Federal Register. Mitigation Strategies To Protect Food Against Intentional Adulteration. Start Preamble. Start Printed Page 3. AGENCY Food and Drug Administration, HHS. ACTION Final rule. Wavosaur Voice Remover Tool there. Operational+Pre+Requisite+Program+%28OPRP%29.jpg' alt='Sqf 13 Prerequisite Programs' title='Sqf 13 Prerequisite Programs' />Sqf 13 Prerequisite ProgramsSUMMARY 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. DATES This rule is effective July 2. See section VIII for compliance dates. Start Further Info. FOR FURTHER INFORMATION CONTACT Ryan Newkirk, Center for Food Safety and Applied Nutrition HFS 0. Food and Drug Administration, 5. Paint Branch Pkwy., College Park, MD 2. Sqf 13 Prerequisite Programs' title='Sqf 13 Prerequisite Programs' />Information about this document as published in the Federal Register. Relevant information about this document from Regulations. This. Ryan. Newkirkfda. End Further Info. End Preamble. Start Supplemental Information. 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. Issuu is a digital publishing platform that makes it simple to publish magazines, catalogs, newspapers, books, and more online. Easily share your publications and get. CONTINUING EDUCATION CREDITS. SQF Professional ReRegistration. Full participation in the SQF International Conference meets the 15 hour continuing professional. Sqf 13 Prerequisite Programs' title='Sqf 13 Prerequisite Programs' />Sqf 13 Prerequisite ProgramsB. Proposed Rule on Intentional Adulteration. C. Appendix 4 to Draft Risk Assessment. D. Public Comments. II. Legal Authority. A. Section 1. 03 of FSMAB. Section 1. 06 of FSMAC. 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 4. 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. Totally Rad Actions Affiliate Program. 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 4. Registration Regulations 2. CFR Part 1, Subpart H and Section 4. Recordkeeping Regulations 2. CFR Part 1, Subpart JB. Other Definitions That We Proposed To Establish in Part 1. 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  1. 21. Exemptions. V. Subpart C Comments on Food Defense Measures. A. Proposed  1. 21. Requirement for a Food Defense Plan. B. Proposed  1. 21. Identification of Actionable Process Steps. C. Proposed  1. 21. Focused Mitigation Strategies for Actionable Process Steps. D. Final  1. 21. Mitigation Strategies Management Components. E. Proposed  1. 21. Monitoring. F. Proposed  1. Corrective Actions. G. Proposed  1. 21. Verification. H. Proposed  1. Training Final  1. VI. Subpart D Comments on Requirements Applying to Records That Must Be Established and Maintained. Cheats World In Conflict Complete Edition Pc'>Cheats World In Conflict Complete Edition Pc. A. Proposed  1. 21. Records Subject to the Requirements of This Subpart DB. Proposed  1. 21. General Requirements Applying to Records. C. Proposed  1. 21. Additional Requirements Applying to the Food Defense Plan. D. Proposed  1. 21. Requirements for Record Retention. E. Proposed  1. 21. Requirements for Official Review. F. Proposed  1. 21. Public Disclosure. G. Proposed  1. 21. Use of Existing Records. VII. Subpart E Comments on ComplianceProposed  1. VIII. Effective and Compliance Dates. IX. Executive Order 1. X. Final Regulatory Impact Analysis. XI. Paperwork Reduction Act of 1. 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 4. 18 of the FD C Act 2. U. S. C. 3. 50g addresses intentional adulteration in the context of facilities that manufacture, process, pack, or hold food and are required to register under section 4. FD C Act 2. U. S. C. 3. 50d. Section 4. FD C Act 2. U. S. C. 3. 50h addresses intentional adulteration in the context of fruits and vegetables that are raw agricultural commodities. Section 4. 20 of the FD C Act 2. U. S. C. 3. 50i 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 4. 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 4. FD C Act. This rule establishes several exemptions as follows The rule does not apply to a very small business i. 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 4. 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 4. FD C Act. Start Printed Page 3. 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  1. 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  1. 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  1.