Mitigation Strategies to Protect Food Against Intentional Adulteration; Proposed Rule

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

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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

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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

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BILLING CODE 4160–01–C

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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. may occur. 2. Economically motivated adulteration (EMA) Not within the scope of intentional adulteration D Considering addressing as part of hazard intended to obtain economic gain, and not to covered under proposed 21 CFR 121. analysis in a preventive controls framework cause public health harm, although public where EMA is ‘‘reasonably likely to occur.’’ health harm may occur. D See section IV.F of this document. 3. Acts intended to cause massive public health Covered within scope, and is the focus of pro- D Considered ‘‘high risk’’ because intent of harm, including acts of terrorism. posed 21 CFR 121. the act is to cause widespread, significant public health harm. D See section IV.A of this document.

II. Facilities or Operations Excluded or Exempted from Proposed 21 CFR 121

Facility or Operation Exclusion or Exemption (and any associated Brief rationale, and relevant corresponding modified requirements) section of the rule *

Activities that fall within the definition of ‘‘farm’’ Excluded ...... D Activities that occur on produce farms are (as defined in 21 CFR § 1.227). not considered ‘‘high risk.’’ D Activities that occur on dairy farms are addressed below. D Activities that occur on other farms are outside the scope of 103, 105, and 106 of FSMA. D See section IV.B of this document. Transportation carriers ...... Excluded ...... D Transportation of bulk liquids is addressed by coverage of shippers and receivers. D Other transportation activities are not considered ‘‘high risk.’’ D See section IV.C of this document.

Activities that occur on dairy farms ...... D Fluid milk storage and loading appear to pose a significant vulnerability. D We seek comment on practical and effective approach to address this vulnerability. D See section IV.H of this document.

Qualified facility, as defined in proposed § 121.3 Exempt, except must provide for FDA review, D Very small businesses are not considered upon request, documentation relied on to ‘‘high risk.’’ demonstrate that the facility qualifies for this D See section V.B.1 of this document. exemption. Holding of food, except the holding of food in Exempt ...... D Not considered ‘‘high risk’’ because these liquid storage tanks. activities do not fit within any of the FDA- identified key activity types. D See section V.B.2 of this document.

Packing, re-packing, labeling, or re-labeling of Exempt ...... D Not considered ‘‘high risk’’ because these food where the container that directly con- activities do not fit within any of the FDA- tacts the food remains intact. identified key activity types. D See section V.B.3 of this document. Activities of a facility that are subject to Stand- Exempt ...... D Activities that occur on produce farms are ards for Produce Safety (proposed 21 CFR not considered ‘‘high risk.’’ 112). D See section V.B.4 of this document. Alcoholic beverages at certain alcohol-related Exempt ...... D Alcoholic beverages at these facilities are facilities, and certain prepackaged food sold outside the scope of 103, 105, and 106 of in limited quantities along with alcoholic bev- FSMA. erages at the same facilities (see proposed D See section V.B.5 of this document. § 121.5(e)). Manufacturing, processing, packing, or holding Exempt ...... D Not considered ‘‘high risk’’ because unlikely of food for animals. to impact human health. D See section V.B.6 of this document. * Please see the corresponding sections of the rule identified in the column for a complete discussion of our analysis, rationale, and tentative conclusions related to the proposed exclusions or exemption.

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Summary of the Major Provisions of the described in proposed § 121.130(a) or training in food defense awareness and Proposed Rule conduct their own facility-specific their respective responsibilities in This proposed rule would establish vulnerability assessments as provided in implementing focused mitigation various food defense measures that an proposed § 121.130(b). strategies (proposed § 121.160). • owner, operator, or agent in charge of a Identify and implement focused • Establish and maintain certain facility would be required to implement mitigation strategies at each actionable records, including the written food to protect against the intentional process step to provide assurances that defense plan; written identification of adulteration of food, as summarized in the significant vulnerability at each step actionable process steps and the Diagram 2. Specifically: will be significantly minimized or assessment leading to that • Prepare and implement a written prevented and the food manufactured, identification; written focused food defense plan that includes processed, packed, or held by the mitigation strategies; written procedures actionable process steps, focused facility will not be adulterated for monitoring, corrective actions, and mitigation strategies, and procedures for (proposed § 121.135). verification; and documentation related • Establish and implement monitoring, corrective actions, and to training of personnel (proposed procedures, including the frequency verification (proposed § 121.126). §§ 121.301 to 121.325). • Identify any actionable process with which they are to be performed, for steps, using one of two procedures. FDA monitoring the focused mitigation As proposed, the effective date is 60 has analyzed vulnerability assessments strategies (proposed § 121.140). days after a final rule is published. conducted using the CARVER+Shock • Establish and implement corrective However, we are providing for a longer methodology and identified four key action procedures that must be taken if timeline for facilities to come into activity types: Bulk liquid receiving and focused mitigation strategies are not compliance. Facilities, other than small loading; Liquid storage and handling; properly implemented (proposed and very small businesses, would have Secondary ingredient handling; and § 121.145). one year after the effective date to Mixing and similar activities. FDA has • Verify that monitoring is being comply with proposed part 121. Small determined that the presence of one or conducted and appropriate decisions businesses (i.e., those employing fewer more of these key activity types at a about corrective actions are being made; than 500 persons) would have 2 years process step (e.g., manufacturing, verify that the focused mitigation after the effective date to comply with processing, packing, or holding of food) strategies are consistently implemented proposed part 121. Very small indicates a significant vulnerability and are effectively and significantly businesses (i.e., businesses that have under section 418 of the FD&C Act and minimizing or preventing the significant less than $10,000,000 in total annual that the food is at high risk of vulnerabilities; and conduct a reanalysis sales of food, adjusted for inflation) intentional adulteration caused by acts of the food defense plan (proposed would be considered a qualified facility of terrorism under section 420 of the § 121.150). and would have 3 years after the FD&C Act. Facilities may identify • Ensure that personnel and effective date to comply with proposed actionable process steps using the FDA- supervisors assigned to actionable § 121.5(a). identified key activity types as process steps receive appropriate BILLING CODE 4160–01–P

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BILLING CODE 4160–01–C

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In addition, we describe our current hazards that may be intentionally possibility of illness, death, and thinking and seek comment on other introduced by acts of terrorism. economic disruption resulting from issues, including activities that occur on intentional adulteration of food. We are Costs and Benefits dairy farms and economically motivated unable to quantify these benefits. adulteration. Finally, elsewhere in this As described in the Preliminary However, we monetize the damage that issue of the Federal Register, FDA is Regulatory Impact Analysis (PRIA), we various intentional adulteration publishing for comment its evaluation estimate the annualized costs of the scenarios might cause, and present a that identifies low-risk activities that actions required by this proposed rule to breakeven analysis showing the number occur at farm mixed-type facilities, with be about $370 million. The benefits of of prevented attacks at which the a specific focus on the risk presented by these actions are a reduction in the benefits are larger than the costs.

ANNUALIZED COST AND BENEFIT OVERVIEW

All numbers are USD millions, annualized over 10 years 3% discount 7% discount

Costs: Learning about Rule ...... $3 $3 Mitigation Costs ...... 59 63 Monitoring and Corrective Action ...... 100 100 Employee Training ...... 4 5 Documentation ...... 6 6

Subtotal (Domestic cost) ...... 172 177 Cost to Foreign Firms ...... 185 190

Total ...... 357 367

Benefits: Lower Chance of Intentional Adulteration ...... Unquantified.

I. Introduction standards for the safe production and which is not addressed by traditional harvesting of produce, and requires that Hazard Analysis and Critical Controls The FDA Food Safety Modernization the rulemaking consider hazards that Point (HACCP) or other food safety Act (FSMA) (Pub. L. 111–353), signed may be intentionally introduced, systems, likely will require different into law on January 4, 2011, enables including by acts of terrorism. kinds of controls. FDA is taking the FDA to better protect public health by Efforts to protect against intentional action described in this proposed rule to helping to ensure the safety and security adulteration require a shift in implement the intentional adulteration of the food supply. FSMA enables us to perspective from that applied to provisions in sections 103, 105, and 106 focus more on preventing food safety traditional food safety. In proposed of FSMA. problems rather than primarily reacting rules entitled ‘‘Current Good to problems after they occur. The law Manufacturing Practice and Hazard II. Background also provides us with new enforcement Analysis and Risk-Based Preventive authorities to help us achieve higher Controls for Human Food’’ (78 FR 3646, Intentional adulteration of the food rates of compliance with prevention- January 16, 2013) (Docket No. FDA– supply can result in catastrophic public and risk-based safety standards and to 2011–N–0920; hereafter referred to as health consequences, widespread public better respond to and contain problems ‘‘the PC proposed rule’’), ‘‘Current Good fear, loss of public confidence in the when they do occur. In addition, the Manufacturing Practice and Hazard safety of food and the ability of law gives us important new tools to Analysis and Risk-Based Preventive government to ensure food safety, and better ensure the safety of imported Controls for Food for Animals’’ (78 FR significant adverse economic impacts, foods and directs us to build an 64736, October 29, 2013) (Docket No. including disruption of trade (Ref. 1, integrated national food safety system in FDA–2011–N–0922; hereafter referred to Ref. 2, Ref. 3, Ref. 4). Acts of intentional partnership with State, local, tribal, and as ‘‘the Animal Food PC proposed adulteration may take several forms, territorial authorities. rule’’), and ‘‘Standards for the Growing, including acts of terrorism; acts of Section 103 of FSMA directs FDA to Harvesting, Packing and Holding of disgruntled employees, consumers, or issue regulations establishing Produce for Human Consumption’’ (78 competitors; and economically requirements for facilities that FR 3504, January 16, 2013) (Docket No. motivated adulteration. Acts of manufacture, process, pack or hold food FDA–2011–N–0921; hereafter referred to terrorism are associated with an intent and requires facilities to consider as ‘‘the Produce Safety proposed rule’’), to cause massive public health harm hazards that may be intentionally FDA tentatively decided not to include and, to a lesser extent, economic introduced, including by acts of requirements to address ‘‘hazards that disruption (Ref. 5, Ref. 2, Ref. 3, Ref. 6). terrorism. Section 106 of FSMA requires may be intentionally introduced, Acts of disgruntled employees, FDA to issue regulations to protect food including by acts of terrorism’’ (sections consumers, or competitors are generally for which there is a high risk of 418(b)(2) and 419(a)(3)(C) of the FD&C understood to be directed at attacking intentional contamination and for Act (21 U.S.C. 350g(b)(2) and the reputation of the company and not which such intentional contamination 350h(a)(3)(C))) and to implement at public health harm. The primary could cause serious adverse health sections 103 and 105 of FSMA regarding purpose of economically motivated consequences or death to humans or such hazards in a separate rulemaking adulteration is to obtain economic gain, animals. In addition, section 105 of (this proposed rule). As noted in those and not to impact public health (Ref. 7, FSMA directs FDA to issue regulations proposed rules, FDA tentatively Ref. 8, Ref. 9), although public health setting forth science-based minimum concluded that intentional adulteration, harm may occur (Ref. 10, Ref. 11).

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‘‘Food defense’’ and ‘‘food security’’ B. Interagency Approach to Food loss of confidence in the food supply, are terms that are sometimes used Defense and interruption of the food stream) interchangeably. We use the term ‘‘food warranted incorporation into the 1. Homeland Security Presidential defense’’ to refer to the effort to protect vulnerability assessment calculus. To Directives and Presidential Policy food from acts of intentional incorporate these considerations, FDA Directives for the Food and Agriculture adulteration where there is an intent to and USDA’s Food Safety and Inspection Sector cause public health harm and economic Service (FSIS) adapted a military disruption. ‘‘Food security’’ is defined Intelligence gathered since the attacks targeting tool known as CARVER to by the World Health Organization on the United States on September 11, assess vulnerabilities of the food and (WHO) to mean ‘‘when all people at all 2001, indicates that terrorist agriculture sector. CARVER is an times have access to sufficient, safe, organizations have discussed acronym for the following six attributes nutritious food to maintain a healthy contamination of the food supply as a used to evaluate the attractiveness of a and active life’’ (Ref. 12). To avoid means to harm U.S. citizens and disrupt target for attack: confusion, we use the term ‘‘food the global economy (Ref. 15). In • Criticality—measure of public defense’’ and not the term ‘‘food response, FDA, along with the Centers health and economic impacts of an security’’ in the context of intentional for Disease Control and Prevention attack; adulteration. (CDC), the United States Department of • Accessibility—ability to physically Agriculture (USDA), the Department of access and egress from target; A. Incidents of Intentional Adulteration Homeland Security (DHS), the Federal • Recuperability—ability of a system of Food Bureau of Investigation (FBI), the to recover from an attack; Several cases of intentional Environmental Protection Agency • Vulnerability—ease of adulteration with the intent to cause (EPA), the Department of Defense, the accomplishing an attack; public health harm and economic Department of Energy, the Department • Effect—amount of direct loss from disruption in the United States have of Commerce, and the Department of the an attack as measured by loss in been documented. For example, in Interior, as well as with State, local, production; and • 1984, in an attempt to prevent the tribal, territorial, and private sector Recognizability—ease of identifying general public from voting in the local partners have coordinated efforts to a target. elections, members of a local religious prevent, prepare for, and respond to A seventh attribute, ‘‘Shock’’, was commune in The Dalles, OR, threats against the food supply. Many of added to the original six attributes to intentionally contaminated food in these efforts were accomplished in assess the combined health, economic, restaurants with Salmonella. A total of accordance with applicable Homeland and psychological impacts of an attack 751 people became ill and 45 were Security Presidential Directives (HSPD), on the food industry. ORM and hospitalized (Ref. 4). In another specifically HSPD–7, HSPD–8, and CARVER+Shock assessment incident, in 1996, 12 laboratory workers HSPD–9, and Presidential Policy conclusions were consistent; however, at a large medical facility in Texas Directives (PPD), specifically PPD–8 and the CARVER+Shock methodology became ill from consuming PPD–21 (Ref. 16, Ref. 17, Ref. 18, Ref. improved vulnerability assessment anonymously donated pastries that were 19, Ref. 20). In accordance with these efforts because its process allowed for intentionally contaminated with directives, FDA, USDA, DHS, State and the identification and estimation of Shigella dysenteriae type 2, which was local governments and the food industry economic and psychological impacts later discovered to have originated from collaborated to conduct vulnerability throughout the food system. the facility’s stock culture (Ref. 13). In assessments of a variety of products and In 2005, the Strategic Partnership 2009, two related incidents resulted in processes within the food and Program Agroterrorism (SPPA), a 49 individuals reporting rapid and acute agriculture sector. public-private cooperative effort was onset of gastrointestinal and established by FDA, USDA, FBI, and neurological symptoms after eating 2. The Evolution of Vulnerability DHS, in partnership with State and meals at a restaurant in Lenexa, KS. Assessments industry partners. The intent of the Investigations concluded that the Initially, FDA used Operational Risk SPPA Initiative was to collect the illnesses were caused by methomyl (an Management (ORM), which is a necessary data to identify food and insecticide) poisoning associated with vulnerability assessment methodology agriculture sector-specific the consumption of salsa at the that uses a six-step sequence of vulnerabilities using the restaurant. Two former employees of the identifying hazards and reducing the CARVER+Shock method, develop restaurant were found guilty of potential for negative public health mitigation strategies, identify research intentionally contaminating the salsa consequences. The ORM process gaps, and increase coordination between (Ref. 14). resulted in three main outcomes: (1) A government and industry partners. The A widespread incident of calculation of risk by combining SPPA initiative ran from 2005 to 2008, economically motivated adulteration assessments of severity and probability resulting in vulnerability assessments of occurred in China in 2008. Some of an attack on a specific food; (2) 36 food products and processes (Ref. Chinese milk firms added melamine, a calculations for specific contaminants 21). The SPPA Initiative was a nitrogen-rich industrial by-product, to and specific food processes or related significant step towards identifying diluted dairy products to increase the activities; and (3) a categorization of vulnerabilities, mitigation strategies, apparent protein content. This specific food/contaminant/food process and research needs within the food and adulteration resulted in significant or related activity into a high, medium, agriculture industries. This initiative public health consequences, with more or low risk scheme. also provided Federal, State, and local than 290,000 ill infants and 6 deaths in At first, ORM-based assessments were government agencies with an in-depth China. In addition, this incident caused focused on reducing large public health look at the vulnerabilities that may be significant economic disruption within consequences of attacks on the food associated with the food and agriculture the Chinese dairy industry, with supply. FDA realized that other industry, and helped enhance estimates approaching $3 billion in loss significant considerations (i.e., large communication among industry, to industry (Ref. 10, Ref. 11). economic disruptions, public alarm, government, and law enforcement

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stakeholders concerned with the of State and local governments and processing, and holding). See also the protection of the U.S. food supply. industry regarding food defense (Ref. discussion in section V.C.3 of this Since the conclusion of the SPPA 27). ALERT identifies five key elements document. Initiative, we have conducted additional that industry can use in food defense The Food Defense Plan Builder vulnerability assessments, which planning: (FDPB) software tool, released in 2013, continue to help inform our research • A—How do you ASSURE that the is a user-friendly computer software and policy. supplies and ingredients you use are program designed to assist owners and from safe and secure sources? operators of food facilities in developing C. Resources for the Food Sector • L—How do you LOOK after the food defense plans for their facilities FDA has issued guidance documents security of the products and ingredients (Ref. 31). In addition to providing new and developed other resources to assist in your facility? functionality for food defense planning industry in their efforts to protect the • E—What do you know about your and implementation, the FDPB software food supply against intentional EMPLOYEES and people coming in and tool harnesses our food defense adulteration. In 2003, FDA issued five out of your facility? guidance documents, CARVER+Shock guidance documents covering food • R—Could you provide REPORTS Vulnerability Assessment software tool, defense preventive measures for various about the security of your products and the MSD into a single application. segments of the food and cosmetic while under your control? The Food Related Emergency Exercise industry: (1) Guidance for Industry: • T—What do you do and who do Bundle (FREE–B), which FDA released Food Producers, Processors, and you notify if you have a THREAT or in 2011 and developed in collaboration Transporters: Food Security Preventive issue at your facility, including with CDC and FSIS and USDA’s Animal Measures Guidance (Ref. 22); (2) suspicious behavior? and Plant Health Inspection Service Guidance for Industry: Importers and Similarly, the Employees FIRST (APHIS), is a compilation of scenarios Filers: Food Security Preventive educational tool, originally released in based on both intentional and Measures Guidance (Ref. 23); (3) 2008, is a food defense awareness unintentional food contamination Guidance for Industry: Dairy Farms, training program for front-line food events. The FREE–B is designed to assist Bulk Milk Transporters, Bulk Milk industry workers about the risk of the food industry, government Transfer Stations and Fluid Milk intentional adulteration and the actions regulatory agencies, and public health Processors: Food Security Preventive they can take to identify and reduce organizations in assessing existing food Measures Guidance (Ref. 24); (4) Retail these risks (Ref. 28). This tool identifies emergency response plans, protocols, Food Stores and Food Service the following five key elements: and procedures (Ref. 32). The FREE–B • Establishments: Food Security F—Follow company food defense tool is designed to allow an individual plan and procedures; agency or industry entity to test its own Preventive Measures Guidance (Ref. 25); • and(5) Cosmetics Processors and I—Inspect your work area and plans, protocols, and procedures surrounding areas; independently. Additionally, the tool Transporters of Cosmetics Security • Preventive Measures Guidance (Ref. 26). R—Recognize anything out of the allows multiple jurisdictions and These guidance documents provide ordinary; organizations (e.g., medical community, • S—Secure all ingredients, supplies, FDA’s recommendations for best private sector, law enforcement, and and finished product; and practices in food defense, and describe first responder communities) to jointly • T—Tell management if you notice preventive measures that establishments conduct exercises. The tool is a set of anything unusual or suspicious. can take to minimize the risk of five scenarios, each of which contains a The CARVER+Shock Vulnerability Facilitator’s Guide, a Lead Planner’s intentional adulteration of food. We Assessment software tool, originally updated the guidance documents in guide, and a Situation Manual. released in 2007, helps users conduct Finally, our food defense training 2007 to include a self-assessment tool vulnerability assessments for their that guides the user through an courses, entitled ‘‘Food Defense 101’’ establishments to identify and prioritize and released in 2013, reflect FDA’s assessment of recommended preventive the ‘‘critical nodes,’’ (also known as measures to identify those most current thinking on how to minimize critical process steps) the potential the likelihood and impact of incidents applicable to the facility. targets vulnerable to intentional FDA also has made available other of intentional adulteration (Ref. 27). adulteration attacks (Ref. 29). It guides resources to help industry identify and Four courses integrated into one module users through a series of questions to mitigate potential vulnerabilities for include: (1) Food Defense Awareness for determine the vulnerability of each of intentional adulteration. These include: Professionals, (2) Food Defense • The ‘‘ALERT’’ program, the nodes within their facility. After the Awareness for Frontline Employees, (3) • The ‘‘Employees FIRST’’ training vulnerabilities are identified, the FDA Regulations, and (4) ALERT for tool, software helps users to identify owners and operators of food facilities. • The ‘‘CARVER+Shock Vulnerability mitigation strategies for reducing the The ALERT program is described Assessment’’ software tool, risk of intentional adulteration. Using previously. The other programs are • The ‘‘Mitigations Strategies the software tool, the user can focus described in section V.C.7 of this Database,’’ resources on protecting the most document. • susceptible points in their system. The ‘‘Food Defense Plan Builder’’ D. Outreach software tool, The Mitigation Strategies Database • The Food Related Emergency (MSD), originally released in 2011, is a We have conducted food defense Exercise Bundle, and database of mitigation strategies that can awareness outreach to international and • The ‘‘Food Defense 101’’ training be applied to different steps in a food domestic stakeholders. Beginning in courses. operation to reduce the risk of 2008, under the auspices of the Asia- We describe each briefly in this intentional adulteration (Ref. 30). The Pacific Economic Cooperation (APEC), section of the document. database is searchable by key words and we collaborated with the U.S. The ALERT program, originally processing steps common to agriculture Department of State, USDA’s Foreign released in 2006, is an educational and food operations (e.g., growing, Agricultural Service, and FSIS to launch program intended to raise the awareness harvesting, packing, manufacturing, the Food Defense Pilot Program for the

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APEC member countries. The Pilot that incorporate food defense elements the FD&C Act. Under section 106 of Program was developed with the intent is the International Featured Standards FSMA, FDA is proposing the to implement the food defense (IFS) Food Version 6 Standard, which requirements applicable to activities at principles endorsed by the APEC specifies that areas critical to security be some facilities not covered by section Counter Terrorism Task Force. The goal identified, food defense hazard analysis 103 of FSMA (i.e., activities subject to of the program was to build and foster and assessment of associated risks be and in compliance with the juice and global capacity to prevent and protect conducted annually or upon changes seafood HACCP regulations in parts 120 against deliberate tampering and that affect food integrity, and an and 123 (21 CFR parts 120 and 123) and intentional contamination of the food appropriate alert system be defined and the manufacturing, processing, packing, supply through information sharing, periodically tested for effectiveness (Ref. or holding of a dietary supplement in outreach, and technical assistance on 35). compliance with certain requirements). food defense, thereby safeguarding food Under section 701(a) of the FD&C Act F. International Food Defense trade and public health across the APEC (21 U.S.C. 371(a)), FDA is authorized to Guidelines member countries. In addition, to issue regulations for the efficient support the international capacity In 2008, WHO issued its ‘‘Terrorist enforcement of the FD&C Act. building goals of FSMA, we conducted Threats to Food—Guidelines for A. Section 103 of FSMA several workshops in various countries Establishing and Strengthening to discuss topics such as increasing food Prevention and Response Systems’’ to Section 103 of FSMA, Hazard defense awareness, developing food provide policy guidance to its Member Analysis and Risk-Based Preventive defense plans, conducting vulnerability States for integrating consideration of Controls, amends the FD&C Act to assessments, and implementing deliberate acts of sabotage of food into create a new section 418 that mandates mitigation strategies. existing prevention and response rulemaking. Section 418(n)(1)(A) of the In 2013, we increased our domestic programs (Ref. 6). WHO uses the term FD&C Act requires that the Secretary of outreach activities with a series of ‘‘food terrorism’’ and defines it as ‘‘an Health and Human Services issue workshops in the United States. Using act or threat of deliberate contamination regulations ‘‘to establish science-based a similar format and agenda as the of food for human consumption with minimum standards for conducting a international workshops, we conducted biological, chemical and physical agents hazard analysis, documenting hazards, 1-day food defense awareness or radionuclear materials for the implementing preventive controls, and workshops to provide industry, State purpose of causing injury or death to documenting the implementation of the and local governments, and academic civilian populations and/or disrupting preventive controls . . ..’’ Section partners with information on food social, economic or political stability.’’ 418(n)(1)(B) of the FD&C Act requires defense, and share tools and resources. Focusing on the two key strategies of that the regulations define the terms During these workshops, we shared prevention and response, WHO ‘‘small business’’ and ‘‘very small information on how to use the new recommends that all segments of the business,’’ taking into consideration the FDPB software tool to develop a food industry consider the development study of the food processing sector comprehensive food defense plan. of security and response plans for their required by section 418(l)(5) of the These workshops also served as a forum establishments, proportional to the FD&C Act. Further, section 103(e) of to discuss food defense concerns, threat and their resources. The FSMA creates a new section 301(uu) in understand industry’s current practices, guidelines state that the key to the FD&C Act (21 U.S.C. 331(uu)) to and share ideas for collaboration to preventing food terrorism is enhancing prohibit ‘‘[t]he operation of a facility better protect the food supply against existing food safety programs and that manufactures, processes, packs, or intentional adulteration. We plan to implementing reasonable security holds food for sale in the United States continue to hold additional workshops measures on the basis of vulnerability if the owner, operator, or agent in charge in 2014. assessments. The guidelines further of such facility is not in compliance state that the most vulnerable foods, with section 418 [of the FD&C Act].’’ E. Industry Standards food ingredients, and food processes In addition to rulemaking Guidelines accompanying industry should be identified, including: the requirements, section 418 of the FD&C standards in the United States have most readily accessible food processes; Act contains requirements applicable to addressed intentional adulteration of foods that are most vulnerable to the owner, operator, or agent in charge food. For example, the Global Food undetected tampering; foods that are the of a facility required to register under Safety Initiative’s (GFSI) Guidance most widely disseminated or spread; section 415 of the FD&C Act. Section Document Sixth Edition (Ref. 33) and the least supervised food 418(a) of the FD&C Act is a general addresses food defense. Some production areas and processes. provision that requires the owner, organizations that own and manage Other national governments, operator, or agent in charge of a facility industry standards have worked or are including Australia, China, France, to evaluate the hazards that could affect working to incorporate food defense Germany, and the United Kingdom, also food manufactured, processed, packed, requirements into their standards to have issued guidelines to assist their or held by the facility, identify and meet this GFSI guideline. For example, food industry stakeholders in protecting implement preventive controls, monitor the Safe Quality Foods (SQF) Code, food against intentional adulteration the performance of those controls, and edition 7.1, issued in 2013, is a process (Ref. 5, Ref. 36, Ref. 37, Ref. 38, Ref. 39). maintain records of the monitoring. In and product certification standard that addition to the general requirements in specifies various food defense elements, III. Legal Authority section 418(a) of the FD&C Act, sections including that the methods, FDA is proposing this regulation 418(b) to (i) of the FD&C Act contain responsibility, and criteria for under the FD&C Act as amended by more specific requirements applicable preventing food adulteration caused by FSMA. Under sections 103 and 106 of to facilities, including several a deliberate act of sabotage or terrorist- FSMA, FDA is proposing the provisions explicitly directed at like incident shall be documented, requirements applicable to the owner, intentional adulteration. For example, implemented and maintained (Ref. 34). operator, or agent in charge of a facility section 418(b)(2) of the FD&C Act Another example of industry standards required to register under section 415 of specifies that the owner, operator, or

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agent in charge of a facility shall measures to prepare and protect the the intentional adulteration of food. identify and evaluate hazards that may food supply chain at specific vulnerable Section 103 of FSMA addresses be intentionally introduced, including points, as appropriate. Section 420(c) of intentional adulteration in the context by acts of terrorism. Section 418(c)(2) of the FD&C Act provides that such of facilities that manufacture, process, the FD&C Act specifies that the owner, regulations are to apply only to food for pack, or hold food and are required to operator, or agent in charge of a facility which there is a high risk of intentional register under section 415 of the FD&C shall identify and implement preventive adulteration and for which such Act. Section 105 of FSMA addresses controls to provide assurances that any intentional adulteration could cause intentional adulteration in the context hazards that relate to intentional serious adverse health consequences or of fruits and vegetables that are raw adulteration will be significantly death to humans or animals. Section agricultural commodities. Section 106 of minimized or prevented and addressed, 420(c)(1) provides that such foods are to FSMA addresses intentional consistent with section 420 of the FD&C include those for which FDA has adulteration in the context of high risk Act. In sections IV and V of this identified clear vulnerabilities. Section foods and exempts farms except for document, we discuss proposed 420(d) of the FD&C Act limits farms that produce milk. requirements (proposed subparts C and applicability on farms to farms that 1. Scope of Intentional Adulteration D of part 121) that would implement produce milk. Further, section 106(d) of Covered by this Rule these provisions of section 418 of the FSMA creates a new section 301(ww) in FD&C Act. the FD&C Act to prohibit ‘‘[t]he failure As noted in section I of this Sections 418(j) to (m) of the FD&C Act to comply with section 420 [of the FD&C document, acts of intentional and sections 103(c)(1)(D) and (g) of Act].’’ We are proposing all of the adulteration may take several forms, FSMA provide authority for certain provisions under section 420 of the including: (1) Acts of terrorism; (2) acts exemptions and modifications to the FD&C Act. of disgruntled employees, consumers, or requirements of section 418 of the FD&C competitors; and (3) economically Act. These include provisions related to C. Intrastate Activities motivated adulteration. With regard to seafood and juice HACCP, and low-acid FDA tentatively concludes that the intentional adulteration from acts of canned food (section 418(j) of the FD&C provisions in the proposed rule should terrorism, we are proposing to require Act); activities of facilities subject to be applicable to activities that are certain facilities covered by this rule to section 419 of the FD&C Act (Standards intrastate in character. Facilities are address significant vulnerabilities by for Produce Safety) (section 418(k)); required to register under section 415 of implementing focused mitigation qualified facilities (section 418(l)); the FD&C Act regardless of whether the strategies at actionable process steps. facilities that are solely engaged in the food from the facility enters interstate While we refer to the protection of the production of food for animals other commerce (§ 1.225(b)). The plain food supply from ‘‘acts of terrorism’’ than man, the storage of raw agricultural language of section 418 of the FD&C Act throughout this rule, we expect our commodities (other than fruits and applies to facilities that are required to proposed approach and the proposed vegetables) intended for further register under section 415 of the FD&C implementation of focused mitigation distribution or processing, or the storage Act (section 418(o)(2)) and does not strategies would generally address acts of packaged foods that are not exposed exclude a facility because food from intended to cause massive public health to the environment (section 418(m)); such a facility is not in interstate harm and, to a lesser extent, economic facilities engaged only in certain low- commerce. Similarly, the plain language disruption, whether committed by risk on-farm activities on certain foods of section 420 of the FD&C Act requires terrorists, terrorist organizations, conducted by small or very small FDA to issue regulations to protect individuals, or groups of individuals. businesses (section 103(c)(1)(D) of against the intentional adulteration of For the reasons described in section FSMA), and dietary supplements food and does not include a limitation IV.E of this document, we have tentatively concluded not to propose (section 103(g) of FSMA). In sections IV to interstate commerce. Further, the additional requirements for the and V of this document, we discuss the prohibited act provisions in sections protection of food against intentional related proposed provisions that would 301(uu) and (ww) of the FD&C Act (21 adulteration caused by acts of implement these provisions of section U.S.C. 331(uu) and (ww)) do not require disgruntled employees, consumers, or 418 of the FD&C Act and section 103 of an interstate commerce nexus. Notably, competitors. We describe our approach FSMA. other subsections in section 301 of the to address economically motivated B. Section 106 of FSMA FD&C Act, and section 304 of the FD&C adulteration in section IV.F of this Act (21 U.S.C. 334) demonstrate that Section 106 of FSMA, Protection document, and seek comment on our Congress has included a specific Against Intentional Adulteration, current thinking on this issue. amends the FD&C Act to create a new interstate commerce nexus in the section 420, which mandates provisions of the FD&C Act when that 2. Identification of Key Activity Types rulemaking. Section 420 of the FD&C is its intent. Accordingly, it is Terrorist attacks on the U.S. food Act requires FDA to issue regulations to reasonable to interpret sections 418, supply have been exceedingly rare. protect against the intentional 420, 301(uu) and (ww) of the FD&C Act However, vulnerability assessments adulteration of food. Section 420(b)(1) of as not limiting the application of the performed by FDA, USDA, DHS, and the FD&C Act requires that such proposed rule only to those facilities FBI, under the SPPA Initiative (Ref. 21), regulations are to specify how a person with a direct connection to interstate show that an attack could have is to assess whether the person is commerce. However, we seek comment devastating public health and economic required to implement mitigation on this interpretation and potential consequences. Because such an attack is strategies or measures intended to alternatives. a low probability but potentially protect against the intentional IV. Regulatory Approach exceedingly high consequence event, we adulteration of food. Section 420(b)(2) of have tentatively determined that the FD&C Act requires that the A. Framework of the Rule requirements should focus on those regulations specify appropriate This proposed regulation implements facilities and process steps within those science—based mitigation strategies or three provisions of FSMA that relate to facilities that pose the greatest risk. To

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assess this risk, FDA and USDA, in 3. Requirement for a HACCP-Type adulteration related to terrorism, this collaboration with DHS, FBI, and State System of Controls same system would be required for and local government and industry We have tentatively concluded that a these activities. Applying the same partners, performed vulnerability preventive controls approach like the regulatory framework under sections assessments using the CARVER+Shock one we proposed for the systematic 418 and 420 of the FD&C Act would methodology. This methodology is control of food safety hazards in the PC facilitate a concise and consistent specifically tailored to assess the risk of proposed rule is the most effective approach to protection against a terrorist attack and is different from an means of ensuring that the focused intentional adulteration of food and the assessment of risk posed by food safety mitigation strategies are consistently efficient enforcement of the hazards (i.e., unintentional applied once the significant requirements. Further, this approach adulteration). vulnerabilities are identified and would be consistent with the approach for unintentional adulteration that many As discussed in section V.C.2 of this appropriate focused mitigation strategies are developed. The evolution of these facilities (those subject to document, based on an analysis of the section 418 of the FD&C Act relative to vulnerability assessments that FDA has and advantages of this system, derived from the HACCP methodology, is the control of food safety hazards) conducted using the CARVER+Shock would already be required to take for methodology, we have identified four discussed in detail in section II.C of the PC proposed rule. The application of unintentional hazards under the PC key activity types: Bulk liquid receiving proposed rule. HACCP-type controls for ensuring the and loading; Liquid storage and We acknowledge that regulation of implementation of food defense handling; Secondary ingredient entities in the food production system handling; and Mixing and similar mitigation strategies is consistent with (in this case, facilities) to reduce the risk activities. FDA has tentatively the approach taken in Publicly of intentional adulteration of food determined that the presence of one or Available Specification (PAS) 96, caused by acts of terrorism is, more of these key activity types at a developed by the Centre for the essentially, without precedent. Such an process step (e.g., manufacturing, Protection of National Infrastructure in endeavor is further complicated by the processing, packing, or holding of food) collaboration with the British Standards low probability and potentially high indicates a significant vulnerability Institution, entitled ‘‘The Threat impact nature of such an attack which under section 418 of the FD&C Act and Assessment Critical Control Point makes estimating potential public that the food is at high risk of (TACCP) Approach’’ (Ref. 5). It is also health benefits and establishing an intentional adulteration caused by acts consistent with WHO recommendations appropriate threshold for requiring of terrorism under section 420 of the on protection against intentional action difficult. We are further FD&C Act. We seek comment on the adulteration (Ref. 6). We request challenged by the paucity of data on the inclusion of these key activity types. comment on the appropriateness of a extent to which facilities have already HACCP-type system to ensure that implemented programs to mitigate this Designation of these key activity types mitigation strategies designed to would serve two purposes. First, it risk, and the effectiveness of various significantly minimize or prevent strategies to prevent intentional would provide a facility with a means intentional adulteration related to to assess whether it is required to adulteration of food caused by acts of terrorism and whether there are terrorism. implement focused mitigation strategies approaches that would be more suitable. or measures intended to protect against In developing this proposed rule we Section 418 of the FD&C Act exempts have relied on our experience in both intentional adulteration under section several kinds of activities (e.g., those 420(b)(1) of the FD&C Act. Second, it implementing preventive control related to seafood, juice, dietary schemes targeting unintentional food would assist a facility subject to section supplements, low-acid canned food [for 418 of the FD&C Act with the safety hazards as well as working with certain microbiological hazards]). These the U.S. intelligence community on the performance of a hazard analysis to activities are subject to preventive threat of a terrorist attack on the food identify and evaluate hazards that may control-type regulations that address and agriculture sector, including be intentionally introduced by acts of food safety, but not food defense, performing vulnerability assessments terrorism, in accordance with section concerns. Section 420 of the FD&C Act and developing guidance for industry. 418(b)(2). instructs FDA to issue regulations to While these activities have provided us Facilities would be able to determine require that science-based mitigation with a useful foundation on which to whether their operations involve one or strategies or measures be applied to develop this proposed rule, the more of the key activity types or choose foods that are at high risk of intentional challenges described previously remain. to perform a vulnerability assessment. adulteration. The exemptions set out in We request comment on our proposed Our experience is that the most section 418 of the FD&C Act are not approach, including on the following challenging part of developing a system applicable to the provisions of section issues: of controls for intentional adulteration 420 of the FD&C Act. We also have • From which entities would related to terrorism is identifying the tentatively determined that some implementation of measures to protect points in the food operation that are activities that are not subject to section against intentional adulteration derive most vulnerable to attack by performing 418 of the FD&C Act that involve the greatest benefit to public health a vulnerability assessment. By using the manufacturing, processing, packing, or protection? How could this proposed FDA-identified key activity types, holding of food are likely to involve one regulation be modified to better target facilities would be able to concentrate of the key activity types (e.g., juice such entities? their efforts on the identification of manufacturing, breaded seafood • Would it be feasible to require appropriate focused mitigation manufacturing, and mixing activity in a measures to protect against intentional strategies and the development and low-acid canned food process). Based adulteration only in the event of a implementation of the HACCP-type on our tentative conclusion that the credible threat? If so, would such an system for ensuring that those strategies HACCP-type system in section 418 of approach be consistent with the are consistently and effectively the FD&C Act is generally appropriate intentional adulteration provisions of implemented. for application to intentional FSMA? How would such requirements

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be communicated to industry in a of the final rule for very small CARVER+Shock methodology, and timely and actionable manner? businesses to come into compliance evaluated whether activities that occur • What is an appropriate level of with the new requirements established on produce farms pose significant public health protection with respect to under FSMA. vulnerabilities (Ref. 40). intentional adulteration, considering the Therefore, as proposed, facilities, Our evaluation found that activities intentional adulteration provisions of other than small and very small that are typically performed on produce FSMA? businesses, that are subject to part 121 farms are at relatively low risk for • Are there other ways to further would have 1 year after the effective intentional adulteration of food from focus the scope of the rule (see also date to comply with proposed part 121. acts of terrorism (Ref. 40). Based on this section IV.I of this document)? Small businesses would have 2 years evaluation, we have tentatively 4. Compliance Dates after the effective date to comply with concluded that requirements for proposed part 121 (see section V.A of produce farms are not necessary to Section 103(i)(1) of FSMA, General this document for a discussion of the minimize the risk of serious adverse Rule, provides that ‘‘[t]he amendments proposed definition of a ‘‘small health consequences or death from this made by this section shall take effect 18 business’’). With respect to very small type of adulteration. Further, we have months after the date of enactment’’ businesses, we are proposing to exempt tentatively concluded that requirements (i.e., by July 4, 2012). Section 103(i)(2) qualified facilities, which include very relating to this form of adulteration are of FSMA, Flexibility for Small small businesses, from the requirements not reasonably necessary to prevent the Businesses, provides that of proposed part 121, except that such introduction of known or reasonably ‘‘[n]otwithstanding paragraph (1),’’ the facilities must, upon request, provide foreseeable hazards and to provide amendments made by this section ‘‘shall for official review documentation that reasonable assurances that the produce apply’’ to a small business and very was relied upon to demonstrate that the is not adulterated under section 402 of small business beginning on the date facility meets this exemption. Very the FD&C Act. For these reasons, we are that are 6 months and 18 months, small businesses then would have 3 not proposing requirements for produce respectively, ‘‘after the effective date’’ of years after the effective date to comply farms to specifically address intentional FDA’s final regulation. Section 106 of with proposed § 121.5(a). FDA intends adulteration related to terrorism. We FSMA does not contain similar to work closely with the food industry, seek comment on this tentative language. FDA is implementing the extension and education organizations, conclusion and our analysis that amendments made by sections 103 and and State partners to develop any informed this tentative decision. 106 of FSMA to the FD&C Act, as they necessary additional tools and training We acknowledge that there may be relate to intentional adulteration, programs needed to facilitate activities that occur on produce farms through this rulemaking. implementation of this rule. for which we are not proposing We have tentatively concluded that it requirements that are similar to off-farm is appropriate to provide a sufficient B. Activities That Occur on Produce activities for which we are proposing to time period following publication of the Farms require the implementation of focused final regulation for facilities to come Section 419 of the FD&C Act requires mitigation strategies. However, there are into compliance with proposed part FDA to issue regulations to establish aspects of the specific on-farm activities 121. FDA recognizes that it can take science-based minimum standards for that minimize the risk for intentional time to develop and implement a food the safe production and harvesting of adulteration caused by acts of terrorism. defense plan that would require, among fruits and vegetables. In developing For example, waxing is an on-farm other things, identification of actionable these regulations, the Act requires us to activity that is similar to coating and process steps, implementation of consider, among others, those hazards that fits within one of the key activity focused mitigation strategies, and that may be intentionally introduced, types. However, there are key monitoring of focused mitigation including by acts of terrorism (section differences that make an on-farm strategies. 419(a)(3)(C) and (c)(1)(A) of the FD&C waxing operation less vulnerable FDA is proposing that the final rule Act). Note that neither section 418 of the compared to a coating operation. With would be effective 60 days after FD&C Act nor section 420 of the FD&C waxing, there is difficulty of mixing a publication in the Federal Register, Act apply to these activities. Section contaminant into a clear, heated wax in with staggered compliance dates, 420 of the FD&C Act specifically a tank in close proximity to the busy consistent with the proposed effective exempts farms, except those that packing line in an on-farm packing dates in the PC proposed rule and produce milk, and section 418 of the house. Conversely, a coating operation Produce Safety proposed rule. Similarly, FD&C Act exempts activities of facilities involves an opaque, ambient or we recognize that businesses of all sizes subject to section 419 of the FD&C Act. refrigerated, aqueous coating mix in a may need more time to comply with the In implementing section 419 of the tank and occurs in a relatively isolated new requirements established under FD&C Act, we considered the risks part of the manufacturing plant. In FSMA. As noted in section VII of the PC posed by a terrorist attack on the kinds addition, the uncertainty about whether proposed rule, FDA believes that it is of activities that occur on produce the produce leaving the farm is destined reasonable to allow for 1 year after the farms. We considered those activities for direct consumption or for further date of publication of the final rule for that fall within the definition of ‘‘farm’’ processing, such as removal of the wax, businesses other than small and very (as defined in 21 CFR 1.227) (e.g., which could inactivate or remove any small businesses to come into planting, tilling, irrigating, treating with contaminant intentionally added, makes compliance with the new requirements pesticides, harvesting, drying for it a relatively less likely target for established under FSMA. FDA also purposes of storing or transporting, intentional adulteration. believes that it is reasonable to allow for hydro-cooling, packing, refrigerating, 2 years after the date of publication of waxing, shelling, sifting, removing C. Transportation Carriers the final rule for small businesses to leaves, stems and husks, culling, One of the key activity types that we come into compliance with the new shelling, and washing). We utilized data have tentatively determined indicates a requirements established under FSMA, gathered from vulnerability assessments significant vulnerability to intentional and 3 years after the date of publication that we conducted employing the adulteration caused by acts of terrorism

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is Bulk liquid receiving and loading. As under that section apply to ‘‘food for we requested comment on where to proposed, receiving and loading of other which there is a high risk of intentional address those hazards that may be types of foods (e.g., non-bulk liquids, contamination.’’ In the spectrum of risk intentionally introduced for economic solid foods, gaseous foods) are not associated with intentional adulteration gain. After additional consideration, we identified as key activity types because of food, attacks perpetrated by terrorist present our current thinking in this we determined that they do not present organizations intent on causing massive section of the document. this same level of risk. By requiring that casualties and, to a lesser extent, For facilities subject to section 418 of shippers and receivers of bulk liquids economic disruption would be ranked the FD&C Act, we have tentatively implement focused mitigation strategies as relatively high risk. On the other concluded that economically motivated at actionable process steps involving hand, attacks by disgruntled employees, adulteration would be best addressed this key activity, as proposed in consumers, or competitors would be under the regulatory regime described § 121.135(a), we expect that shippers consistently ranked as relatively low in the PC and Animal Food PC proposed and receivers will institute focused risk; although these events occur rules and thus best addressed in those mitigation strategies that will annually, their public health and rulemakings. Before we decide to significantly minimize or prevent the economic impact would be generally finalize provisions on economically potential for intention adulteration of quite small. In general, the target food motivated adulteration in the PC and these foods during transportation. Such and the point in its production are those Animal Food PC final rules, FDA plans mitigation strategies may include of convenience (i.e., a point to which to provide new language and an analysis sealing or locking outbound the employee, consumer, or competitor of costs associated with these conveyances of bulk liquid, or requiring has ready access). Should a disgruntled provisions, and seek comment. Under that inbound conveyances be sealed or employee, consumer, or competitor this approach, the owner, operator, or locked as a condition of receipt of the choose to attack at an actionable process agent in charge of a covered facility bulk liquid. Where such measures are step, where the adverse public health would be required to perform a hazard implemented by the shippers and and economic consequences could be analysis to identify those hazards receivers of bulk liquids, we have greater, the provisions of this proposed related to economically motivated tentatively concluded that the food rule would be effective in minimizing adulteration that are reasonably likely to would be sufficiently protected from the opportunity for success. Actions occur. Economically motivated intentional adulteration caused by acts taken to mitigate the potential for a adulteration could be reasonably likely of terrorism, and that no further actions terrorist attack against the food supply to occur, for example, when obtaining by a carrier would be needed to ensure are likely to have collateral benefits in certain ingredients from a country in the safety of the food. For this reason, reducing the potential for an attack by which economically motivated we are not proposing to cover a disgruntled employee, consumer, or adulteration has occurred in those transportation carriers in this proposed competitor (as well as on other security ingredients in the past. Because of past rule. We request comment on our related issues, such as theft and incidents regarding the addition of analysis of this issue, and our tentative vandalism). As a practical matter, melamine to certain food products conclusion. hardening the food supply (i.e., apparently to enhance perceived quality Note that FDA will issue a proposed reducing the opportunity for attack) to and/or protein content, even if there is rule in the near future related to attacks by disgruntled employees, no known history regarding the specific transportation carriers and sanitary consumers, or competitors could require supplier or the specific food product, a transportation practices. taking steps at many more points in the prudent person would implement food system than would be required to preventive controls to address the D. Food for Animals harden the food supply to minimize the potential presence of this hazard in a As discussed in section V.B.6 of this potential for terrorist attack. We have food. The goal of the perpetrator of document, we are proposing to exempt tentatively concluded that the latter can economically motivated adulteration is the manufacturing, processing, packing, be accomplished by focusing on those for the adulterant to be undetected in and holding of animal food from this points in the food system where an the product, so that the perpetrator can proposed regulation with respect to attack would be expected to cause continue to obtain the desired economic intentional adulteration caused by acts massive adverse public health impact, benefits (Ref. 7, Ref. 9). Accordingly, of terrorism. and, to a lesser extent, economic unlike with acts of terrorism, such disruption. occurrences of economic adulteration E. Acts of Disgruntled Employees, are expected to be long term, and would Consumers, or Competitors F. Economically Motivated Adulteration not be appropriately viewed as a rare While the goals and outcomes of acts Efforts to protect against intentional occurrence, but rather as reasonably of disgruntled employees, consumers or adulteration require a shift in likely to occur. competitors can overlap with acts of perspective from that applied to We have tentatively concluded that terrorism, generally, the distinction has traditional food safety. In the PC, this hazard-analysis type approach is to do with differences in scale. Animal Food PC, and Produce Safety better suited to address economically Disgruntled employees are generally proposed rules, we tentatively motivated adulteration than the understood to be interested primarily in concluded that hazards associated with vulnerability assessment-type approach attacking the reputation of the company, intentional adulteration, which are not we are proposing to address intentional and otherwise have little interest in addressed in traditional HACCP or other adulteration related to terrorism. In the public health harm. On the other hand, food safety systems, likely will require latter approach, which we are not terrorist organizations are generally different kinds of controls, and would proposing, significant vulnerabilities understood to be interested in be best addressed in a separate would be identified based either on the maximizing public health harm and, to rulemaking (this proposed rule). presence of key activity types (which a lesser extent, economic disruption However, we also explained how in reflect FDA-conducted vulnerability (Ref. 5, Ref. 6). some circumstances economically assessments) or facility-specific Section 420(c) of the FD&C Act motivated adulteration could be viewed vulnerability assessments. Under a requires that the regulation prepared as reasonably likely to occur. Further, vulnerability assessment-type approach,

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the assessment would need to consider monitoring, corrective actions, manufacturing practice (CGMP) rule, to the degree to which a food is a likely verification, and recordkeeping would include economically motivated target for economically motivated be documented in a food safety plan adulteration that could result in serious adulteration based on the attributes of that would include control of adverse health consequences or death. the food (such as the nature of the food, economically motivated adulteration. Current § 111.70(b) and (c) require its production system, and its supply We believe that addressing both of these establishing component specifications chain) and the capabilities of a potential sources for contamination and in-process specifications to ensure perpetrator (such as availability and within the same framework is likely to the identity, purity, strength, and access to adulterants that can be readily streamline requirements and reduce composition of the dietary supplement, disguised and undetected by currently costs to industry. and we could amend these provisions to accepted testing methods). Factors to We seek comment on our tentative cover economically motivated consider could include previous conclusions presented above. adulteration that could result in serious occurrences of economically motivated Specifically, we are interested in adverse health consequences or death. adulteration; a highly complex supply information on the specific factors that We have also tentatively concluded chain; sudden changes in commodity are most relevant for determining not to require produce farms subject to prices; known inadequacies in whether economically motivated section 419 of the FD&C Act and farms identification and assay testing methods adulteration is reasonably likely to that produce milk (also referred to in for potential adulterants; a highly occur, particularly in instances where this document as ‘‘dairy farms’’) subject complex and variable food ingredient; the specific product or supplier has not to section 420 of the FD&C Act to take been previously associated with such the widespread availability of a measures to address economically adulteration. In addition, we seek potential adulterant; the lack of motivated adulteration. With regard to comment on whether and how these organoleptic properties of a potential produce farms subject to section 419 of relevant factors may be used to develop adulterant; the high cost or scarcity of the FD&C Act, we have tentatively appropriate predictive tools or establish an ingredient; and variation in the value concluded that there are not procedures, a standard for when preventive controls of a food based on variations in levels processes, or practices that are are necessary. of a high value attribute of that food. reasonably necessary to be implemented The nature of economically motivated Section 418 of the FD&C Act contains certain exemptions related to by these entities to prevent the adulteration makes it difficult to introduction of known or reasonably identify all relevant factors to be compliance with FDA’s seafood and juice HACCP regulations and with foreseeable biological, chemical, or considered in a vulnerability assessment physical hazards that can cause serious to predict when novel events of regard to manufacturing, processing, packing or holding dietary supplements adverse health consequences or death as economic adulteration are expected to that are in compliance with the a result of economically motivated occur. Moreover, predictive tools such requirements of sections 402(g)(2) and adulteration. With regard to farms that as CARVER+Shock are not currently 761 of the FD&C Act. Section 420 of the produce milk subject to section 420 of configured to assess the risk of FD&C Act does not contain these the FD&C Act, we have tentatively economically motivated adulteration, exemptions and requires FDA to issue concluded that there are not appropriate nor have extensive vulnerability regulations to protect against the science-based strategies or measures assessments for economically motivated intentional adulteration of food. Seafood intended to protect against adulteration in food products been and juice are currently subject to economically motivated adulteration conducted by FDA or others. Therefore, HACCP-type regulations in §§ 123 and that can be applied at the farm. These we believe the most appropriate 120, respectively, and our current tentative conclusions are based on our framework to assess the risk of thinking is that under section 420 assessment that preventive controls for economically motivated adulteration is economically motivated adulteration economically motivated adulteration are to consider whether it is reasonably could be addressed through the existing suitable to address such adulteration likely to occur (such as whether it has frameworks for these foods. Under this when it is perpetrated by the entity’s occurred under similar circumstances option, FDA would amend the seafood supplier, but not when it is perpetrated with some regularity in the past) as part and juice HACCP regulations to specify by the entity itself, as would be the case of a hazard analysis. that economically motivated for economically motivated adulteration Under this approach, facilities subject adulteration is a hazard that must be at a produce farm or a farm that to section 418 of the FD&C Act would considered in a hazard analysis of these produces milk. Actions such as auditing be expected to implement controls foods, and addressed in a HACCP plan. of suppliers or reliance upon supplier- against economically motivated For example, for seafood, we could supplied test results or production adulteration under circumstances where propose to add ‘‘economically control records are generally considered there has been a pattern of such motivated adulteration that could result unsuitable to address economically adulteration in the past, even though the in serious adverse health consequences motivated adulteration where the past occurrences may not be associated or death’’ to the list of hazards to be supplier, if intentionally adulterating with the specific supplier or the specific considered in a hazard analysis in the food, would already be violating the food product but the pattern suggests a accordance with § 123.6(c)(1). Similarly, law and would be able to subvert these potential for intentional adulteration. for juice we could propose to add controls. For both types of farms, we are Further, a system of monitoring, ‘‘economically motivated adulteration not aware of inputs into the growing, corrective action, verification, and that could result in serious adverse harvesting, packing, or holding of recordkeeping that is similar to those in health consequences or death’’ to the produce or milk (i.e., within our farm the PC and Animal Food PC proposed list of hazards to be considered in a definition) that could be subject to rules would be appropriate for hazard analysis in accordance with economically motivated adulteration economically motivated adulteration. In § 120.7(c). Also under this option, FDA that could cause serious adverse health addition, the elements of a preventive would consider proposing to amend consequences or death under sections control system, including hazard part 111 (21 CFR part 111), the Dietary 419 and 420 of the FD&C Act. We seek analysis, preventive controls, Supplements current good comment on this tentative conclusion.

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G. Low-Risk Activities at Farm Mixed- • Game Meats (Whole or Cut, Not activity type, Liquid storage and Type Facilities Ground or Shredded, Without handling, and fluid milk loading Secondary Ingredients) appears to fit within the key activity Section 103(c)(1)(C) of FSMA directs • Peanuts & Tree Nuts (Raw, In-Shell) type, Bulk liquid receiving and holding. the Secretary of Health and Human • Sugarcane & Sugar Beets (Fresh, The fluid milk storage tank is one of the Services to conduct a science-based risk Intact) actionable process steps that would be analysis as part of the section 103(c) We are considering the results of this applicable to both of these activities on rulemaking. The science-based risk analysis in determining any specific a dairy farm. analysis is to cover ‘‘(i) specific types of exemptions or modified requirements. As discussed in section V.C.2 of this on-farm packing or holding of food that We request comment on whether we document, FDA is proposing to require is not grown, raised, or consumed on should exempt on-farm manufacturing, that the owner, operator, or agent in such farm or another farm under the processing, packing, or holding of the charge of a facility that has one or more same ownership, as such packing and foods identified as having low-risk of the FDA-identified key activity types holding relates to specific foods; and (ii) production practices when conducted identify actionable process steps for specific on-farm manufacturing and by a small or very small business if such those key activity types and implement processing activities as such activities activities are the only activities focused mitigation strategies at any relate to specific foods that are not conducted by the business that are actionable process steps. Because dairy consumed on that farm or on another subject to section 418 of the FD&C Act. farms generally are not facilities as farm under common ownership.’’ In If we were to take this approach, only defined in this rule, they would not be section VIII.G of the PC proposed rule, facilities meeting all of the specified subject to this requirement. However, we describe a draft Qualitative Risk criteria would be exempt as a result of section 420 is applicable to dairy farms Assessment (the draft RA) we performed being engaged in low-risk activities. (see § 420(d)) and fluid milk storage and to satisfy this requirement. Section Thus, a facility located on-farm, that is loading in a dairy farm operation appear 103(c)(1)(D)(i) of FSMA requires FDA to a small or very small business, and only to pose a significant vulnerability. use the results of this analysis to produces fresh, intact apples as a The risk posed by intentional establish exemptions and inspection finished product (e.g., by packing apples adulteration of milk on-farm results frequencies, or modify requirements, for grown on a different farm that is under from a number of factors: (1) The system facilities engaged only in specific types different ownership) would be exempt of milk collection from farms and of on-farm activities that FDA from this proposed rule. On the other subsequent holding and processing determines to be low risk. hand, an apple-packing facility that is serves to distribute contaminants added Elsewhere in this issue of the Federal off-farm would not be exempt, an apple to the milk on the farm into much larger Register, FDA is publishing a notice packing facility that is on-farm but that quantities of fluid milk, increasing the announcing the availability for public is not a small or very small business potential magnitude of an intentional comment Appendix 4 to the draft RA would not be exempt, and an apple adulteration event; (2) in its fluid form (the draft RA Appendix). The purpose of packing facility that also packs green milk has a short shelf life, increasing the the draft RA Appendix is to provide a beans would not be exempt. We request potential for significant adverse public science-based risk analysis of those comment on whether we should health impacts before detection and, foods whose production processes broaden this potential exemption in any once detected, before a public health would be considered low risk with way, such as by removing certain of the intervention can be implemented; (3) respect to the risk of intentional restrictions mentioned immediately fluid milk is widely consumed across adulteration caused by acts of terrorism. above. We also seek comment on different sub-populations, including FDA conducted this evaluation to whether we should instead establish infants and children, increasing the satisfy the requirement in Section modified requirements for facilities that potential for significant adverse public 103(c)(1)(C) of FSMA to conduct a produce foods identified as having low- health impacts and, because of public science-based risk analysis with respect risk production processes, and if so, reaction to child and infant morbidity to the risk of intentional adulteration what those modified requirements and mortality, decreasing public confidence in the food supply; (4) fluid caused by acts of terrorism. We should be and the scope of application milk is consumed in a variety of food evaluated the production processes for of the modified requirements. In forms, including as a beverage (finished the types of finished foods we expect addition, we seek comment on whether food) and as an ingredient in other are produced at farm mixed-type and how we should consider the results finished foods, complicating public facilities to determine whether or not of this analysis in determining whether health intervention; and (5) milk storage they are low-risk with respect to hazards to exempt or modify the inspections tanks are commonly left unlocked (Ref. that may be intentionally introduced by frequency requirements under Section 41, Ref. 42, Ref. 43, Ref. 44, Ref. 45, Ref. acts of terrorism. For the purposes of 421 of the FD&C Act, Targeting of 46, Ref. 47). this analysis, we evaluated whether a Inspection Resources for Domestic production process involved any of the Facilities. 2. Mitigation Strategies four FDA-identified key activity types, H. Activities That Occur on Dairy Farms Farms are not subject to the HACCP- and identified a production process that type system of preventive controls did not involve any of the four key 1. Assessment of Vulnerabilities prescribed in section 418 of the FD&C activity types as a ‘‘low risk production Under section 420 of the FD&C Act, Act, and our current thinking is that, process.’’ Based on this evaluation, we we considered whether activities that should we include requirements relative concluded that the production processes occur on farms that produce milk pose to dairy farms in the final rule, we for the following finished foods are a high risk for intentional adulteration would not require HACCP-type controls ‘‘low-risk’’: of food caused by acts of terrorism that for dairy farms under section 420 of the • Eggs (In-Shell) could cause significant adverse health FD&C Act. Similarly, under section 419 • Fruits & Vegetables Other Than consequences or death. A preliminary of the FD&C Act we did not propose to Pods, Seeds for Direct Consumption, evaluation indicates that fluid milk apply such an approach to and Hesperidia (Fresh, Intact) storage appears to fit within the key unintentional adulteration on produce

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farms in the Produce Safety proposed We also seek comment on whether it I. Other Ways to Focus on Foods With rule (see section IV.D of the Produce would be more appropriate for FDA to a High Risk of Intentional Adulteration Safety proposed rule). Rather, as with require that dairy farm operators receive Caused by Terrorism produce farms, a more appropriate food defense awareness training rather We are requesting comment on approach might be a CGMP-type than requiring that they implement whether, under section 420 of the FD&C provision that relates directly to the focused mitigation strategies to limit Act, there are other ways in which the significant vulnerability. Generally, access to certain steps of their operation. coverage of this proposed regulation can CGMPs set out mandatory, broad, If you support an approach based on be further focused on foods that present generally applicable practices and training rather than mandated focused a high risk of intentional adulteration conditions that are required to be met, mitigation strategies, we are further caused by acts of terrorism. For and the criteria and definitions that are interested in how such an approach example, are there ways in which a applicable in determining whether the would work at those farms where an food’s shelf life, turnover in the food is adulterated. For example, a agent of the farm may not be present at marketplace, batch size, serving size and CGMP approach would identify the all times, given that a system based on servings per batch, distribution and broad, generally applicable mitigation awareness training is premised on the consumption patterns, and intended strategies that dairy farm operators must assumption that such training would consumer could be considered in implement (e.g., limiting access to fluid provide the operator with the tools to providing for an exemption or in setting milk storage tanks), without specifying report and respond to suspicious modified requirements for that food. how that strategy must be accomplished activity that they observe. Ordinarily, these considerations are part and without a further requirement for of a vulnerability assessment, and in monitoring, recordkeeping or the 3. Scope of Dairy Farms Subject to any such assessments the risk reduction development of a plan. We seek Requirement aspects of one attribute may be offset or comment on this approach. exacerbated by those of another FDA previously provided guidance Finally, we seek comment on the attribute, and may be very facility- for the dairy industry, including dairy scope of farms that produce milk that specific. Such attributes specific to the farms, on the potential for intentional should be subject to any requirements food(s) manufactured, processed, contamination and identified the types that we may establish in a final rule. For packed, or held at the facility can be of food defense measures that dairy example, the scope of dairy farms taken into account, should a facility farms may take to minimize the risk that covered could be determined based on choose to perform its own vulnerability fluid milk under their control will be the potential for adverse public health assessment and assign actionable subject to tampering or other malicious, outcome resulting from consumption of process steps, as provided for in criminal, or terrorist actions (Ref. 24). milk produced at a farm, if a proposed § 121.130(b). However, as Among other recommendations, FDA’s contaminant were intentionally discussed in section V.C.2 of this guidance recommends ‘‘limiting access’’ introduced into the milk from that farm. document, facilities would not be to raw and pasteurized milk storage as Farms with less than 50 milk-producing required to perform a facility-specific a food defense preventive measure. We cows contribute a relatively small vulnerability assessment and, instead, acknowledge the difficulties involved in proportion to the total volume of milk would have the option of identifying limiting access to many dairy farms, produced in the United States (i.e., actionable process steps using the including multiple entries to the milk approximately 4.2 percent of total milk procedure in proposed § 121.130(a). We house, multiple visitors with customary produced in the United States), and the are particularly interested in how food- access to the milk house (e.g., State food current trend in the dairy farm industry specific attributes can be taken into safety inspectors, vendors delivering toward consolidation (Ref. 48) likely account in the absence of a general veterinary medications, and drivers further reduces the percentage of requirement for a facility-specific collecting bulk milk for transport to production that such farms will vulnerability assessment. processing and storage facilities); contribute in the future. However, milk continuous milk piping from the V. The Proposal from even very small dairy farms may milking parlor to the bulk milk tank, be pooled with milk from other farms in A. Definitions providing for access points to the bulk raw milk storage tanks at milk milk tank from outside the milk house; In subpart A of proposed part 121, open access to the milking parlor for processing and storage facilities, under § 121.3, FDA is proposing the workers and cows; and automated potentially resulting in a public health following definitions and milking operations where employees are impact from intentional adulteration interpretations of terms relevant to not necessarily present to escort cows that is disproportionate to the size of the proposed part 121. The definitions and into the milking parlor. farm or its contribution to the milk interpretations of terms in section 201 of In light of these circumstances, we supply. We request comment on the the FD&C Act (21 U.S.C. 321) are request comment on whether and how appropriateness of determining the applicable to such terms when used in access to the bulk milk storage tank and scope of dairy farms covered based on this part. As proposed, several terms in associated systems can be limited, and the number of cows on a farm. part 121 have the same definitions as in the costs and other implications of Alternatively, should we consider proposed part 117 and, therefore, we doing so. In addition, we are interested excluding farms based on how the milk have not included an extensive in comment on whether and what types from a farm is distributed (e.g., direct discussion of those terms in this of focused mitigation strategies or other sale to consumers or other end users; proposed rule. See section X.B of the PC measures are currently employed by pooling with milk from other farms; proposed rule for a discussion of the dairy farms. Specifically for fluid milk supplied to the Grade A Milk system for following terms: facility, farm, holding, storage tanks, we seek comment on the production of fluid milk; or used in manufacturing/processing, mixed-type whether and what focused mitigation the production of cheese and other facility, packing, qualified end-user, strategies would be appropriate and products that have a different risk qualified facility, and small business. feasible given current dairy farming associated with intentional adulteration FDA is proposing to define the term practices. caused by acts of terrorism)? ‘‘actionable process step’’ to mean a

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point, step, or procedure in a food related to intentional acts of measure taken by a facility to reduce the process at which food defense measures adulteration caused by acts of terrorism potential for intentional adulteration of can be applied and are essential to with intent to cause public health harm food. A ‘‘focused mitigation strategy’’ is prevent or eliminate a significant and, to a lesser extent, economic such a strategy applied in response to vulnerability or reduce such disruption. Therefore, for the purposes the identification of a significant vulnerability to an acceptable level. The of proposed part 121, we focused the vulnerability and at an actionable term ‘‘actionable process step’’ used in definition of ‘‘contaminant’’ on agents process step. Focused mitigation the food defense context is analogous to that may be intentionally added to food strategies are customized to the the term ‘‘critical control point’’ (CCP), and that may cause illness, injury, or processing step at which they are which is defined as ‘‘a point, step, or death, which is consistent with our applied, tailored to existing facility procedure in a food process at which determination that the primary goal of practices and procedures, and depend control can be applied and is essential such an attack would be public health on an evaluation of the vulnerabilities to prevent or eliminate a food safety harm (i.e., illness, injury, or death). Our identified in a facility. Because they are hazard or reduce such hazard to an proposed definition of ‘‘contaminant’’ in applied in response to a significant acceptable level.’’ Similar to a CCP, in proposed 121.3 would be applicable to vulnerability, we have determined that proposed part 121, an ‘‘actionable proposed part 121 only. We focused mitigation strategies are process step’’ is identified during a acknowledge that this term has a essential to ensure that appropriate vulnerability assessment (analogous to a broader meaning in other settings, as action is taken to protect the food from hazard analysis) in relation to a evidenced by its use in the Codex intentional adulteration caused by acts significant vulnerability (analogous to a Alimentarius guidelines. of terrorism. hazard that is reasonably likely to FDA is proposing to define the term While an option to perform a occur), and is facility-specific. ‘‘facility’’ to mean a domestic facility or vulnerability assessment is provided As discussed in section V.C.2 of this a foreign facility that is required to under proposed § 121.130(b), facilities document, based on vulnerability register under section 415 of the FD&C may choose instead to rely on the assessments, FDA has identified four Act in accordance with the analysis performed by FDA that resulted key activity types that we have requirements of part 1, subpart H (21 in the identification of the key activity tentatively concluded pose significant CFR part 1, subpart H). The proposed types listed in proposed § 121.130(a) vulnerabilities in a food operation. FDA definition would incorporate the when identifying actionable process identified and described these key definition in section 418(o)(2) of the steps and, subsequently, focused activity types (which are not facility- FD&C Act. mitigation strategies, eliminating the specific) with the expectation that an FDA is proposing to define the term need for a full vulnerability assessment. owner, operator, or agent in charge ‘‘farm’’ by reference to the definition of See section V.C.3 of this document for would objectively determine whether that term in proposed § 1.227. We are examples of focused mitigation the processing steps in a facility fit proposing to cross-reference the strategies. within one or more of these key activity definition of ‘‘farm’’ rather than to FDA is proposing to define the term types. The processing steps identified define it in proposed part 121 because ‘‘food defense’’ as the effort to protect by facilities in their food operation that the definition of ‘‘farm,’’ under both food from intentional acts of fit within the FDA-identified key current § 1.227(b)(3) and proposed adulteration where there is an intent to activity types are ‘‘actionable process § 1.227, includes the word ‘‘facility’’ cause public health harm and economic steps,’’ and are steps at which a focused with a meaning that is broader than the disruption. As discussed in section IV.A mitigation strategy would be employed meaning of ‘‘facility’’ in section of this document, acts of intentional to prevent or eliminate a significant 418(o)(2) of the FD&C Act. Under part adulteration may take several forms, vulnerability or reduce it to an 1, subpart H, the term ‘‘facility’’ is not including acts of terrorism; acts of acceptable level. Actionable process limited to entities that are required to disgruntled employees, consumers, or steps might also be identified in a register under section 415 of the FD&C competitors; and economically vulnerability assessment (proposed Act. We are proposing to cross-reference motivated adulteration. We are § 121.130(b)). Though we use the term the definition to reduce the potential proposing to define the term ‘‘food ‘‘actionable process step’’ in FDA’s confusion that could result if we used defense’’ to refer to the sum of actions FDPB software tool (Ref. 31), we the term ‘‘facility’’ to have two different and activities (including identification recognize it is a relatively new term and, meanings within proposed part 121. See of actionable process steps; therefore, we solicit comment on its sections X.B and VIII of the PC proposed implementation of focused mitigation appropriateness and any other more rule for additional information. strategies; monitoring, corrective appropriate alternative terms. FDA is proposing to define the term actions, verification, and training FDA is proposing to define the term ‘‘focused mitigation strategies’’ to mean activities) taken to protect food from ‘‘contaminant’’ as any biological, those risk-based, reasonably appropriate intentional acts of adulteration related chemical, physical or radiological agent measures that a person knowledgeable to terrorism. that may be intentionally added to food about food defense would employ to FDA is proposing to define the term and that may cause illness, injury or significantly minimize or prevent ‘‘holding’’ to mean the storage of food. death. We based the proposed significant vulnerabilities identified at The proposed definition would also definition, in part, on the definition of actionable process steps, and that are state that holding facilities include ‘‘contaminant’’ used in Codex consistent with the current scientific warehouses, cold storage facilities, Alimentarius guidelines (Ref. 49) that understanding of food defense at the storage silos, grain elevators, and liquid refers to any biological or chemical time of the analysis. The term ‘‘focused storage tanks; and that, for farms and agent, foreign matter or other substances mitigation strategies’’ used in the food farm mixed-type facilities, holding also not intentionally added to feed or food defense context is analogous to the term includes activities traditionally that may compromise feed and food ‘‘preventive controls’’ in a HACCP-type performed by farms for the safe or safety or suitability. In this proposal, the framework for food safety. effective storage of raw agricultural term ‘‘contaminant’’ is used in the As discussed in section V.C.3 of this commodities grown or raised on the context of key activity types, which are document, a mitigation strategy is a same farm or another farm under the

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same ownership, but does not include focused mitigation strategies are applicable calendar year was less than activities that transform a raw consistently applied and to produce an $500,000, adjusted for inflation. agricultural commodity, as defined in accurate record for use in verification. We acknowledge that facilities would section 201(r) of the FD&C Act, into a In the intentional adulteration not need to consider the applicability of processed food as defined in section framework, monitoring would be previous paragraph (2) because facilities 201(gg) of the FD&C Act. For performed to ensure that focused that meet this second prong of the consistency of terminology, we are mitigation strategies are consistently definition would be included in our proposing the same definition of applied and to provide a record for use proposed definition of a very small ‘‘holding’’ as in the PC proposed rule in verifying consistent application. business, which is broader. (see proposed §§ 1.227 and 117.3). For FDA is proposing to define the term The proposed definition would a detailed discussion of ‘‘holding,’’ see ‘‘packing’’ to mean placing food into a incorporate the description of ‘‘qualified sections VIII.E and X.B of the PC container other than packaging the food. facility’’ in section 418(l)(1) of the FD&C proposed rule. The proposed definition would also Act with editorial changes to improve FDA is proposing to define the term specify that, for farms and farm mixed- clarity. ‘‘manufacturing/processing’’ to mean type facilities, packing also includes FDA is proposing to define the term making food from one or more activities traditionally performed by ‘‘significant vulnerability’’ to mean a ingredients, or synthesizing, preparing, farms to prepare raw agricultural vulnerability for which a prudent treating, modifying or manipulating commodities grown or raised on the person knowledgeable about food food, including food crops or same farm or another farm under the defense would employ food defense ingredients. The proposed definition same ownership for storage and measures because of the potential for would also state that examples of transport, but does not include activities serious adverse health consequences or manufacturing/processing activities are that transform a raw agricultural death and the degree of accessibility to cutting, peeling, trimming, washing, commodity, as defined in section 201(r) that point in the food process. The term waxing, eviscerating, rendering, of the FD&C Act, into a processed food ‘‘significant vulnerability’’ is analogous cooking, baking, freezing, cooling, as defined in section 201(gg). We are to the term ‘‘hazard that is reasonably pasteurizing, homogenizing, mixing, proposing to use the same definition of likely to occur’’ in a HACCP-type formulating, bottling, milling, grinding, ‘‘packing’’ as in the PC proposed rule framework for food safety. As proposed, extracting juice, distilling, labeling, or (see proposed §§ 1.227 and 117.3). For a ‘‘significant vulnerability’’ is a type of packaging. The proposed definition a detailed discussion of ‘‘packing,’’ see vulnerability for which there is both: (1) would also specify that, for farms and sections VIII.E and X.B of the PC The potential for serious adverse health farm mixed-type facilities, proposed rule. consequences or death from the manufacturing/processing does not FDA is proposing to define the term intentional introduction of a include activities that are part of ‘‘qualified end-user’’ to mean, with contaminant at the particular point in harvesting, packing, or holding. For respect to a food, the consumer of the the process at which the significant consistency of terminology, we are food (where the term consumer does not vulnerability exists; and (2) a significant proposing the same definition of include a business); or a restaurant or degree of accessibility at the particular ‘‘manufacturing/processing’’ as in the retail food establishment (as those terms point in the process. Unlike a ‘‘hazard PC proposed rule (see proposed §§ 1.227 are defined in § 1.227) that: (1) Is that is reasonably likely to occur’’ in a and 117.3). For a detailed discussion of located: (i) in the same State as the HACCP system, a ‘‘significant ‘‘manufacturing/processing,’’ see qualified facility that sold the food to vulnerability’’ exists at a particular sections VIII.E and X.B of the PC such restaurant or establishment; or (ii) point in a process (e.g., during storage proposed rule. not more than 275 miles from such in a bulk tank or during mixing). As FDA is proposing to define the term facility; and (2) is purchasing the food discussed in section V.C.2 of this ‘‘mixed-type facility’’ to mean an for sale directly to consumers at such document, we have determined that establishment that engages in both restaurant or retail food establishment. significant vulnerabilities exist in a food activities that are exempt from The proposed definition would operation at those actionable process registration under section 415 of the incorporate the definition in section steps that fit in the FDA-identified key FD&C Act and activities that require the 418(l)(4)(B) of the FD&C Act. activity types or that are identified as establishment to be registered. The FDA is proposing to define the term part of a vulnerability assessment. proposed definition would also state ‘‘qualified facility’’ to mean (when We have retained in this proposed that an example of such a facility is a including the sales by any subsidiary; definition the concept of a ‘‘prudent ‘‘farm mixed-type facility,’’ which is an affiliate; or subsidiaries or affiliates, person’’ used in the definition of a establishment that grows and harvests collectively, of any entity of which the ‘‘hazard that is reasonably likely to crops or raises animals and may facility is a subsidiary or affiliate) a occur’’ in the PC proposed rule. conduct other activities within the farm facility that is: (1) A very small business However, because intentional definition, but also conducts activities as defined in this part; or (2) a facility adulteration is a potentially high that require the establishment to be to which both of the following apply: (i) consequence but low probability registered. For consistency of During the 3-year period preceding the occurrence, the portion of the proposed terminology, we are proposing the same applicable calendar year, the average definition in the PC proposed rule that definition of ‘‘mixed-type facility’’ as in annual monetary value of the food reads, ‘‘experience, illness data, the PC proposed rule (see proposed manufactured, processed, packed or scientific reports, or other information §§ 1.227 and 117.3). For a detailed held at such facility that is sold directly provides a basis to conclude that there discussion of ‘‘mixed-type facilities,’’ to qualified end-users (as defined in this is a reasonable possibility that the see sections VIII.E and X.B of the PC part) during such period exceeded the hazard will occur in the type of food proposed rule. average annual monetary value of the being manufactured, processed, packed, FDA is proposing to define the term food sold by such facility to all other or held in the absence of those ‘‘monitor’’ to mean to conduct a purchasers; and (ii) the average annual controls,’’ does not appear to be planned sequence of observations or monetary value of all food sold during appropriate. Successful intentional measurements to assess whether the 3-year period preceding the adulteration caused by an act of

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terrorism requires not only the absence organizations is to maximize public adulteration context, we have of focused mitigation strategies designed health harm and, to a lesser extent, tentatively concluded that focusing on to address a significant vulnerability, economic disruption. It is our individual agents or contaminants is but also simultaneous intent by an assessment that such goals are likely to generally not effective or efficient in attacker to adulterate the food. As such, drive terrorist organizations to target the minimizing the risk of intentional the absence of focused mitigation product of relatively large facilities, adulteration caused by acts of terrorism. strategies to address a significant especially those for which the brand is There are a significant number of vulnerability alone may not present a nationally or internationally potential agents or contaminants that reasonable possibility of intentional recognizable. An attack on such a target could be used in a terrorist attack on adulteration. Instead, as described would potentially provide the wide- food, with one or more being suitable above, we have tentatively concluded scale consequences desired by a terrorist for essentially any point in the that the prudent person would consider organization and the significant public production of any specific food. It the potential for public health attention that would accompany an would be extremely difficult, if not consequences should intentional attack on a recognizable brand. Such impossible, to consider the multiple adulteration occur, and the degree of facilities are likely to have larger batch combinations of potential contaminants, access by the attacker to commit the sizes, potentially resulting in greater points in a food operation, and food intentional adulteration, in determining human morbidity and mortality. categories, and to determine a strategy which vulnerabilities are significant. Further, an attack on a well-recognized, that would effectively address all FDA is proposing to define the term trusted brand is likely to result in possible agents. For this reason, ‘‘significantly minimize’’ to mean to greater loss of consumer confidence in determining whether there is an agent reduce to an acceptable level, including the food supply and in the government’s that could be intentionally introduced to eliminate. As noted in section X.B of ability to ensure its safety and, to a specific food that would then cause the PC proposed rule, the term consequently, cause greater economic serious adverse health consequences or ‘‘significantly minimize’’ is used in disruption than a relatively unknown death would not be a useful exercise. FSMA and is consistent with the brand that is distributed regionally (Ref. Further, many agents or contaminants outcome of a ‘‘control measure’’ as 2, Ref. 50, Ref. 3, Ref. 51, Ref. 6). that could be used in such an attack are described in the HACCP regulations for Therefore, we have set a threshold of different from those that are associated seafood (part 123), juice (part 120), and $10,000,000 in total food sales, adjusted with foodborne illnesses caused by meat and poultry (9 CFR part 417). for inflation, as the level defining a very unintentional adulteration and, as such, Generally, a ‘‘control measure’’ is small business. Data from the Dun & are not expected to be well understood implemented so that hazards are Bradstreet Global Business Database by operators of food facilities. Therefore, prevented, reduced to an acceptable show that businesses with less than we have tentatively concluded that in level, or eliminated. $10,000,000 in total food sales represent the intentional adulteration framework FDA is proposing to define the term about 3 percent of the market share of related to acts of terrorism, it is ‘‘small business’’ to mean, for the food commodities, but include the appropriate to refer to ‘‘vulnerabilities’’ purposes of proposed part 121, a majority of food facilities. Of a total of rather than ‘‘hazards’’. According to the business employing fewer than 500 65,900 domestic food facilities that are Merriam-Webster dictionary (Ref. 52), persons. The proposed limit of 500 estimated to have actionable process vulnerability is a ‘‘susceptibility,’’ and employees would include all employees steps, about 51,700 are owned by we believe this concept best captures of the business rather than be limited to businesses with less than $10,000,000 in the idea of a point, step, or procedure the employees of a particular facility. total annual sales. We request comment where someone intent on intentional We are proposing to establish the same adulteration would focus an attack in a definition for small business as that on our proposed definition, and whether a dollar amount of sales more facility’s food process. See section V.C.2 which has been established by the U.S. of this document for a discussion of Small Business Administration under than or less than $10,000,000 would be more appropriate. We also seek assessing vulnerabilities to identify 13 CFR part 121 for most food actionable process steps. manufacturers. comment on whether this threshold should be based on total food sold, as We solicit comment on the proposed FDA is proposing to define the term definitions. ‘‘verification’’ to mean those activities, we proposed, or on some appropriate other than monitoring, that establish proportion of food sales. For example, B. Exemptions in the case of foreign facilities, would it that the system is operating according to In subpart A of proposed part 121, be more appropriate to consider the the food defense plan. As discussed in proposed § 121.5 would establish proportion of food sold for marketing in section V.C.6 of this document, we are exemptions from some or all of the the United States? not proposing to require validation of provisions of this proposed regulation. the focused mitigation strategies and, FDA is proposing to define the term therefore, we are not proposing to ‘‘vulnerability’’ to mean the 1. Proposed § 121.5(a)—Exemption for include a determination of the validity susceptibility of a point, step, or Qualified Facilities of the food defense plan within the procedure in a facility’s food process to Proposed § 121.5(a) would provide definition of verification in proposed intentional adulteration. that proposed part 121 does not apply § 121.3. ‘‘Vulnerability’’ is used in the term to a qualified facility, except that FDA is proposing to define the term ‘‘vulnerability assessment’’ in section qualified facilities must, upon request, ‘‘very small business’’ to mean, for the 420 of the FD&C Act and may best be provide for official review purposes of proposed part 121, a described in the food defense context as documentation that was relied upon to business that has less than $10,000,000 analogous to the term ‘‘hazard’’ in a demonstrate that the facility meets this in total annual sales of food, adjusted HACCP-type framework for food safety. exemption. Such documentation must for inflation. In the discussion on the While hazards in the unintentional be retained for 2 years. regulatory framework in section IV.A of adulteration context may also be a. Exemption of qualified facilities. As this document, we discuss our thought of as analogous to agents or discussed in section V.A of this assessment that the goal of terrorist contaminants in the intentional document, proposed § 121.3 would

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define a qualified facility to mean (when consider comments regarding the study, that a qualified facility is exempt from including the sales by any subsidiary; as well as comments regarding our the requirements of sections 418(a) affiliate; or subsidiaries or affiliates, proposed definition for very small through (i) and (n) (i.e., the collectively, of any entity of which the business, in any final rule based on this requirements for hazard analysis and facility is a subsidiary or affiliate) a proposed rule. risk-based preventive controls), but facility that is: (1) A very small business We note that section 420 of the FD&C must instead submit two types of as defined in this part, or (2) a facility Act does not contain an explicit size- documentation to the Secretary of to which both of the following apply: (i) based exemption, such as the qualified Health and Human Services. The first During the 3-year period preceding the facility provision in section 418 of the type of required documentation relates applicable calendar year, the average FD&C Act. In section IV.A of this to food safety practices at the facility, annual monetary value of the food document, we discuss our assessment and section 418(l)(2)(B)(i) of the FD&C manufactured, processed, packed or that the goal of terrorist organizations is Act provides two options for satisfying held at such facility that is sold directly to maximize public health harm and, to this documentation requirement. Under to qualified end-users (as defined in this a lesser extent, economic disruption. We section 418(l)(2)(B)(i)(I) of the FD&C part) during such period exceeded the have tentatively concluded that such Act, the qualified facility may choose to average annual monetary value of the goals are likely to drive terrorist submit documentation that food sold by such facility to all other organizations to target the product of demonstrates that the owner, operator, purchasers; and (ii) the average annual relatively large facilities, especially or agent in charge of the facility has monetary value of all food sold during those for which the brand is nationally identified potential hazards associated the 3-year period preceding the or internationally recognizable. The with the food being produced, is applicable calendar year was less than regulations issued under section 420 of implementing preventive controls to $500,000, adjusted for inflation. In the FD&C Act are to apply to food for address the hazards, and is monitoring addition, we are proposing to define which there is a high risk of intentional the preventive controls to ensure that very small business to mean a business contamination. We have tentatively such controls are effective. that has less than $10,000,000 in total concluded that designating businesses Alternatively, under section annual sales of food, adjusted for with less than $10,000,000 in total 418(l)(2)(B)(i)(II) of the FD&C Act, the inflation. annual sales of food as very small qualified facility may choose to submit Section 418(l)(2)(A) of the FD&C Act businesses, resulting in their exemption documentation (which may include provides that a qualified facility ‘‘shall from proposed part 121, is consistent licenses, inspection reports, certificates, not be subject to the requirements under with the requirement in section 420 of permits, credentials, certification by an [sections 418(a) through (i) and (n) of the FD&C Act that the regulation be appropriate agency (such as a State the FD&C Act].’’ We have tentatively limited to foods at high risk of department of agriculture), or other concluded that we should include the intentional adulteration. evidence of oversight), as specified by exemption provided in section We acknowledge that the amount of the Secretary of Health and Human 418(l)(2)(A) of the FD&C Act in food sales in the proposed definition of Services, that the facility is in proposed § 121.5(a) to establish by very small business (total annual sales compliance with State, local, county, or regulation the reach of the provision. of food of less than $10,000,000) is other applicable non-Federal food safety Section 418(l)(5) of the FD&C Act significantly higher than the threshold law. requires the Secretary of Health and in the PC proposed rule, in which we The second type of required Human Services, in consultation with co-proposed three amounts ($250,000, documentation relates to whether the the Secretary of Agriculture, to conduct $500,000, and $1,000,000 in total facility satisfies the definition of a a study of the food processing sector annual sales of food). The higher qualified facility. Under section regulated by the Secretary of Health and amount proposed here reflects the 418(l)(2)(B)(ii) of the FD&C Act, the Human Services and to make difference in the nature of risk related facility must submit documentation, as determinations in five areas. These areas to intentional adulteration covered by specified by the Secretary of Health and include, in part: (1) Distribution of food this rule and is consistent with the Human Services in a guidance production by type and size of requirement in section 418(n)(3)(C) of document, that the facility is a qualified operation; (2) the proportion of food the FD&C Act that this regulation facility under section 418(l)(1)(B) or produced by each type and size of ‘‘acknowledge differences in risk and section 418(l)(1)(C). operation; (3) the number and types of minimize, as appropriate, the number of Section 418(l)(7)(A) of the FD&C Act food facilities co-located on farms; (4) separate standards that apply to separate requires that a qualified facility that is the incidence of foodborne illness foods.’’ exempt from the requirements under originating from each size and type of There are some facilities that are not sections 418(a) through (i) and operation; and (5) the effect on subject to section 418 of the FD&C Act subsection (n), and that does not foodborne illness risk associated with but are subject to section 420 of the prepare documentation under section certain activities regarding food. FD&C Act, and would be subject to this 418(l)(2)(B)(i)(I), provide notification to Section 418(n)(1)(B) of the FD&C Act rulemaking because their activities consumers by one of two procedures, requires that the regulations define the would likely involve one of the key depending on whether a food packaging terms ‘‘small business’’ and ‘‘very small activity types (e.g., juice manufacturing label is required on the food. With business,’’ taking into consideration the and breaded seafood manufacturing). respect to a food for which a food study of the food processing sector However, under proposed § 121.5(a), packaging label is required by the required by section 418(l)(5) of the such facilities would be exempt from Secretary of Health and Human Services FD&C Act. Consistent with section proposed part 121 if they are part of under any other provision of the FD&C 418(l)(5) of the FD&C Act, we have businesses with less than $10,000,000 in Act, section 418(l)(7)(A)(i) of the FD&C consulted with USDA during our study total annual sales of food, adjusted for Act requires that a qualified facility of the food processing sector. The study inflation. include prominently and conspicuously is available in the docket established for b. Documentation requirement for on such label the name and business this proposed rule (Ref. 53). We request qualified facilities. Sections 418(l)(2)(A) address of the facility where the food comment on that study. We will and (l)(2)(B) of the FD&C Act provide was manufactured or processed. With

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respect to a food for which a food countries. We tentatively concluded that 2. Proposed § 121.5(b)—Exemption for packaging label is not required by the we would not, for example, require that Holding of Food Secretary of Health and Human Services a facility submit documentation to FDA a. Requirement of section 418 of the under any other provisions of the FD&C demonstrating the content of their FD&C Act. Section 418(m) of the FD&C Act, section 418(l)(7)(A)(ii) of the FD&C hazard identification, preventive Act provides in relevant part that FDA Act requires that a qualified facility controls, or monitoring of the may by regulation ‘‘exempt or modify prominently and conspicuously display, implementation of preventive controls; the requirements for compliance under at the point of purchase, the name and or copies of their non-Federal licenses, [section 418 of the FD&C Act] with business address of the facility where inspection reports, certificates, permits, respect to facilities that are solely the food was manufactured or credentials, or certifications. We engaged in . . . the storage of raw processed, on a label, poster, sign, proposed to require that the information agricultural commodities (other than placard, or documents delivered be resubmitted to FDA at least every 2 fruits and vegetables) intended for contemporaneously with the food in the years, or whenever there is a material further distribution or processing or the normal course of business, or, in the change to the information. Finally, we storage of packaged foods that are not case of Internet sales, in an electronic proposed to require that a qualified exposed to the environment.’’ In the PC notice. facility maintain records relied upon to proposed rule, we proposed exemptions Section XIII.A of the PC proposed rule support their assertion of meeting the and modified requirements based on describes our proposed requirements requirements of the qualified this provision (see proposed §§ 117.5(j), pursuant to the above described exemption. We tentatively concluded 117.7, and 117.206). modified requirements for qualified that it is appropriate to require that the b. Petition relevant to section 418(m) facilities in that proposed rule. In records relied upon to support a self- of the FD&C Act. In a letter dated July summary, in the PC proposed rule, we certified statement be retained and 22, 2011, an industry coalition of the proposed codified language to require made available to FDA upon request. American Bakers Association, the submission of the following to FDA: (1) Proposed § 121.5(a) would require American Frozen Food Institute, the Documentation that the facility is a that qualified facilities, upon request, Grocery Manufacturers Association, the qualified facility; and (2) documentation provide for official review International Bottled Water Association, that demonstrates that the owner, documentation that was relied upon to the International Dairy Foods operator, or agent in charge of the demonstrate that the facility meets this Association, the International facility has identified the potential exemption. In addition, proposed Warehouse Logistics Association, the hazards associated with the food being § 121.5(a) would provide that such Peanut and Tree Nut Processors produced, is implementing preventive documentation must be retained for 2 Association, and the Snack Food controls to address the hazards, and is years. We are not proposing to apply all Association (the section 418(m) monitoring the performance of the of the modified requirements described petitioners) submitted a citizen petition preventive controls to ensure that such in proposed § 117.201 in the PC (Docket No. FDA–2011–P–0561). The controls are effective; or documentation proposed rule to qualified facilities that petition requests that FDA issue (which may include licenses, inspection would be covered under this rule. We regulations under section 418(m) of the reports, certificates, permits, have tentatively concluded that such an FD&C Act ‘‘to exempt from compliance credentials, certification by an approach is reasonable, considering the or modify the requirements for appropriate agency (such as a State context and wording of the statutory compliance under section 418 [of the department of agriculture), or other provision as it relates to intentional FD&C Act] for facilities that are solely evidence of oversight) that the facility is engaged in the storage of packaged foods adulteration caused by acts of terrorism. in compliance with State, local, county, that are not exposed to the environment, or other applicable non-Federal food c. Withdrawal of exemption for by allowing such facilities to satisfy the safety law, including relevant laws and qualified facilities. Section 418(l)(3) of requirements of that section through regulations of foreign countries. In the FD&C Act provides that the compliance with the [CGMPs] mandated Section XIII.A of the PC proposed rule, Secretary of Health and Human Services for such facilities by [current] § 110.93.’’ we clarified that the following may withdraw the exemption provided The section 418(m) petitioners assert submission of information would be in section 418(l)(2)(A) under certain that the food safety issues presented by satisfactory: (1) A statement from the circumstances. We discuss the facilities used only to store packaged owner, operator, or agent in charge of a withdrawal provisions of section foods that are not exposed to the qualified facility certifying that the 418(l)(3) of the FD&C Act, and the environment are essentially the same, facility is a very small business, process we propose to use to withdraw regardless of the type of food. As such, otherwise meets the definition of a an exemption for a qualified facility trade associations representing a variety qualified facility under proposed subject to that rule in section XIV.E of of product sectors are signatories to the § 117.3, or both; and (2) a statement the PC proposed rule. We ask for petition and are supportive of the from the owner, operator, or agent in comment on the appropriateness of request to exempt such facilities from charge of a qualified facility certifying those proposed procedures to withdraw the provisions of section 418 of the that the facility (a) has identified the an exemption for a qualified facility FD&C Act. potential hazards associated with the subject to this proposed rule. We also The section 418(m) petitioners stated, food being produced, is implementing seek input on whether we should ‘‘As an initial matter, the risk of preventive controls to address the include the process for such withdrawal intentional adulteration at facilities hazards, and is monitoring the within proposed part 121 or whether solely engaged in the storage of implementation of the preventive those provisions might be best placed in packaged foods not exposed to the controls to ensure that such controls are a separate part and cross-referenced in environment is quite remote. The food effective; or (b) is in compliance with proposed part 121 in order to reduce in these facilities is stored in unit State, local, county, or other applicable duplication, given these provisions also packaging, meaning any effort to non-Federal food safety law, including appear in the PC and the Produce Safety adulterate the food would be laborious relevant laws and regulations of foreign proposed rules. and likely ineffective.’’ They further

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asserted that, ‘‘Members of the food strategies are necessary with regard to remains intact from the requirements of industry have implemented a number of the holding activities. Under these this proposed regulation. precautions against intentional circumstances, we have tentatively 4. Proposed § 121.5(d)—Exemption for adulteration. Most importantly, these concluded that an exemption is Produce Farms facilities are locked and secured against appropriate. Accordingly, we propose to unauthorized entry. Access is restricted exempt the holding of food, except the Proposed § 121.5(d) would exempt to the employees of the manufacturer holding of food in liquid storage tanks, from the requirements in proposed part dropping off food, any staff employed at from the requirements of this proposed 121 the activities of a facility that are the facility, and the persons who deliver regulation. Although we are not subject to section 419 of the FD&C Act food to retailers and other customers. responding to the merits of the (Standards for Produce Safety). We Food is often held in such facilities for arguments of the section 418(m) discuss our tentative decision not to a short period of time, which would not petitioners with regard to precautions cover produce farms under section 419 be conducive to attempts at intentional against intentional adulteration, we of the FD&C Act in sections IV.B and adulteration. Further, we note that the believe that this proposed exemption IV.F, respectively, of this document. continual activity in these facilities meets the request of the section 418(m) Section 418(k) of the FD&C Act during pickup and drop-off hours serves petitioners. provides that section 418 ‘‘shall not as a deterrent for anyone attempting to apply to activities of a facility that are gain unauthorized access.’’ 3. Proposed § 121.5(c)—Exemption for subject to section 419’’. Section 419 of c. Proposed exemption for the holding Packing, Re-Packing, Labeling, and Re- the FD&C Act, ‘‘Standards for Produce of food. Proposed § 121.5(b) would labeling of Food Safety,’’ requires FDA to establish by regulation ‘‘science-based minimum exempt from the requirements in Proposed § 121.5(c) would exempt standards for the safe production and proposed part 121 the holding of food, from the requirements in proposed part harvesting of those types of fruits and except the holding of food in liquid 121 the packing, re-packing, labeling, or vegetables, including specific mixes or storage tanks. This provision is broader re-labeling of food where the container categories of fruits and vegetables, that in scope than exemptions in proposed that directly contacts the food remains §§ 117.5(j) and 117.7 in the PC proposed are raw agricultural commodities for intact. As discussed in section V.C.2 of which [FDA] has determined that such rule, and would exempt, for example, this document, based on an analysis of storage of whole grains, shell eggs, fruits standards minimize the risk of serious the vulnerability assessments that FDA adverse health consequences or death.’’ and vegetables, and packaged foods has conducted using the (including packaged milk and orange Section 419(h) of the FD&C Act provides CARVER+Shock methodology, we that section 419 ‘‘shall not apply to juice). It would not exempt, for identified four key activity types (Bulk example, storage in bulk storage tanks of activities of a facility that are subject to liquid receiving and loading; Liquid section 418.’’ milk or liquid orange juice. storage and handling; Secondary As discussed in section V.C.2 of this Establishments that are exempt from ingredient handling; and Mixing and document, based on an analysis of the registration under section 415 of the similar activities) as production vulnerability assessments that FDA has FD&C Act as ‘‘farms’’ would not be processes that require focused conducted using the CARVER+Shock subject to section 418 of the FD&C Act methodology, we identified four key mitigation strategies. We are not aware when conducting activities within the activity types (Bulk liquid receiving and of activities performed during the farm definition. Farm mixed-type loading; Liquid storage and handling; packing, re-packing, labeling, or re- facilities would be subject to section 418 Secondary ingredient handling; and labeling of food where the immediate of the FD&C Act when conducting those Mixing and similar activities) as package or container of the food remains activities that trigger the section 415 production processes that require intact that fit within any of these four registration requirement. We have focused mitigation strategies. With the key activity types. tentatively concluded that exception of the holding of food in As discussed in section V.A of this Congressional intent regarding the reach liquid storage tanks, which is not document, the proposed rule would not of section 418(k) of the FD&C Act is included in the proposed exemption, we require a facility that chooses to identify unambiguous in that section 418(k) are not aware of activities performed its actionable process steps under directly limits the exemption to during the holding of food that fit proposed § 121.30(a) to implement activities of the facility that are subject within any of these four key activity focused mitigation strategies for a food to section 419 of the FD&C Act. We have types. process that does not include any of the also tentatively concluded that we We acknowledge that our proposed four key activity types. Even without the should include a provision exemption in § 121.5(b) is not identical exemption, a facility that conducts implementing section 418(k) of the to the exemption in section 418(m) of packing, re-packing, labeling, or re- FD&C Act in the proposed regulation to the FD&C Act. However, as explained labeling activities would be able to establish by regulation the reach of the above, the holding of food that would be conclude that it has no key activity exemption. Therefore, in proposed exempt does not include any of the four types and, therefore, would not be § 121.5(d), we are proposing that key activity types associated with required to implement focused proposed part 121 would not apply to actionable process steps under proposed mitigation strategies. However, without activities of a facility that are subject to § 121.130(a). Consequently, even an exemption, under proposed section 419 of the FD&C Act (Standards without an exemption, this holding of § 121.130, such a facility would be for Produce Safety). food would not require the required to perform a written At the time FDA developed the farm implementation of focused mitigation assessment to make this determination. definition and its interpretations of that strategies under proposed § 121.130(a) We have tentatively concluded that definition, the practical impact of an to protect food against intentional requiring such an assessment is activity’s classification as inside or adulteration. The only requirement unnecessary. Consequently, we propose outside that definition was limited to related to holding activities would be to exempt the packing, re-packing, the potential to trigger the section 415 for a written assessment that would labeling, or re-labeling of food where the registration regulations and the section conclude that no focused mitigation container that directly contacts the food 414 recordkeeping regulations. With the

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advent of FSMA, the scope of the farm that analysis, we proposed, in proposed implement focused mitigation strategies definition has taken on more § 117.5(i), to exempt certain facilities under a HACCP-like system to address importance because, for example, engaged in the manufacturing, intentional adulteration related to activities within the farm definition are processing, packing, or holding of terrorism. In summary, this proposed not subject to section 418 of the FD&C alcoholic beverages and other food. rule would require a facility to Act, but activities outside the farm Consistent with that analysis, we are implement focused mitigation strategies definition are subject to section 418. proposing similar exemptions related to if one or more of four key activity types Therefore, FDA proposed to clarify and alcoholic beverages in this proposed are applicable to its food operation or if adjust the scope of the farm definition, rule on focused mitigation strategies for a facility conducts its own vulnerability including the classification of the protection of food against assessment and identifies actionable manufacturing, processing, packing, and intentional adulteration caused by acts process steps for significant holding activities relevant to that of terrorism. vulnerabilities in its food operation. definition, in the proposed preventive We have tentatively concluded that The identification of a production controls regulations for human food. In we should include a provision step for a food as necessitating focused section VIII.D of the PC proposed rule, implementing section 116 of FSMA in mitigation strategies is premised upon we described a set of organizing the proposed rule to establish by an analysis, based on CARVER+Shock principles that would form the basis for regulation the reach of the provision. methodology, that an attack at these our proposal for classifying activities to We request comment on our points in the production of a food more accurately reflect the scope of interpretation of section 116 of FSMA, would likely result in an outcome that activities traditionally conducted by described in section X.C.7 of the PC is consistent with our understanding of farms and to allow for more certainty proposed rule, and its application to the the goal of terrorist organizations (i.e., among industry with regard to how their proposed exemption in § 121.5(e). maximizing adverse public health impacts and, to a lesser extent, activities will be regulated. 6. Proposed § 121.5(f)—Exemption for economic disruption) (Ref. 54). For Food for Animals 5. Proposed § 121.5(e)—Exemption for human foods, our analyses show the Alcoholic Beverages Proposed § 121.5(f) would exempt potential for significant human Proposed § 121.5(e)(1) would provide from the requirements of proposed part morbidity and mortality should that proposed part 121 does not apply 121 the manufacturing, processing, intentional adulteration occur at any with respect to alcoholic beverages at a packing, and holding of food for animals one or more of these points in a food facility that meets the following two other than man. In the Animal Food PC operation. (Significant economic harm conditions: (i) Under the Federal proposed rule, we proposed to require is also likely, related to the human Alcohol Administration Act (27 U.S.C. that facilities that manufacture, process, morbidity and mortality as well as 201 et seq.) or chapter 51 of subtitle E pack, or hold animal food and that are disruption in the food supply as a result of the Internal Revenue Code of 1986 not otherwise covered by certain of loss of consumer confidence in its (26 U.S.C. 5001 et seq.) the facility is exemptions, design and implement a safety.) In contrast, for animal food, our required to obtain a permit from, system of preventive controls to address analysis shows only minimal potential register with, or obtain approval of a food safety issues. In that proposed for human morbidity or mortality as a notice or application from the Secretary rulemaking, we tentatively concluded result of attacks at key activity types or of the Treasury as a condition of doing that hazards associated with intentional other points in an animal food business in the United States, or is a adulteration would likely require operation. Significantly, our foreign facility of a type that would different kinds of controls and would be CARVER+Shock vulnerability require such a permit, registration, or best addressed in a separate rulemaking. assessments of animal food have had to approval if it were a domestic facility; We also requested comment in that focus entirely on economic and (ii) Under section 415 of the Federal rulemaking on whether to include in consequences because of the lack of Food, Drug, and Cosmetic Act (21 U.S.C. those regulations potential hazards that potential for human morbidity and 350d) the facility is required to register may be intentionally introduced for mortality. as a facility because it is engaged in economic reasons, which we refer to as In considering whether to provide an manufacturing, processing, packing, or economically motivated adulteration, a exemption related to animal food, we holding one or more alcoholic type of intentional adulteration. Our evaluated three types of possible attack beverages. current thinking regarding economically scenarios: (1) Incorporation of a Proposed § 121.5(e)(2) would provide motivated adulteration is discussed in contaminant into feed to be used for that proposed part 121 does not apply section IV.F of this document. muscle meat-producing animals; (2) with respect to food other than alcoholic Section 418(m) of the FD&C Act incorporation of a contaminant into feed beverages at a facility described in authorizes FDA to exempt or modify the to be used for egg-producing or milk- paragraph (e)(1) of this section, requirements for compliance with producing animals; and (3) provided such food: (i) Is in section 418 with regard to facilities that incorporation of a contaminant into pet prepackaged form that prevents any engage solely in the production of food. With regard to the two former direct human contact with such food; animal food. Further, section 420(c) of scenarios, we are not aware of and (ii) Constitutes not more than 5 the FD&C Act requires that regulations contaminants that could be incorporated percent of the overall sales of the that FDA issues under that section into feed at levels that would not facility, as determined by the Secretary apply only to food for which there is a produce noticeable clinical signs and/or of the Treasury. high risk of intentional contamination. mortality in animals but would result in In section X.C.7 of the PC proposed In section IV.A of this document, we significant human morbidity or rule, we explain in detail our discuss how FDA is proposing to mortality among consumers that interpretation of section 116 of FSMA implement the provisions of sections subsequently eat the meat, eggs or milk and our consideration of hazards and 418 and 420 of the FD&C Act with (Ref. 55). While contaminants can preventive controls for the regard to circumstances under which a increase the risk of chronic disease, manufacturing, processing, packing, and facility subject to either of these sections such as cancer, among consumers (Ref. holding of alcoholic beverages. Based on would be required to have and 56), such an outcome is not consistent

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with our understanding of the goals of Proposed § 121.126(a) would require • The written procedures for terrorist organizations, which include a that the owner, operator, or agent in monitoring as required by proposed more immediate impact. We recognize charge of a facility prepare, or have § 121.140(a); that such an attack could result in prepared, and implement a written food • The written corrective action significant economic disruption because defense plan. To make clear that the procedures as required by proposed of the loss of consumer confidence in written plan is related to food defense § 121.145(a)(1); and the safety of the food supply. While rather than to other plans a facility may • The written verification procedures important, attacks of that nature fall have (such as quality control plans or as required by proposed § 121.150(e). significantly below those involving food safety plans), for purposes of this Although we are proposing to require human morbidity and mortality when rulemaking, we have designated the that the contents of food defense plan placed on a scale of risk with regard to ‘‘written plan’’ to be a ‘‘food defense include only the specific elements targeting by terrorist organizations. plan.’’ A written food defense plan is described above, the food defense plan Regarding the third attack scenario essential for a facility covered by this can be used as a resource for facilities (incorporation of a contaminant into pet rule to implement the plan consistently, to capture additional food defense- food), we are aware of contaminants that train its employees, and periodically related information. For example, could be incorporated into feed or pet reanalyze and update the plan. It is also facilities may also wish to include food that could result in significant essential to auditors, and to inspectors, information, such as process flow animal (including pet) morbidity and in the same way written plans are diagrams, an evaluation of broad mortality, including some which could essential to ensuring food safety. A mitigation strategies, emergency contact result in secondary infectious spread of written food defense plan addressing information, crisis management plans, disease (because some infectious agents vulnerabilities associated with action plans for implementation of can be transmitted orally as well as intentional adulteration is analogous to broad mitigation strategies, results of through aerosol). Again, such attacks a written HACCP or food safety plan for supplier audits, and other documents, could be significant from an economic hazards associated with unintentional analysis, reviews, or information the facility finds relevant to its food defense and societal standpoint. However, the contamination. program. FDA has developed and risk that they pose with regard to Proposed § 121.126(a) would provide publicly released the user-friendly targeting by terrorist organizations flexibility for the owner, operator, or FDPB software tool that can be used to appears to be significantly lower than agent in charge of the facility to either assist a facility to develop a robust food those involving human morbidity and prepare the written food defense plan or mortality. We request comment on this defense plan. This free tool is available have that plan prepared, in whole or in on the FDA Web site at http:// assessment of risk. part, on its behalf. In addition, proposed Therefore, notwithstanding the likely www.fda.gov/Food/FoodDefense/ § 121.126 would provide flexibility for ToolsEducationalMaterials/ presence of one or more of the four key facilities in the development of their activity types in the production of many ucm349888.htm. food defense plans by allowing facilities Proposed § 121.126, if finalized, animal foods, we have tentatively to group food types or production concluded that animal food (regardless would establish a requirement for every method types if the vulnerabilities, facility covered by this rule to have its of whether it is produced at a facility focused mitigation strategies, and other solely engaged in the production of own written food defense plan. Like the required procedures, such as food safety plan, this facility-based animal food or at a facility engaged in monitoring, are essentially identical. the production of both animal and nature of the written food defense plan Proposed § 121.126(a) would require human food) does not involve is consistent with the overall framework that the owner, operator, or agent in significant vulnerabilities that require of section 418 of the FD&C Act, which charge of a facility implement the focused mitigation strategies under is directed to a facility rather than, for written food defense plan. Our proposed section 418 of the FD&C Act and is not example, a corporate entity that may requirement to develop and implement at high risk for intentional adulteration have multiple facilities. a food defense plan, which includes the related to terrorism under section 420 of Proposed § 117.126(c) of the PC identification of actionable process the FD&C Act. Consequently, we are proposed rule would require that the steps and implementation of focused proposing to exempt the manufacturing, food safety plan be prepared by (or its mitigation strategies, reflects our processing, packing, and holding of food preparation overseen by) a qualified tentative conclusion that such actions for animals other than man. We request individual (See the discussion in are measures necessary to prepare and comment on these tentative section XII.A.4 of the PC proposed rule). protect the food supply from intentional conclusions. We are proposing to require that the adulteration caused by acts of terrorism. vulnerability assessment be performed C. Food Defense Measures Proposed § 121.126(a) implements by an individual qualified by experience In subpart C of proposed part 121, sections 418(b), (c), (d), (e), (f), and (h), and/or training only when facilities FDA is proposing various food defense and 420(b) of the FD&C Act. We seek choose to identify actionable process measures, including requirements for a comment on these tentative steps in their food defense plans using food defense plan, identification of conclusions. the provisions of proposed § 121.130(b), actionable process steps, b. Proposed § 121.126(b)—Contents of whereby they would perform their own implementation of focused mitigation a food defense plan. Proposed vulnerability assessment. Our proposal strategies and related monitoring, § 121.126(b)(1) through (b)(5) would is based on two considerations. First, we corrective actions, and verification, and require that the contents of a food anticipate that most facilities will training of certain personnel. We defense plan include: develop their food defense plan using • discuss the provisions of proposed The written identification of the procedure in proposed § 121.130(a) subpart C in this section. actionable process steps as required by for identification of actionable process proposed § 121.130; steps. Here, FDA has performed much of 1. Food Defense Plan • The written focused mitigation the scientific analysis required and a. Proposed § 121.126(a)— strategies as required by proposed identified the key activity types (see Requirement for a Food Defense Plan. § 121.135(b); section V.C.2 of this document for

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further discussion). Second, we believe and loading, (2) Liquid storage and assessment leading to that identification that the identification of focused handling, (3) Secondary ingredient be written. A written assessment of mitigation strategies, and the handling, and (4) Mixing and similar whether the facility has one or more of monitoring, corrective action and activities. In this proposed rule we have the key activity types (under proposed verification activities to implement modified the activity type names and § 121.130(a)) or a written vulnerability them requires less technical expertise descriptions from those in the April assessment (under proposed than required for preventive controls 2013 Report for clarity. § 121.130(b)) would help the facility and implementation procedures for Providing these key activity types to organize its assessment, and fully those controls. The former usually facilities for their use in identifying understand the nature of the involve focused mitigation strategies to actionable process steps and developing vulnerabilities. In addition, it is limit access to specific steps in the focused mitigation strategies provides essential for auditors and inspectors to production process with simple visual some advantages over other approaches assess the adequacy of the facility’s checks to monitor them, while the latter that we might have taken, such as assessment. This written identification often involve scientific studies to identifying points in the production of of actionable process steps would also establish critical limits with process specific foods at increased risk for be essential during reanalysis of the control instruments to monitor them. intentional adulteration caused by an food defense plan, as would be required Proposed § 121.126(b) implements acts of terrorism, or requiring each by proposed § 121.150(d). Such a sections 418(h) and 420(b)(2) of the facility to perform its own vulnerability written document would also be useful FD&C Act. assessment. First, publicly providing a for training purposes as a tool to make We seek comment on our proposed list of key activity types does not employees aware of the elements of the provisions related to the written food disclose sensitive information, as might facility’s food defense plan. defense plan and its contents. be the case if we provided The written identification of 2. Identification of Actionable Process CARVER+Shock scores derived from actionable process steps must include Steps our vulnerability assessments for the justification for whatever conclusion process steps for specific foods. the owner, operator, or agent in charge a. FDA’s vulnerability assessments Second, providing a list of key of a facility reaches. Proposed § 121.130 and FDA-identified key activity types. activity types rather than requiring would not limit the requirement for a As noted in section II.B of this facilities to perform their own facility- written identification of actionable document, under the SPPA Initiative, specific vulnerability assessments process steps to only those FDA, along with USDA, FBI, and DHS, relieves the burden upon the facility to circumstances where the owner, conducted vulnerability assessments on assemble a team of individuals with the operator, or agent in charge of a facility products and processes in the food and diverse expertise needed to properly identifies one or more actionable agriculture sector. After conclusion of self-score the steps in their process process steps. Rather, under proposed the initiative, FDA continued (using the CARVER+Shock § 121.130, a written analysis would be conducting assessments for products Vulnerability Assessment software tool required even if the conclusion of the and processes not previously assessed. or another suitable tool). When we analysis is that there are no actionable To implement section 420(a)(1)(A), FDA performed vulnerability assessments process step. combined and analyzed data from a during the SPPA initiative our teams If a facility chooses to identify subset of these assessments (i.e., those included individuals with expertise in actionable process steps using the relevant to the food manufacturing and the production of the food under study, procedure in proposed § 121.130(a), the distribution segments of the food law enforcement, food science, food written documentation would not need system) and identified activities which regulatory systems, and public health. to include the procedures for assessing consistently ranked high for We expect that such an effort is likely the vulnerabilities associated with vulnerability to intentional adulteration. beyond the capacity of many facilities. identified actionable process steps. If a FDA published the results of this Further, by providing a list of key facility chooses to identify actionable analysis in April, 2013 (April 2013 activity types, we eliminate the need to process steps using the procedure in Report) (Ref. 54). identify a CARVER+Shock score, for proposed § 121.130(b), the written CARVER+Shock methodology is a example, as the threshold for the identification of actionable process tool for assessing the vulnerabilities implementation of focused mitigation steps must include information about within a food system and determining strategies. This is important because the appropriate methods used to the most vulnerable points, and CARVER+Shock scores are somewhat conduct the vulnerability assessment focusing resources on protecting the subjective and difficult to correlate and identify actionable process steps, most susceptible points. Using the across food types, making identification and the experience and training of the CARVER+Shock methodology, FDA, in of a universal threshold score person(s) who conducted that collaboration with other U.S. challenging. assessment (see also discussion in government partners conducted over 50 b. Proposed § 121.130—Requirement section V.C.2.d of this document). vulnerability assessments on a wide for written identification of actionable Proposed § 121.130 implements range of food products and processes. process steps. Proposed § 121.130 sections 418(b)(2), 418(b)(3), 420(a)(1), Based on these assessments, we would require that the owner, operator, and 420(b)(1) of the FD&C Act. identified the processing steps with the or agent in charge of a facility identify c. Proposed § 121.130(a)— greatest vulnerability to intentional any actionable process steps, using the Identification of actionable process adulteration caused by acts of terrorism. procedures in either proposed steps using FDA-identified key activity Through this review, we determined § 121.130(a) or proposed § 121.130(b). A types. Proposed § 121.130(a) would that the processing steps we identified facility would be required to follow specify the first of two procedures by fit into one of four groups of activities either one of the two specified which the proposed requirement for occurring at those processing steps. We procedures, but not both. identification of actionable process refer to these as ‘‘key activity types.’’ Proposed § 121.130 would also steps in proposed § 121.130 can be met, The key activity types that we have require that the identification of i.e., using the FDA-identified key identified are: (1) Bulk liquid receiving actionable process steps and the activity types.

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Proposed § 121.130(a) would state reached for virtually all steps that key activity types during reanalysis. We that the owner, operator, or agent in involve mixing, blending, request comment on whether there are charge of a facility must assess, for each homogenizing, or grinding because specific process steps for specific type of food manufactured, processed, these kinds of process steps generally: products that otherwise fit within one of packed or held at the facility, whether (1) Present an opportunity for access to the four key activity types but for which the facility has one or more of the the product at or just prior to the access to the equipment is not possible following key activity types and identify equipment (e.g., in-feed conveyor); and (i.e., because the equipment is fully the actionable process steps associated (2) would cause a contaminant, if enclosed, with no access ports). with any key activity types present: intentionally added, to be distributed If the owner, operator, or agent in 1. Bulk liquid receiving and loading— into the food. We expect this conclusion charge determines that the food a step in which a bulk liquid is received to be reached regardless of whether the operation does not involve any of the and unloaded from an inbound facility may already have mitigation key activity types, there would be no conveyance or loaded into an outbound strategies in place to impede access to need to identify actionable process conveyance where a contaminant can be the mixing tank (e.g., a ‘‘buddy system’’ steps. Such a facility, however, would intentionally introduced and, if it is, it that ensures that at least two employees still be required to document its finding is likely that the contaminant will be were present at the mixing tank at all that none of the key activity types apply distributed throughout the liquid due to times or a lock on the mixing tank to its food processes, under proposed sloshing, movement, or turbulence access ports). The presence of mitigation § 121.130. The documentation would be caused by the receiving and unloading strategies should not be considered a part of the written food defense plan or loading activity; when assessing whether a facility has a required under proposed § 121.126. 2. Liquid storage and handling—a process step that involves one of the key Such a facility would continue to be step in which a liquid is contained in activity types. Any existing mitigation subject to the requirement for reanalysis bulk storage tanks or in holding, surge, strategies and their adequacy to of a food defense plan, as proposed in or metering tanks where a contaminant significantly minimize or prevent the § 121.150(d). can be intentionally introduced and, if significant vulnerability should be Proposed § 121.130(a) would require it is, it is likely that the contaminant considered at a later step when that the process of identification of will be distributed into the food; identifying appropriate focused actionable process steps be done ‘‘for 3. Secondary ingredient handling—a mitigation strategies, in accordance with each type of food manufactured, staging, preparation, addition, or rework proposed § 121.135. processed, packed, or held at the step where a contaminant can be facility.’’ The vulnerability of a food to intentionally introduced into a We acknowledge the possibility, intentional contamination may differ relatively small amount of ingredient or although not likely, that circumstances based on the type of food and associated rework and, if it is, it is likely that the may exist where access at or just prior process, practices, and conditions at the contaminant will be distributed into a to the equipment is not possible (i.e., facility. Therefore, we are proposing larger volume of food; and because the equipment is fully enclosed, that the facility assess whether it has 4. Mixing and similar activities—a with no access ports), and that in such any of the key activity types for each step, such as mixing, blending, a situation this process step would not type of food that is manufactured, homogenizing, or grinding where a be identified as fitting within the key processed, packed, or held at that contaminant can be intentionally activity type. For example, the owner of facility. A facility may find that its introduced and, if it is, it is likely that the same facility may assess a second operation related to one type of food the contaminant will be distributed into mixing tank that is part of an entirely manufactured at that facility involves the food. closed system, with no direct access one or more of the key activity types, The owner, operator, or agent in points into the system, such that an but all other types of food manufactured charge would be required to assess individual attempting to access this at that facility do not involve any of the whether the facility has a food process mixing tank would likely cause a major key activity types. In such an instance, that involves any one or more of the disruption to the line, foiling any actionable process steps would need to specified four key activity types. If the attempted intentional adulteration. be identified and focused mitigation food process is found to involve any key Based on this assessment, the owner strategies implemented only for the food activity types, the owner, operator, or may conclude that the enclosed nature type that involved the key activity agent would be required to identify of this second mixing tank renders the types. actionable process step(s) that are product inaccessible at this step and, Description of key activity types—As associated with each key activity type therefore, it does not fit within the key discussed in section V.C.2.a of this that is present. activity type. In this circumstance, there document, our vulnerability For example, based on proposed would be no requirement to identify an assessments revealed four key activity § 121.130(a), a facility may identify a actionable process step associated with types that most commonly rank high: mixing tank as involving the key this mixing tank (in which case, there Bulk liquid receiving and loading; activity type, Mixing and similar also would be no requirement to Liquid storage and handling; Secondary activities, in its operation because the implement a focused mitigation strategy ingredient handling; and Mixing and mixing tank has an unsecured lid and at this step). Under proposed § 121.130, similar activities. We have tentatively several sample ports which provide the owner would be required to concluded that the presence of any of direct access to the food product and document the basis for the these four key activity types in a food because a contaminant can be determination that the second mixing operation indicates a significant introduced into the tank through the lid tank does not fit within the key activity vulnerability for intentional or one of the sampling ports and, if it type. The second mixing tank would contamination caused by acts of is, the contaminant would be continue to be subject to the terrorism. Based on our assessments, we distributed into the food. The owner requirement for reanalysis of a food believe that these four key activity types would conclude that the mixing tank is defense plan, as proposed in capture the significant vulnerabilities in an actionable process step. We would § 121.150(d) and the facility would a food operation. However, although expect that this conclusion would be consider the applicability of the four generally unlikely, a vulnerability

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assessment of a specific food at a a liquid is contained in bulk storage ingredient to the production area in specific facility conducted under tanks or in holding, surge, or metering advance of being added into the primary proposed § 121.130(b) may identify tanks where a contaminant can be product stream. ‘‘Preparation’’ refers to significant vulnerabilities at actionable intentionally introduced and, if it is, it any act of measuring, weighing, process steps that are not associated is likely that the contaminant will be premixing, or otherwise manipulating with one of these four key activity types. distributed into the food. This key the ingredient prior to addition to the We seek comment on our tentative activity type refers to any processing product stream. ‘‘Addition’’ refers to conclusion. step where a liquid ingredient or any act of physically adding ingredient Proposed § 121.130(a)(1) would intermediate or finished liquid product directly into the product stream or into identify ‘‘Bulk liquid receiving and is stored in either bulk storage tanks or surge or meter hoppers in order to loading’’ as a key activity type, based on smaller secondary, non-bulk holding deliver the ingredient into the product our finding that this activity type tanks or surge tanks and for which there stream. ‘‘Rework’’ refers to clean, commonly ranked high in our is an opportunity for a contaminant to unadulterated food that has been vulnerability assessments. Proposed be intentionally introduced into the removed from processing for reasons § 121.130(a) would describe this key food. Bulk liquid storage refers to any other than insanitary conditions or that activity type as a step in which a bulk storage silo or tank where liquid has been successfully reconditioned by liquid is received and unloaded from an product may be stored prior to reprocessing and that is suitable for use inbound conveyance or loaded into an introduction into the product stream or as food. Staging, preparation, addition, outbound conveyance where a prior to loading for outbound shipping. and rework involving secondary contaminant can be intentionally Non-bulk tanks can be used to store ingredients are key activities because a introduced and, if it is, it is likely that non-bulk liquid ingredients (e.g., fats, contaminant added to a relatively small the contaminant will be distributed oils, vitamin mixes, and sweeteners), volume of product would be distributed throughout the liquid due to sloshing, hold liquid product for sample testing into the large product flow as the movement, or turbulence caused by the and other quality control activity, or to ingredient or rework is combined with receiving and unloading or loading control flow rates of liquid ingredients the other components of the food. activity. Bulk liquid receiving refers to or product through the production Secondary ingredient staging, the inbound movement of liquid system. Non-bulk storage tanks also preparation, addition, and rework are product into a facility for its use in the include tanks or totes where the tamper generally open and accessible and that food production process, whereas bulk evident seals are opened and the accessibility is an inherent component liquid loading refers to the outbound container itself is used for holding. Both of the activity. Thus, these key activities movement of liquid product from a categories of liquid storage can be provide a potential point of access facility for further processing or use by considered key processing steps because where a contaminant could be an end customer/consumer. Examples of if a contaminant were successfully introduced into the product stream. products that may be received or loaded introduced, there is a high probability of Proposed § 121.130(a)(4) would in bulk include juices, high fructose a contaminant mixing within the liquid identify ‘‘Mixing and similar activities’’ corn syrup and other sweeteners, milk, due to the agitation commonly used to as a key activity type, based on our animal fats, syrups, and vegetable oils. prevent separation within the liquid finding that the activities commonly Bulk liquid receiving and loading medium. Access necessary for the ranked high in our vulnerability refers to any processing step where a assessments. Proposed § 121.130(a) introduction of a contaminant is liquid ingredient is being received and would describe this key activity type as generally available through hatches, unloaded at a facility or a liquid a step, such as mixing, blending, sample ports, and the container lid (in intermediate or finished product is homogenizing, coating, glazing, or the case of a tanker or tote for which the being loaded into an outbound shipping grinding where a contaminant can be tamper evident seal has been broken). transport vehicle and for which there is intentionally introduced and, if it is, it an opportunity for a contaminant to be Proposed § 121.130(a)(3) would is likely that the contaminant will be intentionally introduced into the food. identify ‘‘Secondary ingredient distributed into the food. This key This key activity type incorporates the handling’’ as a key activity type, based activity type refers to any processing actions of opening the transport vehicle, on our finding that this activity type step where there is an opportunity for attaching any pumping equipment or commonly ranked high in our a contaminant to be intentionally hoses, and opening any venting hatches. vulnerability assessments. Proposed introduced into the food, and the The characteristics associated with § 121.130(a) would describe this key primary purpose or result of the these activities are such that there is a activity type as the staging, preparation, processing step is: (1) Coating, i.e., to high probability of a contaminant, if addition, or rework step where a layer a powder or liquid onto the intentionally added, mixing within the contaminant can be intentionally surface of a product, such as a batter, liquid, due to significant sloshing, introduced into a relatively small breading, glazing or flavoring; (2) movement, and turbulence associated amount of ingredient or rework and, if mixing, i.e., to blend a powder, dough, with the receiving or loading activity. In it is, it is likely that the contaminant or liquid ingredient together; (3) addition, the need for worker activity will be distributed into a larger volume grinding, i.e., to reduce the particle size associated with these processing steps of food. This key activity type refers to of a solid ingredient or mass to a smaller provides access to hoses, the transport any processing step where ingredients granularity; or (4) homogenizing, i.e., to vessel, and potentially the product as it (either dry or liquid) are manipulated reduce the particle size of an ingredient is being received or loaded. prior to or during addition to the and disperse it throughout a liquid. Proposed § 121.130(a)(2) would product stream by human contact and These are key activities because a identify ‘‘Liquid storage and handling’’ for which there is an opportunity for a potential contaminant successfully as a key activity type, based on our contaminant to be intentionally added at one of these steps would finding that this activity type ranked introduced into the food. ‘‘Staging’’ generally be readily dispersed high in our vulnerability assessments. refers to the process of opening the throughout the product. Further, access Proposed § 121.130(a) would describe tamper evident packaging of a is generally available through access this key activity type as a step in which secondary ingredient and moving the ports, lids, and in-feed conveyors or

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flumes. Examples of equipment the food from intentional adulteration eliminate or remove agents of concern; associated with these activities include: caused by acts of terrorism. As noted (3) the degree of physical access to Mixers, blenders, homogenizers, above, when we performed vulnerability product; (4) the ability of an aggressor cascade breaders, mills, grinders, and assessments during the SPPA initiative to successfully contaminate the product; pulverizers. our teams included individuals with and (5) the volume of product impacted. We seek comment on these key expertise in the production of the food This evaluation should also include the activity types, and whether they are under study, law enforcement, food rationale or justification for which each appropriate to include and science, food regulatory systems, and process steps were and were not whether there are additional activities public health. While we are not identified as significant vulnerabilities; that present significant vulnerability to proposing to specify the particular and intentional adulteration caused by acts training or experience requirements of • Identifying actionable process of terrorism. the individual(s) qualified to conduct steps—for identified significant Proposed § 121.130(a) implements such vulnerability assessments, or the vulnerabilities, indicate where sections 418(a) through (c) and particular methods that must be used to actionable process steps exist in the 420(a)(1)(A) of the FD&C Act. conduct these assessments, facilities food process and where associated d. Proposed § 121.130(b)— choosing this procedure in proposed focused mitigation strategies would be Identification of actionable process § 121.130(b) would be required to required to be implemented, under steps by conducting a vulnerability employ appropriate methods and use a proposed § 121.135. assessment. Proposed § 121.130(b) qualified individual(s) to conduct a Facilities that choose this alternative would provide the second of two robust and scientifically sound may need assistance from outside options for identification of actionable vulnerability assessment of the facility’s experts who are knowledgeable in food process steps. Proposed § 121.130(b) food operation. FDA’s resources defense and vulnerability assessments. would specify that the owner, operator, available online, such as the Some facilities may not have the or agent in charge of a facility must CARVER+Shock Vulnerability resources or the necessary expertise on conduct or have conducted, for each Assessment software tool and the FDPB site and expert advice may be obtained food type manufactured, processed, software tool may be helpful. when necessary from other sources, packed or held at the facility, an Finally, as in the case of proposed such as trade and industry associations, evaluation to identify and prioritize the § 121.130(a), proposed § 121.130(b) independent experts, and regulatory points, steps, and procedures in a food would require that the process of authorities. operation based on their vulnerability to identification of actionable process We seek comment on the need for, intentional adulteration and to identify steps be done ‘‘for each type of food and appropriateness of, proposed actionable process steps. manufactured, processed, packed, or § 121.130(b), including whether, in a Proposed § 121.130(b) would provide held at the facility.’’ See discussion in final rule, we should specify the flexibility to the owner, operator, or section V.C.2 of this document. particular qualifications of individual(s) agent in charge of a facility covered by Elements of a Facility-Specific performing the vulnerability assessment this rule to conduct, or have conducted, Vulnerability Assessment—The or the methods that must be used under their own vulnerability assessment of elements of an approach to conducting this alternative procedure, and whether the food operations at a facility, rather a facility-specific vulnerability the vulnerability assessment elements, than assessing their food operation assessment are: we described previously, provide against the FDA-identified key activity • Planning to conduct a vulnerability sufficient direction regarding types. We are proposing that a assessment—collect and evaluate appropriate methodology. vulnerability assessment conducted appropriate background information on Proposed § 121.130(b) implements under proposed § 121.130(b) must be biological, chemical, physical, and sections 418(a) to (c) and 420(a)(1)(A) of performed by an individual(s) qualified radiological agents of concern, such as the FD&C Act. by experience and/or training using those found in the CDC’s Select Agents 3. Focused Mitigation Strategies appropriate methods. Training or job and Toxins List (Ref. 57); experience is essential to the effective • Assembling the vulnerability a. Requirements of sections 418 and evaluation of vulnerabilities and assessment team—identify appropriate 420 of the FD&C Act. Section 418(c)(2) identification of actionable process individuals within the organization to of the FD&C Act, in relevant part, steps. Only a trained individual or assist in the vulnerability assessment specifies that the owner, operator, or individual qualified by job experience process. This may include personnel agent in charge of a facility shall using appropriate methods would be working in the areas of security, food identify and implement preventive capable of effectively conducting a safety/quality assurance or control, controls to provide assurances that vulnerability assessment, including human resources, operations, hazards identified in the hazard analysis assessing the various points, steps, or maintenance, and other individuals conducted under section 418(b)(2) of the procedures in a food process; deemed necessary to facilitate the FD&C Act will be significantly identifying and prioritizing those formation of a vulnerability assessment; minimized or prevented and addressed, points, steps, or procedures in a food • Developing a process flow consistent with section 420 of the FD&C process that are susceptible to diagram—list out each of the steps in Act, as applicable. Section 418(c)(1)(3) intentional contamination; and the food process to be evaluated; of the FD&C Act, in relevant part, identifying actionable process steps • Identifying significant specifies that the preventive controls where food defense measures are vulnerabilities—evaluate each process must also provide assurances that the essential to address significant step to prioritize vulnerabilities and food manufactured, processed, packed, vulnerabilities. Our proposed definition identify significant vulnerabilities. For or held by such facility will not be of significant vulnerability (in proposed each process step, the evaluation should adulterated under section 402 of the § 121.3), too, reflects the need for a consider, at a minimum: (1) The FD&C Act. Section 418(h) of the FD&C qualified individual to make such potential public health impact if a Act requires that the owner, operator, or assessments where focused mitigation contaminant were added; (2) whether agent in charge of a facility prepare a strategies would be necessary to protect downstream processing steps would written food safety plan that, among

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other things, identifies the preventive food safety contexts. An act of inventory procedures; key security controls within the plan. Section 420(b) intentional adulteration caused by procedures, PINs or passwords; of the FD&C Act requires FDA to issue terrorism, historically, has been a rare procedures to restrict personal items regulations to protect against the event. In the vast majority of cases, the from all food production areas; intentional adulteration of food. Such failure to properly implement a focused procedures requiring IDs and uniforms regulations are to specify appropriate mitigation strategy would not be to be returned when a person’s science–based mitigation strategies or expected to result in intentional employment ends; and supplier measures to prepare and protect the adulteration. With intentional verification or certification procedures; food supply chain at specific vulnerable adulteration, adulteration of food and (5) crisis management planning, points, as appropriate (section 420(b)(2) requires not just the opportunity for a such as maintenance of updated of the FD&C Act). contamination event (i.e., failure of a emergency contact information, Section 418(o)(3) of the FD&C Act mitigation strategy to limit access to an procedures for responding to reported defines preventive controls as ‘‘those actionable process step), but also threats, and establishment of a risk-based, reasonably appropriate someone with intent to cause harm at designated food defense leadership procedures, practices, and processes that same moment. As such, it is team. that a person knowledgeable about the unlikely that a deviation from the Broad mitigation strategies, by nature, safe manufacturing, processing, packing, provisions of this proposed rule would are generally applicable to a facility, or holding of food would employ to necessitate a recall. In contrast, the regardless of the type of food being significantly minimize or prevent the failure to properly implement a processed, and, as such, are not targeted hazards identified under the hazard preventive control for a food safety to a specific processing step in a food analysis conducted under [section hazard (for example, where proper cook operation. Broad mitigation strategies 418(b) of the FD&C Act] and that are temperatures are not reached in a address facility-wide vulnerabilities that consistent with the current scientific process) would be expected to more may present an opportunity for an understanding of safe food likely result in a situation where the attacker to access the facility and manufacturing, processing, packing or food becomes adulterated (e.g., because intentionally adulterate food. Broad holding at the time of the analysis.’’ The the pathogen reasonably likely to be mitigation strategies serve as definition provides that ‘‘those present in the raw food would not be foundational actions or procedures that procedures, practices, and processes eliminated from the food by the improve a facility’s overall defense may include the following: (A) inadequate cooking process), potentially against intentional contamination Sanitation procedures for food-contact necessitating a recall. caused by acts of terrorism. surfaces and utensils and food-contact b. General description of mitigation We are proposing to require the surfaces of equipment; (B) Supervisor, strategies. Mitigation strategies are implementation of focused mitigation manager, and employee hygiene measures taken by a facility to reduce strategies only. However, as set out in training; (C) An environmental the potential for intentional adulteration our guidance documents (Ref. 22, Ref. monitoring program to verify the of food. Based on these vulnerability 23, Ref. 24, Ref. 25, Ref. 26), we think effectiveness of pathogen controls in assessments, FDA previously developed it is prudent for facilities to review our processes where a food is exposed to a recommendations for mitigation guidance and implement those broad potential contaminant in the strategies that can be implemented, as mitigation strategies that are appropriate environment; (D) A food allergen appropriate, to minimize or prevent to minimize the risk for intentional control program; (E) A recall plan; (F) intentional contamination of food. adulteration of food. Current Good Manufacturing Practices These mitigation strategies are ii. Focused mitigation strategies. As (cGMPs) under part 110 of title 21, Code presented in our guidance documents discussed in section V.A of this of Federal Regulations (or any successor (Ref. 22, Ref. 23, Ref. 24, Ref. 25, Ref. document, we are proposing to define regulations); (G) Supplier verification 26), the CARVER+Shock Vulnerability focused mitigation strategies as those activities that relate to the safety of Assessment software tool (Ref. 29), the risk-based, reasonably appropriate food.’’ (emphasis added) MSD (Ref. 30), and the FDPB software measures that a person knowledgeable In section V.A.2 of this document, we tool (Ref. 31). FDA divides mitigation about food defense would employ to discuss our proposed definition of strategies into two types: Broad significantly minimize or prevent focused mitigation strategy and its Mitigation Strategies and Focused significant vulnerabilities identified at relationship to the definition of Mitigation Strategies. We explain each actionable process steps, and that are preventive controls in section 418(o)(3) of these types in this section of the consistent with the current scientific of the FD&C Act. We are not proposing document. understanding of food defense at the requirements for sanitation procedures, i. Broad mitigation strategies. Broad time of the analysis. hygiene training, environmental mitigation strategies are general facility- Focused mitigation strategies are monitoring, food allergen control, and level measures that are intended to specific to an actionable process step in CGMPs because these examples are minimize a facility’s vulnerability, as a a food operation where a significant relevant to food safety, but not to food whole, to potential acts of intentional vulnerability is identified. They defense. We considered proposing to contamination. Examples of broad represent reasonably appropriate require a recall plan (as we did in the mitigation strategies are: (1) Physical measures that are necessary to reduce PC proposed rule in proposed security, such as perimeter security the likelihood of intentional § 117.135(d)(4); see sections XII.C.8 and fencing, locking exterior doors, contamination caused by an act of XII.D of that document). However, we penetration alarms; (2) personnel terrorism at that process step. Focused tentatively conclude that the usefulness security, such as pre-hire background, mitigation strategies are customized to of a recall plan is greatly reduced in the reference checks, identification badges, the processing step at which they are context of preventive controls for and controlled visitor access; (3) applied, tailored to existing facility intentional adulteration. The securing hazardous materials, such as practices and procedures, and depend relationship between an implementation cleaning products, laboratory materials, on an evaluation of the vulnerabilities failure and the status of the food is and pesticides; (4) management identified in a vulnerability assessment. different in intentional adulteration and practices, such as ingredient storage When properly implemented, focused

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mitigation strategies by themselves are dependent both on the food 5. Establishing and implementing a sufficient to significantly minimize or manufactured, processed, packed, or policy for driver check-in and eliminate the chances that an attacker held at the facility and on the practices identification to help confirm driver would be successful if an act of and processes employed at that facility. identity and verify the individual is intentional adulteration were attempted We list in this section some examples of authorized, through verification of at the specific process step. Focused focused mitigation strategies that may shipping documentation or other means, mitigation strategies focus on be appropriate to implement at to deliver or pick-up the shipment and minimizing either the accessibility of an actionable process steps for each of reduce the likelihood that an attacker attacker to the product at a particular these four key activity types. While the could fraudulently pose as a driver as a process step or the opportunity for the decision of which and how many means of gaining access to the facility; attacker to successfully contaminate the focused mitigation strategies would be and product at that process step, or both. appropriate to employ at an actionable 6. Inspecting the shipping conveyance Based on our vulnerability process step is dependent upon the prior to loading bulk liquids to help assessments, we tentatively conclude physical layout and operation at a ensure that no contaminant has been that the implementation of focused specific facility, the examples presented introduced to the conveyance chamber mitigation strategies at actionable in the section immediately below that could then contaminate the product process steps in a food operation is illustrate the decision-making process to once the product is loaded. necessary to minimize or prevent the identify and determine appropriate Liquid storage and handling— significant vulnerabilities that are focused mitigation strategies at an Examples of focused mitigation identified in a vulnerability assessment actionable process step. strategies that may be appropriate (Ref. 21, Ref. 54, Ref. 58), regardless of Bulk liquid receiving and loading— include the following: the existence of broad mitigation Examples of focused mitigation 1. Controlling access to liquid storage, strategies. Although broad mitigation strategies that may be appropriate holding, surge, or metering tanks, strategies are important to further include the following: similar to the strategies that may be reduce the vulnerability for intentional 1. Controlling access to the receiving applied for controlling access to bulk contamination, they are not sufficient to or loading area, conveyances, and liquid receiving and holding; significantly minimize the risk of equipment, including hoses and 2. Ensuring that the area around intentional contamination caused by an pumping machinery, to prevent an liquid storage, holding, surge, or act of terrorism because broad unauthorized person from gaining metering tanks is free of unrelated mitigation strategies are not specific access to the food during receiving or materials, such as personal items enough, for example, to counter the loading. Access controls may include: (backpacks, purses, or packages), and actions of an attacker who has legitimate strategies to easily identify authorized other items that are not directly related access to the facility (i.e., insider attack) persons, such as color-coded uniforms to the food operation, to reduce the or an attacker who circumvents or badges; restricting conveyance likelihood of a contaminant being perimeter protections (e.g., scaling a drivers to areas away from the receiving brought into the area for introduction fence), with the goal of intentionally or loading area (e.g., restricting them to into the tank; contaminating the food. Focused a lounge or break room); securing hoses 3. Ensuring adequate lighting in and mitigation strategies, on the other hand, with locking caps or in cabinets; and around liquid storage, holding, surge or are targeted to actionable process steps ensuring that conveyance access metering tanks, similar to the strategies identified in a food operation to reduce hatches, vents, and inspection ports are the likelihood of intentional that may be applied for ensuring contamination at those process steps secured; adequate lighting at bulk liquid and, therefore, are essential to ensure 2. Ensuring adequate lighting in the receiving and loading; that appropriate food defense measures receiving or loading area, which reduces 4. Installing one-way sample ports in are taken to protect the food from the ability of an attacker to disguise his liquid storage, holding, surge, or intentional contamination caused by or her actions. Adequate lighting in and metering tanks , so that food product acts of terrorism. In contrast to broad around vulnerable areas of a food can be drawn out of the equipment but mitigation strategies, focused mitigation operation increases the likelihood that a contaminant cannot be inserted into strategies are targeted to actionable other staff will witness the actions of an the tank; process steps and, therefore, are more attacker and enable them to take steps 5. Inspecting tanks prior to filling to effective at countering an attacker who to prevent or react to contamination; help ensure that no contaminant has has legitimate access to the facility. We 3. Increasing observation of the been introduced into the empty tank have tentatively concluded that we will receiving or loading area, which reduces that could then contaminate the product continue to encourage the the ability of an attacker to disguise his once loaded; implementation of broad mitigation or her actions. For example, maximizing 6. Inspecting pumping or metering strategies on a voluntary basis, but we the line of sight by removing boxes, equipment prior to use to help ensure will require the implementation of crates, or other obstructions from the that no contaminant has been focused mitigation strategies at area; positioning quality control introduced into the equipment that actionable process steps. We request personnel in the receiving or loading could contaminate the product; comment on this tentative conclusion, area to supervise operations; or utilizing 7. Using enclosed tanks and transfer and on whether we should include, in closed-circuit TV systems or other systems to move materials to reduce the a final rule, a requirement for the monitoring devices; potential for an attacker to access the implementation of any broad mitigation 4. Verifying that seals on a shipping product and introduce a contaminant; strategies. conveyance are intact prior to receiving and iii. Examples of focused mitigation or after loading a bulk liquid to reduce 8. Positioning holding, surge, or strategies for FDA-identified key activity the likelihood that the shipping metering tanks to increase visibility, types. For the FDA-identified key conveyance was or is accessed during such that frequent observation is activity types, a variety of focused transport to introduce a contaminant facilitated and visibility of activity mitigation strategies may be applicable, into the product; around the tank is improved. This

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focused mitigation strategy may be less ingredient handling areas to identify These examples of focused mitigation practical for longer term storage tanks. circumstances that suggest product strategies are consistent with measures Secondary ingredient handling— contamination before a contaminated included in the MSD. The examples are Examples of focused mitigation ingredient is added to the product not intended to be an exhaustive list of strategies that may be appropriate stream. appropriate focused mitigation include the following: Mixing and similar activities— strategies. For additional guidance on 1. Controlling access to ingredient Examples of focused mitigation identifying appropriate focused handling areas, including where strategies that may be appropriate mitigation strategies, see our guidance secondary ingredients or rework are include the following: documents, the MSD, and other staged, prepared, or added to the 1. Controlling access to processing resources (see section II.D of this product stream, to prevent an areas where mixing and similar document). unauthorized person from gaining activities are conducted to prevent an iv. Specific examples of determining access to the ingredients or rework unauthorized person from gaining appropriate focused mitigation during these processes. As with other access to the product and equipment. strategies. In this section, we discuss key activity types, access controls may Access controls may include: strategies specific examples of the decision- include strategies to easily identify to easily identify authorized persons, making process to identify and authorized persons, such as with color such as with color coded uniforms or determine appropriate focused coded uniforms or badges, or badges; conducting these activities in mitigation strategies at an actionable conducting ingredient handling areas behind locking gates, doors, or process step for each of the FDA- activities in areas behind locking gates, other barriers; securing access to identified key activity types. doors, or other barriers; overhead gangways and sampling Bulk liquid receiving and loading— 2. Ensuring the secondary ingredient platforms; and securing hatches, ports, Unloading at Facility A’s bulk tanker handling area is free of unrelated and lids with locks or access alarm truck unloading bay is an actionable materials, such as personal items or devices; process step for this key activity type. other items not directly related to the 2. Ensuring that the area is free of Facility A has a significant vulnerability activity, to help ensure that a unrelated materials, such as personal related to access to the food during the contaminant is not brought into the area items and other items that are not unloading of the bulk liquid. At Facility for introduction into the ingredient directly related to the activity, to reduce A, the tanker truck drives into the during staging, preparation, or addition; the likelihood of a contaminant being unloading bay without passing through 3. Ensuring adequate lighting and brought into the area for introduction any security check-in procedures. A increasing visibility in and around into the ingredient during mixing and single facility employee is assigned to ingredient staging and handling areas, similar activities; this area and takes a facility-owned hose similar to the strategies that may be 3. Ensuring adequate lighting and from an open shelving unit in the employed to ensure adequate lighting at increasing visibility in and around unloading bay and attaches it to the bulk liquid receiving and holding; mixing and similar activities areas, tanker truck’s unloading port. The 4. Reducing staging time to reduce the similar to the strategies that may be driver of the tanker truck assists in opportunity for intentional adulteration. employed to ensure adequate lighting at unloading by opening the venting hatch Any time sealed or tamper-evident bulk receiving and loading; at the top of the tanker truck while the containers are breached provides a 4. Positioning mixing and similar facility employee is attaching the hose. potential opportunity for an attacker to equipment in a manner that maximizes The driver then waits in the unloading introduce a contaminant into the visibility, similar to the strategies that bay area while the truck is being ingredient or rework. Reducing the time may be employed to maximize visibility unloaded. Upon completion of ingredients and rework are staged in for liquid storage and handling; unloading activities, the driver gets back unsecured containers reduces the 5. Using one-way sample ports that in the truck and exits the facility. opportunity for an attacker to adulterate prohibit introduction of a contaminant Facility A is not implementing the ingredient or rework; into the mixing or similar equipment, focused mitigation strategies at this 5. Restricting secondary ingredient similar to the strategies that may be actionable process step such that access handling to senior staff to reduce the employed for liquid storage and to the food during unloading of the bulk accessibility and opportunity for handling; liquid is significantly minimized or intentional adulteration; 6. Conducting inspections of mixing eliminated. The food is significantly 6. Using peer monitoring in the and similar equipment prior to use to vulnerable to an attacker (in this case, ingredient handling area, because help ensure no contaminant has been potentially the driver, the facility requiring at least two staff members to introduced that could contaminate the employee, or a third party) who could be in the area at any given time during product once loaded; intentionally add a contaminant to the operations can reduce the opportunity 7. Restricting mixing and similar product to adulterate the food. One for a contaminant to be discreetly activities to senior staff, similar to the approach for Facility A to significantly introduced into the food; strategies that may be employed for minimize or eliminate the significant 7. Using automated and enclosed secondary ingredient handling; vulnerability at this actionable process ingredient handling equipment, such as 8. Using peer monitoring in this area step is to implement the following automated computer weighing, to ensure that at least two staff members focused mitigation strategies: measuring, and addition equipment, to are in this area at any given time during • Establish a receiving check-in and reduce human contact with secondary operations, reducing the opportunity for verification procedure to ensure that the ingredients or rework and thereby a contaminant to be discreetly shipment is being delivered by the reduce the opportunity for introduction introduced into the food; and proper firm and that the driver is of a contaminant; and 9. Using automated, self-contained, properly identified. The procedure 8. Inspecting secondary ingredients enclosed equipment to reduce human would be documented and maintained held in staging and investigating any contact with the product and reduce the in a shipping log that records the key irregularities in the amount, condition, opportunity for introduction of a identifying information about the driver, or organization of items in secondary contaminant. tanker truck, and shipping

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documentation for the delivered at the top of the tank. Facility B has a required additional focused mitigation product. The facility would also procedure for securing this hatch with strategies to significantly reduce or institute a policy requiring that the a lock, and the facility stores the key to eliminate the risk of intentional shipping documentation include the ID the hatch in the operations manager’s contamination. numbers of the seals on the unloading office. To access a key, a worker must Another example of an actionable ports so that the facility employee can request the key from the operations process step for the key activity type verify that seal numbers match the manager and justify the need to open ‘‘Liquid Storage and Handling’’ is liquid shipping documentation and that the the lock. When an employee checks out storage in a liquid surge tank located seals were not broken, tampered with or the key, the manager’s assistant records above an in-line bottling operation at replaced during transport. the employee’s name, time the key is Facility C. The surge tank is used to • Implement a procedure to store checked out, and the reason. Facility B’s control the flow rate of liquid product hoses securely to reduce the likelihood bulk liquid storage tank also has a into the bottling equipment and is an attacker could add a contaminant to second hatch along the side which is enclosed by an unlocked lid. A ladder the hoses when not in use. This would used for cleaning the tank when empty and walkway enable workers to access include storing hoses in locking and is not locked. This secondary hatch the surge tank as needed to monitor cabinets and placing end caps on the is not accessible while product is in the product flow and take quality control hoses. The facility also would issue keys tank because it opens inward, and samples. Facility C has an operations only to staff working in the tanker truck pressure from product in the tank control room, which is equipped with receiving bay and use a key numbering prevents the hatch from being opened windows to view the production floor. and tracking system to verify that all when product is present. However, the view of the bottling keys are accounted for. In considering the requirement for operation from the operations control • Increase active observation of the focused mitigation strategies at this room is commonly blocked by pallets of unloading process to reduce the actionable process step, Facility B empty bottles awaiting introduction into likelihood of an attacker successfully would determine that it has sufficient the bottling equipment. introducing a contaminant by requiring safeguards in place to significantly It is not practical for Facility C to lock two or more production staff members minimize the likelihood of intentional the surge tank lid because workers need to be present during unloading activities adulteration from an attacker accessing to frequently check the status of product (i.e., peer monitoring), or requiring the the hatch on the top of the bulk storage flow and take quality control samples. bulk liquid unloading operations be tank. However, the facility would Also, it is not practical to physically overseen by a supervisor or a member of identify the secondary hatch as limit access to the ladder or walkway the quality control staff. Alternatively, presenting a significant vulnerability for used to access the surge tank, for the the facility could employ video which insufficient focused mitigation same reasons. One approach for Facility surveillance of the area. If the truck strategies are being implemented. While C to significantly minimize or eliminate driver is permitted to remain in the area food is in the tank, the secondary hatch the significant vulnerability at this of the receiving bay, the introduction of is secure. However, when the tank is actionable process step is to implement active observation practices ensures that empty after cleaning, there is an the following focused mitigation no contaminant could be intentionally opportunity for an attacker to introduce strategies: introduced to the product during a contaminant into the tank via the • Implement a policy to prohibit all unloading activities. Alternatively, the secondary hatch which would then personnel not associated with the facility could limit the driver’s access to contaminate the food when it is added bottling operation from entering the area the product by restricting the location of to the tank. To significantly minimize or and issue uniforms of a particular color the driver to designated areas outside eliminate the significant vulnerability to the bottling personnel only. The staff the loading area while the truck is being presented by the secondary hatch, the working in the bottling area would unloaded. facility would implement focused enforce this policy by instructing any In this example, the focused mitigation strategies to restrict and staff not associated with the bottling mitigation strategies were selected to document access to the secondary hatch operation to leave the area. achieve the following goals: Establishing as is done for the hatch on the top of • Prohibit staff working in the the identity of personnel with access to the tank. To do this, the facility would bottling area from bringing any items the food; ensuring that equipment that install a lock on the secondary hatch not associated with the bottling may be used to introduce a contaminant and incorporate the key for the operation into the work area. is secured when not in use; and secondary hatch into its existing key • Train the staff working in the providing active observation of management system. Alternatively, the bottling area in a peer monitoring activities at actionable process steps. By facility could implement a procedure of program to be attentive to the activity of implementing these focused mitigation monitoring the condition of the tank other staff in the area. strategies, the facility could significantly interior immediately prior to • Stage pallets of empty bottles minimize the significant vulnerability reintroducing product to the tank. This awaiting introduction into the bottling identified at the actionable process step. monitoring check would be recorded in equipment in another location to Liquid storage and handling—The a monitoring log. improve line of sight from the storage of liquid in Facility B’s bulk Facility B already has in place some operations control room. liquid storage tank is an actionable practices that we would consider By implementing these focused process step for this key activity type. appropriate focused mitigation mitigation strategies, the facility could Facility B’s bulk storage tank holding a strategies. The procedures in place to significantly minimize or eliminate the primary ingredient is located within its control access to the top access hatch on significant vulnerability associated with building, and a significant vulnerability the bulk liquid storage tank are the actionable process step at the liquid relates to access to the food during such sufficient to minimize the significant surge tank. storage. In Facility B, a network of vulnerability presented by this hatch. Secondary ingredient handling— gangways, ladders, and platforms However, Facility B still has a Ingredient staging at Facility D is an surround the bulk liquid storage tank so significant vulnerability associated with actionable process step for this key that personnel can gain access to a hatch the secondary access hatch, which activity type. Facility D opens a

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containerized secondary ingredient’s view of the mixer through an connection between the dryer and the tamper evident package, measures out observation window. discharge line is sealed. the required amount into a secondary The mixer is vulnerable to an attacker To goal of focused mitigation container, and pre-positions the who could intentionally introduce a strategies at this actionable process step ingredient in the production area so that contaminant into the food because of would be to reduce access to this it is readily added to the product line. the open nature of the mixer, the lack equipment to significantly reduce the Access to the food during each of these of constant and dedicated observation, likelihood an attacker could introduce a activities at this actionable process step and the lack of physical access control contaminant into the rotating air dryer. presents a significant vulnerability. to the area where it is located. One One way Facility F could do this would Facility D stages a dry, powdered approach for Facility E to significantly be to install a clear plastic shield that ingredient near the mixer the night minimize or eliminate the significant would be affixed to and extend from the before it is intended to be used so that vulnerability at this actionable process discharge of the pneumatic conveyor to it is ready when the production run step is to implement the following the opening of the dryer where it would begins the next morning. Additionally, focused mitigation strategies: also be tightly affixed to the housing of the staging area in Facility D is • Install a lid on the mixer that must the dryer. A clear plastic shield would accessible to all staff and is an open area be opened to add anything to the mixer. enable workers to supervise the product on the production floor. If Facility E determines that it would be flow into the dryer while posing as an One approach for Facility D to disruptive to the production schedule to effective barrier to an attacker wishing significantly minimize or eliminate the install a lock on the lid, the facility to introduce a contaminant into the significant vulnerability at this could install an access alarm that would product at the dryer. This engineering actionable process step is to implement indicate that the lid has been opened. improvement would significantly the following focused mitigation This alarm would sound in the minimize or eliminate access to the food strategies: operation control room where a manager in the dryer and thereby significantly • Reduce staging time, by revising its supervises production operations. reduce or eliminate the likelihood of a procedures so that ingredients are • Assign another member of staff the successful act of intentional staged immediately before they are responsibility of preparing and securely adulteration at this process step. The installation of physical barriers to access added into the product stream. This staging ingredients for later production of equipment at actionable process steps strategy would reduce the time batches. This would alleviate the need can be one of the most effective focused ingredients are accessible. for the mixer operator to leave the area, mitigation strategies because it does not • Change its staffing procedures to leaving the mixer unattended. require restricting personnel or ensure that only senior or long-term With the introduction of these two maintaining active observation of an employees are assigned to measuring focused mitigation strategies, the facility area. The implementation of this and staging secondary ingredients. would have taken steps to enclose the engineering improvement would be Assigning the most trusted employees to mixer, making it more difficult for an detailed in the facility’s food defense work in sensitive areas reduces the risk attacker to introduce a contaminant plan. of intentional contamination. without alerting management (by the • c. Proposed § 121.135(a)— Increase its observation of this area sounding of the alarm), and increased Requirement to identify and implement by installing closed-circuit TV cameras the dedicated observation of this focused mitigation strategies for to monitor the actions of staff in the otherwise vulnerable process step by actionable process steps. Proposed secondary ingredient staging area. ensuring that the mixer operator is not § 121.135(a) would require that the By its nature, the action of ingredient required to leave the area unattended. owner, operator, or agent in charge of a staging is an open and accessible Mixing at Facility F’s rotating air facility identify and implement focused process step. Focused mitigation dryer is another example of an mitigation strategies at each actionable strategies must address personnel access actionable process step for the key process step to provide assurances that so that the likelihood of an intentional activity type ‘‘Mixing and similar the significant vulnerability at each step contamination at this step is activities.’’ In Facility F, product, such will be significantly minimized or significantly reduced or eliminated. By as crackers or breakfast cereals, are fed prevented and the food manufactured, implementing these focused mitigation through drum-like equipment, where processed, packed or held by such strategies, the facility could significantly warm air is blown across it while the facility will not be adulterated under minimize the significant vulnerability drum rotates. Although the goal of this section 402 of the FD&C Act. Under identified at the actionable process step. process is to dry the product, it also § 121.135, we are proposing that, for Mixing and similar activities— could distribute any contaminant each of the identified actionable process Blending in Facility E’s dough mixer is introduced into the dryer evenly across steps, the owner, operator, or agent in an actionable process step for this key the product. Facility F’s rotating air charge of a facility covered by this rule activity type. Facility E operates a dryer is located alongside a commonly identify and implement focused dough mixer to combine several dry and used walkway, but is behind a guard rail mitigation strategies. Focused mitigation liquid ingredients. This mixer is not to prevent employees from coming in strategies would be required only for enclosed and is located in an open area contact with the hot exterior of the actionable process steps. of the facility where it is under dryer. Product is fed into the top of the Because a focused mitigation strategy regular—though not dedicated—human dryer via a pneumatic conveyor. There that would be necessary at an actionable observation. While a batch of product is is sufficient space between the dryer process step must be tailored to address being mixed, the staff member assigned opening and the pneumatic conveyor the significant vulnerability applicable to the mixer may leave the area to discharge to enable an attacker to to the specific actionable process step, retrieve and prepare ingredients for the introduce a contaminant to the dryer at we are not proposing to specify the next production batch. The line of sight this point. That opening is about six feet particular focused mitigation strategies in this area is clear, and management in above the ground, accessible from the that would be appropriate. Rather, we the operations control room located floor of the facility. Product leaves the expect the owner, operator, or agent in above the production floor has a clear dryer through a gravity fed line. The charge of the facility covered by this

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rule to identify the specific focused mitigation strategies. Proposed b. Proposed § 121.140(a)— mitigation strategy(s) that would be § 121.135(b) would require that focused Requirement for written procedures for appropriate, considering the facility and mitigation strategies for actionable monitoring. Proposed § 121.140(a) food it produces, and to ensure the process steps be written. The focused would require that the owner, operator, proper implementation of those mitigation strategy(ies) selected for each or agent in charge of a facility establish strategies to provide assurances that the actionable process step identified in and implement written procedures, significant vulnerability at each accordance with proposed § 121.130, including the frequency with which identified actionable process step is and a justification for how the strategy they are to be performed, for monitoring significantly minimized or prevented significantly reduces or eliminates the the focused mitigation strategies. and the food is not adulterated. In risk of intentional adulteration at that Monitoring the performance of focused section V.C.3.b of this document, we list actionable process step(s) must be mitigation strategies at specified examples of focused mitigation documented. Similar to preventive frequencies would facilitate tracking the strategies and describe scenarios for controls in a food safety plan, written implementation of the focused determining appropriate focused focused mitigation strategies in a food mitigation strategies to provide mitigation strategies at actionable defense plan are essential for the facility assurance that they are consistently process steps for each of the FDA- to implement the focused mitigation applied in a facility covered by this rule. identified key activity types. strategies consistently, and essential for If monitoring shows that a focused A facility would have the flexibility to the facility and inspectors. Written mitigation strategy is frequently not identify and implement focused focused mitigation strategies also would implemented, a facility can consider mitigation strategies from among all be essential for training purposes and whether another focused mitigation procedures, practices, and processes during reanalysis and updates of the strategy would be more appropriate. For available to the facility that would focused mitigation strategies. example, if an ingredient storeroom provide the assurances that would be Proposed § 121.135(b) implements the door is to be kept locked when not in required by proposed § 121.135. The provisions in sections 418(h) and use, but the door is frequently left flexibility provided under this proposed 420(b)(2) of the FD&C Act. unlocked because access to the room is provision acknowledges the existing e. Proposed § 121.135(c)— needed for other purposes, the facility expertise within the food industry in Applicability of monitoring, corrective may replace the previous focused this regard, and recognizes the complex actions, and verification. Proposed mitigation strategy with video and varied nature of operations in food § 121.135(c) would specify that the monitoring. Further, if monitoring is facilities. Additionally, to the extent focused mitigation strategies required conducted with sufficient frequency, it facilities may already be engaging in under this section would be subject to will detect if a focused mitigation practices that constitute focused monitoring as would be required by strategy is not properly implemented proposed § 121.140; corrective actions mitigation strategies, facilities should (e.g., if access to a particular area of a as would be required by proposed consider whether those measures satisfy facility is not being appropriately § 121.145; and verification as would be the requirements of proposed § 121.135, restricted or a bulk liquid tank is not required by proposed § 121.150. such that the implementation of being visually inspected prior to filling), Proposed § 121.135(c)(1) through (c)(3) additional focused mitigation strategies indicating a problem and signaling the would restate the requirements of may not be necessary. (Note that need for an appropriate corrective proposed §§ 121.140, 121.145, and associated requirements, such as action. In addition, the proposed monitoring and verification, would 121.150 to clearly communicate the monitoring requirement would result in apply). applicability of proposed §§ 121.140, written documentation for use in FDA’s existing guidance documents 121.145, and 121.150 to the focused and other resources (discussed in mitigation strategies that would be verification. section II.D of this document) include required under proposed § 121.135 and c. Proposed § 121.140(b)—Frequency guidance for industry on a range of would establish no new requirements. of monitoring. Proposed § 121.140(b) focused mitigation strategies. In would require that the owner, operator, 4. Monitoring particular, the MSD includes a list of or agent in charge of a facility monitor mitigation strategies that can be applied a. General description of monitoring. the focused mitigation strategies with to different steps in a food operation to Proposed § 121.3 would define sufficient frequency to provide reduce the risk of intentional ‘‘monitor’’ to mean ‘‘to conduct a assurances that they are consistently adulteration. The database is searchable planned sequence of observations or applied. Proposed § 121.140(b) does not by key words and processing steps measurements to assess whether specify a single monitoring frequency common to food operations (e.g., focused mitigation strategies are applicable to all facilities and processes. packing, manufacturing, processing and consistently applied and to produce an Rather, it requires monitoring with holding). accurate record for use in verification.’’ ‘‘sufficient frequency’’ to ensure that the Proposed § 121.135(a) implements the In developing the proposed monitoring focused mitigation strategies are provisions in sections 418(c)(2) and requirements related to food defense, we consistently applied in a facility 420(b)(2) of the FD&C Act. FDA requests considered our proposed monitoring covered by this rule. We note that for comments on our analysis and proposed requirements related to food safety, food defense that many focused provisions related to mitigation which are described in section XII.E of mitigation strategies may be monitored strategies necessary to protect against the PC proposed rule. For the same over longer timeframes (non-continuous intentional adulteration of food caused reasons outlined in the PC proposed monitoring) than preventive controls for by acts of terrorism. We also seek input rule, we have tentatively concluded that food safety, which are often monitored on whether and, to what extent, monitoring is necessary to establish the continuously. In large part preventive facilities currently employ broad performance of the implementation of controls for food safety are monitored mitigation strategies and focused the focused mitigation strategies. The continuously because they relate to mitigation strategies. proposed provisions in § 121.140 physical or chemical parameters of the d. Proposed § 121.135(b)— implement section 418(h) of the FD&C process, such as the temperature of a Requirement for written focused Act. pasteurizer, which both lend themselves

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to continuous monitoring and ‘‘corrective actions’’ is used to describe training purposes, so that employees necessitate that level of monitoring to procedures that are in place to correct who would need to implement the ensure that the process is under control. the cause of a deviation to ensure that corrective action procedures will be As discussed in greater detail in section a critical control point is under control prepared for what they would need to V.C.3 of this document, most focused and to ensure that the product produced do. mitigation strategies for food defense are under that deviation is safe, since total Proposed § 121.145(a)(2) would not related to physical or chemical adherence to a planned process may not require that corrective action procedures parameters of the process. They tend to always occur. This concept is discussed describe the steps to be taken to ensure have more in common with sanitation in detail in section XII.F of the PC that appropriate action is taken to preventive controls for food safety in proposed rule. identify and correct a problem with that they relate to conditions around the This same concept can be applied to implementation of a focused mitigation food process, such as access to the the control of intentional adulteration strategy to reduce the likelihood that the equipment. A focused mitigation related to acts of terrorism. Monitoring problem will recur. In the previous strategy such as ‘‘adequate lighting at an may detect a deviation from example in which two staff are required actionable process step’’ or ‘‘secure air implementation of a focused mitigation to be at a work station at all times, the vents on a cooling tank with one-way strategy; corrective actions are corrective action could be speaking with valves’’ would not require continuous implemented to re-establish control. In the employees to ensure they monitoring. Management may choose to developing the proposed corrective understand the importance of remaining monitor lighting on a weekly basis to actions requirements related to food at the work station together, sending ensure that everything is working defense, we considered our proposed staff to a refresher course on food properly and monitoring of the security relevant requirements related to food defense awareness, and ensuring that of air vents with one-way valves on a safety. The proposed provisions in the supervisor knows that there must be cooling tank might be done monthly. § 121.145 implement sections 418(e), adequate staff present on a shift so two Frequency is not prescribed in this 418(h), and 420(b)(2) of the FD&C Act. people can be at the work station at all proposed rule. More frequent (e.g., b. Proposed § 127.145(a)—Corrective times. If the problem recurs, daily) monitoring would be appropriate action procedures. Proposed management may need to consider other for mitigation strategies that relate to § 121.145(a)(1) would require that the measures for preventing access at that conditions or practices that are more owner, operator, or agent in charge of a process step. likely to change more rapidly, such as facility establish and implement written c. Proposed § 121.145(b)— keeping the access door to an actionable corrective action procedures that must Documentation. Proposed § 121.145(b) process step closed when not in use or be taken if focused mitigation strategies would require that all corrective actions ensuring that employees with color are not properly implemented. Having taken in accordance with this section be coded uniforms are staying in the areas written procedures in place would documented in records that are subject designated by the color code. enable facilities covered by this rule to to verification in accordance with d. Proposed § 121.140(c)— act quickly and appropriately when proposed § 121.150(b) and records Requirement for records. To implement focused mitigation strategies are not review in accordance with proposed section 418(g) of the FD&C Act, properly implemented—e.g., a situation § 121.150(c). The records that document proposed § 121.140(c) would require where a work station at an actionable corrective actions would be used to that all monitoring of focused mitigation process step requires two staff at all verify that appropriate decisions about strategies in accordance with this times in a ‘‘buddy system’’ but is only corrective actions are being made and section must be documented in records staffed by one person for a period of appropriate corrective actions are being that are subject to verification in time. taken in facilities covered by this rule. accordance with § 121.150(a) and The benefits of identifying corrective d. Corrective actions proposed to be records review in accordance with action procedures before corrective required by part 117 but not part 121. proposed § 121.150(c). action is needed largely derive from Unlike in proposed part 117, in The monitoring records would be having written procedures. Written proposed part 121, we have not used to verify that the focused corrective action procedures would be proposed a requirement to ensure that mitigation strategies are being essential to the facility’s management, to all affected food is evaluated for food monitored, as would be required by auditors, and to inspectors. The safety if focused mitigation strategies are proposed § 121.150(a), and to verify that facility’s management will be not properly implemented or are found the focused mitigations strategies are responsible for ensuring that to be ineffective. An act of intentional consistently implemented and are appropriate corrective actions are taken adulteration or attempted intentional effective at significantly minimizing or if focused mitigation strategies are not adulteration has historically been a rare preventing the significant properly implemented. Having access to event and, as a result, in the vast vulnerabilities, as would be required by appropriate, written corrective action majority of cases, the failure to properly proposed § 121.150(c). Further, they are procedures determined in advance of implement a focused mitigation strategy necessary to facilitate regulatory review the need for such action can ensure that would not be expected to result in of the system of controls. Together, correct and complete actions are taken contaminated food. This is because proposed §§ 121.140(a), (b), and (c) and in a timely fashion. Having written intentional adulteration requires not just 121.150(a), (c), and (e) would establish corrective action procedures available the opportunity for contamination (i.e., a system that would provide assurances for auditors and for inspectors is failure of a mitigation strategy to limit that the significant vulnerabilities essential for them to assess the access to an actionable process step), identified for a food operation are being adequacy of the food defense plan; the but also someone with intent to cause significantly minimized or prevented. procedures a facility will use to address harm at that same moment. In contrast, implementation failures are essential to the failure to properly implement a 5. Corrective Actions proper, consistent implementation, and preventive control for a food safety a. General description of corrective without them a complete assessment hazard, such as proper cook actions. When a HACCP-type system is cannot be made. Written corrective temperatures, is more likely to result in applied to ensure food safety, the term action procedures also will be useful for adulterated food (e.g., because the

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pathogen reasonably likely to be present § 121.150 implement sections 418(f) and are complete, the activities reflected in in the raw food would not be eliminated 420(b)(2) of the FD&C Act. the records occurred in accordance with from the food by the inadequate cooking b. Proposed § 121.150(a)—Verification the food defense plan, the focused process). However, our decision not to of monitoring. Proposed § 121.150(a) mitigation strategies are effective, and propose these requirements does not would require that the owner, operator, appropriate decisions were made about absolve an owner, operator, or agent in or agent in charge of a facility verify that corrective actions. charge of a facility from their monitoring is being conducted. Proposed § 121.150(c) would establish responsibility to ensure that food is not Verification of monitoring can be that the purpose of the review of records adulterated. In addition, food firms conducted in a number of ways. One is to ensure that the records are would continue to be subject to the example of verification of monitoring is complete, the activities reflected in the reporting requirements under section a periodic observation of the monitoring records occurred in accordance with the 417 of the FD&C Act. Moreover, the activity, e.g., by a supervisor. Another food defense plan, the focused introduction or delivery for introduction example is an independent test made by mitigation strategies are effective, and into interstate commerce of any food a person other than the person doing the appropriate decisions are made about that is adulterated is a prohibited act monitoring. For example, if a shift corrective actions. We tentatively under section 301(a) of the FD&C Act. supervisor is assigned to check at the conclude that review of the records The PC proposed rule also contains end of each shift that chemicals are required by proposed § 121.150(c) requirements for corrective actions that properly stored and secured, another would accomplish these purposes. must be taken in the event of an supervisor may be responsible for Reviewing monitoring records can unanticipated problem. Unlike in checking periodically (e.g., once a week) reveal whether they contain information proposed part 117, in proposed part that this is occurring. In another on all of the activities or measures that 121, we are not proposing a requirement example, if an alarm is supposed to were to be monitored to determine related to unanticipated problems sound if a mixing tank is accessed whether a focused mitigation strategy is because we are not aware of without authorization and the being consistently implemented in circumstances where this would be monitoring procedures provide for accordance with the food defense plan. relevant. Because of the nature of the weekly testing of the alarm, a supervisor For example, a review of monitoring focused mitigation strategies, we expect may be responsible for performing the records can show if the shift supervisor that the outcomes of monitoring will be same test monthly to ensure that the is consistently storing and securing binary, either the focused mitigation alarm and the monitoring procedure are chemicals at the end of each shift as strategy will be in place or it will not both working properly. Proposed may be required by a food defense plan. § 121.150(a) would not specify the Review of monitoring records also can be in place. For this reason, we expect verification activities that must be reveal whether any information is that corrective action plans will be conducted for monitoring. We request missing—e.g., a date or time—so that straightforward, with no provision comment on whether proposed the missing information can be quickly needed for unanticipated corrective § 121.150(a) should do so, and if so, identified and added to the record if actions. This contrasts with the what verification activities should be necessary. circumstances of food safety preventive required. Review of records also can reveal measures, where controls are often more c. Proposed § 121.150(b)—Verification whether appropriate decisions were complex, presenting opportunities for a of corrective actions. Proposed made about corrective actions. The more nuanced corrective action, which § 121.150(b) would require that the review would determine whether all the may not be possible to fully anticipate owner, operator, or agent in charge of a corrective action procedures required by in advance. facility verify that appropriate decisions proposed § 121.145 have been followed We ask for comment on our rationale about corrective actions are being made. to prevent recurrence of the problem. and tentative conclusion not to propose An example of verification that For example, in the previous example these requirements. appropriate decisions about corrective on corrective actions, a review of 6. Verification actions are being made is observation of records could reveal that the supervisor the corrective actions being taken, e.g., spoke to the staff about always having a. General description of verification. by a supervisor. Proposed § 121.150(b) two staff present at the work station as In the preventive controls framework, would not specify the verification required in the food defense plan and, ‘‘verification’’ involves activities that activities that must be conducted for as appropriate, enrolled the staff in a help determine whether the focused corrective actions. We request comment refresher course on food defense mitigation strategies are valid and are on whether proposed § 121.150(b) awareness. implemented according to the food should do so, and if so, what Proposed § 121.150(c) would require defense plan. Verification includes verification activities should be review of the monitoring and corrective confirming that monitoring and required. action records within an appropriate corrective actions are being d. Proposed § 121.150(c)— time after the records are made. We are implemented as planned, through Implementation and effectiveness. not proposing to require review of review of records and periodic Proposed § 121.150(c) would require records within a specified timeframe. reanalysis of the food defense plan. This that the owner, operator, or agent in While the PC proposed rule contains a concept as applied to food safety is charge of a facility verify that the requirement that monitoring and discussed in detail in section XII.G of focused mitigation strategies are corrective action records be reviewed the PC proposed rule. consistently implemented and are within a week after the records are We have tentatively concluded that effectively and significantly minimizing made, in the case of food defense, we do this same concept applies to the control or preventing the significant not believe specifying a timeframe for of intentional adulteration related to vulnerabilities. As appropriate to the records review is necessary. As acts of terrorism. Efforts must be made facility and the food, this must include discussed previously, some focused to ensure that the system of mitigation review of the monitoring and corrective mitigation strategies may be monitored strategies is in place and functioning as action records within appropriate less frequently than are preventive designed. The proposed provisions in timeframes to ensure that the records controls for food safety. In a HACCP-

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type system for food safety, monitoring of a facility reanalyze the food defense conclusion that no additional or revised and corrective action records are often plan to determine whether modification focused mitigation strategies are needed. reviewed a short time after their of the plan is required if a focused It is important to document that a creation to enable action to be taken mitigation strategy is found to be reanalysis has been conducted and the relative to food that may be adulterated ineffective. For example, if the owner, plan has been revised accordingly or (e.g., recall). It is unlikely that an operator, or agent in charge of a facility that no change has been made. Such improperly implemented focused finds that color coding of employee hard documentation demonstrates that a mitigation strategy would result in hats according to their assigned work facility has considered all relevant adulterated food (i.e., because stations or areas is not effective in information on the defense of the adulteration of food would require not preventing employees from crossing operation, including new information only opportunity but also a into areas where they are not assigned that has become available since the last simultaneous intent to cause because employees have found that analysis. The documentation further adulteration). A focused mitigation adhering to the system adversely affects demonstrates that appropriate changes strategy such as ‘‘adequate lighting at product, the owner, operator, or agent in have been made or that current the bulk truck unloading bay’’ or charge may need to consider other procedures for implementing focused ‘‘secure air vents on a cooling tank with focused mitigation strategies to ensure mitigation strategies are adequate to one-way valves’’ may be monitored on that staff access at actionable process significantly minimize or prevent a weekly or monthly basis. Because the steps is controlled. significant vulnerabilities. focused mitigation strategies may be 5. Whenever FDA requires reanalysis f. Proposed § 121.150(e)— monitored less frequently and because to respond to new vulnerabilities and Requirement for records for verification. these frequencies may vary significantly developments in scientific To implement sections 418(g) and from one focused mitigation strategy to understanding including, as 420(b)(2) of the FD&C Act, proposed another, we believe it is appropriate for appropriate, results from a DHS § 121.150(e) would require that all owners, operators, or agents in charge of biological, chemical, radiological, or verification activities taken in a facility to determine when review of other terrorism risk assessment accordance with this section be the monitoring and corrective action (proposed § 121.150(d)(1)(v)). Risk documented in records. records is best performed. assessments or vulnerability g. Verification proposed to be e. Proposed § 121.150(d)—Reanalysis. assessments conducted by DHS or required by part 117 but not part 121. To implement section 418(i) of the others may reveal a significant In the PC proposed rule, we proposed to FD&C Act, proposed § 121.150(d)(1) vulnerability in process steps in require, as part of verification, the would require that the owner, operator, addition to the significant validation of the adequacy of the or agent in charge of a facility conduct vulnerabilities associated with the key preventive controls implemented to a reanalysis of the food defense plan as activity types that FDA has identified. control the hazards identified in the follows: FDA would require reanalysis of food hazard analysis as reasonably likely to 1. At least once every 3 years defense plans, as necessary, to respond occur. In this proposed rule, we are not (proposed § 121.150(d)(1)(i)). to any new knowledge about threats or including a similar proposed 2. Whenever a significant change is vulnerabilities to food operations based requirement. Unlike preventive made in the activities conducted at a on information available to the agency. controls, which often involve processing facility operated by such owner, This requirement for reanalysis could parameters that can be scientifically operator, or agent in charge if the involve a requirement to consider validated, focused mitigations strategies change creates a reasonable potential for whether a new key activity type is for food defense (which correspond to a new vulnerability or a significant relevant to a facility’s food processes. It preventive controls for food safety) often increase in a previously identified could also involve a requirement to are not of a nature that they can be vulnerability (proposed reconsider existing key activity types in scientifically validated. For example, it § 121.150(d)(1)(ii)). For example, if a light of a credible threat of terrorist would not be practical for a facility to facility adds a new product line, then attack on a specific food type, product, attempt to validate the effectiveness of the food defense plan must be brand, or company. a lock on a tank or the use of a ‘buddy reanalyzed to consider whether it Proposed § 121.150(d)(2) would system’ at a particular process step to includes one of the key activity types, require that the owner, operator, or prevent or significantly minimize and, if so to implement appropriate agent in charge of a facility complete the intentional adulteration of food caused focused mitigation strategies. required reanalysis and implement any by a terrorist attack. Most of the 3. Whenever such owner, operator or additional focused mitigation strategies recommended mitigation strategies in agent in charge becomes aware of new needed to address the significant the MSD (Ref. 30) are similar in nature information about potential vulnerabilities identified, if any, before to the two mentioned in the example vulnerabilities associated with the food the change in activities at the facility is above in that validation would be operation or facility (proposed operative or, when necessary, during the impractical. Therefore, we have § 121.150(d)(1)(iii)). For example, an first six weeks of production. The tentatively concluded not to propose a owner, operator, or agent in charge of a purpose of the reanalysis is to identify requirement for validation of focused facility may become aware that access to the need for, and implement, focused mitigation strategies. a particular piece of equipment is mitigation strategies in light of a However, if a facility chooses to use greater than was thought to be the case reasonable potential for a new a processing parameter (e.g., thermal kill when they initially considered whether significant vulnerability, or a significant step) as a focused mitigation strategy, a key activity type is applicable to their increase in a previously identified the facility should employ such a food process. significant vulnerability. processing parameter if it has been 4. Whenever a focused mitigation Proposed § 121.150(d)(3) would demonstrated to be effective in strategy is found to be ineffective require that the owner, operator, or significantly minimizing or preventing (proposed § 121.150(d)(1)(iv)). Proposed agent in charge of a facility revise the the associated significant vulnerability. § 121.150(d)(1)(iv) would require that written plan if a significant change is In many circumstances it is not the owner, operator, or agent in charge made or document the basis for the appropriate to use such strategies

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because they are usually effective document), which takes about 20 seminars and programs offered by against one or several, but not all, minutes to complete, would be private sector entities (Ref. 59, Ref. 60, potential contaminants. See section sufficient to satisfy this element of the Ref. 61, Ref. 62) that may also assist XII.G of the PC proposed rule for proposed training requirement. industry to comply with this training additional discussion of validation. Additionally, training must contain requirement. We seek comment on the The PC proposed rule also includes specifics about the actionable process adequacy of FDA’s Food Defense 101 proposed requirements for calibration of steps where employees are working and training materials, and whether there is process monitoring instruments and their roles in the proper implementation a need for revisions to these existing verification instruments and also of the focused mitigation strategy(ies) FDA courses or the development of records associated with these activities. applied at those actionable process additional FDA training materials. As discussed previously, it is our steps. Training on the application of FDA also previously issued guidance expectation that most of the focused focused mitigation strategies, which is documents for industry on food defense mitigation strategies will not be likely to be specific to each facility or (Ref. 22, Ref. 23, Ref. 24, Ref. 25, Ref. continuously monitored and will not actionable process step, may be added 26), which include recommendations require process monitoring instruments to existing on-the-job training programs related to personnel training. In these or instruments to verification purposes. or provided separately. guidance documents, we recommended Therefore, we do not believe it would be FDA has developed training tools that that all employees have training in food necessary to include those requirements are available for use by the industry. defense awareness, including in this part. FDA revamped its online food defense information on how to prevent, detect, We ask for comment on our tentative courses in 2013, and the revamped and respond to an intentional decision not to include validation of the courses, entitled ‘‘Food Defense 101’’ contamination incident at their facility. focused mitigation strategies and (Ref. 27), address the types of As noted in these guidance documents, calibration of monitoring and intentional contamination that have we recommended incorporating verification instruments in codified occurred in the United States in recent periodic reminders of the importance of requirements in proposed § 121.150. years and reflect FDA’s current thinking food defense procedures into routine 7. Training of Personnel on how to minimize the likelihood and facility communications, such as impact of such incidents. The courses brochures, staff meetings or payroll Proposed § 121.160 would establish included in Food Defense 101 are: (1) stuffers. We further recommended that requirements related to training of Food Defense Awareness for the Food facilities encourage all employees to certain personnel working in a food Professional; (2) Food Defense report unusual or suspicious operation. Proposed § 121.160(a) would Awareness for the Front-line Employee; individuals or activities to management. require that personnel and supervisors (3) Food Defense Regulations; and (4) We reiterate these recommendations assigned to actionable process steps ALERT, for owners and operators of described in our guidance documents. receive appropriate training in food food facilities. The course on Food However, in this proposed rule, we are defense awareness and their respective Defense Awareness for the Food not proposing to include additional responsibilities in implementing Professional provides an understanding specific training requirements to reflect focused mitigation strategies. Because of food defense and information for all of those recommendations. For the effectiveness of a mitigation strategy, professionals in the food industry. The example, although we are not requiring which is applied at an actionable course modules progress through food that all employees at a facility receive process step, is dependent on the proper defense planning including broad training in food defense, we recognize implementation by personnel and mitigation strategies, vulnerability the importance of training as a measure supervisors of the strategy, we are assessments, focused mitigation to protect against intentional proposing to require that personnel and strategies, and food defense plans. The adulteration of food and, therefore, supervisors assigned to actionable course on Food Defense Awareness for reiterate our recommendation that all process steps be appropriately trained in Front-line Employees provides personnel working in a food operation food defense. The purpose of training a information specific to front-line receive training in food defense supervisor, in addition to personnel at workers and simple procedures for these awareness. We request comment on this actionable process steps, is so that the employees to follow in food defense. issue, including on whether we should supervisor can help train employees, The course on Food Defense Regulations require, in a final rule, that basic food recognize conditions that could lead to presents an overview of the Public defense awareness training be intentional contamination, and take Health Security and Bioterrorism completed by all employees at a facility. necessary actions to correct those Preparedness and Response Act of 2002 We also request comment on whether conditions. (the Bioterrorism Act), FSMA, and we should require training to be We are proposing that training FDA’s Reportable Food Registry. repeated periodically, including when required under this provision must Finally, the course on ALERT, which significant changes are made to food cover food defense awareness and the was developed by FDA to help defense plans. respective responsibilities of personnel stakeholders better understand food Proposed § 121.160(b) would require and supervisors assigned to actionable defense and how food defense applies to that all training received in accordance steps in implementing focused the food industry, provides specific with section § 121.160 be documented mitigation strategies. At a minimum, examples of ways to protect a firm from in records. Under proposed § 121.305, such training must include the general the threat of intentional contamination. records would include such information principles of food defense, including FDA’s Food Defense 101 online courses as the date of the training, the topics simple procedures for employees to are available free-of-charge on our Web covered, and the person(s) trained. An follow to adhere to those principles in site at http://www.fda.gov/Food/ example of records that would comply their jobs. We have tentatively FoodDefense/default.htm. with proposed § 121.160(b) is an concluded that completion of FDA’s We expect these existing courses will attendance sheet with the date, list of training course on Food Defense assist industry to comply with this those in attendance, and the particular Awareness for the Front-line Employee training requirement, if finalized as topics covered (such as an overview of (described in this section of the proposed. We are also aware of training food defense principles or food defense

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planning). The records required by including the general requirements, required to be kept under proposed part proposed § 121.160(b) would enable a record retention requirements, and 117. However, we requested comment facility to track the training that requirements for official review and on whether there are any circumstances personnel received, thereby enabling public disclosure, are applicable to all that would warrant not applying part 11 identification of personnel that have the records that would be required under to records that would be kept under prerequisite awareness training for an subpart C. Such records would aid proposed part 117. In section XV.C of assignment at an actionable process facilities in compliance with the that document, we provided examples step. Such records could be used to requirements of proposed part 121, and of circumstances in which we exempted document that a person has, as would allow facilities to show, and FDA to records from the requirements of part 11 be required under proposed determine, compliance with the (21 CFR 1.329(b)) to avoid the necessity § 121.160(a), successfully completed requirements of part 121. The proposed of establishing new recordkeeping training appropriate to the person’s requirements of subpart D are discussed systems as long as current practices duties at an actionable process step. in this document. would satisfy the requirements of the We recognize that industry has Proposed § 121.301(b) would establish Act. In the PC proposed rule, we also already begun to implement food that the requirements of proposed asked for comment on whether we defense measures to meet certain § 121.310 apply only to the written food should allow additional time for industry standards, which include defense plan and is discussed in more electronic records to be kept in guidelines for food defense training detail in section V.D.3 of this document. accordance with part 11. We seek (Ref. 63, Ref. 33, Ref. 35). Our proposed 2. Proposed § 121.305—General similar comment with regard to minimum requirements for training are Requirements Applying to Records circumstances that would warrant not consistent with these standards, as well applying part 11 to records that would as with WHO recommendations for Proposed § 121.305 contains general be kept under proposed part 121 and personnel training in its guidance on requirements that would apply to whether we should allow additional food defense (Ref. 6). We seek comment records that would be required under time for electronic records to be kept in on the feasibility of our proposed proposed part 121, including the format accordance with part 11. Comments training requirements, in light of the for required records, the recording of should provide the basis for any view current state of food defense awareness actual values and observations obtained that the requirements of part 11 are not in the industry and available training during monitoring, when records must warranted. resources. be created, and information that must be b. Proposed § 121.305(b). Proposed included in each record. § 121.305(b) would require that records D. Requirements Applying to Records a. Proposed § 121.305(a). Proposed contain the actual values and That Must Be Established and § 121.305(a) would require that the observations obtained during Maintained records be kept as original records, true monitoring. For example, monitoring of When a HACCP-type system is copies (such as photocopies, pictures, the locking of an access door to an implemented for food safety, records are scanned copies, microfilm, microfiche, actionable process step could be a critical part of the system because they or other accurate reproductions of the recorded as ‘‘locked’’ or ‘‘unlocked’’ (or aid facilities in compliance with the original records), or electronic records. ‘‘yes’’ or ‘‘no’’) and the monitoring of requirements, including all the elements True copies of records should be of the presence of staff with only of a food safety plan as proposed in Part sufficient quality to detect whether the appropriate color uniforms in a 117, and allow facilities to show, and original record was changed or designated area could be recorded as FDA to determine, compliance with the corrected in a manner that obscured the ‘‘100% staff (or 10 of 10 staff) with blue requirements. This concept is discussed original entry (e.g., through the use of uniforms’’ or conversely ‘‘80% staff (or in detail in section XV of the PC white-out). Proposed § 121.305(a) would 8 of 10 staff) with blue uniforms’’ in the proposed rule. We have tentatively provide flexibility for mechanisms for case of an improperly implemented concluded that records are critical to keeping records while maintaining the focused mitigation strategy. In the case protect food from intentional integrity of the recordkeeping system. of an improperly implemented focused adulteration caused by acts of terrorism. The proposed requirement allowing true mitigation strategy, it is important to In subpart D of proposed part 121, copies provides options that may be document the extent to which the FDA is proposing to establish compatible with the way records are strategy was incorrectly applied, as requirements applying to records that currently being kept in facilities. monitoring data can show a trend must be established and maintained Proposed § 121.305(a) also would toward loss of control at an actionable according to the requirements of this require that electronic records be kept in process step. So, in the example in proposed rule. This subpart implements accordance with part 11 (21 CFR part which 8 of 10 staff have blue uniforms, numerous provisions in section 418 of 11). Part 11 provides criteria for a facility may also consider the FD&C Act, including sections 418(a), acceptance by FDA, under certain documenting what color the remaining (b)(3), (g), (h), and (n)(1)(A), as well as circumstances, of electronic records, two staff were wearing if such section 420(b) of the FD&C Act. electronic signatures, and handwritten information would be valuable in signatures executed to electronic establishing a trend. If the recording of 1. Proposed § 121.301—Records Subject records as equivalent to paper records numerical values is possible in the to the Requirements of this Subpart D and handwritten signatures executed on monitoring of a focused mitigation Proposed § 121.301(a) would establish paper. The proposed requirement strategy (e.g., if a facility is using a that, except as provided by proposed clarifies and acknowledges that records processing parameter such as heat § 121.301(b), all records required by required by proposed part 121 may be treatment), then the actual times and proposed subpart C of part 121 would retained electronically, provided that temperatures or other appropriate be subject to all requirements of they comply with part 11. processing data should be recorded. proposed subpart D. We have tentatively In the PC proposed rule, FDA c. Proposed § 121.305(c), (d) and (e). concluded that the requirements in tentatively concluded that it would be Proposed § 121.305(c), (d) and (e) would subpart D describing how records must appropriate to apply the requirements of require that records be accurate, be established and maintained, part 11 to the records that would be indelible, and legible (proposed

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§ 121.305(c)); be created concurrently requirement to indicate that the identity a. Proposed § 121.315(a) and (b). with performance of the activity of the product and the production code Proposed § 121.315(a) would require documented (proposed § 121.305(d)); should be included as part of the record that all records that would be required and be as detailed as necessary to ‘‘where appropriate.’’ We note that, in by proposed part 121 be retained at the provide a history of work performed many cases, it will likely be more facility for at least 2 years after the date (proposed § 121.305(e)). Proposed difficult to include this information for they were prepared. Proposed § 121.305(c) and (d) would ensure that a focused mitigation strategy. As noted § 121.315(b) would require that the food the records are useful to the owner, in the discussion on monitoring in defense plan be retained at the facility operator, or agent in charge of a facility section V.C.5 of this proposed rule, for at least 2 years after its use is in complying with the requirements of some focused mitigation strategies may discontinued (e.g., because the facility proposed part 121, for example, in be monitored weekly or monthly. In that has updated the written food defense documenting compliance with case, it may not be appropriate to plan. The 2-year timeframe for all monitoring requirements and verifying include all of the products and records required by proposed part 121 is compliance with the food defense plan. production codes that may have been consistent with the length of time that These proposed requirements would affected by an improperly implemented nonperishable food products, on also ensure that the records would be focused mitigation strategy. Further, in average, can be expected to be in useful to FDA in determining many cases the identity of the product commercial distribution plus a compliance with the requirements of and the production code will not be reasonable time thereafter to ensure that proposed part 121. Proposed relevant because the monitoring will be the records are available for verification § 121.305(e) would provide flexibility to performed in the area surrounding one activities. This proposed requirement is facilities to tailor the amount of detail or more production lines, used for one similar to the proposed records to the nature of the record. or more products, rather than of retention requirement in the PC d. Proposed § 121.305(f). Proposed processing parameters on a production proposed rule, which contains a § 121.305(f) would require that the line for a specific lot of product. On the discussion of similar requirements records include the following: (1) The other hand, if control of processing found in other FDA regulations and in name and location of the facility; (2) the parameters, such as pasteurization time particular the proposed and final rules date and time of the activity and temperature, are used as a focused implementing the recordkeeping documented; (3) the signature or initials mitigation strategy, it would be requirements of the Bioterrorism Act. of the person performing the activity; appropriate to document the product This 2-year retention period would run and (4) where appropriate, the identity and production code, if any, that was from either the date the record is of the product and the production code, being processed at the time of prepared, for day-to-day operational if any. The name and location of the monitoring. The nature of the focused records, or the date at which use of the facility and the date and time would mitigation strategy should drive the record is discontinued, for the food allow the owner, operator, or agent in decision by an owner, operator, or agent defense plan. We seek comment on this charge of a facility (and, during in charge of a facility regarding whether proposal. inspection, an FDA investigator) to or not to include the identity of the b. Proposed § 121.315(c). Proposed assess whether the record is current, to product and the production code, if any, § 121.315(c) would provide that, except identify when and where any deviation in records. for the food defense plan, use of offsite occurred, and to track corrective storage for records is permitted after 6 actions. The signature of the individual 3. Proposed § 121.310—Additional months following the date that the who made the observation would ensure Requirements Applying to the Food record was made if such records can be responsibility and accountability. In Defense Plan retrieved and provided onsite within 24 addition, if there is a question about the hours of request for official review. The record, a signature would ensure that Proposed § 121.310 would require food defense plan would be required to the source of the record will be known. that the owner, operator, or agent in remain onsite. FDA realizes that the Linking a record to a specific product charge of a facility sign and date the proposed requirements for (and, when applicable, the production food defense plan upon initial recordkeeping could require some code) would enable the owner, operator, completion (proposed § 121.310(a)) and facilities to store a significant quantity or agent in charge of a facility covered upon any modification (proposed of records, and that there may not be by this rule to isolate product if there is § 121.310(b)). Such a signature would adequate storage space in the facility for a question that food has been provide direct evidence of the owner, all of these records. Providing for offsite adulterated. We seek comment on the operator, or agent’s acceptance of the storage of most records after 6 months scope and potential burden associated plan and commitment to would enable a facility to comply with with these proposed requirements. implementation of the plan. the proposed requirements for record The proposed requirement (proposed Additionally, the signature, along with retention while reducing the amount of § 121.305(f)(4)) for the identity of the the date of signing, would serve to space needed for onsite storage of the product and production code, if any, is minimize potential confusion over the records without interfering with the important in the context of food safety, authenticity of any differing versions or purpose of record retention, because the where the production of potentially editions of the document that might records will be readily available. adulterated product may result from exist. Proposed § 121.315(c) also would loss of control during processing, such 4. Proposed § 121.315—Requirements provide that electronic records are as an improper cook temperature, and a for Record Retention considered to be onsite if they are recall may be necessary. It is also accessible from an onsite location. especially applicable for food safety in Proposed § 121.315 contains Computerized systems within cases of continuous monitoring, when requirements on the length of time corporations can be networked, the loss of control can be associated records that would be required under allowing for the sending and receiving with a particular product or production proposed part 121 must be retained and of information in a secure fashion to all code. Consistent with the PC proposed allowances for offsite storage of records of the different food processing facilities rule, we have qualified the proposed under certain circumstances. of that corporation worldwide. This

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type of system can be used to provide prohibited. Under section 301(ww) of based enterprises in domestic or export access at multiple locations to records the FD&C Act, the following act, and the markets. In accordance with the Small from multiple facilities. causing thereof, are prohibited: ‘‘[t]he Business Regulatory Enforcement c. Proposed § 121.315(d). Proposed failure to comply with section 420 [of Fairness Act, the Office of Management § 121.315(d) would provide that if the the FD&C Act].’’ To clearly and Budget (OMB) has determined that facility is closed for a prolonged period, communicate that failure to comply this proposed rule is a major rule for the the records may be transferred to some with the regulations established under purpose of congressional review. other reasonably accessible location but section 420 of the FD&C Act is a D. Unfunded Mandates Reform Act of must be returned to the facility within prohibited act, proposed § 121.401(b) 1995 24 hours for official review upon would establish that the failure to request. Allowing for transfer of records comply with section 420 of the FD&C Section 202(a) of the Unfunded will give practical storage relief to Act or subparts C or D of part 121 is a Mandates Reform Act of 1995 requires seasonal operations or those closed for prohibited act under section 301(ww) of that Agencies prepare a written other reasons for prolonged periods. the FD&C Act. statement, which includes an assessment of anticipated costs and 5. Proposed § 121.320—Requirements VI. Preliminary Regulatory Impact benefits, before proposing ‘‘any rule that for Official Review Analysis includes any Federal mandate that may Proposed § 121.320 would require A. Overview result in the expenditure by State, local, that all records required by proposed and tribal governments, in the aggregate, part 121 be made promptly available to FDA has examined the impacts of the or by the private sector, of $100,000,000 a duly authorized representative of the proposed rule under Executive Order or more (adjusted annually for inflation) Secretary of Health and Human Services 12866, Executive Order 13563, the in any one year.’’ The current threshold upon oral or written request. Regulatory Flexibility Act (5 U.S.C. after adjustment for inflation is $141 601–612), and the Unfunded Mandates million, using the most current (2012) 6. Proposed § 121.325—Public Reform Act of 1995 (Pub. L. 104–4). Implicit Price Deflator for the Gross Disclosure Executive Orders 12866 and 13563 Domestic Product. We expect this Proposed § 121.325 would establish direct Agencies to assess all costs and proposed rule may result in a 1-year that all records required by proposed benefits of available regulatory expenditure that would meet or exceed part 121 will be protected from public alternatives and, when regulation is this amount. disclosure to the extent allowable under necessary, to select regulatory part 20 of this chapter. Our general approaches that maximize net benefits E. Paperwork Reduction Act of 1995 policies, procedures, and practices (including potential economic, This proposed rule contains relating to the protection of confidential environmental, public health and safety, information collection requirements that or otherwise protected information and other advantages; distributive are subject to review by the Office of received from third parties would apply impacts; and equity). We believe that Management and Budget (OMB) under to information received under this rule. this proposed rule is a significant the Paperwork Reduction Act of 1995 regulatory action under Executive Order (PRA) (44 U.S.C. 3501–3520). A E. Compliance 12866. description of these provisions is given Section 103(e) of FSMA amends in the Description section of this B. Regulatory Flexibility Act section 301 of the FD&C Act (21 U.S.C. document with an estimate of the 331) by adding a new section—(uu)—to The Regulatory Flexibility Act annual reporting, recordkeeping, and the list of acts and the causing thereof requires Agencies to analyze regulatory third-party disclosure burden. Included that are prohibited. Under section options that would minimize any in the estimate is the time for reviewing 301(uu) of the FD&C Act, the following significant impact of a rule on small instructions, searching existing data act, and the causing thereof, are entities. The annualized costs per entity sources, gathering and maintaining the prohibited: ‘‘[t]he operation of a facility due to this proposed rule are about data needed, and completing and that manufactures, processes, packs, or $13,000 for a one-facility firm with 100 reviewing each collection of holds food for sale in the United States employees, and there are about 4,100 information. if the owner, operator, or agent in charge small businesses that would be affected FDA invites comments on: (1) of such facility is not in compliance by the proposed rule, so we tentatively Whether the proposed collection of with section 418 [of the FD&C Act].’’ To conclude that the proposed rule could information is necessary for the proper clearly communicate that failure to have a significant economic impact on performance of FDA’s functions, comply with the regulations established a substantial number of small entities. including whether the information will under section 418 of the FD&C Act is a have practical utility; (2) the accuracy of C. Small Business Regulatory prohibited act, proposed § 121.401(a) in FDA’s estimate of the burden of the Enforcement Fairness Act of 1996 subpart E would establish that the proposed collection of information, operation of a facility that manufactures, The Small Business Regulatory including the validity of the processes, packs, or holds food for sale Enforcement Fairness Act of 1996 (Pub. methodology and assumptions used; (3) in the United States if the owner, L. 104–121) defines a major rule for the ways to enhance the quality, utility, and operator, or agent in charge of such purpose of congressional review as clarity of the information to be facility is required to comply with, and having caused or being likely to cause collected; and (4) ways to minimize the is not in compliance with, section 418 one or more of the following: An annual burden of the collection of information or subparts C or D of part 121 is a effect on the economy of $100 million on respondents, including through the prohibited act under section 301(uu) of or more; a major increase in costs or use of automated collection techniques, the FD&C Act. prices; significant adverse effects on when appropriate, and other forms of Section 106(d) of FSMA amends competition, employment, productivity, information technology. section 301 of the FD&C Act by adding or innovation; or significant adverse To ensure that comments on a new section—(ww)—to the list of acts effects on the ability of U.S.-based information collection are received, and the causing thereof that are enterprises to compete with foreign- OMB recommends that written

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comments be faxed to the Office of the Executive order and, consequently, 7. Everstine, K., S. Kennedy, and J. Spink, Information and Regulatory Affairs, a federalism summary impact statement ‘‘Economically Motivated Adulteration OMB, Attn: FDA Desk Officer, FAX: is not required. (EMA) of Food: Common Characteristics of 202–395–7285, or emailed to oira_ EMA Incidents,’’ Journal of Food Protection, IX. Comments 76(4):723–735, 2013. [email protected]. All 8. U.S. Food and Drug Administration. comments should be identified with the We invite public comment on the ‘‘Economically Motivated Adulteration; title ‘‘Focused Mitigation Strategies to matters specified in this document as Public Meeting; Request for Comment,’’ Protect Food Against Intentional well as any other matters concerning Federal Register, 74(64):15497–15499, 2009. Adulteration.’’ this proposed rule that are of interest. http://www.gpo.gov/fdsys/pkg/FR-2009-04- In compliance with the Paperwork Interested persons may submit either 06/pdf/E9-7843.pdf. Accessed September 23, Reduction Act of 1995 (44. U.S.C. electronic comments regarding this 2013. 3407(d)), the agency has submitted the document to http://www.regulations.gov 9. Spink, J. and DC Moyer, ‘‘Defining the Public Health Threat of Food Fraud,’’ Journal information collection provisions of this or written comments to the Division of of Food Science, 75(9):R157–R163, 2011. proposed rule to OMB for review. Dockets Management (see ADDRESSES). It 10. Ingelfinger, J.R., ‘‘Melamine and the Interested persons are requested to send is only necessary to send one set of Global Implications of Food Contamination,’’ comments regarding information comments. Identify comments with the New England Journal of Medicine, collection by January 23, 2014 to the docket number found in brackets in the 359(26):2745–2748, 2008. Office of Information and Regulatory heading of this document. Received 11. Xiu, C. and K.K. Klein, ‘‘Melamine in Affairs, OMB. To ensure that comments comments may be seen in the Division Milk Products in China: Examining the on information collection are received, of Dockets Management between 9 a.m. Factors That Led to Deliberate Use of the Contaminant,’’ Food Policy, 35(5):463–470, OMB recommends that written and 4 p.m., Monday through Friday, and 2010. comments be faxed to the Office of will be posted to the docket at http:// 12. World Health Organization. Food Information and Regulatory Affairs, www.regulations.gov. Security Page. http://www.who.int/trade/ OMB, Attn: FDA Desk Officer, FAX: glossary/story028/en. Accessed September X. References 202–395–6974, or emailed to oira_ 23, 2013 [email protected]. All The following references have been 13. Kolavic, S., A. Kimura, S. Simons, L. comments should be identified with the placed on display in the Division of Slutsker, S. Barth, and C. Haley, ‘‘An Outbreak of Shigella dysenteriae Type 2 title, ‘‘Focused Mitigation Strategies to Dockets Management (see ADDRESSES) and may be seen by interested persons Among Laboratory Workers Due to Protect Food Against Intentional Intentional Food Contamination,’’ Journal of Adulteration.’’ between 9 a.m. and 4 p.m., Monday American Medical Association, 278(5):396– through Friday. (FDA has verified the F. Public Access to the Analyses 398, August 1997. Web site addresses, but FDA is not 14. Anderson, S., J. DeMent, C.B. Ocfemia, The analyses that we have performed responsible for any subsequent changes and D.C. Hunt, Outbreaks of Methomyl to examine the impacts of this proposed to the Web sites after this document Poisoning Caused by the Intentional rule under Executive Order 12866, publishes in the Federal Register.) Contamination of Salsa at the Mi Ranchito Restaurant in Lenexa, KS—August 2009, Executive Order 13563, the Regulatory 1. Kennedy, S.K. and F.F. Busta, ‘‘Chapter Flexibility Act (5 U.S.C. 601–612), the Kansas Department of Health and 5 Biosecurity: Food Protection and Defense,’’ Environment, April 12, 2011. http:// Unfunded Mandates Reform Act of 1995 Food Microbiology: Fundamentals and www.kdheks.gov/epi/download/Final_Mi_ (Pub. L. 104–4), and the Paperwork Frontiers, Edited by M.P. Doyle and L.R. Ranchito_Report.pdf. Accessed October 22, Reduction Act of 1995 (44 U.S.C. 3501– Beuchat, American Society for Microbiology 2013. 3520) are available to the public in the Press: Washington, DC, pp. 87–102, 2007. 15. U.S. Government Printing Office. docket for this final rule (Ref. 64). Accessed October 30, 2013. Senate Hearing 108–491, ‘‘Agroterrorism: The 2. Khan A.S., D.L. Swerdlow, and D.D. Threat to America’s Breadbasket,’’ p. 1, VII. Analysis of Environmental Impact Juranek, ‘‘Precautions Against Biological and November 19, 2003. http://www.gpo.gov/ Chemical Terrorism Directed at Food and The Agency has determined under 21 fdsys/pkg/CHRG-108shrg91045/html/CHRG- Water Supplies,’’ Public Health Reports, 108shrg91045.htm. Accessed September 23, CFR 25.30(h) that this action is of a type 116(1):3–14, 2001. that does not individually or 2013. 3. Sobel, J., A.S. Khan, and D.L. Swerdlow, 16. The White House, Office of the Press cumulatively have a significant effect on ‘‘Threat of a Biological Terrorist Attack on Secretary. Homeland Security Presidential the human environment (Ref. 65). the US Food Supply: The CDC Perspective,’’ Directive/HSPD–8, December, 17, 2003. Therefore, neither an environmental The Lancet, 359(9309):874–880, March 9, https://www.fas.org/irp/offdocs/nspd/hspd- assessment nor an environmental 2002. 8.html. Accessed October 17, 2013. impact statement is required. 4. To¨ro¨k, T.J., R.V. Tauxe, R.P. Wise, et al., 17. The White House, Office of the Press ‘‘A Large Community Outbreak of Secretary. Homeland Security Presidential VIII. Federalism Salmonellosis Caused by Intentional Directive 7: Critical Infrastructure FDA has analyzed this proposed rule Contamination of Restaurant Salad Bars,’’ Identification, Prioritization, and Protection, Journal of American Medical Association, in accordance with the principles set December, 17, 2003. https://www.dhs.gov/ 278(5):389–395, August 1997. homeland-security-presidential-directive-7. forth in Executive Order 13132. FDA 5. British Standards Institute and Centre Accessed October 17, 2013. has determined that the proposed rule, for the Protection of National Infrastructure. 18. The White House, Office of the Press if finalized, would not contain policies ‘‘Publicly Available Specification 96:2010 Secretary. Homeland Security Presidential that would have substantial direct Defending Food and Drink,’’ March 2010. Directive/HSPD–9, January, 30, 2004. effects on the States, on the relationship http://www.cpni.gov.uk/documents/ https://www.fas.org/irp/offdocs/nspd/hspd- between the National Government and publications/non-cpni_pubs/pas96_ 9.html. Accessed October 17, 2013. the States, or on the distribution of vis14.pdf. Accessed September 25, 2013. 19. The White House, Office of the Press power and responsibilities among the 6. World Health Organization. ‘‘Terrorist Secretary. Presidential Policy Directive/PPD– Threats to Food: Guidance for Establishing 8: National Preparedness, March 30, 2011. various levels of government. and Strengthening Prevention and Response http://www.dhs.gov/presidential-policy- Accordingly, the Agency tentatively Systems,’’ Food Safety Issues, Revision May directive-8-national-preparedness. Accessed concludes that the proposed rule does 2008. http://www.who.int/foodsafety/ October 17, 2013. not contain policies that have publications/general/en/terrorist.pdf. 20. The White House, Office of the Press federalism implications as defined in Accessed September 23, 2013. Secretary. Presidential Policy Directive 21:

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Critical Infrastructure Security and Food/FoodDefense/ Dairy Science, 89:1822–1829, 2006. Accessed Resilience, February 12, 2013. http:// ToolsEducationalMaterials/ucm295997.htm. October 22, 2013. www.whitehouse.gov/the-press-office/2013/ Accessed and printed on October 17, 2013. 42. International Dairy Foods Association. 02/12/presidential-policy-directive-critical- 29. U.S. Food and Drug Administration. Global Markets Page. http://www.idfa.org/ infrastructure-security-and-resil. Accessed Vulnerability Assessment Software Page, key-issues/category/global-markets/map/#us. October 7, 2013. Version 2.4, November 2011. http:// Accessed October 23, 2013. 21. U.S. Food and Drug Administration. www.fda.gov/Food/FoodDefense/ 43. Newkirk, R., C. Hedberg, and J. Bender, Strategic Partnership Program Agroterrorism ToolsEducationalMaterials/ucm295900.htm. ‘‘Establishing a Milkborne Disease Outbreak (SPPA) Initiative: Final Summary Report Accessed September 25, 2013. Profile: Potential Food Defense September 2005—September 2008, December 30. U.S. Food and Drug Administration. Implications,’’ Foodborne Pathogens and 2008. http://www.fda.gov/Food/ Mitigation Strategies Database Page. http:// Disease, 8(3):433–437, 2011. FoodDefense/FoodDefensePrograms/ www.fda.gov/Food/FoodDefense/ 44. Popkin, B., ‘‘Patterns of Beverage Use ucm170509.htm. Accessed September 23, ToolsEducationalMaterials/ucm295898.htm. Across the Lifecycle,’’ Physiology and 2013. Accessed September 25, 2013. Behavior, 100(1):4–9, 2010. 22. U.S. Food and Drug Administration, 31. U.S. Food and Drug Administration. 45. Sebastian, R.S., J.D. Goldman, C.W. Center for Food Safety and Applied Food Defense Plan Builder Software Page. Enns, and R.P. LaComb, ‘‘Fluid Milk Nutrition. ‘‘Guidance for Industry: Food http://www.fda.gov/Food/FoodDefense/ Consumption in the United States: What We Producers, Processors, and Transporters: ToolsEducationalMaterials/ucm349888.htm. Eat In America, NHANES 2005–2006,’’ Food Food Security Preventive Measures Accessed September 25, 2013. Surveys Research Group Dietary Data Brief Guidance,’’ March 2003, Revision October 32. U.S. Food and Drug Administration. No. 3, September 2010. http://ars.usda.gov/ 2007. http://www.fda.gov/Food/ Food Related Emergency Exercise Bundle SP2UserFiles/Place/12355000/pdf/DBrief/3_ GuidanceRegulation/ (FREE–B) Page. http://www.fda.gov/Food/ milk_consumption_0506.pdf. Accessed GuidanceDocumentsRegulatoryInformation/ FoodDefense/ToolsEducationalMaterials/ October 23, 2013. FoodDefense/ucm083075.htm. Accessed ucm295902.htm. Accessed October 17, 2013. 46. U.S. Department of Agriculture and September 23, 2013. 33. Global Food Safety Initiative. GFSI Economic Research Service. Dairy Products: 23. U.S. Food and Drug Administration, Guidance Document, Version 6.1, 6(2), Per capita consumption, United States Center for Food Safety and Applied August 2011. http://www.mygfsi.com/ (Annual), 2013. http://www.ers.usda.gov/ Nutrition. ‘‘Guidance for Industry: Importers gfsifiles/Guidance_Document_Sixth_Edition_ data-products/dairy-data.aspx. Accessed and Filers: Food Security Preventive Version_6.1.pdf. Accessed September 23, October 23, 2013. Measures Guidance,’’ March 2003, Revision 2013. 47. Wein, L.M. and Y. Lui, ‘‘Analyzing a October 2007. http://www.fda.gov/Food/ 34. Safe Quality Food Institute. SQF Code: Bioterror Attack on the Food Supply: The GuidanceRegulation/ A HACCP-Based Supplier Assurance Code Case of Botulinum Toxin in Milk,’’ GuidanceDocumentsRegulatoryInformation/ for the Food Industry, Edition 7.1, April Proceedings of the National Academy of FoodDefense/ucm078978.htm. Accessed 2013. http://www.sqfi.com/wp-content/ Sciences of the United States of America, September 23, 2013. uploads/SQF-Code-Ed-7.1-4-3-13.pdf. 102(28):9984–9989, 2005. 24. U.S. Food and Drug Administration, Accessed October 17, 2013. 48. Blayney, D.P., ‘‘The Changing Center for Food Safety and Applied 35. International Featured Standards. Landscape of U.S. Milk Production,’’ Nutrition. ‘‘Guidance for Industry: Dairy Events and Academy Page. http://www.ifs- Statistical Bulletin No. 978, U.S. Department Farms, Bulk Milk Transporters, Bulk Milk certification.us/events. Accessed November of Agriculture, June 2002. http:// Transfer Stations and Fluid Milk Processors: 5, 2013. usda.mannlib.cornell.edu/usda/nass/sb/ Food Security Preventive Measures 36. China Inspection and Quarantine sb978.pdf. Accessed October 23, 2013. Guidance,’’ July 2003, Revision October Service, Administrative Provisions on Filing 49. Codex Alimentarius Commission. 2007. http://www.fda.gov/Food/ of Export Food Production Enterprises Page. General Principles of Food Hygiene, CAC/ GuidanceRegulation/ http://en.ciqcid.com/Zjl/Comprehensives/ RCP 1–1969, 2003. GuidanceDocumentsRegulatoryInformation/ 51829.htm. Accessed September 25, 2013. 50. Sobel J. and J. Watson, ‘‘Chapter 10: FoodDefense/ucm078978.htm. Accessed 37. German Federal Office of Consumer Intentional Terrorism Contamination of Food September 23, 2013. Protection and Food Safety. ‘‘General and Water,’’ Beyond Anthrax, Springer Link, 25. U.S. Food and Drug Administration, Recommendations for Protection of Animal 2009. Center for Food Safety and Applied Feed and Food Supply Chain From the 51. Stinson, T.F., J. Kinsey, D. Degeneffe, Nutrition. ‘‘Guidance for Industry: Retail Intentional Release of Agents,’’ February and K. Ghosh, How Should America’s Anti- Food Stores and Food Service 2011. Accessed October 22, 2013. Terrorism Budget Be Allocated? Findings Establishments: Food Security Preventive 38. French Republic. Guide Containing From a National Survey of Attitudes of U.S. Measures Guidance,’’ December 2003, Recommendations for the Protection of the Residents About Terrorism, The Food Revision October 2007. http://www.fda.gov/ Food Chain From Threats of Malevolent, Industry Center, March 2006. http:// Food/GuidanceRegulation/ Criminal, or Terrorist Acts, May 2007. ageconsearch.umn.edu/bitstream/14351/1/ GuidanceDocumentsRegulatoryInformation/ http://www.frenchfoodintheus.org/IMG/pdf/ tr06–01.pdf. Accessed October 21, 2013. FoodDefense/ucm082751.htm. Accessed I07008308-imtnea-Guide_des_ 52. Merriam-Webster. Vulnerability Page. September 23, 2013. recommandations-ENG_3_.pdf. Accessed and http://www.merriam-webster.com/dictionary/ 26. U.S. Food and Drug Administration, printed on September 23, 2013. vulnerability. Accessed October 21, 2013. Center for Food Safety and Applied 39. Trusted Information Sharing Network 53. U.S. Food and Drug Administration, Nutrition. ‘‘Guidance for Industry: Cosmetics for Critical Infrastructure Protection. A Study and Report on the Food Processing Processors and Transporters of Cosmetics National Strategy for Enhancing the Safety Sector, 2011. Security Preventive Measures Guidance,’’ and Security of our Food Supply, March 54. U.S. Food and Drug Administration. November 2003, Revision October 2007. 2006. http://www.daff.gov.au/__data/assets/ Analysis of Results for FDA Food Defense http://www.fda.gov/Food/ pdf_file/0004/183325/enhancing_safety_ Vulnerability Assessments and Identification GuidanceRegulation/ security_strategy.pdf. Accessed September of Activity Types, April 2013. http:// GuidanceDocumentsRegulatoryInformation/ 23, 2013. www.fda.gov/food/guidanceregulation/fsma/ FoodDefense/ucm082716.htm. Accessed 40. U.S. Food and Drug Administration. ucm347023.htm. Accessed September 25, September 23, 2013. Memorandum to the File: Evaluation of the 2013. 27. U.S. Food and Drug Administration. potential for intentional adulteration of 55. U.S. Food and Drug Administration. Food Defense 101 Page. http://www.fda.gov/ produce during activities that occur on Memorandum to the File: Evaluation of the Food/FoodDefense/ produce farms, September 2013. potential for intentional adulteration of ToolsEducationalMaterials/ucm353774.htm. 41. Buttars, N.K., A.J. Young, D. Bailey, animal feed from acts of terrorism, December Accessed October 17, 2013. ‘‘Adoption of Security Systems by Dairy 2013. 28. U.S. Food and Drug Administration. Farms To Address Bioterrorist Threats in the 56. U.S. Department of Health and Human Employees FIRST Page. http://www.fda.gov/ Intermountain United States,’’ Journal of Services, Public Health Service, and National

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Toxicology Program. Report on Carcinogens, 121.3 Definitions. actionable process steps, and that are 12th Edition, 2011. 121.5 Exemptions. consistent with the current scientific 57. U.S. Department of Health and Human Subpart B—[Reserved] understanding of food defense at the Services, Centers for Disease Control and time of the analysis. Prevention, and U.S. Department of Subpart C—Food Defense Measures Agriculture. HHS and USDA Select Agents Food means food as defined in section 121.126 Requirement for a food defense and Toxins 7 CFR Part 331, 9 CFR Part 121, 201(f) of the Federal Food, Drug, and plan. and 42 CFR Part 73, September 10, 2013. Cosmetic Act (21 U.S.C. 321(f)) and 121.130 Identification of actionable process http://www.selectagents.gov/resources/ includes raw materials and ingredients. List_of_Select_Agents_and_Toxins_2013-09- steps. 121.135 Focused mitigation strategies for Food defense means the effort to 10.pdf. Accessed October 21, 2013. protect food from intentional acts of 58. U.S. Food and Drug Administration. actionable process steps. Vulnerability Assessments of Food Systems: 121.140 Monitoring. adulteration where there is an intent to Final Summary Report, June 2009-February 121.145 Corrective actions. cause public health harm and economic 2012. http://www.fda.gov/downloads/Food/ 121.150 Verification. disruption. FoodDefense/UCM317547.pdf. Accessed 121.160 Training. Holding means storage of food. September 23, 2013. Subpart D—Requirements Applying to Holding facilities include warehouses, 59. AIB International. Food Safety and Records That Must Be Established and cold storage facilities, storage silos, Food Defense Education Page. https:// Maintained grain elevators, and liquid storage tanks. www.aibonline.org/foodsafetyeducation/ index.html. Accessed October 17, 2013. 121.301 Records subject to the requirements For farms and farm mixed-type 60. Center for Agriculture and Food of this subpart. facilities, holding also includes Security and Preparedness and University of 121.305 General requirements applying to activities traditionally performed by Tennessee Knoxville. Instructor-Led Courses records. farms for the safe or effective storage of Page: Agriculture and Food Vulnerability 121.310 Additional requirements applying raw agricultural commodities grown or Assessment Training. http:// to the food defense plan. raised on the same farm or another farm www.vet.utk.edu/cafsp/courses.php. 121.315 Requirements for record retention. 121.320 Requirements for official review. under the same ownership, but does not Accessed October 17, 2013. include activities that transform a raw 61. International Featured Standards. IFS 121.325 Public disclosure. agricultural commodity, as defined in Food: Standard for Auditing Quality and Subpart E—Compliance Food Safety of Food Products, Version 6, section 201(r) of the Federal Food, Drug, January 2012. http://www.ifs- 121.401 Compliance. and Cosmetic Act, into a processed food certification.com/images/ifs_standards/ifs6/ Authority: 21 U.S.C. 331, 342, 350g, as defined in section 201(gg). _ _ _ IFS Food V6 en.pdf. Accessed September 350(i), 371, 374. Manufacturing/processing means 23, 2013. making food from one or more 62. National Center for Food Protection Subpart A—General Provisions ingredients, or synthesizing, preparing, and Defense. Food Defense Online Modules Page. http://www.ncfpd.umn.edu/index.cfm/ § 121.3 Definitions. treating, modifying or manipulating food, including food crops or education/food-defense-online-modules/. The definitions and interpretations of ingredients. Examples of Accessed October 17, 2013. terms in section 201 of the Federal 63. AIB International. The AIB manufacturing/processing activities are Food, Drug, and Cosmetic Act are International Consolidated Standards for cutting, peeling, trimming, washing, applicable to such terms when used in Inspection: Prerequisite and Food Safety waxing, eviscerating, rendering, this part. The following definitions also Programs, January 2013. https:// cooking, baking, freezing, cooling, www.aibonline.org/Standards/ apply: pasteurizing, homogenizing, mixing, 2013FoodSafety_web_ENG.pdf. Accessed Actionable process step means a formulating, bottling, milling, grinding, October 17, 2013. point, step, or procedure in a food extracting juice, distilling, labeling, or 64. U.S. Food and Drug Administration. process at which food defense measures FDA’s Preliminary Regulatory Impact packaging. For farms and farm mixed- can be applied and are essential to Analysis, Preliminary Regulatory Flexibility type facilities, manufacturing/ prevent or eliminate a significant Analysis, Preliminary Unfunded Mandates processing does not include activities vulnerability or reduce such Reform Act Analysis, Preliminary Paperwork that are part of harvesting, packing, or Reduction Act Analysis, December 2013. vulnerability to an acceptable level. 65. U.S. Food and Drug Administration. Contaminant means any biological, holding. Memorandum to the File: Environmental chemical, physical or radiological agent Mixed-type facility means an analysis related to the proposed rule on that may be intentionally added to food establishment that engages in both focused mitigation strategies to protect food and that may cause illness, injury or activities that are exempt from against intentional adulteration, November registration under section 415 of the 2013. death. Facility means a domestic facility or Federal Food, Drug, and Cosmetic Act List of Subjects in 21 CFR Part 121 a foreign facility that is required to and activities that require the register under section 415 of the Federal establishment to be registered. An Food packaging, Foods. example of such a facility is a ‘‘farm Therefore, under the Federal Food, Food, Drug, and Cosmetic Act (21 U.S.C. mixed-type facility,’’ which is an Drug, and Cosmetic Act and under 350d), in accordance with the establishment that grows and harvests authority delegated to the Commissioner requirements of 21 CFR part 1, subpart crops or raises animals and may of Food and Drugs, it is proposed that H. conduct other activities within the farm 21 CFR chapter I be amended by adding Farm means farm as defined in definition, but also conducts activities part 121 to read as follows: § 1.227 of this chapter. FDA means the Food and Drug that require the establishment to be PART 121—FOCUSED MITIGATION Administration. registered. STRATEGIES TO PROTECT FOOD Focused mitigation strategies mean Monitor means to conduct a planned AGAINST INTENTIONAL those risk-based, reasonably appropriate sequence of observations or ADULTERATION measures that a person knowledgeable measurements to assess whether about food defense would employ to focused mitigation strategies are Subpart A—General Provisions significantly minimize or prevent consistently applied and to produce an Sec. significant vulnerabilities identified at accurate record for use in verification.

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Packing means placing food into a Verification means those activities, (ii) Constitutes not more than 5 container other than packaging the food. other than monitoring, that establish percent of the overall sales of the For farms and farm mixed-type that the system is operating according to facility, as determined by the Secretary facilities, packing also includes the food defense plan. of the Treasury. activities traditionally performed by Very small business means a business (f) This part does not apply to the farms to prepare raw agricultural that has less than $10,000,000 in total manufacturing, processing, packing, or commodities grown or raised on the annual sales of food, adjusted for holding of food for animals other than same farm or another farm under the inflation. man. same ownership for storage and Vulnerability means the susceptibility transport, but does not include activities of a point, step, or procedure in a Subpart B—[Reserved] that transform a raw agricultural facility’s food process to intentional commodity, as defined in section 201(r) adulteration. Subpart C—Food Defense Measures of the Federal Food, Drug, and Cosmetic § 121.5 Exemptions. § 121.126 Requirement for a food defense Act, into a processed food as defined in plan. section 201(gg). (a) This part does not apply to a Qualified end-user, with respect to a qualified facility, except that qualified (a) Food defense plan. The owner, food, means the consumer of the food facilities must, upon request, provide operator, or agent in charge of a facility (where the term consumer does not for official review documentation that must prepare, or have prepared, and include a business); or a restaurant or was relied upon to demonstrate that the implement a written food defense plan. retail food establishment (as those terms facility meets this exemption. Such (b) Contents of a food defense plan. are defined in § 1.227 of this chapter) documentation must be retained for 2 The food defense plan must include: that: years. (1) The written identification of actionable process steps as required by (1) Is located: (b) This part does not apply to the § 121.130; (i) In the same State as the qualified holding of food, except the holding of (2) The written focused mitigation facility that sold the food to such food in liquid storage tanks. strategies as required by § 121.135(b); restaurant or establishment; or (c) This part does not apply to the (3) The written procedures for (ii) Not more than 275 miles from packing, re-packing, labeling, or re- monitoring as required by § 121.140(a); such facility; and labeling of food where the container that (4) The written corrective action (2) Is purchasing the food for sale directly contacts the food remains procedures as required by directly to consumers at such restaurant intact. § 121.145(a)(1); and or retail food establishment. (d) This part does not apply to (5) The written verification Qualified facility means (when activities of a facility that are subject to procedures as required by § 121.150(e). including the sales by any subsidiary; section 419 of the Federal Food, Drug, affiliate; or subsidiaries or affiliates, and Cosmetic Act (21 U.S.C. 350h) § 121.130 Identification of actionable collectively, of any entity of which the (Standards for Produce Safety). process steps. facility is a subsidiary or affiliate) a (e)(1) This part does not apply with facility that is: The owner, operator, or agent in respect to alcoholic beverages at a (1) A very small business as defined charge of a facility must identify any facility that meets the following two in this part; or actionable process steps, using the (2) A facility to which both of the conditions: procedures described in either following apply: (i) Under the Federal Alcohol paragraph (a) or paragraph (b) of this (i) During the 3-year period preceding Administration Act (27 U.S.C. 201 et section. The identification of actionable the applicable calendar year, the average seq.) or chapter 51 of subtitle E of the process steps and the assessment annual monetary value of the food Internal Revenue Code of 1986 (26 leading to that identification must be manufactured, processed, packed or U.S.C. 5001 et seq.) the facility is written. held at such facility that is sold directly required to obtain a permit from, (a) Key activity types. The owner, to qualified end-users (as defined in this register with, or obtain approval of a operator, or agent in charge of a facility part) during such period exceeded the notice or application from the Secretary must assess, for each type of food average annual monetary value of the of the Treasury as a condition of doing manufactured, processed, packed or food sold by such facility to all other business in the United States, or is a held at the facility, whether the facility purchasers; and foreign facility of a type that would has one or more of the following key (ii) The average annual monetary require such a permit, registration, or activity types and identify the value of all food sold during the 3-year approval if it were a domestic facility; actionable process steps associated with period preceding the applicable and any key activity types present: calendar year was less than $500,000, (ii) Under section 415 of the Federal (1) Bulk liquid receiving and adjusted for inflation. Food, Drug, and Cosmetic Act (21 U.S.C. loading—a step in which a bulk liquid Significant vulnerability means a 350d) the facility is required to register is received and unloaded from an vulnerability for which a prudent as a facility because it is engaged in inbound conveyance or loaded into an person knowledgeable about food manufacturing, processing, packing, or outbound conveyance where a defense would employ food defense holding one or more alcoholic contaminant can be intentionally measures because of the potential for beverages. introduced and, if it is, it is likely that serious adverse health consequences or (2) This part does not apply with the contaminant will be distributed death and the degree of accessibility to respect to food other than alcoholic throughout the liquid due to sloshing, that point in the food process. beverages at a facility described in movement, or turbulence caused by the Significantly minimize means to paragraph (e)(1) of this section, receiving and unloading or loading reduce to an acceptable level, including provided such food: activity. to eliminate. (i) Is in prepackaged form that (2) Liquid storage and handling—a Small business means a business prevents any direct human contact with step in which a liquid is contained in employing fewer than 500 persons. such food; and bulk storage tanks or in holding, surge,

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or metering tanks where a contaminant focused mitigation strategies with facility operated by such owner, can be intentionally introduced and, if sufficient frequency to provide operator, or agent in charge if the it is, it is likely that the contaminant assurances that they are consistently change creates a reasonable potential for will be distributed into the food. applied. a new vulnerability or a significant (3) Secondary ingredient handling—a (c) All monitoring of focused increase in a previously identified staging, preparation, addition, or rework mitigation strategies in accordance with vulnerability; step where a contaminant can be this section must be documented in (iii) Whenever such owner, operator intentionally introduced into a records that are subject to verification in or agent in charge becomes aware of relatively small amount of ingredient or accordance with § 121.150(a) and new information about potential rework and, if it is, it is likely that the records review in accordance with vulnerabilities associated with the food contaminant will be distributed into a § 121.150(c). operation or facility; larger volume of food. (iv) Whenever a focused mitigation § 121.145 Corrective actions. (4) Mixing and similar activities—a strategy is found to be ineffective; and step, such as mixing, blending, (a) Corrective action procedures. (1) (v) Whenever FDA requires reanalysis homogenizing, or grinding where a The owner, operator, or agent in charge to respond to new vulnerabilities and contaminant can be intentionally of a facility must establish and developments in scientific introduced and, if it is, it is likely that implement written corrective action understanding including, as the contaminant will be distributed into procedures that must be taken if focused appropriate, results from the the food. mitigation strategies are not properly Department of Homeland Security (b) Vulnerability assessment. The implemented. biological, chemical, radiological, or owner, operator, or agent in charge of a (2) The corrective action procedures other terrorism risk assessment. facility must conduct or have must describe the steps to be taken to (2) Complete such reanalysis and conducted, for each type of food ensure that appropriate action is taken implement any additional focused manufactured, processed, packed or to identify and correct a problem with mitigation strategies needed to address held at the facility, an evaluation to implementation of a focused mitigation the significant vulnerabilities identified, identify and prioritize the points, steps, strategy to reduce the likelihood that the if any, before the change in activities at and procedures in a food operation problem will recur. the facility is operative or, when (b) Documentation. All corrective based on their vulnerability to necessary, during the first 6 weeks of actions taken in accordance with this intentional adulteration and to identify production; and actionable process steps. Such section must be documented in records (3) Revise the written plan if a vulnerability assessments must be that are subject to verification in significant change is made or document performed by an individual(s) qualified accordance with § 121.150(b) and the basis for the conclusion that no by experience and/or training using records review in accordance with additional or revised focused mitigation § 121.150(c). appropriate methods. strategies are needed. (e) Documentation. All verification § 121.135 Focused mitigation strategies § 121.150 Verification. for actionable process steps. (a) Monitoring. The owner, operator, activities taken in accordance with this section must be documented in records. (a) The owner, operator, or agent in or agent in charge of a facility must charge of a facility must identify and verify that monitoring is being § 121.160 Training. implement focused mitigation strategies conducted, as required by § 121.140. (a) Personnel and supervisors (b) Corrective actions. The owner, at each actionable process step to assigned to actionable process steps operator, or agent in charge of a facility provide assurances that the significant must receive appropriate training in must verify that appropriate decisions vulnerability at each step will be food defense awareness and their significantly minimized or prevented about corrective actions are being made, as required by § 121.145. respective responsibilities in and the food manufactured, processed, implementing focused mitigation packed, or held by such facility will not (c) Implementation and effectiveness. The owner, operator, or agent in charge strategies. be adulterated under section 402 of the (b) All training received in accordance Federal Food, Drug, and Cosmetic Act of a facility must verify that the focused mitigation strategies are consistently with this section must be documented (21 U.S.C. 342). in records. (b) Focused mitigation strategies must implemented and are effectively and be written. significantly minimizing or preventing Subpart D—Requirements Applying to (c) Focused mitigation strategies the significant vulnerabilities. As Records That Must Be Established and required under this section are subject appropriate to the facility and the food, Maintained to: this must include review of the (1) Monitoring as required by monitoring and corrective actions § 121.301 Records subject to the § 121.140; records within appropriate timeframes requirements of this subpart D. (2) Corrective actions as required by to ensure that the records are complete, (a) Except as provided by paragraph § 121.145; and the activities reflected in the records (b) of this section, all records required (3) Verification as required by occurred in accordance with the food by subpart C of this part are subject to § 121.150. defense plan, the focused mitigation all requirements of this subpart D. strategies are effective, and appropriate (b) The requirements of § 121.310 § 121.140 Monitoring. decisions were made about corrective apply only to the written food defense (a) The owner, operator, or agent in actions. plan. charge of a facility must establish and (d) Reanalysis. The owner, operator, implement written procedures, or agent in charge of a facility must: § 121.305 General requirements applying including the frequency with which (1) Conduct a reanalysis of the food to records. they are to be performed, for monitoring defense plan: Records must: the focused mitigation strategies. (i) At least once every 3 years; (a) Be kept as original records, true (b) The owner, operator, or agent in (ii) Whenever a significant change is copies (such as photocopies, pictures, charge of a facility must monitor the made in the activities conducted at a scanned copies, microfilm, microfiche,

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or other accurate reproductions of the least 2 years after the date they were Subpart E—Compliance original records), or electronic records, prepared. which must be kept in accordance with (b) The food defense plan must be § 121.401 Compliance. part 11 of this chapter; retained for at least 2 years after its use (a) The operation of a facility that (b) Contain the actual values and is discontinued; manufactures, processes, packs, or holds observations obtained during (c) Except for the food defense plan, food for sale in the United States if the monitoring; offsite storage of records is permitted (c) Be accurate, indelible, and legible; after 6 months following the date that owner, operator, or agent in charge of (d) Be created concurrently with the record was made if such records can such facility is required to comply with, performance of the activity documented; be retrieved and provided onsite within and is not in compliance with, section (e) Be as detailed as necessary to 24 hours of request for official review. 418 of the Federal Food, Drug, and provide history of work performed; and The food defense plan must remain Cosmetic Act (21 U.S.C. 350g) or (f) Include: onsite. Electronic records are considered subparts C or D of this part is a (1) The name and location of the to be onsite if they are accessible from prohibited act under section 301(uu) of facility; an onsite location. the Federal Food, Drug, and Cosmetic (2) The date and time of the activity (d) If the facility is closed for a Act (21 U.S.C. 331(uu)). documented; prolonged period, the records may be (3) The signature or initials of the (b) The failure to comply with section transferred to some other reasonably person performing the activity; and 420 of the Federal Food, Drug, and (4) Where appropriate, the identity of accessible location but must be returned Cosmetic Act (21 U.S.C. 350i) or the product and the production code, if to the facility within 24 hours for subparts C or D of this part is a official review upon request. any. prohibited act under section 301(ww) of the Federal Food, Drug, and Cosmetic § 121.310 Additional requirements § 121.320 Requirements for official review. applying to the food defense plan. All records required by this part must Act. The food defense plan must be signed be made promptly available to a duly Dated: December 13, 2013. and dated by the owner, operator, or authorized representative of the Leslie Kux, Secretary of Health and Human Services agent in charge of the facility: Assistant Commissioner for Policy. (a) Upon initial completion; and upon oral or written request. (b) Upon any modification. [FR Doc. 2013–30373 Filed 12–20–13; 8:45 am] § 121.325 Public disclosure. BILLING CODE 4160–01–P § 121.315 Requirements for record Records required by this part will be retention. protected from public disclosure to the (a) All records required by this part extent allowable under part 20 of this must be retained at the facility for at chapter.

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