Action               Final Rule.

SUMMARY    

   The Food and Drug Administration (FDA or we) is issuing this final rule to require domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to address hazards that may be introduced with the intention to cause wide scale public health harm. These food facilities are required to conduct a vulnerability assessment to identify significant vulnerabilities and actionable process steps and implement mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at actionable process steps in a food operation. FDA is issuing these requirements as part of our implementation of the FDA Food Safety Modernization Act (FSMA).

UNIFIED

    Focused Mitigation Strategies To Protect Food

Agenda      
 
     Against Intentional Adulteration

DATES:

    This rule is effective July 26, 2016. See section VIII for compliance dates.

FOR FURTHER INFORMATION CONTACT:

   Ryan Newkirk, Center for Food Safety and Applied Nutrition (HFS-005), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-3712

SUPPLEMENTARY INFORMATION:

    Table of Contents           

Executive Summary

Purpose and Coverage of the Rule

Summary of the Major Provisions of the Rule

Costs and Benefits

I. Background

A. FDA Food Safety Modernization Act

B. Proposed Rule on Intentional Adulteration

C. Appendix 4 to Draft Risk Assessment

D. Public Comments

II. Legal Authority

A. Section 103 of FSMA

B. Section 106 of FSMA

C. Intrastate Activities

III. General Comments on the Proposed Rule

A. Comments on Overall Framework for the Regulatory Approach

B. One Set of Requirements Under Sections 418 and 420 of the FD&C Act

C. Require Measures Only in the Event of a Credible Threat

D. General Comments on Implementation and Compliance

E. Comments on Requests for Additional Exemptions

F. Other General Comments

G. Other Issues Discussed in the Proposed Rule

IV. Subpart A: Comments on Specific Provisions

A. Revisions to Definitions Also Used in Section 415 Registration Regulations (21 CFR Part 1, Subpart H) and Section 414 Recordkeeping Regulations (21 CFR Part 1, Subpart J)

B. Other Definitions That We Proposed To Establish in Part 121

C. Additional Definitions to Clarify Terms Not Defined in the Proposed Rule

D. Comments Asking FDA to Establish Additional Definitions or Otherwise Clarify Terms Not Defined in the Rule

E. Proposed § 121.5—Exemptions

V. Subpart C: Comments on Food Defense Measures

A. Proposed § 121.126—Requirement for a Food Defense Plan

B. Proposed § 121.130—Identification of Actionable Process Steps

C. Proposed § 121.135—Focused Mitigation Strategies for Actionable Process Steps

D. Final § 121.138—Mitigation Strategies Management Components

E. Proposed § 121.140—Monitoring

F. Proposed § 121.145—Corrective Actions

G. Proposed § 121.150—Verification

H. Proposed § 121.160—Training (Final § 121.4)

VI. Subpart D: Comments on Requirements Applying to Records That Must Be Established and Maintained

A. Proposed § 121.301—Records Subject to the Requirements of This Subpart D

B. Proposed § 121.305—General Requirements Applying to Records

C. Proposed § 121.310—Additional Requirements Applying to the Food Defense Plan

D. Proposed § 121.315—Requirements for Record Retention

E. Proposed § 121.320—Requirements for Official Review

F. Proposed § 121.325—Public Disclosure

G. Proposed § 121.330—Use of Existing Records

VII. Subpart E: Comments on Compliance—Proposed § 121.401

VIII. Effective and Compliance Dates

IX. Executive Order 13175

X. Final Regulatory Impact Analysis

XI. Paperwork Reduction Act of 1995

XII. Analysis of Environmental Impact

XIII. Federalism

         XIV. References

Executive Summary    

     Purpose and Coverage of the Rule

              

This regulation implements three provisions of the FD&C Act, as amended by FSMA, that relate to the intentional adulteration of food. Section 418 of the FD&C Act (21 U.S.C. 350g) addresses intentional adulteration in the context of facilities that manufacture, process, pack, or hold food and are required to register under section 415 of the FD&C Act (21 U.S.C. 350d). Section 419 of the FD&C Act (21 U.S.C. 350h) addresses intentional adulteration in the context of fruits and vegetables that are raw agricultural commodities. Section 420 of the FD&C Act (21 U.S.C. 350i) addresses intentional adulteration in the context of high-risk foods and exempts farms except for farms that produce milk. FDA is implementing the intentional adulteration provisions in sections 418, 419, and 420 of the FD&C Act in this rulemaking.

The purpose of this rule is to protect food from intentional acts of adulteration where there is an intent to cause wide scale public health harm. This rule applies to both domestic and foreign facilities that are required to register under section 415 of the FD&C Act. This rule establishes several exemptions as follows:

• The rule does not apply to a very small business (i.e., a business, including any subsidiaries or affiliates, averaging less than $10,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in both sales of human food plus the market value of human food manufactured, processed, packed, or held without sale, e.g., held for a fee), except that the facility is required to provide for official review, upon request, documentation sufficient to show that the facility qualifies for this exemption.
• This rule does not apply to the holding of food, except the holding of food in liquid storage tanks.
• This rule does not apply to the packing, re-packing, labeling, or re-labeling of food where the container that directly contacts the food remains intact.
• This rule does not apply to activities of a farm that are subject to section 419 of the Federal Food, Drug, and Cosmetic Act (Standards for Produce Safety).
• This rule does not apply with respect to alcoholic beverages at a facility that meets certain conditions.
• This rule does not apply to the manufacturing, processing, packing, or holding of food for animals other than man.
• This rule does not apply to on-farm manufacturing, processing, packing, or holding by a small or very small business of certain foods identified as having low-risk production practices if such activities are the only activities conducted by the business subject to section 418 of the FD&C Act.

Summary of the Major Provisions of the Final Rule

This rule establishes various food defense measures that an owner, operator, or agent in charge of a facility is required to implement to protect against the intentional adulteration of food. Specifically:

• Prepare and implement a written food defense plan that includes a vulnerability assessment to identify significant vulnerabilities and actionable process steps, mitigation strategies, and procedures for food defense monitoring, corrective actions, and verification (§ 121.126).
• Identify any significant vulnerabilities and actionable process steps by conducting a vulnerability assessment for each type of food manufactured, processed, packed, or held at the facility using appropriate methods to evaluate each point, step, or procedure in a food operation (§ 121.130).
• Identify and implement mitigation strategies at each actionable process step to provide assurances that the significant vulnerability at each step will be significantly minimized or prevented and the food manufactured, processed, packed, or held by the facility will not be adulterated. For each mitigation strategy implemented at each actionable process step, include a written explanation of how the mitigation strategy sufficiently minimizes or prevents the significant vulnerability associated with the actionable process step (§ 121.135).
• Establish and implement mitigation strategies management components, as appropriate to ensure the proper implementation of each such mitigation strategy, taking into account the nature of the mitigation strategy and its role in the facility's food defense system (§ 121.138).
• Establish and implement food defense monitoring procedures, for monitoring the mitigation strategies, as appropriate to the nature of the mitigation strategy and its role in the facility's food defense system (§ 121.140).
• Establish and implement food defense corrective action procedures that must be taken if mitigation strategies are not properly implemented, as appropriate to the nature of the actionable process step and the nature of the mitigation strategy (§ 121.145).
• Establish and implement specified food defense verification activities, as appropriate to the nature of the mitigation strategy and its role in the facility's food defense system (§ 121.150).
• Conduct a reanalysis of the food defense plan (§ 121.157).
• Ensure that all individuals who perform required food defense activities are qualified to perform their assigned duties (§ 121.4).
• Establish and maintain certain records, including the written food defense plan (vulnerability assessment, mitigation strategies and procedures for food defense monitoring, corrective actions, and verification) and documentation related to training of personnel. All records are subject to certain general recordkeeping and record retention requirements (§§ 121.301 to 121.330).
• The effective date is 60 days after this final rule is published. However, we are providing for a longer timeline for facilities to come into compliance. Facilities, other than small and very small businesses, have 3 years after the effective date to comply with part 121. Small businesses (i.e., those employing fewer than 500 full-time equivalent employees) have 4 years after the effective date to comply with part 121. Very small businesses (i.e., businesses that have less than $10,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in both sales of human food plus the market value of human food manufactured, processed, packed, or held without sale, e.g., held for a fee) have 5 years after the effective date to comply with § 121.5(a).

As discussed in detail in later sections of the rule, we made several major revisions to the provisions of this rule, mainly in response to comments, to provide for greater flexibility and clarity. These major revisions to the regulatory text include the following:

• We removed the key activity types (KATs); however, the use of the KATs is still permissible to conduct a vulnerability assessment and will be further discussed in guidance.
• We specified three elements that must be evaluated when conducting a vulnerability assessment: (1) The potential public health impact (e.g., severity and scale) if a contaminant were added; (2) the degree of physical access to the product; and (3) the ability of an attacker to successfully contaminate the product.
• We specified that the vulnerability assessment must consider the possibility of an inside attacker.
• We removed the distinction between “broad” and “focused” mitigation strategies.
• We made the mitigation strategy management components (food defense monitoring, corrective actions, and verification) more flexible by providing that they are required “as appropriate to ensure the proper implementation of the mitigation strategies, taking into account the nature of each such mitigation strategy and its role in the facility's food defense system.”
• We revised the terminology used for the food defense management components such that monitoring, corrective actions, and verification are now food defense monitoring, food defense corrective actions, and food defense verification.
• We made the requirement to document food defense monitoring more flexible by providing for use of exception records.
• We made the food defense corrective actions requirement more flexible by providing that it is required “as appropriate to the nature of the actionable process step and the nature of the mitigation strategy.”
• We made the requirement for verifying proper implementation of mitigation strategies more flexible by providing for “other activities appropriate for verification of proper implementation of mitigation strategies.”
• We exempted records required by this rule from the requirements of 21 Code of Federal Regulations, part 11.
• We provided for the use of existing records if certain conditions are met.
• We removed the term “qualified facility” and instead refer to “very small business” in the exemption under 121.5(a).
• We established an exemption for certain on-farm manufacturing, processing, packing, or holding by small and very small businesses of certain foods identified as having low-risk production processes.
• We added a new definition for “qualified individual” and included new requirements to ensure that all individuals who perform activities required under subpart C are qualified to perform their assigned activities.
• We provided longer timelines for facilities to come into compliance with the rule.

For more details, to https://www.federalregister.gov/articles/2016/05/27/2016-12373/mitigation-strategies-to-protect-food-against-intentional-adulteration