# Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3A2013-00125

## Record

- **Collection:** Federal Register
- **Document type:** Proposed Rule
- **Published:** January 16, 2013
- **Citation:** 78 FR 3646

## Text

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211
[Docket No. FDA-2011-N-0920]
RIN 0910-AG36
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Proposed rule.

SUMMARY:

The Food and Drug Administration (FDA) is proposing to amend its regulation for Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food (CGMPs) to modernize it and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. FDA also is proposing to revise certain definitions in FDA's current regulation for Registration of Food Facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for “farms.” FDA is taking this action as part of its announced initiative to revisit the CGMPs since they were last revised in 1986 and to implement new statutory provisions in the FD&C Act. The proposed rule is intended to build a food safety system for the future that makes modern, science-, and risk-based preventive controls the norm across all sectors of the food system.

DATES:

Submit either electronic or written comments on the proposed rule by May 16, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by February 15, 2013, (see the “Paperwork Reduction Act of 1995” section of this document).

ADDRESSES:

You may submit comments, identified by Docket No. FDA-2011-N-0920 and/or RIN 0910-AG36, by any of the following methods, except that comments on information collection issues under the Paperwork Reduction Act of 1995 must be submitted to the Office of Regulatory Affairs, Office of Management and Budget (OMB) (see the “Paperwork Reduction Act of 1995” section of this document).

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal:
http://www.regulations.gov
. Follow the instructions for submitting comments.

Written Submissions

Submit written submissions in the following ways:

• FAX: 301-827-6870.

• Mail/Hand delivery/Courier (for paper or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Instructions:
All submissions received must include the Agency name and Docket No. for this rulemaking. All comments received may be posted without change to
http://www.regulations.gov
, including any personal information provided. For additional information on submitting comments, see the “Comments” heading of the
SUPPLEMENTARY INFORMATION
section of this document.

Docket:
For access to the docket to read background documents or comments received, go to
http://www.regulations.gov
and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

With regard to the proposed rule:
Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2166.

With regard to the information collection:
Domini Bean, Office of Information Management, Food and Drug Administration, 1350 Picard Dr., PI50-400T, Rockville, MD 20850,
domini.bean@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

Executive Summary

Purpose and Coverage of the Proposed Rule

Summary of the Major Provisions of the Proposed Rule

Costs and Benefits

I. Introduction

II. Background

A. Regulatory Framework for Human Food

B. FDA Food Safety Modernization Act

C. Preventive Controls and Hazard Analysis and Critical Control Points (HACCP) Systems

D. Food Safety Problems Associated With Manufacturing, Processing, Packing, and Holding Food for Human Consumption

E. The Role of Testing as a Verification Measure in a Food Safety System

F. The Role of Supplier Approval and Verification Programs in a Food Safety System

III. Legal Authority

A. Changes to Current 21 CFR Part 1, Subparts H, I, and J

B. Changes to Current 21 CFR Part 110

C. Hazard Analysis and Risk-Based Preventive Controls

IV. Public Meeting and Preliminary Stakeholder Comments

A. Introduction

B. Comments on Allergen Control

C. Comments on Accredited Laboratories

D. Comments on Environmental Monitoring and Product Testing

E. Comments on Flexibility of Regulations and Guidance

F. Comments on Food Defense

G. Comments on Guidance and Outreach

H. Comments on Preventive Controls

I. Comments on Small and Very Small Business

J. Comments on Submission of Food Safety Plan to FDA

K. Comments on Modified Requirements for Warehouses

V. Placement of Regulatory Requirements

VI. Highlights of the Proposed Rule

A. Overview

B. Proposed Revisions to 21 CFR Part 1, Subparts H, I, and J

C. Proposed Revisions to General Provisions of 21 CFR Part 110 (Part 110) (Proposed Part 117, Subpart A)

D. Proposed Revisions to Current Good Manufacturing Practice Requirements of Part 110 (Proposed Part 117, Subpart B)

E. Proposed New Requirements for Hazard Analysis and Risk-Based Preventive Controls (Proposed Part 117, Subpart C)

F. Proposed New Provisions for Modified Requirements (Proposed Part 117, Subpart D)

G. Proposed New Provisions for Withdrawal of an Exemption Applicable to a Qualified Facility (Proposed Part 117, Subpart E)

H. Proposed New Recordkeeping Requirements (Proposed Part 117, Subpart F)

VII. Compliance Dates

VIII. Rulemaking Required by Section 103(c) of FSMA: On-Farm Activities

A. Section 103(c) of FSMA

B. The Current Legal and Regulatory Framework Under Sections 415 and 418 of the FD&C Act and Regulations Implementing Section 415 of the FD&C Act

C. Why This Rulemaking Is Needed

D. Organizing Principles for How the Status of a Food As a Raw Agricultural Commodity or As a Processed Food Affects the Requirements Applicable to a Farm Under Sections 415 and 418 of the FD&C Act

E. Proposed Revisions to 21 CFR Part 1

F. Impact of Proposed Revisions to the Definitions in 21 CFR Part 1

G. Qualitative Risk Assessment of On-Farm Activities Outside of the Farm Definition

H. Results of the Qualitative Risk Assessment

I. Tentative Conclusions Regarding On-Farm Low-Risk Activity/Food Combinations Under Section 418 of the FD&C Act

J. Tentative Conclusions Regarding On-Farm Low-Risk Activity/Food Combinations Under Section 421 of the FD&C Act

IX. Proposed General Revisions to Current Part 110

A. Title

B. Proposed Redesignations

C. Proposed Revisions for Consistency of Terms

D. Proposed Additions Regarding Cross-Contact

E. Proposed Revisions for Consistency With the Definition of “Food”

F. Proposed Revisions To Address Guidance in Current Part 110

G. Proposed Editorial Changes

X. Proposed Revisions to General Provisions of Part 110 (Proposed Part 117, Subpart A)

A. Proposed § 117.1—Applicability and Status

B. Proposed § 117.3—Definitions

C. Proposed § 117.5—Exemptions

D. Proposed § 117.7—Applicability of Part 117 to a Facility Solely Engaged in the Storage of Packaged Food That is Not Exposed to the Environment

XI. Proposed Revisions to Current Good Manufacturing Practice Requirements of Part 110 (Proposed Part 117, Subpart B)

A. Proposed Deletion of Guidance From Current Part 110

B. Other Potential Revisions to Current Guidance

C. Proposed Revisions for Consistency of Terms

D. Proposed Revisions To Address Cross-Contact

E. Proposed and Potential Revisions to Current § 110.10—Personnel (Proposed § 117.10)

F. Proposed Revisions to Current § 110.20—Plant and Grounds (Proposed § 117.20)

G. Proposed Revisions to Current § 110.35—Sanitary Operations (Proposed § 117.35)

H. Proposed Revisions to Current § 110.37—Sanitary Facilities and Controls (Proposed § 117.37)

I. Proposed Revisions to Current § 110.40—Equipment and Utensils (Proposed § 117.40)

J. Proposed Revisions to Current § 110.80—Processes and Controls (Proposed § 117.80)

K. Proposed Revisions to Current § 110.93—Warehousing and Distribution (Proposed § 117.93)

L. Proposed Revisions to Current § 110.110—Natural or Unavoidable Defects in Food for Human Use That Present No Health Hazard (Proposed § 117.110)

M. Potential Revisions to Establish Requirements in Place of Current Guidance

N. Request for Comment on Additional CGMP Requirements

XII. Proposed New Requirements for Hazard Analysis and Risk-Based Preventive Controls (Proposed Part 117, Subpart C)

A. Proposed § 117.126—Requirement for a Food Safety Plan

B. Proposed § 117.130—Hazard Analysis

C. Proposed § 117.135—Preventive Controls for Hazards That Are Reasonably Likely To Occur

D. Proposed § 117.137—Recall Plan for Food With a Hazard That Is Reasonably Likely To Occur

E. Proposed § 117.140—Monitoring

F. Proposed § 117.145—Corrective Actions

G. Proposed § 117.150—Verification

H. Proposed § 117.155—Requirements Applicable to a Qualified Individual

I. Proposed § 117.175—Records Required for Subpart C

J. Request for Comment on Additional Preventive Controls and Verification Procedures Not Being Proposed

K. Request for Comment on Other Potential Provisions Not Explicitly Included in Section 418 of the FD&C Act

XIII. Proposed New Provisions for Modified Requirements (Proposed Part 117, Subpart D)

A. Proposed § 117.201—Modified Requirements That Apply to a Qualified Facility

B. Proposed § 117.206—Modified Requirements That Apply to a Facility Solely Engaged in the Storage of Packaged Food That Is Not Exposed to the Environment

XIV. Proposed New Provisions for Withdrawal of an Exemption Applicable to a Qualified Facility (Proposed Part 117, Subpart E)

A. Requirements of Section 418 of the FD&C Act

B. Proposed § 117.251—Circumstances That May Lead FDA To Withdraw an Exemption Applicable to a Qualified Facility

C. Proposed § 117.254—Issuance of an Order To Withdraw an Exemption Applicable to a Qualified Facility

D. Proposed § 117.257—Contents of an Order To Withdraw an Exemption Applicable to a Qualified Facility

E. Proposed § 117.260—Compliance With, or Appeal of, an Order To Withdraw an Exemption Applicable to a Qualified Facility

F. Proposed § 117.264—Procedure for Submitting an Appeal

G. Proposed § 117.267—Procedure for Requesting an Informal Hearing

H. Proposed § 117.270—Requirements Applicable to an Informal Hearing

I. Proposed § 117.274—Presiding Officer for an Appeal and for an Informal Hearing

J. Proposed § 117.277—Time Frame for Issuing a Decision on an Appeal

K. Proposed § 117.280—Revocation of an Order To Withdraw an Exemption Applicable to a Qualified Facility

L. Proposed § 117.284—Final Agency Action

M. Conforming Amendments to 21 CFR Part 16

XV. Proposed New Recordkeeping Requirements (Proposed Part 117, Subpart F)

A. Relevant Statutory Provisions

B. Proposed § 117.301—Records Subject to the Requirements of this Subpart F

C. Proposed § 117.305—General Requirements Applying to Records

D. Proposed § 117.310—Additional Requirements Applying to the Food Safety Plan

E. Proposed § 117.315—Requirements for Record Retention

F. Proposed § 117.320—Requirements for Official Review

G. Proposed § 117.325—Public Disclosure

XVI. FSMA's Rulemaking Provisions

A. Requirements in Section 418(n)(3) of the FD&C Act Regarding Content

B. Requirements in Section 418(n)(5) of the FD&C Act Regarding Review of Hazard Analysis and Preventive Controls Programs in Existence on the Date of Enactment of FSMA

XVII. Proposed Removal of 21 CFR Part 110—Current Good Manufacturing Practice In Manufacturing, Packing, Or Holding Human Food

XVIII. Proposed Conforming Amendments

XIX. Preliminary Regulatory Impact Analysis

A. Overview

B. Regulatory Flexibility Act

C. Small Business Regulatory Enforcement Fairness Act of 1996

D. Unfunded Mandates Reform Act of 1995

E. Paperwork Reduction Act of 1995

F. Public Access to the Analyses

XX. Analysis of Environmental Impact

XXI. Federalism

XXII. Comments

XXIII. References

Appendix

I. The Role of Testing as a Verification Measure in a Modern Food Safety System

A. Verification of Preventive Controls

B. Scientifically Valid Sampling and Testing

C. Verification Testing of Raw Materials and Ingredients

D. Verification of Sanitation Controls to Significantly Minimize or Prevent the Potential for an Environmental Pathogen to Contaminate Food

E. Role of Environmental Monitoring in Verifying the Implementation and Effectiveness of Sanitation Controls in Significantly Minimizing or Preventing the Potential for an Environmental Pathogen to Contaminate Food

F. The Role of Finished Product Testing in Verifying the Implementation and Effectiveness of Preventive Controls

G. Metrics for Microbiological Risk Management

II. The Role of Supplier Approval and Verification Programs in a Food Safety System

III. References

Executive Summary

Purpose and Coverage of the Proposed Rule

The proposed rule would revise FDA's current good manufacturing practice (CGMP) regulations regarding the manufacturing, processing, packing, or holding of human food in two fundamental ways. First, it would add new preventive controls provisions as required by the FDA Food Safety Modernization Act (FSMA). In general, with some exceptions the new preventive controls provisions would apply to facilities that are required to register with FDA under FDA's current food facility registration regulations. These preventive controls would include requirements for covered facilities to maintain a food safety plan, perform a hazard analysis, and institute preventive controls for the mitigation of those hazards. Facilities would also be required to monitor their controls, verify that they were effective, take any appropriate corrective actions, and maintain records documenting these actions. Second, the proposed rule would update, revise, or otherwise clarify certain requirements of our CGMP regulations, which were last updated in 1986.

In addition, this proposed rule would clarify the scope of the exemption for “farms” in FDA's current food facility registration regulations and make corresponding clarifications to FDA's current regulations for the establishment, maintenance, and availability of records. These clarifications would affect who would be subject to the current regulations for registration and recordkeeping as well as the new preventive controls requirements that would be established by this proposed rule.

To put these changes in context, and to provide legal, regulatory, scientific, and technical information relevant to the new provisions, we provide several sections of background. This background discusses the history of food regulation and current regulatory framework, provides an overview of the provisions of FSMA applicable to this proposed rule, explains the principles and history of the use of Hazard Analysis and Critical Control Point (HACCP) systems, and describes a variety of hazards that have been associated with foods and food safety problems (including outbreaks of foodborne illness) that have resulted from these hazards. An Appendix also describes the role of testing as a verification measure in a food safety system, and the role of supplier approval and verification programs in a food safety system.

Summary of the Major Provisions of the Proposed Rule

The proposed rule would implement the requirements of FSMA for covered facilities to establish and implement a food safety system that includes a hazard analysis and risk-based preventive controls. Specifically, the proposed rule would establish requirements for:

• A written food safety plan;

• Hazard analysis;

• Preventive controls for hazards that are reasonably likely to occur;

• Monitoring;

• Corrective actions;

• Verification; and

• Associated records.

The application of the preventive controls would be required only in cases where facilities determine that hazards are reasonably likely to occur. We do not expect that all possible preventive measures and verification procedures would be applied to all foods at all facilities.

The proposed rule would also establish a series of exemptions (including modified requirements in some cases) from the requirements for hazard analysis and preventive controls. Facilities that manufacture, process, pack or hold food and that are required to register with FDA under section 415 of the FD&C Act would be required to comply with the proposed regulation unless they are covered by an exemption. The table immediately below summarizes these proposed exemptions in general terms. Importantly, the table in this Executive Summary does not include all the details that you must consider to determine whether an exemption applies to you. We provide those details in the proposed regulation (proposed § 117.5) and explain them in section X.C of this document.

Proposed Exemptions from the New Requirements for Hazard Analysis and Risk-Based Preventive Controls

Who or what would be exempt from the requirements for hazard analysis and risk-based preventive controls
Notes

“Qualified Facility” as defined by FSMA:
FDA is proposing three options for defining “very small business” and requests comment on which to adopt in a final rule.

• Business with average annual sales of < $500,000 and at least half the sales to consumers or local retailers or restaurants (within the same state or within 275 miles); or

Modified requirements would apply—i.e., a qualified facility would be required to:
• Notify FDA about its status; and
• Either:
○ Notify FDA that it is addressing hazards through preventive controls and monitoring; or
○ Notify FDA that it complies with applicable local regulations, and notify consumers of the name and complete business address of the facility where the food was manufactured or processed.

• Very small business

• Option 1: Average annual sales of < $250,000

• Option 2: Average annual sales of < $500,000

• Option 3: Average annual sales of <$1,000,000

• Low risk, on farm activities performed by small business (< 500 employees)
Small and very small on-farm businesses conducting these low risk activities would be exempt from most of the rule's requirements.

-or-

• Low-risk, on-farm activities performed by a very small business
We would define the low-risk activities that qualify for the exemption, including the specific foods to which they relate (such as re-packing intact fruits and vegetables, or grinding/milling/cracking/crushing grains)

○ Option 1: very small = <$250,000

○ Option 2: very small = <$500,000

○ Option 3: very small = <$1,000,000

Activities that are subject to the seafood HACCP requirements of part 123 (21 CFR part 123)
The facility must be in compliance with part 123.

Activities that are subject to the juice HACCP requirements of part 120 (21 CFR part 120)
The facility must be in compliance with part 120.

Activities that are subject to the “low-acid canned food” requirements of part 113 (21 CFR part 113)

• The exemption applies only with respect to microbiological hazards.
• The facility must be in compliance with part 113.

The manufacturing, processing, packing, or holding of a dietary supplement that is subject to the CGMP requirements of part 111 (21 CFR part 111)

• The facility must be in compliance with part 111.
• The facility must be in compliance with requirements for serious adverse event reporting for dietary supplements

Activities of a facility that are subject to section 419 of the FD&C Act (Standards for Produce Safety)
Elsewhere in this issue of the Federal Register, FDA is proposing standards for produce safety.

Alcoholic beverages at a facility that is required to obtain a permit from, register with, or obtain approval of a notice or application from the Secretary of the Treasury as a condition of doing business in the United States
The exemption also would apply to food other than alcoholic beverages at such a facility, provided that the food is in prepackaged form and constitutes not more than 5 percent of the overall sales of the facility.

Facilities that are solely engaged in the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing
A facility that stores raw agricultural commodities that are fruits and vegetables would not be exempt.

A facility solely engaged in the storage of packaged food that is not exposed to the environment
Modified requirements would apply for the storage of refrigerated packaged food.

The proposed rule also would establish the conditions under which an exemption granted to a “qualified facility” could be withdrawn, and the procedures that would be followed to withdraw such an exemption. The proposed rule would establish requirements that would apply to all records that would be required by the various proposed provisions. The proposed recordkeeping provisions would implement specific requirements of FSMA regarding records associated with the new provisions for hazard analysis and risk-based preventive controls and would allow facilities to show, and FDA to determine, compliance with the regulatory requirements.

The proposed rule would require that a qualified individual prepare the food safety plan, validate preventive controls, review records for implementation and effectiveness of preventive controls and the appropriateness of corrective actions, and perform the required reanalysis of a food safety plan. The proposed rule also would establish minimum requirements for the “qualified individual,” who would be required to successfully complete training with a standardized curriculum or be otherwise qualified through job experience to develop and apply a food safety system. Only a trained individual or individual qualified by job experience is capable of effectively executing these activities.

FDA is requesting comment on when and how other elements of a preventive controls system are an appropriate means of implementing the statutory directives, including: a product testing program, an environmental monitoring program, and a supplier approval and verification program, as appropriate.

Costs and Benefits

We summarize the domestic annualized costs of the three options for the proposed rule in the table immediately below. We are unable to estimate the benefits of the proposed rule. Instead we show the Breakeven Illness Percentage for each of the three options for the proposed rule. This is calculated by dividing the number of illnesses that would have to be prevented annually under each option by the total estimated number of illnesses attributable to FDA-regulated food products under the scope of each option of the proposed rule. This

ignores the costs to foreign firms and benefits to foreign consumers.

Total domestic costs annualized at 7 per cent over 7 years
Annual breakeven illness percentage

Proposed Rule with Very Small Business Defined as Less Than or Equal to $250,000 in Annual Revenue
$475 million
24

Proposed Rule with Very Small Business Defined as Less Than or Equal to $500,000 in Annual Revenue
$395 million
20

Proposed Rule with Very Small Business Defined as Less Than or Equal to $1,000,000 in Annual Revenue
$319 million
16

I. Introduction

Each year, about 48 million Americans (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die from food-borne diseases, according to recent estimates from the Centers for Disease Control and Prevention (CDC). This is a significant public health burden that is largely preventable. While many illnesses are the result of improper food handling practices in the home and food service settings, which would not be addressed by this proposed rule, FDA believes that improvements to its current good manufacturing practice (CGMP) regulations in part 110 (21 CFR part 110), including those prescribed by the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-533), can play an important role in reducing foodborne illness.

FSMA, signed into law by President Obama on January 4, 2011, enables FDA to better protect public health by helping to ensure the safety and security of the food supply. FSMA enables us to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides us with new enforcement authorities to help achieve higher rates of compliance with risk-based, prevention-oriented safety standards and to better respond to and contain problems when they do occur. In addition, the law gives us important new tools to better ensure the safety of imported foods and directs us to build an integrated national food safety system in partnership with State, local, tribal, and territorial authorities.

This new law continues efforts by the food industry and government to protect and improve the safety of the nation's food supply. At the Federal level, these efforts go back to the Pure Food and Drug Act of 1906, the United States' first national food safety law. FSMA carries forward the basic principle embodied in the 1906 law that food establishments have the primary responsibility and capacity to make food safe and that government's role is to set standards for food safety and provide oversight to help ensure standards are met.

Since passage of the 1906 Act, and the most recent revision of its basic food safety provisions in the Federal Food, Drug, and Cosmetic Act of 1938, the combined efforts of the food industry and government have produced a set of standards and practices that make the U.S. food supply among the safest in the world. These efforts include the development and adoption by FDA of CGMP standards that have long provided the regulatory foundation for food safety. They also include, in more recent years, the adoption for some elements of the food supply of more targeted, risk-based approaches, such as the Hazard Analysis and Critical Control Points (HACCP) approach to food safety.

HACCP was pioneered by the food industry and reflects the understanding that food safety is best assured if each producer and processor understands the hazards that are reasonably likely to occur in their particular product and operation and puts in place scientifically sound preventive controls to significantly minimize or eliminate the hazard. FDA has by regulation required seafood and juice processors to implement the HACCP approach to preventive controls. The U.S. Department of Agriculture (USDA) has also mandated HACCP for meat and poultry processors, and many food companies have implemented such modern preventive control systems for other commodities.

While these efforts have contributed to progress on food safety, and the United States has one of the safest food supplies in the world, significant food safety challenges persist in today's complex, dynamic, and global food system. Today's food supply is highly diverse and increasingly complex, with many new foods in the marketplace that pose new food safety challenges. New pathogens are emerging, and we are seeing commonly known pathogens appear in foods where they have not been traditionally seen. The population of individuals at greater risk for foodborne illness, such as those who are immune-compromised, is increasing. When illness outbreaks occur, they can have devastating impacts on public health and impose substantial economic disruption and cost on the food industry. The food safety challenge is only compounded by globalization, which has resulted in approximately 15 percent of the U.S. food supply being imported, including 80 percent of our seafood, 50 percent of our fresh fruit, and 20 percent of our vegetables.

Congress responded to today's food safety challenges by enacting FSMA. FSMA builds on past experience and the strong foundation provided by the current food safety system, but it also marks an historic turning point for food safety. FSMA directs FDA to build a food safety system for the future that makes modern, science- and risk-based preventive controls the norm across all sectors of the food system; meets the food safety challenges of the global food system; and establishes stronger partnerships for food safety across all levels of government and with the private sector to ensure optimal use of public and private resources. FDA has embarked on a comprehensive effort to build the food safety system mandated by Congress, as described on its FSMA implementation web page at
http://www.fda.gov/fsma
.

A top priority for FDA are those FSMA-required regulations that provide the framework for industry's implementation of preventive controls and FDA's ability to oversee their implementation for both domestic and imported food. These include, among others, regulations establishing preventive control standards for human food and animal food facilities, produce safety standards, standards that define the accountability of importers to verify the safety of food produced overseas, and a new program for accrediting public and private bodies to provide credible certifications that regulated entities are meeting U.S. safety standards. A proposed rule on foreign supplier verification is closely interconnected to this rule on preventive controls for human food, and is expected to publish soon.

In this document, we propose standards to implement the requirement in section 103 of FSMA for the adoption of preventive controls in human food facilities. The preamble that follows provides critical background on FDA's previous efforts in establishing and implementing CGMPs and preventive controls, because these past efforts are the critical starting point and foundation for FSMA implementation. The preamble then explains and provides background on the rationale for our proposed updating of current CGMP requirements and for the new rules implementing FSMA's preventive controls requirement. We are seeking comments on all aspects of this proposal.

II. Background

A. Regulatory Framework for Human Food

1. Current Good Manufacturing Practice in Manufacturing, Packing or Holding Human Food

In the
Federal Register
of April 26, 1969, FDA issued a final rule to establish in 21 CFR part 128 CGMP requirements for the manufacturing, processing, packing, or holding of human food (34 FR 6977). The CGMP regulation established criteria for effective sanitation control in the manufacture, processing, packing, or holding of human foods to effect compliance with section 402(a)(4) of the FD&C Act (21 U.S.C. 342(a)(4)), under which food is adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health (33 FR 19023, December 20, 1968). In 1973, we amended the CGMP regulation by adding a new section regarding natural or unavoidable defect levels in foods. (38 FR 854, January 5, 1973). In 1977, we redesignated the CGMP regulation as part 110 (21 CFR part 110) (42 FR 14301 at 14338, March 5, 1977).

In the
Federal Register
of June 19, 1986, FDA issued a final rule to revise the CGMP regulation in part 110 (hereinafter current part 110) (51 FR 22458). That final rule established new, updated, and more detailed CGMP requirements for food industry personnel; plants and grounds; sanitary facilities, controls, and operations; equipment and utensils; processes and controls; warehousing and distribution; and natural or avoidable defect levels (51 FR 22458). During the rulemaking to establish current part 110, we clarified that the CGMP regulations also identify the applicable criteria for implementing the requirements of section 402(a)(3) of the FD&C Act (21 U.S.C. 342(a)(3)), such that compliance with the CGMP requirements is also required to ensure that food does not consist in whole or in part of any filthy, putrid, or decomposed substance, or are otherwise unfit for food (51 FR 22458 at 22462). In addition, we noted that the CGMP requirements in part 110 serve two purposes: (1) To provide guidance on how to reduce insanitary manufacturing practices and on how to protect against food becoming contaminated; and (2) to state explicit, objective requirements that enable industry to know what FDA expects when an investigator visits one of its plants (51 FR 22458 at 22459).

In the rulemaking to establish current part 110, we also invoked section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264), which authorizes FDA to issue regulations for any requirements that, in the Commissioner's judgment, are necessary to prevent the introduction, transmission, or spread of food-borne communicable diseases from one State to another (44 FR 33238 at 33239, June 8, 1979). As we noted in that rulemaking, “[b]ecause this authority is designed to eliminate the introduction of diseases * * * from one State to another, this authority must of necessity be exercised upon the disease-causing substance within the State where the food is manufactured, processed, or held,” and that “[d]ue to the nationwide, interrelated structure of the food industry, communicable diseases may, without proper intrastate food controls, easily spread interstate” (44 FR 33238 at 33239).

Current part 110 serves as an “umbrella” regulation applicable to the manufacturing, processing, packing, or holding of all human food, with the exception that it does not apply to establishments engaged solely in the harvesting, storage, or distribution of raw agricultural commodities (RACs) which are ordinarily cleaned, prepared, treated, or otherwise processed before being marketed to consumers (§ 110.19(a)).

In 2002, FDA convened a CGMP Modernization Working Group (the CGMP Working Group) to determine whether part 110 is in need of further revision. The CGMP Working Group initiated research programs, presented preliminary findings, and solicited public comments, data, and scientific information through three public meetings (69 FR 40312, July 2, 2004). In 2005, the CGMP Working Group issued a report (hereinafter the CGMP Working Group Report) summarizing the oral and written comments we received in response to the
Federal Register
notice announcing the public meetings, as well as our key findings (Ref. 1).

The CGMP Working Group Report presented seven “opportunities” for CGMP modernization. The report called for:

• Requiring appropriate training for food production supervisors and workers, including the maintenance of personnel training records;

• Requiring the creation and implementation of a written food allergen control plan for food processing establishments that handle major food allergens;

• Requiring a written environmental pathogen control program, including the maintenance of appropriate implementation records, for food processors that produce ready-to-eat foods that support the growth of the pathogenic microorganism
Listeria monocytogenes;

• Requiring food processors to develop and maintain written cleaning and sanitation procedures, at a minimum for all food-contact equipment and food-contact surfaces, that define the scope, cleaning or sanitation objective, management responsibility, monitoring, corrective action, and recordkeeping associated with the cleaning or sanitation procedure;

• Considering whether to remove the current exemption for facilities solely engaged in the harvesting, packing, storage, and distribution of RACs by requesting further public comment on this issue;

• Requiring food processors to maintain certain critical records that document that controls and systems that ensure food safety are being properly implemented and requiring that FDA be given access to such documents to verify compliance with the CGMP requirements; and

• Requesting further public comments and suggestions regarding how the use of time-temperature relationships can be incorporated into CGMP regulations or guidances for proper refrigerated storage or hot holding (Ref. 1).

2. Other Food Safety Regulations Established by FDA

Although the umbrella CGMP requirements of current part 110 apply to the full range of human food, FDA concluded over time that they do not directly address unique safety issues associated with the manufacturing, processing, packing, or holding of certain specific types of food products. We therefore promulgated additional food safety regulations to provide for

specific process controls for the manufacturing, processing, packing, or holding of certain specific foods that are not captured by the more general part 110 CGMP requirements. Currently, such specific food safety regulations include those for:

• Thermally processed low-acid foods packaged in hermetically sealed containers (i.e., “low-acid canned foods,” hereinafter referred to as LACF) (part 113 (21 CFR part 113)) (Although some hermetically sealed containers (e.g., pouches and glass bottles) used to package thermally processed low-acid foods generally would not be viewed as “cans,” the term “low-acid canned foods” has been used for decades as a shorthand description for “thermally processed low-acid foods packaged in hermetically sealed containers,” and we continue to use that term and its abbreviation, LACF, for the purposes of this document);

• Acidified food (part 114 (21 CFR part 114));

• Bottled drinking water (part 129 (21 CFR part 129));

• Infant formula (parts 106 and 107 (21 CFR parts 106 and 107));

• Fish and fishery products (part 123 (21 CFR part 123));

• Juice (part 120 (21 CFR part 120));

• Dietary supplements (part 111 (21 CFR part 111));

• Refrigeration of shell eggs held for retail distribution (§ 115.50 (21 CFR 115.50); and

• Production, storage, and transportation of shell eggs (part 118) (21 CFR part 118)).

We discuss these food safety regulations immediately below.

a. Acidified food and LACF.
In the
Federal Register
of January 24, 1973, FDA issued a final rule (the canned food CGMP regulation) to establish specific CGMP requirements to address safety issues unique to the manufacturing, processing, packing, and holding of thermally processed foods packaged in hermetically sealed containers (38 FR 2398). In the
Federal Register
of May 14, 1973, we issued a final rule to establish an emergency permit control regulation, in accordance with section 404 of the FD&C Act (21 U.S.C. 344), to serve as an enforcement mechanism for the canned food regulation (38 FR 12716). In the
Federal Register
of January 29, 1974, we issued a final rule to establish procedures to implement the emergency permit control enforcement mechanism (39 FR 3748). The emergency permit control regulation is currently codified in 21 CFR part 108.

In 1979, we issued a final rule to revise the canned food CGMP regulation and separate it into two distinct regulations. One of these regulations, established in part 113, is directed to the safe manufacturing, processing, packing, and holding of LACF (44 FR 16209, March 16, 1979). The second regulation, established in part 114, is directed to the safe manufacturing, processing, packing, and holding of acidified foods (44 FR 16230, March 16, 1979). Acidified foods are low-acid foods to which acid(s) or acid food(s) are added; they have a water activity greater than 0.85 and have a finished equilibrium pH of 4.6 or below; and certain foods are excluded from the coverage of part 114 (21 CFR 114.3(b)). In the
Federal Register
of March 16, 1979, we also issued an emergency permit control regulation to serve as an enforcement mechanism for the new acidified foods regulation (44 FR 16204).

In establishing the regulations for LACF and acidified foods, FDA determined that CGMP regulations specific to LACFs and acidified foods are necessary to control the presence of
Clostridium botulinum
(
C. botulinum
), a bacterium commonly found in soil that can form spores that are capable of prolonged survival under adverse conditions and produce a botulinum toxin under anaerobic conditions, such as those in canned foods (41 FR 30442, July 23, 1976). Botulinum toxin can cause botulism, a rare but serious paralytic illness that can be fatal and is considered a medical emergency (Ref. 2). The primary factors that determine the formation and growth of
C. botulinum
in food are pH, water activity, and storage conditions, and LACFs and acidified foods can pose a risk of botulism if these critical factors are not carefully controlled (44 FR 16209).

Part 113 establishes requirements for equipment; control of components, food product containers, closures, and in-process material; production and process controls; and records and reports for LACF. Part 114 establishes requirements for production and process controls and records and reports for acidified foods. In light of the severity of the hazard presented by botulinum toxin, parts 113 and 114 require that supervisory personnel be trained at schools approved by FDA (§§ 113.10 and 114.10, respectively).

The enforcement regulations in §§ 108.25 and 108.35 require manufacturers, processors, and packers of acidified foods and LACF, respectively, to file food canning establishment registration information with FDA. The registration information must include, among other things: the name, principal place of business, and the location of the establishment engaged in the manufacturing, processing, or packing of acidified foods or LACF; processing methods; and a list of the foods prepared at the establishment (§§ 108.25(c) and 108.35(c), respectively). Under the procedural enforcement regulations of subpart A of part 108, if after an investigation we determine that a manufacturer, processor, or packer of acidified foods or LACF is not in compliance with the requirements of §§ 108.25 or 108.35, respectively, we may issue an order requiring that the entity apply for and obtain a temporary emergency permit from us, which we might or might not issue, before introducing any acidified food or LACF into interstate commerce. Subpart A of part 108 also establishes the criteria and procedures related to a determination of the need for an emergency permit, revocation of the determination of need for an emergency permit, issuance or denial of an emergency permit, and suspension and reinstatement of an emergency permit.

b. Bottled drinking water.
In the
Federal Register
of November 26, 1973, FDA issued a final rule to establish quality standard regulations establishing allowable levels for microbiological, physical, chemical, and radiological contaminants in bottled drinking water (38 FR 32558). The quality standard regulation is codified at 21 CFR § 165.110(b). In the
Federal Register
of March 12, 1975, we issued a final rule to establish CGMP requirements for the processing and bottling of bottled drinking water (40 FR 11566). The bottled water CGMP regulation is codified in part 129 (21 CFR part 129).

FDA promulgated part 129 in light of surveys and analyses of field investigations that we and the U.S. Environmental Protection Agency (EPA) conducted in 1971 and 1972. The surveys and analyses revealed, among other things, that some bottled water failed to meet some of the prevailing regulatory criteria for non-bottled, public drinking water (38 FR 1019 at 1019, January 8, 1973), some of the bottling plants surveyed did not conduct adequate bacteriological and chemical analyses of their products, and in other cases, bottling was not performed under sanitary conditions (38 FR 32563).

Part 129 requires that bottled water be safe and that it be processed, bottled, held, and transported under sanitary conditions. Processing practices addressed in part 129 include the protection of the water source from contamination, sanitation at the bottling

facility, and quality control to ensure the safety of the water. Part 129 also establishes certain analytical testing requirements for chemical, physical, radiological, and microbiological contaminants.

c. Infant formula.
The Infant Formula Act of 1980 (the 1980 infant formula act) (Pub. L. 96-359) amended the FD&C Act to include section 412 (21 U.S.C. 350a) and was intended to improve protection of infants consuming infant formula products by establishing greater regulatory control over the formulation and production of infant formula. Enactment of the law resulted largely from the emergence of a substantial number of cases involving a serious medical disorder known as hypochloremic metabolic alkalosis, which is most frequently characterized by an infant's inability to thrive. The illnesses were found to be associated with prolonged exclusive use of soy protein-based infant formulas that lacked adequate amounts of the essential nutrient, chloride (45 FR 86362 at 86362, December 30, 1980).

In response to the 1980 act, FDA issued final rules to establish the following regulations regarding infant formula:

• Subpart B of part 106 (21 CFR part 106, subpart B) regarding infant formula quality control procedures (47 FR 17016, April 20, 1982);

• Subpart D of part 107 (21 CFR part 107, subpart D) regarding infant formula recalls (47 FR 18832, April 30, 1982);

• Subpart B of part 107 (21 CFR part 107, subpart B) regarding the labeling of infant formula (50 FR 1833, January 4, 1985);

• Subpart C of part 107 (21 CFR part 107, subpart C) regarding exempt infant formula (50 FR 48183, November 22, 1985);

• Subpart D of part 107 (21 CFR part 107, subpart D) regarding nutrient requirements for infant formulas (50 FR 45106, October 30, 1985).

In 1986, Congress amended section 412 of the FD&C Act as part of the Anti-Drug Abuse Act of 1986 (Pub. L. 99-570) (the 1986 infant formula amendments) to address concerns regarding the sufficiency of quality control testing, CGMP, recordkeeping, and recall requirements. In 1989, FDA issued revised recall regulations in subpart E of part 107 (54 FR 4006, January 27, 1989), and in 1991, FDA issued regulations in § 106.100 to implement the provisions of the 1986 infant formula amendments for records and record retention (56 FR 66566, December 24, 1991).

In the
Federal Register
of July 9, 1996, FDA issued a proposed rule to implement the remaining provisions of the 1986 infant formula amendments (61 FR 36154). Specifically, we proposed to amend the existing infant formula regulations in parts 106 and 107 to: (1) Establish CGMPs, including microbiological testing; (2) revise the quality control procedures in part 106 to ensure that an infant formula contains the level of nutrients necessary to support infant growth and development; (3) specify audit procedures to ensure compliance with CGMP and quality control procedure regulations; (4) establish requirements for quality factors to ensure that required nutrients will be in a bioavailable form; (5) establish batch and CGMP recordkeeping requirements; (6) specify submission requirements for registration and notification to FDA before the introduction of an infant formula into interstate commerce; and (7) update 21 CFR part 107 to reflect the 1986 amendments. In 2002 and 2003, FDA held three Food Advisory Committee meetings (67 FR 12571, March 19, 2002; 67 FR 63933; October 16, 2002; 68 FR 8299; February 20, 2003). FDA reopened the comment period for the proposed rule twice (68 FR 22341, April 28, 2003; and 71 FR 43393, August 1, 2006). FDA is developing a final rule.

d. Fish and fishery products.
In the
Federal Register
of December 18, 1995, FDA issued a final rule to establish in part 123 procedures for the safe and sanitary processing and importing of fish and fishery products (60 FR 65096). Part 123 requires seafood processors to develop, implement, and document sanitation control procedures and mandates the application of HACCP procedures. In the remainder of this document, the phrases “seafood HACCP regulation” and “HACCP regulation for seafood” refer to part 123. We discuss the HACCP concept in more detail in section II.C of this document. We describe the seafood HACCP regulation in more detail in section II.C.5.a of this document.

e. Juice.
In the
Federal Register
of January 19, 2001, FDA issued a final rule to establish in part 120 (21 CFR part 120) requirements to ensure the safe and sanitary processing and importation of fruit and vegetable juices and juice products by mandating the application of HACCP principles to the processing of these foods (66 FR 6138). In the remainder of this document, the phrases “juice HACCP regulation” and “HACCP regulation for juice” refer to part 120. We describe the juice HACCP regulation in more detail in section II.C.5.c of this document.

f. Dietary supplements.
The Dietary Supplement Health and Education Act of 1994 (DSHEA) (Pub. L. 103-417) among other things added section 402(g) to the FD&C Act (21 U.S.C. 342(g)). Section 402(g)(2) in part authorizes the Secretary of HHS to promulgate regulations to prescribe CGMPs for dietary supplements. Section 402(g)(2) also stipulates that such regulations must be modeled after existing CGMP regulations for food.

In the
Federal Register
of June 25, 2007, FDA issued a final rule to establish in part 111 (21 CFR part 111) CGMP requirements for the manufacturing, packaging, labeling, and holding of dietary supplements to ensure their quality (72 FR 34752). FDA established part 111 because the umbrella food CGMP provisions of part 110 alone do not adequately address the unique characteristics of dietary supplements (72 FR 34752 at 34761). For example, unlike most foods, the majority of dietary supplements are packaged into tablets, gel caps, and capsules; some dietary supplements may contain bioactive ingredients for which specific, controlled amounts are intended to be in each tablet or capsule; vitamins can present a concentrated source of biologically active components that have adverse health consequences at high doses; and herbal and botanical dietary supplements are often complex mixtures that can vary in composition and be contaminated with substances having adverse health consequences depending on factors such as the part of the plant used, the location of harvesting and growing conditions that can vary from year-to-year (72 FR 34752 at 34761).

Part 111 includes those requirements of part 110 that are common to the manufacturing, packaging, labeling and holding of dietary supplements, such as requirements for personnel, physical plant and grounds, and equipment and utensils. Part 111 also establishes requirements such as for the use of written procedures for certain operations; a production and process control system that includes the establishment of specifications for incoming ingredients and finished product; certain requirements for testing of incoming ingredients and finished product; the establishment and implementation of quality control operations; the preparation and use of a written master manufacturing record for each unique formulation and for each batch size of a given dietary supplement; the preparation of an individual batch production record every time a dietary supplement batch is produced; the establishment and use of certain laboratory control processes; the investigation of any product

complaint that involves the possibility of a failure to meet any CGMP requirement; and the establishment and retention of records associated with the manufacture, packaging, labeling, or holding of a dietary supplement for specified periods of time.

g. Refrigeration of shell eggs held for retail distribution.
In the
Federal Register
of December 5, 2000, FDA issued a final rule that established in § 115.50 (21 CFR 115.50) refrigeration requirements for shell eggs held for retail distribution (the shell egg refrigeration regulation) (65 FR 76092). FDA promulgated the shell egg refrigeration regulation to prevent foodborne illnesses and deaths resulting from the contamination of shell eggs with
Salmonella
Enteritidis (SE), a specific
Salmonella
serotype. As discussed in the proposed rule to establish the shell egg refrigeration regulation (64 FR 36492, July 6, 1999), the disease salmonellosis results from an intestinal infection with
Salmonella
microorganisms and is characterized by diarrhea, fever, abdominal cramps, headache, nausea, and vomiting. Most healthy people recover, but the infection can spread to the bloodstream, and then to other areas of the body, leading to severe and fatal illness, which is more likely to occur in children, the elderly, and persons with weakened immune systems.
Salmonella
spp. is among the leading bacterial causes of foodborne illness in the United States, and shell eggs are the predominant source of SE related cases of salmonellosis in the United States where a food vehicle is identified for the illness (64 FR 36492 at 36493).

The shell egg refrigeration regulation requires that shell eggs held at retail establishments be stored and displayed under refrigeration at a temperature of 7.2 °C (45 °F) or less to help prevent the growth of
Salmonella
spp., except for shell eggs that have been specifically processed to destroy all viable
Salmonella
spp. that might be present. The shell egg refrigeration regulation includes administrative procedures with which refrigeration requirements may be enforced, including providing for the diversion or destruction of shell eggs that have been held in violation of the refrigeration requirements.

h. Production, storage, and transportation of shell eggs.
In the
Federal Register
of July 9, 2009 (74 FR 33030), FDA issued a final rule to establish in part 118 (21 CFR part 118) requirements for shell egg producers to register with FDA, implement measures to prevent SE from contaminating eggs on the farm and from further growth during storage and transportation, and maintain records related to their compliance with the requirements of the regulation. As with the shell egg refrigeration rule, FDA promulgated part 118 to reduce SE-associated illnesses and deaths by reducing the risk that shell eggs are contaminated with SE (74 FR 33030).

3. Food Safety Guidance to Industry

FDA has issued numerous guidance documents (hereinafter, “guidance” or “guidances”) to assist the food industry in implementing food safety regulatory requirements under FDA's jurisdiction. We issue guidances, in accordance with our regulations in § 10.115 (21 CFR 10.115) for “good guidance practices,” to describe our interpretation of or policy on a regulatory issue. Guidances do not establish legally enforceable rights or responsibilities and do not legally bind the public or FDA (§ 10.115(d)(1)). Accordingly, regulated industry is not required to employ the approaches contained in a guidance and instead may choose to use an alternative approach, provided that the alternative approach complies with the relevant statutes and regulations (§ 10.115(d)(2)). Although guidances do not legally bind FDA, they represent our current thinking on a particular interpretation of or policy regarding a given regulatory issue (§ 10.115(d)(3)). Under §§ 10.115(c)(1) and (g), we publish a guidance in draft form for public comment before issuing the guidance in final form, except where prior public participation is not feasible or appropriate, if the guidance (1) sets forth initial interpretations of statutory or regulatory requirements, (2) sets forth changes in interpretation or policy that are of more than a minor nature; (3) includes complex scientific issues, or (4) covers highly controversial issues.

FDA generally issues guidance to industry for the purpose of communicating our policy decisions and interpretations of our regulatory requirements so that regulated industry better understands how to comply with those requirements. In some cases, we issue guidance specifically targeted to assisting industry in complying with a particular food safety regulation. For example, we have issued guidances to assist industry in complying with the seafood HACCP regulation (Ref. 3) and the juice HACCP regulation (Ref. 4). In other cases, we issue guidance that is more narrowly focused in scope or is not directly targeted to assisting industry in complying with a particular food safety regulation. For example, we have issued guidance that addresses the chemical contamination of candy with lead (Ref. 5) and guidance on measures to address the risk for contamination by Salmonella spp. in food containing a peanut-derived product as an ingredient (Ref. 6).

4. Food Safety Compliance Policy Guides

FDA issues guidance to its staff in the form of compliance policy guides (CPGs). The primary purpose of a CPG is to explain FDA's policy on regulatory issues related to the statutes and regulations that we are responsible for implementing. CPGs advise FDA field inspection and compliance personnel as to FDA's standards and procedures to be applied when determining industry compliance with our regulatory requirements. FDA issues CPGs in accordance with our regulation for good guidance practices in § 10.115 and makes the CPGs available to the public, thereby providing regulated industry with additional insight into how we interpret the statutes and regulations we are responsible for implementing for purposes of assessing compliance with our regulatory requirements. In general, our food safety CPGs are relatively focused in scope. For example, we have issued a CPG regarding microbial contaminants in dairy products (Ref. 7 Ref. 7), and a CPG that sets forth the criteria that are to be used by FDA personnel to determine whether foods other than dairy products will be considered adulterated because of the presence of
Salmonella
spp. (Ref. 8).

5. Current Inspection System

Section 704 of the FD&C Act authorizes FDA to enter and inspect establishments in which food is manufactured, processed, packed, or held and to inspect all pertinent equipment, finished and unfinished materials, containers, and labeling located in such establishments (21 U.S.C. 374). We inspect food establishments both for cause, for example as part of foodborne illness outbreak investigations, and as a matter of routine practice. Section 421 of the FD&C Act (21 U.S.C. 350j), which was added to the FD&C Act by section 201 of FSMA, directs FDA to “identify high risk-facilities and * * * allocate resources to inspect facilities according to the known safety risks of the facilities” as determined by several factors, including among other things “[t]he known safety risks of the food manufactured, processed, packed, or held at the facility” and “[t]he compliance history of a facility” (Section 421(a)(1)). In addition, Section 421 requires FDA to: immediately “increase the frequency of inspection of all facilities,” and includes schedules

for the increased frequency with which “domestic high-risk facilities,” “domestic non-high risk facilities,” and “foreign facilities” must be inspected over time (Section 421(a)(2)). Section 421 also directs FDA to “allocate resources to inspect any article of food imported into the United States according to the known safety risks of the article of food” as determined by a number of factors, including among other things “[t]he known safety risks of the countries or regions” from which the food originates or through which it is transported, and “[t]he compliance history of the importer” (Section 421(b)).

FDA inspectors, or inspectors from other Federal agencies or the States authorized to conduct inspections on our behalf, inspect food establishments to determine whether the establishments are in compliance with the requirements of the FD&C Act and other applicable laws and regulations, and document their findings in Establishment Inspection Reports. Following an inspection, FDA may decide that: (1) No further action is required because no objectionable conditions or practices were found during the inspection; (2) voluntary action on the part of the food establishment is appropriate to correct violations that are serious enough to document but not serious enough to warrant a regulatory action, or (3) the practices and conditions discovered during the inspection are significant enough to require regulatory action by FDA (Ref. 9).

If we decide to initiate a regulatory action against a food establishment, we may elect to take an advisory action, such as issuing a Warning Letter, an Untitled Letter, or scheduling a regulatory meeting (Ref. 10). If we determine that the conditions and practices found at a food establishment constitute serious violations of the law that cannot be, or have not been, resolved by voluntary compliance, we may decide to initiate an administrative or judicial action, such as an administrative detention, an order to cease distribution and give notice under section 423(b) of the FD&C Act (21 U.S.C. 3501), a seizure of violative products, an injunction, or a criminal prosecution (Ref. 11) (Ref. 12).

6. Systems for Identifying Food Safety Problems

a. Contamination of food and foodborne illness.
Food can become contaminated (e.g., with biological, chemical, physical, or radiological hazards) at many different steps in the farm-to-table continuum: on the farm; in packing, manufacturing/processing, or distribution facilities; during storage or transit; at retail establishments; in restaurants; and in the home. As discussed more fully in section II.D of this document, consumption of contaminated food can lead to acute or long term illness or injury. Early detection of contamination enables food establishments to prevent contaminated food from entering commerce. When contamination is not detected in time to prevent contaminated food from entering commerce, the contamination may be detected while the food is in storage or in transit; at retail establishments; in restaurants; or in the home. This often necessitates a recall to retrieve the contaminated product from commerce.

We learn about contaminated food through a variety of mechanisms, including required reporting by industry; investigations of outbreaks of foodborne illness; recalls; and state surveillance and reporting programs. We discuss these mechanisms immediately below.

b. Required reporting by industry.
In some cases, a firm that manufactures, processes, packs, or holds food, or a regulatory official, detects contamination of a food in the market. This may occur even when there is no known or suspected association between the food and reports of foodborne illness. The Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-085) established, among other things, section 417 of the FD&C Act (21 U.S.C. 350f), which requires FDA to establish a Reportable Food Registry (RFR). A “reportable food” is an article of food (other than dietary supplements or infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals (Section 417(a)(2) of the FD&C Act). Under section 417(d)(1) of the FD&C Act, food firms that are “responsible parties” as defined in the statute are required to notify FDA electronically with certain information within 24 hours of determining that a food they manufactured, processed, packed, or held is a reportable food. On September 8, 2009, FDA launched the electronic portal for submission of these required reports. Information about reportable foods becomes part of the RFR.

Infant formula and dietary supplements are excluded from the requirements of the RFR. Infant formula manufacturers must comply with notification requirements for violative infant formula as established in 21 CFR 107.240. Manufacturers, packers and/or distributors whose names appear on the label of a dietary supplement marketed in the United States must submit to FDA any report received of a serious adverse event associated with that dietary supplement when used in the United States, accompanied by a copy of the dietary supplement's label, under section 761 of the FD&C Act (21 U.S.C. 379aa-1).

When contamination of food could cause illness or injury, quick action is necessary to remove the food from the market. FDA evaluates the information submitted to the RFR and that submitted by infant formula and dietary supplement firms and takes regulatory action when appropriate. Often this information can be used to determine the distribution of contaminated (and potentially contaminated) food, including raw agricultural commodities, food ingredients, and single- or multi-ingredient processed foods.

c. Outbreaks of foodborne illness.
In some cases, contaminated food goes undetected until it is associated with an outbreak of foodborne illness. (An outbreak of foodborne illness is the occurrence of two or more cases of a similar illness resulting from the ingestion of a common food.) When an outbreak of foodborne illness occurs, quick action is critical to prevent additional illness. The CDC of HHS, and State, local, territorial and/or tribal health departments conduct epidemiologic investigations to identify the food(s) that may be involved in an outbreak. Many outbreaks are reported to the National Outbreak Reporting System (NORS) by the State, local, territorial, or tribal health department that conducted the outbreak investigation. Outbreak reporting is voluntary. Multi-state outbreaks are generally reported to NORS by CDC (Ref. 13). The Foodborne Outbreak Online Database (FOOD) allows the public direct access to information on foodborne outbreaks reported to CDC (Ref. 14).

In July 1995, the Foodborne Diseases Active Surveillance Network (FoodNet) was established as a collaborative program among CDC, 10 state health departments, USDA's Food Safety and Inspection Service (FSIS), and FDA. FoodNet conducts surveillance for infections caused by specific pathogenic microorganisms as diagnosed by laboratory testing of samples from patients. The surveillance area includes approximately 15 percent of the United States population (approximately 46 million persons). The objectives of FoodNet are to determine the burden of foodborne illness in the United States;

monitor trends in the burden of specific foodborne illness over time; attribute the burden of foodborne illness to specific foods and settings; and disseminate information that can lead to improvements in public health practice and the development of interventions to reduce the burden of foodborne illness (Ref. 15). Information from FoodNet is used to assess the impact of food safety initiatives on the burden of foodborne illness (Ref. 16).

FDA works closely with CDC to monitor those outbreaks in which there is some indication or early information to suggest that an FDA regulated product may be implicated in an outbreak of foodborne illness. In some cases (e.g., when it appears unlikely that an implicated food was contaminated at the point of sale, such as at a restaurant), FDA works closely with multidisciplinary Federal, State, local, territorial, and tribal investigators during the investigation of the outbreak. Depending on the circumstances, such multidisciplinary investigations may involve a traceback investigation (i.e., an investigation to determine and document the production chain and the source(s) of contaminated or potentially contaminated food); a traceforward operation (i.e., an operation to determine the distribution of contaminated or potentially contaminated food); regulatory inspections; and, in some cases, root cause investigations (to try and determine the specific causes of contamination and contributing factors).

PulseNet is another collaborative program for the surveillance and detection of foodborne illness that is coordinated by the CDC, with laboratory participants from state health departments, local health departments, and Federal agencies, including FDA and FSIS. Using pulsed-field gel electrophoresis (PFGE), PulseNet participants perform standardized molecular subtyping (or fingerprinting) of foodborne disease causing bacteria. The patterns are then submitted electronically to PulseNet, which is a dynamic database that allows for the rapid comparison of patterns and facilitates identification of common source outbreaks. PulseNet is considered to be a powerful intelligence network that allows for the collection and analysis of state and local epidemiological surveillance data for the identification of outbreaks that may otherwise go unnoticed. In addition, PulseNet helps food regulatory agencies identify areas where the implementation of new measures and enhanced surveillance are likely to increase the safety of our food supply.

The Food Emergency Response Network (FERN) is a network coordinated by the FDA and USDA to integrate the nation's food testing laboratory (Ref. 17). The FERN supports all four phases of incident management—prevention, preparedness, response, and recovery—and coordinates the testing activities of Federal, state, and local laboratories. As of April 2011, FERN has 172 laboratory members (39 Federal, 116 State, and 17 local), located in all 50 States and Puerto Rico. FERN member laboratories represent the large majority of food testing laboratories in the U.S., including public health, agriculture, veterinary diagnostic and environmental laboratories. At this point, it is estimated that the FERN membership represents about 85% of all eligible food regulatory laboratories in the U.S.

FERN members use a web-based information network (the Electronic Laboratory Exchange Network, or eLEXNET) (Ref. 18) as their primary, real-time data exchange and communication system. Many participating laboratories conduct food surveillance testing programs for microbial pathogens (e.g.,
E. coli
O157:H7,
Salmonella
spp.,
Listeria monocytogenes,
), aflatoxin, antibiotics, undeclared allergens, heavy metals, and other threats to the food supply. Laboratory results can be uploaded into eLEXNET for the early identification of threats to the food supply. For example, overlaying laboratory results with distribution and epidemiological data can assist in identifying the source of the outbreak. The system also allows officials to analyze risks and identify trends for future surveillance efforts. In addition, the eLEXNET serves as a method repository for laboratories to rapidly search, access, review, and print methods.

d. Recalls.
In 1978, we established a program regarding recalls, including guidance on policy, procedures, and industry responsibilities (43 FR 26202, June 16, 1978). Our regulations in part 7, subpart C (21 CFR part 7, subpart C) address recall policy; health hazard evaluation and recall classification; recall strategy; FDA-requested recall; firm-initiated recall; recall communications; public notification of recall; recall status reports; termination of a recall; and general industry guidance. In addition, under authority in section 412(f) of the FD&C Act (21 U.S.C. 350a(f)), we have issued regulations establishing specific requirements for infant formula recalls (21 CFR part 107, subpart E). More recently, FSMA amended the FD&C Act by establishing section 423 of the FD&C Act (21 U.S.C. 350l), which provides FDA with mandatory recall authority for food (other than infant formula, which remains subject to section 412(f) of the FD&C Act).

Section 7.41 (Health hazard evaluation and recall classification) describes how we evaluate the health hazard presented by a product being recalled by considering whether any disease or injuries have already occurred from the use of the product; whether any existing conditions could contribute to a clinical situation that could expose consumers to a health hazard; how the hazard could impact various segments of the population (e.g., children, surgical patients), with particular attention paid to the hazard to those individuals who may be at greatest risk; the degree of seriousness of the health hazard to which the populations at risk would be exposed; the likelihood of occurrence of the hazard; and the potential consequences (immediate or long-range) of occurrence of the hazard. On the basis of this evaluation, we classify the recall (i.e., Class I, Class II, or Class III) to indicate the relative degree of health hazard of the product being recalled or considered for recall. A Class I recall is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death (§ 7.3(m)(1)). A Class II recall is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote (§ 7.3(m)(2)). A Class III recall is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences (§ 7.3(m)(3)).

In recent years, recalls of food ingredients have highlighted the potentially large impact that contamination (or potential contamination) of a single food ingredient can have on thousands of food products containing that ingredient (Ref. 19) (Ref. 20) (Ref. 21) (Ref. 22) (Ref. 23) (Ref. 24), with correspondingly significant disruption and cost for industry and consumers.

e. State surveillance and reporting programs.
State food safety agencies are involved in identifying contaminated food by conducting surveillance testing (Ref. 25). Communication of surveillance testing results by state food safety agencies to FDA is essential for identifying contaminated food. State food safety agencies also conduct thousands of inspections and collect and analyze food samples at food

manufacturers/processors every year under contract to FDA. The states perform inspections of food manufacturers, processors, packers and holders to determine compliance with the FD&C Act, state law, or both. Such inspections focus on identifying significant CGMP violations and insanitary conditions which may render the food injurious to health, particularly those involving the introduction of, lack of controls for, and/or growth promotion of pathogenic organisms. State inspections also focus on identifying practices or other conditions that may have caused food to become filthy, putrid, decomposed, or contaminated with foreign objects (Ref. 26). FDA coordinates eLEXNET), which is a web-based information network that allows state food safety officials to share laboratory analysis findings with FDA and other Federal, state and local food safety agencies (Ref. 18). FDA also participates in FERN, which is an FDA/FSIS joint initiative to integrate the nation's food-testing laboratories at the local, state, and Federal levels into a network that is able to respond to emergencies involving biological, chemical, or radiological contamination of food (Ref. 17).

7. Outreach to Consumers and Educators

As part of its efforts to protect the public health, FDA engages in outreach efforts to provide consumers and educators with information regarding the safe handling, preparation, and consumption of food to reduce the incidence of foodborne illness.

We conduct some of our consumer and educator outreach initiatives in cooperation with other Federal departments and agencies. For example, HHS, USDA, and their constituent agencies maintain the Internet site
FoodSafety.gov.

FoodSafety.gov,
which provides consumers and health educators with the most current information regarding, among other things, food recalls and alerts, health risks posed by particular food safety hazards, instructions for the safe handling and preparation of food, and the most current news and information released by FDA and the other participating Federal departments and agencies regarding food safety issues (Ref. 27).

We also engage in consumer outreach in partnership with non-governmental entities. Most prominently, HHS, USDA, and the U.S. Department of Education work with industry associations, academic institutions, consumer and public health organizations, and professional societies in the food sciences to support the Partnership for Food Safety Education. This partnership, among other things, educates consumers about the importance of safe food handling and health risks posed by specific foodborne illnesses, prepares and disseminates food safety curricula for use by educators, and provides information regarding how consumers can be aware of and respond to food recalls (Ref. 28).

FDA also conducts its own independent informational outreach efforts specifically designed for consumers (Ref. 29) and for educators (Ref. 30).

B. FDA Food Safety Modernization Act

1. Requirements for Food Facilities

On January 4, 2011, the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) was signed into law. Section 103 of FSMA, Hazard Analysis and Risk-Based Preventive Controls, amends the FD&C Act to create a new section 418 with the same name. Many of the provisions in section 103 of FSMA that are relevant to this rulemaking are codified in section 418 of the FD&C Act.

a. General requirements.
Section 418 of the FD&C Act contains requirements applicable to food facilities and mandates agency rulemaking. Section 418(a) 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. Section 418(a) specifies that the purpose of the preventive controls is to “prevent the occurrence of such hazards and provide assurances that such food is not adulterated under section 402 [of the FD&C Act] or misbranded under section 403(w) [of the FD&C Act] * * *.”

In addition to those areas specified in section 418(a) of the FD&C Act, sections 418(b)-(i) contain more specific requirements applicable to facilities. These include corrective actions (§ 418(e)), verification (§ 418(f)), a written plan and documentation (§ 418(h)), and reanalysis of hazards (§ 418(i)). Section 103(e) of FSMA creates a new section 301(uu) in the FD&C Act (21 U.S.C. 331(uu)) to prohibit “[t]he 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 not in compliance with section 418 [of the FD&C Act].” In section XII of this document, we discuss proposed requirements (proposed subpart C) that would implement these provisions of section 418 of the FD&C Act.

b. Qualified facilities.
Section 418(l) of the FD&C Act (Modified Requirements for Qualified Facilities) establishes criteria for a facility to be a qualified facility, establishes an exemption for qualified facilities, establishes modified requirements for qualified facilities, and provides that the Secretary may withdraw the exemption otherwise granted to qualified facilities in specified circumstances. Under section 418(l)(1) of the FD&C Act, a facility is a qualified facility if (1) it is a very small business as the term would be defined by this rulemaking or (2) it falls within specified limitations on the average annual monetary value of its sales and types of customers. Section 418(l)(2)(A) of the FD&C Act exempts a qualified facility from the requirements for hazard analysis and risk-based preventive controls as set forth in sections 418(a)-(i) of the FD&C Act, as well as the requirements issued under section 418(n) of the FD&C Act. Section 418(l)(2)(B) of the FD&C Act requires a qualified facility to submit documentation to the Secretary related to its qualified status and also submit either documentation of the facility's implementation and monitoring of preventive controls or documentation of its compliance with other appropriate non-Federal food safety laws. Section 418(l)(3) of the FD&C Act authorizes the Secretary to withdraw the exemption from a qualified facility in specified circumstances. In section X.C.1 of this document, we discuss a proposed exemption for qualified facilities (proposed § 117.5(a)). In section XIV of this document, we discuss a proposed process for withdrawing an exemption for a qualified facility (proposed subpart E). In section XIII.A of this document, we discuss proposed modified requirements for qualified facilities (proposed § 117.201).

c. Exemptions and exceptions.
In addition to the exemption for qualified facilities in section 418(l)(2)(A) of the FD&C Act, there are several other exemptions and exceptions to the requirements specified in section 418 of the FD&C Act. Section 418(j) of the FD&C Act provides an exemption for facilities that are required to comply and are in compliance with the regulations for seafood HACCP, juice HACCP, or thermally processed low-acid foods packed in hermetically sealed containers. Section 418(k) of the FD&C Act provides an exception for activities of facilities subject to section 419 of the FD&C Act (Standards for

Produce Safety). Section 103(g) of FSMA provides an exemption for certain activities regarding a dietary supplement that is in compliance with sections 402(g)(2) and 761 of the FD&C Act (21 U.S.C. 342(g)(2), 379aa-1). In sections X.C.2 through X.C.4 of this document, we discuss proposed exemptions for activities that are subject to part 123 (proposed § 117.5(b)), part 120 (proposed § 117.5(c)), part 113 (proposed § 117.5(d)), section 419 of the FD&C Act (proposed § 117.5(f)), or the manufacturing, processing, packing, and holding of dietary supplements (proposed § 117.5(e)).

As discussed in section II.B.2.e of this document, section 418(m) of the FD&C Act also authorizes the Secretary to create exemptions or modifications to the requirements with respect to certain facilities.

d. Rule of construction regarding alcohol-related facilities.
As discussed in more detail in section X.C.7 of this document, section 116 of FSMA (21 U.S.C. 2206) (Alcohol-Related Facilities) provides a rule of construction for certain facilities engaged in the manufacturing, processing, packing, or holding of alcoholic beverages and other food. In section X.C.7 of this document, we discuss proposed exemptions related to such facilities (proposed § 117.5(i)).

2. Requirements for Agency Rulemaking

Section 103 of FSMA contains two separate rulemaking provisions. Section 103(a) of FSMA requires rulemaking related to the hazard analysis and risk-based preventive controls required by section 418 of the FD&C Act. In addition, section 103(c) of FSMA requires rulemaking in two areas: (1) Clarification of certain aspects of the definition of the term “farm” under section 415 of the FD&C Act (21 U.S.C. 350d) (Registration of Food Facilities) and (2) possible exemption from or modification of requirements of section 418 and section 421 of the FD&C Act (21 U.S.C. 350j) (Targeting of Inspection Resources for Domestic Facilities, Foreign Facilities, and Ports of Entry; Annual Report) for certain facilities as the Secretary deems appropriate and as further specified in section 103(c)(1)(D) of FSMA.

a. General rulemaking requirements.
Section 418(n)(1)(A) of the FD&C Act requires that not later than 18 months after the date of FSMA's enactment, the Secretary issue regulations “to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls * * *.”

b. Definition of small and very small business.
Section 418(l)(5) of the FD&C Act requires the Secretary, in consultation with the Secretary of Agriculture, to conduct a study of the food processing sector regulated by the Secretary and to make determinations in five areas. These areas include, in part, (1) distribution of food production by type and size of operation, (2) the proportion of food produced by each type and size of operation, (3) the number and types of food facilities co-located on farms, (4) the incidence of foodborne illness originating from each size and type of operation, and (5) the effect on foodborne illness risk associated with certain activities regarding food.

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. These terms are significant because section 103 of FSMA contains several provisions specific to such entities.

• Small and very small businesses are subject to modifications or exemptions from requirements under section 418 or 421 of the FD&C Act for facilities engaged only in specific types of on-farm activities and involving foods that the Secretary determines to be low risk (§ 103(c)(1)(D) of FSMA).

• Small and very small businesses are not subject to section 418 of the FD&C Act until 6 months (small businesses) or 18 months (very small businesses) after the effective date of FDA's final rule (§ 103(i) of FSMA).

• A very small business is deemed a “qualified facility” and would, therefore, qualify for the exemptions as discussed in section X.C.1 of this document. (§ 418(l)(1)(B) of the FD&C Act).

Consistent with section 418(l)(5) of the FD&C Act, FDA has consulted with USDA during its study of the food processing sector (Ref. 31). The study is available in the docket established for this proposed rule (Ref. 32). We request comment on that study. In section X.B.4 of this document, we discuss our proposed definitions for small business and very small business. We will consider comments regarding the study, as well as comments regarding our proposed definitions for small and very small business, in any final rule based on this proposed rule.

c. Clarification of the term “facility.”
Generally, section 418 of the FD&C Act applies to the owner, operator, or agent in charge of a “facility.” Section 418(o)(2) of the FD&C Act defines “facility” as “a domestic facility or a foreign facility that is required to register under section 415.” Section 415 of the FD&C Act, in turn, requires any facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States to register with the Secretary.

The requirement in section 415 of the FD&C Act that a facility must register does not apply to farms. FDA's implementing regulations for section 415 (see part 1, subpart H) (21 CFR part 1, subpart H; hereinafter the section 415 registration regulations) define “farm,” in relevant part, as “a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both” (§ 1.227(b)(3)) (21 CFR 1.227(b)(3)). The term “farm” includes a facility that packs or holds food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership (§ 1.227(b)(3)(i)). Under that same definition, the term “farm” also includes a facility that manufactures/processes food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership (§ 1.227(b)(3)(ii)).

Section 103(c)(1)(A) of FSMA requires that not later than 9 months after the date of enactment, the Secretary publish a notice of proposed rulemaking in the
Federal Register
to issue regulations for purposes of section 415 of the FD&C Act with respect to “activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership” and “activities that constitute on-farm manufacturing or processing of food that is not consumed on that farm or on another farm under common ownership.” The regulation is intended to “enhance the implementation” of section 415 and “clarify the activities that are included within the definition of the term `facility' ” (§ 301(c)(1)(B) of FSMA). In section VIII.E of this document, we discuss our proposal to revise the section 415 registration regulations to enhance the implementation of section 415 and to clarify the definition of the term “facility.”

d. Science-based risk analysis and requirements under sections 418 and 421 of the FD&C Act.
Section 103(c)(1)(C) of FSMA requires that in issuing the proposed rule the Secretary conduct a science-based risk analysis of:

• “Specific types of on-farm packing or holding of food that is not grown, raised, or consumed on such farm or

another farm under the same ownership, as such packing and holding relates to specific foods; and

• Specific on-farm manufacturing and processing activities as such activities relate to specific foods that are not consumed on that farm or on another farm under common ownership.”

As part of the rulemaking, the Secretary is required to consider the results of the science-based risk analysis and exempt certain facilities from the requirements in sections 418 and 421 of the FD&C Act or modify those requirements, as the Secretary determines appropriate, if such facilities are only engaged in specific types of on-farm manufacturing, processing, packing, or holding activities the Secretary determines to be low risk, and involving specific foods that the Secretary determines to be low risk (§ 103(c)(1)(D)(i) of FSMA). Any exemption or modification is limited to small and very small businesses (§ 103(c)(1)(D)(ii) of FSMA).

In section VIII.G of this document, we discuss our approach to the requirement in FSMA section 103(c) for a science-based risk analysis of the types of on-farm manufacturing, processing, packing, or holding operations that can involve food that is not consumed on that farm or on another farm under common ownership for purposes of section 415 of the FD&C Act and request comment on that approach. The final approach will consider comments received to this proposed rule.

In sections VIII.I and X.C of this document, we discuss proposed exemptions for small and very small businesses that are solely engaged in certain types of “low risk” activities involving the on-farm manufacturing, processing, packing, and holding of certain “low risk” foods from the requirements of section 418 of the FD&C Act (proposed § 117.5(g) and (h)). In section VIII.J of this document, we discuss our tentative conclusion that we should not exempt or modify the frequency requirements under 421 based solely upon whether a facility only engages in such low-risk activity/food combinations and is a small or very small business and we seek comment on this proposal.

e. Exemption or modification of requirements for certain facilities.
Under section 418(m) of the FD&C Act, the Secretary may exempt or modify the requirements for compliance of section 418 of the FD&C Act for hazard analysis and preventive controls for facilities that are solely engaged in the storage of RACs (other than fruits and vegetables) intended for further distribution or processing. As discussed in section X.C.8 of this document, in accordance with the discretionary language of section 418(m), FDA tentatively concludes that facilities solely engaged in the storage of RACs, other than fruits and vegetables, intended for further distribution or processing should be exempt from the requirements for hazard analysis and preventive controls that we are proposing to establish in subpart C of part 117.

Section 418(m) of the FD&C Act also authorizes the Secretary to exempt or modify the requirements for compliance with section 418 for facilities that are solely engaged in the storage of packaged foods that are not exposed to the environment. In section X.D of this document, we describe our proposal for how the requirements of part 117 would apply to such facilities (proposed § 117.7). In section X.D.4 of this document, we propose modified requirements for such facilities, directed at the storage of packaged foods that are not exposed to the environment and that require time/temperature control to limit the growth of, or toxin formation by, microorganisms of public health significance (proposed § 117.206).

f. Animal food and intentional adulteration.
FDA proposes to implement section 103 of FSMA in several regulations, rather than a single regulation that covers all food and hazards subject to preventive controls. This proposal is applicable to certain hazards that may be associated with a food facility that manufactures, processes, packs or holds human food. Section 103 of FSMA applies to “food,” which is not limited to human food. Section 201(f) of the FD&C Act defines “food” to include “articles used for food or drink for man or other animals” (21 U.S.C. 321(f)). FDA tentatively concludes that the differences between human and animal food are best addressed through separate regulations. FDA plans to propose a separate regulation applicable to certain hazards that may be associated with a food facility that manufactures, processes, packs or holds animal food. Establishments that manufacture, process, pack, or hold food for both humans and animals should consider this proposed rule as well as the future proposed rule directed to CGMPs and hazard analysis and risk-based preventive controls for food for animals, as there may be differences in the requirements that would be applicable to such establishments under the two proposed rules.

In addition, this rulemaking is not intended to address “hazards that may be intentionally introduced, including by acts of terrorism.” (§ 418(b)(2) of the FD&C Act). FDA plans to implement section 103 of FSMA regarding such hazards in a separate rulemaking in the future. FDA tentatively concludes that intentional hazards, 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. However, we also recognize that some kinds of intentional adulterants could be viewed as reasonably likely to occur, e.g., in foods concerning which there is a widely recognized risk of economically motivated adulteration in certain circumstances. An example of this kind of hazard is the addition of melamine to certain food products apparently to enhance perceived quality and/or protein content. We request comment on whether to include potential hazards that may be intentionally introduced for economic reasons. We also request comment on when an economically motivated adulterant can be considered reasonably likely to occur.

C. Preventive Controls and Hazard Analysis and Critical Control Points (HACCP) Systems

1. HACCP Systems

HACCP is a preventive strategy for food safety that involves a systematic approach to the identification and assessment of the risk (likelihood of occurrence and severity) of hazards from a particular food or food production process or practice and the control of those hazards. HACCP has been endorsed by the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) as an effective and rational means of ensuring food safety. NACMCF is an advisory committee chartered under USDA (Ref. 33). NACMCF includes participants from USDA's FSIS, HHS (FDA and CDC), the Department of Commerce (National Marine Fisheries Service), the Department of Defense (Office of the Army Surgeon General), academia, industry, state employees and consumer groups. NACMCF provides guidance and recommendations to the Secretaries of USDA and HHS, as well as other Federal agencies, regarding the microbiological safety of foods. Although HACCP was first introduced in 1971 at the National Conference for Food Protection, it was not widely used by the food industry until the concept was more fully developed by NACMCF. In 1989 NACMCF adopted “HACCP Principles for Food Production,” which was revised in 1992; in 1997, NACMCF adopted its current version, “Hazard Analysis and Critical Control Point

Principles and Application Guidelines” (Ref. 34). Revisions in both the 1992 and 1997 NACMCF HACCP documents were patterned after changes made in HACCP documents issued by the Codex Alimentarius Commission (Codex). (The Codex Alimentarius Commission was formed in 1963 by the Food and Agriculture Organization and the World Health Organization of the United Nations to develop food standards, guidelines, and related texts such as codes of practice, and is recognized under the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures as the international standards organization for food safety.) (See the discussion of Codex HACCP documents in section II.C.5.e of this document).

HACCP is designed for use in all segments of the food industry from growing, harvesting, processing, manufacturing, distributing, and merchandising to preparing food for consumption (Ref. 34). Under HACCP, a food operation develops a plan that identifies food hazards applicable to the food and production process, and the points in the production process where a food hazard could be introduced, controlled or enhanced. A failure at these points would likely result in a food hazard being created or allowed to persist. These points are referred to as critical control points (CCPs). Under HACCP, identified CCPs are systematically monitored to ensure that critical limits are not exceeded, and records are kept of that monitoring. Corrective actions are taken when control of a CCP is lost, including proper disposition of the food produced during that period, and these actions are documented. The effectiveness of HACCP is also systematically verified by the food operation.

2. Section 103 of FSMA and HACCP

FDA tentatively concludes for several reasons that HACCP is the appropriate framework to reference in interpreting and implementing section 103 of FSMA. As discussed in section II.B of this document, section 103 of FSMA amended the FD&C Act by adding section 418. Section 418 of the FD&C Act and section 103 of FSMA are both titled “Hazard Analysis and Risk-Based Preventive Controls.” This title identifies two critical elements of HACCP—hazard analysis and preventive controls. As discussed in section II.C.4.a of this document, a hazard analysis is the first of the seven principles of HACCP, and is key to an effective food safety system. Further, establishment of a system of preventive controls for these hazards is the central purpose of HACCP. (See 66 FR 6138 and 60 FR 65096 stating that FDA issued the juice and seafood HACCP regulations because a system of preventive controls is the most effective and efficient way to ensure that these products are safe.) In addition, section 418(n)(5) of the FD&C Act requires that in promulgating the regulations to implement preventive controls, “the Secretary shall review regulatory hazard analysis and preventive control programs in existence * * * to ensure that such regulations are consistent, to the extent practicable, with applicable domestic and internationally-recognized standards * * *.” (See section XVI.B of this document for a discussion of this review.) The hazard analysis and preventive control systems in existence are all based on HACCP principles. Further, section 418 uses HACCP terminology throughout, including hazard analysis, monitoring, corrective actions, and verification. The close relationship of section 418 to HACCP is further illustrated by an exemption created in section 418(j) for “seafood, juice, and low-acid canned food facilities subject to HACCP.”

At the same time, FDA notes that not every provision in section 418 of the FD&C Act is identical to HACCP as described in current literature. For example, as discussed in section II.C.4.b of this document, HACCP systems focus on determining CCPs, whereas section 418(c) requires that the owner, operator, or agent in charge of a facility identify and implement preventive controls,
including
at critical control points,
if any
(emphasis added). As another example, as discussed in section II.C.4.c of this document, HACCP systems focus on establishing critical limits for CCPs, whereas section 418(c) of the FD&C Act requires that the owner, operator, or agent in charge of a facility identify and implement preventive controls, including at CCPs, if any, without specifying that the preventive controls establish critical limits. In fact, section 418 of the FD&C Act does not use the term “critical limit.” Although the approach in section 418 and this proposed rule aligns well with HACCP, it differs in part in that preventive controls may be required at points other than at critical control points and critical limits would not be required for all preventive controls.

As another example, as discussed in section II.C.4.a of this document, HACCP systems refer to hazards as “biological, chemical and physical agents” whereas section 418(b)(1)(A) of the FD&C Act requires that the owner, operator, or agent in charge of a facility identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility, including “biological, chemical, physical, and
radiological
hazards” (emphasis added). Although radiological hazards are not common, the consequences to consumers of exposure to radiological hazards may be severe (e.g., cancer). As discussed in section II.C.4.a of this document, under HACCP systems the hazard analysis includes a written assessment of the likelihood that the hazard will occur
and its severity
if it does occur (emphasis added). Thus, section 418(b)(1)(A) of the FD&C Act is consistent with the framework for HACCP even though it lists an additional type of hazard that must be considered and controlled as necessary.

Throughout this document, we identify the sections of FSMA applicable to specific proposed provisions and describe how the proposed provisions relate to HACCP principles as established by NACMCF in the NACMCF HACCP guidelines, by Federal agencies in HACCP regulations, and by Codex in the HACCP Annex in the Codex General Principles of Food Hygiene (Ref. 35).

3. Five Preliminary Tasks of HACCP/Preventive Controls

The NACMCF HACCP guidelines recommend a process for developing a HACCP system, or the implementation of a HACCP plan (Ref. 34). The “five preliminary tasks” of HACCP include: (1) Assembling a HACCP team; (2) describing the food and its distribution; (3) identifying the intended use and consumers of the food; (4) developing a flow diagram; and (5) verifying the flow diagram. The NACMCF HACCP guidelines advise that these preliminary tasks be accomplished before the application of HACCP principles to developing a HACCP plan for a specific food and process. Although FDA is not proposing to mandate that the owner, operator, or agent in charge of a facility conduct these preliminary tasks, facilities will greatly benefit from completing these preliminary tasks in developing their hazard analysis and risk-based preventive control systems.

4. The Seven Principles of HACCP

NACMCF has developed and adopted seven principles that describe the HACCP concept: (1) Conduct a hazard analysis; (2) Determine the CCPs; (3) Establish the critical limits; (4) Establish monitoring procedures; (5) Establish corrective actions; (6) Establish verification procedures; and (7) Establish recordkeeping and documentation procedures (Ref. 34). We discuss these immediately below.

a. Principle 1: Conduct a hazard analysis.
The first HACCP principle is the identification of the hazards associated with the product and process. The NACMCF HACCP guidelines define a hazard as a biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control (Ref. 34). The hazard analysis includes an identification of the hazard, an assessment of the likelihood that the hazard will occur and its severity if it does occur, and identification of control measures for each identified hazard, all of which should be documented.

b. Principle 2: Determine the CCPs.
The second HACCP principle is identification of CCPs. The NACMCF HACCP guidelines define a CCP as a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level (Ref. 34). Steps in the manufacturing process that may be CCPs include heat treatment, chilling, product formulation, and metal detection.

c. Principle 3: Establish the critical limits.
The third HACCP principle is establishing the critical limits, which involves establishing values for parameters that must be met for each control measure associated with a CCP. The NACMCF HACCP guidelines define a critical limit as a maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level the occurrence of a food safety hazard (Ref. 34). Critical limits can be thought of as boundaries of safety for each CCP (Codex defines a critical limit as a criterion which separates acceptability from unacceptability (Ref. 35)) and may be set for control measures such as temperature, time, physical dimensions, moisture level, water activity, pH, and available chlorine. A critical limit is used to distinguish between safe and unsafe operating conditions at a CCP. For example, the minimum temperature and the minimum time at that temperature in a heat treatment step that will kill specific pathogens identified as hazards for a food are the critical limits for that CCP.

d. Principle 4: Establish monitoring procedures.
The fourth HACCP principle is establishing monitoring procedures. The NACMCF HACCP guidelines define monitoring to mean conducting a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record of the monitoring for use in future verification procedures (Ref. 34). For example, monitoring can assess whether a CCP is operating within its critical limit. An unsafe food may result if a process is not properly controlled and a deviation occurs. Because of the potentially serious consequences of a deviation from a critical limit, monitoring procedures must be effective. Depending on the circumstances, monitoring may be on a continuous or a non-continuous basis. Continuous monitoring of a critical limit is possible with many types of physical and chemical methods. When it is not possible to monitor a critical limit on a continuous basis, monitoring intervals must be established that are frequent enough to determine whether the measure designed to control the hazard is consistently being met.

e. Principle 5: Establish corrective actions.
The fifth HACCP principle is establishing corrective actions. The NACMCF HACCP guidelines define corrective actions as procedures followed when a deviation occurs (Ref. 34). While the HACCP system is intended to prevent deviations in a planned process from occurring, total prevention can rarely, if ever, be achieved. Therefore, procedures need to be in place to fix or correct the cause of the deviation to ensure that the CCP is brought under control, there is appropriate disposition of any food produced during a deviation, and records are made of the corrective actions taken. Out-of-control situations should be used to identify opportunities for improvement of the process to prevent future occurrences.

f. Principle 6: Establish verification procedures.
The sixth HACCP principle is establishing verification procedures. The NACMCF HACCP guidelines define verification as those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan (Ref. 34). These activities may involve the application of methods, procedures, tests, and evaluations, other than monitoring. Verification activities, particularly those directed to validation, may be very scientific and technical in nature. For additional information about verification activities, see the discussion in section XII.G of this document. For additional information about the specific verification activity of “validation,” see the discussion in section XII.G.2 of this document.

g. Principle 7: Establish recordkeeping and documentation procedures.
The seventh HACCP principle is establishing recordkeeping and documentation procedures. Written HACCP records list the hazards, CCPs, and critical limits identified by the facility, as well as the procedures that the facility intends to use to implement the system. Written HACCP records also include those generated during the operation of the HACCP system.

5. History of the Use of HACCP

a. HACCP regulation for fish and fishery products.
In 1995, FDA issued a final rule to establish in part 123 procedures for the safe and sanitary processing and importing of fish and fishery products (60 FR 65096). Part 123 requires, among other things, that seafood processors apply HACCP principles to the processing of seafood. In the proposed rule to establish part 123, FDA identified several food safety hazards specific to the processing of fish and fishery products that warranted the promulgation of the seafood HACCP regulation, including microbiological hazards, naturally occurring toxins, chemical contaminants that might be present in the aquatic environment, and decomposition of fish and fishery products that might result from improper product handling and produce the toxin, histamine (59 FR 4142 at 4143-4144, January 28, 1994).

The HACCP regulation for seafood incorporated the seven HACCP principles as established in the 1992 revision of NACMCF's HACCP Principles for Food Production (“Hazard Analysis and Critical Control Point System”) (Ref. 36). The HACCP regulation for seafood also requires that individuals assigned the tasks of developing, reassessing, or modifying a HACCP plan, and conducting required records review must be adequately trained in the application of HACCP principles to fish and fishery products, evidenced either by the successful completion of the equivalent of a standardized curriculum recognized as adequate by FDA or by sufficiently adequate work experience (§ 123.10). The HACCP regulation for seafood does not require the use of NACMCF's five preliminary tasks as prerequisites to conducting a hazard analysis or developing a HACCP plan. We believe, however, that processors greatly benefit from using these preliminary steps in developing their HACCP systems (60 FR 65096 at 65117).

The HACCP regulation for seafood also requires that processors of seafood products monitor the conditions and practices of a sanitation standard operating procedure (SSOP); correct, in a timely manner, those conditions and practices that are not met; and document the monitoring and corrections (§ 123.11). In addition, the HACCP regulation for seafood is explicit that the general, umbrella CGMP

requirements for human food of part 110 apply to processors of fish and fishery products in determining whether the facilities, methods, practices, and controls used are safe, and whether the products have been processed under sanitary conditions (§ 123.5(a)).

In section XII of this document, we describe provisions of the HACCP regulation for seafood in more detail when we compare the proposed requirements for hazard analysis and risk-based preventive controls that are the subject of this document to provisions of current HACCP systems, including the HACCP regulation for seafood.

b. HACCP regulation for meat and poultry.
In 1996, FSIS issued a final rule to establish in 9 CFR part 417 a regulation that, among other things, requires each meat and poultry establishment to develop and implement a system of HACCP controls designed to improve the safety of their products (61 FR 38806, July 25, 1996). In the remainder of this document, the phrase “FSIS HACCP regulation for meat and poultry” refers to 9 CFR part 417. FSIS issued its HACCP regulation for meat and poultry in light of outbreaks of foodborne illness and studies (conducted by the National Academy of Sciences, the U.S. General Accounting Office, and FSIS) that established the need for fundamental change in the FSIS meat and poultry inspection program to improve food safety, reduce the risk of foodborne illness in the United States, and make better use of FSIS' resources (61 FR 38806 at 38807).

The FSIS HACCP regulation for meat and poultry incorporates the seven HACCP principles as established in the 1992 revision of NACMCF's HACCP Principles for Food Production (Ref. 36). Unlike our HACCP regulations for seafood and for juice, the FSIS HACCP regulation for meat and poultry requires two of the NACMCF preliminary tasks—i.e., that a flow chart describing the steps of each process and product flow in the establishment be prepared and that the intended use and consumers of the finished product be identified (9 CFR 417.2(a)(2)).

The FSIS HACCP regulation for meat and poultry requires the establishment to develop, implement and maintain written SSOPs that describe the procedures an establishment will conduct daily, before and during operations, to prevent direct contamination or adulteration of products (9 CFR 416.11 and 416.12(a)). Establishments must monitor the implementation of the SSOPs (9 CFR 416.13(c)), take appropriate corrective actions (9 CFR 416.15), and maintain records that document the implementation and monitoring of the SSOPs (9 CFR 416.16).

In section XII of this document, we describe provisions of the FSIS HACCP regulation for meat and poultry in more detail when we compare the proposed requirements for hazard analysis and risk-based preventive controls that are the subject of this document to provisions of current HACCP systems, including the FSIS HACCP regulation for meat and poultry.

c. HACCP regulation for juice.
In 2001, FDA issued a final rule to establish in part 120 requirements to ensure the safe and sanitary processing and importation of fruit and vegetable juices for beverages (66 FR 6138). Part 120 requires, among other things, that processors of juice products apply HACCP principles to the processing of juice. We issued the juice HACCP regulation in light of a number of food safety hazards associated with juice products, including microbiological hazards that led to outbreaks of foodborne illness associated with juice products (63 FR 20449, at 20450-20451, April 24, 1998).

The HACCP regulation for juice incorporated the seven HACCP principles as established in the NACMCF HACCP guidelines adopted in 1997 and published in 1998 (Ref. 34). As with the HACCP regulation for seafood, the HACCP regulation for juice requires that individuals assigned the tasks of developing the hazard analysis, developing a HACCP plan, and verifying and modifying the HACCP plan must be adequately trained in the application of HACCP principles to juice products, evidenced either by the successful completion of the equivalent of a standardized curriculum recognized as adequate by FDA or by sufficiently adequate work experience (§ 120.13). As with the HACCP regulation for seafood, the HACCP regulation for juice does not require the use of NACMCF's five preliminary tasks as prerequisites to conducting a hazard analysis or developing a HACCP plan.

As with the HACCP regulation for seafood, the HACCP regulation for juice requires that processors of juice products monitor the conditions and practices of a sanitation standard operating procedure (SSOP); correct, in a timely manner, those conditions and practices that are not met; and document the monitoring and corrections (§ 120.6). In addition, the HACCP regulation for juice is explicit that the umbrella CGMP requirements of part 110 apply in determining whether the facilities, methods, practices, and controls used to process juice are safe, and whether the juice products have been processed under sanitary conditions (§ 120.5).

Unlike the HACCP regulation for seafood, the HACCP regulation for juice, with certain exceptions, establishes requirements for process controls for pathogen reduction (§ 120.24). The HACCP regulation for juice also establishes requirements for process verification for juice processors, under certain circumstances, to analyze their finished juice products for the presence of
E. coli
using specified sampling and analytical methodologies (§ 120.25).

In section XII of this document, we describe provisions of the HACCP regulation for juice in more detail when we compare the proposed requirements for hazard analysis and risk-based preventive controls that are the subject of this document to provisions of current HACCP systems, including the HACCP regulation for juice.

d. Dairy HACCP pilot program.
The Pasteurized Milk Ordinance (PMO) is a model milk regulation recommended by the U.S. Public Health Service/FDA for voluntary adoption by State and local milk control agencies. This model milk regulation includes provisions governing the processing, packaging and sale of Grade “A” milk and milk products and provides administrative and technical details on how to obtain satisfactory compliance. It is published to assist States and municipalities in initiating and maintaining effective programs for the prevention of milkborne disease. Currently all fifty states, the District of Columbia, and Puerto Rico have adopted the PMO by reference or have codified the PMO in state requirements. At its biennial conferences, the National Conference on Interstate Milk Shipments (NCIMS) considers changes and modifications to the Grade “A” PMO.

Appendix K of the PMO (the PMO HACCP Appendix) describes a voluntary, NCIMS HACCP Program alternative to the traditional inspection system. No milk plant, receiving station or transfer station may participate in the voluntary NCIMS HACCP Program unless the Regulatory Agency responsible for the oversight of the facility agrees to participate with the dairy plant(s), receiving station(s) and transfer station(s) in the NCIMS HACCP Program (Ref. 37).

The PMO HACCP Appendix incorporates the seven HACCP principles established in the 1998 NACMCF HACCP guidelines and essentially follows the same requirements as described in the HACCP regulation for juice (part 120).

SSOPs are referred to as “required prerequisite programs (PPs).” In contrast to the HACCP regulations for seafood and juice, the PMO HACCP Appendix requires that, in addition to the required PPs, any other PPs that the hazard analysis is relying upon to reduce the likelihood of hazards such that they would not be reasonably likely to occur also be monitored, audited, and documented. In this respect, the PMO HACCP Appendix is broader in scope than HACCP, in that it emphasizes the importance of monitoring, auditing, and documentation for the complete food safety system rather than focusing monitoring, auditing, and documentation solely on critical control points.

e. HACCP in the international food safety community.
HACCP is recognized in the international food safety community as the state-of-the-art means to ensure the safety and integrity of food. In particular, the Committee on Food Hygiene of Codex has endorsed the HACCP concept as a worldwide guideline incorporated as an Annex into the Codex General Principles of Food Hygiene (GPFH) (Ref. 35). The European Union (EU) and other countries around the world have begun to require that foods be processed using a HACCP system. A discussion on the comparison of hazard analysis and preventive controls standards in section XVI.B includes those in Regulation (EC) No 852/2004 of the European Parliament and Council of the European Union Regulation (Ref. 38) (the EU Regulation), the Australia-New Zealand Food Standards Code (Ref. 39), and the Canadian Food Inspection Agency's Food Safety Enhancement Program (Ref. 40), all of which are based on the Codex

[Text truncated at 120,000 characters. The full text is on the page linked above.]

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2013-00125. Public record. Not legal advice.