supply-chain program The Supply-Chain program must include: (1) Using approved suppliers (§ ). (2) Determining appropriate supplier verification activities. (3) Conducting supplier verification activities. (4) Documenting supplier verification activities. (5) Verifying a supply-chain applied control, when applicable.

§ General requirements applicable to a supply-chain program The following are appropriate supplier verification activities for raw materials and other ingredients. (1) On-site audits. (2) Sampling and testing of raw materials or other ingredients. (3) Review of supplier’s relevant food safety records. (4) Other appropriate supplier verification activities based on supplier performance and risk associated with the raw material. (FLEXIBILITY)

§ General requirements applicable to a supply-chain program The supply-chain program must provide assurance that a hazard requiring a supply-chain applied control has been significantly minimized or prevented. In approving suppliers and determining appropriate supplier verification activities, the following must be considered: The hazard analysis of the animal food. The entities that will be applying the control for the hazard. Supplier performance (processes and procedures; compliance with regulations; supplier’s food safety history). (e) If the receiving facility determines the supply-chain-applied control is not working, it must take appropriate action.

§ Responsibilities of the receiving facility (a)(1) The receiving facility must approve suppliers. (a)(2) The receiving facility must determine and conduct appropriate verification activities and collect appropriate documentation. (a)(3) An entity other than the receiving facility may do the following: Establish receiving processes and written procedures. Document processes and procedures are being followed. Determine and/or conduct appropriate supplier verification activities. (a)(4) The supplier may conduct and document sampling/testing of materials for the hazard controlled by the supplier, provided that the receiving facility reviews and assesses the information.

§ Responsibilities of the receiving facility A receiving facility may not accept the following as a supplier verification activity. ͏Determination by the supplier the appropriate supplier verification activities. An audit conducted by the supplier. A review of a supplier’s own relevant food safety records. A review of a supplier’s own supplier verification activities. A receiving facility may use a third-party audit conducted by the supplier for supplier approval.

§ Using approved suppliers The receiving facility must approve suppliers and document approval before receiving materials from those suppliers. (b)(1) Written procedures for receiving materials must be established and followed. (b)(2) Written procedures must ensure materials are received from approved suppliers only (provisions for temporary approval needed). (b)(3) Documentation that procedures are followed as needed.

§ Determining appropriate supplier verification activities (including determining the frequency of conducting the activity) Appropriate supplier verification activities (including the frequency of conducting the activity) must be determined (§ (d)).

§ Conducting supplier verification activities for raw materials and other ingredients ͏One or more of the supplier verification activities specified in § (b) must be conducted for each supplier before using the raw material or other ingredient from that supplier and periodically thereafter. (b)(1) When a hazard in a raw material or other ingredient is controlled by the supplier and one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals: The appropriate supplier verification activity is an on-site audit of the supplier. The audit must be conducted before using the material; annual audit thereafter.

§ Conducting supplier verification activities for raw materials and other ingredients (b)(2) The requirements of (b)(1) do not apply if there is a written determination that other verification activities and/or less frequent on-site auditing of the supplier provide adequate assurance that the hazards are controlled. (f) There must not be any financial conflicts of interest that influence the results of the verification activities and payment must not be related to the results of the activity.

§ On-site audit An on-site audit of a supplier must be performed by a qualified auditor. If the raw material or other ingredient at the supplier is subject to one or more FDA food safety regulations, an on-site audit must consider such regulations and include a review of the supplier’s written food safety plan(s). (c)(1) The following may be substituted for an on-site audit (within 1 year): The written results of an appropriate FDA inspection for compliance with applicable food safety regulations. For a foreign supplier, an inspection by FDA or an authority within another country recognized by FDA.

§ Records documenting the supply-chain program The records documenting the supply-chain program are subject to the requirements of subpart F (requirements for FSMA records). The receiving facility must review the records for supply-chain verification in accordance with section § (a)(4). The receiving facility must document the following records: ͏Written supply-chain program. ͏Compliance with FSVP, if an importer. The approval of a supplier. Written procedures for receiving materials. Verification that receiving procedures are followed. Determining appropriate supplier verification activities.

§ Records documenting the supply-chain program (c) The receiving facility must document the following records: Completed on-site audit. On-site audit was completed by a qualified auditor. ͏Sampling/testing conducted for supplier verification. ͏Other appropriate supplier verification activities based on the supplier performance and the risk associated with the raw material or other ingredient. Verification activities other than an on-site audit provide adequate assurance that a dangerous hazard are controlled when it is controlled by the supplier.

§ Records documenting the supply-chain program (c) The receiving facility must document the following records: Written results from FDA inspections (or equivalent) if used for supplier approval. ͏Actions taken with respect to supplier non-conformance. Verification of supply-chain applied control by an entity other than the receiving facility’s supplier. When appropriate, receiving facility’s review and assessment of records by entities other than the receiving facility or suppliers: Written procedures are followed. Appropriate supplier verification activities have been determined. Appropriate supplier verification activities have been conducted. Supplier records for sampling, testing and third-party audits. Appropriate records for supply-chain applied controls by entities other than the receiving facility’s supplier.

FSMA Records Requirements
The centerpiece of your FSMA Documentation will be your written Food Safety Plan and Hazard Analysis § outlines the required implementation records: Monitoring of preventive controls (a)(2) Corrective actions (a)(3) Verification activities (a)(4) Supply-chain program records (a)(5) Detailed in (§ ) Training documentation (a)(6)

§ (a)(6) calls out the training records that are required to be documented Training for the preventive controls qualified individuals Training for qualified auditors § 507.4(d) document training for qualified individuals Training for qualified individuals will need to be documented Production employees Employees performing monitoring activities Employees performing records reviews Likely to be a concern only if food safety problems arise

§ (a)(4) describes the required review of records Monitoring and corrective action records must be reviewed within 7-working days of creation Or reasonable timeframe if written justification is prepared Reviewed by preventive controls qualified individual or under the oversight of Records of calibration, product testing, supplier and supply chain verification activities Within a reasonable timeframe of creation Reviewed by preventive controls qualified individual or under the oversight of

Subpart F outlines general requirements that apply to all records which include: The FSP must be kept on-site, but is not required to be submitted in advance of inspection or registration renewal Records must be retained for 2 years Offsite storage is permitted as long as they can be retrieved within 24 hours of official request Electronic records are permitted Electronic records are exempt from 21 CFR Part 11 requirements unless required under another regulation

Some Exemptions Facilities solely engage in storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing Exempt from Subparts B, C and E Establishments solely engaged in: Holding and/or transportation of one or more RACs Hulling, shelling, drying, packing and/or holding nuts and hulls Ginning of cotton (without manufacturing/processing) Exempt from Subpart B Grain elevators and other facilities that solely store… - grains, not fruits

Some Exemptions Grains - Fruits - Exempt from Subparts B, C and E
Examples: barley, dent- or flint-corn, sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat and oilseeds for oil extraction (such as cottonseed, flaxseed, rapeseed and soybeans) Fruits - Exempt from Subpart B only Examples: lentils, kidney beans, pinto beans, lima beans, coffee beans, cocoa beans, peanuts, tree nuts and seeds for direct consumption Grain elevators and other facilities that solely store… - grains, not fruits

Some Exemptions Facilities solely engage in storage of unexposed packaged animal food that does not require time/temperature control to significantly minimize or prevent the growth of, or toxin production by, pathogens Exempt from Subparts C and E Facilities solely engage in storage of unexposed packaged animal food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, pathogens Subject to modified requirements in §

Compliance Dates Business Size CGMP Compliance Date PC Compliance Date
Business other than small and very small 1 year – Sept. 19, 2016 2 years – Sept. 18, 2017 Small business (a business employing fewer than 500 full-time equivalent employees) 3 years – Sept. 17, 2018 Very small business (a business averaging less than $2,500,000, per year, during the 3-yr period preceding the applicable calendar year in sales of animal food plus the market value of animal food manufactured, processed, packed, or held without sale (e.g., held for a fee or supplied to a farm without sale) 4 years – Sept. 17, 2019 Except for retaining records to support its status as a very small business (January 1, 2017)

Supply-Chain Compliance Dates
TABLE 33 – 80 FR at 56329 Situation Compliance Date A receiving facility is a small business and its supplier will be subject to the CGMPs, but not the preventive control requirements, of the animal food preventive controls rule. 6 months after the receiving facility’s supplier of that raw material or other ingredient is required to comply with the CGMP requirements of this rule. A receiving facility is a small business and its supplier is subject to the animal food preventive controls rule. The later of: September 17, 2018 or 6 months after the receiving facility’s supplier of that raw material or other ingredient is required to comply with this rule. A receiving facility is not a small business or a very small business and its supplier will be subject to CGMPs, but not the preventive control requirements, of the animal food preventive controls rule. A receiving facility is not a small business or a very small business and its supplier will be subject to the animal food preventive controls rule. The later of: September 18, 2017 or 6 months after the receiving facility’s supplier of that raw material or other ingredient is required to comply with the applicable rule.

AFIA Activities FSMA AFIA Member Weekly Updates
Meetings with other trade groups with CVM Animal Food Safety Preventive Controls Alliance (Dr. Henry Turlington, AFIA’s rep) Feed Safety Hazard Analysis (U of MN) –then peer review—delivered to AFIA members in summer 2016 FAQs, videos PC QI training

Upcoming Events Spring 2016 – future AFIA webinar series
Summer – PCQI training at several locations

Upcoming Rulemakings Oct. 31 – Foreign Supplier Verification and March 31, 2016 – Sanitary Transportation May 31, 2016 – Intentional Adulteration (animal food exempt thus far) Plus many guidance documents

What Should You Do?

QUESTIONS

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FSMA: ANIMAL FOOD FINAL RULE

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