Focused Mitigation Strategies To Protect Food Against Intentional Adulteration
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Proposed rule.
CFR Part: "21 CFR Parts 16 and 121"
RIN Number: "RIN 0910-AG63"
Citation: "78 FR 78014"
Document Number: "Docket No.
"Proposed Rules"
SUMMARY:
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Table of Contents
Executive Summary
   Scope of Coverage of the Proposed Rule
   Summary of the Major Provisions of the Proposed Rule
   Costs and Benefits
I. Introduction
II. Background
   A. Incidents of Intentional Adulteration of Food
   B. Interagency Approach to Food Defense
   C. Resources for the Food Sector
   D. Outreach
   E. Industry Standards
   F. International Food Defense Guidelines
III. Legal Authority
   A. Section 103 of FSMA
   B. Section 106 of FSMA
   C. Intrastate Activities
IV. Regulatory Approach
   A. Framework of the Rule
   B. Activities That Occur on
   C. Transportation Carriers
   D. Food for Animals
   E. Acts of Disgruntled Employees, Consumers, or Competitors
   F. Economically Motivated Adulteration
   G. Low-Risk Activities at Farm Mixed-Type Facilities
   H. Activities That Occur on
   I. Other Ways To Focus on Foods With a High Risk of Intentional Adulteration Caused by Terrorism
V. The Proposal
   A. Definitions
   B. Exemptions
   C. Food Defense Measures
   D. Requirements Applying to Records That Must Be Established and Maintained
   E. Compliance
VI. Preliminary Regulatory Impact Analysis
VII. Analysis of Environmental Impact
VIII. Federalism
IX. Comments
X. References
Executive Summary
   This proposed regulation implements three provisions of the Federal Food, Drug, and Cosmetic (FD&C) Act, as amended by the FDA Food Safety Modernization Act (FSMA), that relate to the intentional adulteration of food. Section 418 of the FD&C Act (21 U.S.C. 350g) addresses intentional adulteration in the context of facilities that manufacture, process, pack, or hold food and are required to register under section 415 of the FD&C Act (21 U.S.C. 350d). Section 419 of the FD&C Act (21 U.S.C. 350h) addresses intentional adulteration in the context of fruits and vegetables that are raw agricultural commodities. Section 420 of the FD&C Act (21 U.S.C. 350i) addresses intentional adulteration in the context of high risk foods and exempts farms except for farms that produce milk.
Scope of Coverage of the Proposed Rule
   The subject of this proposed rule is protection of food against intentional adulteration caused by acts of terrorism. This proposed rule would apply to both domestic and foreign facilities that are required to register under section 415 of the FD&C Act. However, as explained in the remainder of this document and shown in Diagram 1 and Table 1, the proposed rule contains several exemptions. (The diagrams and table below are intended to illustrate the proposed scope and requirements of this rule, and do not include all aspects of the proposed regulation.) These exemptions are:
    * The proposed rule would not apply to a qualified facility, except that the facility would be required to provide for official review, upon request, documentation that was relied upon to demonstrate that the facility qualifies for this exemption. As proposed, a qualified facility would be: (1) A very small business (i.e., a business that has less than
    * This proposed rule would not apply to the holding of food, except the holding of food in liquid storage tanks.
    * This proposed rule would not apply to the packing, re-packing, labeling, or re-labeling of food where the container that directly contacts the food remains intact.
    * This proposed rule would not apply to activities of a facility that are subject to section 419 of the Federal Food, Drug, and Cosmetic Act (Standards for Produce Safety).
    * This proposed rule would not apply with respect to alcoholic beverages at a facility that meets certain conditions.
    * This proposed rule would not apply to the manufacturing, processing, packing, or holding of food for animals other than man.
   We seek comment on these exclusions and whether additional exclusions are warranted.
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See Illustration in Original Document.
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Table 1--Scope of Intentional Adulteration and Proposed Exclusions and Exemptions Type of intentional Coverage within scope of Brief rationale, and adulteration proposed relevant corresponding 21 CFR 121 section of the rule * I. Types of Intentional Adulteration Considered in this Proposed Rulemaking 1. Acts of disgruntled Not within the scope of [ ] Not considered employees, consumers, or intentional adulteration "high risk" because not competitors intended to covered under proposed intended to cause attack the reputation of 21 CFR 121 widespread, significant a company, and not to public health harm. cause public health [ ] See section IV.E harm, although public of this document. health harm may occur 2. Economically Not within the scope of [ ] Considering motivated adulteration intentional adulteration addressing as part of (EMA) intended to obtain covered under proposed hazard analysis in a economic gain, and not 21 CFR 121 preventive controls to cause public health framework where EMA is harm, although public "reasonably likely to health harm may occur occur." [ ] See section IV.F of this document. 3. Acts intended to Covered within scope, [ ] Considered "high cause massive public and is the focus of risk" because intent of health harm, including proposed 21 CFR 121 the act is to cause acts of terrorism widespread, significant public health harm. [ ] 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 Brief rationale, and (and any associated relevant corresponding modified requirements) section of the rule * Activities that fall Excluded [ ] Activities that within the definition of occur on produce farms "farm" (as defined in 21 are not considered "high CFR S. 1.227) risk." [ ] Activities that occur on dairy farms are addressed below. [ ] Activities that occur on other farms are outside the scope of 103, 105, and 106 of FSMA. [ ] See section IV.B of this document. Transportation carriers Excluded [ ] Transportation of bulk liquids is addressed by coverage of shippers and receivers. [ ] Other transportation activities are not considered "high risk." [ ] See section IV.C of this document. Activities that occur on [ ] Fluid milk storage and loading appear to dairy farms pose a significant vulnerability. [ ] We seek comment on practical and effective approach to address this vulnerability. [ ] See section IV.H of this document. Qualified facility, as Exempt, except must [ ] Very small defined in proposed S. provide for FDA review, businesses are not 121.3 upon request, considered "high risk." documentation relied on [ ] See section to demonstrate that the V.B.1 of this document. facility qualifies for this exemption Holding of food, except Exempt [ ] Not considered the holding of food in "high risk" because liquid storage tanks these activities do not fit within any of the FDA-identified key activity types. [ ] See section V.B.2 of this document. Packing, re-packing, Exempt [ ] Not considered labeling, or re-labeling "high risk" because of food where the these activities do not container that directly fit within any of the contacts the food FDA-identified key remains intact activity types. [ ] See section V.B.3 of this document. Activities of a facility Exempt [ ] Activities that that are subject to occur on produce farms Standards for Produce are not considered "high Safety (proposed 21 CFR risk." 112) [ ] See section V.B.4 of this document. Alcoholic beverages at Exempt [ ] Alcoholic certain alcohol-related beverages at these facilities, and certain facilities are outside prepackaged food sold in the scope of 103, 105, limited quantities along and 106 of FSMA. with alcoholic beverages [ ] See section at the same facilities V.B.5 of this document. (see proposed S. 121.5(e)) Manufacturing, Exempt [ ] Not considered processing, packing, or "high risk" because holding of food for unlikely to impact human animals health. [ ] 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.
Summary of the Major Provisions of the Proposed Rule
   This proposed rule would establish various food defense measures that an owner, operator, or agent in charge of a facility would be required to implement to protect against the intentional adulteration of food, as summarized in Diagram 2. Specifically:
    * Prepare and implement a written food defense plan that includes actionable process steps, focused mitigation strategies, and procedures for monitoring, corrective actions, and verification (proposed
    * Identify any actionable process steps, using one of two procedures.
    * Identify and implement focused mitigation strategies at each actionable process step to provide assurances that the significant vulnerability at each step will be significantly minimized or prevented and the food manufactured, processed, packed, or held by the facility will not be adulterated (proposed
    * Establish and implement procedures, including the frequency with which they are to be performed, for monitoring the focused mitigation strategies (proposed
    * Establish and implement corrective action procedures that must be taken if focused mitigation strategies are not properly implemented (proposed
    * Verify that monitoring is being conducted and appropriate decisions about corrective actions are being made; verify that the focused mitigation strategies are consistently implemented and are effectively and significantly minimizing or preventing the significant vulnerabilities; and conduct a reanalysis of the food defense plan (proposed
    * Ensure that personnel and supervisors assigned to actionable process steps receive appropriate training in food defense awareness and their respective responsibilities in implementing focused mitigation strategies (proposed
    * Establish and maintain certain records, including the written food defense plan; written identification of actionable process steps and the assessment leading to that identification; written focused mitigation strategies; written procedures for monitoring, corrective actions, and verification; and documentation related to training of personnel (proposed SUBSEC 121.301 to 121.325).
   As proposed, the effective date is 60 days after a final rule is published. However, we are providing for a longer timeline for facilities to come into compliance. Facilities, other than small and very small businesses, would have one year after the effective date to comply with proposed part 121. Small businesses (i.e., those employing fewer than 500 persons) would have 2 years after the effective date to comply with proposed part 121. Very small businesses (i.e., businesses that have less than
BILLING CODE 4160-01-P
See Illustration in Original Document.
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   In addition, we describe our current thinking and seek comment on other issues, including activities that occur on dairy farms and economically motivated adulteration. Finally, elsewhere in this issue of the
Costs and Benefits
   As described in the Preliminary Regulatory Impact Analysis (PRIA), we estimate the annualized costs of the actions required by this proposed rule to be about
Annualized Cost and Benefit Overview All numbers are USD millions, annualized over 10 years 3% 7% discount 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
   The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), signed into law on
   Section 103 of FSMA directs
   Efforts to protect against intentional adulteration require a shift in perspective from that applied to traditional food safety. In proposed rules entitled "Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food" (78 FR 3646,
II. Background
   Intentional adulteration of the food supply can result in catastrophic public health consequences, widespread public fear, loss of public confidence in the safety of food and the ability of government to ensure food safety, and significant adverse economic impacts, including disruption of trade (Ref. 1, Ref. 2, Ref. 3, Ref. 4). Acts of intentional adulteration may take several forms, including acts of terrorism; acts of disgruntled employees, consumers, or competitors; and economically motivated adulteration. Acts of terrorism are associated with an intent to cause massive public health harm and, to a lesser extent, economic disruption (Ref. 5, Ref. 2, Ref. 3, Ref. 6). Acts of disgruntled employees, consumers, or competitors are generally understood to be directed at attacking the reputation of the company and not at public health harm. The primary purpose of economically motivated adulteration is to obtain economic gain, and not to impact public health (Ref. 7, Ref. 8, Ref. 9), although public health harm may occur (Ref. 10, Ref. 11).
   "Food defense" and "food security" are terms that are sometimes used interchangeably. We use the term "food defense" to refer to the effort to protect food from acts of intentional adulteration where there is an intent to cause public health harm and economic disruption. "Food security" is defined by the
A. Incidents of Intentional Adulteration of Food
   Several cases of intentional adulteration with the intent to cause public health harm and economic disruption in
   A widespread incident of economically motivated adulteration occurred in
B. Interagency Approach to Food Defense
1. Homeland Security Presidential Directives and Presidential Policy Directives for the Food and Agriculture Sector
   Intelligence gathered since the attacks on
2. The Evolution of Vulnerability Assessments
   Initially,
   At first, ORM-based assessments were focused on reducing large public health consequences of attacks on the food supply.
    * Criticality--measure of public health and economic impacts of an attack;
    * Accessibility--ability to physically access and egress from target;
    * Recuperability--ability of a system to recover from an attack;
    * Vulnerability--ease of accomplishing an attack;
    * Effect--amount of direct loss from an attack as measured by loss in production; and
    * Recognizability--ease of identifying a target.
   A seventh attribute, "Shock", was added to the original six attributes to assess the combined health, economic, and psychological impacts of an attack on the food industry. ORM and CARVER+Shock assessment conclusions were consistent; however, the CARVER+Shock methodology improved vulnerability assessment efforts because its process allowed for the identification and estimation of economic and psychological impacts throughout the food system.
   In 2005, the Strategic Partnership Program Agroterrorism (SPPA), a public-private cooperative effort was established by
C. Resources for the Food Sector
   FDA has issued guidance documents and developed other resources to assist industry in their efforts to protect the food supply against intentional adulteration. In 2003,
   FDA also has made available other resources to help industry identify and mitigate potential vulnerabilities for intentional adulteration. These include:
    * The "ALERT" program,
    * The "Employees FIRST" training tool,
    * The "CARVER+Shock Vulnerability Assessment" software tool,
    * The "Mitigations Strategies Database,"
    * The "Food Defense Plan Builder" software tool,
    * The Food Related Emergency Exercise Bundle, and
    * The "Food Defense 101" training courses.
   We describe each briefly in this section of the document.
   The ALERT program, originally released in 2006, is an educational program intended to raise the awareness of State and local governments and industry regarding food defense (Ref. 27). ALERT identifies five key elements that industry can use in food defense planning:
    * A--How do you ASSURE that the supplies and ingredients you use are from safe and secure sources?
    * L--How do you LOOK after the security of the products and ingredients in your facility?
    * E--What do you know about your EMPLOYEES and people coming in and out of your facility?
    * R--Could you provide REPORTS about the security of your products while under your control?
    * T--What do you do and who do you notify if you have a THREAT or issue at your facility, including suspicious behavior?
   Similarly, the Employees FIRST educational tool, originally released in 2008, is a food defense awareness training program for front-line food industry workers about the risk of intentional adulteration and the actions they can take to identify and reduce these risks (Ref. 28). This tool identifies the following five key elements:
    * F--Follow company food defense plan and procedures;
    * I--Inspect your work area and surrounding areas;
    * R--Recognize anything out of the ordinary;
    * S--Secure all ingredients, supplies, and finished product; and
    * T--Tell management if you notice anything unusual or suspicious.
   The CARVER+Shock Vulnerability Assessment software tool, originally released in 2007, helps users conduct vulnerability assessments for their establishments to identify and prioritize the "critical nodes," (also known as critical process steps) the potential targets vulnerable to intentional adulteration attacks (Ref. 29). It guides users through a series of questions to determine the vulnerability of each of the nodes within their facility. After the vulnerabilities are identified, the software helps users to identify mitigation strategies for reducing the risk of intentional adulteration. Using the software tool, the user can focus resources on protecting the most susceptible points in their system.
   The Mitigation Strategies Database (MSD), originally released in 2011, is a database of mitigation strategies that can be applied to different steps in a food operation to reduce the risk of intentional adulteration (Ref. 30). The database is searchable by key words and processing steps common to agriculture and food operations (e.g., growing, harvesting, packing, manufacturing, processing, and holding). See also the discussion in section V.C.3 of this document.
   The Food Defense Plan Builder (FDPB) software tool, released in 2013, is a user-friendly computer software program designed to assist owners and operators of food facilities in developing food defense plans for their facilities (Ref. 31). In addition to providing new functionality for food defense planning and implementation, the FDPB software tool harnesses our food defense guidance documents, CARVER+Shock Vulnerability Assessment software tool, and the MSD into a single application.
   The Food Related Emergency Exercise Bundle (FREE-B), which
   Finally, our food defense training courses, entitled "Food Defense 101" and released in 2013, reflect
D. Outreach
   We have conducted food defense awareness outreach to international and domestic stakeholders. Beginning in 2008, under the auspices of the Asia-Pacific Economic Cooperation (APEC), we collaborated with the
   In 2013, we increased our domestic outreach activities with a series of workshops in
E. Industry Standards
   Guidelines accompanying industry standards in
F. International Food Defense Guidelines
   In 2008, WHO issued its "Terrorist Threats to Food--Guidelines for Establishing and Strengthening Prevention and Response Systems" to provide policy guidance to its Member States for integrating consideration of deliberate acts of sabotage of food into existing prevention and response programs (Ref. 6). WHO uses the term "food terrorism" and defines it as "an act or threat of deliberate contamination of food for human consumption with biological, chemical and physical agents or radionuclear materials for the purpose of causing injury or death to civilian populations and/or disrupting social, economic or political stability." Focusing on the two key strategies of prevention and response, WHO recommends that all segments of the food industry consider the development of security and response plans for their establishments, proportional to the threat and their resources. The guidelines state that the key to preventing food terrorism is enhancing existing food safety programs and implementing reasonable security measures on the basis of vulnerability assessments. The guidelines further state that the most vulnerable foods, food ingredients, and food processes should be identified, including: the most readily accessible food processes; foods that are most vulnerable to undetected tampering; foods that are the most widely disseminated or spread; and the least supervised food production areas and processes.
   Other national governments, including
III. Legal Authority
   FDA is proposing this regulation under the FD&C Act as amended by FSMA. Under sections 103 and 106 of FSMA,
A. Section 103 of FSMA
   Section 103 of FSMA, Hazard Analysis and Risk-Based Preventive Controls, amends the FD&C Act to create a new section 418 that mandates rulemaking. Section 418(n)(1)(A) of the FD&C Act requires that the Secretary of
   In addition to rulemaking requirements, section 418 of the FD&C Act contains requirements applicable to the owner, operator, or agent in charge of a facility required to register under section 415 of the FD&C Act. Section 418(a) of the FD&C Act is a general provision that requires the owner, operator, or agent in charge of a facility to evaluate the hazards that could affect food manufactured, processed, packed, or held by the facility, identify and implement preventive controls, monitor the performance of those controls, and maintain records of the monitoring. In addition to the general requirements in section 418(a) of the FD&C Act, sections 418(b) to (i) of the FD&C Act contain more specific requirements applicable to facilities, including several provisions explicitly directed at intentional adulteration. For example, section 418(b)(2) of the FD&C Act specifies that the owner, operator, or agent in charge of a facility shall identify and evaluate hazards that may be intentionally introduced, including by acts of terrorism. Section 418(c)(2) of the FD&C Act specifies that the owner, operator, or agent in charge of a facility shall identify and implement preventive controls to provide assurances that any hazards that relate to intentional adulteration will be significantly minimized or prevented and addressed, consistent with section 420 of the FD&C Act. In sections IV and V of this document, we discuss proposed requirements (proposed subparts C and D of part 121) that would implement these provisions of section 418 of the FD&C Act.
   Sections 418(j) to (m) of the FD&C Act and sections 103(c)(1)(D) and (g) of FSMA provide authority for certain exemptions and modifications to the requirements of section 418 of the FD&C Act. These include provisions related to seafood and juice HACCP, and low-acid canned food (section 418(j) of the FD&C Act); activities of facilities subject to section 419 of the FD&C Act (Standards for Produce Safety) (section 418(k)); qualified facilities (section 418(l)); facilities that are solely engaged in the production of food for animals other than man, the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing, or the storage of packaged foods that are not exposed to the environment (section 418(m)); facilities engaged only in certain low-risk on-farm activities on certain foods conducted by small or very small businesses (section 103(c)(1)(D) of FSMA), and dietary supplements (section 103(g) of FSMA). In sections IV and V of this document, we discuss the related proposed provisions that would implement these provisions of section 418 of the FD&C Act and section 103 of FSMA.
   Section 106 of FSMA, Protection Against Intentional Adulteration, amends the FD&C Act to create a new section 420, which mandates rulemaking. Section 420 of the FD&C Act requires
C. Intrastate Activities
   FDA tentatively concludes that the provisions in the proposed rule should be applicable to activities that are intrastate in character. Facilities are required to register under section 415 of the FD&C Act regardless of whether the food from the facility enters interstate commerce (
IV. Regulatory Approach
A. Framework of the Rule
   This proposed regulation implements three provisions of FSMA that relate to the intentional adulteration of food. Section 103 of FSMA addresses intentional adulteration in the context of facilities that manufacture, process, pack, or hold food and are required to register under section 415 of the FD&C Act. Section 105 of FSMA addresses intentional adulteration in the context of fruits and vegetables that are raw agricultural commodities. Section 106 of FSMA addresses intentional adulteration in the context of high risk foods and exempts farms except for farms that produce milk.
1. Scope of Intentional Adulteration Covered by this Rule
   As noted in section I of this document, acts of intentional adulteration may take several forms, including: (1) Acts of terrorism; (2) acts of disgruntled employees, consumers, or competitors; and (3) economically motivated adulteration. With regard to intentional adulteration from acts of terrorism, we are proposing to require certain facilities covered by this rule to address significant vulnerabilities by implementing focused mitigation strategies at actionable process steps. While we refer to the protection of the food supply from "acts of terrorism" throughout this rule, we expect our proposed approach and the proposed implementation of focused mitigation strategies would generally address acts intended to cause massive public health harm and, to a lesser extent, economic disruption, whether committed by terrorists, terrorist organizations, individuals, or groups of individuals. For the reasons described in section IV.E of this document, we have tentatively concluded not to propose additional requirements for the protection of food against intentional adulteration caused by acts of disgruntled employees, consumers, or competitors. We describe our approach to address economically motivated adulteration in section IV.F of this document, and seek comment on our current thinking on this issue.
2. Identification of Key Activity Types
   Terrorist attacks on the U.S. food supply have been exceedingly rare. However, vulnerability assessments performed by
   As discussed in section V.C.2 of this document, based on an analysis of the vulnerability assessments that
   Designation of these key activity types would serve two purposes. First, it would provide a facility with a means to assess whether it is required to implement focused mitigation strategies or measures intended to protect against intentional adulteration under section 420(b)(1) of the FD&C Act. Second, it would assist a facility subject to section 418 of the FD&C Act with the performance of a hazard analysis to identify and evaluate hazards that may be intentionally introduced by acts of terrorism, in accordance with section 418(b)(2).
   Facilities would be able to determine whether their operations involve one or more of the key activity types or choose to perform a vulnerability assessment. Our experience is that the most challenging part of developing a system of controls for intentional adulteration related to terrorism is identifying the points in the food operation that are most vulnerable to attack by performing a vulnerability assessment. By using the
3. Requirement for a HACCP-Type System of Controls
   We have tentatively concluded that a preventive controls approach like the one we proposed for the systematic control of food safety hazards in the PC proposed rule is the most effective means of ensuring that the focused mitigation strategies are consistently applied once the significant vulnerabilities are identified and appropriate focused mitigation strategies are developed. The evolution and advantages of this system, derived from the HACCP methodology, is discussed in detail in section II.C of the PC proposed rule. The application of HACCP-type controls for ensuring the implementation of food defense mitigation strategies is consistent with the approach taken in Publicly Available Specification (PAS) 96, developed by the
   Section 418 of the FD&C Act exempts several kinds of activities (e.g., those related to seafood, juice, dietary supplements, low-acid canned food [for certain microbiological hazards]). These activities are subject to preventive control-type regulations that address food safety, but not food defense, concerns. Section 420 of the FD&C Act instructs
   We acknowledge that regulation of entities in the food production system (in this case, facilities) to reduce the risk of intentional adulteration of food caused by acts of terrorism is, essentially, without precedent. Such an endeavor is further complicated by the low probability and potentially high impact nature of such an attack which makes estimating potential public health benefits and establishing an appropriate threshold for requiring action difficult. We are further challenged by the paucity of data on the extent to which facilities have already implemented programs to mitigate this risk, and the effectiveness of various strategies to prevent intentional adulteration of food caused by acts of terrorism.
   In developing this proposed rule we have relied on our experience in both implementing preventive control schemes targeting unintentional food safety hazards as well as working with the U.S. intelligence community on the threat of a terrorist attack on the food and agriculture sector, including performing vulnerability assessments and developing guidance for industry. While these activities have provided us with a useful foundation on which to develop this proposed rule, the challenges described previously remain. We request comment on our proposed approach, including on the following issues:
    * From which entities would implementation of measures to protect against intentional adulteration derive the greatest benefit to public health protection? How could this proposed regulation be modified to better target such entities?
    * Would it be feasible to require measures to protect against intentional adulteration only in the event of a credible threat? If so, would such an approach be consistent with the intentional adulteration provisions of FSMA? How would such requirements be communicated to industry in a timely and actionable manner?
    * What is an appropriate level of public health protection with respect to intentional adulteration, considering the intentional adulteration provisions of FSMA?
    * Are there other ways to further focus the scope of the rule (see also section IV.I of this document)?
4. Compliance Dates
   Section 103(i)(1) of FSMA,
   We have tentatively concluded that it is appropriate to provide a sufficient time period following publication of the final regulation for facilities to come into compliance with proposed part 121.
   FDA is proposing that the final rule would be effective 60 days after publication in the
   Therefore, as proposed, facilities, other than small and very small businesses, that are subject to part 121 would have 1 year after the effective date to comply with proposed part 121. Small businesses would have 2 years after the effective date to comply with proposed part 121 (see section V.A of this document for a discussion of the proposed definition of a "small business"). With respect to very small businesses, we are proposing to exempt qualified facilities, which include very small businesses, from the requirements of proposed part 121, except that such facilities must, upon request, provide for official review documentation that was relied upon to demonstrate that the facility meets this exemption. Very small businesses then would have 3 years after the effective date to comply with proposed
B. Activities That Occur on
   Section 419 of the FD&C Act requires
   In implementing section 419 of the FD&C Act, we considered the risks posed by a terrorist attack on the kinds of activities that occur on produce farms. We considered those activities that fall within the definition of "farm" (as defined in 21 CFR 1.227) (e.g., planting, tilling, irrigating, treating with pesticides, harvesting, drying for purposes of storing or transporting, hydro-cooling, packing, refrigerating, waxing, shelling, sifting, removing leaves, stems and husks, culling, shelling, and washing). We utilized data gathered from vulnerability assessments that we conducted employing the CARVER+Shock methodology, and evaluated whether activities that occur on produce farms pose significant vulnerabilities (Ref. 40).
   Our evaluation found that activities that are typically performed on produce farms are at relatively low risk for intentional adulteration of food from acts of terrorism (Ref. 40). Based on this evaluation, we have tentatively concluded that requirements for produce farms are not necessary to minimize the risk of serious adverse health consequences or death from this type of adulteration. Further, we have tentatively concluded that requirements relating to this form of adulteration are not reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards and to provide reasonable assurances that the produce is not adulterated under section 402 of the FD&C Act. For these reasons, we are not proposing requirements for produce farms to specifically address intentional adulteration related to terrorism. We seek comment on this tentative conclusion and our analysis that informed this tentative decision.
   We acknowledge that there may be activities that occur on produce farms for which we are not proposing requirements that are similar to off-farm activities for which we are proposing to require the implementation of focused mitigation strategies. However, there are aspects of the specific on-farm activities that minimize the risk for intentional adulteration caused by acts of terrorism. For example, waxing is an on-farm activity that is similar to coating and that fits within one of the key activity types. However, there are key differences that make an on-farm waxing operation less vulnerable compared to a coating operation. With waxing, there is difficulty of mixing a contaminant into a clear, heated wax in a tank in close proximity to the busy packing line in an on-farm packing house. Conversely, a coating operation involves an opaque, ambient or refrigerated, aqueous coating mix in a tank and occurs in a relatively isolated part of the manufacturing plant. In addition, the uncertainty about whether the produce leaving the farm is destined for direct consumption or for further processing, such as removal of the wax, which could inactivate or remove any contaminant intentionally added, makes it a relatively less likely target for intentional adulteration.
C. Transportation Carriers
   One of the key activity types that we have tentatively determined indicates a significant vulnerability to intentional adulteration caused by acts of terrorism is Bulk liquid receiving and loading. As proposed, receiving and loading of other types of foods (e.g., non-bulk liquids, solid foods, gaseous foods) are not identified as key activity types because we determined that they do not present this same level of risk. By requiring that shippers and receivers of bulk liquids implement focused mitigation strategies at actionable process steps involving this key activity, as proposed in
   Note that
D. Food for Animals
   As discussed in section V.B.6 of this document, we are proposing to exempt the manufacturing, processing, packing, and holding of animal food from this proposed regulation with respect to intentional adulteration caused by acts of terrorism.
E. Acts of Disgruntled Employees, Consumers, or Competitors
   While the goals and outcomes of acts of disgruntled employees, consumers or competitors can overlap with acts of terrorism, generally, the distinction has to do with differences in scale. Disgruntled employees are generally understood to be interested primarily in attacking the reputation of the company, and otherwise have little interest in public health harm. On the other hand, terrorist organizations are generally understood to be interested in maximizing public health harm and, to a lesser extent, economic disruption (Ref. 5, Ref. 6).
   Section 420(c) of the FD&C Act requires that the regulation prepared under that section apply to "food for which there is a high risk of intentional contamination." In the spectrum of risk associated with intentional adulteration of food, attacks perpetrated by terrorist organizations intent on causing massive casualties and, to a lesser extent, economic disruption would be ranked as relatively high risk. On the other hand, attacks by disgruntled employees, consumers, or competitors would be consistently ranked as relatively low risk; although these events occur annually, their public health and economic impact would be generally quite small. In general, the target food and the point in its production are those of convenience (i.e., a point to which the employee, consumer, or competitor has ready access). Should a disgruntled employee, consumer, or competitor choose to attack at an actionable process step, where the adverse public health and economic consequences could be greater, the provisions of this proposed rule would be effective in minimizing the opportunity for success. Actions taken to mitigate the potential for a terrorist attack against the food supply are likely to have collateral benefits in reducing the potential for an attack by a disgruntled employee, consumer, or competitor (as well as on other security related issues, such as theft and vandalism). As a practical matter, hardening the food supply (i.e., reducing the opportunity for attack) to attacks by disgruntled employees, consumers, or competitors could require taking steps at many more points in the food system than would be required to harden the food supply to minimize the potential for terrorist attack. We have tentatively concluded that the latter can be accomplished by focusing on those points in the food system where an attack would be expected to cause massive adverse public health impact, and, to a lesser extent, economic disruption.
F. Economically Motivated Adulteration
   Efforts to protect against intentional adulteration require a shift in perspective from that applied to traditional food safety. In the PC, Animal Food PC, and Produce Safety proposed rules, we tentatively concluded that hazards associated with intentional adulteration, which are not addressed in traditional HACCP or other food safety systems, likely will require different kinds of controls, and would be best addressed in a separate rulemaking (this proposed rule). However, we also explained how in some circumstances economically motivated adulteration could be viewed as reasonably likely to occur. Further, we requested comment on where to address those hazards that may be intentionally introduced for economic gain. After additional consideration, we present our current thinking in this section of the document.
   For facilities subject to section 418 of the FD&C Act, we have tentatively concluded that economically motivated adulteration would be best addressed under the regulatory regime described in the PC and
   We have tentatively concluded that this hazard-analysis type approach is better suited to address economically motivated adulteration than the vulnerability assessment-type approach we are proposing to address intentional adulteration related to terrorism. In the latter approach, which we are not proposing, significant vulnerabilities would be identified based either on the presence of key activity types (which reflect
   Under this approach, facilities subject to section 418 of the FD&C Act would be expected to implement controls against economically motivated adulteration under circumstances where there has been a pattern of such adulteration in the past, even though the past occurrences may not be associated with the specific supplier or the specific food product but the pattern suggests a potential for intentional adulteration. Further, a system of monitoring, corrective action, verification, and recordkeeping that is similar to those in the PC and
   We seek comment on our tentative conclusions presented above. Specifically, we are interested in information on the specific factors that are most relevant for determining whether economically motivated adulteration is reasonably likely to occur, particularly in instances where the specific product or supplier has not been previously associated with such adulteration. In addition, we seek comment on whether and how these relevant factors may be used to develop appropriate predictive tools or establish a standard for when preventive controls are necessary.
   Section 418 of the FD&C Act contains certain exemptions related to compliance with
   We have also tentatively concluded not to require produce farms subject to section 419 of the FD&C Act and farms that produce milk (also referred to in this document as "dairy farms") subject to section 420 of the FD&C Act to take measures to address economically motivated adulteration. With regard to produce farms subject to section 419 of the FD&C Act, we have tentatively concluded that there are not procedures, processes, or practices that are reasonably necessary to be implemented by these entities to prevent the introduction of known or reasonably foreseeable biological, chemical, or physical hazards that can cause serious adverse health consequences or death as a result of economically motivated adulteration. With regard to farms that produce milk subject to section 420 of the FD&C Act, we have tentatively concluded that there are not appropriate science-based strategies or measures intended to protect against economically motivated adulteration that can be applied at the farm. These tentative conclusions are based on our assessment that preventive controls for economically motivated adulteration are suitable to address such adulteration when it is perpetrated by the entity's supplier, but not when it is perpetrated by the entity itself, as would be the case for economically motivated adulteration at a produce farm or a farm that produces milk. Actions such as auditing of suppliers or reliance upon supplier-supplied test results or production control records are generally considered unsuitable to address economically motivated adulteration where the supplier, if intentionally adulterating the food, would already be violating the law and would be able to subvert these controls. For both types of farms, we are not aware of inputs into the growing, harvesting, packing, or holding of produce or milk (i.e., within our farm definition) that could be subject to economically motivated adulteration that could cause serious adverse health consequences or death under sections 419 and 420 of the FD&C Act. We seek comment on this tentative conclusion.
G. Low-Risk Activities at Farm Mixed-Type Facilities
   Section 103(c)(1)(C) of FSMA directs the Secretary of
   Elsewhere in this issue of the
    * Eggs (In-Shell)
    * Fruits & Vegetables Other Than Pods, Seeds for Direct Consumption, and Hesperidia (Fresh, Intact)
    * Game Meats (Whole or Cut, Not Ground or Shredded, Without Secondary Ingredients)
    * Peanuts & Tree Nuts (Raw, In-Shell)
    * Sugarcane & Sugar Beets (Fresh, Intact)
   We are considering the results of this analysis in determining any specific exemptions or modified requirements. We request comment on whether we should exempt on-farm manufacturing, processing, packing, or holding of the foods identified as having low-risk production practices when conducted by a small or very small business if such activities are the only activities conducted by the business that are subject to section 418 of the FD&C Act. If we were to take this approach, only facilities meeting all of the specified criteria would be exempt as a result of being engaged in low-risk activities. Thus, a facility located on-farm, that is a small or very small business, and only produces fresh, intact apples as a finished product (e.g., by packing apples grown on a different farm that is under different ownership) would be exempt from this proposed rule. On the other hand, an apple-packing facility that is off-farm would not be exempt, an apple packing facility that is on-farm but that is not a small or very small business would not be exempt, and an apple packing facility that also packs green beans would not be exempt. We request comment on whether we should broaden this potential exemption in any way, such as by removing certain of the restrictions mentioned immediately above. We also seek comment on whether we should instead establish modified requirements for facilities that produce foods identified as having low-risk production processes, and if so, what those modified requirements should be and the scope of application of the modified requirements. In addition, we seek comment on whether and how we should consider the results of this analysis in determining whether to exempt or modify the inspections frequency requirements under Section 421 of the FD&C Act, Targeting of Inspection Resources for Domestic Facilities.
H. Activities That Occur on
1. Assessment of Vulnerabilities
   Under section 420 of the FD&C Act, we considered whether activities that occur on farms that produce milk pose a high risk for intentional adulteration of food caused by acts of terrorism that could cause significant adverse health consequences or death. A preliminary evaluation indicates that fluid milk storage appears to fit within the key activity type, Liquid storage and handling, and fluid milk loading appears to fit within the key activity type, Bulk liquid receiving and holding. The fluid milk storage tank is one of the actionable process steps that would be applicable to both of these activities on a dairy farm.
   As discussed in section V.C.2 of this document,
   The risk posed by intentional adulteration of milk on-farm results from a number of factors: (1) The system of milk collection from farms and subsequent holding and processing serves to distribute contaminants added to the milk on the farm into much larger quantities of fluid milk, increasing the potential magnitude of an intentional adulteration event; (2) in its fluid form milk has a short shelf life, increasing the potential for significant adverse public health impacts before detection and, once detected, before a public health intervention can be implemented; (3) fluid milk is widely consumed across different sub-populations, including infants and children, increasing the potential for significant adverse public health impacts and, because of public reaction to child and infant morbidity and mortality, decreasing public confidence in the food supply; (4) fluid milk is consumed in a variety of food forms, including as a beverage (finished food) and as an ingredient in other finished foods, complicating public health intervention; and (5) milk storage tanks are commonly left unlocked (Ref. 41, Ref. 42, Ref. 43, Ref. 44, Ref. 45, Ref. 46, Ref. 47).
2. Mitigation Strategies
   Farms are not subject to the HACCP-type system of preventive controls prescribed in section 418 of the FD&C Act, and our current thinking is that, should we include requirements relative to dairy farms in the final rule, we would not require HACCP-type controls for dairy farms under section 420 of the FD&C Act. Similarly, under section 419 of the FD&C Act we did not propose to apply such an approach to unintentional adulteration on produce farms in the Produce Safety proposed rule (see section IV.D of the Produce Safety proposed rule). Rather, as with produce farms, a more appropriate approach might be a CGMP-type provision that relates directly to the significant vulnerability. Generally, CGMPs set out mandatory, broad, generally applicable practices and conditions that are required to be met, and the criteria and definitions that are applicable in determining whether the food is adulterated. For example, a CGMP approach would identify the broad, generally applicable mitigation strategies that dairy farm operators must implement (e.g., limiting access to fluid milk storage tanks), without specifying how that strategy must be accomplished and without a further requirement for monitoring, recordkeeping or the development of a plan. We seek comment on this approach.
   FDA previously provided guidance for the dairy industry, including dairy farms, on the potential for intentional contamination and identified the types of food defense measures that dairy farms may take to minimize the risk that fluid milk under their control will be subject to tampering or other malicious, criminal, or terrorist actions (Ref. 24). Among other recommendations,
   In light of these circumstances, we request comment on whether and how access to the bulk milk storage tank and associated systems can be limited, and the costs and other implications of doing so. In addition, we are interested in comment on whether and what types of focused mitigation strategies or other measures are currently employed by dairy farms. Specifically for fluid milk storage tanks, we seek comment on whether and what focused mitigation strategies would be appropriate and feasible given current dairy farming practices.
   We also seek comment on whether it would be more appropriate for
3. Scope of Dairy Farms Subject to any Requirement
   Finally, we seek comment on the scope of farms that produce milk that should be subject to any requirements that we may establish in a final rule. For example, the scope of dairy farms covered could be determined based on the potential for adverse public health outcome resulting from consumption of milk produced at a farm, if a contaminant were intentionally introduced into the milk from that farm. Farms with less than 50 milk-producing cows contribute a relatively small proportion to the total volume of milk produced in
   We are requesting comment on whether, under section 420 of the FD&C Act, there are other ways in which the coverage of this proposed regulation can be further focused on foods that present a high risk of intentional adulteration caused by acts of terrorism. For example, are there ways in which a food's shelf life, turnover in the marketplace, batch size, serving size and servings per batch, distribution and consumption patterns, and intended consumer could be considered in providing for an exemption or in setting modified requirements for that food. Ordinarily, these considerations are part of a vulnerability assessment, and in such assessments the risk reduction aspects of one attribute may be offset or exacerbated by those of another attribute, and may be very facility-specific. Such attributes specific to the food(s) manufactured, processed, packed, or held at the facility can be taken into account, should a facility choose to perform its own vulnerability assessment and assign actionable process steps, as provided for in proposed
V. The Proposal
A. Definitions
   In subpart A of proposed part 121, under
   FDA is proposing to define the term " actionable process step " to mean a point, step, or procedure in a food process at which food defense measures can be applied and are essential to prevent or eliminate a significant vulnerability or reduce such vulnerability to an acceptable level. The term "actionable process step" used in the food defense context is analogous to the term "critical control point" (CCP), which is defined as "a point, step, or procedure in a food process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to an acceptable level." Similar to a CCP, in proposed part 121, an "actionable process step" is identified during a vulnerability assessment (analogous to a hazard analysis) in relation to a significant vulnerability (analogous to a hazard that is reasonably likely to occur), and is facility-specific.
   As discussed in section V.C.2 of this document, based on vulnerability assessments,
   FDA is proposing to define the term " contaminant " as any biological, chemical, physical or radiological agent that may be intentionally added to food and that may cause illness, injury or death. We based the proposed definition, in part, on the definition of "contaminant" used in Codex Alimentarius guidelines (Ref. 49) that refers to any biological or chemical agent, foreign matter or other substances not intentionally added to feed or food that may compromise feed and food safety or suitability. In this proposal, the term "contaminant" is used in the context of key activity types, which are related to intentional acts of adulteration caused by acts of terrorism with intent to cause public health harm and, to a lesser extent, economic disruption. Therefore, for the purposes of proposed part 121, we focused the definition of "contaminant" on agents that may be intentionally added to food and that may cause illness, injury, or death, which is consistent with our determination that the primary goal of such an attack would be public health harm (i.e., illness, injury, or death). Our proposed definition of "contaminant" in proposed 121.3 would be applicable to proposed part 121 only. We acknowledge that this term has a broader meaning in other settings, as evidenced by its use in the Codex Alimentarius guidelines.
   FDA is proposing to define the term "facility" to mean a domestic facility or a foreign facility that is required to register under section 415 of the FD&C Act in accordance with the requirements of part 1, subpart H (21 CFR part 1, subpart H). The proposed definition would incorporate the definition in section 418(o)(2) of the FD&C Act.
   FDA is proposing to define the term "farm" by reference to the definition of that term in proposed
   FDA is proposing to define the term " focused mitigation strategies " to mean those risk-based, reasonably appropriate measures that a person knowledgeable about food defense would employ to significantly minimize or prevent significant vulnerabilities identified at actionable process steps, and that are consistent with the current scientific understanding of food defense at the time of the analysis. The term "focused mitigation strategies" used in the food defense context is analogous to the term "preventive controls" in a HACCP-type framework for food safety.
   As discussed in section V.C.3 of this document, a mitigation strategy is a measure taken by a facility to reduce the potential for intentional adulteration of food. A "focused mitigation strategy" is such a strategy applied in response to the identification of a significant vulnerability and at an actionable process step. Focused mitigation strategies are customized to the processing step at which they are applied, tailored to existing facility practices and procedures, and depend on an evaluation of the vulnerabilities identified in a facility. Because they are applied in response to a significant vulnerability, we have determined that focused mitigation strategies are essential to ensure that appropriate action is taken to protect the food from intentional adulteration caused by acts of terrorism.
   While an option to perform a vulnerability assessment is provided under proposed
   FDA is proposing to define the term " food defense " as the effort to protect food from intentional acts of adulteration where there is an intent to cause public health harm and economic disruption. As discussed in section IV.A of this document, acts of intentional adulteration may take several forms, including acts of terrorism; acts of disgruntled employees, consumers, or competitors; and economically motivated adulteration. We are proposing to define the term "food defense" to refer to the sum of actions and activities (including identification of actionable process steps; implementation of focused mitigation strategies; monitoring, corrective actions, verification, and training activities) taken to protect food from intentional acts of adulteration related to terrorism.
   FDA is proposing to define the term "holding" to mean the storage of food. The proposed definition would also state that holding facilities include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks; and that, for farms and farm mixed-type facilities, holding also includes activities traditionally performed by farms for the safe or effective storage of raw agricultural commodities grown or raised on the same farm or another farm under the same ownership, but does not include activities that transform a raw agricultural commodity, as defined in section 201(r) of the FD&C Act, into a processed food as defined in section 201(gg) of the FD&C Act. For consistency of terminology, we are proposing the same definition of "holding" as in the PC proposed rule (see proposed SUBSEC 1.227 and 117.3). For a detailed discussion of "holding," see sections VIII.E and X.B of the PC proposed rule.
   FDA is proposing to define the term "manufacturing/processing" to mean making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients. The proposed definition would also state that examples of manufacturing/processing activities are cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling, or packaging. The proposed definition would also specify that, for farms and farm mixed-type facilities, manufacturing/processing does not include activities that are part of harvesting, packing, or holding. For consistency of terminology, we are proposing the same definition of "manufacturing/processing" as in the PC proposed rule (see proposed SUBSEC 1.227 and 117.3). For a detailed discussion of "manufacturing/processing," see sections VIII.E and X.B of the PC proposed rule.
   FDA is proposing to define the term "mixed-type facility" to mean an establishment that engages in both activities that are exempt from registration under section 415 of the FD&C Act and activities that require the establishment to be registered. The proposed definition would also state that an example of such a facility is a "farm mixed-type facility," which is an establishment that grows and harvests crops or raises animals and may conduct other activities within the farm definition, but also conducts activities that require the establishment to be registered. For consistency of terminology, we are proposing the same definition of "mixed-type facility" as in the PC proposed rule (see proposed SUBSEC 1.227 and 117.3). For a detailed discussion of "mixed-type facilities," see sections VIII.E and X.B of the PC proposed rule.
   FDA is proposing to define the term "monitor" to mean to conduct a planned sequence of observations or measurements to assess whether focused mitigation strategies are consistently applied and to produce an accurate record for use in verification. In the intentional adulteration framework, monitoring would be performed to ensure that focused mitigation strategies are consistently applied and to provide a record for use in verifying consistent application.
   FDA is proposing to define the term "packing" to mean placing food into a container other than packaging the food. The proposed definition would also specify that, for farms and farm mixed-type facilities, packing also includes activities traditionally performed by farms to prepare raw agricultural commodities grown or raised on the same farm or another farm under the same ownership for storage and transport, but does not include activities that transform a raw agricultural commodity, as defined in section 201(r) of the FD&C Act, into a processed food as defined in section 201(gg). We are proposing to use the same definition of "packing" as in the PC proposed rule (see proposed SUBSEC 1.227 and 117.3). For a detailed discussion of "packing," see sections VIII.E and X.B of the PC proposed rule.
   FDA is proposing to define the term "qualified end-user" to mean, with respect to a food, the consumer of the food (where the term consumer does not include a business); or a restaurant or retail food establishment (as those terms are defined in
   FDA is proposing to define the term "qualified facility" to mean (when including the sales by any subsidiary; affiliate; or subsidiaries or affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate) a facility that is: (1) A very small business as defined in this part; or (2) a facility to which both of the following apply: (i) During the 3-year period preceding the applicable calendar year, the average annual monetary value of the food manufactured, processed, packed or held at such facility that is sold directly to qualified end-users (as defined in this part) during such period exceeded the average annual monetary value of the food sold by such facility to all other purchasers; and (ii) the average annual monetary value of all food sold during the 3-year period preceding the applicable calendar year was less than
   We acknowledge that facilities would not need to consider the applicability of previous paragraph (2) because facilities that meet this second prong of the definition would be included in our proposed definition of a very small business, which is broader.
   The proposed definition would incorporate the description of "qualified facility" in section 418(l)(1) of the FD&C Act with editorial changes to improve clarity.
   FDA is proposing to define the term " significant vulnerability " to mean a vulnerability for which a prudent person knowledgeable about food defense would employ food defense measures because of the potential for serious adverse health consequences or death and the degree of accessibility to that point in the food process. The term "significant vulnerability" is analogous to the term "hazard that is reasonably likely to occur" in a HACCP-type framework for food safety. As proposed, a "significant vulnerability" is a type of vulnerability for which there is both: (1) The potential for serious adverse health consequences or death from the intentional introduction of a contaminant at the particular point in the process at which the significant vulnerability exists; and (2) a significant degree of accessibility at the particular point in the process. Unlike a "hazard that is reasonably likely to occur" in a HACCP system, a "significant vulnerability" exists at a particular point in a process (e.g., during storage in a bulk tank or during mixing). As discussed in section V.C.2 of this document, we have determined that significant vulnerabilities exist in a food operation at those actionable process steps that fit in the
   We have retained in this proposed definition the concept of a "prudent person" used in the definition of a "hazard that is reasonably likely to occur" in the PC proposed rule. However, because intentional adulteration is a potentially high consequence but low probability occurrence, the portion of the proposed definition in the PC proposed rule that reads, "experience, illness data, scientific reports, or other information provides a basis to conclude that there is a reasonable possibility that the hazard will occur in the type of food being manufactured, processed, packed, or held in the absence of those controls," does not appear to be appropriate. Successful intentional adulteration caused by an act of terrorism requires not only the absence of focused mitigation strategies designed to address a significant vulnerability, but also simultaneous intent by an attacker to adulterate the food. As such, the absence of focused mitigation strategies to address a significant vulnerability alone may not present a reasonable possibility of intentional adulteration. Instead, as described above, we have tentatively concluded that the prudent person would consider the potential for public health consequences should intentional adulteration occur, and the degree of access by the attacker to commit the intentional adulteration, in determining which vulnerabilities are significant.
   FDA is proposing to define the term "significantly minimize" to mean to reduce to an acceptable level, including to eliminate. As noted in section X.B of the PC proposed rule, the term "significantly minimize" is used in FSMA and is consistent with the outcome of a "control measure" as described in the HACCP regulations for seafood (part 123), juice (part 120), and meat and poultry (9 CFR part 417). Generally, a "control measure" is implemented so that hazards are prevented, reduced to an acceptable level, or eliminated.
   FDA is proposing to define the term "small business" to mean, for the purposes of proposed part 121, a business employing fewer than 500 persons. The proposed limit of 500 employees would include all employees of the business rather than be limited to the employees of a particular facility. We are proposing to establish the same definition for small business as that which has been established by the
   FDA is proposing to define the term "verification" to mean those activities, other than monitoring, that establish that the system is operating according to the food defense plan. As discussed in section V.C.6 of this document, we are not proposing to require validation of the focused mitigation strategies and, therefore, we are not proposing to include a determination of the validity of the food defense plan within the definition of verification in proposed
   FDA is proposing to define the term "very small business" to mean, for the purposes of proposed part 121, a business that has less than
   FDA is proposing to define the term " vulnerability " to mean the susceptibility of a point, step, or procedure in a facility's food process to intentional adulteration. "Vulnerability" is used in the term "vulnerability assessment" in section 420 of the FD&C Act and may best be described in the food defense context as analogous to the term "hazard" in a HACCP-type framework for food safety. While hazards in the unintentional adulteration context may also be thought of as analogous to agents or contaminants in the intentional adulteration context, we have tentatively concluded that focusing on individual agents or contaminants is generally not effective or efficient in minimizing the risk of intentional adulteration caused by acts of terrorism. There are a significant number of potential agents or contaminants that could be used in a terrorist attack on food, with one or more being suitable for essentially any point in the production of any specific food. It would be extremely difficult, if not impossible, to consider the multiple combinations of potential contaminants, points in a food operation, and food categories, and to determine a strategy that would effectively address all possible agents. For this reason, determining whether there is an agent that could be intentionally introduced to a specific food that would then cause serious adverse health consequences or death would not be a useful exercise. Further, many agents or contaminants that could be used in such an attack are different from those that are associated with foodborne illnesses caused by unintentional adulteration and, as such, are not expected to be well understood by operators of food facilities. Therefore, we have tentatively concluded that in the intentional adulteration framework related to acts of terrorism, it is appropriate to refer to "vulnerabilities" rather than "hazards". According to the Merriam-
   We solicit comment on the proposed definitions.
B. Exemptions
   In subpart A of proposed part 121, proposed
1. Proposed
   Proposed SEC 121.5(a) would provide that proposed part 121 does not apply to a qualified facility, except that qualified facilities must, upon request, provide for official review documentation that was relied upon to demonstrate that the facility meets this exemption. Such documentation must be retained for 2 years.
   a. Exemption of qualified facilities. As discussed in section V.A of this document, proposed
   Section 418(l)(2)(A) of the FD&C Act provides that a qualified facility "shall not be subject to the requirements under [sections 418(a) through (i) and (n) of the FD&C Act]." We have tentatively concluded that we should include the exemption provided in section 418(l)(2)(A) of the FD&C Act in proposed
   Section 418(l)(5) of the FD&C Act requires the Secretary of
   Section 418(n)(1)(B) of the FD&C Act requires that the regulations define the terms "small business" and "very small business," taking into consideration the study of the food processing sector required by section 418(l)(5) of the FD&C Act. Consistent with section 418(l)(5) of the FD&C Act, we have consulted with
   We note that section 420 of the FD&C Act does not contain an explicit size-based exemption, such as the qualified facility provision in section 418 of the FD&C Act. In section IV.A of this document, we discuss our assessment that the goal of terrorist organizations is to maximize public health harm and, to a lesser extent, economic disruption. We have tentatively concluded that such goals are likely to drive terrorist organizations to target the product of relatively large facilities, especially those for which the brand is nationally or internationally recognizable. The regulations issued under section 420 of the FD&C Act are to apply to food for which there is a high risk of intentional contamination. We have tentatively concluded that designating businesses with less than
   We acknowledge that the amount of food sales in the proposed definition of very small business (total annual sales of food of less than
   There are some facilities that are not subject to section 418 of the FD&C Act but are subject to section 420 of the FD&C Act, and would be subject to this rulemaking because their activities would likely involve one of the key activity types (e.g., juice manufacturing and breaded seafood manufacturing). However, under proposed
   b. Documentation requirement for qualified facilities. Sections 418(l)(2)(A) and (l)(2)(B) of the FD&C Act provide that a qualified facility is exempt from the requirements of sections 418(a) through (i) and (n) (i.e., the requirements for hazard analysis and risk-based preventive controls), but must instead submit two types of documentation to the Secretary of
   The second type of required documentation relates to whether the facility satisfies the definition of a qualified facility. Under section 418(l)(2)(B)(ii) of the FD&C Act, the facility must submit documentation, as specified by the Secretary of
   Section 418(l)(7)(A) of the FD&C Act requires that a qualified facility that is exempt from the requirements under sections 418(a) through (i) and subsection (n), and that does not prepare documentation under section 418(l)(2)(B)(i)(I), provide notification to consumers by one of two procedures, depending on whether a food packaging label is required on the food. With respect to a food for which a food packaging label is required by the Secretary of
   Section XIII.A of the PC proposed rule describes our proposed requirements pursuant to the above described modified requirements for qualified facilities in that proposed rule. In summary, in the PC proposed rule, we proposed codified language to require submission of the following to
   Proposed SEC 121.5(a) would require that qualified facilities, upon request, provide for official review documentation that was relied upon to demonstrate that the facility meets this exemption. In addition, proposed
   c. Withdrawal of exemption for qualified facilities. Section 418(l)(3) of the FD&C Act provides that the Secretary of
2. Proposed
   a. Requirement of section 418 of the FD&C Act. Section 418(m) of the FD&C Act provides in relevant part that
   b. Petition relevant to section 418(m) of the FD&C Act. In a letter dated
   The section 418(m) petitioners stated, "As an initial matter, the risk of intentional adulteration at facilities solely engaged in the storage of packaged foods not exposed to the environment is quite remote. The food in these facilities is stored in unit packaging, meaning any effort to adulterate the food would be laborious and likely ineffective." They further asserted that, "Members of the food industry have implemented a number of precautions against intentional adulteration. Most importantly, these facilities are locked and secured against unauthorized entry. Access is restricted to the employees of the manufacturer dropping off food, any staff employed at the facility, and the persons who deliver food to retailers and other customers. Food is often held in such facilities for a short period of time, which would not be conducive to attempts at intentional adulteration. Further, we note that the continual activity in these facilities during pickup and drop-off hours serves as a deterrent for anyone attempting to gain unauthorized access."
   c. Proposed exemption for the holding of food. Proposed
   As discussed in section V.C.2 of this document, based on an analysis of the vulnerability assessments that
   We acknowledge that our proposed exemption in
3. Proposed
   Proposed SEC 121.5(c) would exempt from the requirements in proposed part 121 the packing, re-packing, labeling, or re-labeling of food where the container that directly contacts the food remains intact. As discussed in section V.C.2 of this document, based on an analysis of the vulnerability assessments that
   As discussed in section V.A of this document, the proposed rule would not require a facility that chooses to identify its actionable process steps under proposed
4. Proposed
   Proposed SEC 121.5(d) would exempt from the requirements in proposed part 121 the activities of a facility that are subject to section 419 of the FD&C Act (Standards for Produce Safety). We discuss our tentative decision not to cover produce farms under section 419 of the FD&C Act in sections IV.B and IV.F, respectively, of this document.
   Section 418(k) of the FD&C Act provides that section 418 "shall not apply to activities of a facility that are subject to section 419". Section 419 of the FD&C Act, "Standards for Produce Safety," requires
   Establishments that are exempt from registration under section 415 of the FD&C Act as "farms" would not be subject to section 418 of the FD&C Act when conducting activities within the farm definition. Farm mixed-type facilities would be subject to section 418 of the FD&C Act when conducting those activities that trigger the section 415 registration requirement. We have tentatively concluded that Congressional intent regarding the reach of section 418(k) of the FD&C Act is unambiguous in that section 418(k) directly limits the exemption to activities of the facility that are subject to section 419 of the FD&C Act. We have also tentatively concluded that we should include a provision implementing section 418(k) of the FD&C Act in the proposed regulation to establish by regulation the reach of the exemption. Therefore, in proposed
   At the time
5. Proposed
   Proposed SEC 121.5(e)(1) would provide that proposed part 121 does not apply with respect to alcoholic beverages at a facility that meets the following two conditions: (i) Under the Federal Alcohol Administration Act (27 U.S.C.
   Proposed SEC 121.5(e)(2) would provide that proposed part 121 does not apply with respect to food other than alcoholic beverages at a facility described in paragraph (e)(1) of this section, provided such food: (i) Is in prepackaged form that prevents any direct human contact with such food; and (ii) Constitutes not more than 5 percent of the overall sales of the facility, as determined by the Secretary of the Treasury.
   In section X.C.7 of the PC proposed rule, we explain in detail our interpretation of section 116 of FSMA and our consideration of hazards and preventive controls for the manufacturing, processing, packing, and holding of alcoholic beverages. Based on that analysis, we proposed, in proposed
   We have tentatively concluded that we should include a provision implementing section 116 of FSMA in the proposed rule to establish by regulation the reach of the provision. We request comment on our interpretation of section 116 of FSMA, described in section X.C.7 of the PC proposed rule, and its application to the proposed exemption in
6. Proposed
   Proposed SEC 121.5(f) would exempt from the requirements of proposed part 121 the manufacturing, processing, packing, and holding of food for animals other than man. In the Animal Food PC proposed rule, we proposed to require that facilities that manufacture, process, pack, or hold animal food and that are not otherwise covered by certain exemptions, design and implement a system of preventive controls to address food safety issues. In that proposed rulemaking, we tentatively concluded that hazards associated with intentional adulteration would likely require different kinds of controls and would be best addressed in a separate rulemaking.
   We also requested comment in that rulemaking on whether to include in those regulations potential hazards that may be intentionally introduced for economic reasons, which we refer to as economically motivated adulteration, a type of intentional adulteration. Our current thinking regarding economically motivated adulteration is discussed in section IV.F of this document.
   Section 418(m) of the FD&C Act authorizes
   The identification of a production step for a food as necessitating focused mitigation strategies is premised upon an analysis, based on CARVER+Shock methodology, that an attack at these points in the production of a food would likely result in an outcome that is consistent with our understanding of the goal of terrorist organizations (i.e., maximizing adverse public health impacts and, to a lesser extent, economic disruption) (Ref. 54). For human foods, our analyses show the potential for significant human morbidity and mortality should intentional adulteration occur at any one or more of these points in a food operation. (Significant economic harm is also likely, related to the human morbidity and mortality as well as disruption in the food supply as a result of loss of consumer confidence in its safety.) In contrast, for animal food, our analysis shows only minimal potential for human morbidity or mortality as a result of attacks at key activity types or other points in an animal food operation. Significantly, our CARVER+Shock vulnerability assessments of animal food have had to focus entirely on economic consequences because of the lack of potential for human morbidity and mortality.
   In considering whether to provide an exemption related to animal food, we evaluated three types of possible attack scenarios: (1) Incorporation of a contaminant into feed to be used for muscle meat-producing animals; (2) incorporation of a contaminant into feed to be used for egg-producing or milk-producing animals; and (3) incorporation of a contaminant into pet food. With regard to the two former scenarios, we are not aware of contaminants that could be incorporated into feed at levels that would not produce noticeable clinical signs and/or mortality in animals but would result in significant human morbidity or mortality among consumers that subsequently eat the meat, eggs or milk (Ref. 55). While contaminants can increase the risk of chronic disease, such as cancer, among consumers (Ref. 56), such an outcome is not consistent with our understanding of the goals of terrorist organizations, which include a more immediate impact. We recognize that such an attack could result in significant economic disruption because of the loss of consumer confidence in the safety of the food supply. While important, attacks of that nature fall significantly below those involving human morbidity and mortality when placed on a scale of risk with regard to targeting by terrorist organizations.
   Regarding the third attack scenario (incorporation of a contaminant into pet food), we are aware of contaminants that could be incorporated into feed or pet food that could result in significant animal (including pet) morbidity and mortality, including some which could result in secondary infectious spread of disease (because some infectious agents can be transmitted orally as well as through aerosol). Again, such attacks could be significant from an economic and societal standpoint. However, the risk that they pose with regard to targeting by terrorist organizations appears to be significantly lower than those involving human morbidity and mortality. We request comment on this assessment of risk.
   Therefore, notwithstanding the likely presence of one or more of the four key activity types in the production of many animal foods, we have tentatively concluded that animal food (regardless of whether it is produced at a facility solely engaged in the production of animal food or at a facility engaged in the production of both animal and human food) does not involve significant vulnerabilities that require focused mitigation strategies under section 418 of the FD&C Act and is not at high risk for intentional adulteration related to terrorism under section 420 of the FD&C Act. Consequently, we are proposing to exempt the manufacturing, processing, packing, and holding of food for animals other than man. We request comment on these tentative conclusions.
C. Food Defense Measures
   In subpart C of proposed part 121,
1. Food Defense Plan
   a. Proposed
   Proposed SEC 121.126(a) would provide flexibility for the owner, operator, or agent in charge of the facility to either prepare the written food defense plan or have that plan prepared, in whole or in part, on its behalf. In addition, proposed
   Proposed SEC 121.126(a) would require that the owner, operator, or agent in charge of a facility implement the written food defense plan. Our proposed requirement to develop and implement a food defense plan, which includes the identification of actionable process steps and implementation of focused mitigation strategies, reflects our tentative conclusion that such actions are measures necessary to prepare and protect the food supply from intentional adulteration caused by acts of terrorism. Proposed
   b. Proposed
    * The written identification of actionable process steps as required by proposed
    * The written focused mitigation strategies as required by proposed
    * The written procedures for monitoring as required by proposed
    * The written corrective action procedures as required by proposed
    * The written verification procedures as required by proposed
   Although we are proposing to require that the contents of food defense plan include only the specific elements described above, the food defense plan can be used as a resource for facilities to capture additional food defense-related information. For example, facilities may also wish to include information, such as process flow diagrams, an evaluation of broad mitigation strategies, emergency contact information, crisis management plans, action plans for implementation of broad mitigation strategies, results of supplier audits, and other documents, analysis, reviews, or information the facility finds relevant to its food defense program.
   Proposed SEC 121.126, if finalized, would establish a requirement for every facility covered by this rule to have its own written food defense plan. Like the food safety plan, this facility-based nature of the written food defense plan is consistent with the overall framework of section 418 of the FD&C Act, which is directed to a facility rather than, for example, a corporate entity that may have multiple facilities.
   Proposed SEC 117.126(c) of the PC proposed rule would require that the food safety plan be prepared by (or its preparation overseen by) a qualified individual (See the discussion in section XII.A.4 of the PC proposed rule). We are proposing to require that the vulnerability assessment be performed by an individual qualified by experience and/or training only when facilities choose to identify actionable process steps in their food defense plans using the provisions of proposed
   Proposed SEC 121.126(b) implements sections 418(h) and 420(b)(2) of the FD&C Act.
   We seek comment on our proposed provisions related to the written food defense plan and its contents.
2. Identification of Actionable Process Steps
   a.
   CARVER+Shock methodology is a tool for assessing the vulnerabilities within a food system and determining the most vulnerable points, and focusing resources on protecting the most susceptible points. Using the CARVER+Shock methodology,
   Providing these key activity types to facilities for their use in identifying actionable process steps and developing focused mitigation strategies provides some advantages over other approaches that we might have taken, such as identifying points in the production of specific foods at increased risk for intentional adulteration caused by an acts of terrorism, or requiring each facility to perform its own vulnerability assessment. First, publicly providing a list of key activity types does not disclose sensitive information, as might be the case if we provided CARVER+Shock scores derived from our vulnerability assessments for process steps for specific foods.
   Second, providing a list of key activity types rather than requiring facilities to perform their own facility-specific vulnerability assessments relieves the burden upon the facility to assemble a team of individuals with the diverse expertise needed to properly self-score the steps in their process (using the CARVER+Shock Vulnerability Assessment software tool or another suitable tool). When we performed vulnerability assessments during the SPPA initiative our teams included individuals with expertise in the production of the food under study, law enforcement, food science, food regulatory systems, and public health. We expect that such an effort is likely beyond the capacity of many facilities. Further, by providing a list of key activity types, we eliminate the need to identify a CARVER+Shock score, for example, as the threshold for the implementation of focused mitigation strategies. This is important because CARVER+Shock scores are somewhat subjective and difficult to correlate across food types, making identification of a universal threshold score challenging.
   b. Proposed
   Proposed SEC 121.130 would also require that the identification of actionable process steps and the assessment leading to that identification be written. A written assessment of whether the facility has one or more of the key activity types (under proposed
   The written identification of actionable process steps must include the justification for whatever conclusion the owner, operator, or agent in charge of a facility reaches. Proposed
   If a facility chooses to identify actionable process steps using the procedure in proposed
   Proposed SEC 121.130 implements sections 418(b)(2), 418(b)(3), 420(a)(1), and 420(b)(1) of the FD&C Act.
   c. Proposed
   Proposed SEC 121.130(a) would state that the owner, operator, or agent in charge of a facility must assess, for each type of food manufactured, processed, packed or held at the facility, whether the facility has one or more of the following key activity types and identify the actionable process steps associated with any key activity types present:
   1. Bulk liquid receiving and loading --a step in which a bulk liquid is received and unloaded from an inbound conveyance or loaded into an outbound conveyance where a contaminant can be intentionally introduced and, if it is, it is likely that the contaminant will be distributed throughout the liquid due to sloshing, movement, or turbulence caused by the receiving and unloading or loading activity;
   2. Liquid storage and handling --a step in which a liquid is contained in bulk storage tanks or in holding, surge, or metering tanks where a contaminant can be intentionally introduced and, if it is, it is likely that the contaminant will be distributed into the food;
   3. Secondary ingredient handling --a staging, preparation, addition, or rework step where a contaminant can be intentionally introduced into a relatively small amount of ingredient or rework and, if it is, it is likely that the contaminant will be distributed into a larger volume of food; and
   4. Mixing and similar activities --a step, such as mixing, blending, homogenizing, or grinding where a contaminant can be intentionally introduced and, if it is, it is likely that the contaminant will be distributed into the food.
   The owner, operator, or agent in charge would be required to assess whether the facility has a food process that involves any one or more of the specified four key activity types. If the food process is found to involve any key activity types, the owner, operator, or agent would be required to identify actionable process step(s) that are associated with each key activity type that is present.
   For example, based on proposed
   We acknowledge the possibility, although not likely, that circumstances may exist where access at or just prior to the equipment is not possible (i.e., because the equipment is fully enclosed, with no access ports), and that in such a situation this process step would not be identified as fitting within the key activity type. For example, the owner of the same facility may assess a second mixing tank that is part of an entirely closed system, with no direct access points into the system, such that an individual attempting to access this mixing tank would likely cause a major disruption to the line, foiling any attempted intentional adulteration. Based on this assessment, the owner may conclude that the enclosed nature of this second mixing tank renders the product inaccessible at this step and, therefore, it does not fit within the key activity type. In this circumstance, there would be no requirement to identify an actionable process step associated with this mixing tank (in which case, there also would be no requirement to implement a focused mitigation strategy at this step). Under proposed
   If the owner, operator, or agent in charge determines that the food operation does not involve any of the key activity types, there would be no need to identify actionable process steps. Such a facility, however, would still be required to document its finding that none of the key activity types apply to its food processes, under proposed
   Proposed SEC 121.130(a) would require that the process of identification of actionable process steps be done "for each type of food manufactured, processed, packed, or held at the facility." The vulnerability of a food to intentional contamination may differ based on the type of food and associated process, practices, and conditions at the facility. Therefore, we are proposing that the facility assess whether it has any of the key activity types for each type of food that is manufactured, processed, packed, or held at that facility. A facility may find that its operation related to one type of food manufactured at that facility involves one or more of the key activity types, but all other types of food manufactured at that facility do not involve any of the key activity types. In such an instance, actionable process steps would need to be identified and focused mitigation strategies implemented only for the food type that involved the key activity types.
   Description of key activity types --As discussed in section V.C.2.a of this document, our vulnerability assessments revealed four key activity types that most commonly rank high: Bulk liquid receiving and loading; Liquid storage and handling; Secondary ingredient handling; and Mixing and similar activities. We have tentatively concluded that the presence of any of these four key activity types in a food operation indicates a significant vulnerability for intentional contamination caused by acts of terrorism. Based on our assessments, we believe that these four key activity types capture the significant vulnerabilities in a food operation. However, although generally unlikely, a vulnerability assessment of a specific food at a specific facility conducted under proposed
   Proposed SEC 121.130(a)(1) would identify " Bulk liquid receiving and loading" as a key activity type, based on our finding that this activity type commonly ranked high in our vulnerability assessments. Proposed
   Bulk liquid receiving and loading refers to any processing step where a liquid ingredient is being received and unloaded at a facility or a liquid intermediate or finished product is being loaded into an outbound shipping transport vehicle and for which there is an opportunity for a contaminant to be intentionally introduced into the food. This key activity type incorporates the actions of opening the transport vehicle, attaching any pumping equipment or hoses, and opening any venting hatches. The characteristics associated with these activities are such that there is a high probability of a contaminant, if intentionally added, mixing within the liquid, due to significant sloshing, movement, and turbulence associated with the receiving or loading activity. In addition, the need for worker activity associated with these processing steps provides access to hoses, the transport vessel, and potentially the product as it is being received or loaded.
   Proposed SEC 121.130(a)(2) would identify " Liquid storage and handling" as a key activity type, based on our finding that this activity type ranked high in our vulnerability assessments. Proposed
   Proposed SEC 121.130(a)(3) would identify " Secondary ingredient handling" as a key activity type, based on our finding that this activity type commonly ranked high in our vulnerability assessments. Proposed
   Proposed SEC 121.130(a)(4) would identify " Mixing and similar activities" as a key activity type, based on our finding that the activities commonly ranked high in our vulnerability assessments. Proposed
   These are key activities because a potential contaminant successfully added at one of these steps would generally be readily dispersed throughout the product. Further, access is generally available through access ports, lids, and in-feed conveyors or flumes. Examples of equipment associated with these activities include: Mixers, blenders, homogenizers, cascade breaders, mills, grinders, and pulverizers.
   We seek comment on these key activity types, and whether they are each appropriate to include and whether there are additional activities that present significant vulnerability to intentional adulteration caused by acts of terrorism.
   Proposed SEC 121.130(a) implements sections 418(a) through (c) and 420(a)(1)(A) of the FD&C Act.
   d. Proposed
   Proposed SEC 121.130(b) would provide flexibility to the owner, operator, or agent in charge of a facility covered by this rule to conduct, or have conducted, their own vulnerability assessment of the food operations at a facility, rather than assessing their food operation against the
   Finally, as in the case of proposed
   Elements of a Facility-Specific Vulnerability Assessment --The elements of an approach to conducting a facility-specific vulnerability assessment are:
    * Planning to conduct a vulnerability assessment--collect and evaluate appropriate background information on biological, chemical, physical, and radiological agents of concern, such as those found in the CDC's Select Agents and Toxins List (Ref. 57);
    * Assembling the vulnerability assessment team--identify appropriate individuals within the organization to assist in the vulnerability assessment process. This may include personnel working in the areas of security, food safety/quality assurance or control, human resources, operations, maintenance, and other individuals deemed necessary to facilitate the formation of a vulnerability assessment;
    * Developing a process flow diagram--list out each of the steps in the food process to be evaluated;
    * Identifying significant vulnerabilities--evaluate each process step to prioritize vulnerabilities and identify significant vulnerabilities. For each process step, the evaluation should consider, at a minimum: (1) The potential public health impact if a contaminant were added; (2) whether downstream processing steps would eliminate or remove agents of concern; (3) the degree of physical access to product; (4) the ability of an aggressor to successfully contaminate the product; and (5) the volume of product impacted. This evaluation should also include the rationale or justification for which process steps were and were not identified as significant vulnerabilities; and
    * Identifying actionable process steps--for identified significant vulnerabilities, indicate where actionable process steps exist in the food process and where associated focused mitigation strategies would be required to be implemented, under proposed
   Facilities that choose this alternative may need assistance from outside experts who are knowledgeable in food defense and vulnerability assessments. Some facilities may not have the resources or the necessary expertise on site and expert advice may be obtained when necessary from other sources, such as trade and industry associations, independent experts, and regulatory authorities.
   We seek comment on the need for, and appropriateness of, proposed
   Proposed SEC 121.130(b) implements sections 418(a) to (c) and 420(a)(1)(A) of the FD&C Act.
3. Focused Mitigation Strategies
   a. Requirements of sections 418 and 420 of the FD&C Act. Section 418(c)(2) of the FD&C Act, in relevant part, specifies that the owner, operator, or agent in charge of a facility shall identify and implement preventive controls to provide assurances that hazards identified in the hazard analysis conducted under section 418(b)(2) of the FD&C Act will be significantly minimized or prevented and addressed, consistent with section 420 of the FD&C Act, as applicable. Section 418(c)(1)(3) of the FD&C Act, in relevant part, specifies that the preventive controls must also provide assurances that the food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 of the FD&C Act. Section 418(h) of the FD&C Act requires that the owner, operator, or agent in charge of a facility prepare a written food safety plan that, among other things, identifies the preventive controls within the plan. Section 420(b) of the FD&C Act requires
   Section 418(o)(3) of the FD&C Act defines preventive controls as "those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis conducted under [section 418(b) of the FD&C Act] and that are consistent with the current scientific understanding of safe food manufacturing, processing, packing or holding at the time of the analysis." The definition provides that "those procedures, practices, and processes may include the following: (A) Sanitation procedures for food-contact surfaces and utensils and food-contact surfaces of equipment; (B) Supervisor, manager, and employee hygiene training; (C) An environmental monitoring program to verify the effectiveness of pathogen controls in processes where a food is exposed to a potential contaminant in the environment; (D) A food allergen control program; (E) A recall plan; (F) Current Good Manufacturing Practices (cGMPs) under part 110 of title 21, Code of Federal Regulations (or any successor regulations); (G) Supplier verification activities that relate to the safety of food." (emphasis added)
   In section V.A.2 of this document, we discuss our proposed definition of focused mitigation strategy and its relationship to the definition of preventive controls in section 418(o)(3) of the FD&C Act. We are not proposing requirements for sanitation procedures, hygiene training, environmental monitoring, food allergen control, and CGMPs because these examples are relevant to food safety, but not to food defense. We considered proposing to require a recall plan (as we did in the PC proposed rule in proposed
   b. General description of mitigation strategies. Mitigation strategies are measures taken by a facility to reduce the potential for intentional adulteration of food. Based on these vulnerability assessments,
   i. Broad mitigation strategies. Broad mitigation strategies are general facility-level measures that are intended to minimize a facility's vulnerability, as a whole, to potential acts of intentional contamination. Examples of broad mitigation strategies are: (1) Physical security, such as perimeter security fencing, locking exterior doors, penetration alarms; (2) personnel security, such as pre-hire background, reference checks, identification badges, and controlled visitor access; (3) securing hazardous materials, such as cleaning products, laboratory materials, and pesticides; (4) management practices, such as ingredient storage inventory procedures; key security procedures, PINs or passwords; procedures to restrict personal items from all food production areas; procedures requiring IDs and uniforms to be returned when a person's employment ends; and supplier verification or certification procedures; and (5) crisis management planning, such as maintenance of updated emergency contact information, procedures for responding to reported threats, and establishment of a designated food defense leadership team.
   Broad mitigation strategies, by nature, are generally applicable to a facility, regardless of the type of food being processed, and, as such, are not targeted to a specific processing step in a food operation. Broad mitigation strategies address facility-wide vulnerabilities that may present an opportunity for an attacker to access the facility and intentionally adulterate food. Broad mitigation strategies serve as foundational actions or procedures that improve a facility's overall defense against intentional contamination caused by acts of terrorism.
   We are proposing to require the implementation of focused mitigation strategies only. However, as set out in our guidance documents (Ref. 22, Ref. 23, Ref. 24, Ref. 25, Ref. 26), we think it is prudent for facilities to review our guidance and implement those broad mitigation strategies that are appropriate to minimize the risk for intentional adulteration of food.
   ii. Focused mitigation strategies. As discussed in section V.A of this document, we are proposing to define focused mitigation strategies as those risk-based, reasonably appropriate measures that a person knowledgeable about food defense would employ to significantly minimize or prevent significant vulnerabilities identified at actionable process steps, and that are consistent with the current scientific understanding of food defense at the time of the analysis.
   Focused mitigation strategies are specific to an actionable process step in a food operation where a significant vulnerability is identified. They represent reasonably appropriate measures that are necessary to reduce the likelihood of intentional contamination caused by an act of terrorism at that process step. Focused mitigation strategies are customized to the processing step at which they are applied, tailored to existing facility practices and procedures, and depend on an evaluation of the vulnerabilities identified in a vulnerability assessment. When properly implemented, focused mitigation strategies by themselves are sufficient to significantly minimize or eliminate the chances that an attacker would be successful if an act of intentional adulteration were attempted at the specific process step. Focused mitigation strategies focus on minimizing either the accessibility of an attacker to the product at a particular process step or the opportunity for the attacker to successfully contaminate the product at that process step, or both.
   Based on our vulnerability assessments, we tentatively conclude that the implementation of focused mitigation strategies at actionable process steps in a food operation is necessary to minimize or prevent the significant vulnerabilities that are identified in a vulnerability assessment (Ref. 21, Ref. 54, Ref. 58), regardless of the existence of broad mitigation strategies. Although broad mitigation strategies are important to further reduce the vulnerability for intentional contamination, they are not sufficient to significantly minimize the risk of intentional contamination caused by an act of terrorism because broad mitigation strategies are not specific enough, for example, to counter the actions of an attacker who has legitimate access to the facility (i.e., insider attack) or an attacker who circumvents perimeter protections (e.g., scaling a fence), with the goal of intentionally contaminating the food. Focused mitigation strategies, on the other hand, are targeted to actionable process steps identified in a food operation to reduce the likelihood of intentional contamination at those process steps and, therefore, are essential to ensure that appropriate food defense measures are taken to protect the food from intentional contamination caused by acts of terrorism. In contrast to broad mitigation strategies, focused mitigation strategies are targeted to actionable process steps and, therefore, are more effective at countering an attacker who has legitimate access to the facility. We have tentatively concluded that we will continue to encourage the implementation of broad mitigation strategies on a voluntary basis, but we will require the implementation of focused mitigation strategies at actionable process steps. We request comment on this tentative conclusion, and on whether we should include, in a final rule, a requirement for the implementation of any broad mitigation strategies.
   iii. Examples of focused mitigation strategies for
   Bulk liquid receiving and loading --Examples of focused mitigation strategies that may be appropriate include the following:
   1. Controlling access to the receiving or loading area, conveyances, and equipment, including hoses and pumping machinery, to prevent an unauthorized person from gaining access to the food during receiving or loading. Access controls may include: strategies to easily identify authorized persons, such as color-coded uniforms or badges; restricting conveyance drivers to areas away from the receiving or loading area (e.g., restricting them to a lounge or break room); securing hoses with locking caps or in cabinets; and ensuring that conveyance access hatches, vents, and inspection ports are secured;
   2. Ensuring adequate lighting in the receiving or loading area, which reduces the ability of an attacker to disguise his or her actions. Adequate lighting in and around vulnerable areas of a food operation increases the likelihood that other staff will witness the actions of an attacker and enable them to take steps to prevent or react to contamination;
   3. Increasing observation of the receiving or loading area, which reduces the ability of an attacker to disguise his or her actions. For example, maximizing the line of sight by removing boxes, crates, or other obstructions from the area; positioning quality control personnel in the receiving or loading area to supervise operations; or utilizing closed-circuit TV systems or other monitoring devices;
   4. Verifying that seals on a shipping conveyance are intact prior to receiving or after loading a bulk liquid to reduce the likelihood that the shipping conveyance was or is accessed during transport to introduce a contaminant into the product;
   5. Establishing and implementing a policy for driver check-in and identification to help confirm driver identity and verify the individual is authorized, through verification of shipping documentation or other means, to deliver or pick-up the shipment and reduce the likelihood that an attacker could fraudulently pose as a driver as a means of gaining access to the facility; and
   6. Inspecting the shipping conveyance prior to loading bulk liquids to help ensure that no contaminant has been introduced to the conveyance chamber that could then contaminate the product once the product is loaded.
   Liquid storage and handling --Examples of focused mitigation strategies that may be appropriate include the following:
   1. Controlling access to liquid storage, holding, surge, or metering tanks, similar to the strategies that may be applied for controlling access to bulk liquid receiving and holding;
   2. Ensuring that the area around liquid storage, holding, surge, or metering tanks is free of unrelated materials, such as personal items (backpacks, purses, or packages), and other items that are not directly related to the food operation, to reduce the likelihood of a contaminant being brought into the area for introduction into the tank;
   3. Ensuring adequate lighting in and around liquid storage, holding, surge or metering tanks, similar to the strategies that may be applied for ensuring adequate lighting at bulk liquid receiving and loading;
   4. Installing one-way sample ports in liquid storage, holding, surge, or metering tanks, so that food product can be drawn out of the equipment but a contaminant cannot be inserted into the tank;
   5. Inspecting tanks prior to filling to help ensure that no contaminant has been introduced into the empty tank that could then contaminate the product once loaded;
   6. Inspecting pumping or metering equipment prior to use to help ensure that no contaminant has been introduced into the equipment that could contaminate the product;
   7. Using enclosed tanks and transfer systems to move materials to reduce the potential for an attacker to access the product and introduce a contaminant; and
   8. Positioning holding, surge, or metering tanks to increase visibility, such that frequent observation is facilitated and visibility of activity around the tank is improved. This focused mitigation strategy may be less practical for longer term storage tanks.
   Secondary ingredient handling --Examples of focused mitigation strategies that may be appropriate include the following:
   1. Controlling access to ingredient handling areas, including where secondary ingredients or rework are staged, prepared, or added to the product stream, to prevent an unauthorized person from gaining access to the ingredients or rework during these processes. As with other key activity types, access controls may include strategies to easily identify authorized persons, such as with color coded uniforms or badges, or conducting ingredient handling activities in areas behind locking gates, doors, or other barriers;
   2. Ensuring the secondary ingredient handling area is free of unrelated materials, such as personal items or other items not directly related to the activity, to help ensure that a contaminant is not brought into the area for introduction into the ingredient during staging, preparation, or addition;
   3. Ensuring adequate lighting and increasing visibility in and around ingredient staging and handling areas, similar to the strategies that may be employed to ensure adequate lighting at bulk liquid receiving and holding;
   4. Reducing staging time to reduce the opportunity for intentional adulteration. Any time sealed or tamper-evident containers are breached provides a potential opportunity for an attacker to introduce a contaminant into the ingredient or rework. Reducing the time ingredients and rework are staged in unsecured containers reduces the opportunity for an attacker to adulterate the ingredient or rework;
   5. Restricting secondary ingredient handling to senior staff to reduce the accessibility and opportunity for intentional adulteration;
   6. Using peer monitoring in the ingredient handling area, because requiring at least two staff members to be in the area at any given time during operations can reduce the opportunity for a contaminant to be discreetly introduced into the food;
   7. Using automated and enclosed ingredient handling equipment, such as automated computer weighing, measuring, and addition equipment, to reduce human contact with secondary ingredients or rework and thereby reduce the opportunity for introduction of a contaminant; and
   8. Inspecting secondary ingredients held in staging and investigating any irregularities in the amount, condition, or organization of items in secondary ingredient handling areas to identify circumstances that suggest product contamination before a contaminated ingredient is added to the product stream.
   Mixing and similar activities --Examples of focused mitigation strategies that may be appropriate include the following:
   1. Controlling access to processing areas where mixing and similar activities are conducted to prevent an unauthorized person from gaining access to the product and equipment. Access controls may include: strategies to easily identify authorized persons, such as with color coded uniforms or badges; conducting these activities in areas behind locking gates, doors, or other barriers; securing access to overhead gangways and sampling platforms; and securing hatches, ports, and lids with locks or access alarm devices;
   2. Ensuring that the area is free of unrelated materials, such as personal items and other items that are not directly related to the activity, to reduce the likelihood of a contaminant being brought into the area for introduction into the ingredient during mixing and similar activities;
   3. Ensuring adequate lighting and increasing visibility in and around mixing and similar activities areas, similar to the strategies that may be employed to ensure adequate lighting at bulk receiving and loading;
   4. Positioning mixing and similar equipment in a manner that maximizes visibility, similar to the strategies that may be employed to maximize visibility for liquid storage and handling;
   5. Using one-way sample ports that prohibit introduction of a contaminant into the mixing or similar equipment, similar to the strategies that may be employed for liquid storage and handling;
   6. Conducting inspections of mixing and similar equipment prior to use to help ensure no contaminant has been introduced that could contaminate the product once loaded;
   7. Restricting mixing and similar activities to senior staff, similar to the strategies that may be employed for secondary ingredient handling;
   8. Using peer monitoring in this area to ensure that at least two staff members are in this area at any given time during operations, reducing the opportunity for a contaminant to be discreetly introduced into the food; and
   9. Using automated, self-contained, enclosed equipment to reduce human contact with the product and reduce the opportunity for introduction of a contaminant.
   These examples of focused mitigation strategies are consistent with measures included in the MSD. The examples are not intended to be an exhaustive list of appropriate focused mitigation strategies. For additional guidance on identifying appropriate focused mitigation strategies, see our guidance documents, the MSD, and other resources (see section II.D of this document).
   iv. Specific examples of determining appropriate focused mitigation strategies. In this section, we discuss specific examples of the decision-making process to identify and determine appropriate focused mitigation strategies at an actionable process step for each of the
   Bulk liquid receiving and loading --Unloading at Facility A's bulk tanker truck unloading bay is an actionable process step for this key activity type. Facility A has a significant vulnerability related to access to the food during the unloading of the bulk liquid. At Facility A, the tanker truck drives into the unloading bay without passing through any security check-in procedures. A single facility employee is assigned to this area and takes a facility-owned hose from an open shelving unit in the unloading bay and attaches it to the tanker truck's unloading port. The driver of the tanker truck assists in unloading by opening the venting hatch at the top of the tanker truck while the facility employee is attaching the hose. The driver then waits in the unloading bay area while the truck is being unloaded. Upon completion of unloading activities, the driver gets back in the truck and exits the facility.
   Facility A is not implementing focused mitigation strategies at this actionable process step such that access to the food during unloading of the bulk liquid is significantly minimized or eliminated. The food is significantly vulnerable to an attacker (in this case, potentially the driver, the facility employee, or a third party) who could intentionally add a contaminant to the product to adulterate the food. One approach for Facility A to significantly minimize or eliminate the significant vulnerability at this actionable process step is to implement the following focused mitigation strategies:
   ablish a receiving check-in and verification procedure to ensure that the shipment is being delivered by the proper firm and that the driver is properly identified. The procedure would be documented and maintained in a shipping log that records the key identifying information about the driver, tanker truck, and shipping documentation for the delivered product. The facility would also institute a policy requiring that the shipping documentation include the ID numbers of the seals on the unloading ports so that the facility employee can verify that seal numbers match the shipping documentation and that the seals were not broken, tampered with or replaced during transport.
    * Implement a procedure to store hoses securely to reduce the likelihood an attacker could add a contaminant to the hoses when not in use. This would include storing hoses in locking cabinets and placing end caps on the hoses. The facility also would issue keys only to staff working in the tanker truck receiving bay and use a key numbering and tracking system to verify that all keys are accounted for.
    * Increase active observation of the unloading process to reduce the likelihood of an attacker successfully introducing a contaminant by requiring two or more production staff members to be present during unloading activities (i.e., peer monitoring), or requiring the bulk liquid unloading operations be overseen by a supervisor or a member of the quality control staff. Alternatively, the facility could employ video surveillance of the area. If the truck driver is permitted to remain in the area of the receiving bay, the introduction of active observation practices ensures that no contaminant could be intentionally introduced to the product during unloading activities. Alternatively, the facility could limit the driver's access to the product by restricting the location of the driver to designated areas outside the loading area while the truck is being unloaded.
   In this example, the focused mitigation strategies were selected to achieve the following goals: Establishing the identity of personnel with access to the food; ensuring that equipment that may be used to introduce a contaminant is secured when not in use; and providing active observation of activities at actionable process steps. By implementing these focused mitigation strategies, the facility could significantly minimize the significant vulnerability identified at the actionable process step.
   Liquid storage and handling-- The storage of liquid in Facility B's bulk liquid storage tank is an actionable process step for this key activity type. Facility B's bulk storage tank holding a primary ingredient is located within its building, and a significant vulnerability relates to access to the food during such storage. In Facility B, a network of gangways, ladders, and platforms surround the bulk liquid storage tank so that personnel can gain access to a hatch at the top of the tank. Facility B has a procedure for securing this hatch with a lock, and the facility stores the key to the hatch in the operations manager's office. To access a key, a worker must request the key from the operations manager and justify the need to open the lock. When an employee checks out the key, the manager's assistant records the employee's name, time the key is checked out, and the reason. Facility B's bulk liquid storage tank also has a second hatch along the side which is used for cleaning the tank when empty and is not locked. This secondary hatch is not accessible while product is in the tank because it opens inward, and pressure from product in the tank prevents the hatch from being opened when product is present.
   In considering the requirement for focused mitigation strategies at this actionable process step, Facility B would determine that it has sufficient safeguards in place to significantly minimize the likelihood of intentional adulteration from an attacker accessing the hatch on the top of the bulk storage tank. However, the facility would identify the secondary hatch as presenting a significant vulnerability for which insufficient focused mitigation strategies are being implemented. While food is in the tank, the secondary hatch is secure. However, when the tank is empty after cleaning, there is an opportunity for an attacker to introduce a contaminant into the tank via the secondary hatch which would then contaminate the food when it is added to the tank. To significantly minimize or eliminate the significant vulnerability presented by the secondary hatch, the facility would implement focused mitigation strategies to restrict and document access to the secondary hatch as is done for the hatch on the top of the tank. To do this, the facility would install a lock on the secondary hatch and incorporate the key for the secondary hatch into its existing key management system. Alternatively, the facility could implement a procedure of monitoring the condition of the tank interior immediately prior to reintroducing product to the tank. This monitoring check would be recorded in a monitoring log.
   Facility B already has in place some practices that we would consider appropriate focused mitigation strategies. The procedures in place to control access to the top access hatch on the bulk liquid storage tank are sufficient to minimize the significant vulnerability presented by this hatch. However, Facility B still has a significant vulnerability associated with the secondary access hatch, which required additional focused mitigation strategies to significantly reduce or eliminate the risk of intentional contamination.
   Another example of an actionable process step for the key activity type "Liquid Storage and Handling" is liquid storage in a liquid surge tank located above an in-line bottling operation at Facility C. The surge tank is used to control the flow rate of liquid product into the bottling equipment and is enclosed by an unlocked lid. A ladder and walkway enable workers to access the surge tank as needed to monitor product flow and take quality control samples. Facility C has an operations control room, which is equipped with windows to view the production floor. However, the view of the bottling operation from the operations control room is commonly blocked by pallets of empty bottles awaiting introduction into the bottling equipment.
   It is not practical for Facility C to lock the surge tank lid because workers need to frequently check the status of product flow and take quality control samples. Also, it is not practical to physically limit access to the ladder or walkway used to access the surge tank, for the same reasons. One approach for Facility C to significantly minimize or eliminate the significant vulnerability at this actionable process step is to implement the following focused mitigation strategies:
    * Implement a policy to prohibit all personnel not associated with the bottling operation from entering the area and issue uniforms of a particular color to the bottling personnel only. The staff working in the bottling area would enforce this policy by instructing any staff not associated with the bottling operation to leave the area.
    * Prohibit staff working in the bottling area from bringing any items not associated with the bottling operation into the work area.
    * Train the staff working in the bottling area in a peer monitoring program to be attentive to the activity of other staff in the area.
    * Stage pallets of empty bottles awaiting introduction into the bottling equipment in another location to improve line of sight from the operations control room.
   By implementing these focused mitigation strategies, the facility could significantly minimize or eliminate the significant vulnerability associated with the actionable process step at the liquid surge tank.
   Secondary ingredient handling-- Ingredient staging at Facility D is an actionable process step for this key activity type. Facility D opens a containerized secondary ingredient's tamper evident package, measures out the required amount into a secondary container, and pre-positions the ingredient in the production area so that it is readily added to the product line. Access to the food during each of these activities at this actionable process step presents a significant vulnerability. Facility D stages a dry, powdered ingredient near the mixer the night before it is intended to be used so that it is ready when the production run begins the next morning. Additionally, the staging area in Facility D is accessible to all staff and is an open area on the production floor.
   One approach for Facility D to significantly minimize or eliminate the significant vulnerability at this actionable process step is to implement the following focused mitigation strategies:
    * Reduce staging time, by revising its procedures so that ingredients are staged immediately before they are added into the product stream. This strategy would reduce the time ingredients are accessible.
    * Change its staffing procedures to ensure that only senior or long-term employees are assigned to measuring and staging secondary ingredients. Assigning the most trusted employees to work in sensitive areas reduces the risk of intentional contamination.
    * Increase its observation of this area by installing closed-circuit TV cameras to monitor the actions of staff in the secondary ingredient staging area.
   By its nature, the action of ingredient staging is an open and accessible process step. Focused mitigation strategies must address personnel access so that the likelihood of an intentional contamination at this step is significantly reduced or eliminated. By implementing these focused mitigation strategies, the facility could significantly minimize the significant vulnerability identified at the actionable process step.
   Mixing and similar activities-- Blending in Facility E's dough mixer is an actionable process step for this key activity type. Facility E operates a dough mixer to combine several dry and liquid ingredients. This mixer is not enclosed and is located in an open area of the facility where it is under regular--though not dedicated--human observation. While a batch of product is being mixed, the staff member assigned to the mixer may leave the area to retrieve and prepare ingredients for the next production batch. The line of sight in this area is clear, and management in the operations control room located above the production floor has a clear view of the mixer through an observation window.
   The mixer is vulnerable to an attacker who could intentionally introduce a contaminant into the food because of the open nature of the mixer, the lack of constant and dedicated observation, and the lack of physical access control to the area where it is located. One approach for Facility E to significantly minimize or eliminate the significant vulnerability at this actionable process step is to implement the following focused mitigation strategies:
    * Install a lid on the mixer that must be opened to add anything to the mixer. If Facility E determines that it would be disruptive to the production schedule to install a lock on the lid, the facility could install an access alarm that would indicate that the lid has been opened. This alarm would sound in the operation control room where a manager supervises production operations.
    * Assign another member of staff the responsibility of preparing and securely staging ingredients for later production batches. This would alleviate the need for the mixer operator to leave the area, leaving the mixer unattended.
   With the introduction of these two focused mitigation strategies, the facility would have taken steps to enclose the mixer, making it more difficult for an attacker to introduce a contaminant without alerting management (by the sounding of the alarm), and increased the dedicated observation of this otherwise vulnerable process step by ensuring that the mixer operator is not required to leave the area unattended.
   Mixing at Facility F's rotating air dryer is another example of an actionable process step for the key activity type "Mixing and similar activities." In Facility F, product, such as crackers or breakfast cereals, are fed through drum-like equipment, where warm air is blown across it while the drum rotates. Although the goal of this process is to dry the product, it also could distribute any contaminant introduced into the dryer evenly across the product. Facility F's rotating air dryer is located alongside a commonly used walkway, but is behind a guard rail to prevent employees from coming in contact with the hot exterior of the dryer. Product is fed into the top of the dryer via a pneumatic conveyor. There is sufficient space between the dryer opening and the pneumatic conveyor discharge to enable an attacker to introduce a contaminant to the dryer at this point. That opening is about six feet above the ground, accessible from the floor of the facility. Product leaves the dryer through a gravity fed line. The connection between the dryer and the discharge line is sealed.
   To goal of focused mitigation strategies at this actionable process step would be to reduce access to this equipment to significantly reduce the likelihood an attacker could introduce a contaminant into the rotating air dryer. One way Facility F could do this would be to install a clear plastic shield that would be affixed to and extend from the discharge of the pneumatic conveyor to the opening of the dryer where it would also be tightly affixed to the housing of the dryer. A clear plastic shield would enable workers to supervise the product flow into the dryer while posing as an effective barrier to an attacker wishing to introduce a contaminant into the product at the dryer. This engineering improvement would significantly minimize or eliminate access to the food in the dryer and thereby significantly reduce or eliminate the likelihood of a successful act of intentional adulteration at this process step. The installation of physical barriers to access of equipment at actionable process steps can be one of the most effective focused mitigation strategies because it does not require restricting personnel or maintaining active observation of an area. The implementation of this engineering improvement would be detailed in the facility's food defense plan.
   c. Proposed
   Because a focused mitigation strategy that would be necessary at an actionable process step must be tailored to address the significant vulnerability applicable to the specific actionable process step, we are not proposing to specify the particular focused mitigation strategies that would be appropriate. Rather, we expect the owner, operator, or agent in charge of the facility covered by this rule to identify the specific focused mitigation strategy(s) that would be appropriate, considering the facility and food it produces, and to ensure the proper implementation of those strategies to provide assurances that the significant vulnerability at each identified actionable process step is significantly minimized or prevented and the food is not adulterated. In section V.C.3.b of this document, we list examples of focused mitigation strategies and describe scenarios for determining appropriate focused mitigation strategies at actionable process steps for each of the
   A facility would have the flexibility to identify and implement focused mitigation strategies from among all procedures, practices, and processes available to the facility that would provide the assurances that would be required by proposed
   FDA's existing guidance documents and other resources (discussed in section II.D of this document) include guidance for industry on a range of focused mitigation strategies. In particular, the MSD includes a list of mitigation strategies that can be applied to different steps in a food operation to reduce the risk of intentional adulteration. The database is searchable by key words and processing steps common to food operations (e.g., packing, manufacturing, processing and holding).
   Proposed SEC 121.135(a) implements the provisions in sections 418(c)(2) and 420(b)(2) of the FD&C Act.
   d. Proposed
   Proposed SEC 121.135(b) implements the provisions in sections 418(h) and 420(b)(2) of the FD&C Act.
   e. Proposed
4. Monitoring
   a. General description of monitoring. Proposed
   b. Proposed
   c. Proposed
   d. Proposed
   The monitoring records would be used to verify that the focused mitigation strategies are being monitored, as would be required by proposed
5. Corrective Actions
   a. General description of corrective actions. When a HACCP-type system is applied to ensure food safety, the term "corrective actions" is used to describe procedures that are in place to correct the cause of a deviation to ensure that a critical control point is under control and to ensure that the product produced under that deviation is safe, since total adherence to a planned process may not always occur. This concept is discussed in detail in section XII.F of the PC proposed rule.
   This same concept can be applied to the control of intentional adulteration related to acts of terrorism. Monitoring may detect a deviation from implementation of a focused mitigation strategy; corrective actions are implemented to re-establish control. In developing the proposed corrective actions requirements related to food defense, we considered our proposed relevant requirements related to food safety. The proposed provisions in
   b. Proposed
   The benefits of identifying corrective action procedures before corrective action is needed largely derive from having written procedures. Written corrective action procedures would be essential to the facility's management, to auditors, and to inspectors. The facility's management will be responsible for ensuring that appropriate corrective actions are taken if focused mitigation strategies are not properly implemented. Having access to appropriate, written corrective action procedures determined in advance of the need for such action can ensure that correct and complete actions are taken in a timely fashion. Having written corrective action procedures available for auditors and for inspectors is essential for them to assess the adequacy of the food defense plan; the procedures a facility will use to address implementation failures are essential to proper, consistent implementation, and without them a complete assessment cannot be made. Written corrective action procedures also will be useful for training purposes, so that employees who would need to implement the corrective action procedures will be prepared for what they would need to do.
   Proposed SEC 121.145(a)(2) would require that corrective action procedures describe the steps to be taken to ensure that appropriate action is taken to identify and correct a problem with implementation of a focused mitigation strategy to reduce the likelihood that the problem will recur. In the previous example in which two staff are required to be at a work station at all times, the corrective action could be speaking with the employees to ensure they understand the importance of remaining at the work station together, sending staff to a refresher course on food defense awareness, and ensuring that the supervisor knows that there must be adequate staff present on a shift so two people can be at the work station at all times. If the problem recurs, management may need to consider other measures for preventing access at that process step.
   c. Proposed
   d. Corrective actions proposed to be required by part 117 but not part 121. Unlike in proposed part 117, in proposed part 121, we have not proposed a requirement to ensure that all affected food is evaluated for food safety if focused mitigation strategies are not properly implemented or are found to be ineffective. An act of intentional adulteration or attempted intentional adulteration has historically been a rare event and, as a result, in the vast majority of cases, the failure to properly implement a focused mitigation strategy would not be expected to result in contaminated food. This is because intentional adulteration requires not just the opportunity for contamination (i.e., failure of a mitigation strategy to limit access to an actionable process step), but also someone with intent to cause harm at that same moment. In contrast, the failure to properly implement a preventive control for a food safety hazard, such as proper cook temperatures, is more likely to result in adulterated food (e.g., because the pathogen reasonably likely to be present in the raw food would not be eliminated from the food by the inadequate cooking process). However, our decision not to propose these requirements does not absolve an owner, operator, or agent in charge of a facility from their responsibility to ensure that food is not adulterated. In addition, food firms would continue to be subject to the reporting requirements under section 417 of the FD&C Act. Moreover, the introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act under section 301(a) of the FD&C Act.
   The PC proposed rule also contains requirements for corrective actions that must be taken in the event of an unanticipated problem. Unlike in proposed part 117, in proposed part 121, we are not proposing a requirement related to unanticipated problems because we are not aware of circumstances where this would be relevant. Because of the nature of the focused mitigation strategies, we expect that the outcomes of monitoring will be binary, either the focused mitigation strategy will be in place or it will not be in place. For this reason, we expect that corrective action plans will be straightforward, with no provision needed for unanticipated corrective actions. This contrasts with the circumstances of food safety preventive measures, where controls are often more complex, presenting opportunities for a more nuanced corrective action, which may not be possible to fully anticipate in advance.
   We ask for comment on our rationale and tentative conclusion not to propose these requirements.
6. Verification
   a. General description of verification. In the preventive controls framework, "verification" involves activities that help determine whether the focused mitigation strategies are valid and are implemented according to the food defense plan. Verification includes confirming that monitoring and corrective actions are being implemented as planned, through review of records and periodic reanalysis of the food defense plan. This concept as applied to food safety is discussed in detail in section XII.G of the PC proposed rule.
   We have tentatively concluded that this same concept applies to the control of intentional adulteration related to acts of terrorism. Efforts must be made to ensure that the system of mitigation strategies is in place and functioning as designed. The proposed provisions in
   b. Proposed
   c. Proposed
   d. Proposed
   Proposed SEC 121.150(c) would establish that the purpose of the review of records is to ensure that the records are complete, the activities reflected in the records occurred in accordance with the food defense plan, the focused mitigation strategies are effective, and appropriate decisions are made about corrective actions. We tentatively conclude that review of the records required by proposed
   Review of records also can reveal whether appropriate decisions were made about corrective actions. The review would determine whether all the corrective action procedures required by proposed
   Proposed SEC 121.150(c) would require review of the monitoring and corrective action records within an appropriate time after the records are made. We are not proposing to require review of records within a specified timeframe. While the PC proposed rule contains a requirement that monitoring and corrective action records be reviewed within a week after the records are made, in the case of food defense, we do not believe specifying a timeframe for records review is necessary. As discussed previously, some focused mitigation strategies may be monitored less frequently than are preventive controls for food safety. In a HACCP- type system for food safety, monitoring and corrective action records are often reviewed a short time after their creation to enable action to be taken relative to food that may be adulterated (e.g., recall). It is unlikely that an improperly implemented focused mitigation strategy would result in adulterated food (i.e., because adulteration of food would require not only opportunity but also a simultaneous intent to cause adulteration). A focused mitigation strategy such as "adequate lighting at the bulk truck unloading bay" or "secure air vents on a cooling tank with one-way valves" may be monitored on a weekly or monthly basis. Because the focused mitigation strategies may be monitored less frequently and because these frequencies may vary significantly from one focused mitigation strategy to another, we believe it is appropriate for owners, operators, or agents in charge of a facility to determine when review of the monitoring and corrective action records is best performed.
   e. Proposed
   1. At least once every 3 years (proposed
   2. Whenever a significant change is made in the activities conducted at a facility operated by such owner, operator, or agent in charge if the change creates a reasonable potential for a new vulnerability or a significant increase in a previously identified vulnerability (proposed
   3. Whenever such owner, operator or agent in charge becomes aware of new information about potential vulnerabilities associated with the food operation or facility (proposed
   4. Whenever a focused mitigation strategy is found to be ineffective (proposed
   5. Whenever
   Proposed SEC 121.150(d)(2) would require that the owner, operator, or agent in charge of a facility complete the required reanalysis and implement any additional focused mitigation strategies needed to address the significant vulnerabilities identified, if any, before the change in activities at the facility is operative or, when necessary, during the first six weeks of production. The purpose of the reanalysis is to identify the need for, and implement, focused mitigation strategies in light of a reasonable potential for a new significant vulnerability, or a significant increase in a previously identified significant vulnerability.
   Proposed SEC 121.150(d)(3) would require that the owner, operator, or agent in charge of a facility revise the written plan if a significant change is made or document the basis for the conclusion that no additional or revised focused mitigation strategies are needed. It is important to document that a reanalysis has been conducted and the plan has been revised accordingly or that no change has been made. Such documentation demonstrates that a facility has considered all relevant information on the defense of the operation, including new information that has become available since the last analysis. The documentation further demonstrates that appropriate changes have been made or that current procedures for implementing focused mitigation strategies are adequate to significantly minimize or prevent significant vulnerabilities.
   f. Proposed
   g. Verification proposed to be required by part 117 but not part 121. In the PC proposed rule, we proposed to require, as part of verification, the validation of the adequacy of the preventive controls implemented to control the hazards identified in the hazard analysis as reasonably likely to occur. In this proposed rule, we are not including a similar proposed requirement. Unlike preventive controls, which often involve processing parameters that can be scientifically validated, focused mitigations strategies for food defense (which correspond to preventive controls for food safety) often are not of a nature that they can be scientifically validated. For example, it would not be practical for a facility to attempt to validate the effectiveness of a lock on a tank or the use of a `buddy system' at a particular process step to prevent or significantly minimize intentional adulteration of food caused by a terrorist attack. Most of the recommended mitigation strategies in the MSD (Ref. 30) are similar in nature to the two mentioned in the example above in that validation would be impractical. Therefore, we have tentatively concluded not to propose a requirement for validation of focused mitigation strategies.
   However, if a facility chooses to use a processing parameter (e.g., thermal kill step) as a focused mitigation strategy, the facility should employ such a processing parameter if it has been demonstrated to be effective in significantly minimizing or preventing the associated significant vulnerability. In many circumstances it is not appropriate to use such strategies because they are usually effective against one or several, but not all, potential contaminants. See section XII.G of the PC proposed rule for additional discussion of validation.
   The PC proposed rule also includes proposed requirements for calibration of process monitoring instruments and verification instruments and also records associated with these activities. As discussed previously, it is our expectation that most of the focused mitigation strategies will not be continuously monitored and will not require process monitoring instruments or instruments to verification purposes. Therefore, we do not believe it would be necessary to include those requirements in this part.
   We ask for comment on our tentative decision not to include validation of the focused mitigation strategies and calibration of monitoring and verification instruments in codified requirements in proposed
7. Training of Personnel
   Proposed SEC 121.160 would establish requirements related to training of certain personnel working in a food operation. Proposed
   We are proposing that training required under this provision must cover food defense awareness and the respective responsibilities of personnel and supervisors assigned to actionable steps in implementing focused mitigation strategies. At a minimum, such training must include the general principles of food defense, including simple procedures for employees to follow to adhere to those principles in their jobs. We have tentatively concluded that completion of
   FDA has developed training tools that are available for use by the industry.
   FDA also previously issued guidance documents for industry on food defense (Ref. 22, Ref. 23, Ref. 24, Ref. 25, Ref. 26), which include recommendations related to personnel training. In these guidance documents, we recommended that all employees have training in food defense awareness, including information on how to prevent, detect, and respond to an intentional contamination incident at their facility. As noted in these guidance documents, we recommended incorporating periodic reminders of the importance of food defense procedures into routine facility communications, such as brochures, staff meetings or payroll stuffers. We further recommended that facilities encourage all employees to report unusual or suspicious individuals or activities to management. We reiterate these recommendations described in our guidance documents. However, in this proposed rule, we are not proposing to include additional specific training requirements to reflect all of those recommendations. For example, although we are not requiring that all employees at a facility receive training in food defense, we recognize the importance of training as a measure to protect against intentional adulteration of food and, therefore, reiterate our recommendation that all personnel working in a food operation receive training in food defense awareness. We request comment on this issue, including on whether we should require, in a final rule, that basic food defense awareness training be completed by all employees at a facility. We also request comment on whether we should require training to be repeated periodically, including when significant changes are made to food defense plans.
   Proposed SEC 121.160(b) would require that all training received in accordance with section
   We recognize that industry has already begun to implement food defense measures to meet certain industry standards, which include guidelines for food defense training (Ref. 63, Ref. 33, Ref. 35). Our proposed minimum requirements for training are consistent with these standards, as well as with WHO recommendations for personnel training in its guidance on food defense (Ref. 6). We seek comment on the feasibility of our proposed training requirements, in light of the current state of food defense awareness in the industry and available training resources.
D. Requirements Applying to Records That Must Be Established and Maintained
   When a HACCP-type system is implemented for food safety, records are a critical part of the system because they aid facilities in compliance with the requirements, including all the elements of a food safety plan as proposed in Part 117, and allow facilities to show, and
   In subpart D of proposed part 121,
1. Proposed
   Proposed SEC 121.301(a) would establish that, except as provided by proposed
   Proposed SEC 121.301(b) would establish that the requirements of proposed
2. Proposed
   Proposed SEC 121.305 contains general requirements that would apply to records that would be required under proposed part 121, including the format for required records, the recording of actual values and observations obtained during monitoring, when records must be created, and information that must be included in each record.
   a. Proposed
   Proposed SEC 121.305(a) also would require that electronic records be kept in accordance with part 11 (21 CFR part 11). Part 11 provides criteria for acceptance by
   In the PC proposed rule,
   b. Proposed
   c. Proposed
   d. Proposed
   The proposed requirement (proposed
3. Proposed
   Proposed SEC 121.310 would require that the owner, operator, or agent in charge of a facility sign and date the food defense plan upon initial completion (proposed
4. Proposed
   Proposed SEC 121.315 contains requirements on the length of time records that would be required under proposed part 121 must be retained and allowances for offsite storage of records under certain circumstances.
   a. Proposed
   b. Proposed
   Proposed SEC 121.315(c) also would provide that electronic records are considered to be onsite if they are accessible from an onsite location. Computerized systems within corporations can be networked, allowing for the sending and receiving of information in a secure fashion to all of the different food processing facilities of that corporation worldwide. This type of system can be used to provide access at multiple locations to records from multiple facilities.
   c. Proposed
5. Proposed
   Proposed SEC 121.320 would require that all records required by proposed part 121 be made promptly available to a duly authorized representative of the Secretary of
6. Proposed
   Proposed SEC 121.325 would establish that all records required by proposed part 121 will be protected from public disclosure to the extent allowable under part 20 of this chapter. Our general policies, procedures, and practices relating to the protection of confidential or otherwise protected information received from third parties would apply to information received under this rule.
E. Compliance
   Section 103(e) of FSMA amends section 301 of the FD&C Act (21 U.S.C. 331) by adding a new section--(uu)--to the list of acts and the causing thereof that are prohibited. Under section 301(uu) of the FD&C Act, the following act, and the causing thereof, are prohibited: "[t]he operation of a facility that manufactures, processes, packs, or holds food for sale in
   Section 106(d) of FSMA amends section 301 of the FD&C Act by adding a new section--(ww)--to the list of acts and the causing thereof that are prohibited. Under section 301(ww) of the FD&C Act, the following act, and the causing thereof, are prohibited: "[t]he failure to comply with section 420 [of the FD&C Act]." To clearly communicate that failure to comply with the regulations established under section 420 of the FD&C Act is a prohibited act, proposed
VI. Preliminary Regulatory Impact Analysis
A. Overview
   FDA has examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this proposed rule is a significant regulatory action under Executive Order 12866.
B. Regulatory Flexibility Act
   The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. The annualized costs per entity due to this proposed rule are about
C. Small Business Regulatory Enforcement Fairness Act of 1996
   The Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121) defines a major rule for the purpose of congressional review as having caused or being likely to cause one or more of the following: An annual effect on the economy of
D. Unfunded Mandates Reform Act of 1995
   Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing "any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of
E. Paperwork Reduction Act of 1995
   This proposed rule contains information collection requirements that are subject to review by the
   FDA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of
   To ensure that comments on information collection are received, OMB recommends that written comments be faxed to the
   In compliance with the Paperwork Reduction Act of 1995 (44. U.S.C. 3407(d)), the agency has submitted the information collection provisions of this proposed rule to OMB for review. Interested persons are requested to send comments regarding information collection by
F. Public Access to the Analyses
   The analyses that we have performed to examine the impacts of this proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) are available to the public in the docket for this final rule (Ref. 64).
VII. Analysis of Environmental Impact
   The Agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment (Ref. 65). Therefore, neither an environmental assessment nor an environmental impact statement is required.
VIII. Federalism
   FDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132.
IX. Comments
   We invite public comment on the matters specified in this document as well as any other matters concerning this proposed rule that are of interest. Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the
X. References
   The following references have been placed on display in the
   1. Kennedy, S.K. and
   2. Khan A.S.,
   3. Sobel, J.,
   4. Toeroek, T.J.,
   5.
   6.
   7. Everstine, K., S. Kennedy, and
   8.
   9. Spink, J. and DC Moyer, "Defining the Public Health Threat of Food Fraud,"
   10. Ingelfinger, J.R., "Melamine and the Global Implications of Food Contamination,"
   11. Xiu, C. and K.K. Klein, "Melamine in Milk Products in
   12.
   13. Kolavic, S., A.
   14.
   15.
   16. The White House,
   17. The White House,
   18. The White House,
   19. The White House,
   20. The White House,
   21.
   22.
   23.
   24.
   25.
   26.
   27.
   28.
   29.
   30.
   31.
   32.
   33. Global Food Safety Initiative. GFSI Guidance Document, Version 6.1, 6(2),
   34.
   35. International Featured Standards. Events and Academy Page. http://www.ifs-certification.us/events. Accessed
   36. China Inspection and Quarantine Service, Administrative Provisions on Filing of Export Food Production Enterprises Page. http://en.ciqcid.com/Zjl/Comprehensives/51829.htm. Accessed
   37.
   38.
   39.
   40.
   41. Buttars, N.K.,
   42.
   43. Newkirk, R.,
   44. Popkin, B., "Patterns of Beverage Use Across the Lifecycle," Physiology and Behavior, 100(1):4-9, 2010.
   45. Sebastian, R.S., J.D. Goldman,
   46.
   47.
   48. Blayney, D.P., "The Changing Landscape of U.S. Milk Production," Statistical Bulletin No. 978,
   49.
   50. Sobel J. and
   51. Stinson, T.F.,
   52. Merriam-
   53.
   54.
   55.
   56.
   57.
   58.
   59.
   60.
   61. International Featured Standards. IFS Food: Standard for Auditing Quality and Food Safety of
   62.
   63.
   64.
   65.
List of Subjects in 21 CFR Part 121
   Food packaging, Foods.
   Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR chapter I be amended by adding part 121 to read as follows:
PART 121--FOCUSED MITIGATION STRATEGIES TO PROTECT FOOD AGAINST INTENTIONAL ADULTERATION
Subpart A--General Provisions
Sec.
121.3 Definitions.
121.5 Exemptions.
Subpart B--[Reserved]
Subpart C--Food Defense Measures
121.126 Requirement for a food defense plan.
121.130 Identification of actionable process steps.
121.135 Focused mitigation strategies for actionable process steps.
121.140 Monitoring.
121.145 Corrective actions.
121.150 Verification.
121.160 Training.
Subpart D--Requirements Applying to Records That Must Be Established and Maintained
121.301 Records subject to the requirements of this subpart.
121.305 General requirements applying to records.
121.310 Additional requirements applying to the food defense plan.
121.315 Requirements for record retention.
121.320 Requirements for official review.
121.325 Public disclosure.
Subpart E--Compliance
121.401 Compliance.
   Authority: 21 U.S.C. 331, 342, 350g, 350(i), 371, 374.
Subpart A--General Provisions
   The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act are applicable to such terms when used in this part. The following definitions also apply:
   Actionable process step means a point, step, or procedure in a food process at which food defense measures can be applied and are essential to prevent or eliminate a significant vulnerability or reduce such vulnerability to an acceptable level.
   Contaminant means any biological, chemical, physical or radiological agent that may be intentionally added to food and that may cause illness, injury or death.
   Facility means a domestic facility or a foreign facility that is required to register under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), in accordance with the requirements of 21 CFR part 1, subpart H.
   Farm means farm as defined in
   FDA means the
   Focused mitigation strategies mean those risk-based, reasonably appropriate measures that a person knowledgeable about food defense would employ to significantly minimize or prevent significant vulnerabilities identified at actionable process steps, and that are consistent with the current scientific understanding of food defense at the time of the analysis.
   Food means food as defined in section 201(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(f)) and includes raw materials and ingredients.
   Food defense means the effort to protect food from intentional acts of adulteration where there is an intent to cause public health harm and economic disruption.
   Holding means storage of food. Holding facilities include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks. For farms and farm mixed-type facilities, holding also includes activities traditionally performed by farms for the safe or effective storage of raw agricultural commodities grown or raised on the same farm or another farm under the same ownership, but does not include activities that transform a raw agricultural commodity, as defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act, into a processed food as defined in section 201(gg).
   Manufacturing/processing means making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients. Examples of manufacturing/processing activities are cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling, or packaging. For farms and farm mixed-type facilities, manufacturing/processing does not include activities that are part of harvesting, packing, or holding.
   Mixed-type facility means an establishment that engages in both activities that are exempt from registration under section 415 of the Federal Food, Drug, and Cosmetic Act and activities that require the establishment to be registered. An example of such a facility is a "farm mixed-type facility," which is an establishment that grows and harvests crops or raises animals and may conduct other activities within the farm definition, but also conducts activities that require the establishment to be registered.
   Monitor means to conduct a planned sequence of observations or measurements to assess whether focused mitigation strategies are consistently applied and to produce an accurate record for use in verification.
   Packing means placing food into a container other than packaging the food. For farms and farm mixed-type facilities, packing also includes activities traditionally performed by farms to prepare raw agricultural commodities grown or raised on the same farm or another farm under the same ownership for storage and transport, but does not include activities that transform a raw agricultural commodity, as defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act, into a processed food as defined in section 201(gg).
   Qualified end-user, with respect to a food, means the consumer of the food (where the term consumer does not include a business); or a restaurant or retail food establishment (as those terms are defined in
   (1) Is located:
   (i) In the same State as the qualified facility that sold the food to such restaurant or establishment; or
   (ii) Not more than 275 miles from such facility; and
   (2) Is purchasing the food for sale directly to consumers at such restaurant or retail food establishment.
   Qualified facility means (when including the sales by any subsidiary; affiliate; or subsidiaries or affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate) a facility that is:
   (1) A very small business as defined in this part; or
   (2) A facility to which both of the following apply:
   (i) During the 3-year period preceding the applicable calendar year, the average annual monetary value of the food manufactured, processed, packed or held at such facility that is sold directly to qualified end-users (as defined in this part) during such period exceeded the average annual monetary value of the food sold by such facility to all other purchasers; and
   (ii) The average annual monetary value of all food sold during the 3-year period preceding the applicable calendar year was less than
   Significant vulnerability means a vulnerability for which a prudent person knowledgeable about food defense would employ food defense measures because of the potential for serious adverse health consequences or death and the degree of accessibility to that point in the food process.
   Significantly minimize means to reduce to an acceptable level, including to eliminate.
   Small business means a business employing fewer than 500 persons.
   Verification means those activities, other than monitoring, that establish that the system is operating according to the food defense plan.
   Very small business means a business that has less than
   Vulnerability means the susceptibility of a point, step, or procedure in a facility's food process to intentional adulteration.
   (a) This part does not apply to a qualified facility, except that qualified facilities must, upon request, provide for official review documentation that was relied upon to demonstrate that the facility meets this exemption. Such documentation must be retained for 2 years.
   (b) This part does not apply to the holding of food, except the holding of food in liquid storage tanks.
   (c) This part does not apply to the packing, re-packing, labeling, or re-labeling of food where the container that directly contacts the food remains intact.
   (d) This part does not apply to activities of a facility that are subject to section 419 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350h) (Standards for Produce Safety).
   (e)(1) This part does not apply with respect to alcoholic beverages at a facility that meets the following two conditions:
   (i) Under the Federal Alcohol Administration Act (27 U.S.C.
   (ii) Under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) the facility is required to register as a facility because it is engaged in manufacturing, processing, packing, or holding one or more alcoholic beverages.
   (2) This part does not apply with respect to food other than alcoholic beverages at a facility described in paragraph (e)(1) of this section, provided such food:
   (i) Is in prepackaged form that prevents any direct human contact with such food; and
   (ii) Constitutes not more than 5 percent of the overall sales of the facility, as determined by the Secretary of the Treasury.
   (f) This part does not apply to the manufacturing, processing, packing, or holding of food for animals other than man.
Subpart B--[Reserved]
Subpart C--Food Defense Measures
   (a) Food defense plan. The owner, operator, or agent in charge of a facility must prepare, or have prepared, and implement a written food defense plan.
   (b) Contents of a food defense plan. The food defense plan must include:
   (1) The written identification of actionable process steps as required by
   (2) The written focused mitigation strategies as required by
   (3) The written procedures for monitoring as required by
   (4) The written corrective action procedures as required by
   (5) The written verification procedures as required by
   The owner, operator, or agent in charge of a facility must identify any actionable process steps, using the procedures described in either paragraph (a) or paragraph (b) of this section. The identification of actionable process steps and the assessment leading to that identification must be written.
   (a) Key activity types. The owner, operator, or agent in charge of a facility must assess, for each type of food manufactured, processed, packed or held at the facility, whether the facility has one or more of the following key activity types and identify the actionable process steps associated with any key activity types present:
   (1) Bulk liquid receiving and loading --a step in which a bulk liquid is received and unloaded from an inbound conveyance or loaded into an outbound conveyance where a contaminant can be intentionally introduced and, if it is, it is likely that the contaminant will be distributed throughout the liquid due to sloshing, movement, or turbulence caused by the receiving and unloading or loading activity.
   (2) Liquid storage and handling --a step in which a liquid is contained in bulk storage tanks or in holding, surge, or metering tanks where a contaminant can be intentionally introduced and, if it is, it is likely that the contaminant will be distributed into the food.
   (3) Secondary ingredient handling --a staging, preparation, addition, or rework step where a contaminant can be intentionally introduced into a relatively small amount of ingredient or rework and, if it is, it is likely that the contaminant will be distributed into a larger volume of food.
   (4) Mixing and similar activities --a step, such as mixing, blending, homogenizing, or grinding where a contaminant can be intentionally introduced and, if it is, it is likely that the contaminant will be distributed into the food.
   (b) Vulnerability assessment. The owner, operator, or agent in charge of a facility must conduct or have conducted, for each type of food manufactured, processed, packed or held at the facility, an evaluation to identify and prioritize the points, steps, and procedures in a food operation based on their vulnerability to intentional adulteration and to identify actionable process steps. Such vulnerability assessments must be performed by an individual(s) qualified by experience and/or training using appropriate methods.
SEC 121.135 Focused mitigation strategies for actionable process steps.
   (a) The owner, operator, or agent in charge of a facility must identify and implement focused mitigation strategies at each actionable process step to provide assurances that the significant vulnerability at each step will be significantly minimized or prevented and the food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342).
   (b) Focused mitigation strategies must be written.
   (c) Focused mitigation strategies required under this section are subject to:
   (1) Monitoring as required by SEC 121.140;
   (2) Corrective actions as required by SEC 121.145; and
   (3) Verification as required by SEC 121.150.
SEC 121.140 Monitoring.
   (a) The owner, operator, or agent in charge of a facility must establish and implement written procedures, including the frequency with which they are to be performed, for monitoring the focused mitigation strategies.
   (b) The owner, operator, or agent in charge of a facility must monitor the focused mitigation strategies with sufficient frequency to provide assurances that they are consistently applied.
   (c) All monitoring of focused mitigation strategies in accordance with this section must be documented in records that are subject to verification in accordance with SEC 121.150(a) and records review in accordance with SEC 121.150(c).
SEC 121.145 Corrective actions.
   (a) Corrective action procedures. (1) The owner, operator, or agent in charge of a facility must establish and implement written corrective action procedures that must be taken if focused mitigation strategies are not properly implemented.
   (2) The corrective action procedures must describe the steps to be taken to ensure that appropriate action is taken to identify and correct a problem with implementation of a focused mitigation strategy to reduce the likelihood that the problem will recur.
   (b) Documentation. All corrective actions taken in accordance with this section must be documented in records that are subject to verification in accordance with SEC 121.150(b) and records review in accordance with SEC 121.150(c).
SEC 121.150 Verification.
   (a) Monitoring. The owner, operator, or agent in charge of a facility must verify that monitoring is being conducted, as required by SEC 121.140.
   (b) Corrective actions. The owner, operator, or agent in charge of a facility must verify that appropriate decisions about corrective actions are being made, as required by SEC 121.145.
   (c) Implementation and effectiveness. The owner, operator, or agent in charge of a facility must verify that the focused mitigation strategies are consistently implemented and are effectively and significantly minimizing or preventing the significant vulnerabilities. As appropriate to the facility and the food, this must include review of the monitoring and corrective actions records within appropriate timeframes to ensure that the records are complete, the activities reflected in the records occurred in accordance with the food defense plan, the focused mitigation strategies are effective, and appropriate decisions were made about corrective actions.
   (d) Reanalysis. The owner, operator, or agent in charge of a facility must:
   (1) Conduct a reanalysis of the food defense plan:
   (i) At least once every 3 years;
   (ii) Whenever a significant change is made in the activities conducted at a facility operated by such owner, operator, or agent in charge if the change creates a reasonable potential for a new vulnerability or a significant increase in a previously identified vulnerability;
   (iii) Whenever such owner, operator or agent in charge becomes aware of new information about potential vulnerabilities associated with the food operation or facility;
   (iv) Whenever a focused mitigation strategy is found to be ineffective; and
   (v) Whenever FDA requires reanalysis to respond to new vulnerabilities and developments in scientific understanding including, as appropriate, results from the
   (2) Complete such reanalysis and implement any additional focused mitigation strategies needed to address the significant vulnerabilities identified, if any, before the change in activities at the facility is operative or, when necessary, during the first 6 weeks of production; and
   (3) Revise the written plan if a significant change is made or document the basis for the conclusion that no additional or revised focused mitigation strategies are needed.
   (e) Documentation. All verification activities taken in accordance with this section must be documented in records.
SEC 121.160 Training.
   (a) Personnel and supervisors assigned to actionable process steps must receive appropriate training in food defense awareness and their respective responsibilities in implementing focused mitigation strategies.
   (b) All training received in accordance with this section must be documented in records.
Subpart D--Requirements Applying to Records That Must Be Established and Maintained
SEC 121.301 Records subject to the requirements of this subpart D.
   (a) Except as provided by paragraph (b) of this section, all records required by subpart C of this part are subject to all requirements of this subpart D.
   (b) The requirements of SEC 121.310 apply only to the written food defense plan.
SEC 121.305 General requirements applying to records.
   Records must:
   (a) Be kept as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic records, which must be kept in accordance with part 11 of this chapter;
   (b) Contain the actual values and observations obtained during monitoring;
   (c) Be accurate, indelible, and legible;
   (d) Be created concurrently with performance of the activity documented;
   (e) Be as detailed as necessary to provide history of work performed; and
   (f) Include:
   (1) The name and location of the facility;
   (2) The date and time of the activity documented;
   (3) The signature or initials of the person performing the activity; and
   (4) Where appropriate, the identity of the product and the production code, if any.
SEC 121.310 Additional requirements applying to the food defense plan.
   The food defense plan must be signed and dated by the owner, operator, or agent in charge of the facility:
   (a) Upon initial completion; and
   (b) Upon any modification.
SEC 121.315 Requirements for record retention.
   (a) All records required by this part must be retained at the facility for at least 2 years after the date they were prepared.
   (b) The food defense plan must be retained for at least 2 years after its use is discontinued;
   (c) Except for the food defense plan, offsite storage of records is permitted after 6 months following the date that the record was made if such records can be retrieved and provided onsite within 24 hours of request for official review. The food defense plan must remain onsite. Electronic records are considered to be onsite if they are accessible from an onsite location.
   (d) If the facility is closed for a prolonged period, the records may be transferred to some other reasonably accessible location but must be returned to the facility within 24 hours for official review upon request.
SEC 121.320 Requirements for official review.
   All records required by this part must be made promptly available to a duly authorized representative of the Secretary of Health and Human Services upon oral or written request.
SEC 121.325 Public disclosure.
   Records required by this part will be protected from public disclosure to the extent allowable under part 20 of this chapter.
Subpart E--Compliance
SEC 121.401 Compliance.
   (a) The operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is required to comply with, and is not in compliance with, section 418 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350g) or subparts C or D of this part is a prohibited act under section 301(uu) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(uu)).
   (b) The failure to comply with section 420 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350i) or subparts C or D of this part is a prohibited act under section 301(ww) of the Federal Food, Drug, and Cosmetic Act.
   Dated:
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30373 Filed 12-20-13;
BILLING CODE 4160-01-P
| Copyright: | (c) 2013 Federal Information & News Dispatch, Inc. |
| Wordcount: | 48746 |
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