Vol. 78 Tuesday, No. 247 December 24, 2013 Part III Department of Health and Human Services Food and Drug Administration 21 CFR Parts 16 and 121 Focused Mitigation Strategies To Protect Food Against Intentional Adulteration; Proposed Rule VerDate Mar<15>2010 17:30 Dec 23, 2013 Jkt 232001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\24DEP2.SGM 24DEP2 sroberts on DSK5SPTVN1PROD with PROPOSALS 78014 Federal Register / Vol. 78, No. 247 / Tuesday, December 24, 2013 / Proposed Rules DEPARTMENT OF HEALTH AND • Federal eRulemaking Portal: http:// A. Framework of the Rule HUMAN SERVICES www.regulations.gov. Follow the B. Activities That Occur on Produce Farms instructions for submitting comments. C. Transportation Carriers Food and Drug Administration Written Submissions D. Food for Animals Submit written submissions in the E. Acts of Disgruntled Employees, Consumers, or Competitors 21 CFR Parts 16 and 121 following ways: • F. Economically Motivated Adulteration Mail/Hand delivery/Courier (for G. Low-Risk Activities at Farm Mixed-Type [Docket No. FDA–2013–N–1425] paper or CD–ROM submissions): Facilities Division of Dockets Management (HFA– H. Activities That Occur on Dairy Farms RIN 0910–AG63 305), Food and Drug Administration, I. Other Ways To Focus on Foods With a 5630 Fishers Lane, rm. 1061, Rockville, High Risk of Intentional Adulteration Focused Mitigation Strategies To MD 20852. Caused by Terrorism Protect Food Against Intentional Instructions: All submissions received V. The Proposal Adulteration A. Definitions must include the Agency name and B. Exemptions AGENCY: Food and Drug Administration, Docket No. FDA–2013–N–1425 and C. Food Defense Measures HHS. Regulatory Information Number (RIN) D. Requirements Applying to Records That 0910–AG63 for this rulemaking. All Must Be Established and Maintained ACTION: Proposed rule. comments received may be posted E. Compliance VI. Preliminary Regulatory Impact Analysis SUMMARY: The Food and Drug without change to http:// VII. Analysis of Environmental Impact Administration (FDA or we) is www.regulations.gov, including any personal information provided. For VIII. Federalism proposing to require domestic and IX. Comments foreign food facilities that are required additional information on submitting X. References to register under the Federal Food, Drug, comments, see the ‘‘Comments’’ heading and Cosmetic Act (the FD&C Act) to of the SUPPLEMENTARY INFORMATION Executive Summary address hazards that may be section of this document. This proposed regulation implements intentionally introduced by acts of Docket: For access to the docket to three provisions of the Federal Food, terrorism. These food facilities would be read background documents or Drug, and Cosmetic (FD&C) Act, as required to identify and implement comments received, go to http:// amended by the FDA Food Safety focused mitigation strategies to www.regulations.gov and insert the Modernization Act (FSMA), that relate significantly minimize or prevent docket number, found in brackets in the to the intentional adulteration of food. significant vulnerabilities identified at heading of this document, into the Section 418 of the FD&C Act (21 U.S.C. actionable process steps in a food ‘‘Search’’ box and follow the prompts 350g) addresses intentional adulteration operation. FDA is proposing these and/or go to the Division of Dockets in the context of facilities that requirements as part of our Management, 5630 Fishers Lane, rm. manufacture, process, pack, or hold implementation of the FDA Food Safety 1061, Rockville, MD 20852. food and are required to register under Modernization Act (FSMA). Further, as FOR FURTHER INFORMATION CONTACT: section 415 of the FD&C Act (21 U.S.C. part of the proposal, FDA discusses an Regarding the provisions with respect to 350d). Section 419 of the FD&C Act (21 approach to addressing economically human food: Ryan Newkirk, Center for U.S.C. 350h) addresses intentional motivated intentional adulteration. We Food Safety and Applied Nutrition adulteration in the context of fruits and expect the proposed rule, if finalized as (HFS–005), Food and Drug vegetables that are raw agricultural proposed, would help to protect food Administration, 5100 Paint Branch commodities. Section 420 of the FD&C from intentional adulteration caused by Pkwy., College Park, MD 20740, 240– Act (21 U.S.C. 350i) addresses acts of terrorism. 402–2428. Regarding the provisions intentional adulteration in the context of high risk foods and exempts farms DATES: Submit either electronic or with respect to food for animals: Alfred except for farms that produce milk. FDA written comments on the proposed rule Montgomery, Center for Veterinary is implementing the intentional by March 31, 2014. Submit comments Medicine (HFV–200), Food and Drug adulteration provisions in sections 418, on information collection issues under Administration, 7519 Standish Pl., 419, and 420 of the FD&C Act in this the Paperwork Reduction Act of 1995 by Rockville, MD 20855, 240–453–6836. rulemaking. January 23, 2014, (see the ‘‘Paperwork SUPPLEMENTARY INFORMATION: Reduction Act of 1995’’ section of this Table of Contents Scope of Coverage of the Proposed Rule document). Executive Summary The subject of this proposed rule is ADDRESSES: You may submit comments, protection of food against intentional identified by Docket No. FDA–2013–N– Scope of Coverage of the Proposed Rule adulteration caused by acts of terrorism. Summary of the Major Provisions of the 1425 and/or Regulatory Information Proposed Rule This proposed rule would apply to both Number (RIN) 0910–AG63, by any of the Costs and Benefits domestic and foreign facilities that are following methods, except that I. Introduction required to register under section 415 of comments on information collection II. Background the FD&C Act. However, as explained in issues under the Paperwork Reduction A. Incidents of Intentional Adulteration of the remainder of this document and Act of 1995 must be submitted to the Food shown in Diagram 1 and Table 1, the Office of Information and Regulatory B. Interagency Approach to Food Defense proposed rule contains several Affairs, Office of Management and C. Resources for the Food Sector exemptions. (The diagrams and table Budget (OMB) (see the ‘‘Paperwork D. Outreach below are intended to illustrate the E. Industry Standards Reduction Act of 1995’’ section of this F. International Food Defense Guidelines proposed scope and requirements of this document). III. Legal Authority rule, and do not include all aspects of the proposed regulation.) These Electronic Submissions A. Section 103 of FSMA B. Section 106 of FSMA exemptions are: Submit electronic comments in the C. Intrastate Activities • The proposed rule would not apply following way: IV. Regulatory Approach to a qualified facility, except that the VerDate Mar<15>2010 17:30 Dec 23, 2013 Jkt 232001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\FR\FM\24DEP2.SGM 24DEP2 sroberts on DSK5SPTVN1PROD with PROPOSALS Federal Register / Vol. 78, No. 247 / Tuesday, December 24, 2013 / Proposed Rules 78015 facility would be required to provide for to qualified end-users (as defined in this • This proposed rule would not apply official review, upon request, part) during such period exceeded the to activities of a facility that are subject documentation that was relied upon to average annual monetary value of the to section 419 of the Federal Food, Drug, demonstrate that the facility qualifies food sold by such facility to all other and Cosmetic Act (Standards for for this exemption. As proposed, a purchasers; and (b) the average annual Produce Safety). qualified facility would be: (1) A very monetary value of all food sold during • This proposed rule would not apply small business (i.e., a business that has the 3-year period preceding the with respect to alcoholic beverages at a less than $10,000,000 in total annual applicable calendar year was less than facility that meets certain conditions. sales of food, adjusted for inflation), or $500,000, adjusted for inflation. • • This proposed rule would not apply This proposed rule would not apply (2) a facility that meets two to the holding of food, except the to the manufacturing, processing, requirements, i.e., (a) During the 3-year holding of food in liquid storage tanks. packing, or holding of food for animals period preceding the applicable • This proposed rule would not apply other than man. calendar year, the average annual to the packing, re-packing, labeling, or We seek comment on these exclusions monetary value of the food re-labeling of food where the container and whether additional exclusions are manufactured, processed, packed or that directly contacts the food remains warranted. held at such facility that is sold directly intact. BILLING CODE 4160–01–P VerDate Mar<15>2010 17:30 Dec 23, 2013 Jkt 232001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 E:\FR\FM\24DEP2.SGM 24DEP2 sroberts on DSK5SPTVN1PROD with PROPOSALS 78016 Federal Register / Vol. 78, No. 247 / Tuesday, December 24, 2013 / Proposed Rules BILLING CODE 4160–01–C VerDate Mar<15>2010 17:30 Dec 23, 2013 Jkt 232001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 E:\FR\FM\24DEP2.SGM 24DEP2 sroberts on DSK5SPTVN1PROD with PROPOSALS EP24DE13.026</GPH> Federal Register / Vol. 78, No. 247 / Tuesday, December 24, 2013 / Proposed Rules 78017 TABLE 1—SCOPE OF INTENTIONAL ADULTERATION AND PROPOSED EXCLUSIONS AND EXEMPTIONS Coverage within scope of proposed Brief rationale, and relevant corresponding Type of intentional adulteration 21 CFR 121 section of the rule * I. Types of Intentional Adulteration Considered in this Proposed Rulemaking 1. Acts of disgruntled employees, consumers, Not within the scope of intentional adulteration D Not considered ‘‘high risk’’ because not in- or competitors intended to attack the reputa- covered under proposed 21 CFR 121. tended to cause widespread, significant tion of a company, and not to cause public public health harm. health harm, although public health harm D See section IV.E of this document.