FDA Tweaks Its Four Foundational FSMA Proposed Rules

FDA has published supplemental proposed rules for the four “foundational” rules that will implement the Food Safety Modernization Act (FSMA).  Those four rules are:

1. Produce Safety;
2. Preventive Controls for Human Food;
3. Preventive Controls for Animal Food; and
4. Foreign Supplier Verification Programs (FSVP).

Comments on the supplemental proposed rules are due December 15, 2014.

The “Supplementals” respond to many of the strongest criticisms of the proposed rules, including:

• Criticism that the proposed rule on Preventive Controls for Human Food would cause many farms to have to comply with both that rule and the Produce Safety rule;
• Criticism of the agricultural water standards in the Produce Safety rule as unrealistic and not scientifically based;
• Criticism that it would be unfair to require product testing, environmental monitoring, and supplier verification in the final rules on Preventive Controls for Human Food and Preventive Controls for Animal Food without first offering specific regulatory language for public comment; and
• Criticism that FDA access to audit reports required in the Preventive Controls for Human Food and FSVP rules would discourage free communication between third-party auditors and audited facility personnel.

FDA officials are claiming that the Supplementals would increase the flexibility of the proposed rules and reduce the burden of compliance.  While that is true for the most part, the Supplementals would also increase the burden on industry in some respects.  Some examples of that increased burden include:

• The aforementioned addition of product testing, environmental monitoring, and supplier verification (and new recordkeeping requirements associated with those new measures) in the two preventive controls rules;
• The added requirement that importers perform a broad risk evaluation (and associated recordkeeping) in the FSVP rule; and
• The added requirement that the hazard analysis performed by facilities under the preventive controls rules and by importers under the FSVP rule consider the potential for economically motivated adulteration.

Another concern is the use of somewhat vague or subjective standards that will require further elucidation in guidance and inevitably leave much discretion to FDA field inspectors.  Examples of this include:

• The two preventive controls rules would require product testing as a verification measure, when appropriate, based on the facility, the food, and the nature of the preventive control.
• The preventive controls rules and the FSVP rule would permit use of supplier verification activities other than annual onsite audits for hazards that present a threat of serious adverse health consequences or death to humans or animals (SAHCODHA) if the facility or importer documents its determination that such other verification activities are adequate to ensure safety. Under what circumstances would such a determination be reasonable?
• Under the preventive controls rules and the FSVP rule, facilities and importers would be required to consider economically motivated adulteration in their hazard analyses when that type of adulteration is reasonably foreseeable. Although FDA offers some discussion of when economically motivated adulteration should be considered reasonably foreseeable, there are certainly to be many instances where this is likely to be a close call.

Below we provide what we hope is a handy summary of the major changes to the four proposed rules that would be made by the Supplementals.

Produce Safety

• Changes the scope of farms subject to the Produce Safety Rule:
  • The definition of “farm” would be expanded to include farms that engage in certain additional activities (g., packing raw agricultural commodities (RACs) grown on other farms not under the same ownership, drying/dehydrating RACs to create a distinct commodity where such drying is akin to harvesting).
  • Farms and farm mixed-type facilities with average annual sales of produce (not all food) of $25,000 or less during the previous 3-year period would be exempt.

• Revises the water quality standard and water testing frequency:
  • Quantitative microbial quality standards consistent with the Environmental Protection Agency’s (EPA) 2012 recreational water quality criteria (RWQC) would be adopted.
  • Farms would be able to meet the new standards by alternative means (g., allowing a sufficient time interval between last irrigation and harvesting to allow for microbial die-off using a specified die-off rate, allowing a sufficient time interval between last irrigation and end of storage to allow for microbial die-off).
  • Different frequencies for water testing would be established based on the source and use of the water.

• Revises the interval between application of biological soil amendments and harvesting:
  • The proposed 9-month interval for untreated manure would be withdrawn, to be replaced by a to-be-decided interval after FDA conducts additional research and a risk assessment.
  • The proposed 45-day interval for composted manure has been eliminated as unnecessary.
  • FDA states that it does not intend to object, for the time being, to farmers that comply with the intervals specified for organic crops in the National Organic Program regulations.

• Clarifies that the Produce Safety Rule does not require farms to engage in “taking” of threatened or endangered species, destroy wild animal habitat, or clear borders around outdoor growing areas or drainages.

• Establishes withdrawal and reinstatement procedures for the exemption for “qualified facilities.”

Preventive Controls for Human Food

• Expands exemptions from preventive controls:
  • The definition of “farm” would be expanded to encompass farms that engage in certain additional activities (consistent with the Produce Safety Rule change discussed above).
  • The exemption for facilities solely engaged in the storage of RACs, other than fruits and vegetables, for further distribution or processing would be expanded to encompass storage facilities that engage in activities incidental to the storage of food (g., fumigation, blending lots of the same RAC, grading).
  • The exemption for facilities solely engaged in the storage of packaged foods that are not exposed to the environment would be expanded to include storage facilities that also engage in activities incidental to the storage of food (g., affixing tracking labels, breaking down pallets, assembling variety packs).
  • “Very small business” would be defined to mean businesses with annual sales of human food of less than $1 million.

• Expands exclusions from current good manufacturing practice (CGMP) to include:
  • Farms (using the expanded definition of “farm” discussed above);
  • Activities of farm mixed-type facilities that fall within the definition of “farm”:
  • Holding or transportation of RACs;
  • Hulling, shelling, and drying of nuts (but not roasting, which constitutes “manufacturing/processing”); and
  • Fishing vessels that are not required to register with FDA.

• Expands the hazard analysis requirement:
  • A covered facility’s hazard analysis would be required to consider the risk of economically motivated adulteration where there is a past history of such adulteration involving that food.
  • A covered facility’s hazard analysis would be required to consider environmental pathogens where a ready-to-eat (RTE) food is exposed to the environment prior to packaging and the packaged food does not receive a treatment that would significantly minimize the environmental pathogen.

• Adds supplier controls as a new preventive control:
  • Receiving facilities would be required to implement supplier control programs for raw materials and ingredients for which they have identified a significant hazard that is controlled before the raw materials or ingredients reach the receiving facility.
  • “Receiving facility” would be defined as a facility subject to preventive controls that manufactures/processes raw materials or ingredients. Therefore, facilities that only pack or hold food (g., warehouses) would not be required to have supplier controls.
  • Supplier controls would not be required if the hazard is controlled by: (a) the receiving facility; or (b) the receiving facility’s customer (provided the receiving facility annually obtains from the customer written assurance that the customer follows procedures to control the hazard).
  • To verify their suppliers, receiving facilities may choose from four options: (a) onsite audits of suppliers; (b) sampling/testing of raw materials and ingredients; (c) review of suppliers’ food safety records; and/or (d) other appropriate verification activities.
    • However, if there is a reasonable probability that the hazard in a raw material or ingredient would cause serious adverse health consequences or death to humans, the receiving facility must conduct annual onsite audits of the supplier, unless it can document that other verification activities or less frequent audits provide adequate assurance that the hazard is controlled.
    • Alternative verification requirements would apply to “qualified facilities” and farms that are not subject to the Produce Safety Rule.
  • In lieu of onsite audits of a supplier, a receiving facility may rely on inspections by FDA or a foreign food safety authority of a country whose food safety system FDA has officially recognized as comparable or equivalent to the U.S.
  • The receiving facility would be required to take action to address supplier nonconformance, but FDA would not mandate any particular action.

• Adds requirement to conduct product testing and environmental monitoring, under certain circumstances, to verify the implementation and effectiveness of a facility’s preventive controls:
  • Product testing would be required where a covered facility determines it is appropriate based on the facility, the food, and the nature of the preventive controls (which product testing would be used to verify).
  • Environmental monitoring would be required where an environmental pathogen is identified as a significant hazard in a RTE food that is exposed to the environment prior to packaging and does not receive a treatment that would significantly minimize the pathogen after packaging.

• Adds new recordkeeping requirements, but clarifies that existing records may be used to satisfy all recordkeeping requirements.

• Clarifies that human food facilities that ship byproducts for use in animal food are not subject to the Preventive Controls for Animal Food Rule, unless they engage in processing of the byproducts for use in animal food (g., drying, heat treatment).

• Establishes procedures for withdrawal and reinstatement of exemption for “qualified facilities.”

Preventive Controls for Animal Food

Note: Some of these changes (e.g., requirements for product testing and environmental monitoring, supplier controls, and addressing economically motivated adulteration) are being proposed explicitly to garner public comments and will not necessarily be included in the rules when finalized.

• Expands exemptions from preventive controls:
  • The definition of “farm” would be expanded to encompass farms that engage in certain additional activities (consistent with the Produce Safety Rule change discussed above).
  • The exemption for facilities solely engaged in the storage of RACs, other than fruits and vegetables, for further distribution or processing would be expanded to encompass storage facilities that engage in activities incidental to the storage of food (g., fumigation, blending lots of the same RAC, grading).
  • The exemption for facilities solely engaged in the storage of packaged foods that are not exposed to the environment would be expanded to include storage facilities that also engage in activities incidental to the storage of food (g., affixing tracking labels, breaking down pallets, assembling variety packs).
  • “Very small business” would be defined to mean businesses with annual sales of animal food of less than $2.5 million.
  • Human food facilities that provide byproducts used in animal food would be exempt, unless they further process such byproducts.

• Adds requirement that a facility’s hazard analysis to consider the potential for economically motivated adulteration.

• Adds supplier controls as a new preventive control:
  • Receiving facilities would be required to implement supplier control programs for raw materials and ingredients for which they have identified a significant hazard that is controlled before the raw materials or ingredients reach the receiving facility.
  • “Receiving facility” would be defined as a facility subject to preventive controls that manufactures/processes raw materials or ingredients. Therefore, facilities that only pack or hold food (g., warehouses) would not be required to have supplier controls.
  • Supplier controls would not be required if the hazard is controlled by: (a) the receiving facility; or (b) the receiving facility’s customer (provided the receiving facility annually obtains from the customer written assurance that the customer follows procedures to control the hazard).
  • To verify their suppliers, receiving facilities may choose from four options: (a) onsite audits of suppliers; (b) sampling/testing of raw materials and ingredients; (c) review of suppliers’ food safety records; and/or (d) other appropriate verification activities.
    • However, if there is a reasonable probability that the hazard in a raw material or ingredient would cause serious adverse health consequences or death to animals, the receiving facility must conduct annual onsite audits of the supplier, unless it can document that other verification activities or less frequent audits provide adequate assurance that the hazard is controlled.
    • Alternative verification requirements would apply to “qualified facilities” and farms that are not subject to the Produce Safety Rule.
  • In lieu of onsite audits of a supplier, a receiving facility may rely on inspections by FDA or a foreign food safety authority of a country whose food safety system FDA has officially recognized as comparable or equivalent to the U.S.
  • A receiving facility would be required to take action to address a supplier’s nonconformance, but FDA would not mandate any particular action.

• Adds requirement to conduct product testing and environmental monitoring, under certain circumstances, to verify the implementation and effectiveness of a facility’s preventive controls:
  • Product testing would be required where a covered facility determines it is appropriate based on the facility, the animal food, and the nature of the preventive controls.
  • Environmental monitoring would be required where an environmental pathogen is identified as a significant hazard in a RTE animal food (g., dog and cat kibble) that is exposed to the environment prior to packaging and does not receive a treatment that would significantly minimize the pathogen after packaging.

• Makes changes to proposed animal food CGMP:
  • The requirement that ill employees be excluded from working in animal food facilities would be deleted.
  • The requirement that raw material and ingredients must be free of microorganisms harmful to human or animal health, or be treated to eliminate them, would be deleted.
  • Facilities that hold animal food would be required to store them in a manner that prevents contamination from garbage or trash, and shipping containers and bulk vehicles used to distribute animal food would be required to be inspected prior to use.

• FDA is also requesting comment regarding whether feed mills associated with fully vertically-integrated animal farming operations should be subject to CGMP and preventive controls. FDA is considering whether to subject fully vertically-integrated farming operations to the same regulatory requirements as vertically-integrated operations that provide feed to contract farmers.

Foreign Supplier Verification Programs

• Expands the hazard analysis requirement, adding a new “risk evaluation”:
  • The requirement that importers conduct a compliance status review of each foreign supplier and imported food would be deleted, but that requirement would be folded into the new risk evaluation.
  • A new risk evaluation requirement would be added. The risk evaluation would be required to evaluate the hazard analysis, which entity is controlling identified hazards, the foreign supplier’s food safety procedures and practices, applicable FDA food safety regulations and the foreign supplier’s compliance with those regulations, the foreign supplier’s food safety performance history, and other appropriate factors (g., storage and transportation practices, recent changes in the management of the foreign supplier).
  • The importer’s hazard analysis would be required to consider the risk of economically motivated adulteration where there is a past history of such adulteration in that type of food from that country.
  • The importer’s hazard analysis would be required to consider environmental pathogens where an environmental pathogen is a significant hazard in a RTE food that is exposed to the environment prior to packaging and does not receive a treatment that would significantly minimize the pathogen after packaging.

• Modifies the verification activities that importers must perform:
  • Importers generally would be able to choose from four options: (a) onsite audits of foreign suppliers; (b) sampling/testing of imported foods; (c) review of foreign suppliers’ food safety records; and/or (d) other appropriate verification activities.
    • However, if there is a reasonable probability that the hazard in an imported food would cause SAHCODHA, the importer must conduct annual onsite audits of the foreign supplier, unless it can document that other verification activities or less frequent audits provide adequate assurance that the hazard is controlled.
    • Alternative verification requirements would apply when the foreign supplier is a farm that is not subject to the Produce Safety Rule.
  • In lieu of onsite audits of a supplier, a receiving facility may rely on inspections by FDA or a foreign food safety authority of a country whose food safety system FDA has officially recognized as comparable or equivalent to the U.S.
  • Verification activities would not be required if: (a) preventive controls by the importer (under the Preventive Controls for Human Food Rule) are adequate to significantly minimize or prevent all significant hazards in the imported food; or (b) preventive controls by the importer’s customer (under the Preventive Controls for Human Food Rule) are adequate to significantly minimize or prevent all significant hazards in the imported food, and the importer annually obtains from its customer written assurance that it follows procedures to control such hazards.
  • A new requirement that the importer establish and follow written procedures to ensure that it imports food only from approved foreign suppliers would be added. However, importers would be permitted to import food from unapproved foreign suppliers when necessary on a temporary basis, provided the importer conducts adequate verification activities (g., sampling and testing individual shipments) before using or distributing such food.
  • The requirement that importers maintain a list of all of their foreign suppliers would be deleted.

• Defines “very small importer” and “very small foreign supplier” to mean an importer or foreign supplier with less than $1 million in annual sales of human food. Modified requirements apply to very small importers and imports from very small foreign suppliers.
• Clarifies that importers that are also facilities subject to one of the preventive controls rules, and that are in compliance with the supplier control requirements of the applicable preventive controls rule, are deemed to be in compliance with FSVP Rule, except that they must still identify the importer at time of entry.