[Federal Register Volume 78, Number 11 (Wednesday, January 16, 2013)]
[Proposed Rules]
[Pages 3646-3824]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-00125]


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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.

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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

[[Page 3647]]

    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 Sec.  117.1--Applicability and Status
    B. Proposed Sec.  117.3--Definitions
    C. Proposed Sec.  117.5--Exemptions
    D. Proposed Sec.  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 Sec.  110.10--
Personnel (Proposed Sec.  117.10)
    F. Proposed Revisions to Current Sec.  110.20--Plant and Grounds 
(Proposed Sec.  117.20)
    G. Proposed Revisions to Current Sec.  110.35--Sanitary 
Operations (Proposed Sec.  117.35)
    H. Proposed Revisions to Current Sec.  110.37--Sanitary 
Facilities and Controls (Proposed Sec.  117.37)
    I. Proposed Revisions to Current Sec.  110.40--Equipment and 
Utensils (Proposed Sec.  117.40)
    J. Proposed Revisions to Current Sec.  110.80--Processes and 
Controls (Proposed Sec.  117.80)
    K. Proposed Revisions to Current Sec.  110.93--Warehousing and 
Distribution (Proposed Sec.  117.93)
    L. Proposed Revisions to Current Sec.  110.110--Natural or 
Unavoidable Defects in Food for Human Use That Present No Health 
Hazard (Proposed Sec.  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 Sec.  117.126--Requirement for a Food Safety Plan
    B. Proposed Sec.  117.130--Hazard Analysis
    C. Proposed Sec.  117.135--Preventive Controls for Hazards That 
Are Reasonably Likely To Occur
    D. Proposed Sec.  117.137--Recall Plan for Food With a Hazard 
That Is Reasonably Likely To Occur
    E. Proposed Sec.  117.140--Monitoring
    F. Proposed Sec.  117.145--Corrective Actions
    G. Proposed Sec.  117.150--Verification
    H. Proposed Sec.  117.155--Requirements Applicable to a 
Qualified Individual
    I. Proposed Sec.  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 Sec.  117.201--Modified Requirements That Apply to a 
Qualified Facility
    B. Proposed Sec.  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 Sec.  117.251--Circumstances That May Lead FDA To 
Withdraw an Exemption Applicable to a Qualified Facility
    C. Proposed Sec.  117.254--Issuance of an Order To Withdraw an 
Exemption Applicable to a Qualified Facility
    D. Proposed Sec.  117.257--Contents of an Order To Withdraw an 
Exemption Applicable to a Qualified Facility
    E. Proposed Sec.  117.260--Compliance With, or Appeal of, an 
Order To Withdraw an Exemption Applicable to a Qualified Facility
    F. Proposed Sec.  117.264--Procedure for Submitting an Appeal
    G. Proposed Sec.  117.267--Procedure for Requesting an Informal 
Hearing
    H. Proposed Sec.  117.270--Requirements Applicable to an 
Informal Hearing
    I. Proposed Sec.  117.274--Presiding Officer for an Appeal and 
for an Informal Hearing
    J. Proposed Sec.  117.277--Time Frame for Issuing a Decision on 
an Appeal
    K. Proposed Sec.  117.280--Revocation of an Order To Withdraw an 
Exemption Applicable to a Qualified Facility
    L. Proposed Sec.  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 Sec.  117.301--Records Subject to the Requirements 
of this Subpart F

[[Page 3648]]

    C. Proposed Sec.  117.305--General Requirements Applying to 
Records
    D. Proposed Sec.  117.310--Additional Requirements Applying to 
the Food Safety Plan
    E. Proposed Sec.  117.315--Requirements for Record Retention
    F. Proposed Sec.  117.320--Requirements for Official Review
    G. Proposed Sec.  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 Sec.  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                Notes
     risk-based preventive controls
------------------------------------------------------------------------
``Qualified Facility'' as defined by     FDA is proposing three options
 FSMA:                                    for defining ``very small
                                          business'' and requests
                                          comment on which to adopt in a
                                          final rule.

[[Page 3649]]

 
     Business with average       Modified requirements would
     annual sales of < $500,000 and at    apply--i.e., a qualified
     least half the sales to consumers    facility would be required to:
     or local retailers or restaurants    Notify FDA about its
     (within the same state or within     status; and
     275 miles); or.                      Either:
                                         [cir] Notify FDA that it is
                                          addressing hazards through
                                          preventive controls and
                                          monitoring; or
                                         [cir] 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           Small and very small on-farm
     activities performed by small        businesses conducting these
     business (< 500 employees).          low risk activities would be
                                          exempt from most of the rule's
                                          requirements.
-or-
     Low-risk, on-farm           We would define the low-risk
     activities performed by a very       activities that qualify for
     small business.                      the exemption, including the
                                          specific foods to which they
                                          relate (such as re-packing
                                          intact fruits and vegetables,
                                          or grinding/milling/cracking/
                                          crushing grains)
        [cir] Option 1: very small =
         <$250,000.
        [cir] Option 2: very small =
         <$500,000.
        [cir] Option 3: very small =
         <$1,000,000.
Activities that are subject to the       The facility must be in
 seafood HACCP requirements of part 123   compliance with part 123.
 (21 CFR part 123).
Activities that are subject to the       The facility must be in
 juice HACCP requirements of part 120     compliance with part 120.
 (21 CFR part 120).
Activities that are subject to the        The exemption applies
 ``low-acid canned food'' requirements    only with respect to
 of part 113 (21 CFR part 113).           microbiological hazards.
                                          The facility must be
                                          in compliance with part 113.
The manufacturing, processing, packing,   The facility must be
 or holding of a dietary supplement       in compliance with part 111.
 that is subject to the CGMP              The facility must be
 requirements of part 111 (21 CFR part    in compliance with
 111).                                    requirements for serious
                                          adverse event reporting for
                                          dietary supplements
Activities of a facility that are        Elsewhere in this issue of the
 subject to section 419 of the FD&C Act   Federal Register, FDA is
 (Standards for Produce Safety).          proposing standards for
                                          produce safety.
Alcoholic beverages at a facility that   The exemption also would apply
 is required to obtain a permit from,     to food other than alcoholic
 register with, or obtain approval of a   beverages at such a facility,
 notice or application from the           provided that the food is in
 Secretary of the Treasury as a           prepackaged form and
 condition of doing business in the       constitutes not more than 5
 United States.                           percent of the overall sales
                                          of the facility.
Facilities that are solely engaged in    A facility that stores raw
 the storage of raw agricultural          agricultural commodities that
 commodities (other than fruits and       are fruits and vegetables
 vegetables) intended for further         would not be exempt.
 distribution or processing.
A facility solely engaged in the         Modified requirements would
 storage of packaged food that is not     apply for the storage of
 exposed to the environment.              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

[[Page 3650]]

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

------------------------------------------------------------------------
                                Total domestic
                               costs annualized      Annual breakeven
                                 at 7 per cent      illness percentage
                                 over 7 years
------------------------------------------------------------------------
Proposed Rule with Very Small  $475 million....                       24
 Business Defined as Less
 Than or Equal to $250,000 in
 Annual Revenue.
Proposed Rule with Very Small  $395 million....                       20
 Business Defined as Less
 Than or Equal to $500,000 in
 Annual Revenue.
Proposed Rule with Very Small  $319 million....                       16
 Business Defined as Less
 Than or Equal to $1,000,000
 in Annual Revenue.
------------------------------------------------------------------------

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.

[[Page 3651]]

    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 (Sec.  
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

[[Page 3652]]

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 
(Sec.  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 (Sec. Sec.  
113.10 and 114.10, respectively).
    The enforcement regulations in Sec. Sec.  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 (Sec. Sec.  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 Sec. Sec.  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 Sec.  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

[[Page 3653]]

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 
Sec.  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

[[Page 3654]]

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 Sec.  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 [deg]C (45[emsp14][deg]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 
Sec.  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 (Sec.  
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 (Sec.  
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 (Sec.  10.115(d)(3)). Under 
Sec. Sec.  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 Sec.  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

[[Page 3655]]

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;

[[Page 3656]]

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 (Sec.  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 
(Sec.  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 (Sec.  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

[[Page 3657]]

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 (Sec.  418(e)), 
verification (Sec.  418(f)), a written plan and documentation (Sec.  
418(h)), and reanalysis of hazards (Sec.  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 Sec.  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 Sec.  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

[[Page 3658]]

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 Sec.  117.5(b)), part 120 (proposed Sec.  117.5(c)), part 113 
(proposed Sec.  117.5(d)), section 419 of the FD&C Act (proposed Sec.  
117.5(f)), or the manufacturing, processing, packing, and holding of 
dietary supplements (proposed Sec.  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 Sec.  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 (Sec.  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 
(Sec.  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. (Sec.  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'' (Sec.  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 
(Sec.  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 (Sec.  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' '' (Sec.  
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

[[Page 3659]]

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 (Sec.  103(c)(1)(D)(i) of 
FSMA). Any exemption or modification is limited to small and very small 
businesses (Sec.  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 
Sec.  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 Sec.  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 Sec.  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.'' 
(Sec.  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

[[Page 3660]]

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.

[[Page 3661]]

    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 (Sec.  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 (Sec.  123.11). In addition, the HACCP regulation for 
seafood is explicit that the general, umbrella CGMP

[[Page 3662]]

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 (Sec.  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 (Sec.  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 (Sec.  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 (Sec.  120.5).
    Unlike the HACCP regulation for seafood, the HACCP regulation for 
juice, with certain exceptions, establishes requirements for process 
controls for pathogen reduction (Sec.  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 (Sec.  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).

[[Page 3663]]

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 
HACCP Annex.
    The HACCP reference documents from NACMCF and Codex have changed 
over the years as experience has been gained from the application of 
the concept in food production. These reference documents remain 
consistent with each other. This harmonization is critical, as these 
documents serve as the basis for hazard analysis and preventive 
controls standards internationally, thus providing for harmonized food 
safety standards among countries. Such harmonization facilitates trade 
by establishing a framework for ensuring safety. In addition to these 
standards serving as the basis for requirements by governments, there 
has been widespread international adoption of HACCP/preventive controls 
by industry at the company level, and as the foundation for food safety 
in third-party auditing schemes and certification efforts for 
companies, such as those benchmarked through the Global Food Safety 
Initiative (GFSI) (Ref. 41). (See section II of the Appendix to this 
document for more information on GFSI.)
    The proposed rule would require that a food safety system similar 
to HACCP be implemented in food facilities and would harmonize our 
requirements with the recommendations and requirements of 
internationally recognized food safety experts/authorities, such as 
experts/authorities in NACMCF (Ref. 34), Codex (Ref. 35), FSANZ (Ref. 
39), CFIA (Ref. 40), and the European Union (Ref. 38). The World Health 
Organization has recognized the importance of the HACCP system for 
prevention of foodborne diseases for more than 30 years and has played 
an important role in its development and promotion (Ref. 42). FAO 
likewise emphasizes the importance of HACCP and promotes it through 
international training and food safety manuals, e.g., for mycotoxin 
prevention and control (Ref. 43).
    The Final Act of the Uruguay Round of the General Agreement on 
Tariffs and Trade (GATT), particularly the Agreement on the Application 
of Sanitary and Phytosanitary Measures (the ``SPS Agreement'') and the 
Agreement on Technical Barriers to Trade, had significant implications 
for Codex standards. Specifically, the SPS Agreement identifies Codex 
standards, guidelines and other recommendations as the baseline for 
consumer protection. As a result, the work of Codex (including the 
Codex HACCP Annex (Ref. 35) has become the reference for international 
food safety requirements. The Codex GPFH recommends a HACCP approach 
wherever possible to enhance food safety (Ref. 44). The international 
recognition of the HACCP approach as essential to ensuring the safety 
and suitability of food for human consumption enhances the potential 
for international trade as well as food safety (Ref. 43).

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

1. Contamination of Food
    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. Consumption of 
contaminated food can lead to acute or long term illness or injury. CDC 
estimates that each year approximately 48 million illnesses, 128,000 
hospitalizations, and 3,000 deaths are food related (Ref. 45) (Ref. 
46). These numbers include all illnesses that CDC estimates are 
attributable to food, including those illnesses caused by unspecified 
agents. These estimates also include a correction factor to account for 
the fact that foodborne illness is under-reported (Ref. 47). Focusing 
only on the foodborne illnesses attributable to particular pathogens, a 
recent CDC report estimated that consumption of food contaminated with 
pathogenic bacteria (such as Campylobacter spp., Clostridium 
perfringens, Shiga toxin-producing Escherichia coli (STEC) O157, STEC 
non-O157, Listeria monocytogenes, Salmonella spp., Vibrio species, 
Yersinia enterocolitica), parasites (such as Cryptosporidium spp. and 
Giardia intestinalis) and viruses (such as norovirus) cause more than 9 
million episodes of foodborne illness, nearly 56,000 hospitalizations, 
and more than 1,300 deaths in the United States each year (Ref. 45). (A 
pathogenic microorganism is a microorganism capable of causing illness 
or injury.) Other food-related problems are caused by chemicals, 
allergens, and other harmful substances, such as glass (see sections 
II.D.2.b through II.D.2.d of this document for a discussion of these 
problems).
    Early detection of contamination enables food establishments to 
prevent contaminated food from leaving their premises. When 
contamination is not detected in time to prevent contaminated food from 
leaving an establishment, the contamination may be detected while the 
food is in storage or in transit; at retail establishments; in 
restaurants; or in the home and often results in the need for a recall. 
Contamination after the food leaves the establishment may be detected 
during an investigation of an outbreak of foodborne illness or may be 
detected by end users (e.g., restaurants and consumers may identify 
physical hazards such as metal fragments or pieces of glass).
    In recent years, we have taken a number of actions to prevent 
contamination of food at each step in the farm-to-table continuum. We 
have worked with other Federal, State, local, territorial, tribal, and 
foreign counterpart food safety agencies to strengthen the Nation's 
food safety systems across the entire distribution chain. This 
cooperative work has resulted in a greater awareness of potential 
vulnerabilities, the creation of more effective prevention programs, 
new or better surveillance systems, and the ability to respond more 
quickly to

[[Page 3664]]

outbreaks 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.) However, changes in consumer 
preferences, changes in industry practices, and the rising volume of 
imports continue to pose significant challenges for FDA (72 FR 8750, 
February 27, 2007; 73 FR 55115, September 24, 2008). There are also 
many foodborne illnesses associated with unknown agents, which presents 
challenges in outbreak investigations (Ref. 46). In addition, 
microorganisms can change their characteristics by acquiring genes, 
including those for virulence, from other microorganisms (Ref. 48).
2. Microbiological, Chemical, Physical, and Radiological Hazards
    In the following discussion of hazards, we highlight four 
categories: microbial, chemical (including allergens), physical, and 
radiological. Of the four types of hazards, there is far more 
information and data on microbiological problems associated with foods 
than with the others.
    a. Microbiological hazards. Foodborne illness can have very serious 
consequences, including death. Below, we discuss several microorganisms 
commonly associated with foodborne illness.
Salmonella spp.
    Salmonella contamination has been associated with eggs, milk and 
dairy products, fish, shrimp, frog legs, yeast, coconut, sauces and 
salad dressing, cake mixes, cream-filled desserts and toppings, dried 
gelatin, peanut butter, cocoa, and chocolate (Ref. 49). In a recent 
report tracking trends in foodborne illness, CDC reported that in 2010 
Salmonella spp. was the most common foodborne pathogen and the most 
common cause of hospitalization and death (Ref. 50). The incidence of 
foodborne illness due to Salmonella spp. has not declined significantly 
in the last 15 years (Ref. 50). Salmonella spp. can cause serious and 
sometimes fatal infections in young children, frail or elderly people, 
and others with weakened immune systems (Ref. 49) (Ref. 51). Healthy 
persons infected with Salmonella spp. often experience fever, diarrhea 
(which may be bloody), nausea, vomiting, and abdominal pain. In rare 
circumstances, infection with Salmonella spp. can result in the 
organism getting into the blood stream and producing more severe 
illnesses such as arterial infections (i.e., infected aneurysms), 
endocarditis, and arthritis (Ref. 49) (Ref. 51).
Listeria Monocytogenes
    Listeria monocytogenes is another pathogen often implicated in 
foodborne illness. In 2011, CDC reported that of all the foodborne 
pathogens tracked by CDC through FoodNet, L. monocytogenes had the 
highest case fatality rate (12.8 percent) and the highest 
hospitalization rate (89.6 percent) (Ref. 50). L. monocytogenes is a 
bacterium that occurs widely in both agricultural (soil, plants and 
water) and food processing environments. L. monocytogenes can multiply 
slowly at refrigeration temperatures, thereby challenging an important 
defense against foodborne pathogens--i.e., refrigeration (Ref. 52) 
(Ref. 53). Ingestion of L. monocytogenes can cause listeriosis, which 
can be a life-threatening human illness. Serious illness almost always 
occurs in people considered to be at higher risk, such as the elderly 
and those who have a preexisting illness that reduces the effectiveness 
of their immune system (Ref. 54). In addition, perinatal listeriosis 
results from foodborne exposure of the pregnant mother leading to in 
utero exposure of the fetus, resulting in fetal infection that leads to 
fetal death, premature birth, or neonatal illness and death. L. 
monocytogenes also causes listerial gastroenteritis, a syndrome 
typically associated with mild gastrointestinal symptoms in healthy 
individuals (Ref. 54) (Ref. 55).
    The risk of illness from L. monocytogenes associated with a 
particular food is dependent on five key factors (Ref. 52) (Ref. 53):
     Amount and frequency of consumption of a food;
     Frequency and extent of contamination of a food with L. 
monocytogenes;
     Ability of the food to support the growth of L. 
monocytogenes;
     Temperature of refrigerated/chilled food storage; and
     Duration of refrigerated/chilled storage.
    In 2003, FDA and FSIS, in consultation with CDC, released a 
quantitative assessment (the FDA/FSIS Lm RA) of relative risk 
associated with consumption of 23 categories of ready-to-eat (RTE) 
foods that had a history of contamination with L. monocytogenes, or 
that were implicated epidemiologically with an outbreak or a sporadic 
case of listeriosis (Ref. 53). The FDA/FSIS Lm RA shows that the risk 
of illness from L. monocytogenes increases with the number of cells 
ingested and that there is greater risk of illness from RTE foods that 
support growth of L. monocytogenes than from those that do not (Ref. 
56). FAO/WHO released a risk assessment on L. monocytogenes in RTE 
foods in 2004. A key finding of that risk assessment was that the 
models developed predict that nearly all cases of listeriosis result 
from the consumption of high numbers of the pathogen (Ref. 54). 
Refrigerated foods present a greater risk from L. monocytogenes because 
some refrigerated foods that support growth may be held for an extended 
period of time, thus increasing the risk if L. monocytogenes is present 
in a food. Growth of L. monocytogenes does not occur if the food is 
frozen, but the organism may survive. If a frozen food contaminated 
with L. monocytogenes is thawed and held at temperatures that support 
growth, e.g., under refrigeration, the risk of illness from L. 
monocytogenes in that food increases.
Escherichia Coli O157:H7
    One of the most serious foodborne pathogens in terms of symptoms is 
Escherichia coli O157:H7, one of the enterohemorrhagic strains of E. 
coli. While the incidence of E. coli O157:H7 infection has been 
declining in recent years, it is still among the top five pathogens 
causing hospitalization as a result of foodborne illness (Ref. 45).
    E. coli is a normal inhabitant of the intestines of all animals, 
including humans. However, E. coli O157:H7 is a rare variety of E. coli 
that, among other virulence factors, produces one or more related, 
potent toxins that cause severe damage to the lining of the intestine. 
Hemorrhagic colitis is the name of the acute disease caused by E. coli 
O157:H7. The illness is characterized by severe cramping (abdominal 
pain) and diarrhea, which often becomes bloody. Occasionally vomiting 
occurs. The illness is usually self-limited and lasts for an average of 
8 days. Some victims, particularly the very young, develop hemolytic 
uremic syndrome (HUS), characterized by renal failure and hemolytic 
anemia. From 0 to 15 percent of hemorrhagic colitis victims may develop 
HUS. The disease can lead to permanent loss of kidney function and 
death (Ref. 49).
Noroviruses
    Noroviruses are a group of related, single-stranded RNA, non-
enveloped viruses that cause acute gastroenteritis in humans. Norovirus 
is the official genus name for the group of viruses previously 
described as ``Norwalk-like viruses'' (NLV) or small round structured 
viruses (SRSVs) because of their morphologic features. Norovirus 
infection usually presents as acute-onset vomiting, watery non-bloody 
diarrhea

[[Page 3665]]

with abdominal cramps, and nausea. Low-grade fever also occasionally 
occurs, and diarrhea is more common than vomiting in children. 
Dehydration is the most common complication, especially among the young 
and elderly, and may require medical attention. Symptoms usually last 
24 to 72 hours. Recovery is usually complete and there is no evidence 
of any serious long-term sequelae (i.e., chronic conditions resulting 
from the illness) (Ref. 57). Noroviruses are transmitted primarily 
through the fecal-oral route, either by consumption of fecally 
contaminated food or water or by direct person-to-person spread. 
Noroviruses are highly contagious and as few as 10 viral particles may 
be sufficient to infect an individual. During outbreaks of norovirus 
gastroenteritis, more than one mode of transmission has been 
documented--e.g., initial foodborne transmission in a restaurant by a 
contaminated food, followed by secondary person-to-person transmission 
to household contacts. CDC recently estimated that there are 5.4 
million cases of domestically-acquired foodborne illness each year due 
to norovirus infection, and more than 58 percent of all foodborne 
illnesses can be attributed to norovirus (Ref. 45).
    As part of the work of the CGMP Working Group, FDA reviewed its 
food recall records for recall actions that were classified I or II for 
fiscal years 1999 through 2003 to identify those recalls that took 
place because of problems that could have been prevented by CGMP-type 
preventive measures such as proper equipment sanitation, adequate 
training of employees, review of product labels for accuracy and 
agreement with the product formulation, and adequate preventive 
maintenance of equipment (Ref. 58). The review did not include Class 
III recalls because these recalled products are not likely to have 
caused adverse health consequences. FDA repeated this type of review 5 
years later, for the period 2008-2009 (Ref. 59). In these two reports, 
the second most common reason for such recalls was microbiological 
contamination (Ref. 58) (Ref. 59). Approximately 17 percent of such 
recalls during 1999-2003 and 24 percent of such recalls during 2008-
2009 were linked to microbiological hazards. During 2008-2009, the two 
most commonly implicated pathogens in such recalls were L. 
monocytogenes (9.9 percent) and Salmonella spp. (7.6 percent). In the 
first annual report on the Reportable Food Registry, the three main 
pathogens associated with the 229 primary reports received by the RFR 
were Salmonella spp. (37.6 percent), L. monocytogenes (14.4 percent), 
and E. coli O157:H7 (2.6 percent) (Ref. 60). In the second annual 
report on the Reportable Food Registry, the three main pathogens 
associated with the 225 primary reports received by the RFR were 
Salmonella spp. (38.2 percent), L. monocytogenes (17.8 percent), and E. 
coli O157:H7 (0.4 percent) (Ref. 61).
    There are many other pathogens associated with foodborne illness; 
however the four described above have been implicated in many recent 
outbreaks of foodborne illness as demonstrated by the examples below.
     In 2006-2007, a commercial brand peanut butter 
contaminated with Salmonella enterica serotype Tennessee (usually 
shortened to Salmonella Tennessee) caused 715 confirmed cases of 
illness, including 129 hospitalizations (Ref. 62). (Salmonella spp. are 
grouped into serotypes (also called serovars) based on cell surface 
antigens, which are determined by serologic testing. The serotype is 
often named after the location where it was isolated.) This was the 
first outbreak associated with peanut butter in the United States (Ref. 
63). Investigators detected Salmonella spp. in environmental samples 
collected at the manufacturer's facility as well as in finished product 
(Ref. 64) (Ref. 65). Two years later, in 2008-2009, another large 
Salmonella outbreak was linked to peanut butter and peanut paste (Ref. 
66) (Ref. 67). Implicated products included contaminated peanut butter 
consumed at institutional settings and peanut crackers made with the 
contaminated peanut butter as an ingredient (Ref. 66). This single 
outbreak resulted in 714 confirmed cases of illnesses, including 166 
hospitalizations, and 9 deaths (Ref. 67). Inspections conducted by FDA 
at the manufacturing facilities revealed lack of controls to prevent 
product contamination from pests, from an insanitary air-circulation 
system, from insanitary food-contact surfaces, and from the processing 
environment (Ref. 68) (Ref. 69).
     In 2007, a puffed snack food was implicated in a 
Salmonella Wandsworth and Salmonella Typhimurium outbreak. There were 
87 confirmed reports of illnesses, including 8 hospitalizations. The 
likely source of contamination was a contaminated ingredient--i.e., 
imported dried vegetable powder that was applied to the puffed snack 
food after the cooking step (Ref. 51) (Ref. 70).
     From October 2008 to March 2009, a multistate L. 
monocytogenes outbreak was linked to Mexican-style cheese that was 
contaminated post-pasteurization. There were 8 confirmed cases of 
illness in 5 states (Ref. 71). An investigation at the plant revealed 
the potential for product contamination due to deficiencies in cleaning 
and plant and equipment maintenance (Ref. 72).
     In 2008-2009, white pepper was implicated in a Salmonella 
Rissen outbreak that resulted in a 87 confirmed cases of illness, 
including 8 hospitalizations and 1 death (Ref. 73) (Ref. 74). During 
the investigation, FDA isolated the outbreak strain from raw whole 
white pepper, in-process samples, finished products, and environmental 
samples taken at various locations throughout the processing areas 
(Ref. 75).
     In 2009, a prepackaged, refrigerated cookie dough was 
implicated in an E. coli O157:H7 outbreak that caused 76 confirmed 
cases of illness, including 35 hospitalizations (Ref. 76) (Ref. 77). E. 
coli O157:H7 was found in unopened packages of cookie dough in the 
production facility, although it was not the outbreak strain (Ref. 77) 
(Ref. 78).
     In 2011, an outbreak of listeriosis from cantaloupes was 
attributed to insanitary conditions at a facility that washed, packed, 
cooled, and stored intact cantaloupes (Ref. 79) (Ref. 80). The outbreak 
appears to have occurred due to a combination of factors, including 
pooled water on the floor of the facility (which was also difficult to 
clean), poorly designed equipment (not easily cleaned and sanitized) 
that was previously used for a different commodity, no pre-cool step, a 
truck parked near the packing area that had visited a cattle operation, 
and possible low level contamination from the growing/harvesting 
operation (Ref. 79).
    b. Chemical hazards other than food allergens. There are a variety 
of ``chemical'' hazards that may be associated with food, including 
pesticide and drug residues, natural toxins, decomposition resulting in 
the production of toxins such as histamine, unapproved food or color 
additives, and food allergens. (We discuss food allergens in more 
detail in the next section of this document). Under the FD&C Act, 
certain products, such as food additives, color additives, new animal 
drugs, and pesticides require premarket approval before they may be 
legally used. (In the case of pesticides, EPA ``registers'' (i.e., 
approves) the use of pesticides and establishes tolerances (the maximum 
amounts of residues that are permitted in or on a food) if the use of a 
particular pesticide may result in residues in or on food. FDA enforces 
those tolerances, except for meat, poultry, and certain egg products, 
which are the responsibility of FSIS (Ref. 81).

[[Page 3666]]

Moreover, this approval can be limited so that the product may only be 
used legally on or with specific foods, or for specific purposes, for 
which approval has been obtained. This limitation reflects a 
longstanding recognition that the safety of these types of products is 
variable and must be established on a use-by-use basis. Whether an 
additive, drug, or pesticide is safe for a particular use, in a 
particular food, at a particular level, depends on factors such as the 
amount of the food that is consumed and, if the additive, drug, or 
pesticide is ingested by a living animal before slaughter, how the 
product is metabolized in that animal.
    Therefore, an additive, drug, or pesticide that has been approved 
for use in some foods, but not other foods, is deemed by the FD&C Act 
to be unsafe for use with those other foods. By specifically 
identifying pesticides, drug residues, and unapproved food and color 
additives as potential known or reasonably foreseeable hazards that a 
facility must consider and evaluate in its hazard analysis, section 
418(b) of the FD&C Act emphasizes the current provisions of the FD&C 
Act regarding substances that require premarket review.
    Natural toxins (such as aflatoxin in foods such as peanuts and tree 
nuts and patulin in apple juice products) are well recognized as 
hazards (Ref. 82) (Ref. 83) (Ref. 84) (Ref. 85). Decomposition products 
such as histamine, produced from the amino acid histidine when certain 
bacteria grow, can pose a risk to health. Biogenic amines other than 
histamine have been associated with illnesses, and these may also be 
formed when bacteria grow in some foods. Although certain fish species 
are the most common source of illness from histamine and other biogenic 
amines, illness from histamine has been reported from consumption of 
other foods, in particular cheese (Ref. 86) (Ref. 87). Heavy metals 
(such as lead) can lead to adverse health consequences (such as 
impaired cognitive development in children) (Ref. 88).
    Depending on the particular chemical hazard and its level in the 
food, contamination of food with a chemical hazard may lead to 
immediate or near-term onset of illness (e.g., gastrointestinal 
illness), or may more commonly be associated with chronic exposure and 
long-term effects. Industrial chemicals (such as caustic cleaning 
compounds) can cause an acute reaction. Examples of long-term effects 
include impaired cognitive development in children exposed over time to 
relatively low levels of lead in contaminated candy (Ref. 88) and liver 
cancer as the result of chronic exposure to the mycotoxin aflatoxin 
(Ref. 89 (Ref. 90).
    c. Chemical hazards--food allergens. Food allergies are immune-
mediated adverse reactions to proteins. It has been estimated that food 
allergies affect four to six percent of children and two to three 
percent of adults (Ref. 91) (Ref. 92) (Ref. 93). A recent study by CDC 
estimates that approximately 3 million children in the United States 
(3.9 percent) have food allergies (Ref. 94). This study also reported 
that the prevalence of food allergies increased by 18 percent in this 
age group between 1997 and 2007 (Ref. 94).
    The severity of a food allergic reaction varies depending on 
factors such as the amount of allergen ingested, the type of allergen, 
and the presence of other underlying medical conditions. Sensitive 
individuals may experience reactions to allergen doses as low as a few 
micrograms of food protein (Ref. 95) (Ref. 96) (Ref. 97). As high as 
one-third of sensitive individuals can experience severe reactions at 
the minimal eliciting dose of an allergen.
    Allergic reactions from food result in an estimated 125,000 
emergency room visits in the United States each year (Ref. 98), and as 
many as 100-150 deaths in the United States each year (Ref. 99) (Ref. 
100). For children under 18 years of age, CDC estimates that there are 
approximately 9,500 food allergy-related hospitalizations per year 
(Ref. 101). The signs and symptoms associated with allergic reactions 
can range from oral irritation and swelling to cardiovascular collapse 
(Ref. 102).
    Although more than 170 different foods have been reported to cause 
allergic reactions, most severe reactions are caused by the major food 
allergens defined in the Food Allergen Labeling and Consumer Protection 
Act (FALCPA) (21 U.S.C. 321(qq)): milk, egg, fish, crustacean 
shellfish, tree nuts, wheat, peanuts, and soybeans. These eight 
allergens account for 90 percent of allergic reactions in affected 
individuals (Ref. 101). FALCPA amended the FD&C Act to prescribe the 
manner in which food labels must disclose that a food is, or contains 
an ingredient that bears or contains, a major food allergen (one of the 
eight listed above).
    The most common CGMP related problem we have identified that 
resulted in a recall, both before and after FALCPA was passed, is 
labeling problems (i.e., undeclared allergen). In conjunction with the 
work of the CGMP Working Group, FDA reviewed CGMP-related food recalls 
during the period 1999-2003 (Ref. 58). Labeling problems accounted for 
68 percent of food recalls, including 34 percent of recalls due to 
undeclared major food allergens. FDA followed up with a similar review 
of CGMP-related food recalls during the period 2008-2009, with a focus 
on primary recalls. (A primary recall is a recall initiated by a firm 
where the food safety problem first occurred. A subsequent recall is 
triggered by a primary recall. In a subsequent recall, the recalling 
firm is a recipient of an ingredient that is implicated in a primary 
recall.) In that follow-up review, labeling problems accounted for 62 
percent of primary food recalls, including 43 percent of recalls due to 
undeclared major food allergens (Ref. 59). Thus, although FALCPA was 
passed in 2004, we continue to see problems with undeclared allergens 
in foods, as evidenced by recalls.
    Some of the problems with undeclared allergens come to light only 
after consumers experience allergic reactions. For example, in August 
2010, a prepared food with undeclared milk was recalled after a 
consumer complaint of an allergic reaction. It was discovered that the 
``natural flavors'' used might have contained a milk product, but milk 
was not listed as an allergen on the product label (Ref. 103). In 
December 2010, a snack product with undeclared egg was recalled after a 
consumer complaint of an allergic reaction. The egg-containing product 
was mistakenly packaged in packaging designed for a similar product 
that did not contain egg (Ref. 104).
    d. Physical hazards. Physical hazards include stones, glass, or 
metal fragments that could inadvertently be introduced into food. 
Physical hazards may be associated with raw materials, especially raw 
agricultural commodities. The facility and equipment can also be a 
source of physical hazards, e.g., container glass and metal fragments 
such as nuts and bolts from equipment used in manufacturing/processing.
    The first RFR Annual Report issued in January 2011 identified only 
three primary RFR entries for ``foreign objects'' (which were physical 
hazards that could have resulted in serious adverse health consequences 
or death), and all of these were in animal feed or pet food (Ref. 60). 
However, there have been recalls of human foods due to contamination or 
potential contamination with physical hazards. In October 2010, several 
types of frozen vegetables were recalled after shards of broken glass 
were found in some packages (Ref. 105) and in May 2011 several types of 
English muffins and bread products were recalled due to

[[Page 3667]]

possible contamination with small pieces of metal (Ref. 106).
    e. Radiological hazards. Radiological contamination of foods is a 
rare event. Examples of radiological hazards include radionuclides such 
as radium-226, radium-228, uranium-235, uranium-238, plutonium-239, 
strontium-90, iodine-131, and cesium-137. The most common way these 
radionuclides are incorporated into foods is through use of water that 
contains a radionuclide to manufacture a food. For example, in certain 
locations in the United States, high concentrations of radium-226, 
radium-228 and uranium have been detected in private wells (Ref. 107) 
(Ref. 108). Radiological hazards also may result from accidental 
contamination, e.g., contamination arising from accidental release from 
a nuclear facility or from damage to a nuclear facility from a natural 
disaster. In 2011, following the damage to a nuclear power plant during 
an earthquake and tsunami in Japan, radioactivity was subsequently 
detected in foods, particularly milk, vegetables, and seafood produced 
in areas neighboring the plant (Ref. 109).
    Consuming food contaminated with radioactive material will increase 
the amount of radioactivity a person is exposed to, which could have 
adverse health effects. The health effect depends upon the radionuclide 
and the amount a person is exposed to. For instance, exposure to 
certain levels of radioactive iodine is associated with increased risk 
of thyroid cancer (Ref. 109).
    f. Summary. As discussed above, food safety problems associated 
with microbiological, chemical, physical, and radiological hazards 
continue to cause illnesses and deaths and result in significant 
recalls. In its reviews of CGMP-related food recalls, FDA summarized 
key factors that contributed to the food safety problems that initiated 
the recalls. For recalls during 1999-2003, FDA concluded that the 
contributing factors (there could be more than one for a single recall) 
included incorrect packaging/labeling (68 percent), ineffective 
employee training (32 percent), failure to follow processing standard 
operation procedures (26 percent), excess/mistaken addition of 
chemicals/ingredients (9 percent), contamination of raw materials (8 
percent), ineffective use of sanitation principles (8 percent), and 
unknown (4 percent). For recalls during 2008-2009, FDA used a slightly 
different methodology to categorize the contributing factors; the 
contributing factors included lack of label controls (57 percent), lack 
of supplier controls (37 percent), deficiencies in employee training 
(24 percent), lack of sanitation controls (17 percent), poor processing 
controls (13 percent), lack of environmental monitoring (9 percent), 
and unknown (1 percent). The findings from the two recall analyses 
demonstrate that over the past decade, similar types of food safety 
problems caused by similar types of contributing factors continue to 
challenge the food industry (Ref. 58) (Ref. 59).
3. Preventing Food Safety Problems
    As discussed in section II.C of this document, HACCP is a 
preventive food safety strategy that is a systematic approach to the 
identification and assessment of the risk of hazards from a particular 
food or food production process or practice and the control of those 
hazards that are reasonably likely to occur. The HACCP system aims to 
identify the points in the manufacturing process at which hazards might 
occur and to continuously monitor and control those points in an 
attempt to ensure that products meet pre-specified performance criteria 
(Ref. 34). The HACCP system is universally endorsed by international 
bodies such as Codex, the Food and Agriculture Organization, and the 
World Health Organization. During the last few years, HACCP systems 
have been mandated by U.S. Federal regulations established by FDA for 
seafood and juice, and established by FSIS for meat and poultry. (In 
the remainder of this document, we use the term ``Federal HACCP 
regulations'' to refer to these HACCP regulations for seafood, juice, 
and meat and poultry.) Codex has issued guidelines for HACCP systems 
(Ref. 35), and several industrialized nations or unions have mandated 
HACCP for part or all of their food industries (Ref. 38) (Ref. 39) 
(Ref. 40).
    As discussed in sections II.C.1 through II.C.4 of this document, 
HACCP is a preventive system made up of interdependent activities 
including hazard analysis, preventive controls, monitoring, corrective 
actions, verification, and record keeping associated with these 
activities. These activities work together to prevent food safety 
problems; the individual activities, by themselves, are not as 
effective as the combination of these activities in the complete HACCP 
system. For example, a facility may determine that certain pathogens 
are reasonably likely to occur in a food product and establish and 
implement a heat treatment, for a specified combination of time and 
temperature, as a control to prevent the pathogens from contaminating 
finished food products. Unless the facility monitors the temperature 
and time during the heat treatment, the facility will not be able to 
determine whether its preventive control was, in fact, implemented. 
Moreover, the monitoring, by itself, would provide less value if the 
temperature was not documented during the monitoring and the 
documentation was not reviewed so that the facility can verify that the 
proper temperature was achieved for sufficient time. If the proper 
temperature or time is not achieved, corrective actions would be 
necessary to ensure that the food is reprocessed, diverted to a use 
that does not raise a food safety concern, or disposed. For the heat 
treatment to be effective, the level of any pathogens contaminating 
ingredients or other raw materials used to make the food must not 
exceed the level of pathogens that the heat treatment is validated to 
eliminate.
    As discussed in section III of this document, FDA tentatively 
concludes that a modern food safety system based on HACCP principles 
can address the food safety problems discussed in sections II.D.1 
through II.D.2 of this document.

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

    The safety of food is principally ensured by the effective 
implementation of scientifically valid preventive control measures 
throughout the food chain (Ref. 34) (Ref. 110). Prevention of hazards 
in food is much more effective than trying to differentiate safe from 
unsafe food using testing. Although testing is rarely considered a 
control measure, it plays a very important role in ensuring the safety 
of food. An important purpose of testing is to verify that control 
measures, including those related to suppliers and those verified 
through environmental monitoring, are controlling the hazard (Ref. 111) 
(Ref. 112). Testing is used in conjunction with other verification 
measures in the food safety system, such as audits of suppliers, 
observations of whether activities are being conducted according to the 
food safety plan, and reviewing records to determine whether process 
controls are meeting specified limits for parameters established in the 
food safety plan. As discussed in the Appendix to this document (see 
sections I.C, I.E, and I.F of the Appendix), microbial testing may 
include:
     Testing raw materials and ingredients to verify that 
suppliers have significantly minimized or prevented hazards reasonably 
likely to occur in the raw materials and ingredients;

[[Page 3668]]

     Testing the environment to verify that sanitation controls 
have significantly minimized or prevented the potential for 
environmental pathogens to contaminate RTE food; and
     Testing finished product to verify that preventive 
controls have significantly minimized or prevented hazards reasonably 
likely to occur in the food.
    Each type of testing provides information applicable to managing 
hazards in foods, depending on the food and process. We discuss the 
role of testing as a verification measure in a food safety system in 
section I of the Appendix to this document.

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

    The development of a supplier approval and verification program can 
be part of a preventive approach. Because many facilities acting as 
suppliers procure their raw materials and ingredients from other 
suppliers, there is often a chain of suppliers before a raw material or 
other ingredient reaches the manufacturer/processor. Using a preventive 
approach, a facility receiving raw materials or ingredients from a 
supplier can help ensure that the supplier (or a supplier to the 
supplier) has implemented preventive controls to significantly minimize 
or prevent hazards that the receiving facility has identified as 
reasonably likely to occur in that raw material or other ingredient 
unless the receiving facility will itself control the identified 
hazard.
    A supplier approval and verification program is a means of ensuring 
that raw materials and ingredients are procured from those suppliers 
that can meet company specifications and have appropriate programs in 
place, including those related to the safety of the raw materials and 
ingredients. A supplier approval program can ensure a methodical 
approach to identifying such suppliers. A supplier verification program 
can help provide initial and ongoing assurance that suppliers are 
complying with practices to achieve adequate control of hazards in raw 
materials or ingredients. We discuss supplier approval and verification 
programs in more detail in section II of the Appendix to this document.

III. Legal Authority

    FDA is proposing changes to the Current Good Manufacturing 
Regulation under the FD&C Act and the Public Health Service Act. FDA is 
proposing changes to 21 CFR Part 1, Subparts H, I, and J under the FDA 
Food Safety Modernization Act and the FD&C Act. FDA is proposing all 
other new requirements under the FDA Food Safety Modernization Act, the 
FD&C Act and the Public Health Service Act.

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

    Section 103(c)(1)(A) of FSMA requires that 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 (Registration 
of Food Facilities) 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.'' In section VIII.E of this document, we discuss our 
proposal to revise the section 415 registration regulations (21 CFR 
subpart H) to clarify the types of activities that are included as part 
of the definition of the term ``facility'' under section 415 of the 
FD&C Act and the scope of the exemption for ``farms'' provided by 
section 415 of the FD&C Act. The proposed rule also would make 
corresponding changes in part 1, subpart I (Prior Notice of Imported 
Food) and in part 1, subpart J (Establishment, Maintenance, and 
Availability of Records). FDA's legal authority to modify these 
regulations is derived from section 103(c) of FSMA and 21 U.S.C. 414, 
415, 381(m) and 371(a).

B. Changes to Current 21 CFR Part 110

    FDA's legal authority to require Current Good Manufacturing 
Practices derives from sections 402(a)(3), (a)(4) and 701(a) of the 
FD&C Act (21 U.S.C. 342(a)(3), 342(a)(4), and 371(a)). Section 
402(a)(3) of the FD&C Act provides that a food is adulterated if it 
consists in whole or in part of any filthy, putrid, or decomposed 
substance, or if it is otherwise unfit for food. Section 402(a)(4) of 
the FD&C Act provides that a 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. Under section 701(a) of the FD&C Act, FDA 
is authorized to issue regulations for the efficient enforcement of the 
FD&C Act. The changes to the current CGMP regulation proposed in this 
document clarify the existing requirements of the regulation and update 
existing requirements to reflect changes in the food industry and in 
scientific understanding of food safety since issuance of the current 
regulation. In addition to the FD&C Act, FDA's legal authority for the 
proposed changes to current CGMP requirements derives from the PHS Act 
to the extent such measures are related to communicable disease. 
Authority under the PHS Act for the proposed regulations is derived 
from the provisions of sections 311, 361, and 368 (42 U.S.C. 243, 264, 
and 271) that relate to communicable disease. The PHS Act authorizes 
the Secretary to make and enforce such regulations as ``are necessary 
to prevent the introduction, transmission, or spread of communicable 
diseases from foreign countries into the States * * * or from one State 
* * * into any other State'' (section 361(a) of the PHS Act). (See sec. 
1, Reorg. Plan No. 3 of 1966 at 42 U.S.C. 202 for transfer of authority 
from the Surgeon General to the Secretary.)

C. Hazard Analysis and Risk-Based Preventive Controls

    Section 103 of FSMA, Hazard Analysis and Risk-Based Preventive 
Controls, amends the FD&C Act to create a new section 418, which 
mandates rulemaking. Section 418(n)(1)(A) of the FD&C Act requires that 
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 * * *.'' 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. 
Further, 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 addition to rulemaking requirements, section 418 contains 
requirements applicable to the owner, operator, or agent in charge of a 
facility required to register under section 415. 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

[[Page 3669]]

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 the general requirements in 
section 418(a) of the FD&C Act, sections 418(b)-(i) contain more 
specific requirements applicable to facilities. These include hazard 
analysis (Sec.  418(b)), preventive controls (Sec.  418(c)), monitoring 
(Sec.  418(d)), corrective actions (Sec.  418(e)), verification (Sec.  
418(f)), recordkeeping (Sec.  418(g)), a written plan and documentation 
(Sec.  418(h)), and reanalysis of hazards (Sec.  418(i)). In sections 
XII and XV of this document, we discuss proposed requirements (proposed 
subparts C and F) that would implement these provisions of section 418 
of the FD&C Act.
    Sections 418(j)-(m) of the FD&C Act and sections 103(c)(1)(D) and 
(g) of FSMA provide authority for certain exemptions and modifications 
to the requirements of section 418 of the FD&C Act. These include 
provisions related to seafood and juice HACCP, and low-acid canned food 
(Sec.  418(j)); activities of facilities subject to section 419 of the 
FD&C Act (Standards for Produce Safety) (Sec.  418(k)); qualified 
facilities (Sec.  418(l)); facilities that are solely engaged in the 
production of food for animals other than man, the storage of raw 
agricultural commodities (other than fruits and vegetables) intended 
for further distribution or processing, or the storage of packaged 
foods that are not exposed to the environment (Sec.  418(m)); 
facilities engaged only in certain low-risk on-farm activities on 
certain foods conducted by small or very small businesses (Sec.  
103(c)(1)(D) of FSMA), and dietary supplements (Sec.  103(g) of FSMA). 
In sections X.C, XIII, and XIV of this document, we discuss proposed 
provisions (proposed Sec.  117.5(a)-(j), and proposed subparts D and E) 
that would implement these provisions of section 418 of the FD&C Act 
and section 103 of FSMA.
    FDA tentatively concludes that the provisions in subpart C and 
related requirements in subparts A, D, and F should be applicable to 
activities that are intrastate in character. Facilities are required to 
register under section 415 of the FD&C Act regardless of whether the 
food from the facility enters interstate commerce (Sec.  1.225(b)). The 
plain language of Section 418 of the FD&C Act applies to facilities 
that are required to register under section 415 (Sec.  418(o)(2) of the 
FD&C Act) and does not exclude a facility because food from such a 
facility is not in interstate commerce. Section 301(uu) of the FD&C Act 
provides that ``the operation of a facility that manufactures, 
processes, packs, or holds food for sale in the United States if the 
owner, operator, or agent in charge of such facility is not in 
compliance with section 418'', or the causing thereof, is a prohibited 
act.
    FDA also is proposing the provisions in subpart C and related 
requirements in Subparts A, D, and F, under sections 402(a)(3), 
402(a)(4), 403(w), and 701(a) of the FD&C Act to the extent such 
requirements are necessary to prevent food from being held under 
insanitary conditions whereby it may become contaminated with filth or 
rendered injurious to health, or being unfit for food; and to the 
extent necessary to prevent food from being misbranded under section 
403(w). FDA is also proposing those provisions under sections 311, 361, 
and 368 of the PHS Act relating to communicable disease to the extent 
those provisions are necessary to prevent the interstate spread of 
communicable disease. FDA tentatively concludes that a modern food 
safety system based on HACCP principles can address the food safety 
problems discussed in section II.D of this document. The food safety 
system that we are proposing would require a facility to conduct a 
hazard analysis to determine those hazards that are reasonably likely 
to occur and establish and implement preventive controls for those 
hazards. To ensure that controls are properly implemented and 
effectively controlling the hazards, the proposed food safety system 
would establish requirements for monitoring, corrective actions, and 
verification, including validation that the preventive controls are 
adequate to control the identified hazards. Certain activities would be 
required to be conducted (or overseen) by a qualified individual and 
certain activities would be required to be documented. A written food 
safety plan would include the hazard analysis, the preventive controls 
that would be established and implemented to address those hazards 
determined to be reasonably likely to occur, procedures for monitoring, 
corrective actions, and verification, and a recall plan. The written 
plan and other documentation would be required to be made promptly 
available to FDA upon oral or written request.
    FDA tentatively concludes that, taken as a whole, the food safety 
system described here is necessary to help prevent food safety problems 
associated with microbiological, chemical, physical, and radiological 
hazards in foods. Therefore, the proposed system is necessary to 
prevent food from being adulterated because it is unfit for food or 
because it has been held under insanitary conditions whereby it may 
become contaminated with filth or may be rendered injurious to health; 
to prevent food from becoming misbranded under section 403(w) of the 
FD&C Act; and to prevent the spread of communicable disease.

IV. Public Meeting and Preliminary Stakeholder Comments

A. Introduction

    On April 20, 2011, FDA held a public meeting entitled ``FDA Food 
Safety Modernization Act: Focus on Preventive Controls for Facilities'' 
(Federal Register of April 13, 2011, 71 FR 20588). The purpose of the 
public meeting was to provide interested persons with an opportunity to 
discuss implementation of the provisions in section 418 of the FD&C 
Act. Although the meeting included introductory presentations by FDA, 
the primary purpose of the meeting was to listen to our stakeholders. 
In order to meet that goal, FDA provided multiple opportunities for 
individuals to express their views, including by providing 
opportunities for individuals to make presentations at the meeting 
during an open public and webcast comment session, whereby participants 
could make presentations in person or via webcast, and during another 
listening session that was held at the end of the day. Various 
stakeholders made presentations during these public sessions, including 
presentations made by representatives from consumer groups, industry 
trade associations, food companies, and state agencies. The major 
topics discussed in these comments included food allergens and the 
importance of allergen controls, verification and the importance of 
testing, submission of food safety plans to FDA, education and training 
on preventive controls, the need for flexibility in the regulations, 
modified requirements for certain packaged food items not exposed to 
the environment, on-farm manufacturing, processing, packing and holding 
activities, and states partnering with FDA to conduct inspections.
    Stakeholders were given additional opportunities to express their 
views during break-out sessions focused on specific topics. Topics for 
the break-out sessions included preventive controls guidance, on-farm 
manufacturing and small business, preventive controls and the 
relationship to CGMPs, product testing and environmental monitoring, 
and training and technical assistance. A transcript of FDA's remarks at 
the opening session, the open public and

[[Page 3670]]

webcast comment session, and the listening session is available on 
FDA's Web site (Ref. 113). In addition, webcast videos were prepared 
for the public meeting and subsequently provided on FDA's Web site, 
including webcast videos of the opening session, open public comment 
session, listening session, and several breakout sessions (Ref. 114).
    The notice announcing the public meeting also requested written 
comments. In response to this request, FDA received 30 written comment 
letters. The major issues presented in the written comment letters 
included the following: allergen control, accredited laboratories, 
environmental monitoring and product testing, flexibility of 
regulations and guidance, food defense, guidance and outreach, 
preventive controls, small businesses and exempted facilities, 
submission of the food safety plans to FDA, and modified requirements 
for warehouses. In the remainder of this section, we summarize each of 
the major issues raised in the written comments and identify the key 
proposed provisions applicable to the comments.

B. Comments on Allergen Control

    Comments state that FDA should address the evaluation of allergens 
as a food hazard and the need for preventive controls for allergens in 
its implementation of section 418 of the FD&C Act. One comment notes 
that an effective allergen control plan is critical to protecting the 
health and confidence of consumers. Comments recommend that any 
required allergen control programs be limited to ``major food 
allergens,'' as defined in the FD&C Act.
    We propose a definition of ``food allergen'' (proposed Sec.  117.3) 
in section X.B.4 of this document and discuss proposed requirements for 
preventive controls directed to food allergens (proposed Sec.  
117.135(d)(2)) in section XII.C.6 of this document.

C. Comments on Accredited Laboratories

    Several comments urge FDA to require use of accredited laboratories 
only when there is a known or suspected food safety problem and not in 
the routine course of business (testing raw/ingredient, in-process, or 
finished product). Some comments state it would be inconsistent with 
its statutory authority for FDA to require use of accredited 
laboratories beyond limited ``for cause'' circumstances, e.g., testing 
for ``identified or suspected food safety problems'' or imports.
    Section 202 of FSMA creates a new section 422 in the FD&C Act 
addressing laboratory accreditation for the analyses of foods, 
including use of accredited laboratories in certain circumstances. This 
document does not propose additional requirements for the use of 
accredited laboratories and does not include a discussion of section 
422 of the FD&C Act.

D. Comments on Environmental Monitoring and Product Testing

    Many comments assert that the role and need for product testing and 
environmental monitoring varies depending on the type of products and 
processing operation and that it should be the facility's 
responsibility to determine the testing needed to verify that its 
preventive controls are effective. Others state that environmental and 
product testing may be appropriate in certain instances as verification 
activities, but they do not constitute a control step. A number of 
comments assert that finished product testing is extremely costly and 
cannot establish safety. As such, they recommend that industry and FDA 
should focus on ensuring that preventive measures are properly 
designated and effective instead of relying on finished product 
testing. One comment mentions that effective testing programs use 
aggressive and robust environmental testing and recognize the limited 
value of finished product testing. A few comments point out that 
finished product testing is particularly important for RTE products, 
and others suggest that environmental monitoring should be required 
only in the part of the facility that handles exposed RTE product. Some 
comments maintain that FDA should require verification testing when any 
food has an identified hazard for which a facility has implemented a 
preventive control, and others state that high-risk plants should be 
required to do microbial sampling to a standard and frequency set by 
FDA. A few comments encourage FDA to require plants to conduct both 
environmental sampling and testing of finished products to provide 
assurances that product coming off the end of the line has been 
produced in accordance with the plant's preventive control plan.
    Section I in the Appendix to this document discusses a number of 
issues associated with environmental monitoring and product testing. 
Although we are not including provisions for environmental monitoring 
or product testing in this proposed rule, in section XII.J of this 
document, we request comment on these issues.

E. Comments on Flexibility of Regulations and Guidance

    The majority of comments addressing this topic state that 
regulations and guidance should be science and risk-based, non-
prescriptive, and flexible because of the wide variety of facilities 
that will be subject to the regulations. One notes that regulations 
should not require companies to hire outside consultants either 
explicitly or in practical terms because of their complexity.
    As discussed in section XVI.A of this document, section 418(n)(3) 
of the FD&C Act requires that the content of the regulations 
promulgated under Sec.  418(n)(1) of the FD&C Act provide sufficient 
flexibility to be practicable for all sizes and types of facilities; 
comply with chapter 35 of title 44, United States code (commonly known 
as the ``Paperwork Reduction Act''); acknowledge differences in risk 
and minimize, as appropriate, the number of separate standards that 
apply to separate foods; and not require a facility to hire a 
consultant or other third party to identify, implement, certify, or 
audit preventative controls. Section XVI.A of this document also 
addresses how this proposed rule complies with the requirements in 
section 418(n)(3) of the FD&C Act.

F. Comments on Food Defense

    Numerous comments reiterate the need for food defense to be treated 
distinctly from food safety, because they address separate issues and 
often involve different types of expertise within companies. They 
recommend that FDA allow manufacturers to develop and maintain two 
distinct sets of documents on these separate issues. One comment 
suggests that FDA consider implementing the food and feed defense-
related provisions of FSMA through guidance, rather than regulation.
    FDA discusses its tentative decision not to address ``hazards that 
may be intentionally introduced, including by acts of terrorism'' in 
section II.B.2.f of this document. As stated there, FDA plans to 
implement section 103 regarding such hazards in a separate rulemaking 
in the future.

G. Comments on Guidance and Outreach

    Comments urge FDA to focus on education and outreach for farms, 
facilities, distributors, inspectors, and state departments of 
agriculture. They support guidance that would include information on 
conducting valid hazard analyses and risk assessments,

[[Page 3671]]

implementing preventive controls, and what constitutes a valid food 
safety plan. They also support guidance that would provide access to 
background resources, such as scientific studies, risk analyses and 
risk-based modeling. They state that guidance should include examples 
of food safety plans, both acceptable and unacceptable ones. One 
comment envisions several different types of guidance: how to identify 
hazards and how to distinguish preventive controls associated with 
HACCP plans from those falling outside HACCP plans; preventive controls 
that should be considered for certain categories of food (e.g., high 
risk food); and what constitutes a hazard and how you determine its 
likely occurrence.
    Section 103(b) of FSMA requires FDA to issue a guidance document 
related to the ``regulations promulgated under subsection (b)(1) with 
respect to the hazard analysis and preventive controls under section 
418'' of the FD&C Act. In addition, section 103(d) of FSMA requires, 
within 180 days after the issuance of the regulations, that FDA issue a 
small entity compliance policy guide setting forth in plain language 
the requirements of the regulations established under section 418(n) of 
the FD&C Act and section 103 of FSMA to assist small entities in 
complying with the hazard analysis and other activities required under 
section 418 of the FD&C Act and section 103 of FSMA. On May 23, 2011, 
FDA published a Federal Register notice announcing the opening of a 
docket [Docket No. FDA-2011-N-0238] to obtain information about 
preventive controls and other practices used by facilities to identify 
and address hazards associated with specific types of food and specific 
processes (76 FR 29767). FDA established this docket to provide an 
opportunity for interested parties to provide information and share 
views that will inform the development of guidance on preventive 
controls for food facilities that manufacture, process, pack, or hold 
human food. FDA anticipates issuing these required guidance documents 
in a timely manner in coordination with issuing the final regulations 
to assist our stakeholders in complying with the regulations.
    FDA did not conduct HACCP training for persons subject to our HACCP 
regulations for seafood or juice. However, when implementing those 
regulations, FDA worked with an alliance of representatives from 
Federal and State agencies, industry and academia, to create a uniform, 
core training program that serves as the standardized curriculum 
against which other course materials can be judged. FDA will be working 
with an alliance to develop such a standardized curriculum for any 
final rule establishing requirements for hazard analysis and risk-based 
preventive controls.

H. Comments on Preventive Controls

    A number of comments point out that not all preventive controls 
need to be constructed as critical control points. Some urge FDA to 
work with each industry segment to develop a set of general preventive 
controls for that segment or to use existing preventive controls 
programs that may already exist for a segment of industry; those 
general preventive controls would be tailored to each situation, plant 
design, and product. One comment asserts that preventive controls must 
consider incoming water as a key risk and states that the risk 
assessment must be informed by current standards and methodologies and 
take into account resistance to traditional disinfectants.
    FDA is proposing requirements for preventive controls in proposed 
Sec.  117.135 (discussed in section XII.C of this document).

I. Comments on Small and Very Small Businesses

    Several comments urge FDA to define a very small business. Many 
recommend that these businesses should be significantly smaller than 
those that gross $500,000 a year. One comment proposes that FDA define 
very small business as having fewer than 20 employees, stating that the 
Small Business Administration has done so. Another suggests that ``very 
small'' business be defined by the volume of product that they put into 
commerce. For facilities that satisfy criteria for the ``qualified 
facility'' exemption and therefore have the option of submitting 
documentation related to preventive controls or compliance with State, 
local, county, or other applicable non-Federal food safety law, several 
comments urge FDA to require that such facilities submit documentation 
of one option or the other. One comment disagrees that small processors 
should be exempt, since small processors frequently pose a risk to the 
public precisely because of their lack of sophistication and 
availability of trained technical staff.
    We discuss our proposed definitions for small and very small 
businesses (proposed Sec.  117.3) in section X.B.4 of this document. We 
discuss our proposed definition for ``qualified facility'' (proposed 
Sec.  117.3) in section X.B.4 of this document; our proposed exemption 
from subpart C for a ``qualified facility'' (proposed Sec.  117.5(a)) 
in section X.C.1 of this document; proposed modified requirements for a 
``qualified facility'' (proposed Sec.  117.201) in section XIII.A of 
this document; and a proposed process that would govern withdrawal of 
an exemption from subpart C for a ``qualified facility'' (proposed 
Subpart E) in section XIV of this document.

J. Comments on Submission of Food Safety Plan to FDA

    Most comments agree that FDA should not require electronic 
submission of food safety plans, pointing out that not only would it be 
impractical, but also that food safety plans are most appropriately 
reviewed by FDA during on-site facility inspections, with the support 
of people familiar with the system who can answer questions and show an 
inspector relevant equipment, operations, and procedures. They note 
that plans are of limited utility outside of the plant context. 
However, a few comments state that FDA should request all initial food 
safety plans, as this would give us an idea of any misunderstandings of 
the preventive control requirements. These comments also note that 
submission of plans could help FDA quickly determine if high-risk 
facilities are developing effective plans and might help FDA prioritize 
inspections.
    FDA is not proposing to require submission of food safety plans. We 
discuss this topic and request comment on alternate approaches in 
section XII.K of this document.

K. Comments on Modified Requirements for Warehouses

    All comments submitted on the issue of warehouses urge FDA to 
modify the preventive controls requirements for facilities, such as 
warehouses, that are solely engaged in the storage of packaged foods 
that are not exposed to the environment, since no manufacturing or 
processing takes place at such food warehouses and the product is not 
exposed to the environment. Most state that the facility should have 
procedures in place addressing general controls, such as sanitation, 
pest control, storage, segregation, security, and recordkeeping.
    FDA is proposing modified requirements for warehouses solely 
engaged in the storage of packaged food that is not exposed to the 
environment in proposed Sec.  117.7 (discussed in section X.D of this 
document) and proposed Sec.  117.206 (discussed in section XIII.B of 
this document).

[[Page 3672]]

V. Placement of Regulatory Requirements

    We are proposing to establish the revised umbrella CGMP 
requirements, together with the new requirements for hazard analysis 
and risk-based preventive controls, in proposed part 117. As discussed 
in section XVII of this document, we are proposing to remove current 
part 110 after the compliance date for all businesses to be in 
compliance with the requirements of new part 117.

VI. Highlights of the Proposed Rule

A. Overview

    The proposed rule would revise FDA's current regulations in part 
110 regarding the manufacturing, processing, packing, or holding of 
human food in two fundamental ways. First, it would add new provisions 
to implement section 103 of FSMA. Second, it would update, revise, or 
otherwise clarify certain requirements of our current regulations in 
part 110. The new provisions and revisions to the current CGMP 
requirements would be established in part 117. Under the proposed rule, 
new part 117 would be divided into the following subparts:
     Subpart A--General Provisions;
     Subpart B--Current Good Manufacturing Practice;
     Subpart C--Hazard Analysis and Risk-Based Preventive 
Controls;
     Subpart D--Modified Requirements;
     Subpart E--Withdrawal of an Exemption Applicable to a 
Qualified Facility; and
     Subpart F--Requirements Applying to Records That Must Be 
Established and Maintained.
     Subpart G would be reserved.
    In the remainder of this section, we highlight key provisions of 
the proposed rule.

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

    To implement section 103(c) of FSMA, the proposed rule would revise 
certain definitions in FDA's current section 415 registration 
regulations. These revisions would clarify the types of activities that 
are included as part of the definition of the term ``facility'' under 
section 415 of the FD&C Act and the scope of the exemption for 
``farms'' provided by section 415 of the FD&C Act. The proposed rule 
also would make corresponding changes in part 1, subpart I (Prior 
Notice of Imported Food) and in part 1, subpart J (Establishment, 
Maintenance, and Availability of Records).

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

    The proposed rule would both revise current provisions of subpart A 
of part 110 and add new provisions to subpart A as it would be 
established in proposed part 117. The new provisions would include 
specified exemptions for certain facilities, or for certain activities 
conducted by facilities, from the proposed requirements for hazard 
analysis and preventive controls in proposed part 117, subpart C. The 
proposed exemptions would be consistent with requirements established 
by FSMA or discretion provided by FSMA. The subjects of the specified 
exemptions relate to:
     A ``qualified'' facility;
     Activities subject to our existing HACCP regulations for 
seafood and juice, our regulations governing microbiological hazards in 
low acid canned foods, and our dietary supplement CGMP regulations;
     Activities of a facility that are subject to the Standards 
for Produce Safety in section 419 of the FD&C Act;
     Certain low-risk packing or holding activity/food 
combinations conducted on a farm by a small or very small business;
     Certain low-risk manufacturing/processing activity/food 
combinations conducted on a farm by a small or very small business;
     The receipt, manufacturing, processing, packing, holding, 
and distribution of alcoholic beverages and other prepackaged food sold 
in conjunction with alcoholic beverages (e.g., gift baskets);
     Facilities that are solely engaged in the storage of RACs 
(other than fruits and vegetables) intended for further distribution or 
processing; and
     Facilities solely engaged in the storage of packaged food 
that is not exposed to the environment, although the storage of such 
food that requires time/temperature control to prevent the growth of, 
or toxin formation by, pathogenic microorganisms would be subject to 
modified requirements that would be established in proposed subpart D.

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

    In order to modernize current CGMP requirements, the proposed rule 
would make revisions including:
     Modernizing and updating the language throughout (e.g., by 
replacing the word ``shall'' with the word ``must'' and by using 
certain terms consistently throughout proposed part 117);
     Deleting certain provisions containing recommendations, 
including the specific temperatures for maintaining refrigerated, 
frozen or hot foods;
     Clarifying that certain CGMP provisions requiring 
protection against contamination require protection against cross-
contact of food as well to address allergens; and
     Proposing that provisions directed to preventing 
contamination of food and food-contact substances be directed to 
preventing contamination of food-packaging materials as well.

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

1. Written Food Safety Plan
    We propose to require that the owner, operator, or agent in charge 
of a facility have and implement a written food safety plan that 
includes as applicable:
     A hazard analysis;
     Preventive controls;
     Monitoring procedures;
     Corrective action procedures;
     Verification procedures; and
     A recall plan.
2. Written Hazard Analysis
    We propose to require that the written hazard analysis identify and 
evaluate known or reasonably foreseeable hazards for each type of food 
manufactured, processed, packed, or held at the facility to determine 
whether there are hazards that are reasonably likely to occur, 
including biological, chemical, physical, and radiological hazards. The 
hazard analysis would include an evaluation of the identified hazards 
to determine whether the hazards are reasonably likely to occur, 
including an assessment of the severity of the illness or injury if the 
hazard were to occur.
3. Written Preventive Controls
    We propose to require that the owner, operator, or agent in charge 
of a facility identify and implement preventive controls (including at 
critical control points, if any) to provide assurances that hazards 
that are reasonably likely to occur will be significantly minimized or 
prevented and that the food manufactured, processed, packed or held by 
such facility will not be adulterated under section 402 of the FD&C Act 
or misbranded under section 403(w) of the FD&C Act. The preventive 
controls would include, as appropriate:
     Parameters associated with the control of the hazard and 
the maximum or minimum value, or combination of

[[Page 3673]]

values, to which any biological, chemical, physical, or radiological 
parameter must be controlled to significantly minimize or prevent a 
hazard that is reasonably likely to occur;
     Process controls;
     Food allergen controls;
     Sanitation controls;
     A recall plan; and
     Any other necessary controls.
4. Written Recall Plan
    We propose to require that the written recall plan be developed for 
food with hazards that are reasonably likely to occur.
5. Monitoring
    We propose to require the monitoring of the preventive controls to 
provide assurance that they are consistently performed, including 
requirements to establish and implement written monitoring procedures 
and establish and maintain records documenting the implementation of 
the monitoring procedures.
6. Corrective Actions
    We propose to require that facilities establish and implement 
written corrective action procedures that would be used if preventive 
controls are not properly implemented and take corrective actions in 
the event of an unanticipated problem.
7. Verification
    We propose to require that facilities conduct certain verification 
activities, including:
     Validation of a subset of the preventive controls;
     Verification that monitoring is being conducted;
     Verification that appropriate decisions about corrective 
actions are being made; and
     Verification that the preventive controls are consistently 
implemented and are effectively and significantly minimizing or 
preventing the hazards that are reasonably likely to occur.
    We also propose to require reanalysis of the food safety plan at 
least once every 3 years and more often when circumstances warrant.
8. Qualified Individual
    We propose to establish qualification requirements for a 
``qualified individual,'' who would be required to do or oversee the 
preparation of the food safety plan, validation of preventive controls, 
review of records for implementation and effectiveness of preventive 
controls and the appropriateness of corrective actions, and reanalysis 
of a food safety plan. A ``qualified individual'' 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. Job experience may qualify an individual to perform 
these functions if such experience has provided an individual with 
knowledge at least equivalent to that provided through the standardized 
curriculum.
9. List of Required Records
    We propose to establish a list of records that would be required 
under proposed subpart C, including the written food safety plan and 
records documenting monitoring of preventive controls, corrective 
actions, verification, and applicable training for the qualified 
individual.

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

    Proposed subpart D would implement certain provisions in sections 
418(l) and (m) of the FD&C Act for modified requirements with respect 
to:
     Qualified facilities: Implementing the modified 
requirements specified in section 418(l) of the FD&C Act for facilities 
that satisfy the statutory criteria for a ``qualified facility,'' we 
propose to establish requirements that include:
     Submission to FDA of documentation that the facility is a 
qualified facility; and
     Submission to FDA of documentation demonstrating that the 
owner, operator, or agent in charge of the facility has identified the 
potential hazards associated with the food being produced, is 
implementing preventive controls to address the hazards, and is 
monitoring the performance of the preventive controls to ensure that 
such controls are effective; or
     Submission to FDA of documentation that the facility is in 
compliance with State, local, county, or other applicable non-Federal 
food safety law, including relevant laws and regulations of foreign 
countries.
     Facilities solely engaged in the storage of packaged food 
that is not exposed to the environment: Acting on the discretion 
provided to FDA by section 418(m) of the FD&C Act, we propose to 
require that the owner, operator, or agent in charge of a facility 
solely engaged in the storage of packaged food that is not exposed to 
the environment conduct certain activities for any such refrigerated 
packaged food that requires time/temperature control to significantly 
minimize or prevent the growth of, or toxin production by, 
microorganisms of public health significance, including:
     Establishing and implementing temperature controls;
     Monitoring the temperature controls;
     Taking appropriate corrective actions when there is a 
problem with temperature controls;
     Verifying that temperature controls are consistently 
implemented; and
     Establishing and maintaining the following records:
     Records documenting the monitoring of temperature 
controls;
     Records of corrective actions; and
     Records documenting verification activities.
    We seek comment on these proposed requirements.

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

    Proposed subpart E would implement the provisions of section 
418(l)(3) of the FD&C Act and 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.

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

    Proposed subpart F would establish requirements that would apply to 
all records that would be required by the various proposed provisions 
of proposed part 117, including:
     General requirements related to the content and form of 
records;
     Additional requirements specific to the food safety plan;
     Requirements for record retention;
     Requirements for official review of records by FDA; and
     Public disclosure.

VII. Compliance Dates

    Section 103(i)(1) of FSMA, General Rule, provides that ``[t]he 
amendments made by this section shall take effect 18 months after the 
date of enactment'' (i.e., by July 4, 2012). Section 103(i)(2) of FSMA, 
Flexibility for Small Businesses, provides that ``[n]otwithstanding 
paragraph (1),'' the amendments made by this section ``shall apply'' to 
a small business and very small business beginning on the dates that 
are 6 months and 18 months, respectively, ``after the effective date'' 
of FDA's final regulation.
    FDA is implementing the amendments made by section 103 to the FD&C 
Act through this rulemaking

[[Page 3674]]

(except as relates to animal food and intentional contamination). FDA 
tentatively concludes that it is appropriate to provide a sufficient 
time period following publication of the final regulation for 
facilities to come into compliance. The final regulation will contain 
provisions that affect which facilities are subject to section 418 and 
which provisions apply to particular facilities. Without these 
provisions of the regulation in effect, facilities would be uncertain 
as to the applicability of certain requirements to them. Further, FDA 
tentatively concludes that compliance with section 418 will be 
facilitated greatly by the detail and explanation that will be provided 
by the final regulation.
    The current practices of many businesses are sufficient to satisfy 
some of the proposed requirements. However, the majority of businesses 
will need to make at least some changes if the proposed regulations are 
adopted. FDA recognizes that it can take time to implement a food 
safety system that would require, among other things, performance of a 
hazard analysis, development of preventive controls, and monitoring of 
preventive controls.
    FDA is proposing that the final rule would be effective 60 days 
after publication in the Federal Register, with staggered compliance 
dates. However, we recognize that businesses of all sizes may need more 
time to comply with the new requirements established under FSMA. FDA 
believes that it is reasonable to allow for 1 year after the date of 
publication of the final rule for businesses other than small and very 
small businesses to come into compliance with the new requirements 
established under FSMA. FDA also believes that it is reasonable to 
allow for 2 years after the date of publication of the final rule for 
small businesses to come into compliance with the new requirements 
established under FSMA, and 3 years after the date of publication of 
the final rule for very small businesses to come into compliance with 
the new requirements established under FSMA. FDA intends to work 
closely with the food industry, extension and education organizations, 
and state partners to develop the tools and training programs needed to 
facilitate implementation of this rule.
    FDA also is proposing to modernize the existing CGMP requirements, 
and businesses already subject to current part 110 will be subject to 
the modernized CGMPs that would be established in proposed part 117. 
FDA believes that it is reasonable to allow for the same compliance 
periods for the modernized CGMPs as for the other provisions in 
proposed part 117 so that a facility would be subject to all of the 
relevant provisions in proposed part 117 at the same time. To provide 
for this staggered implementation of the modernized CGMPs, FDA is 
proposing to establish the revised regulations in a new part (i.e., 
part 117) so that current part 110 can remain unchanged and in effect 
for compliance purposes until all businesses have reached the date when 
they must be in compliance with new part 117. Thus, as discussed in 
section XVII of this document, we are proposing that current part 110 
be removed on the date that is 3 years after the date of publication of 
the final rule.

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

A. Section 103(c) of FSMA

1. Clarification of the Activities That Are Included as Part of the 
Definition of the Term ``Facility'' Under Section 415 of the FD&C Act
    Section 103(c)(1)(A) of FSMA requires the Secretary to ``publish a 
notice of proposed rulemaking in the Federal Register to promulgate 
regulations with respect to--(i) 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 for purposes of 
section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 
350d), as amended by [FSMA]; and (ii) activities that constitute on-
farm manufacturing or processing of food that is not consumed on that 
farm or on another farm under common ownership for purposes of such 
section 415.'' Section 103(c)(1)(B) of FSMA stipulates that such 
rulemaking ``shall enhance the implementation of such section 415 and 
clarify the activities that are included as part of the definition of 
the term `facility' under such section.'' Section 415 of the FD&C Act, 
in turn, directs the Secretary to require by regulation that any 
facility engaged in manufacturing, processing, packing, or holding food 
for consumption in the United States be registered with the Secretary. 
The registration requirement in section 415 of the FD&C Act does not 
apply to farms. Our regulations that implement section 415 and require 
food facilities to register with FDA are established in part 1 (21 CFR 
part 1), subpart H (Registration of Food Facilities) (the section 415 
registration regulations).
    To implement sections 103(c)(1)(A) and (B) of FSMA, in this 
document we are proposing to clarify the treatment of activities that 
are included as part of the definition of the term ``facility'' in 
section 415 of the FD&C Act in order to enhance the implementation of 
section 415. By doing so, we also clarify the coverage of section 418 
of the FD&C Act, because section 418 applies to domestic and foreign 
facilities that are required to register under section 415 (see section 
418(o)(2)) except where exemptions from section 418 apply. In the 
remainder of this section VIII of this document:
     We discuss the current legal and regulatory framework for 
farms under sections 415 and 418 of the FD&C Act, including 
requirements for registration of food facilities in the section 415 
registration regulations. (See section VIII.B.)
     We explain why we tentatively conclude that rulemaking is 
needed to implement sections 103(c)(1)(A) and (B) of FSMA. (See section 
VIII.C.)
     We explain how the status of a food as a raw agricultural 
commodity (RAC) or a processed food affects the requirements applicable 
to a farm under sections 415 and 418 of the FD&C Act. We also 
articulate a comprehensive set of organizing principles that form the 
basis for proposed revisions to the section 415 registration 
regulations. (See section VIII.D.)
     We describe our proposed revisions to the definitions in 
the section 415 registration regulations, based on the organizing 
principles articulated in section VIII.D, to clarify the treatment of 
activities that are included as part of the definition of the term 
``facility'' in those regulations and to enhance and clarify the 
application of those definitions. We also describe conforming changes 
to part 1, subpart I (Prior Notice of Imported Food) (hereinafter the 
prior notice regulations, established under section 307 of the Public 
Health Security and Bioterrorism Preparedness and Response Act of 2002 
(Pub. L. 107-188) (hereinafter the ``BT Act'')) and part 1, subpart J 
(Establishment, Maintenance, and Availability of Records) (hereinafter 
the section 414 recordkeeping regulations, established under section 
414 of the FD&C Act). (See section VIII.E.)
     We describe the impact of the proposed revisions to the 
definitions in the section 415 registration regulations on farms and on 
``farm mixed-type'' facilities. A ``farm mixed-type'' facility conducts 
activities that are outside the scope of the definition of ``farm'' 
(e.g., slicing or chopping fruits or vegetables) even though it also 
conducts activities that are within the scope of the definition of farm 
(e.g., growing and harvesting crops or raising animals). Conducting 
activities outside the definition of ``farm'' triggers the requirements 
in the section 415

[[Page 3675]]

registration regulations and, thus, brings the facility within the 
scope of section 418 of the FD&C Act. (See section VIII.F.)
2. Science-Based Risk Analysis Covering Specific Types of On-Farm 
Manufacturing, Processing, Packing and Holding Activities
    Section 103(c)(1)(C) of FSMA directs the Secretary to conduct a 
science-based risk analysis as part of the section 103(c) rulemaking. 
The science-based risk analysis is to cover ``(i) 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 (ii) 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.'' In section VIII.G of this document, we 
describe a draft Qualitative Risk Assessment (the section 103(c)(1)(C) 
draft RA) (Ref. 115) we performed to satisfy this requirement.
3. Exemptions and Modified Requirements for Certain Facilities
    Section 103(c)(1)(D)(i) of FSMA requires that, as part of the 
section 103(c) rulemaking, ``the Secretary shall consider the results 
of the science-based risk analysis * * * and shall exempt certain 
facilities from the requirements in section 418 of the Federal Food, 
Drug, and Cosmetic Act (as added by [section 103 of FSMA]) including 
hazard analysis and preventive controls, and the mandatory inspection 
frequency in section 421 of such Act (as added by section 201 [of 
FSMA]), or modify the requirements in such sections 418 or 421, as the 
Secretary determines appropriate, if such facilities are engaged only 
in specific types of on-farm manufacturing, processing, packing, or 
holding activities that the Secretary determines to be low risk 
involving specific foods the Secretary determines to be low risk.'' 
Section 103(c)(1)(D)(ii) of FSMA provides that the exemptions or 
modifications described in section 103(c)(1)(D)(i) ``shall not include 
an exemption from the requirement to register under section 415 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), as amended by 
[FSMA], if applicable, and shall apply only to small businesses and 
very small businesses, as defined in the regulation promulgated under 
section 418(n) of the Federal Food, Drug, and Cosmetic Act[.]'' In 
section VIII.H of this document, we discuss the results of the section 
103(c)(1)(C) draft RA. In section VIII.I of this document, we set forth 
our tentative conclusions regarding combinations of on-farm 
manufacturing, processing, packing, and holding activities and foods 
determined to be low risk, considering the results of the section 
103(c)(1)(C) draft RA. In section VIII.J of this document, we discuss a 
proposed approach to using the results of the section 103(c)(1)(C) 
draft RA for the purposes of section 421 of the FD&C Act. In section 
X.C.6 of this document, we discuss our proposal to exempt low-risk 
combinations of activities and foods from the requirements of section 
418 of the FD&C Act when performed by farm mixed-type facilities that 
are small or very small businesses as would be defined in proposed 
Sec.  117.3 (see discussion of the proposed definitions of ``small 
business'' and ``very small business'' in section X.B.4 of this 
document).

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

    As noted in the previous section, section 415 of the FD&C Act 
directs the Secretary to require by regulation that any facility 
engaged in manufacturing, processing, packing, or holding food for 
consumption in the United States be registered with the Secretary. 
Section 1.227 in the section 415 registration regulations includes 
definitions that are relevant to the scope of those regulations, 
including definitions for types of establishments (``facility'' and 
``farm'') and for types of activities (``holding,'' ``manufacturing/
processing,'' ``packaging,'' and ``packing''). In relevant part, these 
definitions play a role in determining whether an establishment is a 
facility that must register with FDA and implement a provision (in 
section 415(b)(1) of the FD&C Act) exempting ``farms'' from the 
registration requirement in section 415. We have issued guidance to 
assist food facilities in complying with the section 415 registration 
regulations (hereinafter ``Food Facility Registration Guidance'') (Ref. 
116).
    Section 418(n) of the FD&C Act directs the Secretary to establish 
regulations implementing the requirements of section 418 for hazard 
analysis and risk-based preventive controls applicable to the owner, 
operator, or agent in charge of a ``facility.'' Section 418(o)(2) of 
the FD&C Act defines ``facility'' for the purpose of section 418 as ``a 
domestic or foreign facility that is required to register under section 
415.''
    Under the framework established by section 415 of the FD&C Act and 
the section 415 registration regulations, farms are establishments that 
do conduct activities described in the farm definition in Sec.  
1.227(b)(3) but do not conduct other activities (such as manufacturing/
processing on food that is not consumed on that farm or another farm 
under the same ownership) that would trigger the requirements in the 
section 415 registration regulations. Because establishments that 
satisfy the definition of ``farm'' in Sec.  1.227(b)(3) are not 
required to register under section 415, they do not satisfy the 
definition of ``facility'' in section 418(o)(2) of the FD&C Act and, 
thus, they are not subject to section 418 of the FD&C Act.
    The current legal and regulatory framework provided in sections 415 
and 418 of the FD&C Act, the section 415 registration regulations, and 
the Food Facility Registration Guidance is relevant to the FSMA section 
103(c) rulemaking and the FD&C Act section 418(n) rulemaking that are 
the subjects of this document. That framework determines which 
establishments and activities are subject to the requirements of 
section 418 of the FD&C Act. We describe key provisions applicable to 
the current legal and regulatory framework in Table 1.

 Table 1--Key Provisions Applicable to the Current Legal and Regulatory Framework Under Sections 415 and 418 of
                                                  the FD&C Act
----------------------------------------------------------------------------------------------------------------
Provision of the Section 415 Registration Regulations or the FD&C
                               Act                                           Definition or Requirement
----------------------------------------------------------------------------------------------------------------
Sec.   1.227(b)(2): Current definition of ``facility''...........  For the purposes of section 415 of the FD&C
                                                                    Act, a facility is, in relevant part, any
                                                                    establishment, structure, or structures
                                                                    under one ownership at one general physical
                                                                    location, or, in the case of a mobile
                                                                    facility, traveling to multiple locations,
                                                                    that manufactures/processes, packs, or holds
                                                                    food for consumption in the United States.

[[Page 3676]]

 
Sec.   1.225: Requirement to register............................  The owner, operator, or agent in charge of
                                                                    either a domestic or foreign facility must
                                                                    register in accordance with the section 415
                                                                    registration regulations if the facility is
                                                                    engaged in the manufacturing/processing,
                                                                    packing, or holding of food for consumption
                                                                    in the United States, unless the facility
                                                                    qualifies for one of the exemptions in Sec.
                                                                     1.226.
Sec.   1.226(b): Exemption from registration for farms...........  Farms are not subject to the registration
                                                                    requirement in Sec.   1.225.
Sec.   1.227(b)(3): Current definition of ``farm''...............  Farm means a facility in one general physical
                                                                    location devoted to the growing and
                                                                    harvesting of crops, the raising of animals
                                                                    (including seafood), or both. Washing,
                                                                    trimming of outer leaves of, and cooling
                                                                    produce are considered part of harvesting.
                                                                    The term ``farm'' includes facilities that
                                                                    pack or hold food, provided that all food
                                                                    used in such activities is grown, raised, or
                                                                    consumed on that farm or another farm under
                                                                    the same ownership; and facilities that
                                                                    manufacture/process food, provided that all
                                                                    food used in such activities is consumed on
                                                                    that farm or another farm under the same
                                                                    ownership.
Sec.   1.227(b)(5): Current definition of ``holding''............  Holding means storage of food. Holding
                                                                    facilities include warehouses, cold storage
                                                                    facilities, storage silos, grain elevators,
                                                                    and liquid storage tanks.
Sec.   1.227(b)(6): Current definition of ``manufacturing/         Manufacturing/processing means making food
 processing''.                                                      from one or more ingredients, or
                                                                    synthesizing, preparing, treating, modifying
                                                                    or manipulating food, including food crops
                                                                    or ingredients. Examples of manufacturing/
                                                                    processing activities are cutting, peeling,
                                                                    trimming, washing, waxing, eviscerating,
                                                                    rendering, cooking, baking, freezing,
                                                                    cooling, pasteurizing, homogenizing, mixing,
                                                                    formulating, bottling, milling, grinding,
                                                                    extracting juice, distilling, labeling, or
                                                                    packaging.
Sec.   1.227(b)(8): Current definition of ``packaging''..........  Packaging (when used as a verb) means placing
                                                                    food into a container that directly contacts
                                                                    food and that the consumer receives.
Sec.   1.227(b)(9): Current definition of ``packing''............  Packing means placing food into a container
                                                                    other than packaging the food.
Section 418(o)(2) of the FD&C Act................................  A facility that is subject to the
                                                                    requirements of section 418 of the FD&C Act
                                                                    is a domestic facility or a foreign facility
                                                                    that is required to register under section
                                                                    415 of the FD&C Act.
----------------------------------------------------------------------------------------------------------------

    Together, the provisions described in Table 1 establish that a 
business qualifies as a ``farm'' that is exempt from the section 415 
registration regulations if it satisfies the definition of ``farm'' in 
Sec.  1.227(b)(3), including the activities performed, where the 
activities take place, where the food used in the activities comes 
from, and where the food is consumed:
     A farm is devoted to the growing and harvesting of crops. 
Washing, trimming of outer leaves of, and cooling produce are 
considered part of harvesting.
     A farm can pack or hold food, provided that all food used 
in such activities is grown, raised, or consumed on that farm or 
another farm under the same ownership.
     A farm can manufacture/process food, provided that all 
food used in such activities is consumed on that farm or another farm 
under the same ownership.
    We note that FDA established the same definitions of the terms 
``facility,'' ``farm,'' ``holding,'' ``manufacturing/processing,'' 
``packaging,'' and ``packing'' in the section 414 recordkeeping 
regulations (Sec.  1.328), because farms are excluded from FDA's 
authority to establish recordkeeping requirements under section 414(b) 
of the FD&C Act.

C. Why This Rulemaking Is Needed

    Farms are subject to many provisions of the FD&C Act and FDA's 
authorities thereunder, such as FDA's inspection authority under 
section 704 and the general adulteration provisions for food in section 
402. FDA has long recognized that regulation of farms should be 
sensitive to the agricultural setting. As early as 1969, FDA exempted 
establishments ``engaged solely in the harvesting, storage, or 
distribution'' of raw agricultural commodities from certain regulatory 
requirements (34 FR 6977 at 6980, April 26, 1969). The BT Act provided 
FDA with the authority to require domestic and foreign facilities that 
manufacture, process, pack, or hold food for consumption in the United 
States to register with FDA, and to issue regulations regarding the 
establishment and maintenance of certain records (codified as sections 
415 and 414 of the FD&C Act, respectively). Sections 415 and 414 
explicitly exclude ``farms,'' but do not define that term. In notice 
and comment rulemaking implementing these provisions, FDA developed a 
definition of the term ``farm.'' FDA first proposed to define ``farm'' 
as a facility in one general physical location devoted to the growing 
of crops for food, the raising of animals for food (including seafood), 
or both. Under that proposed definition, the term ``farm'' would also 
have included (i) facilities that pack or hold food, provided that all 
food used in such activities is grown or raised on that farm or is 
consumed on that farm; and (ii) facilities that manufacture/process 
food, provided that all food used in such activities is consumed on 
that farm or another farm under the same ownership (68 FR 5378 at 5418, 
February 3, 2003).
    FDA received comments stating that the proposed definition was too 
narrow because it would not include farms that engage in activities 
traditionally performed on farms for nearly all commodities, such as 
washing, trimming outer leaves, and cooling (68 FR 58894 at 58905, 
October 10, 2003). Accordingly, to reflect the intent of Congress to 
exempt establishments engaging in activities farms traditionally 
perform from the section 415 registration regulations, in the final 
rule FDA revised the first part of the farm definition in Sec.  
1.227(b)(3) to state that a farm is a facility in one general location 
that is devoted to the growing and harvesting of crops, the raising of 
animals (including seafood), or both, and that washing, trimming outer 
leaves, and cooling of food are considered part of harvesting (68 FR 
58894 at 58905) (emphasis added). FDA also established the same 
definition of ``farm'' at Sec.  1.328 for the purpose of exempting 
farms from the section 414 recordkeeping regulations (69 FR 71652, 
December 9, 2004). In post-rulemaking

[[Page 3677]]

guidances implementing the section 415 registration regulations and the 
section 414 regulations, FDA further addressed and interpreted the farm 
definition with the goal of doing so in a manner recognizing the 
traditional activities of establishments commonly recognized to be 
farms (see the Food Facility Registration Guidance (Ref. 116) and 
``Guidance for Industry: Questions and Answers Regarding Establishment 
and Maintenance of Records (Edition 4), September 2006 (hereinafter 
``Recordkeeping Guidance'' (Ref. 117)).
Farm Mixed-Type Facilities
    Consistent with the current legal and regulatory framework under 
sections 415 and 418 of the FD&C Act and the section 415 registration 
regulations, activities within the farm definition in Sec.  1.227(b)(3) 
would not be subject to the requirements of this proposed rule. 
Activities that are not within the farm definition and that trigger the 
section 415 registration regulations would be subject to the 
requirements of section 418 of the FD&C Act (and therefore to the 
relevant parts of this proposed rule), except where an exemption 
applies. (For a discussion of proposed exemptions, see section X.C of 
this document.)
    For the purposes of this document, a ``farm mixed-type facility'' 
is an establishment that grows and harvests crops or raises animals and 
may conduct other activities within the farm definition, but that also 
conducts activities that trigger the section 415 registration 
regulations (see the discussion of our proposed definition of ``farm 
mixed-type facility'' in section VIII.E of this document). Section 418 
of the FD&C Act does not explicitly address whether a farm mixed-type 
facility is subject to section 418 with respect to all of its 
activities or only with respect to its activities that trigger the 
section 415 registration regulations. Considering the text of section 
103 of FSMA and the FD&C Act as a whole, FDA tentatively concludes that 
a farm mixed-type facility should be subject to section 418 only with 
respect to its activities that trigger the section 415 registration 
regulations, and not with respect to its activities that are within the 
farm definition. Put another way, we would apply section 418 only to 
the ``non-farm'' portion of the establishment's activities, and not to 
the ``farm'' portion of its activities.
    Because section 418(o)(2) of the FD&C Act defines the term 
``facility'' for the purposes of section 418 to mean only those 
facilities required to register under section 415 of the FD&C Act, FDA 
tentatively concludes that Congress intended the exemptions from the 
section 415 registration regulations, including the farm exemption in 
Sec.  1.226(b), to be meaningful for the purposes of defining the 
applicability of section 418. Section 418(a) requires the owner, 
operator, or agent in charge of a facility that is required to register 
under section 415 to ``evaluate the hazards that could affect food 
manufactured, processed, packed, or held by such facility'' and to take 
other steps discussed more fully in section XII of this document, 
including identifying and implementing preventive controls, monitoring 
preventive controls, and maintaining records. The use of the phrase 
``food manufactured, processed, packed, or held by the facility'' in 
section 418(a) parallels the language in section 415(a)(1) providing 
that ``[t]he Secretary shall by regulation require that any facility 
engaged in manufacturing, processing, packing, or holding food for 
consumption in the United States be registered with the Secretary.'' 
Considering the text of FSMA and the FD&C Act as a whole, FDA 
tentatively concludes that only those manufacturing, processing, 
packing, or holding activities that trigger registration under the 
section 415 registration regulations should be considered to be 
manufacturing, processing, packing, or holding of food by a facility 
for the purposes of section 418. Put another way, FDA tentatively 
concludes that a mixed-type facility should only be subject to section 
418 with respect to its activities that actually trigger the section 
415 registration regulations, and not with respect to its other 
activities, at the same location, that would not trigger the section 
415 registration regulations. To conclude otherwise would mean that, 
for example, the farm exemption from registration would be rendered 
irrelevant to the coverage of section 418, except for activities on 
farms that will be subject to requirements under section 419 of the 
FD&C Act (see the discussion of the exemption provided by section 
418(k) of the FD&C Act to such farms in section X.C.5 of this 
document). Under such an interpretation many ``farm'' portions of farm 
mixed-type facilities would be subject to section 418, including, for 
example, dairies, egg farms, farms raising livestock for food, and 
farms growing produce that is not subject to requirements under section 
419. However, section 103(c)(1)(D) of FSMA, which directs FDA to 
consider exempting or modifying the requirements of section 418 for 
activities conducted by a farm mixed-type facility outside the farm 
exemption, seems to mean that Congress did not intend the ``farm'' 
portion of such a facility to be covered by section 418, even though 
Congress intended the ``non-farm'' portions of such a facility to be 
subject to section 418 (including under modified requirements) 
(provided that FDA concluded that it was appropriate to do so after 
conducting the science-based risk analysis required by section 
103(c)(1)(C) of FSMA). (See section VIII.G for a discussion of the 
analysis FDA conducted and section VIII.H of this document for a 
discussion of FDA's proposed actions in light of that analysis).
    Therefore, unless an exemption from section 418 of the FD&C Act 
applies, FDA tentatively concludes that a facility that is required to 
register under section 415 of the FD&C Act should be subject to section 
418 with respect to all its activities that trigger the section 415 
registration regulations, but not with respect to its activities that 
would not trigger the section 415 registration regulations (such as 
activities within the farm definition set forth in Sec.  1.227(b)(3)). 
Thus, it is particularly important to clarify the classification of 
various activities included in the ``facility'' definition in section 
415 as manufacturing, processing, packing, or holding--and in doing so 
to clarify the scope of the farm definition in Sec.  1.227(b)(3)--to 
make clear the extent to which a farm mixed-type facility must comply 
with section 418.
Clarification of Activities Relevant to Farm Mixed-Type Facilities
    At the time FDA developed the farm definition and its 
interpretations of that definition, the practical impact of an 
activity's classification as inside or outside that definition was 
limited to the potential to trigger the section 415 registration 
regulations and the section 414 recordkeeping regulations. With the 
advent of FSMA, the scope of the farm definition has taken on more 
importance because, for example and as discussed in this section, 
activities within the farm definition are not subject to section 418 of 
the FD&C Act, but activities outside the farm definition are subject to 
section 418. Therefore, it is important that FDA clarify the scope of 
the farm definition, including the classification of manufacturing, 
processing, packing and holding activities relevant to that definition, 
and adjust it if necessary and appropriate to enhance implementation of 
section 418 of the FD&C Act, as well as section 415 of the FD&C Act. 
Accordingly, in the remainder of this section VIII FDA articulates a 
comprehensive set of organizing principles that would form

[[Page 3678]]

the basis for our proposal for classifying activities to more 
accurately reflect the scope of activities traditionally conducted by 
farms and to allow for more certainty among industry with regard to how 
their activities will be regulated. We seek comment on this proposal.

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

1. Statutory Framework for Raw Agricultural Commodities and Processed 
Food
    To clarify the scope of the farm definition, FDA considered how the 
activities of farms relate to the statutory concepts of ``raw 
agricultural commodity'' and ``processed food.'' The FD&C Act defines 
``raw agricultural commodity'' and ``processed food'' in relation to 
each other, and identifies certain activities that transform a RAC into 
a processed food and others that do not. Section 201(r) of the FD&C Act 
(21 U.S.C. 321(r)) defines ``raw agricultural commodity'' to mean ``any 
food in its raw or natural state, including all fruits that are washed, 
colored, or otherwise treated in their unpeeled natural form prior to 
marketing.'' Section 201(gg) of the FD&C Act (21 U.S.C. 321(gg)) 
defines ``processed food'' to mean ``any food other than a raw 
agricultural commodity and includes any raw agricultural commodity that 
has been subject to processing, such as canning, cooking, freezing, 
dehydration, or milling.'' In addition, section 201(q)(1)(B)(i)(II) of 
the FD&C Act (which defines pesticide chemicals) contains the following 
language regarding activities that do not transform a RAC into a 
processed food: ``the treatment [with pesticide chemicals] is in a 
manner that does not change the status of the food as a raw 
agricultural commodity (including treatment through washing, waxing, 
fumigating, and packing such commodities in such manner).''
    The status of a food as a RAC or processed food is relevant for 
many different purposes under the FD&C Act. For example, under section 
403(q)(4) of the FD&C Act (21 U.S.C. 343(q)(4)), FDA has established a 
voluntary nutrition labeling program that applies to RACs but not to 
processed foods. Under 403(w) of the FD&C Act (21 U.S.C. 343(w)), 
labeling requirements related to major food allergens apply to 
processed foods but do not apply to RACs. Under sections 201(q), 
403(k), 403(l), and 408 of the FD&C Act (21 U.S.C. 321(q), 343(k), 
343(l), and 346a), the status of a food as a RAC has an impact on the 
manner in which pesticide chemicals and their residues are regulated. 
FSMA created more provisions in the FD&C Act and elsewhere that take 
status as a RAC or processed food into account, including section 
417(f) of the FD&C Act (21 U.S.C. 350f(f)), establishing notification 
requirements for reportable foods that do not apply to fruits and 
vegetables that are RACs; section 418(m) of the FD&C Act, which 
authorizes FDA to exempt or modify the requirements for compliance 
under section 418 with respect to facilities that are solely engaged in 
the storage of RACs other than fruits and vegetables intended for 
further distribution or processing; section 419(a)(1)(A) of the FD&C 
Act (21 U.S.C. 350h(a)(1)(A)), which authorizes FDA to establish 
minimum science-based standards applicable to certain fruits and 
vegetables that are RACs; and section 204(d)(6)(D) of FSMA (21 U.S.C. 
2223(d)(6)(D)), which contains special provisions for commingled RACs 
applicable to FDA's authority under section 204 of FSMA to establish 
additional recordkeeping requirements for high risk foods. FDA has also 
established by regulation an exemption from the current CGMP 
requirements applicable to establishments engaged solely in the 
harvesting, storage, or distribution of one or more RACs (Sec.  
110.19). (We discuss this exemption in detail in section X.C.9 of this 
document.)
    The term ``raw agricultural commodity'' and similar terms also 
appear in other Federal statutes. While these statutes are not 
implemented or enforced by FDA and do not directly impact the 
interpretation of the definitions in sections 201(r) and 201(gg) of the 
FD&C Act, they do provide some suggestions about what ``raw 
agricultural commodity'' and related concepts can mean in various 
circumstances. For example, the Secretary of Transportation may 
prescribe commercial motor vehicle safety standards under 49 U.S.C. 
31136, but the Motor Carrier Safety Improvement Act of 1999 (Pub. L. 
106-159, title II, Sec. 229, Dec. 9, 1999), as added and amended by the 
Safe, Accountable, Flexible, Efficient Transportation Equity Act: A 
Legacy for Users (Pub. L. 109-59, title IV, Sec. 4115, 4130, Aug. 10, 
2005), provided an exemption from maximum driving or on-duty times for 
drivers transporting ``agricultural commodities'' or farm supplies 
within specific areas during planting and harvest periods. In that 
circumstance, ``agricultural commodity'' is defined as ``any 
agricultural commodity, non-processed food, feed, fiber, or livestock * 
* * and insects'' (49 U.S.C. 31136 note). Another example is 19 U.S.C. 
1677(4)(E), which provides for certain circumstances in which producers 
or growers of raw agricultural products may be considered part of the 
industry producing processed foods made from the raw agricultural 
product for the purposes of customs duties and tariffs related to such 
processed foods. In that circumstance, ``raw agricultural product'' is 
defined as ``any farm or fishery product'' (19 U.S.C. 1677(4)(E)). 
These statutes are informative in that they suggest that the ``raw 
agricultural commodity'' concept describes and signifies the products 
of farms in their natural states, or, in other words, that which a farm 
exists to produce on a basic level.
2. Interpretive Documents and Guidance Regarding Whether an Activity 
Transforms a Raw Agricultural Commodity Into a Processed Food
    Because the status of a food as a RAC or processed food is of great 
importance in defining the jurisdiction of FDA and EPA over 
antimicrobial substances, FDA and EPA have developed guidance regarding 
whether or not various activities transform RACs into processed foods. 
FDA and EPA jointly issued a legal and policy interpretation of the 
agencies' jurisdiction under the FD&C Act over antimicrobial substances 
used in or on food (hereinafter the ``1998 Joint EPA/FDA Policy 
Interpretation'') (63 FR 54532, October 9, 1998). In 1999, FDA issued 
guidance addressing several of the issues discussed in the 1998 Joint 
EPA/FDA Policy Interpretation. (See Guidance for Industry: 
Antimicrobial Food Additives, July 1999 (hereinafter ``Antimicrobial 
Guidance'') (Ref. 118)). As discussed in these documents, FDA and EPA 
agreed that the following ``post-harvest'' activities do not transform 
a RAC into processed food within the meaning of that term in section 
201(gg) of the FD&C Act: ``washing, coloring, waxing, hydro-cooling, 
refrigeration, shelling of nuts, ginning of cotton, and the removal of 
leaves, stems, and husks'' (Ref. 118, section 7 and 63 FR 54532 at 
54541). FDA and EPA also agreed that the following activities do 
transform a RAC into a processed food: ``canning, freezing, cooking, 
pasteurization or homogenization, irradiation, milling, grinding, 
chopping, slicing, cutting, or peeling'' (Ref. 118, section 7 and 63 FR 
54532 at 54541). In addition, these documents set forth the conclusion 
of

[[Page 3679]]

EPA and FDA that drying a RAC causes it to become a processed food, 
unless the drying is for the purpose of facilitating storage or 
transportation of the commodity (Ref. 118, section 7 and 63 FR 54532 at 
54541-2); this conclusion was based on EPA's policy statement on the 
status of dried commodities as RACs (61 FR 2386, January 25, 1996). FDA 
and EPA also identified slaughter of animals for food and activities 
done to carcasses post-slaughter as ``processing'' for the purposes of 
the processed food definition (Ref. 118, section 7 and 63 FR 54532 at 
54542). Table 2 summarizes activities that cause food RACs to become 
processed foods and activities that do not change the status of a food 
RAC, as provided in the FD&C Act and addressed in the 1998 Joint EPA/
FDA Policy Interpretation and the Antimicrobial Guidance.

        Table 2--The Effect of Activities on RACs That Are Foods
------------------------------------------------------------------------
Activities that change a RAC into a   Activities that do not change the
           processed food                      status of a RAC.
------------------------------------------------------------------------
Canning.                             Application of pesticides
                                      (including by washing, waxing,
                                      fumigation, or packing).
Chopping.                            Coloring.
Cooking.                             Drying for the purpose of storage
                                      or transportation.
Cutting.                             Hydro-cooling.
Drying that creates a distinct       Otherwise treating fruits in their
 commodity.                           unpeeled natural form.
Freezing.                            Packing.
Grinding.                            Refrigeration.
Homogenization.                      Removal of leaves, stems, and
                                      husks.
Irradiation.                         Shelling of nuts.
Milling.                             Washing.
Pasteurization.                      Waxing.
Peeling.                             Activities designed only to isolate
                                      or separate the commodity from
                                      foreign objects or other parts of
                                      the plant.
Slaughtering animals for food and    ...................................
 activities done to carcasses post-
 slaughter, including skinning,
 eviscerating, and quartering.
Slicing.                             ...................................
Activities that alter the general    ...................................
 state of the commodity.
------------------------------------------------------------------------

    The summary in Table 2 demonstrates that the activities that 
transform a RAC into a processed food (and are sometimes therefore 
referred to as ``processing'' in the context of a food's status as a 
RAC or processed food) are not coextensive with the definition of 
``manufacturing/processing'' that FDA established in Sec. Sec.  
1.227(b)(6) and 1.328 for the purposes of the section 415 registration 
regulations and the section 414 recordkeeping regulations, 
respectively. The definition of ``Manufacturing/processing'' in those 
regulations includes most food-handling activities because it is 
satisfied by any degree of ``making food from one or more ingredients, 
or synthesizing, preparing, treating, modifying or manipulating food.'' 
In contrast, transforming a RAC into a processed food seems to require 
meeting a threshold of altering the general state of the commodity 
(Ref. 118, section 7 and 63 FR 54532 at 54541), sometimes referred to 
as transformation of the RAC into a new or distinct commodity (61 FR 
2386 at 2388). Because the activities that transform a RAC into a 
processed food are not coextensive with the definition of 
``manufacturing/processing'' in Sec. Sec.  1.227(b)(6) and 1.328, a 
given activity may be manufacturing/processing under the current 
definition in Sec. Sec.  1.227(b)(6) and 1.328 without transforming a 
RAC into a processed food. Examples of such activities include 
coloring, washing, and waxing.
3. The Organizing Principles
    The current section 415 registration regulations, section 414 
recordkeeping regulations, and related guidances demonstrate that some 
activities may be classified differently on farms and off farms. For 
example, ``washing'' is an example of manufacturing/processing under 
the definition of that term in Sec. Sec.  1.227(b)(6) and 1.328. 
However, ``washing'' produce is identified as part of harvesting under 
the farm definition in Sec. Sec.  1.227(b)(3) and 1.328, so washing on 
farms is harvesting rather than manufacturing/processing. To date, FDA 
has not articulated organizing principles explaining these differences. 
In this document, we are tentatively articulating the following 
organizing principles to explain and clarify the basis for our proposed 
revisions to the definitions that classify activities on-farm and off-
farm in the section 415 registration regulations and in the section 414 
recordkeeping regulations, and that we interpret in guidances. In 
section VIII.E of this document, we propose to incorporate these 
organizing principles into the definitions, previously established in 
Sec. Sec.  1.227 and 1.328, that classify activities related to foods 
on farms and farm mixed-type facilities. FDA tentatively concludes that 
doing so would more accurately reflect which activities of these 
establishments should fall within the farm definition.
    a. First organizing principle. The statutes we describe in section 
VIII.D.1 of this document, and previous interpretations of the concepts 
of RACs and processed food as set forth in the 1998 Joint EPA/FDA 
Policy Interpretation and the Antimicrobial Guidance, lead FDA to 
tentatively conclude that the basic purpose of farms is to produce RACS 
and that RACs are the essential products of farms. This tentative 
conclusion is the first organizing principle that we would incorporate 
into the definitions that classify activities related to foods on farms 
and farm mixed-type facilities.
    b. Second organizing principle. In light of the first organizing 
principle (i.e., that the basic purpose of farms is to produce RACs, 
and that RACs are the essential products of farms), we also tentatively 
conclude that activities that involve RACs and that farms traditionally 
do for the purposes of growing their own RACs, removing them from the 
growing areas, and preparing them for use as a food RAC, and for 
packing, holding and transporting them, should all be within the 
definition of ``farm'' in Sec. Sec.  1.227(b)(3) and 1.328. Doing so 
would appropriately implement the intent of Congress (under sections 
415(b)(1) and 414(b) of the FD&C Act) that FDA

[[Page 3680]]

exempt ``farms'' from the section 415 registration regulations and the 
section 414 recordkeeping regulations. This is the case even if the 
same activities off-farm would be considered to be manufacturing/
processing under the definition of that term in Sec. Sec.  1.227(b)(6) 
and 1.328, because those activities involve ``making food from one or 
more ingredients, or synthesizing, preparing, treating, modifying or 
manipulating food.'' This tentative conclusion regarding a special 
classification for on-farm activities is the second organizing 
principle that we would incorporate into the definitions that classify 
activities related to foods on farms and farm mixed-type facilities.
    c. Third organizing principle. In light of the first organizing 
principle (i.e., that the basic purpose of farms is to produce RACs, 
and that RACs--but not processed foods--are the essential products of 
farms) FDA tentatively concludes that the second organizing principle 
(i.e., the special classification of on-farm activities) should only 
apply to RACs. Thus, the third organizing principle that we would 
incorporate into the definitions that classify activities related to 
foods on farms and farm mixed-type facilities is that activities should 
be classified based in part on whether the food operated on is a RAC or 
a processed food, and on whether the activity transforms a RAC into a 
processed food. A farm that chooses to transform its RACs into 
processed foods should be considered to have chosen to expand its 
business beyond the traditional business of a farm, thereby opting to 
become a farm mixed-type facility subject to the section 415 
registration regulations, section 414 recordkeeping regulations, and 
other requirements linked to the registration requirement of section 
415 of the FD&C Act by FSMA (such as compliance with section 418 of the 
FD&C Act).
    d. Fourth organizing principle. In light of the first organizing 
principle (i.e., that the essential purpose of a farm is to produce 
RACs, and that RACs are the essential products of farms), FDA also 
tentatively concludes that the second organizing principle (i.e., the 
special classification of on-farm activities) should only apply to RACs 
grown or raised on the farm itself or on other farms under the same 
ownership because the essential purpose of a farm is to produce its own 
RACs, not to handle RACs grown on unrelated farms for distribution into 
commerce. (For the purposes of this discussion, FDA refers to RACs 
grown or raised on a farm or another farm under the same ownership as a 
farm's ``own RACs,'' in contrast to RACs grown on a farm under 
different ownership, which FDA refers to as ``others' RACs.'') Notably, 
when FDA first undertook to define ``farm,'' it received a comment 
implicitly recognizing this, urging the agency to define farms to 
include typical post-harvesting operations, if all food is grown on the 
farm (emphasis added) (68 FR 5378 at 5379). Therefore, activities farms 
may perform on others' RACs should appropriately be classified as 
manufacturing/processing, packing, or holding in the same manner as 
these activities are classified off-farm when the RACs are to be 
distributed into commerce. In general, when a farm opts to perform 
activities outside the farm definition (and, thus, becomes a farm 
mixed-type facility), the establishment's activities that are within 
the farm definition should be classified as manufacturing/processing, 
packing, or holding in the same manner as for a farm that is not a 
mixed-type facility, but the activities that are outside the farm 
definition should be classified in the same manner as for an off-farm 
food establishment. This is the fourth organizing principle that we 
would incorporate into the definitions that classify activities related 
to foods on farms and farm mixed-type facilities.
    e. Fifth organizing principle. FDA tentatively concludes that 
manufacturing/processing, packing, or holding food--whether RACs or 
processed foods, from any source--for consumption on the farm should 
remain within the farm definition because otherwise farms could not 
feed people and animals on the farm without being required to register 
under section 415 of the FD&C Act. This is the fifth organizing 
principle that we would incorporate into the definitions that classify 
activities related to foods on farms and farm mixed-type facilities.
    f. Summary of organizing principles. For the convenience of the 
reader, Table 3 summarizes the organizing principles that FDA is 
articulating in this document to explain and clarify the basis for our 
proposed revisions to the definitions that classify activities on-farm 
and off-farm in the section 415 registration regulations and in the 
section 414 recordkeeping regulations, and that we interpret in 
guidances.

  Table 3--Summary of Organizing Principles Regarding Classification of
                     Activities On-Farm and Off-Farm
------------------------------------------------------------------------
          No.                          Organizing Principle
------------------------------------------------------------------------
1......................  The basic purpose of farms is to produce RACs
                          and RACs are the essential products of farms.
2......................  Activities that involve RACs and that farms
                          traditionally do for the purposes of growing
                          their own RACs, removing them from the growing
                          areas, and preparing them for use as a food
                          RAC, and for packing, holding and transporting
                          them, should all be within the definition of
                          ``farm'' in Sec.  Sec.   1.227 and 1.328.
3......................  Activities should be classified based in part
                          on whether the food operated on is a RAC or a
                          processed food, and on whether the activity
                          transforms a RAC into a processed food.
4......................  Activities farms may perform on others' RACs
                          should appropriately be classified as
                          manufacturing/processing, packing, or holding
                          in the same manner as these activities are
                          classified off-farm when the RACs are to be
                          distributed into commerce.
5......................  Manufacturing/processing, packing, or holding
                          food--whether RACs or processed foods, from
                          any source--for consumption on the farm should
                          remain within the farm definition.
------------------------------------------------------------------------

E. Proposed Revisions to 21 CFR Part 1

1. Proposed Redesignation of the Definitions in Sec.  1.227
    FDA is proposing to redesignate all definitions in the section 415 
registration regulations (i.e., current Sec.  1.227) to eliminate 
paragraph designations (such as (a), (b), (1), (2), and (3)). Paragraph 
designations are not necessary when definitions are presented in 
alphabetical order. New definitions that FDA is proposing to add to the 
section 415 registration regulations and the section 414 recordkeeping 
regulations would be added in alphabetical order.
    2. Proposed Substantive Revisions to the Definitions in Sec. Sec.  
1.227 and 1.328
    FDA is proposing to revise the definitions in the section 415 
registration regulations (Sec.  1.227) and in the section 414 
recordkeeping regulations (Sec.  1.328), and to add new definitions to 
those regulations, to reflect the organizing principles articulated in 
section VIII.D of this document and to clarify how those

[[Page 3681]]

definitions apply to specific activities depending on where the 
activities take place, the food used in the activities, where the food 
comes from, and where the food is consumed.
    FDA is proposing to add a new definition of the term ``Mixed-type 
facility'' to Sec. Sec.  1.227 and 1.328. ``Mixed-type facility'' would 
mean an establishment that engages in both activities that are exempt 
from registration under section 415 of the FD&C Act and activities that 
require the establishment to be registered. This term and its 
definition were initially developed in the preamble to the proposed 
rule on food facility registration (68 FR 5378 at 5381) and in the 
interim final rule on food facility registration (68 FR 58894 at 58906-
7, 58914, 58934-8) and would be codified in our proposed revisions to 
Sec. Sec.  1.227 and 1.328 with the same meaning. The proposed 
definition would also provide, as an example of such a facility, a 
definition of a ``farm mixed-type facility.'' A ``farm mixed-type 
facility'' would be defined as an establishment that grows and harvests 
crops or raises animals and may conduct other activities within the 
farm definition, but also conducts activities that require the 
establishment to be registered. FDA tentatively concludes that it is 
necessary to define this term to satisfy the directives of FSMA section 
103(c) to enhance the implementation of section 415 of the FD&C Act, 
clarify the activities that are included as part of the term facility 
under section 415, and to conduct this rulemaking addressing activities 
that constitute on-farm packing or holding of food 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 
not consumed on that farm or another farm under common ownership. 
Because the specific classes of activities mentioned in FSMA section 
103(c) are, by definition, on-farm activities that do not fall within 
the farm definition, Congress has explicitly directed FDA to engage in 
rulemaking addressing establishments that conduct activities that are 
outside the farm definition on farms. Accordingly, FDA is proposing to 
define the term ``farm mixed-type facility'' to refer to these 
establishments.
    FDA is proposing to add a new definition of the term ``Harvesting'' 
to Sec. Sec.  1.227 and 1.328. Harvesting would apply to farms and farm 
mixed-type facilities and be defined as activities that are 
traditionally performed by farms for the purpose of removing raw 
agricultural commodities from the place they were grown or raised and 
preparing them for use as food. Harvesting would be limited to 
activities performed on raw agricultural commodities on the farm on 
which they were grown or raised, or another farm under the same 
ownership. Harvesting would not include activities that transform a raw 
agricultural commodity, as defined in section 201(r) of the FD&C Act, 
into a processed food as defined in section 201(gg) of the FD&C Act. 
Gathering, washing, trimming of outer leaves of, removing stems and 
husks from, sifting, filtering, threshing, shelling, and cooling raw 
agricultural commodities grown on a farm or another farm under the same 
ownership would be listed as examples of harvesting. This proposed 
definition would include the same examples of ``harvesting'' that were 
previously part of the farm definition (washing, trimming of outer 
leaves, and cooling) and would add other examples to help clarify the 
scope of the definition of harvesting. FDA also proposes to make clear 
that these activities are ``harvesting'' when conducted on any of a 
farm's own RACs, not just ``produce.'' For example, unpasteurized shell 
eggs are RACs, and washing such eggs on the farm on which the eggs were 
produced would be part of harvesting the eggs. ``Harvesting'' is a 
category of activities that is only applicable to farms and farm mixed-
type facilities. Activities that would be ``harvesting'' when performed 
on a farm on the farm's own RACs would be classified differently under 
other circumstances, such as at a processing facility that is not on a 
farm, or when performed by a farm on others' RACs. For example, at an 
off-farm processing facility that pasteurizes eggs, washing the 
unpasteurized shell eggs after they are received would not be 
``harvesting'' because it is not being performed on the farm that 
produced the eggs (or another farm under the same ownership). Instead, 
washing eggs at the off-farm processing facility would be 
``manufacturing/processing,'' because it involves preparing, treating, 
modifying or manipulating food.
    FDA is proposing to revise the definition of ``Holding'' in current 
Sec. Sec.  1.227(b)(5) and 1.328 by adding to the existing definition 
an expanded definition applicable to farms and farm mixed-type 
facilities. The proposed revision would state that, for farms and farm 
mixed-type facilities, holding would also include activities 
traditionally performed by farms for the safe or effective storage of 
RACs grown or raised on the same farm or another farm under the same 
ownership, but would not include activities that transform a RAC, as 
defined in section 201(r) of the FD&C Act, into a processed food as 
defined in section 201(gg) of the FD&C Act. This would mean that more 
activities than just storage of food would be classified as ``holding'' 
when a farm or farm mixed-type facility performs those activities on 
its own RACs. For example, fumigating or otherwise treating a farm's 
own RACs against pests for the purpose of safe and effective storage 
would be ``holding'' under this proposed definition. However, 
fumigating or otherwise treating food against pests under other 
circumstances (such as off-farm or by a farm handling others' RACs) 
would not be ``holding'' food because it is not storage of food, which 
would remain the definition of holding applicable to most 
circumstances.
    FDA is proposing to revise the definition of ``Manufacturing/
processing'' in current Sec. Sec.  1.227(b)(6) and 1.328 by adding to 
the existing definition a criterion applicable to farms and farm mixed-
type facilities. The proposed revision would state that, for farms and 
farm mixed-type facilities, manufacturing/processing would not include 
activities that are part of harvesting, packing, or holding. Under this 
proposed revision, expanded definitions of ``packing'' and ``holding,'' 
and the extra category ``harvesting'' would apply to activities 
performed by farms and farm mixed-type facilities on their own RACs. 
These expanded and extra categories would not apply off-farm or to 
foods other than a farm's own RACs or a farm mixed-type facility's own 
RACs. Thus, some activities that would otherwise be manufacturing/
processing would instead be defined as packing, holding, or harvesting 
by virtue of being performed by a farm or farm mixed-type facility on 
its own RACs. Accordingly, these activities would not be manufacturing/
processing because they would already be classified into the expanded 
definitions of packing or holding, or into the extra category of 
harvesting.
    FDA is proposing to revise the definition of ``Packing'' in current 
Sec. Sec.  1.227(b)(9) and 1.328 by adding to the existing definition 
an expanded definition applicable to farms and farm mixed-type 
facilities. The proposed revision would state that, for farms and farm 
mixed-type facilities, packing would also include activities (which may 
include packaging) traditionally performed by farms to prepare RACs 
grown or raised on the same farm or another farm under the same 
ownership for storage and transport, but would not include activities 
that transform a RAC, as defined in section 201(r) of the FD&C

[[Page 3682]]

Act, into a processed food as defined in section 201(gg) of the FD&C 
Act. This would mean that more activities than just placing food into a 
container other than packaging would be classified as ``packing'' when 
a farm or farm mixed-type facility performs those activities on its own 
RACs. For example, packaging (placing food into a container that 
directly contacts the food and that the consumer receives) a farm's own 
RACs would be ``packing'' under this definition because farms 
traditionally do this to provide greater protection for fragile RACs 
than would be possible if the RACs were placed in containers other than 
the consumer container, and because this activity does not transform a 
RAC into a processed food. However, packaging food under other 
circumstances would not be ``packing'' food because packaging is 
explicitly excluded from the definition of packing applicable to most 
circumstances (placing food into a container other than packaging). 
Other examples of activities that could be packing when performed by a 
farm or a farm mixed-type facility on its own RACs include packaging or 
packing a mix of RACs together (e.g., in a bag containing three 
different colored bell peppers, or a box of mixed produce for a 
community sponsored agriculture program farm share); coating RACs with 
wax, oil, or resin coatings used for the purposes of storage or 
transport; placing stickers on RACs; labeling packages containing RACs; 
sorting, grading, or culling RACs; and drying RACs for the purpose of 
storage or transport.
    Table 4 provides examples of how we would classify activities 
conducted off-farm and on-farm (including farm mixed-type facilities) 
using these proposed revisions to the definitions in the section 415 
registration regulations and in the section 414 recordkeeping 
regulations.

  Table 4--Classification of Activities Conducted Off-Farm and On-Farm
                 [Including farm mixed-type facilities]
------------------------------------------------------------------------
                                                    On-Farm (Including
        Classification              Off-Farm          farm mixed-type
                                                        facilities)
------------------------------------------------------------------------
Harvesting...................  Notes: Not         Notes: Activities
                                applicable.        traditionally
                                Harvesting is a    performed by farms
                                classification     for the purpose of
                                that only          removing RACs from
                                applies on farms   growing areas and
                                and farm mixed-    preparing them for
                                type facilities.   use as food.
                                                   Harvesting is limited
                                                   to activities
                                                   performed on RACs on
                                                   the farm on which
                                                   they were grown or
                                                   raised, or another
                                                   farm under the same
                                                   ownership. Harvesting
                                                   does not include
                                                   activities that
                                                   change a RAC into
                                                   processed food.
                                                   Activities that are
                                                   harvesting are within
                                                   the farm definition.
Harvesting...................  Examples: Not      Examples: Activities
                                applicable.        that fit this
                                                   definition when
                                                   performed on a farm's
                                                   ``own RACs'' (a term
                                                   we use to include
                                                   RACs grown or raised
                                                   on that farm or
                                                   another farm under
                                                   the same ownership)
                                                   include gathering,
                                                   washing, trimming of
                                                   outer leaves,
                                                   removing stems and
                                                   husks, sifting,
                                                   filtering, threshing,
                                                   shelling, and
                                                   cooling. These
                                                   activities, performed
                                                   on a farm's own RACs,
                                                   are inside the farm
                                                   definition.
Packing......................  Notes: Placing     Notes: Placing food in
                                food in a          a container other
                                container other    than packaging the
                                than packaging     food (using the same
                                the food (where    definition of
                                packaging means    packaging), or
                                placing food       activities (which may
                                into a container   include packaging)
                                that directly      traditionally
                                contacts the       performed by farms to
                                food and that      prepare RACs grown or
                                the consumer       raised on that farm
                                receives).         or another farm under
                                                   the same ownership
                                                   for storage or
                                                   transport. Packing
                                                   does not include
                                                   activities that
                                                   change a RAC into a
                                                   processed food.
                                                   Activities that are
                                                   packing are within
                                                   the farm definition
                                                   when they are
                                                   performed on food
                                                   grown, raised, or
                                                   consumed on that farm
                                                   or another farm under
                                                   the same ownership;
                                                   under any other
                                                   circumstances they
                                                   are outside the farm
                                                   definition.
Packing......................  Examples: Putting  Examples: Activities
                                individual unit    that fit the
                                cartons into a     definition of packing
                                larger box used    when performed on a
                                for shipping,      farm's own RACs
                                and putting        include packaging,
                                articles of        mixing, coating with
                                produce in non-    wax/oil/resin for the
                                consumer           purpose of storage or
                                containers (such   transport, stickering/
                                as shipping        labeling, drying for
                                crates).           the purpose of
                                                   storage or transport,
                                                   and sorting/grading/
                                                   culling. These
                                                   activities, performed
                                                   on a farm's own RACs,
                                                   are inside the farm
                                                   definition.
                               .................  Activities that fit
                                                   the definition of
                                                   packing when
                                                   performed on a farm
                                                   on any other foods,
                                                   including RACs grown
                                                   or raised on a farm
                                                   not under the same
                                                   ownership, include
                                                   putting individual
                                                   unit cartons into a
                                                   larger box used for
                                                   shipping, and putting
                                                   articles of produce
                                                   in non-consumer
                                                   containers (such as
                                                   shipping crates)--the
                                                   same activities that
                                                   fit the definition of
                                                   packing off farm.
                                                   These activities,
                                                   performed on food
                                                   other than a farm's
                                                   own RACs, are outside
                                                   the farm definition
                                                   unless done on food
                                                   for consumption on
                                                   the farm.
Holding......................  Notes: Storage of  Notes: Storage of
                                food.              food, or activities
                                                   traditionally
                                                   performed by farms
                                                   for the safe or
                                                   effective storage of
                                                   RACs grown or raised
                                                   on that farm or
                                                   another farm under
                                                   the same ownership.
                                                   Holding does not
                                                   include activities
                                                   that change a RAC
                                                   into a processed
                                                   food. Activities that
                                                   are holding are
                                                   within the farm
                                                   definition when they
                                                   are performed on food
                                                   grown, raised, or
                                                   consumed on that farm
                                                   or another farm under
                                                   the same ownership;
                                                   under any other
                                                   circumstances they
                                                   are outside the farm
                                                   definition.
Holding......................  Example: Storing   Examples: activities
                                food, such as in   that fit the
                                a warehouse.       definition of holding
                                                   when performed on a
                                                   farm's own RACs
                                                   include fumigating
                                                   during storage, and
                                                   storing food, such as
                                                   in a warehouse. These
                                                   activities, performed
                                                   on a farm's own RACs,
                                                   are inside the farm
                                                   definition.
                               .................  An activity that fits
                                                   the definition of
                                                   holding when
                                                   performed on a farm
                                                   on any other foods,
                                                   including RACs grown
                                                   or raised on a farm
                                                   not under the same
                                                   ownership, is storing
                                                   food, such as in a
                                                   warehouse--the same
                                                   activity that fits
                                                   the definition of
                                                   holding off farm.
                                                   This activity,
                                                   performed on food
                                                   other than a farm's
                                                   own RACs, is outside
                                                   the farm definition
                                                   unless done on food
                                                   for consumption on
                                                   the farm.

[[Page 3683]]

 
Manufacturing/...............  Notes: Making      Notes: Making food
Processing...................   food from one or   from one or more
                                more               ingredients, or
                                ingredients, or    synthesizing,
                                synthesizing,      preparing, treating,
                                preparing,         modifying, or
                                treating,          manipulating food;
                                modifying, or      except for things
                                manipulating       that fall into the
                                food. Includes     categories of
                                packaging          harvesting, packing,
                                (putting food in   or holding (see rows
                                a container that   above). Activities
                                directly           that are
                                contacts food      manufacturing/
                                and that the       processing are
                                consumer           outside the farm
                                receives).         definition unless
                                                   done on food for
                                                   consumption on the
                                                   farm.
Manufacturing/...............  Examples:          Examples: Activities
Processing...................   Activities that    that fit the
                                fit this           definition of
                                definition         manufacturing/
                                include washing,   processing when
                                trimming of        performed on a farm's
                                outer leaves,      own RACs include
                                removing stems     slaughtering animals
                                and husks,         or post-slaughter
                                sifting,           operations,
                                filtering,         irradiation, cutting/
                                threshing,         coring/chopping/
                                shelling,          slicing, canning,
                                cooling,           coating with things
                                packaging,         other than wax/oil/
                                mixing, coating,   resin, drying that
                                stickering/        creates a distinct
                                labeling,          commodity, artificial
                                drying, sorting/   ripening, cooking,
                                grading/culling    pasteurizing/
                                not incidental     homogenizing,
                                to packing or      infusing, distilling,
                                holding,           salting, smoking,
                                fumigating,        grinding/milling, and
                                slaughtering       freezing. These
                                animals or post-   activities, performed
                                slaughter          on a farm's own RACs,
                                operations,        are outside the farm
                                irradiation,       definition unless
                                cutting/coring/    done on food for
                                chopping/          consumption on the
                                slicing,           farm.
                                canning,
                                artificial
                                ripening,
                                cooking,
                                pasteurizing/
                                homogenizing,
                                infusing,
                                distilling,
                                salting,
                                smoking,
                                grinding/
                                milling, and
                                freezing.
                               .................  Activities that fit
                                                   the definition of
                                                   manufacturing/
                                                   processing when
                                                   performed on a farm
                                                   on any other foods,
                                                   including RACs grown
                                                   or raised on a farm
                                                   not under the same
                                                   ownership include
                                                   washing, trimming of
                                                   outer leaves,
                                                   removing stems and
                                                   husks, sifting,
                                                   filtering, threshing,
                                                   shelling, cooling,
                                                   packaging, mixing,
                                                   coating, stickering/
                                                   labeling, drying,
                                                   sorting/grading/
                                                   culling not
                                                   incidental to packing
                                                   or holding,
                                                   fumigating,
                                                   slaughtering animals
                                                   or post-slaughter
                                                   operations,
                                                   irradiation, cutting/
                                                   coring/chopping/
                                                   slicing, canning,
                                                   artificial ripening,
                                                   cooking, pasteurizing/
                                                   homogenizing,
                                                   infusing, distilling,
                                                   salting, smoking,
                                                   grinding/milling, and
                                                   freezing--the same
                                                   activities that fit
                                                   the definition of
                                                   manufacturing/
                                                   processing off farm.
                                                   These activities,
                                                   performed on food
                                                   other than a farm's
                                                   own RACs, are outside
                                                   the farm definition
                                                   unless done on food
                                                   for consumption on
                                                   the farm.
------------------------------------------------------------------------

3. Proposed Technical Amendments and Conforming Changes
    As a technical amendment for clarity and for consistency with our 
current approach to citing the FD&C Act in new regulations, FDA is 
proposing to delete the definition of ``Act'' in current Sec.  1.227 of 
the section 415 registration regulations and revise all remaining 
definitions in current Sec.  1.227 to refer to ``the Federal Food, 
Drug, and Cosmetic Act'' rather than ``the act.'' As a conforming 
change, FDA is proposing to revise current Sec.  1.241 in the section 
415 registration regulations to refer to ``the Federal Food, Drug, and 
Cosmetic Act'' rather than ``the act.''
    Likewise, as a technical amendment for clarity and for consistency 
with our current approach to citing the FD&C Act in new regulations, 
FDA is proposing to delete the definition of ``Act'' in current Sec.  
1.328 of the section 414 recordkeeping regulations and revise all 
remaining definitions in current Sec.  1.328 to refer to ``the Federal 
Food, Drug, and Cosmetic Act'' rather than ``the act.'' As a conforming 
change, FDA is proposing to revise current Sec. Sec.  1.361 and 1.363 
in the section 414 registration regulations to refer to ``the Federal 
Food, Drug, and Cosmetic Act'' rather than ``the act.''
    As a conforming change to the proposed definition of 
``harvesting,'' FDA is proposing to revise the definition of ``Farm'' 
in current Sec. Sec.  1.227(b)(3) and 1.328 to delete examples of 
harvesting that currently appear in that definition. With the proposed 
new, separate definition of harvesting, it would be redundant to retain 
the examples of harvesting within the definition of ``Farm.''
    As a conforming change to the proposed redesignation of Sec.  1.227 
to eliminate paragraph designations, FDA is proposing to revise Sec.  
1.276(b)(9) in the prior notice regulations to cross-reference Sec.  
1.227 (without any paragraph designations) rather than to cross-
reference Sec.  1.227(b)(6).

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

1. Approach
    FDA has previously addressed whether various activities fall within 
the farm definition or not and, as discussed more fully in sections 
VIII.F.2 through VIII.F.5 of this document, has provided guidance on 
these issues in the rulemakings establishing the section 415 
registration regulations and the section 414 recordkeeping regulations 
and in accompanying guidance (Ref. 116) (Ref. 117). For most of the 
activities FDA has previously addressed, applying the proposed 
definitions described in section VIII.E of this document would result 
in the same classification with respect to whether the activities are 
within the farm definition or not. However, because we have not 
previously articulated a comprehensive set of organizing principles 
that form the basis for classification of activities, in some cases the 
classification of an activity (e.g., packing, holding, or harvesting), 
or the rationale leading to the classification of an activity, may be 
different under the proposed revisions to the definitions in part 1 
than under the current definitions in part 1.
    In sections VIII.F.2 through VIII.F.5 of this document, we discuss 
several examples of activities that we previously addressed and 
interpreted during the rulemakings to establish the section 415 
registration regulations and the section 414 recordkeeping

[[Page 3684]]

regulations, or in related guidances. We also explain what, if any, 
impact our proposed revisions to the definitions in part 1 would have 
on our interpretation of whether or how an activity conducted on a farm 
or a farm mixed-type facility would be within the farm definition or 
would be outside the farm definition (and, thus, trigger the section 
415 registration regulations and be within the scope of section 418 of 
the FD&C Act). We focus on examples of activities where we consider 
that the proposed revisions to the definitions in part 1 would result 
in some change in outcome. For the convenience of the reader, in 
section VIII.F.6 of this document we provide a table summarizing these 
examples.
    In sections VIII.F.2 through VIII.F.5 of this document, for the 
sake of simplicity, we discuss activities that would be classified as 
manufacturing/processing outside the farm definition under this 
proposal, without stating each time that such activities would still be 
within the farm definition if performed on food for a farm or farm 
mixed-type facility's own consumption. The discussion below should not 
be read to suggest that the activities discussed could not be within 
the farm definition if they were performed on food for a farm or farm 
mixed-type facility's own consumption.
2. Application of Pesticides to a Farm or Farm Mixed-Type Facility's 
Own Raw Agricultural Commodities
    The general term ``treating'' is part of the definition of 
manufacturing/processing in current Sec. Sec.  1.227(b)(6) and 1.328, 
and would remain in the proposed revision to that definition. FDA 
previously addressed ``treating against pests'' on farms and farm 
mixed-type facilities in the preamble to the interim final rule on food 
facility registration (68 FR 58894 at 58905), the Food Facility 
Registration Guidance (Questions 2.5, 2.6, and 11.1) (Ref. 116), and 
the preamble to the Establishment and Maintenance of Records final rule 
(69 FR 71562, 71587, December 9, 2004). In those documents, FDA 
previously concluded that treating crops against pests by applying 
pesticides prior to harvest is an integral part of growing crops and is 
therefore ``growing'' within the farm definition. For other post-
harvest pesticide applications FDA previously concluded that the 
applications are manufacturing/processing outside the farm definition, 
because such applications are directed at the food rather than at the 
entire plant. However, for one specific postharvest pesticide 
application (i.e., applying wash water containing chlorine), FDA 
previously concluded both that some uses are washing within the farm 
definition and that another use is manufacturing/processing outside the 
farm definition. Specifically, FDA previously concluded that the 
following two uses of water containing chlorine are washing within the 
farm definition: (1) The application by a farm of chlorinated water 
from public or other water supplies that are chlorinated for other 
purposes and (2) the application by a farm of wash water containing 
chlorine added by the farm to wash water at levels below 200 parts per 
million (ppm) total chlorine. FDA also previously concluded that the 
application by a farm of wash water containing chlorine added by the 
farm to wash water at levels above 200 ppm is manufacturing/processing 
outside the farm definition because such levels constitute treating the 
crop against pests rather than washing.
    Some but not all of these previous conclusions regarding the 
application of a pesticide to a farm or farm mixed-type facility's own 
RACs would change under the proposed revisions to part 1. Under both 
the current definitions in part 1 and the proposed revisions to those 
definitions, treatment of food crops against pests before harvest while 
the crop is still in the growing area has been, and would continue to 
be, considered an inherent part of the growing process and thus 
classified within the farm definition. Thus, the classification of such 
treatments would not be affected by the proposed revisions to part 1.
    However, under the proposed revisions to part 1 FDA would now 
classify pesticide treatments of a farm's own RACs or a farm mixed-type 
facility's own RACs for the purpose of safe or effective storage to be 
holding within the farm definition rather than manufacturing/processing 
outside the farm definition. An example of such activity is fumigating 
a farm's own raw nuts to prevent insect infestation and damage during 
the potentially long storage period of the nuts. FDA is aware that such 
treatments are traditionally performed by farms and may be a practical 
necessity for the preservation of some crops during storage, and such 
treatments do not transform a RAC into a processed food. Thus, these 
treatments fit the proposed definition of ``holding'' applicable to 
farms and farm mixed-type facilities with respect to their own RACs.
    Likewise, under the proposed revisions to part 1 FDA would now 
classify pesticide treatment of a farm's own RACs or a farm mixed-type 
facility's own RACs for the purpose of removing the crop from the 
growing area and preparing it for use as food to be harvesting. An 
example of such activity is washing a crop in water containing an 
antimicrobial chemical after removing the crop from the growing area. 
Generally, antimicrobial chemicals are intended only to ensure the 
safety of the wash water. However, if an antimicrobial chemical was 
also intended to reduce the microbial load on the crop itself as a 
safety measure, under the proposed revisions to part 1 addition of that 
antimicrobial chemical to reduce the microbial load on a farm's own 
RACs or a farm mixed-type facility's own RACs would now be classified 
within the farm definition rather than be classified as manufacturing/
processing outside the farm definition. For example, the application of 
wash water containing chlorine added by the farm at levels above 200 
ppm to its own RACs would now be classified as washing and/or treating 
(depending on the circumstances), either of which would be harvesting 
within the farm definition rather than as manufacturing/processing 
outside the farm definition. FDA is aware that such treatments are 
traditionally performed by farms and that they are part of preparing 
the crop for safe use as food, and such treatments do not transform a 
RAC into a processed food. Thus, these treatments fit the proposed 
definition of ``harvesting'' applicable to farms and farm mixed-type 
facilities with respect to their own RACs. Except for the two examples 
discussed above where FDA previously concluded that certain 
applications of water containing chlorine are washing within the farm 
definition, the classification of washing a crop in water containing an 
antimicrobial chemical as within the farm definition would represent a 
change from its previous classification as manufacturing/processing 
outside the farm definition.
    Continuing to use the general term ``treating'' in the proposed 
definition of manufacturing/processing in Sec. Sec.  1.227 and 1.328 is 
not in conflict with the tentative conclusions FDA is reaching in this 
document. First, the general term ``treating'' refers broadly to 
treatments of any kind, and not specifically ``treating against 
pests.'' Under both the current definitions and the proposed revisions 
to the definitions, some ``treating'' (e.g., delivering a heat 
treatment) has been, and would continue to be, classified as 
manufacturing/processing outside the farm definition. Second, for a 
farm or farm mixed-type facility conducting operations on its own RACs, 
only those activities that do not satisfy either the

[[Page 3685]]

expanded definition of packing or holding, or the new definition of 
harvesting, would be classified as manufacturing/processing outside the 
farm definition. Thus, although application of a pesticide treatment to 
a farm's own RACs would now be classified within the farm definition 
when such treatment falls within the categories of holding or 
harvesting, application of a pesticide treatment off-farm has been, and 
would be continue to be, classified as manufacturing/processing outside 
the farm definition, because the exclusion applicable to a farm or farm 
mixed-type facility operating on its own RACs would not apply.
3. Coating a Farm or Farm Mixed-Type Facility's Own Raw Agricultural 
Commodities for Storage or Transport (e.g., Wax, Oil, or Resin 
Coatings)
    FDA lists ``waxing'' as an example of a manufacturing/processing 
activity in the definition of that term in current Sec. Sec.  
1.227(b)(6) and 1.328, and waxing would remain as an example in the 
proposed revision to that definition. In addition, FDA has previously 
addressed ``waxing'' on farms and farm mixed-type facilities in the 
preamble to the interim final rule on Food Facility Registration (68 FR 
58894 at 58912) and the preamble to the Establishment and Maintenance 
of Records final rule (69 FR 71562 at 71587). In those documents, FDA 
previously concluded that on-farm waxing was manufacturing/processing 
outside the farm definition.
    This previous conclusion that on-farm waxing was manufacturing/
processing outside the farm definition would change for certain types 
of waxing under the proposed revisions to part 1. Under those proposed 
revisions, applying a coating to a farm or farm mixed-type facility's 
own RACs for the purpose of protecting them during storage or 
transport, and not to create a distinct commodity, would now be within 
the expanded definition of packing and thus be classified within the 
farm definition rather than be classified as manufacturing/processing 
outside the farm definition. Examples of such coatings are waxes, oils, 
and resins applied to fresh produce such as cucumbers, apples, and 
avocados. FDA is aware that such treatments are traditionally performed 
by farms to prepare crops for storage or transport. These coatings do 
not transform a RAC into a processed food. Thus, these treatments fit 
the proposed definition of ``packing'' applicable to farms and farm 
mixed-type facilities with respect to their own RACs. By contrast, if a 
farm or a farm mixed-type facility applies a coating to its own RACs in 
a manner that creates a distinct commodity (e.g., coating nuts in 
chocolate or coating apples in caramel), that activity would create a 
processed food and would not fit the expanded definition of packing. 
Thus, the act of applying the coating would continue to be classified 
as manufacturing/processing outside the farm definition.
    Continuing to use ``waxing'' as an example in the proposed 
definition of manufacturing/processing in Sec. Sec.  1.227 and 1.328 is 
not in conflict with these tentative conclusions. As explained with 
respect to pesticide treatments, activities that are conducted on a 
farm or farm mixed-type facility and are within the expanded 
definitions of packing and holding, or the new definition of 
harvesting, would be classified within the farm definition rather than 
classified as manufacturing/processing outside the farm definition. The 
current definition of manufacturing/processing in Sec. Sec.  
1.227(b)(6) and 1.328 and the examples of harvesting within the 
definition of farm in Sec. Sec.  1.227(b)(3) and 1.328 demonstrate that 
FDA has consistently cited some activities as examples of 
manufacturing/processing as a general matter, but classified them 
differently in specific situations based on relevant circumstances. 
Washing, trimming, and cooling are all examples of manufacturing/
processing in current Sec. Sec.  1.227(b)(6) and 1.328, but washing, 
trimming outer leaves of, and cooling produce are part of harvesting in 
the farm definition in current Sec. Sec.  1.227(b)(3) and 1.328. Use of 
an activity as an example of manufacturing/processing in current 
Sec. Sec.  1.227(b)(6) and 1.328, or the proposed revision of that 
definition, does not represent a conclusion that the activity is always 
classified as manufacturing/processing under all circumstances. FDA 
expects that its proposed revisions to part 1 will clarify this.
4. Drying a Farm or Farm Mixed-Type Facility's Own Raw Agricultural 
Commodities To Create a Distinct Commodity
    FDA has previously addressed drying RACs on farms and farm mixed-
type facilities in the Food Facility Registration Guidance (Ref. 116) 
and the Recordkeeping Guidance (Ref. 117). In those documents, FDA 
previously reached three conclusions relevant to drying: (1) Drying 
peppermint naturally during storage in a barn would not be 
manufacturing/processing; (2) drying hay naturally or artificially is 
an essential part of harvesting hay to prevent spontaneous combustion 
and is therefore not manufacturing/processing; and (3) drying alfalfa 
would be part of harvesting if it was an activity traditionally 
performed during the removing of the crop from the field through the 
safe storage of the crop.
    One of these previous conclusions regarding drying (i.e., the 
previous conclusion regarding drying herbs) would change under the 
proposed revisions to part 1. As discussed in section VIII.D of this 
document, FDA tentatively concludes that the question of whether an 
activity transforms a RAC into a processed food should be part of 
defining what activities are within the farm definition, because RACs 
are essential products of farms and processed foods are not. Thus, 
activities that transform foods from RACs into processed foods would 
not be within the expanded definitions of packing or holding, or the 
new definition of harvesting, that apply to farms and farm mixed-type 
facilities conducting activities on their own RACs. Instead, anything 
that transforms a RAC into a processed food would be classified as 
manufacturing/processing outside the farm definition (unless it is done 
only for consumption on the farm or farm mixed-type facility).
    In the Antimicrobial Guidance (Ref. 118), FDA approved of and 
referenced the 1996 EPA interpretive ruling entitled ``Pesticides; 
Status of Dried Commodities as Raw Agricultural Commodities'' (61 FR 
2386). As discussed briefly in section VIII.D of this document, in the 
1998 EPA/FDA Joint Policy Interpretation and the Antimicrobial 
Guidance, FDA and EPA concluded that a RAC becomes a processed food 
when it is dried, unless the purpose of the drying is to facilitate 
transportation or storage of the commodity prior to processing. As a 
practical matter, this means that some RACs become processed foods when 
they are dried, because the drying creates a distinct commodity from 
the RAC. An example of this kind of drying is drying grapes to create 
raisins; raisins are processed foods (61 FR 2386 at 2388). When the 
drying is for the purpose of storage or transport and does not create a 
distinct commodity, however (such as for grains, nuts, legumes, hays, 
other grasses, hops, rice, beans, and corn), the dried commodity 
remains a RAC (61 FR 2386 at 2388).
    Accordingly, under the proposed revisions to part 1 drying hay and 
alfalfa would now be classified within the expanded definitions of 
packing or holding, depending on how the drying is conducted (before 
storage or during storage, respectively), because these crops are 
traditionally dried by farms for

[[Page 3686]]

the purpose of preparing for storage or transport (for packing) or for 
safe and effective storage (for holding), and because drying these 
crops does not create a distinct commodity (so the dried commodity is 
still a RAC). Drying hay and alfalfa in the manner FDA previously 
discussed would continue to be classified within the farm definition. 
In contrast, drying herbs such as peppermint would now be classified as 
manufacturing/processing outside the farm definition, because drying an 
herb creates a distinct commodity and therefore a processed food, just 
as drying a fruit creates a distinct commodity and therefore a 
processed food.
5. Off-Farm Packaging of Raw Agricultural Commodities
    Current Sec. Sec.  1.227(b)(8) and 1.328 define ``packaging'' (when 
used as a verb) as placing food into a container that directly contacts 
the food and that the consumer receives, and that definition of 
``packaging'' would remain unchanged under the proposed revisions to 
the definitions in part 1. Packaging is listed as an example of 
manufacturing/processing in current Sec. Sec.  1.227(b)(6) and 1.328 
(as well as in Sec.  1.226(a)), and would continue to be listed as an 
example of manufacturing/processing under the proposed revisions to 
part 1. As discussed in section VIII.E.2 of this document, current 
Sec. Sec.  1.227(b)(9) and 1.328 distinguish ``packaging'' from 
``packing'' and define ``packing'' as placing food into a container 
other than packaging the food. Under the proposed revisions to the 
definitions in part 1, that definition of ``packing'' would be expanded 
to include activities traditionally performed by farms for the safe or 
effective storage of RACs grown or raised on the same farm or another 
farm under the same ownership, but would not include activities that 
transform a RAC, as defined in section 201(r) of the FD&C Act, into a 
processed food as defined in section 201(gg) of the FD&C Act.
    FDA has previously addressed packaging on farms and farm mixed-type 
facilities, and off-farm, in the Food Facility Registration Guidance 
(Ref. 116), the preamble to the Establishment and Maintenance of 
Records final rule (69 FR 71562 at 71587), and the Recordkeeping 
Guidance (Ref. 117). In those documents, FDA previously reached four 
conclusions relevant to ``packaging'' and ``packing'' activities on 
farms and farm mixed-type facilities: (1) Placing RACs into consumer-
ready containers (e.g., placing strawberries in clamshell packages, and 
placing eggs in a carton) both on the farm that grew them and at off-
farm packing houses is ``more akin to packing'' than packaging (despite 
meeting the definition of packaging) because it does not alter the form 
of the food, so it is not manufacturing/processing; (2) bottling wine 
(placing it in a container that touches the food and that the consumer 
receives) is packaging and therefore manufacturing/processing because 
it preserves the manufactured condition of the wine; (3) placing cereal 
in a plastic cereal box liner is packaging and therefore manufacturing/
processing; and (4) placing apples received from elsewhere in bulk into 
plastic bags is packaging and therefore manufacturing/processing.
    Most of these conclusions would remain the same under the proposed 
revisions to part 1, although the reasoning for those conclusions would 
instead be based on the organizing principles articulated in the 
proposed revisions to the definitions in part 1. Specifically, bottling 
wine and placing cereal in plastic box liners would continue to be 
classified as packaging and therefore manufacturing/processing, 
regardless of where such activities are performed, because those foods 
are processed foods to which the expanded proposed definition of 
packing would not be applicable. Placing apples received from elsewhere 
in bulk into plastic bags would continue to be classified as packaging 
and therefore manufacturing/processing, because the activity is 
conducted on others' RACs.
    Under the proposed revisions to the definitions in part 1, a farm 
or farm mixed-type facility that places its own RACs in consumer 
containers that contact the food would now be classified as packing 
because farms traditionally do this to prepare their RACs for storage 
or transport, and this activity does not transform the RACs into a 
processed food. Examples of this kind of activity include an egg farm 
putting its own eggs in cartons, a strawberry farm placing its own 
strawberries in clamshell packages, or an apple farm placing its own 
apples into plastic bags. Such packing activities would continue to be 
classified within the farm definition.
    Under the proposed revisions to part 1, there would be a change in 
how FDA considers the act of placing RACs into consumer containers (1) 
off-farm and (2) on a farm or farm mixed-type facility with respect to 
others' RACs. Off-farm, the expanded definition of packing would not 
apply, so this activity would be now be classified as packaging (and, 
therefore, manufacturing/processing). Off-farm, as a practical matter 
this change should have no practical impact because off-farm 
establishments that conduct this activity are already required to 
register under section 415 of the FD&C Act, and therefore already are 
subject to section 418 of the FD&C Act, whether this activity is 
classified as packing or manufacturing/processing. However, on a farm 
or farm mixed-type facility that places others' RACs into consumer 
containers, this activity would now be classified as packaging and 
therefore manufacturing/processing, because the expanded definition of 
packing would only apply to a farm's own RACs. This change in 
classification would impact a farm or farm mixed-type facility that 
conducts such activities if it is not currently required to register. 
This classification result is consistent with the organizing principles 
articulated in section VIII.D of this document because, while it may be 
a practical necessity for a farm to place its own fragile RACs in 
consumer packages to protect them during storage and transport, 
packaging others' RACs is not part of the essential purpose of a farm 
(producing the farm's own RACs). Farms that conduct such activities are 
acting as distributors for another farm's products and FDA considers 
that the activities they conduct on others' RACs should be classified 
as manufacturing/processing, packing, or holding in the same manner as 
are activities performed by off-farm distributors of RACs. Therefore 
FDA tentatively concludes that these activities should now be outside 
the farm definition. We seek comment on this proposal.
6. Summary of Examples of the Impact of the Proposed Revisions to the 
Definitions in 21 CFR Part 1 on a Farm or Farm Mixed-Type Facility
    For the convenience of the reader, Table 5 summarizes the examples 
discussed in sections VIII.F.2 through VIII.F.5 of this document.

[[Page 3687]]



   Table 5--Summary of the Examples of the Impact of the Proposed Revisions to the Definitions in 21 CFR Part 1 on a Farm or Farm Mixed-Type Facility
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                  Using the
                                                               Using FDA's current       How would FDA       classification under
                                      How does FDA classify   classification, would  classify the activity   the proposed revised        Would the
                                     the activity under the      conducting the        under the proposed     definitions, would    classification under
              Activity               current definitions in   activity trigger the      revisions to the        conducting the      the proposed revised
                                     Sec.  Sec.   1.227 and        section 415        definitions in Sec.    activity trigger the  definitions represent
                                             1.328?               registration          Sec.   1.227 and         section 415             a change?
                                                                  regulations?               1.328?              registration
                                                                                                                 regulations?
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                Application of Pesticide
--------------------------------------------------------------------------------------------------------------------------------------------------------
Applying pesticides to own RACs      Growing within the      No....................  Growing within the     No...................  No.
 prior to harvest.                    farm definition                                 farm definition
                                      (because it is an                               (because it is an
                                      integral part of                                integral part of
                                      growing crops).                                 growing crops).
Fumigating own raw nuts to prevent   Manufacturing/          Yes...................  Holding within the     No...................  Yes.
 insect infestation and damage        processing outside                              farm definition (for
 during the potentially long          the farm definition                             the purpose of safe
 storage period of the nuts.          (because application                            or effective
                                      of pesticides after                             storage).
                                      harvest is
                                      necessarily directed
                                      at the food, not the
                                      entire plant).
Use of pesticides in wash water      Harvesting within the   Depends on source and   Harvesting within the  No...................  Yes.
 applied to own RACs.                 farm definition if      level of chlorine in    farm definition
                                      water is from a         water; FDA has not      (washing and/or
                                      public or other         previously addressed    treating against
                                      supply chlorinated      chemicals other than    pests for the
                                      for other purposes,     chlorine.               purpose of removing
                                      or if chlorine is                               the crop from the
                                      added at 200 ppm or                             growing area and
                                      less (washing that                              preparing it for use
                                      does not treat the                              as food).
                                      crop); manufacturing/
                                      processing outside
                                      the farm definition
                                      if chlorine is added
                                      at levels above 200
                                      ppm.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         Coating
--------------------------------------------------------------------------------------------------------------------------------------------------------
Applying coatings to own RACs        Manufacturing/          Yes, for waxing         Waxes, oils, and       Waxes, oils, and       Yes.
 (e.g., applying waxes, oils, and     processing outside      generally; FDA has      resins on fresh        resins on fresh
 resins to fresh produce; coating     the farm definition     not previously          produce: Packing       produce: No.
 raw nuts in chocolate; coating       (waxing generally,      addressed other         within the farm       Chocolate on nuts or
 apples in caramel).                  not specific to fresh   coatings.               definition (for the    caramel on apples:
                                      produce).                                       purpose of             Yes.
                                                                                      protecting them
                                                                                      during storage or
                                                                                      transport, and not
                                                                                      to create a distinct
                                                                                      commodity);
                                                                                     Chocolate on nuts or
                                                                                      caramel on apples:
                                                                                      Manufacturing/
                                                                                      processing outside
                                                                                      the farm definition
                                                                                      (creates a distinct
                                                                                      commodity and thus
                                                                                      creates a processed
                                                                                      food).
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         Drying
--------------------------------------------------------------------------------------------------------------------------------------------------------
Drying peppermint naturally during   Storage within the      No....................  Manufacturing/         Yes..................  Yes.
 storage in a barn.                   farm definition.                                processing outside
                                                                                      the farm definition
                                                                                      (transforms a RAC
                                                                                      into a processed
                                                                                      food).

[[Page 3688]]

 
Drying hay naturally or              Harvesting within the   No....................  Packing or holding     No...................  No.
 artificially.                        farm definition (an                             within the farm
                                      essential part of                               definition
                                      harvesting hay to                               (depending on
                                      prevent spontaneous                             whether the drying
                                      combustion).                                    is before storage or
                                                                                      during storage).
Drying alfalfa.....................  Harvesting within the   No....................  Packing within the     No...................  No.
                                      farm definition                                 farm definition
                                      (traditionally                                  (done before storage
                                      performed during the                            to prepare a RAC for
                                      removing of the crop                            storage or transport
                                      from the field                                  and does not create
                                      through the safe                                a distinct
                                      storage of the crop).                           commodity).
Drying grapes to create raisins....  FDA has not previously  FDA has not previously  Manufacturing/         Yes..................  Yes (because FDA is
                                      addressed this          addressed this          processing outside                            addressing this
                                      activity.               activity.               the farm definition                           activity for the
                                                                                      (transforms a RAC                             first time).
                                                                                      into a processed
                                                                                      food).
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Packing/Packaging
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bottling wine......................  Packaging, which is     Yes...................  Packaging, which is    Yes..................  No.
                                      manufacturing/                                  manufacturing/
                                      processing outside                              processing outside
                                      the farm definition                             the farm definition
                                      (because it preserves                           (because the food is
                                      the manufactured                                a processed food so
                                      condition of the                                the expanded
                                      wine).                                          definition of
                                                                                      packing does not
                                                                                      apply).
Placing cereal in a plastic cereal   Packaging, which is     Yes...................  Packaging, which is    Yes..................  No.
 box liner.                           manufacturing/                                  manufacturing/
                                      processing outside                              processing outside
                                      the farm definition.                            the farm definition
                                                                                      (because the food is
                                                                                      a processed food so
                                                                                      the expanded
                                                                                      definition of
                                                                                      packing does not
                                                                                      apply).
Placing a farm's or farm mixed-type  Packing within the      No....................  Packing within the     No...................  No.
 facility's own RACs into consumer-   farm definition                                 farm definition
 ready containers (e.g., placing      (because it does not                            (because farms
 strawberries in clamshell            alter the form of the                           traditionally do
 packages, and placing eggs in a      food).                                          this to prepare
 carton).                                                                             their RACs for
                                                                                      storage or
                                                                                      transport, and this
                                                                                      activity does not
                                                                                      transform the RACs
                                                                                      into a processed
                                                                                      food).
Placing others' RACs into consumer-  Packaging, which is     Yes...................  Packaging, which is    Yes..................  No.
 ready packages on a farm or farm     manufacturing/                                  manufacturing/
 mixed-type facility (e.g., placing   processing outside                              processing outside
 others' apples received in bulk      the farm definition.                            the farm definition
 into plastic bags).                                                                  (because the
                                                                                      activity is
                                                                                      conducted on others'
                                                                                      RACS).

[[Page 3689]]

 
Placing others' RACs into consumer-  Packing (because it     Yes...................  Packaging, which is    Yes..................  Yes, but while the
 ready containers off-farm (e.g.,     does not alter the                              manufacturing/                                classification of
 placing strawberries in clamshell    form of the food),                              processing (because                           the activity changes
 packages, and placing eggs in a      but not within the                              the activity is                               from packing to
 carton at a facility not co-         farm definition                                 conducted off-farm,                           manufacturing/
 located on a farm or farm mixed-     because conducted off-                          so the expanded                               processing, under
 type facility).                      farm.                                           definition of                                 both the current and
                                                                                      packing does not                              proposed revised
                                                                                      apply).                                       definitions, the
                                                                                                                                    activity would
                                                                                                                                    trigger
                                                                                                                                    registration.
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

    As discussed in section VIII.A.2 of this document, section 
103(c)(1)(C) of FSMA directs the Secretary to conduct a science-based 
risk analysis as part of the section 103(c) rulemaking. The science-
based risk analysis is to cover ``(i) 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 (ii) 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 used in section 103(c)(1) of FSMA, the term ``risk analysis'' is 
ambiguous. One interpretation is that the common meaning of the term is 
intended--a simple evaluation of whether activity/food combinations are 
likely to result in the consumer becoming ill. Another interpretation 
is that the ``risk analysis'' should be consistent with the formal 
definition and related terms used by Codex with respect to food safety 
(Ref. 119):
     Risk is a function of the probability of an adverse health 
effect and the severity of that effect, consequential to a hazard(s) in 
food.
     Risk analysis is a process consisting of three components: 
risk assessment, risk management and risk communication.
     Risk assessment is a scientifically-based process 
consisting of hazard identification, hazard characterization, exposure 
assessment, and risk characterization.
     Risk management is the process, distinct from risk 
assessment, of weighing policy alternatives, in consultation with 
interested parties, considering risk assessment and other factors 
relevant for the health protection of consumers and for the promotion 
of fair trade practices, and, if needed, selecting appropriate 
prevention and control options.
     Risk communication is the interactive exchange of 
information and opinions throughout the risk analysis process 
concerning risk, risk-related factors and risk perceptions, among risk 
assessors, risk managers, consumers, industry, the academic community 
and other interested parties, including the explanation of risk 
assessment findings and the basis of risk management decisions.
    Because section 103(c)(1)(C) of FSMA calls for a science-based risk 
analysis, we are applying the Codex definitions to the extent possible. 
It is not clear whether the requirement of section 103(c)(1)(C) of FSMA 
to conduct a science-based risk analysis was intended to encompass all 
three components of risk analysis. Section 103(c)(1)(D) of FSMA 
requires the Secretary to consider the results of the science-based 
risk analysis and exempt certain facilities from the requirements in 
section 418 of the FD&C Act, including hazard analysis and preventive 
controls, and the mandatory inspection frequency of section 421, or to 
modify those requirements for facilities engaged in on-farm 
manufacturing, processing, packing or holding activities determined to 
be low risk involving foods determined to be low risk. Thus, section 
103(c)(1)(D) of FSMA is focused on ensuring that the agency's risk 
management decisions with respect to exempting or modifying 
requirements applicable to low-risk on-farm activity/food combinations 
under sections 418 and 421 are science-based, as determined by an 
analysis of the risk of specific types of on-farm activity/food 
combinations required by section 103(c)(1)(C). We therefore tentatively 
conclude that the analysis required by section 103(c)(1)(C) should be 
limited to an assessment of the risk of specific types of on-farm 
activity/food combinations for the purposes of making the risk 
management decisions required by section 103(c)(1)(D). The risk 
communication component of the risk analysis is accomplished through 
the discussion of that assessment in this document, the opportunities 
for public comment (on the risk assessment and on this proposed rule), 
and our evaluation of, and response to, comments in a final rule.
    Consistent with this approach, we conducted a qualitative risk 
assessment (Ref. 115) (``Section 103(c)(1)(C) draft RA'') related to 
activity/food combinations for the purpose of determining which 
activity/food combinations would be considered low risk. We focused on 
activity/food combinations that we identified as being conducted on 
farms (and, thus, might be conducted by farm mixed-type facilities), 
but we did not consider activity/food combinations that would be solely 
within the farm definition (such as growing fruits and vegetables) and, 
thus, are not relevant to the requirements of section 103 of FSMA. We 
focused on considering the risk of activity/food combinations rather 
than separately considering the risk of specific food categories 
because doing so better enabled us to focus on whether

[[Page 3690]]

a specific manufacturing, processing, packing, or holding activity 
conducted on food by a farm mixed-type facility warranted an exemption 
from, or modified requirements for, the provisions of section 418 of 
the FD&C Act.
    Elsewhere in this issue of the Federal Register, FDA is making the 
section 103(c)(1)(C) draft RA available for public comment. We will 
consider comments regarding the section 103(c)(1)(C) draft RA in 
preparing a final version of the RA and will announce the availability 
of the final version of the RA when it is available. The final 
preventive controls rule will take into account the final version of 
the section 103(c)(1)(C) RA.

H. Results of the Qualitative Risk Assessment

    In this section, we report the results of the section 103(c)(1)(C) 
draft RA, arranged in three lists. References to ``farms'' in these 
lists should be understood to include farm mixed-type facilities. The 
lists are shaped by the proposed definitions for harvesting, 
manufacturing/processing, packing, or holding in the section 415 
registration regulations (discussed in section VIII.E of this 
document), the organizing principles (discussed in section VIII.D of 
this document) that form the basis for those proposed definitions, and 
the examples of activity classifications (discussed in section VIII.F 
of this document). As discussed in section VIII.E of this document, the 
same activity may be classified differently (among the categories of 
harvesting, manufacturing/processing, packing, or holding) depending on 
whether the food being operated upon is a RAC and whether the RAC was 
grown or raised on the farm or farm mixed-type facility performing the 
activity or a farm under the same ownership. We request comment on the 
lists in sections VIII.H.1 through VIII.H.3.
    For the purposes of this document, a fruit is the edible 
reproductive body of a seed plant or tree nut (such as apple, orange, 
and almond) such that fruit means the harvestable or harvested part of 
a plant developed from a flower. For the purposes of this document, a 
vegetable is the edible part of an herbaceous plant (such as cabbage or 
potato) or fleshy fruiting body of a fungus (such as white button or 
shiitake) grown for an edible part such that vegetable means the 
harvestable or harvested part of any plant or fungus whose fruit, 
fleshy fruiting bodies, seeds, roots, tubers, bulbs, stems, leaves, or 
flower parts are used as food and includes mushrooms, sprouts, and 
herbs (such as basil or cilantro). Examples of fruits and vegetables 
are apples, apricots, avocados, bananas, berries, broccoli, cabbage, 
cantaloupe, carrots, cauliflower, celery, cherries, citrus, cucumbers, 
garlic, grapes, green beans, herbs (such as basil, chives, cilantro, 
mint, oregano, and parsley), honeydew, kiwifruit, lettuce, mangos, 
mushrooms, onions, papaya, peaches, pears, peas, peppers, pineapple, 
plums, radish, scallions, snow peas, spinach, sprouts, squash, 
tomatoes, and watermelon. For the purposes of this document, grains 
means the small, hard fruits or seeds of arable crops, or the crops 
bearing these fruits or seeds, that are grown and processed for use as 
meal, flour, baked goods, cereals and oils rather than for fresh 
consumption (including cereal grains, pseudo cereals, oilseeds and 
other plants used in the same fashion). Examples of food grains include 
barley, dent- or flint-corn, sorghum, oats, rice, rye, wheat, amaranth, 
quinoa, buckwheat, cotton seed, and soybeans.
    For the purpose of the section 103(c)(1)(C) draft RA, ``intact 
fruits and vegetables'' refers only to fruits and vegetables other than 
cocoa beans, coffee beans, peanuts, sugar beets, sugarcane, and tree 
nuts. Cocoa beans, coffee beans, peanuts, sugar beets, sugarcane, and 
tree nuts can be considered part of ``fruits and vegetables'' as a 
general matter, but we addressed those foods separately for the purpose 
of section 103(c)(1)(C) draft RA in order to accurately reflect 
differences in activity/food combinations likely to be performed on 
farm mixed-type facilities on those foods as compared to other fruits 
and vegetables, as well as specific hazards associated with certain of 
those foods.
1. List of Low-Risk On-Farm Packing and Holding Activity/Food 
Combinations When Conducted on Food Not Grown, Raised, or Consumed on 
That Farm or Another Farm Under the Same Ownership
    The section 103(c)(1)(C) draft RA identified the following low-risk 
packing and holding activity/food combinations when conducted on a farm 
on food not grown, raised, or consumed on that farm or another farm 
under the same ownership--i.e., packing or re-packing (including 
weighing or conveying incidental to packing or re-packing); sorting, 
culling, or grading incidental to packing or storing; and storing 
(ambient, cold and controlled atmosphere) of:
     Hard candy, fudge, taffy, and toffee;
     Cocoa products;
     Cocoa beans and coffee beans (raw or roasted);
     Grains and grain products;
     Honey (raw and pasteurized);
     Intact fruits and vegetables;
     Jams, jellies and preserves;
     Maple sap for syrup and maple syrup;
     Peanuts and tree nuts;
     Soft drinks and carbonated water; and
     Sugar beets, sugarcane, and sugar.
    We note that the same activities performed on a farm's own RACs, or 
food consumed on the farm or another farm under the same ownership, 
would be within the farm definition and therefore were outside the 
scope of the section 103(c)(1)(C) draft RA.
2. List of Low-Risk On-Farm Manufacturing/Processing Activity/Food 
Combinations When Conducted on the Farm's Own Raw Agricultural 
Commodities for Distribution Into Commerce
    The section 103(c)(1)(C) draft RA identified the following low-risk 
manufacturing/processing activity/food combinations when conducted on a 
farm on the farm's own RACs for distribution into commerce:
     Artificial ripening of intact fruits and vegetables;
     Boiling/evaporation of maple sap to make maple syrup;
     Chopping raw peanuts and raw tree nuts;
     Coating (with coatings other than wax, oil, or resin used 
for the purpose of storage or transportation) intact fruits and 
vegetables (e.g., caramel apples) and raw peanuts and raw tree nuts 
(e.g., adding seasonings);
     Drying/dehydrating intact fruits and vegetables (without 
the addition of sulfites) where the drying creates a distinct commodity 
(e.g., drying fruits or herbs);
     Extracting oil from grains;
     Grinding/milling/cracking/crushing grains (e.g., making 
grain products such as corn meal) and raw peanuts or raw tree nuts 
(e.g., making ground peanuts);
     Making jams, jellies and preserves from acid foods (e.g., 
acid fruits);
     Making sugar from sugarcane and sugar beets; and
     Salting raw peanuts and raw tree nuts.
3. List of Low-Risk On-Farm Manufacturing/Processing Activity/Food 
Combinations When Conducted on Food Other Than the Farm's Own Raw 
Agricultural Commodities, for Distribution Into Commerce
    The section 103(c)(1)(C) draft RA identified the following low-risk 
manufacturing/processing activity/food combinations when conducted on a

[[Page 3691]]

farm on food other than the farm's own RACs, for distribution into 
commerce.
     Artificial ripening of intact fruits and vegetables;
     Chopping peanuts and tree nuts;
     Coating (with coatings other than wax, oil, or resin used 
for the purpose of storage or transportation) intact fruits and 
vegetables (e.g., caramel apples) and peanuts and tree nuts (e.g., 
adding seasonings);
     Cooling intact fruits and vegetables using cold air;
     Drying/dehydrating (whether for storage/transport or for 
creating a distinct commodity) intact fruits and vegetables (without 
sulfiting), cocoa beans, coffee beans, grains and grain products, and 
peanuts and tree nuts;
     Extracting oils from grains (e.g., corn, oilseeds, 
soybeans);
     Fermenting cocoa beans and coffee beans;
     Grinding/milling/cracking/crushing cocoa beans, coffee 
beans, grains (e.g., making grain products such as corn meal), and 
peanuts and tree nuts (e.g., making ground peanuts);
     Labeling (including stickering) hard candy, cocoa beans, 
cocoa products from roasted cocoa beans (other than milk chocolate), 
coffee beans, intact fruits and vegetables, grain and grain products 
(other than those containing wheat in a form that would not be 
recognized as containing wheat without a label declaration), honey, 
jams/jellies/preserves, maple sap, maple syrup, intact single-
ingredient peanuts or tree nuts (shelled and unshelled), soft drinks 
and carbonated beverages, sugar beets, sugarcane, and sugar;
     Making hard candy, fudge, taffy, and toffee;
     Making cocoa products from roasted cocoa beans;
     Making honey;
     Making jams, jellies and preserves from acid foods (e.g., 
acid fruits);
     Making maple syrup;
     Making soft drinks and carbonated water;
     Making sugar from sugar beets and sugarcane;
     Mixing cocoa beans, coffee beans, intact fruits and 
vegetables, grain and grain products, honey, maple sap and maple syrup, 
and peanuts and tree nuts;
     Packaging hard candy, fudge, taffy, and toffee; cocoa 
beans; cocoa products; coffee beans; intact fruits and vegetables 
(other than modified atmosphere or vacuum packaging); grain and grain 
products; honey; jams, jellies and preserves; maple syrup; peanuts and 
tree nuts (including modified atmosphere or vacuum packaging); soft 
drinks and carbonated water; and sugar beets, sugarcane, and sugar;
     Salting peanuts and tree nuts;
     Shelling/hulling cocoa beans (i.e., winnowing), intact 
fruits and vegetables (e.g., dried beans and peas), and peanuts and 
tree nuts;
     Sifting grains and grain products;
     Sorting, culling and grading (other than when incidental 
to packing or storage) hard candy, fudge, taffy, and toffee; cocoa 
beans; cocoa products; coffee beans; intact fruits and vegetables; 
grain and grain products; honey; jams, jellies and preserves; maple 
sap; maple syrup; peanuts and tree nuts; soft drinks and carbonated 
water; and sugar beets and sugarcane;
     Treating cocoa beans, coffee beans, intact fruits and 
vegetables, grain and grain products, and peanuts and tree nuts against 
pests (other than during growing) (e.g., fumigation); and
     Waxing (wax, oil, or resin used for the purpose of storage 
or transportation) intact fruits and vegetables.
    We note that the list in this section (i.e., section VIII.H.3) for 
low-risk manufacturing/processing activity/food combinations for foods 
other than a farm's own RACs is longer than the corresponding list in 
the previous section (i.e., section VIII.H.2) for low-risk 
manufacturing/processing activity/food combinations for a farm's own 
RACs. This relates to the fact that some activities that would be 
manufacturing/processing when performed on foods other than a farm's 
own RACs are not manufacturing/processing when performed on a farm's 
own RACs. As discussed in sections VIII.E and VIII.F of this document, 
when some activities are performed on the farm's own RACs, those 
activities are classified as packing, holding, or harvesting and are 
within the farm definition, making them outside the scope of the 
section 103(c)(1)(C) draft RA and resulting in a shorter list of low-
risk activity/food combinations for the purpose of the rulemaking 
required by section 103(c) of FSMA.

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

    Based on the results of the section 103(c)(1)(C) draft RA regarding 
on-farm low-risk activity/food combinations, we are proposing in Sec.  
117.5(g) and (h) to exempt farm mixed-type facilities that are small or 
very small businesses (as defined in proposed Sec.  117.3) from 
requirements under section 418 of the FD&C Act if the only activities 
subject to section 418 that the business conducts are low-risk 
activity/food combinations (see the discussion of these proposed 
exemptions in section X.C.6 of this document). The proposed exemptions 
would not exempt eligible facilities from the requirement to register 
under section 415 of the FD&C Act.

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

    We tentatively conclude that FDA should consider the low-risk on-
farm activity/food combinations identified in the section 103(c)(1)(C) 
draft RA as a factor in identifying high-risk facilities that are small 
and very small businesses and allocating inspection resources under 
Section 421 of the FD&C Act, Targeting of Inspectional Resources for 
Domestic Facilities. However, at this time, FDA tentatively concludes 
that it 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. 
Current data limitations impact our ability to accurately identify such 
facilities, and we must be able to identify such facilities in order to 
implement an exempted or modified inspection frequency schedule. We 
request comment on whether we should establish data submission 
requirements that would allow us to identify these types of facilities 
in order to exempt them from the inspection frequencies, or modify the 
inspection frequencies that apply to them, under section 421 of the 
FD&C Act. Examples of data elements that we might need in order to 
identify these facilities include: Identification of a facility as a 
farm mixed-type facility, annual monetary value of sales, number of 
employees, food category/activity type. We also request comment on 
these possible data elements and any other criteria that may be 
appropriate for the purposes of allocating inspection resources to 
these facilities.

IX. Proposed General Revisions to Current Part 110

A. Title

    FDA is proposing to revise the title of current subpart B from 
``Current Good Manufacturing Practice in Manufacturing, Packing, or 
Holding Human Food'' to ``Current Good Manufacturing Practice and 
Hazard Analysis and Risk-Based Preventive Controls for Human Food.'' 
The proposed title would reflect that proposed part 117 would include 
both CGMP requirements (including those established prior to the 
enactment of FSMA) and requirements for risk-based preventive controls 
for domestic and

[[Page 3692]]

foreign facilities that are required to register under section 415 of 
the FD&C Act. As proposed, the title of proposed part 117 would no 
longer identify specific activities (i.e., manufacturing, packing, and 
holding). The activities covered by the CGMP requirements would be 
identified within the requirements themselves and are not necessary to 
include in the title of proposed part 117. We request comment on the 
proposed title for part 117.

B. Proposed Redesignations

    FDA is proposing to redesignate the subparts of current part 110 
and to include in proposed part 117, subpart B the CGMP provisions 
already established in part 110. The proposed redesignation will 
clearly separate current CGMP requirements, and any newly proposed CGMP 
requirements, from newly proposed requirements that would implement 
section 418 of the FD&C Act. The proposed redesignation is intended to 
make it easy for persons who would be exempt from requirements 
established under section 418 of the FD&C Act to identify the CGMP 
requirements that apply to them.
    FDA also is proposing a general reorganization and redesignation of 
the provisions currently in part 110 as they would be established in 
proposed part 117. The proposed revisions are intended to enhance the 
clarity of proposed part 117 as a whole. Table 6 shows the proposed 
reorganization and redesignation of current provisions. In sections X 
and XI of this document, we discuss proposed changes to the current 
provisions of part 110 in the order in which they would appear in a 
final rule based on this proposed rule. Provisions that we do not 
propose to delete or revise would be re-established in part 117 
unchanged.

                 Table 6--Proposed Rearrangement of Provisions and Subparts of Current Part 110
----------------------------------------------------------------------------------------------------------------
                                       Current subpart           Proposed
        Current designation                location            redesignation        Proposed subpart location
----------------------------------------------------------------------------------------------------------------
Sec.   110.3--Definitions.........  Subpart A............  Proposed Sec.         Proposed Subpart A.
                                                            117.3.
Sec.   110.5--Current good          Subpart A............  Proposed Sec.         Proposed Subpart A.
 manufacturing practice.                                    117.1.
Sec.   110.10--Personnel..........  Subpart A............  Proposed Sec.         Proposed subpart B.
                                                            117.10.
Sec.   110.19--Exclusions.........  Subpart A............  Proposed Sec.         Proposed subpart A.
                                                            117.5(k).
Sec.   110.20--Plant and grounds..  Subpart B............  Proposed Sec.         Proposed subpart B.
                                                            117.20.
Sec.   110.35--Sanitary operations  Subpart B............  Proposed Sec.         Proposed subpart B.
                                                            117.35.
Sec.   110.37--Sanitary facilities  Subpart B............  Proposed Sec.         Proposed subpart B.
 and controls.                                              117.37.
Sec.   110.40--Equipment and        Subpart C............  Proposed Sec.         Proposed subpart B.
 utensils.                                                  117.40.
Sec.   110.80--Processes and        Subpart E............  Proposed Sec.         Proposed subpart B.
 controls.                                                  117.80.
Sec.   110.93--Warehousing and      Subpart E............  Proposed Sec.         Proposed subpart B.
 distribution.                                              117.93.
Sec.   110.110--Natural or          Subpart G............  Proposed Sec.         Proposed subpart B.
 unavoidable defects in food for                            117.110.
 human use that present no health
 hazard.
----------------------------------------------------------------------------------------------------------------

C. Proposed Revisions for Consistency of Terms

1. Activities Subject to Proposed Part 117
    FDA is proposing to revise provisions of current part 110 to make 
clear that the activities that would be subject to proposed part 117 
include manufacturing, processing, packing and holding. We describe 
each of these proposed revisions elsewhere in this document, in an 
order consistent with the placement of the current or revised 
provision. Section 418 of the FD&C Act uses this group of terms to 
broadly identify activities that take place in food facilities. In 
addition, we have previously described activities that may be 
considered ``manufacturing, processing, packing, or holding'' by 
establishing definitions for ``manufacturing/processing'' in current 
Sec. Sec.  1.227(b)(6) and 1.328, ``packing'' in current Sec. Sec.  
1.227(b)(9) and 1.328, and ``holding'' in current Sec. Sec.  
1.227(b)(5) and 1.328. This proposed rule proposes certain revisions to 
these existing definitions (see section VIII.E of this document) and 
would incorporate the revised definitions of manufacturing/processing, 
packing, and holding in proposed part 117. We tentatively conclude 
there is no meaningful distinction between ``manufacturing/
processing,'' ``packing,'' and ``holding'' as defined in our proposed 
revisions to Sec. Sec.  1.227 and 1.328 and those terms as they have 
been used in current part 110. We also tentatively conclude that 
consistent use of these terms throughout proposed part 117, in 
reference to activities taking place in food facilities, 
establishments, or plants, would make the regulations more clear and 
have no substantive effect on the current requirements. We request 
comment on this proposed revision.
2. The Term ``Facility''
    FDA is proposing to replace the term ``facility'' or ``facilities'' 
in current part 110 with the term ``establishment'' or ``plant'' in 
proposed part 117 whenever the term ``facility'' or ``facilities'' 
could be confused with the firms that are subject to the proposed 
requirements for hazard analysis and risk-based preventive controls 
required by section 418 of the FD&C Act. FDA is proposing this change 
to distinguish between the requirements of current part 110 (Current 
Good Manufacturing Practices) and requirements that we are proposing to 
establish under section 103 of FSMA. The term ``facility'' as used in 
current part 110 reflects the common meaning of that term as something 
designed, built, or installed to serve a specific function. However, 
after issuance of current part 110, in our regulation implementing 
section 415 of the FD&C Act, ``Registration of Food Facilities'' (Sec.  
1.227(b)(2) in part 1, subpart H), we defined the term ``facility'' to 
have a very specific meaning for the purpose of that regulation as 
follows:
    Current section 1.227(b)(2) provides in part that ``[f]acility 
means any establishment, structure, or structures under one ownership 
at one general physical location, or, in the case of a mobile facility, 
traveling to multiple locations, that manufactures/processes, packs, or 
holds food for consumption in the United States.'' Part 1, subpart H 
broadly defines the term ``facility'' for the purposes of that subpart, 
and provides that facilities must register unless they qualify for one 
of the exemptions in that subpart. For example, current Sec.  
1.227(b)(3) defines ``farm'' as a type of facility, and Sec.  1.226(b) 
provides that farms do not need to register.
    Section 418(o)(2) of the FD&C Act defines ``facility'' for the 
purposes of section 418 to mean ``a domestic facility or a foreign 
facility that is required to register under section 415'' of the FD&C 
Act, and proposed Sec.  117.3 would define ``facility'' to incorporate 
this statutory

[[Page 3693]]

definition. Under proposed Sec.  117.3, the term ``facility'' would 
have a meaning for the purposes of proposed part 117 that is more 
narrow than the common meaning of the term or the definition of 
facility in current Sec.  1.227(b)(2), in that it would encompass only 
those facilities that are required to register under section 415 of the 
FD&C Act (and part 1, subpart H). Our proposal to replace the term 
``facility'' in current part 110 with ``establishment'' or ``plant'' in 
proposed part 117 is intended to avoid confusion about the 
applicability of proposed part 117 to plants or establishments that 
satisfy the definition of the term ``facility'' in current Sec.  
1.227(b) but are exempt from the requirement to register. We describe 
each of these proposed revisions elsewhere in this document, in an 
order consistent with the placement of the current or revised 
provision. We request comment on this proposed revision.
    We are not proposing to replace the use of the term ``facilities'' 
in current requirements directed to specific functional parts of a 
plant or establishment, such as ``toilet facilities'' and ``hand-
washing facilities.'' We tentatively conclude that the use of the term 
``facilities'' in these contexts would not create confusion. We request 
comment on whether there is potential for confusion such that we should 
eliminate all use of the term ``facility'' or ``facilities'' as it is 
used in current part 110 irrespective of context.
3. Owner, Operator, or Agent in Charge
    Section 418 of the FD&C Act establishes requirements applicable to 
the ``owner, operator, or agent in charge'' of a facility. Current part 
110 establishes requirements for persons not explicitly identified as 
``owner, operator, or agent in charge'' of a food plant or 
establishment. For example, current Sec.  110.10 establishes 
requirements applicable to ``plant management'' and current Sec.  
110.20(a) establishes requirements for the ``operator'' of a food 
plant. We request comment on whether there is any meaningful difference 
between the persons identified in current part 110 and the ``owner, 
operator, or agent in charge'' identified in section 418 of the FD&C 
Act. We also request comment on whether it would be appropriate to 
refer to the ``owner, operator, or agent in charge'' of a plant, 
establishment, or facility throughout proposed part 117 and, if so, 
whether the requirements would be clear if we revise the proposed rule 
to use pronouns (such as ``you'' and ``your'') within proposed part 
117. Pronouns are commonly used in contemporary regulations and 
simplify the presentation of the requirements.
4. Food-Packaging Materials
    Most provisions of current part 110 directed to preventing 
contamination of food and food-contact substances also are directed to 
preventing contamination of food-packaging materials. Because food-
packaging materials come in contact with food, if they become 
contaminated this could lead to contamination of the food. FDA is 
proposing that provisions of current part 110 directed to preventing 
contamination of food and food-contact substances consistently be 
directed to preventing contamination of food-packaging materials as 
well. We describe each of these proposed revisions elsewhere in this 
document, in an order consistent with the placement of the current or 
revised provision.

D. Proposed Additions Regarding Cross-Contact

    Proposed Sec.  117.3 would define the term ``cross-contact'' to 
mean the unintentional incorporation of a food allergen into a food. 
``Food allergen'' would be defined as a major food allergen as defined 
in section 201(qq) of the Federal Food, Drug, and Cosmetic Act. As 
discussed in section X.B.4 of this document, it has been estimated that 
food allergies affect four to six percent of children and two to three 
percent of adults in the U.S. Food allergies can cause life threatening 
reactions to foods. Because there is no cure for food allergy, 
sensitive consumers and their families must practice avoidance to 
prevent reactions. To do so they must rely on food labels to be 
complete, clear, and accurate. Manufacturers can provide consumers with 
the food labels they need by using controls to ensure that labels 
declare all the food allergens that are intended to be present, 
controls to ensure that the correct label is applied to the product, 
and controls that prevent the unintended presence of food allergens 
through cross-contact.
    Comments submitted to the Food CGMP Modernization Working Group 
emphasized the importance of controls to prevent cross-contact (Ref. 
1). After considering the comments, the CGMP Working Group report 
recommended that food processing establishments that handle any of the 
major food allergens be required to develop and adopt a food allergen 
control plan that addresses six areas of control, one of which is 
``[p]revention of cross-contact during processing'' (Ref. 1). FDA 
interprets current part 110 to require protection against cross-
contact, which can constitute insanitary conditions that may cause a 
food to be adulterated under section 402(a)(4) of the FD&C Act if the 
food may have been rendered injurious to health. Consistent with this 
interpretation, FDA issued a Notice to Manufacturers titled ``Allergy 
Warning Letter'' on June 10, 1996, advising with regard to cross-
contact that adhering to CGMPs is essential for effective reduction of 
adverse reactions, and urging manufacturers to take all steps necessary 
to eliminate cross contamination and to ensure the absence of 
unintended food allergens (Ref. 120). In the past, inadvertent 
incorporation of an allergen into a food was referred to as 
``contamination'' or ``cross contamination'' (Ref. 121), and in many 
instances these terms are still used (Ref. 122). More recently, the 
term ``cross-contact'' (rather than ``contamination'' or ``cross 
contamination'') has been applied with respect to unintentional 
transfer of allergenic proteins from a food containing the proteins to 
one that does not (Ref. 123) (Ref. 124), because an allergen is a 
normal component of food, and not itself a contaminant. Given this 
shift in the scientific literature distinguishing ``cross-contact'' 
from ``contamination'' and ``cross contamination,'' FDA tentatively 
concludes that it should begin using the term ``cross-contact'' to 
describe inadvertent incorporation of an allergen into food, rather 
than the general term ``contamination,'' for purposes of clarity. To 
make it clear that CGMPs require protection against cross-contact, and 
to ensure that CGMPs continue to address health concerns related to 
allergens, FDA is proposing to revise several provisions of current 
part 110 to explicitly address cross-contact in proposed part 117.
    We describe each of these proposed additions elsewhere in this 
document, in an order consistent with the placement of the current or 
revised provision. We request comment on this proposed revision to the 
CGMPs.

E. Proposed Revisions for Consistency With the Definition of ``Food''

    Current Sec.  110.3 defines ``food'' to mean food as defined in 
section 201(f) of the FD&C Act and includes raw materials and 
ingredients. We are proposing to retain that definition in this 
proposed rule. There is an overlap between raw materials and 
ingredients. Not all raw materials are ingredients. For example, under 
section 201(f) of the FD&C Act, a food additive is food and, thus, the 
manufacture of a food additive is subject to current part 110. An 
example of a food additive is sucrose

[[Page 3694]]

fatty acid esters. Under Sec.  172.859, sucrose fatty acid esters are 
the mono-, di-, and tri-esters of sucrose with fatty acids and are 
derived from sucrose and edible tallow or hydrogenated edible tallow or 
edible vegetable oils. The only solvents which may be used in the 
preparation of sucrose fatty acid esters are those generally recognized 
as safe in food or regulated for such use by an appropriate section in 
this part. Ethyl acetate or methyl ethyl ketone or dimethyl sulfoxide 
and isobutyl alcohol (2-methyl-1-propanol) may be used in the 
preparation of sucrose fatty acid esters. The regulation for sucrose 
fatty acid esters identifies a number of raw materials used in the 
production of sucrose fatty acid esters. Because the production process 
transforms those raw materials into the substance ``sucrose fatty acid 
esters,'' those raw materials generally would not be viewed as 
``ingredients'' of the final chemical product. Likewise, if a facility 
adds the food additive ``sucrose fatty acid esters'' to a food product, 
the facility would view that food additive as an ingredient of its food 
product, but would not view the chemicals used to produce sucrose fatty 
acid esters as ingredients of its food product.
    The title of current Sec.  110.80(a) and several provisions within 
current Sec.  110.80 refer to ``raw materials and other ingredients'' 
rather than to ``raw materials and ingredients'' as in the definition 
of ``food.'' For consistency with the definition of food, we are 
proposing to change the title of current Sec.  110.80(a) (which would 
be proposed Sec.  117.80(b)) to ``Raw materials and ingredients.'' As a 
companion change to this change in title, we are proposing to 
substitute ``ingredients'' for ``other ingredients'' throughout 
provisions in current Sec.  110.80 that refer to both raw materials and 
ingredients. We do not list every instance where this proposed revision 
would apply in proposed Sec.  110.80.

F. Proposed Revisions To Address Guidance in Current Part 110

    In 2000, we codified our policies and procedures for the 
development, issuance, and use of guidance documents in Sec.  10.115 
(21 CFR 10.115) (65 FR 56468, September 19, 2000). Under Sec.  
10.115(b), guidance documents are documents prepared for FDA staff, 
applicants/sponsors, and the public that describe our interpretation of 
or policy on a regulatory issue. They include documents that relate to 
the design, production, labeling, promotion, manufacturing, and testing 
of regulated products; the processing, content, and evaluation or 
approval of submissions; and inspection and enforcement policies. Under 
Sec.  10.115(d), guidance documents do not establish legally 
enforceable rights or responsibilities and do not legally bind the 
public or FDA.
    Comments submitted to the Food CGMP Modernization Working Group 
noted that several provisions of current part 110 use non-binding 
language such as ``should'' and recommended that we revise part 110 to 
express all provisions using binding language (e.g., ``shall'' in place 
of ``should'') (Ref. 1). Consistent with these comments and with 21 CFR 
10.115, we are proposing to delete some non-binding provisions of 
current part 110 (e.g., provisions using ``should'' or ``compliance may 
be achieved by''). We request comment on this proposal. In section XI.M 
of this document, we request comment on whether to revise other non-
binding provisions to establish new requirements in proposed part 117 
or to simply retain them as useful provisions of a comprehensive CGMP. 
We describe each of these in more detail elsewhere in this document.

G. Proposed Editorial Changes

    FDA is proposing to revise current part 110 to make several changes 
that are editorial in nature. These editorial changes have no 
substantive effect on the current requirements of part 110 and, thus, 
we do not list every instance where these proposed editorial changes 
would apply. We are proposing to:
     Refer to the ``Federal Food, Drug, and Cosmetic Act'' 
rather than to ``the act'' for clarity and for consistency with our 
current approach to citing the FD&C Act in new regulations;
     Replace the term ``shall'' with the term ``must.'' The 
term ``must'' is a more common word than ``shall,'' and we are using 
``must'' in new regulations.
     Replace the phrase ``includes, but is not limited to'' 
with ``includes,'' because the use of the word ``includes'' indicates 
that the specified list that follows is not exclusive. The phrase ``but 
is not limited to'' is unnecessary. (72 FR 34752 at 34765, June 25, 
2007)
     Replace the phrase ``adulteration within the meaning of 
the act'' with the single term ``adulteration'' because ``within the 
meaning of the act'' is not needed for the term ``adulteration'' to 
have the meaning assigned by section 402 of the FD&C Act (21 U.S.C. 
Sec.  342 (Adulterated food).
     Replace the term ``whenever'' with ``when'' for 
grammatical simplicity.

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

A. Proposed Sec.  117.1--Applicability and Status

    FDA is proposing to redesignate current Sec.  110.5(a) as proposed 
Sec.  117.1(a) with associated editorial changes described in section 
IX.G of this document. Current Sec.  110.5(a) establishes that the 
criteria and definitions in part 110 apply in determining whether a 
food is adulterated (1) within the meaning of section 402(a)(3) of the 
act in that the food has been manufactured under such conditions that 
it is unfit for food; or (2) within the meaning of section 402(a)(4) of 
the FD&C Act in that the food 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. 
Current Sec.  110.5(a) also establishes that the criteria and 
definitions in part 110 apply in determining whether a food is in 
violation of section 361 of the Public Health Service Act (42 U.S.C. 
264). FDA is proposing to retain the provisions of current Sec.  
110.5(a) in proposed Sec.  117.1(a). The provisions of current Sec.  
110.5(a) as re-established in proposed Sec.  117.1(a) would continue to 
apply to all provisions that currently are established in part 110 and 
would be re-established in proposed part 117. Under this proposed rule, 
proposed Sec.  117.1 also would apply to new provisions of proposed 
part 117, including provisions that would be added under the authority 
of sections 402(a)(3), 402(a)(4), or 418 of the FD&C Act, section 361 
of the PHS Act, or a combination of those authorities. We note that 
section 418(a) of the FD&C Act provides that facilities subject to that 
section must ``identify and implement preventive controls to * * * 
provide assurances that * * * food is not adulterated under section 402 
[of the FD&C Act]'' and that similar references to preventing 
adulteration under section 402 of the FD&C Act also appear in section 
418(c) and (e). In section III of this document, we explain how the 
proposed provisions are necessary to protect against contamination with 
hazards that may adulterate food. We tentatively conclude that the link 
between the proposed provisions and the potential for adulteration 
provides a basis for applying the criteria and definitions in proposed 
part 117 in determining whether, under particular circumstances, a food 
is adulterated under section 402(a)(3) or (a)(4) or in violation of 
section 361 of the PHS Act.

[[Page 3695]]

    Section 103(e) of FSMA amends section 301 of the FD&C Act (21 
U.S.C. 331) by adding a new section--(uu)--to the list of acts and the 
causing thereof that are prohibited. Under section 301(uu), the 
following act, and the causing thereof, is prohibited: ``[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].'' To clearly communicate that failure to comply with 
regulations established under section 418 is a prohibited act, proposed 
Sec.  117.1(b) would establish that the operation of a facility that 
manufactures, processes, packs, or holds food for sale in the United 
States if the owner, operator, or agent in charge of such facility is 
required to comply with, and is not in compliance with, section 418 of 
the FD&C Act or subparts C, D, E, or F of part 117 is a prohibited act 
under section 301(uu) of the FD&C Act (21 U.S.C. 331(uu)).
    FDA is proposing to redesignate current Sec.  110.5(b) as proposed 
Sec.  117.1(c) with no changes. Current Sec.  110.5(b) establishes that 
food covered by specific current good manufacturing practice 
regulations also is subject to the requirements of those regulations. 
As discussed in sections II.A.1 and II.A.2 of this document, following 
the establishment of the umbrella CGMPs in 1969 (34 FR 6977), FDA 
established additional CGMP requirements, including CGMP requirements 
for thermally processed low-acid foods packaged in hermetically sealed 
containers (proposed rule, 41 FR 30444, July 23, 1976; final rule, 44 
FR 16209, March 16, 1979; currently established in part 113) and CGMP 
requirements for acidified foods (proposed rule, 41 FR 30457, July 23, 
1976; final rule, 44 FR 16230, March 16, 1979; currently established in 
part 114). In the preamble to the proposed rule to establish current 
Sec.  110.5(b), we explained that this provision was intended to 
communicate that foods covered by such specific CGMPs are still subject 
to part 110 (44 FR 33238, at 33239, June 8, 1979). Since current Sec.  
110.5(b) was established, we have established additional food safety 
regulations, such as the 1995 HACCP regulations in part 123 for fish 
and fishery products (60 FR 65096, December 18, 1995) and the 2001 
HACCP regulations in part 120 for juice (66 FR 6138, January 19, 2001). 
As with foods that are subject to part 113 or part 114, foods that are 
subject to part 123 or part 120 are subject to the requirements of part 
123 or 120 even though they are foods covered by the current good 
manufacturing practice requirements that are currently established in 
part 110 and would be re-established in part 117. See section II.A of 
this document for a discussion of other food safety regulations for 
specific foods to which this would also apply.
    Importantly, section 418 of the FD&C Act requires that we establish 
regulations to implement requirements for hazard analysis and risk-
based preventive controls for human food. As discussed in section V of 
this document, we tentatively conclude that it is appropriate to 
establish these requirements for hazard analysis and risk-based 
preventive controls within the framework of current part 110, as would 
be re-established in proposed part 117. As discussed in section IX.A of 
this document, we are proposing that the title of proposed part 117 
reflect the addition of these new requirements. As discussed more fully 
in section X.C of this document, section 418 of the FD&C Act 
establishes several exemptions from the proposed requirements for 
hazard analysis and risk-based preventive controls. For example, 
section 418(j)(1) of the FD&C Act provides that section 418 of the FD&C 
Act ``shall not apply to a facility if the owner, operator, or agent in 
charge of such facility is required to comply with, and is in 
compliance with * * * (A) [t]he Seafood Hazard Analysis Critical 
Control Points Program * * *'' (We interpret ``Seafood Hazard Analysis 
Critical Control Points Program'' to mean the requirements of part 123 
for fish and fishery products.) As discussed below, consistent with 
section 418(j)(1)(A), proposed Sec.  117.5(b) would provide that 
proposed subpart C of proposed part 117 would not apply with respect to 
activities that are subject to part 123 at a facility, if the owner, 
operator, or agent in charge of the facility is required to comply 
with, and is in compliance with part 123. However, under current Sec.  
110.5(b) and proposed Sec.  117.1(c), all activities at that facility 
have been, and would continue to be, subject to the CGMP requirements 
in proposed subpart B and the requirements of part 123. The same would 
be true for establishments and facilities that are subject to other 
food safety regulations, consistent with the exemptions that would be 
established in proposed Sec.  117.5.

B. Proposed Sec.  117.3--Definitions

1. Redesignation
    FDA is proposing to redesignate all definitions in current Sec.  
110.3(a) through (r) as proposed Sec.  117.3, eliminate paragraph 
designations (such as (a), (b), and (c)), and add new definitions in 
alphabetical order. Paragraph designations are not necessary when the 
definitions are presented in alphabetical order. Proposed Sec.  117.3 
would remain within subpart A.
2. Current Definitions That FDA Is Proposing To Delete
    Current Sec.  110.3(p) defines ``shall'' to be used to state 
mandatory requirements. FDA is proposing to delete the definition of 
``shall'' and use ``must'' instead, as discussed in section IX.G of 
this document.
3. Current Definitions That FDA Is Proposing To Revise
    Current Sec.  110.3(e) defines ``critical control point'' to mean a 
point in a food process where there is a high probability that improper 
control may cause, allow, or contribute to a hazard or to filth in the 
final food or decomposition of the final food. Current Sec.  110.3(e) 
was established in 1986. Current Sec.  110.3(e) preceded various 
currently used definitions of ``critical control point'' (CCP)--e.g., 
in the NACMCF HACCP guidelines (Ref. 34), the Codex HACCP Annex (Ref. 
35), and Federal HACCP regulations for seafood (part 123), juice (part 
120), and meat and poultry (9 CFR part 417). Proposed Sec.  117.3 would 
revise the current definition of ``critical control point'' to match 
the statutory definition in section 418(o)(1) of the FD&C Act and to be 
consistent with definitions in the NACMCF HACCP guidelines, the Codex 
HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat 
and poultry. Proposed Sec.  117.3 would define ``critical control 
point'' to mean a point, step, or procedure in a food process at which 
control can be applied and is essential to prevent or eliminate a food 
safety hazard or reduce such hazard to an acceptable level.
    A non-substantive difference between the definition of CCP in 
proposed Sec.  117.3 and the definition of CCP in Sec.  120.3(d) is 
that proposed Sec.  117.3 would incorporate the phrase ``food safety 
hazard'' into the definition of CCP, whereas Sec.  120.3(d) uses the 
phrase ``food hazard.'' We see no meaningful difference between ``food 
safety hazard'' and ``food hazard,'' whether comparing proposed Sec.  
117.3 to Sec.  120.3(d) or whether comparing Sec.  120.3(d) to Sec.  
123.3(b) (which uses the phrase ``food safety hazard'' in its 
definition of CCP). In fact, we see no meaningful difference between 
``food safety hazard'' and ``hazard'' and are proposing to define the 
term ``hazard'' rather than ``food safety hazard'' for the purpose of 
proposed part 117 (see the discussion of our definition of the term 
``hazard'' in

[[Page 3696]]

section X.B.4 of this document). Section 418 of the FD&C Act largely 
refers to ``hazards'' and the single reference to ``food safety 
hazard'' is in the statutory definition of CCP. Because the phrase 
``food safety hazard'' appears in so many current definitions of CCP, 
we tentatively conclude it is appropriate to propose to establish the 
statutory definition of CCP into the proposed rule, even though this 
will be the only place in the proposed rule where we use the term 
``food safety hazard.''
    There are slight differences in wording among the various currently 
used definitions of CCP--e.g., whether the definition uses the term 
``control'' or the phrase ``control measure'' and in how the definition 
incorporates concepts such as ``essential,'' ``preventing,'' 
eliminating'' or ``reducing to acceptable level'' hazards. Part 123 
preceded the 1998 NACMCF guidelines and, thus, has the most 
differences. For the purpose of this proposed rule, we do not see these 
differences as meaningful and tentatively conclude that the statutory 
definition of CCP in section 418(o)(1) of the FD&C Act is, for 
practical purposes, consistent with existing definitions and that our 
proposed definition of CCP would present no conflict with existing 
recommendations.
    The definition of CCP in proposed Sec.  117.3 would also differ 
from the definition of CCP in current Sec.  110.3(e) in that the 
definition of CCP would no longer explicitly address filth. Deleting 
filth from the definition of CCP is consistent with section 418(o)(1) 
of the FD&C Act, and with the various current definitions of CCP, to 
emphasize food safety hazards generally rather than specifically 
identifying filth, which may or may not present a food safety hazard, 
depending on the circumstances. Similarly, the definition of CCP in 
proposed Sec.  117.3 also would no longer explicitly address 
decomposition of the final food. However, section 418(b)(1) of the FD&C 
Act refers to decomposition among the hazards to be identified and 
evaluated and, thus, decomposition is considered within the term 
``hazard'' when it affects the safety of the product.
    Current Sec.  110.3(g) defines ``food-contact surfaces'' as those 
surfaces that contact human food and those surfaces from which drainage 
onto the food or onto surfaces that contact the food ordinarily occurs 
during the normal course of operations. Current Sec.  110.3(g) also 
specifies that ``food-contact surfaces'' includes utensils and food-
contact surfaces of equipment. FDA is proposing to revise the 
definition for ``food-contact surfaces'' to include the phrase ``or 
other transfer'' after ``drainage.'' FDA is proposing this revision to 
clarify that surfaces from which any transfer involving liquids or non-
liquids onto the food or onto surfaces that contact the food are food-
contact surfaces. Proposed Sec.  117.3 would define ``food-contact 
surfaces'' to mean those surfaces that contact human food and those 
surfaces from which drainage, or other transfer, onto the food or onto 
surfaces that contact the food ordinarily occurs during the normal 
course of operations. Proposed Sec.  117.3 would also specify that 
``food-contact surfaces'' includes utensils and food-contact surfaces 
of equipment.
    Current Sec.  110.3(i) defines ``microorganisms'' to mean yeasts, 
molds, bacteria, and viruses and includes, but is not limited to, 
species having public health significance. Current Sec.  110.3(i) also 
specifies that the term ``undesirable microorganisms'' includes those 
microorganisms that are of public health significance, that subject 
food to decomposition, that indicate that food is contaminated with 
filth, or that otherwise may cause food to be adulterated within the 
meaning of the act. Current Sec.  110.3(i) also states that, 
occasionally in these regulations, FDA used the adjective ``microbial'' 
instead of using an adjectival phrase containing the word 
microorganism. FDA is proposing to revise the definition for 
``microorganisms'' to also include protozoa and microscopic parasites. 
FDA is proposing this revision to clarify that FDA considers not only 
yeasts, molds, bacteria and viruses, but also protozoa and microscopic 
parasites, to be microorganisms of importance in the safe and sanitary 
production of foods. As discussed in section IX.G of this document, FDA 
is proposing to delete the phrases ``but is not limited to,'' and 
``within the meaning of the act.'' FDA also is proposing to delete the 
last sentence in the definition because it is not needed. Proposed 
Sec.  117.3 would define ``microorganisms'' to mean yeasts, molds, 
bacteria, viruses, protozoa, and microscopic parasites and includes 
species having public health significance. Proposed Sec.  117.3 would 
also specify that the term ``undesirable microorganisms'' includes 
those microorganisms that are of public health significance, that 
subject food to decomposition, that indicate that food is contaminated 
with filth, or that otherwise may cause food to be adulterated.
    Current Sec.  110.3(k) defines ``plant'' to mean the building or 
facility or parts thereof, used for or in connection with the 
manufacturing, packaging, labeling, or holding of human food. FDA is 
proposing to revise the definition for ``plant'' by adding 
``processing'' and ``packing'' and deleting ``labeling'' and 
``packaging'' so that activities listed in the definition are 
consistent with activities covered by proposed part 117. As discussed 
in section IX.C.2 of this document, FDA is proposing to consistently 
use the terms ``manufacturing, processing, packing and holding'' to 
reflect the group of terms used in section 418(a) of the FD&C Act to 
broadly identify activities that take place in food facilities. As 
discussed later in this section, ``labeling'' and ``packaging'' would 
be included in the definition of manufacturing/processing and do not 
need to be repeated in the definition of ``plant.'' As discussed above 
in section IX.C.2 of this document, FDA also is proposing to replace 
the term ``facility'' with the term ``establishment.'' Proposed Sec.  
117.3 would define ``plant'' to mean the building or establishment or 
parts thereof, used for or in connection with the manufacturing, 
processing, packing, or holding of human food.
    Current Sec.  110.3(n) defines ``safe-moisture level'' as a level 
of moisture low enough to prevent the growth of undesirable 
microorganisms in the finished product under the intended conditions of 
manufacturing, storage, and distribution. Current Sec.  110.3(n) also 
specifies that the maximum safe moisture level for a food is based on 
its water activity (aw), and that an aw will be 
considered safe for a food if adequate data are available that 
demonstrate that the food at or below the given aw will not 
support the growth of undesirable microorganisms. FDA is proposing to 
revise the definition for ``safe-moisture level'' to:
     Delete the hyphen between ``safe'' and ``moisture.'' The 
hyphen is not necessary.
     Remove the word ``maximum'' before ``safe moisture 
level.'' FDA tentatively concludes that this word is not needed, since 
the word ``maximum'' is implicit when referring to ``safe'' with 
respect to moisture level.
     Replace the phrase ``based on'' with ``related to.'' FDA 
tentatively concludes that the term ``related to'' is more appropriate 
because moisture level is not the only factor that determines water 
activity.
     Replace the phrase ``manufacturing, storage, and 
distribution'' with the phrase ``manufacturing, processing, packing, 
and holding.'' As discussed in section IX.C.1 of this document, we are 
proposing to use this group of terms to broadly identify activities 
that take place in food facilities.
    With these proposed changes, proposed Sec.  117.3 would define 
``safe

[[Page 3697]]

moisture level'' to mean a level of moisture low enough to prevent the 
growth of undesirable microorganisms in the finished product under the 
intended conditions of manufacturing, processing, packing, and holding. 
Proposed Sec.  117.3 would also specify that the safe moisture level 
for a food is related to its water activity (aw), and that 
an aw will be considered safe for a food if adequate data 
are available that demonstrate that the food at or below the given 
aw will not support the growth of undesirable 
microorganisms.
    Current Sec.  110.3(o) defines ``sanitize'' to mean to adequately 
treat food-contact surfaces by a process that is effective in 
destroying vegetative cells of microorganisms of public health 
significance, and in substantially reducing numbers of other 
undesirable microorganisms, but without adversely affecting the product 
or its safety for the consumer. FDA is proposing to revise the 
definition for ``sanitize'' to include the term ``cleaned'' before 
``food-contact surfaces.'' It is well established that sanitizers can 
be inactivated by organic material and, thus, are not effective unless 
used on clean surfaces (Ref. 125). Proposed Sec.  117.3 would define 
``sanitize'' to mean to adequately treat cleaned food-contact surfaces 
by a process that is effective in destroying vegetative cells of 
microorganisms of public health significance, and in substantially 
reducing numbers of other undesirable microorganisms, but without 
adversely affecting the product or its safety for the consumer.
4. New Definitions
    FDA is proposing to define the term ``affiliate'' to mean any 
facility that controls, is controlled by, or is under common control 
with another facility. The proposed definition would incorporate the 
definition in section 418(l)(4)(A) of the FD&C Act and would make the 
meaning of the term clear when used in the proposed definition of 
``qualified facility.''
    FDA is proposing to define ``calendar day'' to mean every day shown 
on the calendar.
    FDA is proposing to define the term ``cross-contact'' to mean the 
unintentional incorporation of a food allergen into a food. We discuss 
cross-contact in more detail in section IX.D of this document.
    FDA is proposing to define the term ``environmental pathogen'' to 
mean a microorganism that is of public health significance and is 
capable of surviving and persisting within the manufacturing, 
processing, packing, or holding environment. Examples of environmental 
pathogens include Salmonella spp. and Listeria monocytogenes. FDA 
requests comment on this definition and the types of organisms that 
should be considered environmental pathogens, including whether spores 
of pathogens such as Clostridium perfringens or Bacillus cereus should 
be considered environmental pathogens.
    FDA is proposing to define the term ``facility'' to mean a domestic 
facility or a foreign facility that is required to register under 
section 415 of the FD&C Act in accordance with the requirements of 21 
CFR part 1, subpart H. The proposed definition would incorporate the 
definition in section 418(o)(2) of the FD&C Act.
    FDA is proposing to define the term ``farm'' by reference to the 
definition of that term in proposed Sec.  1.227. See section VIII of 
this document for detailed discussion of farms and mixed-type 
facilities. We are proposing to cross-reference the definition of 
``farm'' rather than to define it in proposed part 117 because the 
definition of ``farm,'' under both current Sec.  1.227(b)(3) and 
proposed Sec.  1.227, includes the word ``facility'' with a meaning 
that is broader than the meaning of ``facility'' in section 418(o)(2) 
of the FD&C Act. Under part I, subpart H, the term ``facility'' is not 
limited to entities that are required to register under section 415 of 
the FD&C Act. We are proposing to cross-reference the definition to 
reduce the potential confusion that could result if we used the term 
``facility'' to have two different meanings within proposed part 117.
    FDA is proposing to define the term ``FDA'' to mean the Food and 
Drug Administration. Defining this term within the definitions 
applicable to part 117 would eliminate the need to define the term 
within each distinct section of the regulation and would provide for 
the substitution of ``Food and Drug Administration'' with ``FDA'' each 
time ``Food and Drug Administration appears in current part 110.
    FDA is proposing to define the term ``food allergen'' to mean a 
major food allergen as defined in section 201(qq) of the FD&C Act. 
Section 201(qq) defines the term ``major food allergen'' to mean any of 
the following: Milk, egg, fish (e.g., bass, flounder, or cod), 
Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., 
almonds, pecans, or walnuts), wheat, peanuts, and soybeans, or a food 
ingredient that contains protein derived from one of these foods, with 
certain exceptions. The proposed definition would be consistent with 
the requirement in section 418(a) of the FD&C Act that the owner, 
operator, or agent in charge of a facility ``identify and implement 
preventive controls to significantly minimize or prevent the occurrence 
of * * * hazards and provide assurances that [food manufactured, 
processed, packed, or held by the facility] is not * * * misbranded 
under section 403(w) [of the FD&C Act].'' Section 403(w) of the FD&C 
Act provides certain labeling requirements for foods that bear or 
contain a major food allergen, with certain exceptions.
    FDA is proposing to define the term ``harvesting'' as applicable to 
farms and farm mixed-type facilities and meaning activities that are 
traditionally performed by farms for the purpose of removing raw 
agricultural commodities from the place they were grown or raised and 
preparing them for use as food. The proposed definition would also 
specify that harvesting is limited to activities performed on raw 
agricultural commodities on the farm on which they were grown or 
raised, or another farm under the same ownership; and that harvesting 
does not include activities that transform a raw agricultural 
commodity, as defined in section 201(r) of the FD&C Act, into a 
processed food as defined in section 201(gg) of the FD&C Act. The 
proposed definition would state that gathering, washing, trimming of 
outer leaves of, removing stems and husks from, sifting, filtering, 
threshing, shelling, and cooling raw agricultural commodities grown on 
a farm or another farm under the same ownership are examples of 
harvesting. We are proposing to use the same definition of 
``harvesting'' as would be established in proposed Sec.  1.227. See 
section VIII.E of this document for a detailed discussion of 
``harvesting.''
    FDA is proposing to define ``hazard'' to mean any biological, 
chemical, physical, or radiological agent that is reasonably likely to 
cause illness or injury in the absence of its control. The proposed 
definition is consistent with the NACMCF HACCP guidelines, the Codex 
HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat 
and poultry. The NACMCF HACCP guidelines (Ref. 34) and our HACCP 
regulation for juice (Sec.  120.3(g)) define ``hazard'' and ``food 
hazard,'' respectively as a biological, chemical, or physical agent 
that is reasonably likely to cause illness or injury in the absence of 
its control. The Codex HACCP Annex defines ``hazard'' as a biological, 
chemical or physical agent in, or condition of, food with the potential 
to cause an adverse health effect (Ref. 35). Our HACCP regulation for 
seafood (Sec.  123.3(f)) and the FSIS HACCP regulation for meat and 
poultry (9 CFR 417.1) define ``food safety hazard'' as any biological, 
chemical, or physical

[[Page 3698]]

property that may cause a food to be unsafe for human consumption. A 
difference between the proposed definition of ``hazard'' and the 
definitions established in the NACMCF HACCP guidelines, the Codex HACCP 
Annex, and Federal HACCP regulations for seafood, juice, and meat and 
poultry is that the proposed definition would include radiological 
agents whereas the various definitions of ``hazard,'' ``food hazard'' 
and ``food safety hazard'' under these HACCP systems do not. We are 
proposing to include radiological agents to implement section 
418(b)(1)(A) of the FD&C Act, which includes radiological hazards as an 
example of known or reasonably foreseeable hazards that may be 
associated with the facility. We describe biological, chemical, 
radiological, and physical hazards in sections II.D and XII.B.3 of this 
document.
    FDA is proposing to define the term ``hazard that is reasonably 
likely to occur'' to mean a hazard for which a prudent person who 
manufactures, processes, packs, or holds food would establish controls 
because experience, illness data, scientific reports, or other 
information provides a basis to conclude that there is a reasonable 
possibility that the hazard will occur in the type of food being 
manufactured, processed, packed, or held in the absence of those 
controls. The proposed definition is consistent with Federal HACCP 
regulations for seafood, juice, and meat and poultry. Our HACCP 
regulation for seafood describes a food safety hazard that is 
reasonably likely to occur as one for which a prudent processor would 
establish controls because experience, illness data, scientific 
reports, or other information provide a basis to conclude that there is 
a reasonable possibility that it will occur in the particular type of 
fish or fishery product being processed in the absence of those 
controls (Sec.  123.6(a)). Our HACCP regulation for juice describes a 
food hazard that is reasonably likely to occur as one for which a 
prudent processor would establish controls because experience, illness 
data, scientific reports, or other information provide a basis to 
conclude that there is a reasonable possibility that, in the absence of 
those controls, the food hazard will occur in the particular type of 
product being processed (Sec.  120.7(a)(2)). The FSIS HACCP regulation 
for meat and poultry describes a food safety hazard that is reasonably 
likely to occur as one for which a prudent establishment would 
establish controls because it historically has occurred, or because 
there is a reasonable possibility that it will occur in the particular 
type of product being processed, in the absence of those controls (9 
CFR 417.2(a)). In section XII.B.4 of this document, we explain how the 
term ``hazard that is reasonably likely to occur'' would implement 
section 418(b)(1) of the FD&C Act and relate this term to the NACMCF 
HACCP guidelines and the Codex HACCP Annex.
    FDA is proposing to define the term ``holding'' to mean the storage 
of food. The proposed definition would also state that holding 
facilities include warehouses, cold storage facilities, storage silos, 
grain elevators, and liquid storage tanks; and that, for farms and farm 
mixed-type facilities, holding also includes activities traditionally 
performed by farms for the safe or effective storage of raw 
agricultural commodities grown or raised on the same farm or another 
farm under the same ownership, but does not include activities that 
transform a raw agricultural commodity, as defined in section 201(r) of 
the FD&C Act, into a processed food as defined in section 201(gg) of 
the FD&C Act. We are proposing to use the same definition of 
``holding'' as would be established in proposed Sec.  1.227. See 
section VIII.E of this document for a detailed discussion of 
``holding.''
    FDA is proposing to define the term ``manufacturing/processing'' to 
mean making food from one or more ingredients, or synthesizing, 
preparing, treating, modifying or manipulating food, including food 
crops or ingredients. The proposed definition would also state that 
examples of manufacturing/processing activities are cutting, peeling, 
trimming, washing, waxing, eviscerating, rendering, cooking, baking, 
freezing, cooling, pasteurizing, homogenizing, mixing, formulating, 
bottling, milling, grinding, extracting juice, distilling, labeling, or 
packaging. The proposed definition would also specify that, for farms 
and farm mixed-type facilities, manufacturing/processing does not 
include activities that are part of harvesting, packing, or holding. We 
are proposing to use the same definition of ``manufacturing/
processing'' as would be established in proposed Sec.  1.227. See 
section VIII.E of this document for a detailed discussion of 
``manufacturing/processing.''
    FDA is proposing to define the term ``mixed-type facility'' to mean 
an establishment that engages in both activities that are exempt from 
registration under section 415 of the FD&C Act and activities that 
require the establishment to be registered. The proposed definition 
would also state that an example of such a facility is a ``farm mixed-
type facility,'' which is an establishment that grows and harvests 
crops or raises animals and may conduct other activities within the 
farm definition, but also conducts activities that require the 
establishment to be registered. We are proposing to use the same 
definition as would be established in proposed Sec.  1.227. See section 
VIII.E of this document for a detailed discussion of ``mixed-type 
facilities.''
    FDA is proposing to define the term ``monitor'' to mean to conduct 
a planned sequence of observations or measurements to assess whether a 
process, point, or procedure is under control and to produce an 
accurate record for use in verification. The proposed definition is 
consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and 
Federal HACCP regulations for seafood, juice, and meat and poultry. The 
proposed definition is the same as the definition in our HACCP 
regulation for juice (Sec.  120.3(i)). The NACMCF guidelines define 
``monitor'' to mean to conduct a planned sequence of observations or 
measurements to assess whether a CCP is under control and to produce an 
accurate record for future use in verification (Ref. 34). The Codex 
HACCP Annex defines ``monitor'' to mean the act of conducting a planned 
sequence of observations or measurements of control parameters to 
assess whether a CCP is under control (Ref. 35). Our HACCP regulation 
for seafood, and the FSIS HACCP regulation for meat and poultry were 
each established before the current NACMCF HACCP guidelines and do not 
define the term ``monitor.'' However, as discussed in section XII.E of 
this document, both of these regulations establish requirements that 
are consistent with the definition of ``monitor'' in proposed Sec.  
117.3 and in the NACMCF HACCP guidelines, the Codex HACCP Annex, and 
our HACCP regulation for juice.
    FDA is proposing to define the term ``packaging'' to mean (when 
used as a verb) placing food into a container that directly contacts 
the food and that the consumer receives. FDA is proposing to use the 
same definition of ``packaging'' as would be established in proposed 
Sec.  1.227. See section VIII.E of this document for a detailed 
discussion of ``packaging.''
    FDA is proposing to define the term ``packing'' to mean placing 
food into a container other than packaging the food. The proposed 
definition would also specify that, for farms and farm mixed-type 
facilities, packing also includes activities traditionally performed by

[[Page 3699]]

farms to prepare raw agricultural commodities grown or raised on the 
same farm or another farm under the same ownership for storage and 
transport, but does not include activities that transform a raw 
agricultural commodity, as defined in section 201(r) of the FD&C Act, 
into a processed food as defined in section 201(gg) of the FD&C Act. We 
are proposing to use the same definition of ``packing'' as would be 
established in proposed Sec.  1.227. See section VIII.E of this 
document for a detailed discussion of ``packing.''
    FDA is proposing to define the term ``preventive controls'' to mean 
those risk-based, reasonably appropriate procedures, practices, and 
processes that a person knowledgeable about the safe manufacturing, 
processing, packing, or holding of food would employ to significantly 
minimize or prevent the hazards identified under the hazard analysis 
that are consistent with the current scientific understanding of safe 
food manufacturing, processing, packing, or holding at the time of the 
analysis. The proposed definition would incorporate the definition in 
section 418(o)(3) of the FD&C Act.
    FDA is proposing to define the term ``qualified end-user'' to mean, 
with respect to a food, the consumer of the food (where the term 
consumer does not include a business); or a restaurant or retail food 
establishment (as those terms are defined in Sec.  1.227) that (1) is 
located (a) in the same State as the qualified facility that sold the 
food to such restaurant or establishment; or (b) not more than 275 
miles from such facility; and (2) is purchasing the food for sale 
directly to consumers at such restaurant or retail food establishment. 
The proposed definition would incorporate the definition in section 
418(l)(4)(B) of the FD&C Act.
    FDA is proposing to define the term ``qualified facility'' to mean 
(when including the sales by any subsidiary; affiliate; or subsidiaries 
or affiliates, collectively, of any entity of which the facility is a 
subsidiary or affiliate) a facility that is a very small business as 
defined in this part, or a facility as to which both of the following 
apply:
     During the 3-year period preceding the applicable calendar 
year, the average annual monetary value of the food manufactured, 
processed, packed or held at such facility that is sold directly to 
qualified end-users (as defined in this part) during such period 
exceeded the average annual monetary value of the food sold by such 
facility to all other purchasers; and
     The average annual monetary value of all food sold during 
the 3-year period preceding the applicable calendar year was less than 
$500,000, adjusted for inflation.
    The proposed definition would incorporate the description of 
``qualified facility'' in section 418(l)(1) of the FD&C Act with 
editorial changes to improve clarity.
    FDA is proposing to define the term ``qualified individual'' to 
mean a person who has successfully completed training in the 
development and application of risk-based preventive controls at least 
equivalent to that received under a standardized curriculum recognized 
as adequate by the FDA or is otherwise qualified through job experience 
to develop and apply a food safety system. FDA is proposing to define 
the term ``qualified individual'' to have a concise term to use in 
proposed provisions that would require that an activity be performed by 
such an individual. We are proposing to establish requirements for a 
qualified individual in proposed section Sec.  117.155 (see section 
XII.H of this document).
    FDA is proposing to define the term ``ready-to-eat food (RTE 
food)'' to mean any food that is normally eaten in its raw state or any 
other food, including processed food, for which it is reasonably 
foreseeable that the food would be eaten without further processing 
that will significantly minimize biological hazards. Our proposed 
definition is consistent with the definition in the Codex Guidelines on 
the Application of General Principles of Food Hygiene to the Control of 
Listeria Monocytogenes in Foods (Ref. 52), which defines an RTE food as 
any food which is normally eaten in its raw state or any food handled, 
processed, mixed, cooked, or otherwise prepared into a form which is 
normally eaten without further listericidal steps. By referring to 
``any other food, including processed food,'' our proposed definition 
for RTE food, in combination with our proposed definition of 
``manufacturing/processing,'' would incorporate the concepts in the 
Codex guidelines for control of Listeria that RTE food includes foods 
that have been processed, mixed, cooked, or otherwise prepared into a 
form that can be eaten without processing in a manner that adequately 
reduces pathogens. Our proposed definition would generalize the Codex 
definition established for the purpose of guidelines directed to a 
single hazard--i.e., the environmental pathogen L. monocytogenes--to 
any biological hazard that would be addressed under section 418 of the 
FD&C Act. In so doing, our proposed definition would state that RTE 
foods are normally eaten without further ``processing that will 
significantly minimize biological hazards,'' rather than ``listericidal 
steps.'' In a draft guidance directed to the control of L. 
monocytogenes in refrigerated or frozen RTE foods (Ref. 126), we 
defined RTE food to mean ``a food that is customarily consumed without 
cooking by the consumer, or that reasonably appears to be suitable for 
consumption without cooking by the consumer.'' We are proposing a 
definition of RTE food that is more closely aligned to the definition 
in the Codex guidelines on the control of Listeria than the definition 
in our draft guidance regarding the control of Listeria to emphasize 
that RTE foods include foods that are already processed to some degree 
but have reached the point at which no further steps to significantly 
minimize biological hazards will be applied before it is eaten. This 
emphasis is needed for clarity with respect to proposed requirements 
that would be directed to control of environmental pathogens at a 
facility. As discussed in section XII.B.4.b of this document, proposed 
Sec.  117.130(c)(2) would require that a hazard analysis include an 
evaluation of whether environmental pathogens are reasonably likely to 
occur whenever a RTE food is exposed to the environment prior to 
packaging. As discussed in section XII.G.7 of this document, under 
proposed Sec.  117.135(d)(3) preventive controls must include, as 
appropriate and where necessary to significantly minimize or prevent 
hazards that are reasonably likely to occur (including any 
environmental pathogen that is reasonably likely to occur in a ready-
to-eat food that is exposed to the environment prior to packaging, any 
microorganism of public health significance that is reasonably likely 
to occur in a ready-to-eat food due to employee handling, and any food 
allergen hazard) sanitation controls that include procedures for the 
(A) Cleanliness of food-contact surfaces, including food-contact 
surfaces of utensils and equipment; and (B) Prevention of cross-contact 
and cross-contamination from insanitary objects and from personnel to 
food, food packaging material, and other food-contact surfaces and from 
raw product to processed product.
    Our proposal to include in the proposed definition of RTE food the 
concept that it includes food that ``is reasonably foreseeable that the 
food would be eaten without further processing to significantly 
minimize biological hazards'' would retain the concept, in the draft 
guidance directed to the control of L. monocytogenes in

[[Page 3700]]

refrigerated or frozen RTE foods, that an RTE food includes food that 
``reasonably appears to be suitable for consumption without cooking by 
the consumer.'' For example, it is well known that consumers eat raw 
cookie dough; an outbreak of foodborne illness caused by E. coli 
O157:H7 has been linked to consumption of raw cookie dough (Ref. 77). 
It also is well known that consumers use dried soup mix in RTE form as 
a component of a dip; multiple dried soup mix products were recalled 
due to the potential for contamination with Salmonella spp. from an 
ingredient (hydrolyzed vegetable protein) (Ref. 24).
    FDA is proposing to define the term ``reasonably foreseeable 
hazard'' to mean a potential biological, chemical, physical, or 
radiological hazard that may be associated with the facility or the 
food. The term ``reasonably foreseeable hazard'' is not used in NACMCF 
HACCP guidelines, the Codex HACCP Annex, or Federal HACCP regulations 
for seafood, juice, or meat and poultry. However, the term is used in 
FSMA and, as discussed in section XII.B.2.a of this document, the 
concept is grounded in the hazard evaluation process in HACCP systems.
    FDA is proposing to define the term ``significantly minimize'' to 
mean to reduce to an acceptable level, including to eliminate. The 
specific terms ``significantly minimize'' and ``preventive control'' 
are not used in the NACMCF HACCP guidelines, the Codex HACCP Annex, or 
Federal HACCP regulations for seafood, juice, or meat and poultry. 
However, these terms are used in FSMA and are consistent with the 
definition of ``control measure'' in the NACMCF HACCP guidelines, the 
Codex HACCP Annex, and our HACCP regulation for juice. The NACMCF HACCP 
guidelines define ``control measure'' as any action or activity that 
can be used to prevent, eliminate or reduce a significant hazard (Ref. 
34). The Codex HACCP Annex defines ``control measure'' as any action or 
activity that can be used to prevent or eliminate a food safety hazard 
or reduce it to an acceptable level (Ref. 35). Our HACCP regulation for 
juice defines ``control measure'' as any action or activity to prevent, 
reduce to acceptable levels, or eliminate a hazard (Sec.  120.3(c)). 
Our HACCP regulation for seafood, and the FSIS HACCP regulation for 
meat and poultry, which were established prior to the current NACMCF 
HACCP guidelines, do not define ``control measure.'' However, these 
Federal HACCP regulations nonetheless reflect the same concept that 
would be established in the proposed definition of ``significantly 
minimize'' in the definition of ``critical control point,'' which is 
defined in the HACCP regulation for seafood as a point, step, or 
procedure in a food process at which control can be applied, and a food 
safety hazard can as a result be prevented, eliminated, or reduced to 
acceptable levels (Sec.  123.3(b)) and in the FSIS HACCP regulation for 
meat and poultry as a point, step, or procedure in a food process at 
which control can be applied and, as a result, a food safety hazard can 
be prevented, eliminated, or reduced to acceptable levels (9 CFR 
417.1).
    FDA is proposing to define the term ``small business'' to mean, for 
the purposes of part 117, a business employing fewer than 500 persons. 
See section X.B.5 for additional discussion of the definition of small 
business.
    FDA is proposing to define the term ``subsidiary'' to mean any 
company which is owned or controlled directly or indirectly by another 
company. The proposed definition would incorporate the definition in 
section 418(l)(4)(D) of the FD&C Act.
    FDA is proposing to define the term ``validation'' to mean that 
element of verification focused on collecting and evaluating scientific 
and technical information to determine whether the food safety plan, 
when properly implemented, will effectively control the identified 
hazards. The proposed definition is consistent with the NACMCF HACCP 
guidelines, the Codex HACCP Annex, and our HACCP regulation for juice. 
The NACMCF guidelines (Ref. 34) and our HACCP regulation for juice 
(Sec.  120.3(p)) define validation as that element of verification 
focused on collecting and evaluating scientific and technical 
information to determine whether the HACCP plan, when properly 
implemented, will effectively control the identified food hazards. The 
Codex HACCP Annex defines validation as obtaining evidence that the 
elements of the HACCP plan are effective (Ref. 35). Another Codex 
document (i.e., ``Guidelines for the Validation of Food Safety Control 
Measures'' (Codex validation guidelines)) defines validation more 
broadly than in the realm of HACCP systems as obtaining evidence that a 
control measure or combination of control measures, if properly 
implemented, is capable of controlling the hazard to a specified 
outcome (Ref. 127). Our HACCP regulation for seafood, and the FSIS 
HACCP regulation for meat and poultry, do not define the term 
``validation.'' We discuss our proposed requirements for validation 
(proposed Sec.  117.150(a)), and their relationship to HACCP systems, 
in section XII.G.2.a of this document.
    FDA is proposing to define the term ``verification'' to mean those 
activities, other than monitoring, that establish the validity of the 
food safety plan and that the system is operating according to the 
plan. The proposed definition is consistent with the NACMCF HACCP 
guidelines, the Codex HACCP Annex and validation guidelines, and our 
HACCP regulation for juice. The NACMCF guidelines (Ref. 34), and our 
HACCP regulation for juice (Sec.  120.3(q)) 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. 
The Codex HACCP Annex defines verification as the application of 
methods, procedures, tests and other evaluations, in addition to 
monitoring to determine compliance with the HACCP plan (Ref. 35). The 
Codex validation guidelines define verification as the application of 
methods, procedures, tests and other evaluations, in addition to 
monitoring to determine whether a control measure is or has been 
operating as intended (Ref. 127). Our HACCP regulation for seafood, and 
the FSIS HACCP regulation for meat and poultry, do not define the term 
``verification.''
    FDA is proposing to define the term ``very small business'' to 
mean, for the purposes of proposed part 117, a business that has less 
than $250,000 in total annual sales of foods, adjusted for inflation 
(Option 1 of co-proposal). As one co-proposal, we are proposing to 
define the term ``very small business'' to mean a business that has 
less than $500,000 in total annual sales of foods, adjusted for 
inflation (Option 2). As another co-proposal, we are proposing to 
define the term ``very small business'' to mean a business that has 
less than $1,000,000 in total annual sales of foods, adjusted for 
inflation (Option 3). See section X.B.5 for additional discussion of 
the definition of very small business.
5. Food Processing Sector Study and the Definitions of ``Small 
Business'' and ``Very Small Business''
    FDA conducted a Food Processing Sector Study as required by section 
418(l)(5) of the FD&C Act (Ref. 32) . The purpose of that study was to 
make determinations in five areas as required by section 418(l)(5)(A) 
of the FD&C Act and to use the results of the study in defining the 
terms ``small business'' and ``very small business.'' 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)

[[Page 3701]]

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. The Food Processing Sector 
Study provides information on the number of establishments and average 
sales per establishment by industry and size of operation. FDA's 
proposed definitions are informed by that study. The food processing 
sector study is available in the docket established for this proposed 
rule (Ref. 32). We request comment on that study. We will consider 
comments regarding the study, as well as comments regarding our 
proposed definitions ``small business'' and ``very small business,'' in 
any final rule based on this proposed rule.
    Section 418(l)(5)(B) of the FD&C Act required consideration of 
harvestable acres, income, the number of employees, and the volume of 
product in defining the terms ``small business'' and ``very small 
business.'' The Food Processing Sector Study (Ref. 32) concluded that 
there was no consistent pattern across food categories in terms of 
which sizes of establishments contribute most to foodborne illness 
risk. ``Harvestable acres,'' ``income,'' ``the number of employees,'' 
and ``the volume of food harvested'' are all ways to measure the size 
of an operation. Income does not appear to be the most relevant 
measure, since facility income may be derived from multiple sources, 
many of which are not food-related. ``Harvestable acres'' and ``volume 
of food harvested'' are similar measures that appear primarily relevant 
to the growing and harvesting of crops, which are activities not 
subject to this regulation. Harvestable acres and volume of food 
harvested do not provide a meaningful measure with respect to the risk 
from food produced by a farm mixed-type facility (a food facility co-
located on a farm subject to this regulation); our qualitative risk 
assessment of manufacturing, processing, packing and holding activities 
conducted in a facility co-located on a farm showed that risk was 
related to activity/food combinations; these foods could be harvested 
from large or small farms (see section VIII.G of this document for a 
discussion of that qualitative risk assessment). A high risk activity/
food combination could be conducted on a farm with many harvestable 
acres or very few harvestable acres. For example, an on-farm facility 
producing bagged salads (which would not be considered a low-risk 
activity/food combination) could be one that has very few acres, or the 
bagged salads production could be a small component of a large 
vegetable growing farm. FDA has previously used both number of 
employees and annual sales as criteria for defining small and very 
small businesses, e.g., in 21 CFR 120.1(b)(1) and (b)(2). We have 
limited data on number of employees, income, and annual sales upon 
which to base our definitions of small and very small business, but no 
data for ``harvestable acres'' or ``the volume of food harvested.''
    a. Definition of ``Small Business.'' FDA is proposing to define the 
term ``small business'' to mean, for the purposes of part 117, a 
business employing fewer than 500 persons. The proposed limit of 500 
employees would include all employees of the business rather than be 
limited to the employees at a particular facility. We are proposing to 
establish the same definition for small business as that which has been 
established by the U.S. Small Business Administration under 13 CFR 121 
for most food manufacturers. This is also the same definition for small 
business as we used to define a small business in our juice HACCP 
regulation (Sec.  120.1(b)(1)). The definition of small business is 
relevant to two provisions in the proposed rule. It would affect which 
facilities qualify for the exemption in Sec.  117.5(g) for on-farm 
packing or holding, and the exemption in Sec.  117.5((h) for on-farm 
manufacturing/processing, of food by a small business if the only 
activities subject to section 418 of the FD&C Act are the specific low-
risk activity/food combinations listed in those sections. It would also 
affect what the compliance date is for such facilities.
    Effect on proposed Sec.  117.5(g) and proposed Sec.  117.5(h).
    Under proposed Sec.  117.5(g) a farm mixed-type facility that meets 
the definition of a small business and only conducts specific packing 
or holding activity/food combinations would be eligible for an 
exemption from subpart C. Similarly, under proposed Sec.  117.5(h) a 
farm mixed-type facility that meets the definition of a small business 
and only conducts specific manufacturing/processing activity/food 
combinations would be eligible for an exemption from subpart C. Based 
on the Food Processing Sector Study, we estimate that approximately 
97,169 facilities would be part of a small business under the proposed 
definition and thus satisfy the size requirement of the exemption in 
proposed Sec.  117.5(g) and proposed Sec.  117.5(h). Of those 
facilities, we estimate that approximately 1,661 would be co-located on 
farms. A subset of those facilities would qualify for the exemption 
from Subpart C based on their manufacturing/processing and packing and 
holding activities.
    Other Effects.
    Based on the Food Processing Sector Study we estimate that 
businesses employing fewer than 500 employees produce approximately 18 
percent (based on sales) of all manufactured food produced in the 
United States. As discussed in section VII of this document, the 
compliance date for a small business would be 2 years after the date of 
publication of the final rule. Under our proposed definition, 97,169 
facilities would be subject to this compliance date.
    b. Definition of ``Very Small Business.'' In addition to defining 
``small business,'' FDA is required to define ``very small business.'' 
FDA has not reached a tentative conclusion on how best to define ``very 
small business'' for the purposes of this rule. Consequently, we are 
proposing three possible definitions based on annual sales of $250,000, 
$500,000, or $1,000,000 and requesting comment on which of these three 
options to include in a final rule. All three proposed definitions are 
informed by the findings of the Food Processing Sector Study (Ref. 32). 
We request comment on whether a dollar amount of sales that is more 
than, or less than, the $250,000, $500,000, or $1,000,000 dollar 
amounts we are proposing would be appropriate. We also request comment 
on how a particular dollar amount of sales would be in keeping with 
Congressional intent--i.e., in light of the provisions in section 
418(l) regarding qualified facilities, including the statutory 
limitations on sales to qualified end-users.
    The definition of very small business is relevant to 3 provisions 
of the proposed rule. It would affect which facilities qualify for the 
exemption in Sec.  117.5(g) for on-farm packing or holding, and the 
exemption in Sec.  117.5((h) for on-farm manufacturing/processing, of 
food by a very small business if the only activities subject to section 
418 of the FD&C Act are the specific low-risk activity/food 
combinations listed in those sections. It would also affect which 
facilities are automatically ``qualified'' facilities subject to the 
modified requirements in Sec.  117.201 and what the compliance date is 
for such facilities.
    i. Effect on proposed Sec.  117.5(g) and proposed Sec.  117.5(h). 
The definition of very small business affects which facilities qualify 
for the exemption in Sec.  117.5(g) for on-farm packing or holding, and 
the exemption in Sec.  117.5((h) for on-farm manufacturing/

[[Page 3702]]

processing, of food by a very small business if the only activities 
subject to section 418 of the FD&C Act are the specific low-risk 
activity/food combinations listed in those sections,
    ii. Other Effects. The definition of very small business affects 
which facilities are automatically ``qualified'' facilities subject to 
the modified requirements in Sec.  117.201, and the applicable 
compliance dates for such facilities. There are two ways a facility may 
be ``qualified'' and thus subject to the modified requirements in 
proposed Sec.  117.201. The first, limited annual monetary value of 
sales, is based on fixed criteria set out in FSMA Sec.  418(l)(1)(C). 
The second, as provided by Sec.  418(l)(1)(B), is to be a very small 
business as defined by FDA. Therefore, we discuss the affect of the 
proposed definitions for very small business in relation to the 
existing requirements for qualified facilities in Sec.  418(l)(1)(C).
    Less than $250,000 in Total Annual Sales--Effect on proposed Sec.  
117.5(g) and proposed Sec.  117.5(h).
    One possible definition of the term ``very small business,'' for 
the purposes of proposed part 117, would be a business that has less 
than $250,000 in total annual sales of foods, adjusted for inflation 
(Option 1 of the co-proposal). From the Food Processing Sector Study it 
is apparent that the number of co-located facilities is concentrated at 
the smaller end of the size spectrum. Using data from Dun & Bradstreet, 
FDA estimates that 736 facilities would meet the size requirement for 
the exemptions in proposed Sec.  117.5(g) and proposed Sec.  117.5(h). 
A subset of those facilities would then qualify for the exemption from 
Subpart C based on their manufacturing/processing, packing or holding 
activities.
    Less than $250,000 in Total Annual Sales--Effect on number of 
qualified facilities.
    The proposed definition of $250,000 uses a dollar amount for sales 
that is, essentially, the same as the maximum dollar amount of sales by 
a qualified facility to end-users other than those that would satisfy 
the definition of ``qualified end-users,'' except unlike with Sec.  
418(l)(1)(C), there would be no requirement that more than half of 
sales must be to qualified end-users. The $250,000 definition of very 
small business would add approximately 34,600 domestic facilities to 
the number of qualified facilities beyond the approximately 11,500 
domestic facilities that are qualified facilities under section 
418(l)(1)(C) of the FD&C Act, leading to a total of 46,100 domestic 
qualified facilities. These 46,100 domestic qualified facilities would 
have a 3 year compliance date. As a group, businesses with less than 
$250,000 in total annual sales of foods produce less than one-half of 
one percent of all food produced in the United States when measured by 
dollar value.
    Less than $500,000 in Total Annual Sales--Effect on proposed Sec.  
117.5(g) and proposed Sec.  117.5(h).
    One possible definition of the term ``very small business,'' for 
the purposes of proposed part 117, would be a business that has less 
than $500,000 in total annual sales of foods, adjusted for inflation 
(Option 2 of the co-proposal). From the Food Processing Sector Study it 
is apparent that the number of co-located facilities is concentrated at 
the smaller end of the size spectrum. Using data from Dun & Bradstreet, 
FDA estimates that 903 facilities would meet the size requirement for 
the exemptions in proposed Sec.  117.5(g) and proposed Sec.  117.5(h). 
A subset of those facilities would then qualify for the exemption from 
Subpart C based on their manufacturing/processing, packing or holding 
activities.
    Less than $500,000 in Total Annual Sales--Effect on number of 
qualified facilities.
    Defining very small business to mean a business that has less than 
$500,000 in total annual sales of foods would add approximately 45,900 
domestic facilities to the number of qualified facilities beyond the 
approximately 11,500 domestic facilities that are qualified facilities 
under section 418(l)(1)(C) of the FD&C Act, leading to a total of 
57,400 domestic qualified facilities. These 57,400 domestic qualified 
facilities would have a 3 year compliance date. As a group, businesses 
with less than $500,000 in total annual sales of foods produce less 
than one percent of all food produced in the United States when 
measured by dollar value.
    Less than $1,000,000 in Total Annual Sales--Effect on proposed 
Sec.  117.5(g) and proposed Sec.  117.5(h).
    One possible definition of the term ``very small business,'' for 
the purposes of proposed part 117, would be a business that has less 
than $1,000,000 in total annual sales of foods, adjusted for inflation 
(Option 3 of the co-proposal). From the Food Processing Sector Study it 
is apparent that the number of co-located facilities is concentrated at 
the smaller end of the size spectrum. Using data from Dun & Bradstreet, 
FDA estimates that 1,227 facilities would meet the size requirement for 
the exemption in proposed Sec.  117.5(g) and proposed Sec.  117.5(h). A 
subset of those facilities would then qualify for the exemption from 
Subpart C based on their manufacturing/processing, packing or holding 
activities.
    Less than $1,000,000 in Total Annual Sales--Effect on number of 
qualified facilities.
    As compared to option two, defining very small business to mean a 
business that has less than $1,000,000 in total annual sales of foods 
would add approximately 63,500 domestic facilities to the number of 
qualified facilities beyond the approximately 11,500 domestic 
facilities that are qualified facilities under section 418(l)(1)(C) of 
the FD&C Act, leading to a total of 75,000 domestic qualified 
facilities. These 75,000 domestic qualified facilities would have 3 
year compliance date. As a group, businesses with less than $1,000,000 
in total annual sales of foods produce less than two percent of all 
food produced in the United States when measured by dollar value.

C. Proposed Sec.  117.5--Exemptions

    For a summary list of the exemptions in proposed Sec.  117.5, see 
the table in the Executive Summary of this document.
1. Proposed Sec.  117.5(a)--Exemption Applicable to a Qualified 
Facility
    Section 418(l) of the FD&C Act establishes modified requirements 
for ``qualified facilities.'' We describe what a qualified facility is 
in section XIII.A of this document, where we propose the modified 
requirements for such a facility (proposed Sec.  117.201). We also 
define the term ``qualified facility'' in proposed Sec.  117.3 (see the 
discussion of definitions in section X.B.4 of this document). Section 
418(l)(2)(A) of the FD&C Act provides that a qualified facility ``shall 
not be subject to the requirements under [sections 418(a) through (i) 
and (n) of the FD&C Act];'' as a practical matter with respect to the 
provisions of this proposed rule, section 418(l)(2)(A) of the FD&C Act 
provides that a qualified facility would be exempt from the proposed 
requirements of subpart C. Importantly, section 418(l)(3) of the FD&C 
Act provides that the Secretary of HHS may withdraw the exemption 
provided in section 418(l)(2)(A) under certain circumstances. We 
discuss the withdrawal provisions of section 418(l)(3), and our 
proposed provisions to implement section 418(l)(3) (proposed subpart 
E), in section XIV of this document.
    We tentatively conclude that we should include the exemption 
provided in section 418(l)(2)(A) of the FD&C Act in the proposed rule 
to establish by regulation the reach of the provision. Proposed Sec.  
117.5(a) would provide that subpart C would not apply to a qualified

[[Page 3703]]

facility, except as provided by subpart E (i.e., except as provided by 
the proposed provisions for withdrawal), and that qualified facilities 
are subject to the modified requirements in Sec.  117.201.
2. Proposed Sec.  117.5(b) and (c)--Exemptions Applicable to Food 
Subject to HACCP Requirements for Fish and Fishery Products or for 
Juice
    Section 418(j)(1)(A) of the FD&C Act provides that section 418 of 
the FD&C Act shall not apply to a facility that is required to comply 
with, and is in compliance with, the Seafood Hazard Analysis Critical 
Control Points Program. Likewise, section 418(j)(1)(B) of the FD&C Act 
provides that section 418 of the FD&C Act shall not apply to a facility 
if the owner, operator, or agent in charge of such facility is required 
to comply with, and is in compliance with, ``[t]he Juice Hazard 
Analysis Critical Control Points Program* * *.'' (We interpret ``Juice 
Hazard Analysis Critical Control Points Program'' to mean the 
requirements of part 120 for juice.)
    The purpose of sections 418(j)(1)(A) and (B) appears clear--to 
exclude food covered by and in compliance with current HACCP 
requirements (parts 120 and 123) from section 418 of the FD&C Act. The 
exclusion likely reflects a determination that the similarity of the 
existing HACCP requirements in parts 120 and 123 to the preventive 
control requirements in section 418 makes application of section 418 
unnecessary to foods currently subject to and in compliance with part 
120 or 123. Although the purpose of the exemption appears clear, FDA 
considers the language of sections 418(j)(1)(A) and (B) to be ambiguous 
with regard to application of the exemption. The language of sections 
418(j)(1)(A) and (B) premise exemption from section 418 on an owner, 
operator, or agent in charge of a facility being required to comply 
with, and being in compliance with, part 120 or 123 ``with respect to 
such facility[.]'' However, parts 120 and 123 do not apply to 
``facilities,'' establishments, or plants. Rather, they apply to the 
specified foods (juice and fish and fishery products, respectively) and 
to persons defined as ``processors'' who conduct certain activities 
involving those foods. See, e.g., Sec.  120.1 (``The requirements of 
this part shall apply to any juice * * *''), Sec.  120.3(k) (definition 
of ``Processor''), Sec.  123.3(l) (definition of ``Processor''), and 
Sec.  123.6(b) (``The purpose of this part is to set forth requirements 
specific to the processing of fish and fishery products''). Thus, it is 
unclear for purposes of sections 418(j)(1)(A) and (B) under what 
circumstances a juice or seafood processor is required to comply with 
parts 120 or 123 ``with respect to [a] facility,'' especially when such 
a person also conducts activities involving other foods not subject to 
parts 120 or 123 at the same facility. Because of this ambiguity, FDA 
considered three possible interpretations.
    First, we could interpret sections 418(j)(1)(A) and (B) to exempt 
all food manufactured, processed, packed, or held by a facility from 
section 418 of the FD&C Act if the owner, operator, or agent in charge 
of the facility is required to comply with and is in compliance with 
part 123 or 120 with respect to any activities in the facility. Under 
this interpretation, food manufactured, processed, packed, or held by a 
facility that is not subject to part 120 or 123 would be excluded from 
section 418 if the owner, operator, or agent in charge of the facility 
is required to comply with, and is in compliance with, part 120 or 123 
for any food manufactured, processed, packed, or held by the facility. 
For example, if a facility processes juice products and the owner, 
operator, or agent in charge is in compliance with the juice HACCP 
regulation (part 120), all food manufactured, processed, packed, or 
held by the facility--both the juice subject to part 120 and food not 
subject to part 120 (e.g., dairy products)--would be exempt from 
section 418. The exclusion for juice appears consistent with the 
purpose of section 418(j)(1)(B) because the juice is already subject to 
the HACCP requirements in part 120. The resulting exclusion for dairy 
products, however, does not serve the purpose of the exclusion because 
the dairy products are not subject to the HACCP requirements in parts 
120 or 123. Further, the exclusion of food not subject to part 120 or 
123 (e.g., dairy products) would create a gap in the coverage of 
preventive controls, and therefore not be protective of public health.
    For example, there could be hazards reasonably likely to occur with 
regard to the dairy products, including environmental pathogens such as 
L. monocytogenes, but such hazards would not trigger any preventive 
control requirements because the facility would be excluded from 
section 418 of the FD&C Act. Finally, there is no apparent reason to 
regulate the same type of food not subject to part 120 or 123 (e.g., 
dairy products) differently depending on whether the food is 
manufactured, processed, packed, or held by a facility that 
manufactures, processes, packs, or holds other food that is subject to 
part 120 or 123. Therefore, we tentatively conclude that this 
interpretation results in an exclusion that is too broad.
    Second, we could interpret sections 418(j)(1)(A) and (B) to exempt 
an entire facility from section 418 only if the owner, operator, or 
agent in charge of the facility is subject to and in compliance with 
part 120 or 123 with regard to all food manufactured, processed, 
packed, or held by the facility. Under this interpretation, juice and 
seafood in a facility would, in addition to being subject to part 120 
or 123, be subject to the requirements in section 418 if the facility 
manufactures, processes, packs, or holds any food not subject to part 
120 or 123. For example, juice processing activities subject to part 
120 at a facility that processes juice and dairy products would be 
subject to section 418 because the facility manufacturers, processes, 
packs, or holds food not subject to part 120 or 123. The resulting 
application of section 418 to the dairy products in the example is a 
logical outcome--the dairy products are not subject to any other 
preventive control-type requirements. Further, the coverage gap created 
by the first possible interpretation is avoided. The application of 
section 418 to the juice in the example, however, is problematic. The 
juice is subject to part 120, thus application of section 418 to the 
juice would result in a circumstance that the exclusion in sections 
418(j)(1)(A) and (B) was likely intended to avoid--subjecting food 
covered by current HACCP requirements to additional preventive control 
requirements in section 418. Therefore, we tentatively conclude that 
this interpretation results in an exclusion that is too narrow.
    Finally, we considered a third interpretation. We could interpret 
sections 418(j)(1)(A) and (B) of the FD&C Act to exempt those 
activities of a facility that are subject to part 120 or 123, and only 
those activities, regardless of whether the facility manufactures, 
processes, packs, or holds other food. This interpretation would 
fulfill the apparent goal of the exemption-- to exclude food covered by 
and in compliance with current HACCP requirements (parts 120 and 123) 
from section 418. Further, this interpretation is neither too broad 
(because it does not exclude food that is not subject to part 120 or 
123) nor is it too narrow (because it does not result in overlapping 
requirements when food not subject to part 120 or 123 is processed in 
the same facility as food that is subject to part 120 or 123). This is 
the interpretation that seems most reasonable and that we propose to 
adopt in this proposed rule. We request comment on our

[[Page 3704]]

interpretation of sections 418(j)(1)(A) and (B).
    We tentatively conclude that we should include the exemptions 
provided in sections 418(j)(1)(A) and (B) of the FD&C Act in the 
proposed rule to establish by regulation the reach of the exemption as 
we have interpreted it. Proposed Sec.  117.5(b) would provide that 
Subpart C would not apply with respect to activities that are subject 
to part 123 (Fish and Fishery Products) at a facility if the owner, 
operator, or agent in charge of the facility is required to comply 
with, and is in compliance with, part 123 with respect to such 
activities. Likewise, proposed Sec.  117.5(c) would provide that 
Subpart C would not apply with respect to activities that are subject 
to part 120 (Hazard Analysis and Critical Control Point (HACCP) 
Systems) at a facility if the owner, operator, or agent in charge of 
the facility is required to comply with, and is in compliance with, 
part 120 with respect to such activities. Proposed Sec.  117.5(b) and 
(c) would make clear that the exemptions provided by sections 
418(j)(1)(A) and (B) of the FD&C Act would apply to particular 
activities at a facility rather than to the facility as a whole. For 
example, a facility producing juice and dairy beverages would be exempt 
only with respect to juices subject to, and in compliance, with part 
120. Such a facility would be subject to subpart C with respect to its 
dairy beverages, unless it qualified for another exemption.
    We request comment on the criteria that should be used to determine 
whether a facility is in compliance with part 123 or part 120.
3. Proposed Sec.  117.5(d)--Exemption Applicable to Food Subject to 
Part 113--Thermally Processed Low-Acid Foods Packaged In Hermetically 
Sealed Containers
    Section 418(j)(1)(C) of the FD&C Act provides that section 418 of 
the FD&C Act shall not apply to a facility if the owner, operator, or 
agent in charge of such facility is required to comply with, and is in 
compliance with, ``[t]he Thermally Processed Low-Acid Foods Packaged in 
Hermetically Sealed Containers standards of the [FDA] (or any successor 
standards).'' (We interpret ``Thermally Processed Low-Acid Foods 
Packaged in Hermetically Sealed Containers standards'' to mean the 
requirements of part 113.) Importantly, section 418(j)(2) of the FD&C 
Act limits the express exemption associated with part 113 to 
microbiological hazards that are regulated under part 113 (or any 
successor regulations). FDA considers the language of section 
418(j)(1)(C) of the FD&C Act to be ambiguous with regard to application 
of the exemption. As discussed with regard to sections 418(j)(1)(A) and 
(B) above, the language of section 418(j)(1)(C) premises exemption from 
section 418 of the FD&C Act on an owner, operator, or agent in charge 
of a facility being required to comply with, and being in compliance 
with, part 113 ``with respect to such facility[.]'' However, part 113 
does not apply to ``facilities,'' establishments, or plants. Rather, it 
applies to the specified foods (low-acid canned foods) and to persons 
defined as ``commercial processors'' who conduct certain activities 
involving those foods. See, e.g., Sec.  113.3(d) (definition of 
``Commercial processor''), and section 404 of the FD&C Act (21 U.S.C. 
344), which provides FDA with legal authority to issue part 113 (``[The 
Secretary] shall promulgate regulations providing for the issuance, to 
manufacturers, processors, or packers of such class of food [presenting 
specific risks defined in the section] in such locality of permits to 
which shall be attached such conditions governing the manufacture, 
processing, or packaging of such class of food * * *''). Thus, it is 
unclear for purposes of section 418(j)(1)(C) under what circumstances a 
low-acid canned food processor is required to comply with part 113 
``with respect to [a] facility,'' especially when such a person also 
conducts activities involving other foods not subject to part 113 at 
the same facility.
    We considered the same three interpretations of section 
418(j)(1)(C) of the FD&C Act as we considered for sections 418(j)(1)(A) 
and (B) of the FD&C Act for the purpose of proposed Sec.  117.5(b) and 
(c). We tentatively conclude that we should interpret section 
418(j)(1)(C) in the same manner as we interpreted sections 418(j)(1)(A) 
and (B)--i.e., to exempt those activities of a facility that are 
subject to part 113, and only those activities. Such an interpretation 
would fulfill the apparent goal of the exemption without being too 
narrow or too broad. We also tentatively conclude that we should 
include the exemption provided in section 418(j)(1)(C) of the FD&C Act 
in the proposed rule to establish by regulation the reach of the 
exemption as we have interpreted it. Proposed Sec.  117.5(d)(1) would 
provide that Subpart C would not apply with respect to activities that 
are subject to part 113 (Thermally Processed Low-Acid Foods Packaged in 
Hermetically Sealed Containers) at a facility if the owner, operator, 
or agent in charge of the facility is required to comply with, and is 
in compliance with, part 113 with respect to such activities. For 
example, a facility producing both low-acid foods packaged in 
hermetically sealed containers and acidified foods subject to part 114 
would be exempt only with respect to low-acid foods subject to, and in 
compliance with, part 113. Consistent with section 418(j)(2) of the 
FD&C Act, proposed Sec.  117.5(d)(2) would establish that the exemption 
in proposed Sec.  117.5(d)(1) would be applicable only with respect to 
the microbiological hazards that are regulated under part 113. A 
facility that is required to comply with, and is in compliance with, 
part 113 would be subject to the requirements in proposed subpart C for 
hazards such as chemical hazards (e.g., pesticide residues), physical 
hazards (e.g., metal fragments that could be introduced from equipment) 
and radiological hazards (e.g., high concentrations of radium-226, 
radium-228 or uranium in well water used in product). A facility that 
is required to comply with, and is in compliance with, part 113 also 
would be subject to the requirements in proposed subpart C for 
biological hazards not regulated under part 113. For example, the heat-
stable toxin produced by the Staphylococcus aureus is a biological 
hazard that would not be inactivated or destroyed by the processing 
required under part 113 (Ref. 128) (Ref. 129).
    We request comment on the criteria that should be used to determine 
whether a facility is in compliance with part 113.
4. Proposed Sec.  117.5(e)--Exemption Applicable to a Facility That 
Manufactures, Processes, Packs, or Holds a Dietary Supplement
    Section 103(g) of FSMA provides that ``[n]othing in the amendments 
made by [section 103 of FSMA] shall apply to any facility with regard 
to the manufacturing, processing, packing, or holding of a dietary 
supplement that is in compliance with the requirements of sections 
402(g)(2) and 761 of the [FD&C Act] (21 U.S.C. 342(g)(2), 379aa-1).'' 
Section 402(g)(2) of the FD&C Act authorizes FDA to issue regulations 
to require good manufacturing practices for dietary supplements. FDA 
has issued such a regulation at part 111 (21 CFR 111) (Current Good 
Manufacturing Practice in Manufacturing, Packaging, Labeling, or 
Holding Operations for Dietary Supplements). Section 761 of the FD&C 
Act requires serious adverse event reporting for dietary supplements. 
FDA has issued guidance implementing section 761 (Ref. 130).
    We interpret section 103(g) of FSMA in a manner analogous to our

[[Page 3705]]

interpretation of sections 418(j) and (k) of the FD&C Act--i.e., as an 
exemption from the requirements for hazard analysis and preventive 
controls that we are proposing to establish in subpart C of proposed 
part 117. We interpret the reference in section 103(g) of FSMA to 
``compliance with section 402(g)(2)'' to mean compliance with part 111 
(i.e., the regulation authorized by section 402(g)(2) of the FD&C Act). 
We tentatively conclude that Congressional intent regarding the reach 
of section 103(g) of FSMA is unambiguous in that section 103(g) of FSMA 
directly limits the provision ``with regard to the manufacturing, 
processing, packing, or holding of a dietary supplement * * *.'' We 
also tentatively conclude that we should include a provision 
implementing section 103(g) of FSMA in the proposed rule to establish 
by regulation the reach of the provision. Proposed Sec.  117.5(e) would 
provide that Subpart C would not apply to any facility with regard to 
the manufacturing, processing, packing, or holding of a dietary 
supplement that is in compliance with the requirements of Part 111 
(Current good manufacturing practice in manufacturing, packing, 
labeling, or holding operations for dietary supplements) and section 
761 of the FD&C Act (Serious Adverse Event Reporting for Dietary 
Supplements).
    We request comment on the criteria that should be used to determine 
whether a facility is in compliance with part 111 and with section 761 
of the FD&C Act.
5. Proposed Sec.  117.5(f)--Exemptions Applicable to Activities Subject 
to Standards for Produce Safety in Section 419 of the FD&C Act
    Section 418(k) of the FD&C Act provides that section 418 of the 
FD&C Act ``shall not apply to activities of a facility that are subject 
to section 419 [of the FD&C Act]''. Section 419, ``Standards for 
Produce Safety,'' requires FDA to establish by regulation ``science-
based minimum standards for the safe production and harvesting of those 
types of fruits and vegetables, including specific mixes or categories 
of fruits and vegetables, that are raw agricultural commodities for 
which [FDA] has determined that such standards minimize the risk of 
serious adverse health consequences or death.'' Section 419(h) of the 
FD&C Act provides that section 419 of the FD&C Act ``shall not apply to 
activities of a facility that are subject to section 418 [of the FD&C 
Act].'' Elsewhere in this issue of the Federal Register, FDA is issuing 
a proposed rule to implement section 419. That proposed rule would 
apply section 419 to (1) ``farms'' (as would be defined in proposed 
Sec. Sec.  1.227 and 1.328) that are not required to register under 
section 415 of the FD&C Act; and to (2) farms that conduct an activity 
(or activities) that triggers the section 415 registration requirement 
(``farm mixed-type facilities''), but only with respect to their 
activities that are within the farm definition and therefore do not 
trigger the registration requirement. See section VIII.E of this 
document for a discussion of our proposed revisions and additions to 
the definitions in current Sec. Sec.  1.227(b) and 1.328.
    Establishments that are exempt from registration under section 415 
of the FD&C Act as ``farms'' would not be subject to section 418 of the 
FD&C Act when conducting activities within the farm definition. Farm 
mixed-type facilities would be subject to section 418 of the FD&C Act 
when conducting those activities that trigger the section 415 
registration requirement. We tentatively conclude that Congressional 
intent regarding the reach of section 418(k) of the FD&C Act is 
unambiguous in that section 418(k) directly limits the exemption to 
activities of the facility that are subject to section 419 of the FD&C 
Act. We also tentatively conclude that we should include a provision 
implementing section 418(k) of the FD&C Act in the proposed rule to 
establish by regulation the reach of the exemption. Proposed Sec.  
117.5(f) would provide that Subpart C would not apply to activities of 
a facility that are subject to section 419 of the FD&C Act (Standards 
for Produce Safety).
    As discussed immediately below in section X.C.6 of this document, 
proposed Sec.  117.5(g) and (h) would provide for an exemption from the 
requirements of proposed subpart C for certain on-farm, low-risk 
manufacturing, processing, packing or holding activities by a small or 
very small business.
6. Proposed Sec.  117.5(g) and (h)--Exemption Applicable to Certain On-
farm Manufacturing, Processing, Packing or Holding Food by a Small or 
Very Small Business
    a. Requirements of section 103 of FSMA. As discussed in section 
VIII.A.1 of this document, section 103(c)(1)(A) of FSMA requires that 
the Secretary publish a proposed rule to promulgate regulations with 
respect to ``(i) 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 for purposes of section 415 of the [FD&C 
Act]; and (ii) activities that constitute on-farm manufacturing or 
processing of food that is not consumed on that farm or on another farm 
under common ownership for purposes of section 415.'' Section 
103(c)(1)(B) of FSMA directs that the rulemaking ``shall enhance the 
implementation of such section 415 [of the FD&C Act] and clarify the 
activities that are included as part of the definition of the term 
``facility'' under such section 415.'' In section VIII of this 
document, we discuss clarifications of certain on-farm activities and 
whether they trigger the section 415 registration requirement in order 
to enhance the implementation of section 415 by clarifying the 
treatment of various activities for purposes of section 415, including 
activities conducted on farms.
    As discussed in section VIII.A.2 of this document, section 
103(c)(1)(C) of FSMA requires that the Secretary conduct a science-
based risk analysis of ``(i) 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 (ii) 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 discussed in section VIII.G of this document, 
consistent with the requirements of section 103(c)(1)(C) of FSMA we 
have conducted a qualitative risk assessment related to activity/food 
combinations for the purpose of determining which activity/food 
combinations would be considered low risk.
    Section 103(c)(1)(D)(i) of FSMA requires that, in promulgating the 
regulations under Section 103(c)(1)(A), ``the Secretary shall consider 
the results of the science-based risk analysis conducted under [Section 
103(c)(1)(C) of FSMA], and shall exempt certain facilities from the 
requirements in section 418 of the [FD&C Act] * * *, including hazard 
analysis and preventive controls, and the mandatory inspection 
frequency in section 421 of [the FD&C Act] * * * or modify the 
requirements in [sections 418 or 421 of the FD&C Act], as the Secretary 
determines appropriate, if such facilities are engaged only in specific 
types of on-farm manufacturing, processing, packing, or holding 
activities that the Secretary determines to be low risk involving 
specific foods the Secretary determines to be low risk.'' Section 
103(c)(1)(D)(ii) of FSMA provides that ``[t]he exemptions or 
modifications under [section 103(c)(1)(D)(i) of FSMA] shall not include 
an exemption from the requirement to register under section 415 of the 
[FD&C Act] * * * if applicable, and shall apply only to

[[Page 3706]]

small businesses and very small businesses, as defined in the 
regulation promulgated under section 418(n) of the [FD&C Act].''
    b. FDA's interpretation of section 103(c)(1)(D)(i) of FSMA. FDA 
considers the language of section 103(c)(1)(D)(i) of FSMA to be 
unambiguous with regard to the reach of the exemption. The language of 
section 103(c)(1)(D)(i) includes the requirement ``if such facilities 
are engaged only in specific types of on-farm manufacturing, 
processing, packing, or holding activities that the Secretary 
determines to be low risk involving specific foods the Secretary 
determines to be low risk.'' FDA tentatively concludes that this 
language is unambiguous and means that Congress intended us to exempt a 
facility from, or modify the requirements of, section 418 of the FD&C 
Act under this authority if the facility only conducts a limited set of 
low-risk activity/food combinations that would otherwise be subject to 
section 418, that is, to the extent the facility is subject to section 
418, it ``is engaged only in'' the identified activities involving the 
identified foods. This interpretation seems both protective of public 
health and consistent with the preventive purpose of section 418 of the 
FD&C Act. This interpretation would mean that a facility would be 
required to conduct a hazard analysis and establish and implement risk-
based preventive controls for all activities conducted on all foods 
(including low-risk activity/food combinations) if a facility conducts 
a single activity subject to section 418 of the FD&C Act that is not a 
low-risk activity/food combination, unless the facility qualifies for 
another exemption from subpart C.
    c. Proposed Sec.  117.5(g)--Exemptions for on-farm low-risk packing 
or holding activity/food combinations. Proposed Sec.  117.5(g) would 
provide that subpart C would not apply to on-farm packing or holding of 
food by a small or very small business if the only packing and holding 
activities subject to section 418 of the FD&C Act that the business 
conducts are the following low-risk packing or holding activity/food 
combinations on food not grown, raised, or consumed on that farm mixed-
type facility or another farm or farm mixed-type facility under the 
same ownership--i.e., packing or re-packing (including weighing or 
conveying incidental to packing or re-packing); sorting, culling, or 
grading incidental to packing or storing; and storing (ambient, cold 
and controlled atmosphere) of:
    (1) Hard candy, fudge, taffy, and toffee;
    (2) Cocoa beans and coffee beans (raw and roasted);
    (3) Cocoa products.
    (4) Grains and grain products;
    (5) Honey (raw and pasteurized);
    (6) Intact fruits and vegetables (for purposes of proposed 
Sec. Sec.  117.5(g) and (h) only, ``intact fruits and vegetables'' 
refers only to fruits and vegetables other than cocoa beans, coffee 
beans, peanuts, sugar beets, sugarcane, and tree nuts);
    (7) Jams, jellies and preserves;
    (8) Maple sap for syrup and maple syrup;
    (9) Peanuts and tree nuts;
    (10) Sugar beets, sugarcane, and sugar; and
    (11) Soft drinks and carbonated water.
    The low-risk on farm packing and holding activity/food combinations 
on food not grown, raised, or consumed on that farm mixed-type facility 
or another farm or farm mixed-type facility under the same ownership 
reflect the findings of the analysis required by section 103(c)(1)(C) 
of FSMA, discussed in sections VIII.G and VIII.H of this document. For 
purposes of proposed Sec.  117.5(g) and (h) only, ``intact fruits and 
vegetables'' refers only to fruits and vegetables other than cocoa 
beans, coffee beans, peanuts, sugar beets, sugarcane, and tree nuts. 
Cocoa beans, coffee beans, peanuts, sugar beets, sugarcane, and tree 
nuts can be considered part of ``fruits and vegetables'' as a general 
matter, but FDA has addressed those foods separately for the purpose of 
the analysis required by section 103(c)(1)(C) of FSMA and the proposed 
Sec.  117.5(g) and (h) exemptions in order to accurately reflect 
differences in activity/food combinations likely to be performed on 
farm mixed-type facilities on those foods as compared to other fruits 
and vegetables, as well as differences in risk across those activity/
food combinations.
    d. Proposed Sec.  117.5(h)--Exemptions for on-farm low-risk 
manufacturing/processing activity/food combinations. Proposed Sec.  
117.5(h) would provide that subpart C would not apply to on-farm low-
risk manufacturing/processing activities conducted by a small or very 
small business if the only manufacturing/processing activities subject 
to section 418 of the FD&C Act that the business conducts are the 
following:
    (1) When conducted on a farm mixed-type facility's own raw 
agricultural commodities as defined in section 201(r) of the Federal 
Food, Drug, and Cosmetic Act (those grown or raised on that farm mixed-
type facility or another farm/farm mixed-type facility under the same 
ownership) for distribution into commerce:
    (i) Artificial ripening of intact fruits and vegetables;
    (ii) Boiling/evaporation of maple sap to make maple syrup;
    (iii) Chopping peanuts and tree nuts;
    (iv) Coating (with coatings other than wax, oil, or resin used for 
the purpose of storage or transportation) intact fruits and vegetables 
(e.g., caramel apples) and coating peanuts or tree nuts (e.g., adding 
seasonings);
    (v) Drying/dehydrating intact fruits and vegetables (without the 
addition of sulfites) where the drying creates a distinct commodity 
(e.g., drying fruits or herbs);
    (vi) Extracting oil from grains (e.g., corn, oilseeds, soybeans);
    (vii) Grinding/milling/cracking/crushing grains (e.g., making grain 
products such as corn meal) and raw peanuts or raw tree nuts (e.g., 
making ground peanuts);
    (viii) Making jams, jellies and preserves from acid foods (e.g., 
acid fruits);
    (ix) Making sugar from sugar beets and sugarcane; and
    (x) Salting raw peanuts and raw tree nuts;
    (2) When conducted on food other than the farm mixed-type 
facility's own raw agricultural commodities for distribution into 
commerce:
    (i) Artificial ripening of intact fruits and vegetables;
    (ii) Chopping peanuts and tree nuts;
    (iii) Coating (with coatings other than wax, oil, or resin used for 
the purpose of storage or transportation) intact fruits and vegetables 
(e.g., caramel apples), and peanuts and tree nuts (e.g., adding 
seasonings);
    (iv) Cooling intact fruits and vegetables using cold air;
    (v) Drying/dehydrating (whether for storage/transport or for 
creating a distinct commodity) intact fruits and vegetables (without 
sulfiting), cocoa beans, coffee beans, grains and grain products, and 
peanuts and tree nuts;
    (vi) Extracting oils from grains (e.g., corn, soybeans, oilseeds);
    (vii) Fermenting cocoa beans and coffee beans;
    (viii) Grinding/milling/cracking/crushing cocoa beans, coffee 
beans, grains (e.g., making grain products such as corn meal), and 
peanuts and tree nuts (e.g., making ground peanuts);
    (ix) Labeling (including stickering) hard candy, cocoa beans, cocoa 
products from roasted cocoa beans (other than milk chocolate) coffee 
beans, intact fruits and vegetables, grain and grain products (other 
than those containing wheat in a form that would not be recognized as 
containing wheat without a label declaration), honey,

[[Page 3707]]

jams/jellies/preserves, maple sap, maple syrup, intact single-
ingredient peanuts or tree nuts (shelled and unshelled), soft drinks 
and carbonated beverages, sugar beets, sugarcane, and sugar;
    (x) Making hard candy, fudge, taffy, and toffee;
    (xi) Making cocoa products from roasted cocoa beans;
    (xii) Making honey;
    (xiii) Making jams, jellies and preserves from acid foods (e.g., 
acid fruits);
    (xiv) Making maple syrup;
    (xv) Making soft drinks and carbonated water;
    (xvi) Making sugar from sugar beets and sugarcane;
    (xvii) Mixing cocoa beans, coffee beans, intact fruits and 
vegetables, grain and grain products, honey, maple sap and maple syrup, 
and peanuts and tree nuts;
    (xviii) Packaging hard candy, fudge, taffy, toffee; cocoa beans; 
cocoa products; coffee beans; intact fruits and vegetables (other than 
modified atmosphere or vacuum packaging); grain and grain products; 
honey; jams, jellies and preserves; and maple syrup; peanuts and tree 
nuts (including modified atmosphere or vacuum packaging); soft drinks 
and carbonated water; and sugar beets, sugarcane, and sugar;
    (xix) Salting peanuts and tree nuts;
    (xx) Shelling cocoa beans (i.e., winnowing), intact fruits and 
vegetables (e.g., dried beans and peas), and peanuts and tree nuts;
    (xxi) Sifting grains and grain products;
    (xxii) Sorting, culling and grading (other than when incidental to 
packing or storage) hard candy, fudge, taffy, and toffee; cocoa beans; 
cocoa products; coffee beans; intact fruits and vegetables; grain and 
grain products; honey; jams, jellies, and preserves; maple sap; maple 
syrup; peanuts and tree nuts; soft drinks and carbonated water; and 
sugar beets, sugarcane, and sugar;
    (xxiii) Treating cocoa beans, coffee beans, intact fruits and 
vegetables, grain and grain products, and peanuts and tree nuts against 
pests (other than during growing) (e.g., fumigation);
    (xxiv) Waxing (wax, oil, or resin used for the purpose of storage 
or transportation) intact fruits and vegetables.
    The low-risk on-farm manufacturing/processing activity/food 
combinations reflect the findings of the analysis required by section 
103(c)(1)(C) of FSMA, discussed in sections VIII.G and VIII.H of this 
document.
7. Proposed Sec.  117.5(i)-- Exemptions Related to Alcoholic Beverages
    a. Requirements of FSMA. Section 116(a) of FSMA (21 U.S.C 2206(a)) 
provides that, except as provided by certain listed sections in FSMA, 
nothing in FSMA, or the amendments made by FSMA, ``shall be construed 
to apply to a facility that--(1) under the Federal Alcohol 
Administration Act (27 U.S.C. 201 et seq.) or chapter 51 of subtitle E 
of the Internal Revenue Code of 1986 (26 U.S.C. 5001 et seq.) is 
required to obtain a permit or to register with the Secretary of the 
Treasury as a condition of doing business in the United States; and (2) 
under section 415 of the [FD&C Act] is required to register as a 
facility because such facility is engaged in manufacturing, processing, 
packing, or holding 1 or more alcoholic beverages, with respect to the 
activities of such facility that relate to the manufacturing, 
processing, packing, or holding of alcoholic beverages.''
    Section 116(b) of FSMA (21 U.S.C. 2206(b)) provides that section 
116(a) of FSMA ``shall not apply to a facility engaged in the receipt 
and distribution of any non-alcohol food, except that [section 116(a) 
of FSMA] shall apply to a facility described in [section 116(a) of 
FSMA] that receives and distributes non-alcohol food, provided such 
food is received and distributed--(1) in a prepackaged form that 
prevents any direct human contact with such food; and (2) in amounts 
that constitute not more than 5 percent of the overall sales of such 
facility, as determined by the Secretary of the Treasury.''
    Section 116(c) of FSMA (21 U.S.C. 2206(c)) provides that, 
``[e]xcept as provided in [sections 116(a) and (b) of FSMA], [section 
116] shall not be construed to exempt any food, other than alcoholic 
beverages, as defined in section 214 of the Federal Alcohol 
Administration Act (27 U.S.C. 214), from the requirements of [FSMA] 
(including the amendments made by [FSMA]).''
    b. FDA's interpretation of Section 116(a)(1) of FSMA. FDA is aware 
that some facilities that manufacture, process, pack, or hold alcoholic 
beverages are required to obtain what is technically called a 
``permit'' from the Secretary of the Treasury (``Treasury'') and some 
are required to ``register'' (such as ``dealers'' under 26 U.S.C. 5124) 
with Treasury. Others must adhere to functionally similar requirements 
by submitting a notice or application and obtaining approval from 
Treasury prior to commencing business. As examples, distilled spirits 
plants require a Federal Alcohol Administration Act (FAA Act) basic 
permit (27 U.S.C. 203-204) and must register under the Internal Revenue 
Code of 1986 (IRC) (26 U.S.C. 5171-72); wineries must obtain an FAA Act 
basic permit to produce or blend wine and as a bonded wine cellar must 
obtain approval of an application under the IRC (26 U.S.C. 5351 and 
5356); and breweries must file a brewer's notice under the IRC and must 
obtain approval of that notice from Treasury (26 U.S.C. 5401). Because 
Treasury informs FDA that these are functionally similar requirements, 
and because FDA has not identified a public health basis or an 
indication that Congress intended for these various facilities to be 
treated differently for the purposes of section 116 of FSMA, FDA 
tentatively concludes that the phrase ``obtain a permit or register'' 
is ambiguous and should be interpreted broadly, to include not only 
facilities that must obtain what is technically named a ``permit'' or 
must ``register'' with Treasury, but also those facilities that must 
adhere to functionally similar requirements as a condition of doing 
business in the United States, namely, by submitting a notice or 
application to Treasury and obtaining Treasury approval of that notice 
or application. Proposed Sec.  117.5(i)(1)(i) would provide that 
obtaining approval of a notice or application from the Secretary of the 
Treasury as a condition of doing business in the United States under 
the relevant statutes would be treated the same as obtaining a permit 
or registering with Treasury under those statutes for the purposes of 
section 418 of the FD&C Act.
    FDA understands that all of the facilities described in FSMA 
section 116(a)(1) are located in the United States (including Puerto 
Rico under the FAA Act). In isolation, therefore, section 116(a)(1) of 
FSMA appears to operate to exempt only certain domestic facilities from 
the requirements of section 418 of the FD&C Act. Under this 
interpretation, while domestic facilities would be exempt from section 
418 of the FD&C Act if they met all of the required criteria, foreign 
facilities would not be exempt because they do not satisfy section 
116(a)(1) of FSMA.
    This raises the question of whether such a construction of section 
116(a)(1) of FSMA would be consistent with the risk-based public health 
principles underlying section 418 of the FD&C Act and FSMA generally; 
and raises concerns related to U.S. trade obligations, for example, 
those found in the World Trade Organization Agreements. See, e.g., The 
General Agreement on Tariffs and Trade 1994,

[[Page 3708]]

(GATT 1994) Art. III(4) (``The products of the territory of any 
contracting party imported into the territory of any other contracting 
party shall be accorded treatment no less favorable than that accorded 
to like products of national origin in respect of all laws, regulations 
and requirements affecting their internal sale* * *.''); Agreement on 
the Application of Sanitary and Phytosanitary Measures, (SPS 
Agreement), Art. 2(3) (``Member shall ensure that their sanitary and 
phytosanitary measures do not arbitrarily or unjustifiably discriminate 
between Members where identical or similar conditions prevail, 
including between their own territory and that of other Members.''). 
Importantly, section 404 of FSMA provides that ``Nothing in this Act * 
* * shall be construed in a manner inconsistent with the agreement 
establishing the World Trade Organization or any other treaty or 
international agreement to which the United States is a party.''
    As a result, FDA considers the language of section 116 of FSMA, 
read together with the language of section 404 of FSMA, to be ambiguous 
with regard to foreign facilities that manufacture, process, pack, or 
hold alcoholic beverages. There are multiple possible interpretations 
of this provision. For example, section 116 of FSMA could be read to 
exempt only domestic facilities from the requirements of section 418 of 
the FD&C Act, or section 404 of FSMA could be read to make the section 
116(a)(1) exemption inapplicable for all facilities for the purposes of 
section 418 of the FD&C Act. In considering sections 116 and 404 
together, FDA tentatively concludes that it is reasonable to construe 
section 116(a)(1) to refer not only to domestic firms, but also to 
foreign firms in order to be consistent with the risk-based public 
health principles underlying section 418 of the FD&C Act and FSMA 
generally, and to avoid any inconsistency with treaties or 
international agreements to which the United States is a party. 
Accordingly, proposed Sec.  117.5(i)(1)(i) would apply the exemption 
not only to domestic facilities that are required to secure a permit, 
registration, or approval from Treasury under the relevant statutes, 
but also to foreign facilities of a type that would require such a 
permit, registration, or approval if they were domestic facilities.
    c. FDA's interpretation of Section 116(b) of FSMA. FDA also 
considers the language of section 116 of FSMA to be ambiguous with 
regard to the reach of the exemption for facilities that manufacture, 
process, pack, or hold alcoholic beverages and also receive, 
manufacture, process, pack, hold, or distribute non-alcohol food (for 
clarity FDA is using the term ``food other than alcoholic beverages'' 
rather than ``non-alcohol food'' in the codified and discussion that 
follows). Section 116(b) of FSMA provides that section 116(a) ``shall 
not apply to a facility engaged in the receipt and distribution of any 
non-alcohol food,'' except when the non-alcohol food is ``received and 
distributed--(1) in a prepackaged form that prevents any direct human 
contact with such food; and (2) in amounts that constitute not more 
than 5 percent of the overall sales of such facility, as determined by 
the Secretary of the Treasury.''
    In order to interpret the application of section 116 to food other 
than alcoholic beverages, FDA must interpret the meaning of the phrase 
``received and distributed * * * in a prepackaged form that prevents 
any direct human contact with such food'' in section 116(b) of FSMA. 
FDA tentatively concludes that this phrase refers to food that is 
completely enclosed in packaging during the entire time it is under the 
facility's direct control, such that direct human contact with such 
food is prevented. Under this interpretation, facilities that conduct 
activities using such packaged food without opening the packaging after 
receiving the food and before distributing it are receiving and 
distributing food in prepackaged form that prevents any direct human 
contact with such food. For example, a winery that assembles gift 
baskets containing bottles of its own wine and prepackaged boxes of 
crackers purchased from a supplier, without opening the boxes of 
crackers, would be receiving and distributing the food other than 
alcoholic beverages (crackers) in prepackaged form that prevents direct 
human contact with such food.
    Considering this interpretation and the fact that alcohol-related 
facilities also handle food other than alcoholic beverages in other 
ways, one interpretation of section 116(b) could be that facilities 
described in 116(a) that also receive and distribute any food other 
than alcoholic beverages would be entirely ineligible for the 
exemption, and therefore wholly subject to section 418 of the FD&C Act, 
unless such food is received and distributed in prepackaged form and in 
amounts that constitute no more than 5 percent of a facility's overall 
sales. For example, if a brewery receives grain and distributes spent 
grain as animal feed, the entire brewery and all of its activities, 
including the manufacturing, processing, packing, and holding of beer, 
would be subject to section 418 of the FD&C Act under this 
interpretation because it receives and distributes food other than 
alcoholic beverages that is not in prepackaged form. However, if the 
same brewery simply disposed of its spent grain as waste, the brewery's 
manufacturing, processing, packing, and holding of beer would not be 
subject to section 418 of the FD&C Act. In other words, under this 
interpretation, whether the facility's manufacturing, processing, 
packing, or holding of alcohol would be subject to section 418 of the 
FD&C Act would depend on the facility's activities relating to food 
other than alcoholic beverages.
    When considering the provision as a whole and in its statutory 
context, FDA tentatively concludes that another interpretation is more 
reasonable. The agency understands section 116 of FSMA, in general, to 
indicate that the manufacturing, processing, packing, or holding of 
alcoholic beverages at most alcohol-related facilities should not be 
subject to section 418 of the FD&C Act. FDA understands section 116(b) 
of FSMA to indicate that the receipt and distribution of food other 
than alcoholic beverages, including any manufacturing, processing, 
packing, or holding of such food occurring at the facility between 
receipt and distribution, should be subject to section 418 of the FD&C 
Act, unless that food is received and distributed in prepackaged form 
and in amounts that constitute 5 percent or less of the facility's 
overall sales. Thus, activities related to alcoholic beverages 
(including the manufacturing, processing, packing, or holding of 
alcoholic beverages) at facilities within the scope of 116(a) of FSMA 
would not be subject to section 418 of the FD&C Act. Activities related 
to food other than alcoholic beverages (including the receiving, 
manufacturing, processing, packing, holding, and distributing of such 
foods) would be subject to section 418 of the FD&C Act even if those 
activities occur at facilities that are otherwise within the scope of 
116(a) (unless they qualify for another exemption or are in prepackaged 
form and constitute 5 percent or less of the facility's overall sales). 
For example, if an alcoholic beverage distillery also makes non-
alcoholic beverages, under this interpretation the alcoholic beverage 
distilling activities would be exempt from section 418 of the FD&C Act, 
but the activities related to non-alcoholic beverages would be subject 
to section 418 (assuming the non-alcoholic beverages are not in 
prepackaged form and constitute less than 5 percent of the facility's 
overall sales) unless they

[[Page 3709]]

qualify for another exemption. This interpretation is also consistent 
with the rule of construction in section 116(c) of FSMA, which states, 
``except as provided in [sections 116(a) and (b) of FSMA], [section 116 
of FSMA] shall not be construed to exempt any food, other than 
alcoholic beverages, * * * from the requirements of this Act.''
    When considering the statute as a whole, including its underlying 
purpose, this interpretation of section 116 also provides a more 
consistent, risk-based approach supported by public health principles. 
FDA concludes that Congress must have considered identifying hazards 
and implementing preventive controls for the manufacturing, processing, 
packing, and holding of alcoholic beverages to warrant lower priority 
from a public health perspective than other foods. Congress may have 
made such a conclusion in light of the potential antimicrobial function 
of the alcohol content in such beverages and the concurrent regulation 
of alcoholic beverage-related facilities by both FDA and the Alcohol 
and Tobacco Tax and Trade Bureau (TTB). The definition of ``food'' 
under the FD&C Act includes ``articles used for food or drink'' and 
thus includes alcoholic beverages. See 21 U.S.C. 321(f). As such, 
alcoholic beverages are subject to the FD&C Act adulteration 
provisions, and implementing regulations, related to food. For example, 
manufacturers of alcoholic beverages are responsible for adhering to 
the requirements of current part 110. In addition, alcoholic beverages 
are regulated by TTB under the Federal Alcohol Administration Act and 
Chapter 51 of the Internal Revenue Code, which together establish ``a 
comprehensive system of controls of alcoholic beverages, including on-
site inspections and procedures that require the advance approval of 
statements of process and of formulas showing each ingredient to be 
used in the product'' (Ref. 131 at II.B). FDA tentatively concludes 
that Congress intended to exempt certain alcohol-related facilities 
from section 418 of the FD&C Act because it found that, in light of the 
relatively low public health risk presented by the manufacturing, 
processing, packing, and holding of alcoholic beverages and their joint 
regulation by both FDA and TTB, the current regulatory scheme was 
sufficient to control the hazards associated with the manufacturing, 
processing, packing, and holding of alcoholic beverages. At the same 
time, FDA tentatively concludes that Congress did not intend to exempt 
manufacturing, processing, packing, or holding of food other than 
alcoholic beverages from section 418 except in the very limited 
circumstances set forth in section 116(b)(1) and (2) of FSMA.
    At times, the manufacturing, processing, packing, or holding of 
alcoholic beverages is inseparable from the manufacturing, processing, 
packing, or holding of food other than alcoholic beverages. For 
example, a brewery that sells its spent grains as animal feed may be 
manufacturing beer and animal feed simultaneously for at least part of 
the brewing process. FDA tentatively concludes that section 418 of the 
FD&C Act does not apply to such inseparable activities. FDA tentatively 
concludes that section 418 applies to the food other than alcoholic 
beverages starting at the point at which it becomes physically separate 
from the alcoholic beverage because section 116(c) demonstrates 
Congress's intent to limit the reach of the exemption to alcoholic 
beverages. Thus, in the case of the brewery manufacturing animal feed, 
section 418 of the FD&C Act would apply to the spent grain sold as 
animal feed once the spent grain is physically separated from the beer, 
but not before that point.
    Proposed Sec.  117.5(i)(1) would provide that subpart C would not 
apply with respect to alcoholic beverages at facilities meeting the 
criteria in proposed Sec.  117.5(i)(1)(i) and (ii). Proposed Sec.  
117.5(i)(2) would provide that subpart C would not apply with respect 
to food other than alcoholic beverages at facilities described in 
proposed Sec.  117.5(i)(1), provided such food is in prepackaged form 
that prevents direct human contact with the food and constitutes not 
more than 5 percent of the overall sales of the facility, as determined 
by the Secretary of the Treasury.
    We tentatively conclude that we should include a provision 
implementing section 116 of FSMA in the proposed rule to establish by 
regulation the reach of the provision. We request comment on our 
interpretation of section 116 of FSMA.
8. Proposed Sec.  117.5(j)--Exemption Applicable to Facilities Solely 
Engaged in Storage of Raw Agricultural Commodities Other than Fruits 
and Vegetables Intended for Further Distribution or Processing
    Section 418(m) of the FD&C Act provides in relevant part that FDA 
may by regulation ``exempt or modify the requirements for compliance 
under [section 418 of the FD&C Act] with respect to facilities that are 
solely engaged in * * * the storage of raw agricultural commodities 
(other than fruits and vegetables) intended for further distribution or 
processing''.
    Proposed Sec.  117.5(j) would exempt facilities that are solely 
engaged in the storage of raw agricultural commodities (other than 
fruits and vegetables) intended for further distribution or processing 
from the requirements of subpart C. This provision would exempt, for 
example, facilities that only store whole grains (such as corn, wheat, 
barley, rye, grain sorghum, oats, rice, wild rice, and soybeans), 
unpasteurized shell eggs, and unpasteurized milk from subpart C. This 
would include facilities such as grain elevators and silos, provided 
that such facilities do not conduct other activities subject to section 
418 of the FD&C Act. Outbreaks of foodborne illness have not been 
traced back to storage facilities solely engaged in the storage of non-
fruit or vegetable RACs. In addition, as discussed in section X.C.9 of 
this document, facilities that are solely engaged in the storage of 
RACs are exempt from the current CGMP regulation, and FDA proposes to 
maintain this exemption from the CGMPs. FDA tentatively concludes that 
there would not be significant public health benefit to be gained by 
subjecting facilities that solely store non-fruit and vegetable RACs 
intended for further distribution or processing to the requirements of 
subpart C. Such facilities would remain subject to the requirements of 
the FD&C Act. For example, if storage is done under insanitary 
conditions whereby the food may become contaminated with filth or 
rendered injurious to health, the food would be adulterated under 
section 402(a)(4) of the FD&C Act.
9. Proposed Sec.  117.5(k)--Exemption Applicable to Farms, Activities 
of ``Farm Mixed-type Facilities'' Within the Definition of ``Farm,'' 
and the Holding or Transportation of One or More Raw Agricultural 
Commodities
    Current Sec.  110.19(a) provides that establishments engaged solely 
in the harvesting, storage, or distribution of one or more ``raw 
agricultural commodities,'' as defined in section 201(r) of the FD&C 
Act, which are ordinarily cleaned, prepared, treated, or otherwise 
processed before being marketed to the consuming public, are exempt 
from the requirements of part 110. The exemption in current Sec.  
110.19(a) is commonly referred to as the ``RAC exemption.'' Current 
Sec.  110.19(b) states that we will issue special regulations if it is 
necessary to cover operations excluded under current Sec.  110.19(a). 
In section VIII.D of

[[Page 3710]]

this document, we discuss the meaning of the term ``raw agricultural 
commodity'' (RAC).
    FDA is proposing a series of changes to current Sec.  110.19. As 
discussed more fully below, FDA is proposing to redesignate current 
Sec.  110.19(a) as proposed Sec.  117.5(k) and revise the newly 
established provision as follows:
     Delete current Sec.  110.19(b);
     Make clear that the exemption from requirements in 
proposed part 117 remains limited to the current requirements (which 
presently are established in current part 110, subparts B, C, E, and G 
and would be re-established in proposed part 117, subpart B under this 
proposed rule); and
     Adjust and clarify what activities fall within this 
exemption based on experience and changes in related areas of the law 
since issuance of the CGMP regulation.
    Proposed Sec.  117.5(k) would provide that Subpart B does not apply 
to ``farms'' (as would be defined in proposed Sec.  1.227), activities 
of farm mixed-type facilities (as would be defined in proposed Sec.  
1.227) that fall within the definition of ``farm,'' or the holding or 
transportation of one or more ``raw agricultural commodities,'' as 
defined in section 201(r) of the FD&C Act.
    Redesignating current Sec.  110.19(a) as proposed Sec.  117.5(k) 
would simplify the rule by listing all exemptions in a single place. 
Deleting current Sec.  110.19(b) would have no substantive effect, 
because current Sec.  110.19(b) establishes no binding requirement on 
FDA or on persons that would be subject to part 110 and is unnecessary 
to retain in part 110. We may issue special regulations if it is 
necessary to do so irrespective of whether such a possibility is 
provided for in part 110. Making clear that the exemption remains 
limited to the requirements in current part 110 is necessary because 
establishments that previously qualified for the RAC exemption would be 
subject to section 418 of the FD&C Act if they are required to register 
under section 415 of the FD&C Act, unless they otherwise qualify for an 
exemption from section 418 (in proposed Sec.  117.5(a) through (j)).
    Based on FDA's experience since issuance of the CGMP regulation and 
changes in related areas of the law since that time, FDA proposes to 
modify the existing language so that this exemption would apply to 
farms (as would be defined in proposed Sec.  1.227), activities of farm 
mixed-type facilities that fall within the farm definition, and 
activities related to holding or transporting RACs.
    FDA proposes to explicitly apply this exemption to ``farms'' within 
the meaning of that term in proposed Sec.  1.227. In current Sec.  
110.19(a), FDA used the term ``harvesting'' to describe one type of 
activity that could qualify for the exemption. Current Sec.  110.19(a) 
and its use of the term ``harvesting'' predated the BT Act of 2002, 
which exempted ``farms'' from the new authorities in sections 414 and 
415 of the FD&C Act. As discussed in section VIII.C of this document, 
FDA developed a definition of the term ``farm'' through notice and 
comment rulemaking implementing those authorities. Through those 
rulemakings, FDA learned that the terms ``growing'' and ``harvesting'' 
were not enough to capture the scope of the activities traditionally 
done on farms, and expanded the farm definition accordingly. Further, 
in this rulemaking, FDA is proposing to further clarify the scope of 
the farm definition. FDA recognizes today that farms within the 
definition of ``farm'' in proposed Sec.  1.227 grow/raise and harvest 
their own RACs, pack and hold their own RACs or any food they may 
consume themselves, and/or manufacture food for their own consumption. 
The term ``harvesting'' in current Sec.  110.19(a) is narrower than the 
current farm definition, but FDA concludes that the RAC exemption 
should apply to all activities within the farm definition and not 
merely to harvesting because other controls (such as those in the 
proposed produce safety rule under section 419 of the FD&C Act, and the 
statutory adulteration provision for food, section 402 of the FD&C Act) 
are more appropriate to apply to farms and their activities than is the 
CGMP regulation, which was developed and established for establishments 
other than farms. This is consistent with how FDA has interpreted the 
RAC exemption with respect to farms. For example, our ``Guide to 
Produce Farm Investigations'' (Ref. 132) advises FDA staff that 
``[f]arming operations, and subsequent operations in packing sheds and 
buildings, may not meet all requirements outlined in 21 CFR part 110 or 
recommendations in the GAP Guide (Ref. 133). However these documents 
serve as a useful tool in assessing whether raw agricultural products 
are handled under conditions that may adulterate the food.'' Farms 
within the proposed Sec.  1.227 definition are also not covered by 
section 418 of the FD&C Act because they do not have to register under 
section 415 of the FD&C Act, so they are not covered by any of proposed 
part 117. Activities within the farm definition are addressed by the 
adulteration provisions of the FD&C Act and the requirements in part 
118 for egg producers (as applicable), and will also be addressed (as 
applicable) in the proposed rule to establish produce safety standards 
under section 419 of the FD&C Act.
    FDA also proposes to exclude activities of farm mixed-type 
facilities that fall within the farm definition in proposed Sec.  1.227 
from subpart B. See sections VIII.C and VIII.E of this document for a 
discussion of the term ``farm mixed-type facility.'' FDA tentatively 
concludes that the portion of a farm mixed-type facility that is within 
the farm definition should be treated the same for the purposes of 
subpart B as are the same activities on farms that only conduct 
activities within the farm definition. FDA also proposes to exclude 
activities related to holding or transporting RACs, whether or not such 
activities are performed on farms. The term ``holding'' would have the 
same meaning here as in the revisions we are proposing to current Sec.  
1.227(b)(5). Current Sec.  110.19(a) uses the term ``storage'' to 
describe these activities. In proposed Sec.  1.227, ``holding'' is 
defined as ``storage of food'' for establishments other than farms and 
farm mixed-type facilities. The term ``transportation'' would be used 
instead of the current term ``distribution'' to make clear that the 
scope of the activities exempted by that term is limited to movement of 
RACs in commerce by a motor vehicle or rail vehicle, and does not 
extend to other activities, such as packing, that might be considered 
to be part of the broader term ``distribution.'' Entities that would be 
entirely exempted by these terms in the proposed revised provision 
would include warehouses, silos, or other entities that only store RACs 
and transporters that only handle RACs. Because section 418 of the FD&C 
Act applies to any facility that is required to register under section 
415 unless an exemption from section 418 applies, it is a separate 
question whether these entities would be subject to subpart C. Many of 
the establishments that are exempted from subpart B by this proposed 
provision are also likely to be exempt from subpart C or subject to 
modified requirements under section 418 of the FD&C Act, either because 
they do not have to register under section 415 (e.g., common carriers), 
or they qualify for an exemption or modified requirements under section 
418 (e.g., modified requirements for certain warehouses under proposed 
Sec.  117.7, exemption for small or very small businesses performing 
only on-farm low-risk activity/food combinations under

[[Page 3711]]

proposed Sec.  117.5(g) and (h), exemption for facilities that are 
solely engaged in the storage of raw agricultural commodities (other 
than fruits and vegetables) intended for further distribution or 
processing under proposed Sec.  117.5(j)).
    By removing the term ``distribution'' from current Sec.  110.19(a), 
FDA proposes to exclude packing of RACs that does not fall within the 
farm definition from the revised exemption, i.e., to subject packing of 
RACs to the requirements of subpart B. As discussed in section II.A.1 
of this document, the CGMP working group recommended that the agency 
consider removing the RAC exclusion entirely, and recommended that the 
agency request further comments on the appropriate application of CGMP 
controls to raw agricultural product harvesting, packing, storage and 
distribution (Ref. 1). These concerns were based on investigations of 
outbreaks linked to fresh produce that had ``identified contamination 
during production and harvest, initial processing and packing, 
distribution, and final processing as the likely source of product 
contamination.'' (Ref. 1). Since issuance of the CGMP working group 
report, FDA has continued to investigate foodborne illness outbreaks 
and contamination events associated with fresh produce and other RACs, 
and continues to be concerned about sanitation practices at 
establishments that pack RACs. Packing of RACs has been implicated as a 
likely source of contamination in multi-state foodborne illness 
outbreaks associated with RACs (Ref. 134) (Ref. 135) (Ref. 136).
    Accordingly, FDA tentatively concludes that packing of RACs should 
be subject to the CGMP requirements in proposed subpart B, but that the 
other activities discussed above for RACs are sufficiently addressed, 
or will be addressed, by FDA in other ways. We seek comment on this 
proposal. Growing/raising and harvesting of RACs, and all activities 
within the farm definition, such as on-farm packing and holding of a 
farm's own RACs, will continue to be addressed through the statutory 
adulteration provisions in the FD&C Act, the requirements of part 118 
for egg producers (as applicable), and the proposed rule to establish 
produce safety standards (as applicable) under section 419 of the FD&C 
Act. FDA tentatively concludes that it is appropriate to address food 
safety on farms in this fashion, rather than by requiring farms to 
comply with subpart B. Manufacturing/processing steps conducted on RACs 
are already subject to the current CGMP regulation and will continue to 
be subject to the requirements of subpart B, which applies to 
manufacturing/processing, including when such activities are performed 
on RACs. This includes manufacturing/processing steps that may occur at 
establishments that are commonly known as ``packinghouses,'' such as 
washing and treating fruits and vegetables. ``Distribution'' is a term 
that might include activities such as transportation and packing 
(including re-packing). For clarity, we now discuss those two steps 
separately. Transportation of non-RACs is subject to the CGMP 
requirements in current Sec.  110.93, and FDA further expects to 
address transportation of food in more detail in rulemaking to 
implement the Sanitary Food Transportation Act of 2005 (Pub. L. 109-59) 
and section 416 of the FD&C Act (75 FR 22713, April 30, 2010). Section 
416(b) of the FD&C Act requires FDA to promulgate regulations to 
``require shippers, carriers by motor vehicle or rail vehicle, 
receivers, and other persons engaged in the transportation of food to 
use sanitary transportation practices prescribed by the Secretary to 
ensure that food is not transported under conditions that may render 
the food adulterated.'' In addition, FDA is not currently aware of 
foodborne illness outbreaks related to RACs that were likely to have 
been caused by insanitary conditions during transportation conditions. 
This leaves only packing as a step of concern that is not being 
sufficiently addressed, either through application of the CGMP 
requirements or in another way. Therefore, FDA tentatively concludes 
that packing of RACs that does not fall within the farm definition 
should be subject to the requirements in proposed subpart B. We request 
comment on this conclusion and on whether there any aspects of proposed 
subpart B that should not apply to the packing of RACs.
    Because the current exemption in Sec.  110.19(a) is limited to 
``establishments engaged solely in'' the listed activities, it does not 
exempt establishments that conduct any activities relating to food for 
human consumption other than the specifically identified activities for 
RACs. FDA tentatively concludes that it would be reasonable to revise 
the exemption so that it would exempt the specifically identified 
activities when performed on RACs, regardless of whether the 
establishment that conducts those activities also conducts other 
activities that do not qualify for the exemption. This is because, as 
in the section 418(j)(1) exemptions discussed in sections X.C.2 and 
X.C.3 of this document (for activities covered by parts 120, 123, and 
113), it is more appropriate to subject these activities to controls 
other than those in proposed subpart B, and these activities should be 
regulated in the same way whether or not other activities subject to 
proposed subpart B take place at the same establishment. If activities 
subject to proposed subpart B do take place at the same establishment, 
compliance with proposed subpart B with respect to those activities 
should provide the necessary protection for food subject to those 
activities regardless of whether RACs are also stored or transported by 
the same establishment, or if activities inside the farm definition are 
conducted at the same establishment.
    FDA also proposes to delete ``which are ordinarily cleaned, 
prepared, treated, or otherwise processed before being marketed to the 
consuming public'' from the current exemption. While this phrase 
captured FDA's original reasoning for providing the RAC exemption, it 
is confusing because many RACs are not so processed (as is often the 
case for fresh produce, for example) and the operative part of the 
exemption is that it applies to RACs, not only some RACs depending on 
whether they receive later manipulation.

D. Proposed Sec.  117. 7--Applicability of Part 117 to a Facility 
Solely Engaged in the Storage of Packaged Food That Is Not Exposed to 
the Environment

1. Requirements of Section 418 of the FD&C Act
    Section 418(m) of the FD&C Act provides, in relevant part, that 
``[t]he Secretary may, by regulation, exempt or modify the requirements 
for compliance under [section 418 of the FD&C Act] with respect to 
facilities that are solely engaged in * * * the storage of packaged 
foods that are not exposed to the environment.''
2. Petition Relevant to Section 418(m) of the FD&C Act
    In a letter dated July 22, 2011, an industry coalition of the 
American Bakers Association, the American Frozen Food Institute, the 
Grocery Manufacturers Association, the International Bottled Water 
Association, the International Dairy Foods Association, the 
International Warehouse Logistics Association, the Peanut and Tree Nut 
Processors Association, and the Snack Food Association (the section 
418(m) petitioners) submitted a citizen petition (Docket No. FDA-2011-
P-0561). The petition requests that FDA promulgate regulations under 
section 418(m) of the FD&C Act ``to exempt from compliance

[[Page 3712]]

or modify the requirements for compliance under section 418 [of the 
FD&C Act] for facilities that are solely engaged in the storage of 
packaged foods that are not exposed to the environment, by allowing 
such facilities to satisfy the requirements of that section through 
compliance with the [CGMPs] mandated for such facilities by [current] 
Sec.  110.93.'' The section 418(m) petitioners assert that the food 
safety issues presented by facilities used only to store packaged foods 
that are not exposed to the environment are essentially the same, 
regardless of the type of food. As such, trade associations 
representing a variety of product sectors are signatories to the 
petition and are supportive of the request to exempt such facilities 
from the provisions of section 418 of the FD&C Act. In the remainder of 
this document, we refer to packaged food not exposed to the environment 
as ``unexposed packaged food.'' We consider ``not exposed to the 
environment'' and ``unexposed'' to mean that the food is in a form that 
prevents any direct human contact with the food.
    The section 418(m) petitioners state that most of the potential 
hazards and preventive controls noted in section 418 of the FD&C Act 
are not relevant to facilities solely engaged in the storage of 
unexposed packaged foods and that the foods handled in these facilities 
would have already been subjected to hazard analyses and preventive 
controls (including CGMPs) throughout the process of their manufacture 
and packaging for delivery to retailers and end-users. They further 
state that most of the preventive control activities carried out in 
food production settings (such as sanitation of food-contact surfaces 
and utensils) offer no benefit for a facility storing unexposed 
packaged foods and that controls such as supplier verification and 
recall plans would be addressed by the manufacturing facility from 
which the foods originated.
    The section 418(m) petitioners state that the ``few hazards'' that 
may arise in facilities solely engaged in the storage of unexposed 
packaged foods, ``including those relating to environmental, climate, 
and pest controls, are already addressed under FDA's existing CGMPs 
governing warehousing and distribution [in current Sec.  110.93].'' 
They state that storage facilities themselves pose ``a very limited, if 
any, food-safety risk'' and that they are not aware of any significant 
foodborne illness outbreaks attributable to storage at such facilities.
    The section 418(m) petitioners note that many packaged food 
warehouses contain a variety of foods that can come from many different 
manufacturing facilities or even different companies. According to the 
petitioners, warehouse operators work closely with the food 
manufacturers to understand the conditions and controls that need to be 
utilized to ensure the quality of the foods they store and distribute 
and, in many cases, those conditions and controls are formalized in 
written contracts.
    The section 418(m) petitioners assert that the warehouse operators 
themselves do not have access to product formulations and other 
relevant information that would be necessary for them to conduct a 
hazard analysis, develop preventive controls, and monitor them. They 
state that the food manufacturer, on the other hand, does understand 
the products it produces and factors in the storage and distribution 
parameters and considerations into the hazard analysis and 
appropriately instructs the warehouses to ensure unexposed packaged 
foods are being properly stored. The section 418(m) petitioners thus 
assert that responsibility for hazard analysis and risk-based 
preventive controls under section 418 of the FD&C Act is properly and 
best shouldered by the food manufacturer.
    The section 418(m) petitioners propose that FDA use the following 
language as part of its regulations implementing section 418 of the 
FD&C Act: ``A facility that is engaged solely in the storage, holding, 
warehousing, or distribution of packaged foods that are not exposed to 
the environment shall be exempt from the requirements of section 418 of 
the Federal Food, Drug, and Cosmetic Act if the facility complies with 
the requirements set forth at 21 CFR 110.93.''
    FDA notes that petitioners also make arguments for their position 
relevant to ``hazards that may be intentionally introduced, including 
by acts of terrorism,'' as described in Sec.  418(b)(2). As discussed 
in sections II.B.2.f and XII.B.1, those hazards will be addressed in a 
future rulemaking so FDA is not addressing that aspect of the petition 
in this proposal.
3. FDA's Tentative Response to the Petition
    We tentatively agree in part, and disagree in part, with the 
section 418(m) petitioners. As discussed more fully below, we agree it 
is appropriate for facilities solely engaged in the storage of 
unexposed packaged food to be exempt from the requirements that would 
be established in proposed subpart C, provided that the food does not 
require time/temperature control for safety. For unexposed packaged 
food that requires time/temperature control for safety, we disagree 
that such an exemption is warranted, but tentatively conclude that 
unexposed packaged food that requires time/temperature control for 
safety could be subject to modified requirements rather than to the 
full requirements that would be established in proposed subpart C.
    We disagree that warehouse operators do not have access to 
information relevant to conducting a hazard analysis and establishing 
risk-based preventive controls. The principal hazard that would be 
identified in any hazard analysis for unexposed packaged food is the 
potential for the growth of, or toxin formation by, microorganisms of 
public health significance when an unexposed refrigerated packaged food 
requires time/temperature control for safety. Information about this 
hazard and appropriate preventive controls for this hazard is widely 
available (Ref. 137) (Ref. 138) (Ref. 139) (Ref. 140). For example, the 
2009 Edition of FDA's Food Code defines ``Potentially Hazardous Food 
(Time/Temperature Control for Safety Food)'' as a food that requires 
time/temperature control for safety to limit pathogenic microorganism 
growth or toxin formation (Ref. 137). Earlier editions (e.g., the 2001 
Food Code) included a similar definition for ``potentially hazardous 
food''; since 2005, the definition jointly refers to ``potentially 
hazardous food'' and ``time/temperature control for safety food'' 
(commonly referred to as TCS food) to emphasize the importance of 
temperature control in keeping food safe. Although we disagree that 
warehouse operators do not have access to information relevant to 
conducting a hazard analysis and establishing risk-based preventive 
controls, we agree that it is not necessary for each facility solely 
engaged in the storage of unexposed packaged food to conduct its own 
hazard analysis to identify this hazard for unexposed refrigerated 
packaged food as reasonably likely to occur and for each such facility 
to determine that time/temperature control is the appropriate 
preventive control.
    We also disagree that current Sec.  110.93 alone is adequate for 
addressing environmental problems such as a flood in the facility and 
pest control problems, even though the food in question is not exposed 
to the environment and pest control problems with the container would 
likely be visible to the warehouse operator. However, we tentatively 
conclude that proposed Sec.  117.93, along with other applicable 
provisions of proposed part

[[Page 3713]]

117, subpart B, such as pest control in proposed Sec.  117.35, do 
adequately address most safety-related issues that may arise in 
facilities solely engaged in the storage of unexposed packaged food. We 
disagree that current Sec.  110.93 or other provisions in proposed part 
117, subpart B justifies the exemption from all preventive control 
requirements sought by the petitioners in the specific case of 
unexposed refrigerated packaged food that requires time/temperature 
control for safety (hereinafter unexposed refrigerated packaged TCS 
food). As discussed more fully in section XIII.B of this document, such 
food requires the implementation of an appropriate preventive control 
(temperature), monitoring that control, taking corrective actions when 
there is a problem with that control, verifying that the control is 
consistently implemented, and establishing and maintaining records 
documenting the monitoring, corrective actions, and verification. FDA 
tentatively concludes that it is appropriate for our response to the 
petition to distinguish between packaged food that requires such time/
temperature control and packaged food that does not.
    We also disagree that an exemption provided under section 418(m) of 
the FD&C Act should be established in a manner that has the potential 
to be interpreted more broadly than section 418(m) provides. The 
section 418(m) petitioners request that we establish a provision that 
``A facility that is engaged solely in the storage, holding, 
warehousing, or distribution of packaged foods that are not exposed to 
the environment shall be exempt from the requirements of section 418 
[of the FD&C Act]'', whereas section 418(m) provides discretion for an 
exemption ``with respect to facilities that are solely engaged in * * * 
the storage of packaged foods that are not exposed to the 
environment.'' Under proposed Sec.  117.3, ``holding'' would mean 
storage of food and holding facilities would include, relevant to 
unexposed packaged food, warehouses and cold storage facilities. To the 
extent that a facility that is engaged solely in ``warehousing'' or 
``distribution'' of unexposed packaged food is merely ``storing'' or 
``holding'' the food, an exemption established using the language 
provided by section 418(m) would apply to that facility. However, to 
the extent that a facility that is engaged solely in ``warehousing'' or 
``distribution'' of unexposed packaged food is not merely ``storing'' 
or ``holding'' the food, an exemption established using the language 
provided by section 418(m) would not apply to that facility.
    In response to the petition, FDA is proposing to establish an 
exemption from subpart C for facilities solely engaged in the storage 
of unexposed packaged food (proposed Sec.  117.7). FDA also is 
proposing to establish modified requirements at such facilities to 
require that the owner, operator, or agent in charge of such a facility 
comply with modified requirements for any unexposed refrigerated 
packaged TCS food (proposed Sec.  117.206). See the discussion of 
proposed Sec.  117.7 in the next section of this document and the 
discussion of proposed Sec.  117.206 in section XIII.B of this 
document.
4. Proposed Sec.  117.7--Applicability of Part 117 to a Facility Solely 
Engaged in the Storage of Packaged Food That Is Not Exposed to the 
Environment
    Proposed Sec.  117.7(a) would provide that subpart C does not apply 
to a facility solely engaged in the storage of packaged food that is 
not exposed to the environment. Proposed Sec.  117.7(b) would establish 
that unexposed packaged food at such facilities is subject to modified 
requirements that would be established in proposed Sec.  117.206. As 
discussed more fully in section XIII.B of this document, the modified 
requirements would mandate that such a facility establish and implement 
appropriate temperature controls, monitor the temperature controls, 
take corrective actions, verify that the temperature controls are 
consistently implemented, and establish and maintain records 
documenting the monitoring, corrective actions, and verification 
activities for unexposed refrigerated packaged TCS food. These modified 
requirements would be a subset of the proposed requirements that would 
be established in subpart C.
    There are limited routes of contamination for unexposed packaged 
food in a facility that solely stores unexposed packaged food (e.g., 
packaged food in containers in a warehouse). Contamination can occur, 
for example, if rodents gnaw through packages or if human waste from an 
improperly maintained toilet facility spills and seeps into paper-based 
packaging. However, with one exception, the CGMP requirements in 
proposed part 117, subpart B (e.g., proposed Sec. Sec.  117.20, 117.35, 
117.37, and 117.93) would apply to the storage of unexposed packaged 
food and be adequate to prevent such contamination so that it would not 
be necessary for the owner, operator, or agent in charge of a facility 
to address these routes of contamination by applying the hazard 
analysis and risk-based preventive controls that would be established 
in proposed subpart C. The exception would be for the rare circumstance 
in which RACs are packaged in a manner in which the RACs are not 
exposed to the environment. Under current Sec.  110.19(a), an 
establishment solely engaged in storing RACs is exempt from CGMPs in 
current part 110; under proposed Sec.  117.5(k), such an establishment 
would continue to be exempt from CGMPs. Such an establishment is now, 
and would continue to be, subject to section 402(a)(4) of the FD&C Act. 
An establishment that is solely engaged in the storage of packaged RACs 
that are not exposed to the environment may find the provisions of 
proposed subpart B helpful in ensuring compliance with section 
402(a)(4) of the FD&C Act.
    Many of the requirements that would be established in proposed 
subpart C would be directed to manufacturing, processing, and packing 
food and would not apply to the storage of unexposed packaged food that 
does not require time/temperature control for safety. This is the case 
for:
     Process controls (proposed Sec.  117.135(d)(1));
     Food allergen controls (proposed Sec.  117.135(d)(2));
     Sanitation controls (proposed Sec.  117.135(d)(3));
     Monitoring of process controls, food allergen controls, 
and sanitation controls (proposed Sec.  117.140);
     Corrective actions (proposed Sec.  117.145);
     Verification (including initial validation) of process 
controls (proposed Sec.  117.150); and
     A recall plan (proposed Sec.  117.137) (recalls generally 
are initiated by the manufacturer, processor, or packer of the food).
    FDA tentatively concludes that the outcome of a hazard analysis for 
storage of unexposed packaged food that does not require time/
temperature control for safety is that there are no hazards reasonably 
likely to occur. We also tentatively conclude that there would be 
little public health benefit to requiring the owner, operator, or agent 
in charge of each facility solely engaged in the storage of such food 
to conduct its own hazard analysis and document that outcome in its own 
food safety plan. Likewise, we tentatively conclude that there would be 
no need for the facility to establish and implement preventive 
controls, with corresponding monitoring, corrective actions, or 
verification (including validation), because there would be no hazards 
reasonably likely to occur to trigger such

[[Page 3714]]

activities. We also tentatively conclude that there would be no need 
for a qualified individual to conduct activities such as preparing the 
food safety plan (proposed Sec.  117.126(c)); developing the hazard 
analysis (proposed Sec.  117.130(a)(3)); validating the preventive 
controls (proposed Sec.  117.150(a)(1)); reviewing records for 
implementation and effectiveness of preventive controls and 
appropriateness of corrective actions (proposed Sec.  117.150(d)(2)); 
or performing reanalysis of the food safety plan (proposed Sec.  
117.150(e)(1)(iv)), because the facility would not need to conduct 
these activities. Thus, with the exception of the unexposed 
refrigerated packaged TCS food, we tentatively conclude that the food 
safety system that would be established in proposed subpart C is not 
needed to significantly minimize or prevent the occurrence of hazards 
that could affect unexposed packaged food at a facility solely engaged 
in the storage of such food.
    The purpose of proposed Sec.  117.7(b) is to make clear that 
although a facility solely engaged in the storage of unexposed packaged 
food is exempt from subpart C, such a facility is subject to modified 
requirements that would be established in proposed Sec.  117.206. These 
requirements would apply to the storage of unexposed refrigerated 
packaged TCS food. We explain the basis for those proposed requirements 
in section XIII.B of this document.

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

    As discussed in section IX.F of this document, FDA is proposing a 
number of revisions to delete some guidance currently established in 
part 110 (e.g., provisions using ``should'' or ``compliance may be 
achieved by''). Table 8 identifies each of the proposed deletions and 
either explains the deletion or, for deletions with longer 
explanations, refers to the section of the preamble where the deletion 
is explained.

Table 8--Proposed Deletion of Guidance Currently Established in Part 110
------------------------------------------------------------------------
   Current designation of
   provision that includes    Guidance that FDA is       Explanation
          guidance             proposing to delete
------------------------------------------------------------------------
Sec.   110.10(b)(5)           Gloves should be of   We considered the
 (Cleanliness).                an impermeable        diversity of food
                               material.             that is
                                                     manufactured,
                                                     processed, packed
                                                     or held and would
                                                     be subject to the
                                                     requirements of
                                                     proposed part 117.
                                                     The use of an
                                                     impermeable
                                                     material may be
                                                     important for
                                                     handling a ready-to-
                                                     eat food but may
                                                     not be required for
                                                     handling a food
                                                     that will receive a
                                                     validated heat
                                                     treatment. Thus, we
                                                     tentatively
                                                     conclude that it
                                                     would not be
                                                     appropriate to
                                                     require that gloves
                                                     used for the
                                                     handling of all
                                                     foods be made of an
                                                     impermeable
                                                     material and that a
                                                     discussion of
                                                     gloves would be
                                                     more appropriate in
                                                     a guidance
                                                     document, which
                                                     could describe
                                                     factors to consider
                                                     in selecting and
                                                     using gloves in the
                                                     production of food.
Sec.   110.35(b)(2)           Follow all relevant   Although such a
 (Substances used in           regulations           recommendation may
 cleaning and sanitizing).     promulgated by        be helpful and
                               other Federal,        could be included
                               State, and local      in future guidance,
                               government agencies   FDA tentatively
                               for the               concludes that it
                               application, use,     is more properly
                               or holding of toxic   addressed by the
                               cleaning compounds,   applicable Federal,
                               sanitizing agents,    State, and local
                               and pesticide         government agencies
                               chemicals.            and is outside the
                                                     scope of proposed
                                                     part 117.
Sec.   110.37(d) (Toilet      Compliance with the   See explanation in
 facilities).                  requirements for      section XI.H.2 of
                               toilet facilities     this document.
                               may be accomplished
                               by four specified
                               mechanisms.
Sec.   110.37(e) (Hand-       Compliance with the   See explanation in
 washing facilities).          requirements for      section XI.H.3 of
                               hand-washing          this document.
                               facilities may be
                               accomplished by six
                               specified
                               mechanisms.
Sec.   110.40(e) (Equipment   Each freezer and      It is now very
 and utensils).                cold storage          common for freezer
                               compartment used to   and cold storage
                               store and hold food   compartments to be
                               capable of            fitted with an
                               supporting growth     automatic control
                               of microorganisms     for regulating
                               should be fitted      temperature. Thus,
                               with an automatic     we tentatively
                               control for           conclude that it is
                               regulating            not necessary to
                               temperature or with   revise current Sec.
                               an automatic alarm      110.40(e) to
                               system to indicate    require, rather
                               a significant         than recommend, use
                               temperature change    of an automatic
                               in a manual           control for
                               operation.            regulating
                                                     temperature or an
                                                     automatic alarm
                                                     system, because the
                                                     design of modern
                                                     freezer and cold
                                                     storage
                                                     compartments has
                                                     established this
                                                     approach without
                                                     the need for a
                                                     Federal
                                                     requirement.
Sec.   110.80(a)(2)           Compliance with the   We tentatively
 (Processes and controls--     requirements for      conclude that there
 raw materials and             the safety of raw     are more mechanisms
 ingredients).                 materials and         for achieving
                               ingredients may be    compliance than the
                               achieved by           single mechanism
                               purchasing raw        identified in
                               materials and         current Sec.
                               ingredients under a   110.80(a)(2)--e.g.,
                               supplier's            in some cases,
                               guarantee or          compliance could be
                               certification.        achieved by testing
                                                     raw materials and
                                                     ingredients. Rather
                                                     than propose to
                                                     require a subset of
                                                     mechanisms to
                                                     achieve compliance,
                                                     FDA tentatively
                                                     concludes that
                                                     these
                                                     recommendations
                                                     would be more
                                                     appropriate in a
                                                     guidance document.
Sec.   110.80(a)(3)           Compliance with       See explanation in
 (Processes and controls--     action levels for     section XI.J.2 of
 raw materials and             poisonous or          this document.
 ingredients).                 deleterious
                               substances before
                               these materials or
                               ingredients are
                               incorporated into
                               finished food.

[[Page 3715]]

 
Sec.   110.80(a)(3)           Compliance with the   We tentatively
 (Processes and controls--     requirement for raw   conclude that there
 raw materials and             materials and other   may be more
 ingredients).                 ingredients           mechanisms for
                               susceptible to        achieving
                               contamination with    compliance than
                               aflatoxin or other    those mechanisms
                               natural toxins to     identified in
                               comply with current   current Sec.
                               FDA regulations for   110.80(a)(3).
                               poisonous or          Rather than propose
                               deleterious           to require a subset
                               substances before     of mechanisms to
                               these materials or    achieve compliance,
                               ingredients are       FDA tentatively
                               incorporated into     concludes that
                               finished food may     these
                               be accomplished by    recommendations
                               purchasing raw        would be more
                               materials and other   appropriate in a
                               ingredients under a   guidance document.
                               supplier's
                               guarantee or
                               certification, or
                               may be verified by
                               analyzing these
                               materials and
                               ingredients for
                               aflatoxins and
                               other natural
                               toxins.
Sec.   110.80(a)(4)           Raw materials, other  See explanation in
 (Processes and controls--     ingredients, and      section XI.J.2 of
 raw materials and             rework susceptible    this document.
 ingredients).                 to contamination
                               with pests,
                               undesirable
                               microorganisms, or
                               extraneous material
                               must comply with
                               applicable FDA
                               defect action
                               levels for natural
                               or unavoidable
                               defects if a
                               manufacturer wishes
                               to use the
                               materials in
                               manufacturing food.
Sec.   110.80(a)(4)           The requirement for   We tentatively
 (Processes and controls--     raw materials,        conclude that there
 raw materials and             other ingredients,    may be more
 ingredients).                 and rework            mechanisms for
                               susceptible to        achieving
                               contamination with    compliance than
                               pests, undesirable    those mechanisms
                               microorganisms, or    identified in
                               extraneous material   current Sec.
                               to comply with        110.80(a)(4).
                               applicable FDA        Rather than propose
                               regulations for       to require a subset
                               natural or            of mechanisms to
                               unavoidable defects   achieve compliance,
                               if a manufacturer     FDA tentatively
                               wishes to use the     concludes that
                               materials in          these
                               manufacturing food    recommendations
                               may be verified by    would be more
                               any effective         appropriate in a
                               means, including      guidance document.
                               purchasing the
                               materials under a
                               supplier's
                               guarantee or
                               certification, or
                               examination of
                               these materials for
                               contamination.
Sec.   110.80(b)(2)           One way to comply     We considered the
 (Manufacturing operations).   with the              diversity of food
                               requirement for all   that is
                               food manufacturing,   manufactured,
                               including packaging   processed, packed
                               and storage, to be    or held and would
                               conducted under       be subject to the
                               such conditions and   requirements of
                               controls as are       proposed part 117
                               necessary to          and the physical
                               minimize the          factors and
                               potential for the     manufacturing
                               growth of             operations that
                               microorganisms, or    could be monitored
                               for the               to minimize the
                               contamination of      growth of
                               food is careful       microorganisms. FDA
                               monitoring of         tentatively
                               physical factors      concludes that this
                               such as time,         diversity does not
                               temperature,          make it appropriate
                               humidity, water       to propose
                               activity, pH,         establishing these
                               pressure, flow        specific
                               rate, and             recommendations as
                               manufacturing         requirements and
                               operations such as    that these
                               freezing,             recommendations
                               dehydration, heat     would be more
                               processing,           appropriate in a
                               acidification, and    guidance document.
                               refrigeration to
                               ensure that
                               mechanical
                               breakdowns, time
                               delays, temperature
                               fluctuations, and
                               other factors do
                               not contribute to
                               the decomposition
                               or contamination of
                               food.
Sec.   110.80(b)(3)           Compliance with the   We considered the
 (Manufacturing operations).   requirement for       diversity of food
                               food that can         that is
                               support the rapid     manufactured,
                               growth of             processed, packed
                               undesirable           or held and would
                               microorganisms to     be subject to the
                               be held in a manner   requirements of
                               that prevents the     proposed part 117,
                               food from becoming    as well as the
                               adulterated within    temperatures that
                               the meaning of the    are needed for the
                               FD&C Act may be       safe holding of
                               accomplished by any   foods. FDA
                               effective means,      tentatively
                               including             concludes that this
                               maintaining           diversity does not
                               refrigerated foods    make it appropriate
                               at 45[deg]F           to propose to
                               (7.2[deg]C) or        establish these
                               below as              specific
                               appropriate for the   recommendations as
                               particular food       requirements and
                               involved,             that these
                               maintaining frozen    recommendations
                               foods in a frozen     would be more
                               state, maintaining    appropriate in a
                               hot foods at          guidance document.
                               140[deg]F             In addition, we
                               (60[deg]C) or         note that current
                               above, and heat       Sec.
                               treating acid or      110.80(b)(3)(iv)
                               acidified foods.      provides for heat
                                                     treating acid or
                                                     acidified foods to
                                                     destroy mesophilic
                                                     microorganisms when
                                                     those foods are to
                                                     be held in
                                                     hermetically sealed
                                                     containers at
                                                     ambient
                                                     temperatures.
                                                     However, current
                                                     Sec.   110.80(b)(4)
                                                     addresses measures,
                                                     including heat
                                                     treating, taken to
                                                     destroy or prevent
                                                     the growth of
                                                     undesirable
                                                     microorganisms. We
                                                     tentatively
                                                     conclude that
                                                     proposing to revise
                                                     current Sec.
                                                     110.80(b)(3)(iv)
                                                     would create a
                                                     redundancy with
                                                     current Sec.
                                                     110.80(b)(4).
Sec.   110.80(b)(8)           Compliance with the   We considered the
 (Manufacturing operations).   requirement for       diversity of food
                               effective measures    that is
                               to be taken to        manufactured,
                               protect against the   processed, packed
                               inclusion of metal    or held and would
                               or other extraneous   be subject to the
                               material in food be   requirements of
                               accomplished by       proposed part 117
                               using sieves,         and the methods
                               traps, magnets,       that could be used
                               electronic metal      to protect against
                               detectors, or other   the inclusion of
                               suitable effective    metal or other
                               means.                extraneous material
                                                     in food. FDA
                                                     tentatively
                                                     concludes that it
                                                     would not be
                                                     appropriate to
                                                     establish such
                                                     specific
                                                     recommendations as
                                                     requirements and
                                                     that such
                                                     recommendations
                                                     would be more
                                                     appropriate in a
                                                     guidance document.

[[Page 3716]]

 
Sec.   110.80(b)(10)          Protection may be     We considered that
 (Manufacturing operations).   provided during       the cleaning and
                               manufacturing steps   sanitizing of food-
                               such as washing,      contact surfaces
                               peeling, trimming,    would already be
                               cutting, sorting      addressed in
                               and inspecting,       proposed Sec.
                               mashing,              117.35(d), which
                               dewatering,           would require that
                               cooling, shredding,   all food-contact
                               extruding, drying,    surfaces, including
                               whipping,             utensils and food-
                               defatting, and        contact surfaces of
                               forming by adequate   equipment, be
                               cleaning and          cleaned as
                               sanitizing of all     frequently as
                               food-contact          necessary to
                               surfaces.             protect against
                                                     cross-contact and
                                                     contamination of
                                                     food, and in
                                                     proposed Sec.
                                                     117.80(c)(1), which
                                                     would require, in
                                                     relevant part, that
                                                     equipment and
                                                     utensils be
                                                     maintained in an
                                                     acceptable
                                                     condition through
                                                     appropriate
                                                     cleaning and
                                                     sanitizing, as
                                                     necessary.
Sec.   110.80(b)(10)          Protection may be     We considered the
 (Manufacturing operations).   provided during       diversity of food
                               manufacturing steps   that is
                               such as washing,      manufactured,
                               peeling, trimming,    processed, packed
                               cutting, sorting      or held and would
                               and inspecting,       be subject to the
                               mashing,              requirements of
                               dewatering,           proposed part 117
                               cooling, shredding,   and that use of
                               extruding, drying,    time and
                               whipping,             temperature
                               defatting, and        controls at and
                               forming by using      between each
                               time and              manufacturing step
                               temperature           may not be required
                               controls at and       for all foods. For
                               between each          example, the use of
                               manufacturing step.   time and
                                                     temperature
                                                     controls would not
                                                     be necessary for
                                                     shelf-stable foods
                                                     used as ingredients
                                                     in another product.
                                                     FDA tentatively
                                                     concludes that this
                                                     recommendation
                                                     would be more
                                                     appropriate in a
                                                     guidance document.
Sec.   110.80(b)(12)          Recommendations for   Recommendations to
 (Manufacturing operations).   how to comply with    comply by using
                               requirements for      ingredients free of
                               batters, breading,    contamination,
                               sauces, gravies,      employing adequate
                               dressings, and        heat processes
                               other similar         where applicable,
                               preparations to be    and providing
                               treated or            adequate physical
                               maintained in such    protection of
                               a manner that they    components from
                               are protected         contaminants that
                               against               may drip, drain, or
                               contamination.        be drawn into them,
                                                     would already be
                                                     addressed in
                                                     proposed Sec.  Sec.
                                                       117.80(b)(2),
                                                     117.80(c)(2),
                                                     117.80(c)(4) and
                                                     117.80(c)(10),
                                                     respectively. As
                                                     discussed regarding
                                                     our proposed
                                                     revisions to
                                                     current Sec.
                                                     110.80(b)(10)
                                                     earlier in this
                                                     section, FDA
                                                     tentatively
                                                     concludes that
                                                     establishing
                                                     requirements for
                                                     time and
                                                     temperature
                                                     controls is not
                                                     appropriate in
                                                     light of the
                                                     diversity of food
                                                     operations. The
                                                     remaining
                                                     recommendations
                                                     regarding cooling
                                                     batters to an
                                                     adequate
                                                     temperature and
                                                     disposing of
                                                     batters at
                                                     appropriate
                                                     intervals are
                                                     better addressed in
                                                     guidance.
                                                     Therefore, FDA is
                                                     proposing to
                                                     provide flexibility
                                                     to industry by
                                                     retaining the
                                                     performance
                                                     standard in current
                                                     Sec.
                                                     110.80(b)(12)
                                                     (i.e., protection
                                                     against
                                                     contamination) but
                                                     deleting the
                                                     examples of
                                                     mechanisms to
                                                     achieve compliance
                                                     rather than
                                                     proposing to
                                                     establish these
                                                     recommendations as
                                                     requirements.
Sec.   110.80(b)(13)          Compliance with the   FDA is proposing to
 (Manufacturing operations).   requirement for       provide flexibility
                               filling,              to industry by
                               assembling,           retaining the
                               packaging, and        performance
                               other operations to   standard in current
                               be performed in       Sec.
                               such a way that the   110.80(b)(12)
                               food is protected     (i.e., protection
                               against               against
                               contamination may     contamination) but
                               be accomplished by    deleting the
                               any effective         examples of
                               means, including      mechanisms to
                               (i) use of a          achieve compliance.
                               quality control       FDA tentatively
                               operation in which    concludes that such
                               the critical          examples would be
                               control points are    more appropriate in
                               identified and        a guidance
                               controlled during     document.
                               manufacturing; (ii)
                               adequate cleaning
                               and sanitizing of
                               all food-contact
                               surfaces and food
                               containers; (iii)
                               using materials for
                               food containers and
                               food- packaging
                               materials that are
                               safe and suitable,
                               as defined in Sec.
                                130.3(d); (iv)
                               providing physical
                               protection from
                               contamination,
                               particularly
                               airborne
                               contamination; and
                               (v) using sanitary
                               handling procedures.
Sec.   110.80(b)(14)          Mechanisms for        We considered that
 (Manufacturing operations).   compliance with the   the listed
                               requirement for       mechanisms are not
                               food (such as dry     the only possible
                               mixes, nuts,          mechanisms for
                               intermediate          achieving
                               moisture food, and    compliance. FDA
                               dehydrated food)      tentatively
                               that relies on the    concludes that it
                               control of water      would not be
                               activity for          appropriate to
                               preventing the        establish these
                               growth of             recommendations as
                               undesirable           requirements and
                               microorganisms to     that such
                               be processed to and   recommendations
                               maintained at a       would be more
                               safe moisture level.  appropriate in a
                                                     guidance document.

[[Page 3717]]

 
Sec.   110.80(b)(15)          Compliance with the   We considered that
 (Manufacturing operations).   requirement for       the listed
                               food (such as acid    mechanisms are not
                               and acidified food)   the only possible
                               that relies           mechanisms for
                               principally on the    achieving
                               control of pH for     compliance. FDA
                               preventing the        tentatively
                               growth of             concludes that it
                               undesirable           would not be
                               microorganisms to     appropriate to
                               be monitored and      establish these
                               maintained at a pH    recommendations as
                               of 4.6 or below may   requirements and
                               be accomplished by    that such
                               any effective         recommendations
                               means, including      would be more
                               employment of one     appropriate in a
                               or more of the        guidance document.
                               following
                               practices: (i)
                               monitoring the pH
                               of raw materials,
                               food in process,
                               and finished food
                               and (ii)
                               controlling the
                               amount of acid or
                               acidified food
                               added to low-acid
                               food.
Sec.   110.80(b)(17)          Food-manufacturing    FDA tentatively
 (Processes and controls--     areas and equipment   concludes that this
 manufacturing operations).    used for              recommendation
                               manufacturing human   would be more
                               food should not be    appropriate in a
                               used to manufacture   guidance document,
                               nonhuman food-grade   which could include
                               animal feed or        examples of
                               inedible products,    situations where
                               unless there is no    there is no
                               reasonable            reasonable
                               possibility for the   possibility for the
                               contamination of      contamination of
                               the human food.       the human food.
Sec.   110.110(e)...........  Information that a    The organizational
                               compilation of the    entity identified
                               current defect        in current Sec.
                               action levels for     110.110(e) (i.e.,
                               natural or            HFS-565) no longer
                               unavoidable defects   exists and FDA no
                               in food for human     longer has printed
                               use that present no   copies of the
                               health hazard may     compilation of
                               be obtained upon      defect action
                               request from the      levels. An
                               Center for Food       electronic
                               Safety and Applied    compilation of such
                               Nutrition (HFS-       current defect
                               565), Food and Drug   action levels is
                               Administration,       available on the
                               5100 Paint Branch     internet (Ref.
                               Pkwy., College        141).
                               Park, MD 20740.
------------------------------------------------------------------------

B. Other Potential Revisions to Current Guidance

    As discussed in sections IX.F and XI.A of this document, FDA is 
proposing a number of revisions to delete some guidance currently 
established in part 110 (e.g., provisions using ``should'' or 
``compliance may be achieved by''). In section XI.M of this document, 
FDA requests comment on whether to revise other non-binding provisions 
to establish new requirements in proposed part 117 or retain them as 
useful recommended provisions of a comprehensive CGMP provision.

C. Proposed Revisions for Consistency of Terms

    As discussed in section IX.C of this document, FDA is proposing 
revisions to use terms consistently throughout proposed part 117. Table 
9 identifies and explains each of these proposed revisions. Because 
other revisions also may be proposed for certain sections included in 
Table 9 (e.g., if FDA also is proposing a revision to address cross-
contact), Table 9 does not state the proposed requirement and instead 
refers to the section of this document containing the complete proposed 
requirement, including all proposed revisions

                              Table 9--Proposed Revisions for Consistency of Terms
----------------------------------------------------------------------------------------------------------------
                       Current designation                               Proposed revision and explanation
----------------------------------------------------------------------------------------------------------------
Sec.   110.20(b) (Plant Construction and Design).................  (1) Replace the phrase ``food-manufacturing
                                                                    purposes'' with the phrase ``food-production
                                                                    purposes (i.e., manufacturing, processing,
                                                                    packing, and holding) to consistently use
                                                                    the same group of terms in proposed part
                                                                    117.
                                                                   (2) Replace the phrase ``plant and
                                                                    facilities'' with the single term ``plant''
                                                                    as would be defined in proposed Sec.
                                                                    117.3. The requirement would be clear using
                                                                    the single term ``plant'' and, thus, the
                                                                    term ``facilities'' is unnecessary. In
                                                                    addition, under proposed Sec.   117.3
                                                                    (Definitions) the term ``facilities'' would
                                                                    be based on the definition in section
                                                                    418(o)(2) of the FD&C Act, which is not how
                                                                    the term is used in current Sec.
                                                                    110.20(b).
                                                                   See section XI.F for the proposed
                                                                    requirement.
Sec.   110.20(b)(4) (Plant Construction and Design)..............  (3) Add ``food-packaging materials'' to the
                                                                    requirement that aisles or working spaces be
                                                                    provided between equipment and walls and be
                                                                    adequately unobstructed and of adequate
                                                                    width to permit employees to perform their
                                                                    duties and to protect against contaminating
                                                                    food or food-contact surfaces with clothing
                                                                    or personal contact. Contamination of food-
                                                                    packaging materials could lead to
                                                                    contamination of the food. See section XI.F
                                                                    for the proposed requirement.
Sec.   110.35(c) (Pest control)..................................  Replace the phrase ``processing area'' with
                                                                    the phrase ``manufacturing, processing,
                                                                    packing and holding areas'' to consistently
                                                                    use the same group of terms in proposed part
                                                                    117 and to provide for internal consistency
                                                                    between the requirements in current Sec.
                                                                    110.35(c) to not allow pests in ``any area
                                                                    of a food plant'' and to take effective
                                                                    measures to exclude pests from the plant.
                                                                    Pests do not belong in any areas where
                                                                    manufacturing, processing, packing or
                                                                    holding of food occurs. See section XI.G.3
                                                                    for the proposed requirement.
Sec.   110.35(d)(1) (Food-contact surfaces)......................  Replace the term ``manufacturing'' with
                                                                    ``manufacturing/processing'' in light of our
                                                                    proposed definition of manufacturing/
                                                                    processing (see discussion of the definition
                                                                    of manufacturing/processing in section X.B
                                                                    of this document). See section XI.G.4 for
                                                                    the proposed requirement.
Sec.   110.35(d)(3) (Non-food-contact surfaces)..................  Add ``food-packaging materials'' to the
                                                                    recommendation that non-food-contact
                                                                    surfaces of equipment used in the operation
                                                                    of food plants be cleaned as frequently as
                                                                    necessary to protect against contamination
                                                                    of food. Contamination of food-packaging
                                                                    materials could lead to contamination of the
                                                                    food. See section XI.G.5 for the proposed
                                                                    provision.

[[Page 3718]]

 
Sec.   110.35(d)(4) (Food-contact surfaces)......................  Add ``food-packaging materials'' to the
                                                                    requirement that single-service articles be
                                                                    handled, dispensed, used, and disposed of in
                                                                    a manner that protects against contamination
                                                                    of food or food-contact surfaces.
                                                                    Contamination of food-packaging materials
                                                                    could lead to contamination of the food. See
                                                                    section XI.G.4 for the proposed requirement.
Sec.   110.37(a) (Water supply)..................................  Add ``food-packaging materials'' to the
                                                                    requirement that any water that contacts
                                                                    food, food-contact surfaces, or food-
                                                                    packaging materials be safe and of adequate
                                                                    sanitary quality. Contamination of food-
                                                                    packaging materials could lead to
                                                                    contamination of the food. See section
                                                                    XI.H.1 for the proposed requirement.
Sec.   110.37(f) (Rubbish and offal disposal)....................  Add ``food-packaging materials'' to the
                                                                    requirement that rubbish and any offal be so
                                                                    conveyed, stored, and disposed of as to
                                                                    protect against contamination of food, food-
                                                                    contact surfaces, water supplies, and ground
                                                                    surfaces. Contamination of food-packaging
                                                                    materials could lead to contamination of the
                                                                    food. See section XI.H.4 for the proposed
                                                                    requirement.
Sec.   110.80(b)(7) (Manufacturing operations)...................  (1) Replace the term ``storage'' with the
                                                                    term ``holding'' for consistency with use of
                                                                    the term ``holding'' throughout proposed
                                                                    part 117.
                                                                   (2) Add ``processing'' and ``packing'' as
                                                                    activities where protection is needed
                                                                    against contamination (and against cross-
                                                                    contact) because contamination and cross-
                                                                    contact can occur during any activities
                                                                    subject to proposed part 117.
                                                                   (3) Inserting an ``and,'' rather than an
                                                                    ``or,'' between the cited activities to make
                                                                    clear that the requirements for protection
                                                                    against cross-contact and contamination
                                                                    apply to all activities at a plant.
                                                                   See section XI.J.3 for the proposed
                                                                    requirement.
Sec.   110.110(c) (Defect action levels).........................  Change the designated persons who must
                                                                    ``observe good manufacturing practices'' and
                                                                    ``at all times utilize quality control
                                                                    operations that reduce natural or
                                                                    unavoidable defects to the lowest level
                                                                    currently feasible'' from the currently
                                                                    identified persons, (i.e., manufacturers,
                                                                    distributors and holders of food) to
                                                                    manufacturers, processors, packers and
                                                                    holders of food for consistency with
                                                                    terminology used throughout proposed part
                                                                    117.
                                                                   See section XI.L for the proposed
                                                                    requirement.
----------------------------------------------------------------------------------------------------------------

D. Proposed Revisions to Address Cross-Contact

    As discussed in section IX.D of this document, FDA is proposing a 
number of revisions to address cross-contact. Some of these proposed 
revisions would clarify that an existing provision that requires 
protection against contamination also requires protection against 
cross-contact. Table 10 identifies and explains each of these proposed 
revisions addressing cross-contact. Table 10 does not state the 
proposed requirement and instead refers to the section of this document 
containing the complete proposed requirement, including all proposed 
revisions.

                              Table 10--Proposed Revisions Regarding Cross-Contact
----------------------------------------------------------------------------------------------------------------
                       Current designation                           Nature of proposed change and explanation
----------------------------------------------------------------------------------------------------------------
Sec.   110.10(b) (Cleanliness)...................................  Clarification. Poor hygiene may result in the
                                                                    transfer of food allergens from persons
                                                                    working in direct contact with food, food-
                                                                    contact surfaces, and food-packaging
                                                                    materials to food. See section XI.E.1 for
                                                                    the proposed requirement.
Sec.   110.10(b)(1) (Cleanliness)................................  Clarification. Appropriate use of outer
                                                                    garments protects against the transfer of
                                                                    food allergens from food to person to food.
                                                                    See section XI.E.1 for the proposed
                                                                    requirement.
Sec.   110.10(b)(9) (Cleanliness)................................  Clarification. Poor hygiene may result in the
                                                                    transfer of food allergens from persons
                                                                    working in direct contact with food, food-
                                                                    contact surfaces, and food-packaging
                                                                    materials to food. See section XI.E.1 for
                                                                    the proposed requirement.
Sec.   110.20(b)(2) (Plant construction and design)..............  Clarification. Inadequate construction and
                                                                    design of a plant can result in the transfer
                                                                    of food allergens to food. Separation of
                                                                    operations is a key means of preventing
                                                                    cross-contact. See section XI.F for the
                                                                    proposed requirement.
Sec.   110.20(b)(6) (Plant construction and design)..............  Clarification. Inadequate construction and
                                                                    design of a plant can result in the transfer
                                                                    of food allergens to food. Proper
                                                                    ventilation, e.g., over powder dumping
                                                                    operations, and proper operation of fans and
                                                                    other air-blowing equipment are essential to
                                                                    prevent the transfer of allergens via dust
                                                                    in air currents. See section XI.F for the
                                                                    proposed requirement.
Sec.   110.35(a) (General maintenance)...........................  Clarification. Improper cleaning and
                                                                    sanitizing that leaves food residues on
                                                                    utensils or equipment may result in the
                                                                    transfer of food allergens from utensils or
                                                                    equipment to food, food-contact surfaces, or
                                                                    food packaging materials that come in
                                                                    contact with the improperly cleaned and
                                                                    sanitized surfaces. See section XI.G.1 for
                                                                    the proposed requirement.
Sec.   110.35(d) (Sanitation of food-contact surfaces)...........  Clarification. Inadequate sanitation of food-
                                                                    contact surfaces may leave residues of food
                                                                    containing allergens on the surfaces and
                                                                    result in the transfer of food allergens
                                                                    from food-contact surfaces to food. See
                                                                    section XI.G.4 for the proposed requirement.
Sec.   110.35(d)(2) (Sanitation of food-contact surfaces)........  Clarification. Inadequate sanitation of food-
                                                                    contact surfaces may leave residues of food
                                                                    containing allergens on the surfaces and
                                                                    result in the transfer of food allergens
                                                                    from food-contact surfaces to food. See
                                                                    section XI.G.4 for the proposed requirement.
Sec.   110.35(d)(3) (Sanitation of non-food-contact surfaces)....  Clarification. Inadequate sanitation of non-
                                                                    food contact surfaces may leave residues of
                                                                    food containing allergens on the surfaces
                                                                    and result in the transfer of food allergens
                                                                    from such surfaces to food-contact surfaces
                                                                    or food. See section XI.G.5 for the proposed
                                                                    requirement.
Sec.   110.35(d)(4) (Sanitation of food-contact surfaces)........  Clarification. Failure to properly store
                                                                    single-service articles (such as utensils
                                                                    intended for one-time use, paper cups, and
                                                                    paper towels) could lead to cross-contact.
                                                                    See section XI.G.4 for the proposed
                                                                    requirement.

[[Page 3719]]

 
Sec.   110.35(e) (Storage and handling of cleaned portable         Clarification. Failure to properly store and
 equipment and utensils).                                           handle cleaned portable equipment and
                                                                    utensils could lead to cross-contact of the
                                                                    equipment and utensils and then to cross-
                                                                    contact of food if the equipment and
                                                                    utensils come in contact with food. See
                                                                    section XI.G.6 for the proposed requirement.
Sec.   110.40(a) (Equipment and utensils)........................  Clarification. Equipment and utensils that
                                                                    are improperly designed, cleaned and
                                                                    maintained may result in the transfer of
                                                                    food allergens from equipment and utensils
                                                                    to food. See section XI.I for the proposed
                                                                    requirement.
Sec.   110.40(b) (Equipment and utensils)........................  Clarification. Equipment and utensils that
                                                                    are improperly designed, cleaned and
                                                                    maintained may result in the transfer of
                                                                    food allergens from equipment and utensils
                                                                    to food. See section XI.I for the proposed
                                                                    requirement.
Sec.   110.80 (Processes and controls)...........................  Clarification. Inadequate processes and
                                                                    controls practices may result in the
                                                                    transfer of food allergens to food. See
                                                                    section XI.J.1 for the proposed requirement.
Sec.   110.80 (Processes and controls--General)..................  Clarification. Inadequate processes and
                                                                    controls practices may result in the
                                                                    transfer of food allergens to food. See
                                                                    section XI.J.1 for the proposed requirement.
Sec.   110.80(a)(1) (Processes and controls--raw materials and     Clarification. Raw materials and ingredients
 ingredients.).                                                     subject to cross-contact due to improper
                                                                    segregation prior to receipt or during
                                                                    storage may result in undeclared allergens
                                                                    in food. See section XI.J.2 for the proposed
                                                                    requirement.
Sec.   110.80(a)(5) (Processes and controls--raw materials and     Clarification. Improper handling of raw
 ingredients.).                                                     materials and ingredients may result in the
                                                                    transfer of food allergens to food. See
                                                                    section XI.J.2 for the proposed requirement.
Sec.   110.80(a)(7) (Processes and controls--raw materials and     Clarification. Improper handling of raw
 ingredients.).                                                     materials and ingredients may result in the
                                                                    transfer of food allergens to food. See
                                                                    section XI.J.2 for the proposed requirement.
N/A..............................................................  Cross-contact may be associated with improper
                                                                    identification and holding of raw materials
                                                                    and ingredients that are food allergens, and
                                                                    rework that contains food allergens.
                                                                    Improper identification of an allergen-
                                                                    containing raw material, such as a seasoning
                                                                    mix that is not identified as containing soy
                                                                    protein, can result in the unintended
                                                                    incorporation of an allergen into a food
                                                                    (i.e., cross-contact). Improper holding,
                                                                    e.g., storing open-containers of raw
                                                                    materials or ingredients, including those
                                                                    containing allergens, in the same location
                                                                    can result in cross-contact. See section
                                                                    XI.J.2 for the proposed requirement.
Sec.   110.80(b)(5) (Processes and controls--manufacturing         Clarification. Manufacturing operations may
 operations).                                                       result in the transfer of food allergens to
                                                                    food. See section XI.J.3 for the proposed
                                                                    requirement.
Sec.   110.80(b)(6) (Processes and controls--manufacturing         Clarification. Manufacturing operations may
 operations).                                                       result in the transfer of food allergens to
                                                                    food. Allergens may be transferred from one
                                                                    food to another when raw materials or
                                                                    ingredients are unprotected and allergens in
                                                                    unprotected refuse could contaminate food.
                                                                    Cross-contact can occur when food is
                                                                    conveyed unprotected. See section XI.J.3 for
                                                                    the proposed requirement.
Sec.   110.80(b)(7) (Processes and controls--manufacturing         Clarification. Manufacturing operations may
 operations).                                                       result in the transfer of food allergens to
                                                                    food. See section XI.J.3 for the proposed
                                                                    requirement.
Sec.   110.80(b)(10) (Processes and controls--manufacturing        Clarification. Manufacturing operations may
 operations).                                                       result in the transfer of food allergens to
                                                                    food. See section XI.J.3 for the proposed
                                                                    requirement.
Sec.   110.80(b)(12) (Processes and controls--manufacturing        Clarification. Manufacturing operations may
 operations).                                                       result in the transfer of food allergens to
                                                                    food. See section XI.J.3 for the proposed
                                                                    requirement.
Sec.   110.80(b)(13) (Processes and controls--manufacturing        Clarification. Manufacturing operations may
 operations).                                                       result in the transfer of food allergens to
                                                                    food. See section XI.J.3 for the proposed
                                                                    requirement.
Sec.   110.93 (Warehousing and distribution).....................  Clarification. Inadequate storage and
                                                                    transportation conditions may result in the
                                                                    transfer of food allergens to food. See
                                                                    section XI.K for the proposed requirement.
----------------------------------------------------------------------------------------------------------------

We seek comment on these proposed changes.

E. Proposed and Potential Revisions to Current Sec.  110.10--Personnel 
(Proposed Sec.  117.10)

1. Proposed Revisions to Current Sec.  110.10(b)--Cleanliness
    As discussed in section XI.D of this document, FDA is proposing to 
revise current Sec.  110.10(b) (Cleanliness), (b)(1) and (b)(9) to make 
clear that certain provisions involving hygienic practices protect 
against cross-contact. Proposed Sec.  117.10(b) would require that all 
persons working in direct contact with food, food-contact surfaces, and 
food-packaging materials conform to hygienic practices while on duty to 
the extent necessary to protect against cross-contact and contamination 
of food (emphasis added). Proposed Sec.  117.10(b)(1) would require 
that the methods for maintaining cleanliness include wearing outer 
garments suitable to the operation in a manner that protects against 
the contamination of food, food-contact surfaces, or food-packaging 
materials, and to protect against the cross-contact of food (emphasis 
added). Proposed Sec.  117.10(b)(9) would require taking any other 
necessary precautions to protect against the contamination of food, 
food-contact surfaces, or food-packaging materials with microorganisms 
or foreign substances (including perspiration, hair, cosmetics, 
tobacco, chemicals, and medicines applied to the skin) and to protect 
against the cross-contact of food (emphasis added).
    As discussed in section XI.A of this document, FDA is proposing to 
revise current Sec.  110.10(b)(5) to remove the recommendation that 
gloves be of an impermeable material. Proposed Sec.  117.10(b)(5) would 
require that the methods for maintaining cleanliness include 
maintaining gloves, if they are used in food handling, in an intact, 
clean, and sanitary condition.
2. Potential Revisions to Current Sec.  110.10(c)--Education and 
Training
    Current Sec.  110.10(c) provides guidance that personnel 
responsible for identifying sanitation failures or food contamination 
should have a background of education or experience, or a combination 
thereof, to provide a level of competency necessary for production of 
clean and safe food. Current Sec.  110.10(c) further recommends that 
food handlers and supervisors receive appropriate training in proper 
food handling techniques and food-protection principles and should be 
informed of the danger of poor personal hygiene and insanitary 
practices.

[[Page 3720]]

    As discussed in section II.A.1 of this document, the CGMP Working 
Group Report identified specific areas that presented an opportunity to 
modernize the regulation. One recommendation was to ``require 
appropriate training for supervisors and workers to ensure that they 
have the necessary knowledge and expertise in food hygiene, food 
protection, employee health and personal hygiene to produce safe food 
products. This training must be delivered in a manner that can be 
easily understood by the worker. Food processors must maintain a record 
of this training for each worker'' (Ref. 1). Our analysis of recalls 
also indicates that ineffective employee training was a root cause of 
32 percent of CGMP-related recalls in the 1999-2003 analysis (Ref. 58); 
deficiencies in training were identified as a contributing factor in 24 
percent of CGMP-related primary recalls in the 2008-2009 analysis (Ref. 
59). In addition, as discussed with respect to the proposed definition 
of preventive controls (see section X.C.4 of this document), section 
418(o)(3) of the FD&C Act recognizes the importance of both training 
and CGMPs in preventing hazards from occurring in foods in its 
definition of preventive controls, which identifies supervisor, 
manager, and employee hygiene training (Sec.  418(o)(3)(B)) and CGMPs 
under part 110 (Sec.  418(o)(3)(F)) as some of the procedures, 
practices, and processes that may be included as preventive controls.
    FDA is proposing to re-establish current Sec.  110.10(c) as 
proposed Sec.  117.10(c). In addition, as discussed in section XI.M of 
this document, FDA is requesting comment on how best to revise current 
Sec.  110.10(c) to implement section 418(o)(3) of the FD&C Act and the 
recommendations of the CGMP Working Group with respect to training.
3. Proposed Revisions to Current Sec.  110.10(d)--Supervision
    Current Sec.  110.10(d) requires that responsibility for 
``assuring'' compliance by all personnel with all requirements of part 
110 be clearly assigned to competent supervisory personnel. FDA is 
proposing to revise current Sec.  110.10(d) to replace the term 
``assuring'' with ``ensuring'' to clarify FDA's expectation that 
supervisory personnel make certain that all personnel comply with the 
CGMP requirements of proposed subpart B. As a grammatical matter, the 
word ``ensure'' more accurately communicates this expectation than the 
word ``assure.'' FDA also is proposing to narrow the requirement for 
supervisory personnel to ensure compliance with proposed part 117, 
subpart B rather than with all of proposed part 117. Current Sec.  
110.10(d) is directed at the requirements already established in part 
110 and does not apply to the proposed requirements that would be 
established in proposed part 117, subpart C. Proposed Sec.  117.10(d) 
would now state that responsibility for ensuring compliance by all 
personnel with all requirements of this subpart must be clearly 
assigned to competent supervisory personnel (emphasis added).

F. Proposed Revisions to Current Sec.  110.20--Plant and Grounds 
(Proposed Sec.  117.20)

    As discussed in section XI.C of this document, FDA is proposing to 
revise current Sec.  110.20(b) (Plant Construction and Design) to make 
two changes for consistency with terms used throughout proposed part 
117. Proposed Sec.  117.20(b) would require that the plant buildings 
and structures be suitable in size, construction, and design to 
facilitate maintenance and sanitary operations for food-production 
purposes (i.e., manufacturing, processing packing, and holding) and 
would require that specific construction and design requirements apply 
to the ``plant'' rather than the ``plant and facilities'' (emphasis 
added).
    As discussed in section XI.D of this document, FDA also is 
proposing to revise current Sec.  110.20(b)(2) and (b)(6) to clarify 
that plants must be constructed and designed to protect against cross-
contact in addition to protecting against the contamination of food. 
Proposed Sec.  117.20(b)(2) would require that the plant take proper 
precautions to reduce the potential for contamination of food, food-
contact surfaces, or food-packaging materials with microorganisms, 
chemicals, filth, and other extraneous material, and to reduce the 
potential for cross-contact (emphasis added). The potential for cross-
contact and contamination must be reduced by adequate food safety 
controls and operating practices or effective design, including the 
separation of operations in which cross-contact and contamination are 
likely to occur, by one or more of the following means: location, time, 
partition, air flow, enclosed systems, or other effective means 
(emphasis added). Separation of operations is a key means of preventing 
cross-contact. Proposed Sec.  117.20(b)(6) would require that a plant 
provide adequate ventilation or control equipment to minimize odors and 
vapors (including steam and noxious fumes) in areas where they may 
contaminate food; and locate and operate fans and other air-blowing 
equipment in a manner that minimizes the potential for contaminating 
food, food-packaging materials, and food-contact surfaces and for 
cross-contact (emphasis added). Proper ventilation, e.g., over powder 
dumping operations, and proper operation of fans and other air-blowing 
equipment are essential to prevent the transfer of allergens via dust 
in air currents.
    In addition, FDA is proposing to broaden current Sec.  110.20(b)(3) 
by removing the term ``fermentation'' so that the construction and 
design requirements to permit the taking of proper precautions to 
protect food would apply to all outdoor bulk vessels (e.g., 
fermentation vessels, silos, vessels, and bins) rather than be limited 
to outdoor bulk fermentation vessels. Outdoor bulk vessels containing 
food lack the basic protection from environmental factors provided by a 
building, irrespective of whether the purpose of the outdoor bulk 
vessel is fermentation or storage. Proposed Sec.  117.20(b)(3) would 
require that the construction and design of a plant permit the taking 
of proper precautions to protect food in outdoor bulk vessels by any 
effective means. A conforming editorial change to current Sec.  
110.20(b)(3)(iv) would revise ``skimming the fermentation vessels'' 
(emphasis added) to ``skimming fermentation vessels'' to make clear 
that fermentation vessels would now be only one kind of vessel subject 
to proposed Sec.  117.20(b)(3).
    In addition, as discussed in section XI.C of this document, FDA is 
proposing to revise current Sec.  110.20(b)(4) so that it is directed 
to preventing contamination of food-packaging materials as well as food 
and food-contact substances. Proposed Sec.  117.20(b)(4) would require 
that the plant be constructed in such a manner that floors, walls, and 
ceilings may be adequately cleaned and kept clean and kept in good 
repair; that drip or condensate from fixtures, ducts and pipes does not 
contaminate food, food-contact surfaces, or food-packaging materials; 
and that aisles or working spaces are provided between equipment and 
walls and are adequately unobstructed and of adequate width to permit 
employees to perform their duties and to protect against contaminating 
food, food-contact surfaces, or food-packaging materials with clothing 
or personal contact (emphasis added).

[[Page 3721]]

G. Proposed Revisions to Current Sec.  110.35--Sanitary Operations 
(Proposed Sec.  117.35)

1. Proposed Revisions to Current Sec.  110.35(a)--General Maintenance
    As discussed in section XI.D of this document, FDA is proposing to 
revise current Sec.  110.35(a) (General maintenance) to clarify that 
cleaning and sanitizing of utensils and equipment must be conducted in 
a manner that protects against cross-contact of food, food-contact 
surfaces, or food packaging materials in addition to protecting these 
items against contamination. Proposed Sec.  117.35(a) would require 
that cleaning and sanitizing of utensils and equipment be conducted in 
a manner that protects against cross-contact and contamination of food, 
food-contact surfaces, or food-packaging materials (emphasis added).
2. Proposed Revisions to Current Sec.  110.35(b)--Substances Used in 
Cleaning and Sanitizing; Storage of Toxic Materials
    FDA is proposing to revise current Sec.  110.35(b)(1) to emphasize 
that mechanisms to comply with provisions related to cleaning compounds 
and sanitizing agents must be safe and effective rather than to 
emphasize that there are multiple ways to achieve such compliance. With 
this shift in emphasis, proposed Sec.  117.35(b)(1) would require that 
cleaning compounds and sanitizing agents used in cleaning and 
sanitizing procedures must be free from undesirable microorganisms and 
must be safe and adequate under the conditions of use. Compliance with 
this requirement must be verified by any effective means, including 
purchase of these substances under a supplier's guarantee or 
certification or examination of these substances for contamination 
(emphasis added). FDA considered whether to delete the examples of 
mechanisms to achieve compliance as nonbinding recommendations, but 
tentatively concludes that the examples provide useful information that 
is suitable in the context in which it remains in the provision.
    As discussed in section XI.A of this document, FDA is proposing to 
revise current Sec.  110.35(b)(2) to remove the recommendation for 
following all relevant regulations promulgated by other Federal, State, 
and local government agencies for the application, use, or holding of 
toxic cleaning compounds, sanitizing agents, and pesticide chemicals. 
FDA tentatively concludes that although such a recommendation may be 
helpful and could be included in future guidance, it is more properly 
addressed by the applicable Federal, State, and local government 
agencies and is outside the scope of proposed part 117.
3. Proposed Revisions to Current Sec.  110.35(c)--Pest Control
    FDA is proposing to revise current Sec.  110.35(c) (Pest control) 
to make a change for internal consistency and clarity as well as to 
harmonize with terminology used in section 418 of the FD&C Act. 
Proposed Sec.  117.35(c) would require ``Pests must not be allowed in 
any area of a food plant. Guard or guide dogs may be allowed in some 
areas of a plant if the presence of the dogs is unlikely to result in 
contamination of food, food-contact surfaces, or food-packaging 
materials. Effective measures must be taken to exclude pests from the 
manufacturing, processing, packing and holding areas and to protect 
against the contamination of food on the premises by pests. The use of 
insecticides or rodenticides is permitted only under precautions and 
restrictions that will protect against the contamination of food, food-
contact surfaces, and food-packaging materials'' (emphasis added).
4. Proposed Revisions to Current Sec.  110.35(d)--Sanitation of Food-
Contact Surfaces
    FDA is proposing several revisions to current Sec.  110.35(d) 
(Sanitation of food-contact surfaces). First, FDA is proposing to 
redesignate current Sec.  110.35(d)(3) as proposed Sec.  117.35(e) 
(Sanitation of non-food-contact surfaces). Current Sec.  110.35(d)(3) 
addresses sanitation of non-food-contact surfaces and, thus, does not 
belong in current Sec.  110.35(d), which addresses sanitation of food-
contact surfaces. As a conforming editorial change, current Sec.  
110.35(e) would become proposed Sec.  117.35(f).
    Second, FDA is proposing to revise current Sec.  110.35(d)(1) to be 
more explicit that food-contact surfaces used for manufacturing/
processing or holding low-moisture food must be in a clean condition at 
the time of use. Current Sec.  110.35(d)(1) requires that food-contact 
surfaces used for manufacturing or holding low-moisture food be in a 
dry, sanitary condition at the time of use; to be sanitary, a food-
contact surface must be clean. As discussed in section XI.C of this 
document, the proposed revision would apply to ``manufacturing/
processing'' rather than only to ``manufacturing.'' Proposed Sec.  
117.35(d)(1) would require that food-contact surfaces used for 
manufacturing/processing or holding low-moisture food be in a clean, 
dry, sanitary condition at the time of use (emphasis added).
    Third, as discussed in section XI.D of this document, FDA is 
proposing to revise current Sec.  110.35(d) and (d)(2) to address 
cross-contact and clarify that sanitation of food-contact surfaces must 
protect against cross-contact of food. Proposed Sec.  117.35(d) would 
require that all food-contact surfaces, including utensils and food-
contact surfaces of equipment, be cleaned as frequently as necessary to 
protect against cross-contact and contamination of food (emphasis 
added). Proposed Sec.  117.35(d)(2) would require in wet processing, 
when cleaning is necessary to protect against cross-contact and the 
introduction of microorganisms into food, all food-contact surfaces be 
cleaned and sanitized before use and after any interruption during 
which the food-contact surfaces may have become contaminated (emphasis 
added).
    Fourth, as discussed in section XI.C of this document, FDA also is 
proposing to revise current Sec.  110.35(d)(4) (proposed Sec.  
117.35(d)(3)) so that it is directed to preventing contamination of 
food-packaging materials as well as food and food-contact substances. 
As discussed in section XI.D of this document, FDA also is proposing to 
revise current Sec.  110.35(d)(4) (proposed Sec.  117.35(d)(3)) to 
address cross-contact and clarify that single-service articles (such as 
utensils intended for one-time use, paper cups, and paper towels) must 
be handled, dispensed, used, and disposed of in a manner that protects 
against cross-contact of food. In addition, in section XI.M of this 
document, we are requesting comment on whether to require, rather than 
recommend, that single-service articles (such as utensils intended for 
one-time use, paper cups, and paper towels) be stored in appropriate 
containers to prevent contamination of food, food-contact surfaces, or 
food-packaging materials. Proposed Sec.  117.35(d)(3) would provide 
that single-service articles (such as utensils intended for one-time 
use, paper cups, and paper towels) should be stored in appropriate 
containers and must be handled, dispensed, used, and disposed of in a 
manner that protects against cross-contact and contamination of food, 
food-contact surfaces, or food-packaging materials (emphasis added).
    Fifth, FDA is proposing to delete current Sec.  110.35(d)(5), which 
requires that sanitizing agents be adequate and safe under conditions 
of use and recommends that cleaning agents be adequate and safe under 
conditions of use. Current Sec.  110.35(d)(5) is redundant with 
proposed Sec.  117.35(b)(1), which requires that both cleaning 
compounds

[[Page 3722]]

and sanitizing agents be safe and adequate under the conditions of use.
5. Proposed Revisions to Current Sec.  110.35(d)(3)--Sanitation of Non-
Food-Contact Surfaces
    As discussed in sections XI.C and XI.D of this document, FDA is 
proposing to revise current Sec.  110.35(d)(3) (proposed Sec.  
117.35(e); sanitation of non-food-contact surfaces) to recommend that 
such cleaning of non-food contact surfaces protect against cross-
contact as well as against contamination and to recommend that such 
cleaning protect against contamination of food-packaging materials as 
well as protect against contamination of food and food-contact 
surfaces. Proposed Sec.  117.35(e) would recommend that non-food-
contact surfaces of equipment used in the operation of a food plant be 
cleaned in a manner and as frequently as necessary to protect against 
cross-contact and contamination of food, food-contact surfaces, and 
food-packaging materials (emphasis added). In addition, as discussed in 
section XI.M of this document, FDA also is requesting comment on 
whether to revise current Sec.  110.35(d)(3) (proposed Sec.  117.35(e)) 
to require, rather than recommend, that non-food-contact surfaces of 
equipment used in the operation of a food plant be cleaned in a manner 
and as frequently as necessary to protect against cross-contact and 
contamination of food, food-contact surfaces, and food-packaging 
materials.
6. Proposed Revisions to Current Sec.  110.35(e)--Storage and Handling 
of Cleaned Portable Equipment and Utensils
    As discussed in section XI.D of this document, FDA is proposing to 
revise current Sec.  110.35(e) (proposed Sec.  117.35(f); storage and 
handling of cleaned portable equipment and utensils) to address cross-
contact and to recommend storing cleaned and sanitized portable 
equipment with food-contact surfaces and utensils in a location and 
manner that protects food-contact surfaces from cross-contact as well 
as from contamination. Proposed Sec.  117.35(f) would recommend that 
cleaned and sanitized portable equipment with food-contact surfaces and 
utensils be stored in a location and manner that protects food-contact 
surfaces from cross-contact and contamination (emphasis added). In 
addition, as discussed in section XI.M of this document, FDA also is 
requesting comment on whether to revise current Sec.  110.35(e) 
(proposed Sec.  117.35(f)) to require, rather than recommend, that 
cleaned and sanitized portable equipment with food-contact surfaces and 
utensils be stored in a location and manner that protects food-contact 
surfaces from cross-contact and contamination.

H. Proposed Revisions to Current Sec.  110.37--Sanitary Facilities and 
Controls (Proposed Sec.  117.37)

1. Proposed Revisions to Current Sec.  110.37(a)--Water Supply
    As discussed in section XI.C of this document, FDA is proposing to 
revise current Sec.  110.37(a) so that it is directed to preventing 
contamination of food-packaging materials as well as food and food-
contact substances. Proposed Sec.  117.37(a) would require that the 
water supply be sufficient for the operations intended and be derived 
from an adequate source. Any water that contacts food, food-contact 
surfaces, or food-packaging materials must be safe and of adequate 
sanitary quality (emphasis added). Running water at a suitable 
temperature, and under pressure as needed, must be provided in all 
areas where required for the processing of food, for the cleaning of 
equipment, utensils, and food-packaging materials, or for employee 
sanitary facilities.
2. Proposed Revisions to Current Sec.  110.37(d)--Toilet Facilities
    Current Sec.  110.37(d) requires that each plant provide its 
employees with adequate, readily accessible toilet facilities and 
provides recommendations for how compliance with the requirements may 
be accomplished. These recommendations address issues such as the 
sanitary and overall physical condition of the toilet facilities, as 
well as the type and location of toilet facilities' doors.
    We considered whether to revise current Sec.  110.37(d) to require, 
rather than recommend, specific provisions for achieving compliance 
with the requirements for toilet facilities. In doing so, we considered 
comments received in response to proposed bathroom requirements 
contained in the proposed rule to establish CGMP requirements for 
dietary supplements (the dietary supplement proposed rule; 68 FR 12158 
at 12254). The dietary supplement proposed rule would have 
established--as requirements--provisions similar to the recommendations 
in current Sec.  110.37(d). Comments on these proposed bathroom 
requirements stated that firms should be given flexibility in designing 
their bathrooms (72 FR 34752 at 34817). FDA agreed that it is 
unnecessary to require specific bathroom features because firms may be 
able to achieve compliance through means better suited to their 
operations. The final rule replaced requirements for specific bathroom 
features with more general requirements for providing employees with 
adequate, readily accessible bathrooms, and for bathrooms to be kept 
clean and not be a potential source of contamination to components, 
dietary supplements, or contact surfaces (Sec.  111.15(h)).
    We tentatively conclude that revising current Sec.  110.37(d) to 
establish a performance standard for toilet facilities similar to the 
one found in Sec.  111.15(h) is a better approach than mandating the 
recommendations in current Sec.  110.37(d). Consistent with the 
discussion in section XI.C of this document, the proposed performance 
standard would be directed to preventing contamination of food-
packaging materials as well as food and food-contact substances. 
Proposed Sec.  117.37(d) would maintain the current requirement that 
each plant provide its employees with adequate, readily accessible 
toilet facilities. In addition, proposed Sec.  117.37(d) would require 
that toilet facilities be kept clean and not be a potential source of 
contamination of food, food-contact surfaces, or food-packaging 
materials.
3. Proposed Revisions to Current Sec.  110.37(e)--Hand-washing 
Facilities
    Current Sec.  110.37(e) requires that hand-washing facilities be 
adequate and convenient and be furnished with running water at a 
suitable temperature and provides recommendations for how compliance 
with the requirements may be accomplished. These recommendations 
address issues such as providing hand-washing and hand-sanitizing 
facilities, hand-cleaning and sanitizing preparations, towel service or 
suitable drying devices, water control valves, appropriate signs and 
refuse receptacles that are properly constructed and maintained.
    We considered whether to revise current Sec.  110.37(e) to require, 
rather than recommend, mechanisms for achieving compliance with the 
requirements for hand-washing facilities. In doing so, we considered 
comments received in response to proposed hand-washing facility 
requirements contained in the dietary supplement proposed rule (68 FR 
12158 at 12254). The dietary supplement proposed rule would have 
established--as requirements--provisions similar to the recommendations 
in current Sec.  110.37(e). Comments on these proposed hand-washing 
facility requirements stated that firms should be given flexibility to 
design their hand-

[[Page 3723]]

washing facilities and that an overall sanitation requirement should be 
sufficient (72 FR 34752 at 34818). FDA agreed that it is unnecessary to 
require specific hand-washing mechanisms because firms may be able to 
achieve compliance through other means better suited for their 
operations; however, we disagreed that an overall sanitation 
requirement would be sufficient because such a requirement would not 
clearly state the purpose of the requirement, which is to ensure that 
an employee's hands are not a source of contamination. The final rule 
replaced requirements for specific hand-washing facility features with 
more general requirements for providing hand-washing facilities 
designed to ensure that an employee's hands are not a source of 
contamination of components, dietary supplements, or any contact 
surface, by providing facilities that are adequate, convenient, and 
furnish running water at a suitable temperature (Sec.  111.15(i)).
    We tentatively conclude that establishing a performance standard 
for hand-washing facilities similar to the one found in Sec.  111.15(i) 
is a better approach than mandating the current recommendations in 
Sec.  110.37(e). Consistent with the discussion in section XI.C of this 
document, the proposed performance standard would be directed to 
preventing contamination of food-packaging materials as well as food 
and food-contact substances. Proposed Sec.  117.37(e) would require 
that each plant provide hand-washing facilities designed to ensure that 
an employee's hands are not a source of contamination of food, food-
contact surfaces, or food-packaging materials by providing facilities 
that are adequate, convenient, and furnish running water at a suitable 
temperature.
4. Proposed Revisions to Current Sec.  110.37(f)-- Rubbish and Offal 
Disposal
    As discussed in section XI.C of this document, FDA is proposing to 
revise current Sec.  110.37(f) so that it is directed to preventing 
contamination of food-packaging materials as well as food and food-
contact substances. Proposed Sec.  117.37(f) would require that rubbish 
and any offal be so conveyed, stored, and disposed of as to minimize 
the development of odor, minimize the potential for the waste becoming 
an attractant and harborage or breeding place for pests, and protect 
against contamination of food, food-contact surfaces, food-packaging 
materials, water supplies, and ground surfaces (emphasis added).

I. Proposed Revisions to Current Sec.  110.40--Equipment and Utensils 
(Proposed Sec.  117.40)

    FDA is proposing to reorganize the provisions found in current 
Sec.  110.40(a) by creating paragraph designations (1) through (6) with 
associated editorial changes. This is a non-substantive revision to 
make it easier to see the distinct requirements. As discussed in 
section XI.M of this document, FDA also is requesting comment on 
whether to revise current Sec.  110.40(a) to require, rather than 
recommend, that all equipment be so installed and maintained as to 
facilitate the cleaning of the equipment and of all adjacent spaces 
(proposed Sec.  117.40(a)(3)).
    As discussed in section XI.D of this document, FDA is proposing to 
(1) revise current Sec.  110.40(a) (in proposed Sec.  117.40(a)(5)) to 
clarify that all plant equipment and utensils must protect against 
cross-contact in addition to the contamination of food and (2) revise 
current Sec.  110.40(b) to clarify that seams on food-contact surfaces 
must be smoothly bonded or maintained so as to minimize the opportunity 
for cross-contact. Proposed Sec.  117.40(a)(5) would require that food-
contact surfaces be maintained to protect food from cross-contact and 
from being contaminated by any source, including unlawful indirect food 
additives (emphasis added). Proposed Sec.  117.40(b) would require that 
seams on food-contact surfaces be smoothly bonded or maintained so as 
to minimize accumulation of food particles, dirt, and organic matter 
and thus minimize the opportunity for growth of microorganisms and 
cross-contact (emphasis added).
    As discussed in section XI.A of this document, FDA is proposing to 
delete the recommendation in current Sec.  110.40(e) that each freezer 
and cold storage compartment used to store and hold food capable of 
supporting growth of microorganisms be fitted with an automatic control 
for regulating temperature or with an automatic alarm system to 
indicate a significant temperature change in a manual operation. 
Proposed Sec.  117.40(e) would require that each freezer and cold 
storage compartment used to store and hold food capable of supporting 
growth of microorganisms be fitted with an indicating thermometer, 
temperature-measuring device, or temperature-recording device so 
installed as to show the temperature accurately within the compartment.
    FDA is proposing to revise current Sec.  110.40(f) to require that 
instruments and controls used for measuring, regulating, or recording 
temperatures, pH, acidity, water activity, or other conditions that 
control or prevent the growth of undesirable microorganisms in food be 
precise as well as accurate. By using the word ``precise'' we mean that 
individual measurements must be close to each other when made under the 
same conditions so that the variation in measurements is not 
statistically significant. An instrument that gives widely varying 
readings from one use to the next cannot be consistently accurate and 
therefore cannot ensure product safety over time. The proposed 
requirement for such instruments and controls to be precise as well as 
accurate would be consistent with the requirements in the dietary 
supplement GMPs (Sec.  111.27(a)(6)(i)), which were established after 
the requirements in current Sec.  110.40(f). Proposed Sec.  117.40(f) 
would require that instruments and controls used for measuring, 
regulating, or recording temperatures, pH, acidity, water activity, or 
other conditions that control or prevent the growth of undesirable 
microorganisms in food be accurate and precise and adequately 
maintained, and adequate in number for their designated uses (emphasis 
added).

J. Proposed Revisions to Current Sec.  110.80--Processes and Controls 
(Proposed Sec.  117.80)

1. Proposed Revisions to Current Sec.  110.80
    FDA is proposing to reorganize the provisions found in six 
sentences that precede current Sec.  110.80(a) by creating paragraph 
designations (a)(1) through (6) with associated editorial changes, 
including the title ``General'' for new paragraph (a) of proposed Sec.  
117.80. This is a non-substantive revision to make it easier to see the 
distinct requirements and to clearly identify each requirement with a 
paragraph citation. As corresponding changes, current Sec.  110.80(a) 
would become proposed Sec.  117.80(b) and current Sec.  110.80(b) would 
become proposed Sec.  117.80(c).
    As discussed in section XI.D of this document, FDA is proposing to 
revise two provisions to current Sec.  110.80 to clarify that certain 
practices involving processes and controls must protect against cross-
contact. Proposed Sec.  117.80(a)(4), in relevant part, would require 
that reasonable precautions be taken to ensure that production 
procedures do not contribute to cross-contact and contamination from 
any source (emphasis added). Proposed Sec.  117.80(a)(5) would require 
that chemical, microbial, or extraneous-material testing procedures be 
used where necessary to identify sanitation

[[Page 3724]]

failures or possible cross-contact and food contamination (emphasis 
added).
2. Proposed Revisions to Current Sec.  110.80(a)--Raw Materials and 
Other Ingredients
    As discussed in section XI.D of this document, FDA is proposing a 
number of revisions to current Sec.  110.80(a) (i.e., to current Sec.  
110.80(a)(1), (a)(5), and (a)(7)) to clarify that certain practices 
involving raw materials and ingredients must protect against cross-
contact. As discussed in section XI.D of this document, FDA also is 
proposing to clarify that three of the five separate statements within 
current Sec.  110.80(a)(1) address cross-contact as well as 
contamination. Proposed Sec.  117.80(b)(1) would require, in relevant 
part, that raw materials and ingredients must be inspected and 
segregated or otherwise handled as necessary to ascertain that they are 
clean and suitable for processing into food and be stored under 
conditions that will protect against cross-contact and contamination, 
and minimize deterioration (emphasis added). Water may be reused for 
washing, rinsing, or conveying food if it does not increase the level 
of contamination of the food or cause cross-contact (emphasis added). 
Proposed Sec.  117.80(b)(1) would continue to recommend that containers 
and carriers of raw materials should be inspected on receipt to ensure 
that their condition has not contributed to cross-contact, 
contamination, or deterioration of food (emphasis added). As discussed 
in section XI.M of this document, FDA also is requesting comment on 
whether to revise current Sec.  110.80(a)(1) to require, rather than 
recommend, that containers and carriers of raw materials be inspected 
on receipt to ensure that their condition has not contributed to the 
cross-contact, contamination or deterioration of food.
    Current Sec.  110.80(a)(2) requires that raw materials and other 
ingredients either not contain levels of microorganisms that may 
produce food poisoning or other disease in humans, or they be 
pasteurized or otherwise treated during manufacturing operations so 
that they no longer contain levels that would cause the product to be 
adulterated within the meaning of the act. FDA is proposing to revise 
current Sec.  110.80(a)(2) by replacing the phrase ``may produce food 
poisoning or other disease in humans'' with ``may render the food 
injurious to the health of humans.'' The proposed revision would align 
the provision with the adulteration provision in section 402(a)(4) of 
the FD&C Act. As discussed in section XI.A of this document, FDA also 
is proposing to delete guidance regarding how to comply with the 
requirements of current Sec.  110.80(a)(2). Proposed Sec.  117.80(b)(2) 
would require that raw materials and ingredients either not contain 
levels of microorganisms that may render the food injurious to the 
health of humans, or they be pasteurized or otherwise treated during 
manufacturing operations so that they no longer contain levels that 
would cause the product to be adulterated (emphasis added).
    Current Sec.  110.80(a)(3) requires that raw materials and other 
ingredients susceptible to contamination with aflatoxin or other 
natural toxins comply with current FDA regulations and action levels 
for poisonous or deleterious substances before these materials or 
ingredients are incorporated into finished food. An action level for an 
added poisonous or deleterious substance may be established to define a 
level of contamination at which a food may be regarded as adulterated 
(Sec.  109.4) (21 CFR 109.4). In 1990, we issued a final rule to revise 
part 109 to clarify that action levels constitute prosecutorial 
guidance rather than substantive rules (55 FR 20782, May 21, 1990). 
Because action levels themselves constitute guidance, revising current 
Sec.  110.80(a)(3) to reflect that action levels are nonbinding would 
be duplicative and unnecessary and FDA is proposing to delete the 
current requirement for compliance with action levels from current 
Sec.  110.80(a)(3). Importantly, the proposed deletion merely reflects 
an administrative practice to limit the number of recommendations we 
include in our regulations; we continue to regard action levels as an 
important approach to food safety. As discussed in section XI.A of this 
document, FDA also is proposing to delete guidance regarding how to 
comply with the requirements of current Sec.  110.80(a)(3). Proposed 
Sec.  117.80(b)(3) would require that raw materials and ingredients 
susceptible to contamination with aflatoxin or other natural toxins 
comply with current Food and Drug Administration regulations for 
poisonous or deleterious substances before these materials or 
ingredients are incorporated into finished food (emphasis added).
    Current Sec.  110.80(a)(4) requires that raw materials, other 
ingredients, and rework susceptible to contamination with pests, 
undesirable microorganisms, or extraneous material comply with 
applicable FDA regulations and defect action levels for natural or 
unavoidable defects if a manufacturer wishes to use the materials in 
manufacturing food. Defect action levels are guidance for natural or 
unavoidable defects in food for human use that present no health hazard 
(Ref. 141). FDA establishes maximum levels for these defects in foods 
produced under current good manufacturing practice and uses these 
levels in deciding whether to recommend regulatory action (Ref. 141). 
As discussed above in this section, in 1990, we issued a final rule to 
revise part 109 to clarify that action levels are prosecutorial 
guidance rather than substantive rules (55 FR 20782). Because defect 
action levels themselves constitute guidance, revising current Sec.  
110.80(a)(4) to reflect that action levels are nonbinding would be 
duplicative and unnecessary. Therefore, FDA is proposing to delete the 
current requirement for compliance with defect action levels in current 
Sec.  110.80(a)(4). As discussed in section XI.A of this document, FDA 
also is proposing to delete guidance regarding how to comply with the 
requirements of current Sec.  110.80(a)(4). Proposed Sec.  117.80(b)(4) 
would require raw materials, ingredients, and rework susceptible to 
contamination with pests, undesirable microorganisms, or extraneous 
material comply with applicable Food and Drug Administration 
regulations for natural or unavoidable defects if a manufacturer wishes 
to use the materials in manufacturing food.
    As discussed in section XI.D of this document, FDA is proposing to 
revise current Sec.  110.80(a)(5) to clarify that raw materials, 
ingredients, and rework be held in bulk, or in containers designed and 
constructed so as to protect against cross-contact as well as against 
contamination. Proposed Sec.  117.80(b)(5) would require that raw 
materials, ingredients, and rework be held in bulk, or in containers 
designed and constructed so as to protect against cross-contact and 
contamination and must be held at such temperature and relative 
humidity and in such a manner as to prevent the food from becoming 
adulterated. Material scheduled for rework must be identified as such. 
(Emphasis added.)
    As discussed in section XI.D of this document, FDA is proposing to 
revise current Sec.  110.80(a)(7) to clarify that liquid or dry raw 
materials and ingredients received and stored in bulk form must be held 
in a manner that protects against cross-contact as well as 
contamination. Proposed Sec.  117.80(b)(7) would require that liquid or 
dry raw materials and ingredients received and stored in bulk form be 
held in a manner that protects against cross-contact and contamination 
(emphasis added).
    As discussed in section XI.D of this document, FDA is proposing to 
establish a new requirement in current

[[Page 3725]]

Sec.  110.80(a) regarding cross-contact. Proposed Sec.  117.80(b)(8) 
would require that raw materials and ingredients that are food 
allergens, and rework that contains food allergens, be identified and 
held in a manner that prevents cross-contact. We seek comment on this 
proposal.
3. Proposed Revisions to Current Sec.  110.80(b)--Manufacturing 
Operations
    As discussed in section XI.C of this document, FDA is proposing to 
revise current Sec.  110.80(b)(2) by replacing the phrase 
``manufacturing, including packaging and storage'' with 
``manufacturing, processing, packing and holding.'' As discussed in 
section XI.A of this document, FDA also is proposing to delete guidance 
regarding how to comply with the requirements of current Sec.  
110.80(b)(2). Proposed Sec.  117.80(c)(2) would require that all food 
manufacturing, processing, packing and holding, be conducted under such 
conditions and controls as are necessary to minimize the potential for 
the growth of microorganisms or for the contamination of food (emphasis 
added).
    Current Sec.  110.80(b)(3) requires that food that can support the 
rapid growth of undesirable microorganisms, particularly those of 
public health significance, be held in a manner that prevents the food 
from becoming adulterated within the meaning of the FD&C Act and 
provides recommendations for complying with this requirement. FDA is 
proposing a series of revisions to current Sec.  110.80(b)(3). 
Specifically, FDA is proposing to:
     Replace the phrase ``in a manner'' with ``at 
temperatures'' to identify a specific manner in which food that 
supports the rapid growth of microorganisms must be held--i.e., through 
temperature control. Temperature control is generally recognized as 
essential to food safety for foods that can support the rapid growth of 
microorganisms (Ref. 137) (Ref. 138) (Ref. 139) (Ref. 140).
     Include the phrase ``during manufacturing, processing, 
packing and holding'' to emphasize that temperature controls do not end 
with the manufacturing/processing phase, but extend through packing and 
holding.
     Delete the recommendations in current Sec.  
110.80(b)(3)(i) through (iv). (See the discussion of the proposed 
deletion in section XI.A of this document.)
    With these changes, proposed Sec.  117.80(c)(3) would require that 
food that can support the rapid growth of undesirable microorganisms be 
held at temperatures that will prevent the food from becoming 
adulterated, during manufacturing, processing, packing and holding 
(emphasis added).
    Current Sec.  110.80(b)(4) requires that measures such as 
sterilizing, irradiating, pasteurizing, freezing, refrigerating, 
controlling pH or controlling aw that are taken to destroy 
or prevent the growth of undesirable microorganisms, particularly those 
of public health significance, shall be adequate under the conditions 
of manufacture, handling, and distribution to prevent food from being 
adulterated within the meaning of the act. FDA is proposing to include 
``cooking'' as an additional such measure. Cooking, if done adequately, 
is well accepted as a mechanism of destroying microorganisms (Ref. 
142). FDA also is proposing to delete the phrase ``particularly those 
of public health significance'' because it is redundant with the 
proposed definition for the term ``microorganisms'' (proposed Sec.  
117.3), which identifies microorganisms of public health significance 
as a type of undesirable microorganism, and therefore is unnecessary. 
Proposed Sec.  117.80(c)(4) would require measures such as sterilizing, 
irradiating, pasteurizing, cooking, freezing, refrigerating, 
controlling pH or controlling aw that are taken to destroy 
or prevent the growth of undesirable microorganisms be adequate under 
the conditions of manufacture, handling, and distribution to prevent 
food from being adulterated (emphasis added).
    Current Sec.  110.80(b)(5) requires that work-in-process be handled 
in a manner that protects against contamination. FDA is proposing to 
revise current Sec.  110.80(b)(5) to require handling in a manner to 
protect against the growth of undesirable microorganisms. The growth of 
any undesirable microorganisms already present in a food, such as 
pathogenic sporeformers, must be controlled, as well as protecting the 
food against the introduction of contaminants. As discussed in section 
XI.D of this document, FDA also is proposing to clarify that work-in-
process must be handled in a manner to protect against cross-contact. 
In addition we are proposing to revise current Sec.  110.80(b)(5) to 
broaden the provision to include ``rework.'' The term ``rework'' would 
be defined in proposed Sec.  117.3 to mean clean, unadulterated food 
that has been removed from processing for reasons other than insanitary 
conditions or that has been successfully reconditioned by reprocessing 
and that is suitable for use as food. As with work-in-process, improper 
handling of rework could result in cross-contact, contamination, or 
growth of undesirable microorganisms. Proposed Sec.  117.80(c)(5) would 
require that work-in-process and rework be handled in a manner that 
protects against cross-contact, contamination, and growth of 
undesirable microorganisms (emphasis added).
    As discussed in section XI.D of this document, FDA is proposing to 
clarify that three provisions in current Sec.  110.80(b)(6) require 
that effective measures be taken to protect finished food from cross-
contact as well as from contamination. Proposed Sec.  117.80(c)(6) 
would require that effective measures be taken to protect finished food 
from cross-contact and contamination by raw materials, ingredients, or 
refuse (emphasis added). When raw materials, ingredients, or refuse are 
unprotected, they must not be handled simultaneously in a receiving, 
loading, or shipping area if that handling could result in cross-
contact or contaminated food (emphasis added). Food transported by 
conveyor must be protected against cross-contact and contamination as 
necessary (emphasis added).
    As discussed in section XI.D of this document, FDA is proposing to 
clarify that current Sec.  110.80(b)(7) requires that equipment, 
containers, and utensils used to convey, hold, or store raw materials, 
work-in-process, rework, or food be constructed, handled, and 
maintained during manufacturing or storage in a manner that protects 
against cross-contact as well as against contamination. As discussed in 
section XI.C of this document, FDA also is proposing to replace the 
term ``storage'' with the term ``holding'' for consistency with use of 
the term ``holding'' throughout proposed part 117 and to add processing 
and packing as activities where protection is needed against 
contamination and cross-contact. Proposed Sec.  117.80(c)(7) would 
require that equipment, containers, and utensils used to convey, hold, 
or store raw materials, work-in-process, rework, or food be 
constructed, handled, and maintained during manufacturing, processing, 
packing and holding in a manner that protects against cross-contact and 
contamination (emphasis added).
    As discussed in section XI.A of this document, FDA is proposing to 
delete guidance regarding how to comply with the requirements of 
current Sec.  110.80(b)(8). Proposed Sec.  117.80(c)(8) would require 
that effective measures be taken to protect against the inclusion of 
metal or other extraneous material in food.

[[Page 3726]]

    Current Sec.  110.80(b)(9) requires that food, raw materials, and 
other ingredients that are adulterated must be disposed of in a manner 
that protects against the contamination of other food. It further 
requires that if the adulterated food is capable of being 
reconditioned, it be reconditioned using a method that has been proven 
to be effective or it be reexamined and found not to be adulterated 
within the meaning of the act before being incorporated into other 
food. FDA is proposing to delete the option for reexamination so that 
adulterated food can only be disposed of or reconditioned if the food 
is capable of being reconditioned. FDA is proposing this deletion 
because a food may test positive for a contaminant in one test and 
negative in one or more additional tests although the food continues to 
be contaminated. For example, the distribution of a pathogen in a food 
may not be homogeneous. Therefore, a food found to be adulterated must 
be reconditioned before it is reexamined. FDA also is proposing to 
combine the two sentences in current Sec.  110.80(b)(9) with an ``or'' 
to make clear that reconditioning, rather than disposal, is an option. 
Proposed Sec.  117.80(c)(9) would require food, raw materials, and 
ingredients that are adulterated be disposed of in a manner that 
protects against the contamination of other food or, if the adulterated 
food is capable of being reconditioned, it be reconditioned using a 
method that has been proven to be effective (emphasis added).
    Current Sec.  110.80(b)(10) requires that mechanical manufacturing 
steps such as washing, peeling, trimming, cutting, sorting and 
inspecting, mashing, dewatering, cooling, shredding, extruding, drying, 
whipping, defatting, and forming shall be performed so as to protect 
food against contamination. FDA is proposing to revise current Sec.  
110.80(b)(10) to replace the phrase ``mechanical manufacturing steps'' 
with the single term ``steps'' because ``mechanical manufacturing'' 
does not accurately describe all steps listed in the current provision. 
Current Sec.  110.80(b)(10) also includes three recommendations. As 
discussed in section XI.A of this document, FDA is proposing to delete 
two of these recommendations (regarding adequate cleaning and 
sanitizing of all food-contact surfaces and regarding the use of time 
and temperature controls). As discussed in section XI.D of this 
document, FDA also is proposing to clarify that steps identified in 
current Sec.  110.80(b)(10) require protection against cross-contact. 
Proposed Sec.  117.80(c)(10) would require that steps such as washing, 
peeling, trimming, cutting, sorting and inspecting, mashing, 
dewatering, cooling, shredding, extruding, drying, whipping, defatting, 
and forming be performed so as to protect food against cross-contact 
and contamination and would continue to recommend that food should be 
protected from contaminants that may drip, drain, or be drawn into the 
food (emphasis added). As discussed in section XI.M of this document, 
FDA is requesting comment on whether to establish the third 
recommendation (regarding physical protection of food from contaminants 
that may drip, drain, or be drawn into the food) as a requirement.
    Current Sec.  110.80(b)(11) requires, in relevant part, that where 
a blanched food is washed prior to filling, water used be safe and of 
adequate sanitary quality. FDA is proposing to delete this requirement 
because water quality would already be addressed in proposed Sec.  
117.37(a) and would be redundant in proposed Sec.  117.80(c)(11). 
Current Sec.  110.80(b)(11) also recommends that heat blanching, when 
required in the preparation of food, be effected by heating the food to 
the required temperature, holding it at this temperature for the 
required time, and then either rapidly cooling the food or passing it 
to subsequent manufacturing without delay. As discussed in section 
XI.M, of this document, FDA is requesting comment on whether to 
establish this recommendation as a requirement. Current Sec.  
110.80(b)(11) also recommends that thermophilic growth and 
contamination in blanchers be minimized by the use of adequate 
operating temperatures and by periodic cleaning. As discussed in 
section XI.M of this document, FDA is requesting comment on whether to 
establish this recommendation as a requirement. Proposed Sec.  
117.80(c)(11) would continue to recommend that heat blanching, when 
required in the preparation of food, should be effected by heating the 
food to the required temperature, holding it at this temperature for 
the required time, and then either rapidly cooling the food or passing 
it to subsequent manufacturing without delay (emphasis added). Proposed 
Sec.  117.80(c)(11) also would continue to recommend that thermophilic 
growth and contamination in blanchers should be minimized by use of 
adequate operating temperatures and by periodic cleaning (emphasis 
added).
    Current Sec.  110.80(b)(12) requires that batters, breading, 
sauces, gravies, dressings, and other similar preparations be treated 
or maintained in such a manner that they are protected against 
contamination and provides several recommendations for how to comply 
with this requirement. As discussed in section XI.A of this document, 
FDA is proposing to delete these recommendations. As discussed in 
section XI.D of this document, FDA also is proposing to clarify that 
steps identified in current Sec.  110.80(b)(12) require protection 
against cross-contact. Proposed Sec.  117.80(c)(12) would require that 
batters, breading, sauces, gravies, dressings, and other similar 
preparations be treated or maintained in such a manner that they are 
protected against cross-contact and contamination (emphasis added).
    Current Sec.  110.80(b)(13) requires that filling, assembling, 
packaging, and other operations be performed in such a way that the 
food is protected against contamination. FDA is proposing to revise 
current Sec.  110.80(b)(13) to require that filling, assembling, 
packaging, and other operations be performed in such a way that the 
food is protected against the growth of undesirable microorganisms as 
well as against contamination. The growth of any undesirable 
microorganisms already present in a food must be controlled, in 
addition to the introduction of contaminants. Current Sec.  
110.80(b)(13) also includes several recommendations for achieving 
compliance. As discussed in section XI.A of this document, FDA is 
proposing to delete these recommendations. As discussed in section XI.D 
of this document, FDA also is proposing to require protection against 
cross-contact. Proposed Sec.  117.80(c)(13) would require that filling, 
assembling, packaging, and other operations be performed in such a way 
that the food is protected against cross-contact, contamination, and 
growth of undesirable microorganisms (emphasis added).
    Current Sec.  110.80(b)(14) requires that food, such as, but not 
limited to, dry mixes, nuts, intermediate moisture food, and dehydrated 
food, that relies on the control of aw for preventing the 
growth of undesirable microorganisms be processed to and maintained at 
a safe moisture level. Current Sec.  110.80(b)(14) also provides 
recommendations for accomplishing compliance with this requirement. As 
discussed in section XI.A of this document, FDA is proposing to delete 
these recommendations. Proposed Sec.  117.80(c)(14) would require that 
food, including dry mixes, nuts, intermediate moisture food, and 
dehydrated food, that relies on the control of aw for 
preventing the growth of undesirable

[[Page 3727]]

microorganisms be processed to and maintained at a safe moisture level 
(emphasis added).
    Current Sec.  110.80(b)(15) requires that food such as, but not 
limited to, acid and acidified food, that relies principally on the 
control of pH for preventing the growth of undesirable microorganisms 
be monitored and maintained at a pH of 4.6 or below and includes two 
recommendations for how to comply with the requirement. As discussed in 
section XI.A of this document, FDA is proposing to delete these 
recommendations. Proposed Sec.  117.80(c)(15) would require food, 
including acid and acidified food, that relies principally on the 
control of pH for preventing the growth of undesirable microorganisms 
be monitored and maintained at a pH of 4.6 or below.

K. Proposed Revisions to Current Sec.  110.93--Warehousing and 
Distribution (Proposed Sec.  117.93)

    Current Sec.  110.93 requires that storage and transportation of 
finished food be under conditions that will protect food against 
physical, chemical, and microbial contamination as well as against 
deterioration of the food and the container. FDA is proposing a series 
of revisions to current Sec.  110.93.
    FDA is proposing to delete the term ``finished'' before ``food'' 
because the requirements in this provision must apply to all food being 
held for distribution regardless of whether it is a raw material or 
ingredient or in its finished state. To ensure food safety throughout 
the food chain, food, whether a raw material or finished product, must 
be protected against contamination.
    As discussed in section XI.D of this document, FDA also is 
proposing to revise Sec.  110.93 to clarify that storage and 
transportation of food must be under conditions that will protect 
against cross-contact of food in addition to protecting against 
contamination of food.
    FDA also is proposing to add radiological hazards as an additional 
category of contaminants to the list of contaminants which may be 
encountered in warehousing and distribution because food may be subject 
to contamination with radiological hazards. As discussed in section 
XII.B, FDA now recognizes four types of hazards: biological, chemical, 
physical and radiological. Our CGMP regulation for bottled water in 
part 129 requires plants to analyze product samples for 
bacteriological, chemical, physical and radiological purposes (Sec.  
129.80(g)). Therefore, the proposed addition of radiological 
contaminants to the list of contaminants would be consistent with part 
129. FDA tentatively concludes that there is no basis for requiring a 
facility to protect against some types of hazards but not others, and 
thus is proposing to include radiological hazards among those from 
which food must be protected.
    FDA also is proposing to require protection against ``biological,'' 
rather than ``microbial'' contamination of food so that, when a 
provision specifies all four types of hazards that must be addressed, 
the list is presented consistently throughout proposed part 117. In 
section XII.B.3 of this document, we discuss a requirement, which would 
be established in proposed Sec.  117.130(b), for a hazard analysis to 
address biological, chemical, radiological, and physical hazards. FDA 
also is proposing to present the list of types of hazards in the same 
order as the list would be presented in proposed Sec.  117.130(b).
    Proposed Sec.  117.93 would require that storage and transportation 
of food be under conditions that will protect against cross-contact and 
biological, chemical, physical, and radiological contamination of food 
as well as against deterioration of the food and the container 
(emphasis added).

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

    As discussed in section XI.C of this document, FDA is proposing to 
revise current Sec.  110.110(c) to change the designated persons who 
must ``observe good manufacturing practices'' and ``at all times 
utilize quality control operations that reduce natural or unavoidable 
defects to the lowest level currently feasible'' from the currently 
identified persons (i.e., manufacturers, distributors and holders of 
food) to manufacturers, processors, packers and holders of food. FDA 
also is proposing to update the reference in current Sec.  110.110(c) 
to section 402(a)(4) of the FD&C Act to make it more complete by 
specifying that the insanitary conditions are those whereby food may 
have become contaminated with filth, or whereby food may have been 
rendered injurious to health. Proposed Sec.  117.110(c) would specify 
that compliance with defect action levels does not excuse violation of 
the requirement in section 402(a)(4) of the Federal Food, Drug, and 
Cosmetic Act that food not be prepared, packed, or held under 
unsanitary conditions whereby it may have become contaminated with 
filth, or whereby it may have been rendered injurious to health, or the 
requirements in part 117 that food manufacturers, processors, packers, 
and holders must observe current good manufacturing practice (emphasis 
added). Evidence indicating that such a violation exists causes the 
food to be adulterated, even though the amounts of natural or 
unavoidable defects are lower than the currently established defect 
action levels. The manufacturer, processor, packer and holder of food 
must at all times utilize quality control operations that reduce 
natural or unavoidable defects to the lowest level currently feasible.
    FDA is proposing to revise current Sec.  110.110(d) to replace the 
clause ``The mixing of a food containing defects above the current 
defect action level * * *'' with ``The mixing of a food containing 
defects at levels that render the food adulterated * * *'' We are 
proposing this change to clarify that food containing defects above the 
current defect action level is not automatically adulterated under the 
FD&C Act. A defect action level is nonbinding and is directed to a 
natural or unavoidable defect in food that presents no health hazards 
for humans (Ref. 141). Whether food containing defects above the 
current defect action levels adulterate the food is a case-by-case 
determination that depends on the circumstances. Proposed Sec.  
117.110(d) would specify that the mixing of a food containing defects 
at levels that render that food adulterated with another lot of food is 
not permitted and renders the final food adulterated, regardless of the 
defect level of the final food (emphasis added).
    As discussed in section XI.A of this document, FDA is proposing to 
delete current Sec.  110.110(e), which provides that a compilation of 
the current defect action levels for natural or unavoidable defects in 
food for human use that present no health hazard may be obtained upon 
request.

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

1. Overview
    In sections IX.F and XI.A of this document, we discuss our intent 
to delete some non-binding provisions of current part 110 (e.g., 
provisions using ``should'' or ``compliance may be achieved by''). In 
this section of this document, we request comment on whether to revise 
other non-binding provisions to establish new requirements in proposed 
part 117 or retain them as useful recommendations of a comprehensive 
CGMP provision.

[[Page 3728]]

We discuss each of these immediately below.
    We believe that these CGMP provisions are science-based and an 
important part of a modern food safety system. Because these non-
binding provisions have been in place for decades, they are widely used 
and commonly accepted in many sectors of the food industry. In 
addition, under section 418(o)(3) of the FD&C Act, the procedures, 
practices, and processes described in the definition of preventive 
controls may include sanitation procedures for food contact surfaces of 
utensils and equipment; supervisor, manager, and employee hygiene 
training; and CGMPs under part 110 of title 21 (or any successor 
regulations).
    The vast majority of the costs related to a revised mandatory 
sanitary operations, process and controls program would be for the time 
that workers are in training for the alternative requirements rather 
than in production. We estimate that this alternative, when implemented 
as part of a preventive approach, could impose an incremental annual 
cost of $560-$28,000 per facility based on size (number of employees) 
to facilities that do not already comply with this alternative. This 
would result in an estimated aggregate cost of $16 million for domestic 
facilities and an estimated aggregate cost of $17,400,000 for foreign 
facilities. This estimate assumes that about half of the qualified 
facilities would need to review their operations and perform the 
training. Most non-qualified facilities would have met the requirements 
by following the requirements for sanitation controls in subpart C but 
for those that do not have hazards that are reasonably likely to occur 
or for those with sanitation controls that do not fully address the 
requirements of the sanitary operations, they would need to review 
their operations and perform the training. Further details are provided 
in the ``Consideration of Other Provisions'' section of the RIA.
2. Summary of Potential Revisions To Establish Requirements in Place of 
Current Guidance
    Table 11 identifies each of the potential revisions to establish 
new requirements and either explains the reason for establishing the 
requirement or, for such revisions with longer explanations, refers to 
the section of this document where the potential requirement is 
explained.

   Table 11--Potential Revisions To Establish Requirements in Place of
                            Current Guidance
------------------------------------------------------------------------
                              Potential additional
                                   revision to
   Designation of proposed         establish a       Basis for potential
          provision           requirement in place        revision
                               of a recommendation
                                (emphasis added)
------------------------------------------------------------------------
Sec.   117.10(c)............  Personnel             See explanation and
                               responsible for       questions about
                               identifying           whether more detail
                               sanitation failures   would be
                               or food               appropriate in
                               contamination must    section XI.M.3 of
                               have a background     this document.
                               of education or
                               experience, or a
                               combination
                               thereof, to provide
                               a level of
                               competency
                               necessary for
                               production of clean
                               and safe food. Food
                               handlers and
                               supervisors must
                               receive appropriate
                               training in proper
                               food handling
                               techniques and food-
                               protection
                               principles and
                               should be informed
                               of the danger of
                               poor personal
                               hygiene and
                               insanitary
                               practices.
Sec.   117.35(d)(3)           Single-service        Failure to properly
 (Sanitation of food-contact   articles (such as     store such articles
 substances).                  utensils intended     could lead to
                               for one-time use,     contamination of
                               paper cups, and       the articles and
                               paper towels) must    then to
                               be stored in          contamination of
                               appropriate           food if the
                               containers and must   articles come in
                               be handled,           contact with food.
                               dispensed, used,
                               and disposed of in
                               a manner that
                               protects against
                               cross-contact and
                               contamination of
                               food, food-contact
                               surfaces, or food-
                               packaging materials.
Sec.   117.35(e) (Sanitation  Non-food-contact      Failure to clean non-
 of non-food-contact           surfaces of           food-contact
 substances).                  equipment used in     surfaces could lead
                               the operation of a    to contamination of
                               food plant must be    food-contact
                               cleaned in a manner   surfaces of the
                               and as frequently     equipment and
                               as necessary to       utensils and then
                               protect against       to contamination of
                               cross-contact and     food if the
                               contamination of      contaminated
                               food and food-        equipment and
                               contact surfaces.     utensils come in
                                                     contact with food.
                                                     For example,
                                                     cleaning non-food-
                                                     contact surfaces is
                                                     essential to
                                                     prevent
                                                     contamination of
                                                     food from
                                                     environmental
                                                     pathogens such as
                                                     L. monocytogenes
                                                     and Salmonella spp.
Sec.   117.35(f) (Storage     Cleaned and           Failure to properly
 and handling of cleaned       sanitized portable    store and handle
 portable equipment and        equipment with food-  such equipment and
 utensils).                    contact surfaces      utensils could lead
                               and utensils must     to contamination of
                               be stored in a        the equipment and
                               location and manner   utensils and then
                               that protects food-   to contamination of
                               contact surfaces      food if the
                               from contamination.   equipment and
                                                     utensils come in
                                                     contact with food.
Sec.   117.40(a)(1)           All equipment must    Failure to properly
 (Equipment and utensils).     be so installed and   clean equipment and
                               maintained as to      adjacent spaces due
                               facilitate the        to improper
                               cleaning of the       installation and
                               equipment and of      maintenance could
                               all adjacent spaces.  lead to
                                                     contamination of
                                                     the equipment and
                                                     then contamination
                                                     of food if the
                                                     equipment comes in
                                                     contact with the
                                                     food.
Sec.   117.80(b)(1)           Containers and        Containers and
 (Processes and controls--     carriers of raw       carriers of raw
 raw materials and             materials must be     materials not
 ingredients).                 inspected on          properly maintained
                               receipt to ensure     can lead to
                               that their            contamination or
                               condition has not     deterioration of
                               contributed to the    food.
                               contamination or
                               deterioration of
                               food.
Sec.   117.80(c)(10)           Food must be         There are no
 (Manufacturing operations).   protected from        circumstances where
                               contaminants that     it would not be
                               may drip, drain, or   necessary to
                               be drawn into the     provide adequate
                               food during           physical protection
                               manufacturing steps   of food from
                               such as washing,      contaminants that
                               peeling, trimming,    may drip, drain, or
                               cutting, sorting      be drawn into food.
                               and inspecting,
                               mashing,
                               dewatering,
                               cooling, shredding,
                               extruding, drying,
                               whipping,
                               defatting, and
                               forming.

[[Page 3729]]

 
Sec.   117.80(c)(11)          Heat blanching, when  Properly heating and
 (Manufacturing operations).   required in the       cooling food during
                               preparation of        blanching is
                               food, must be         necessary to
                               effected by heating   protect food from
                               the food to the       contamination and
                               required              would apply in all
                               temperature,          cases for food when
                               holding it at this    heat blanching is
                               temperature for the   required in the
                               required time, and    preparation.
                               then either rapidly
                               cooling the food or
                               passing it to
                               subsequent
                               manufacturing
                               without delay.
Sec.   117.80(c)(11)          Thermophilic growth   Adequate operating
 (Manufacturing operations).   and contamination     temperatures and
                               in blanchers must     proper cleaning are
                               be minimized by the   necessary for
                               use of adequate       controlling growth
                               operating             of thermophilic
                               temperatures and by   bacteria and
                               periodic cleaning.    contamination and
                                                     would apply in all
                                                     cases for food when
                                                     heat blanching is
                                                     required in the
                                                     preparation.
------------------------------------------------------------------------

3. Potential Revisions To Establish Requirements in Place of Current 
Guidance for Education and Training
    Current Sec.  110.10(c) provides guidance that personnel 
responsible for identifying sanitation failures or food contamination 
should have a background of education or experience, or a combination 
thereof, to provide a level of competency necessary for production of 
clean and safe food. Current Sec.  110.10(c) further recommends that 
food handlers and supervisors receive appropriate training in proper 
food handling techniques and food-protection principles and should be 
informed of the danger of poor personal hygiene and insanitary 
practices.
    As discussed in section II.A.1 of this document, the CGMP Working 
Group Report identified specific areas that presented an opportunity to 
modernize the regulation. One recommendation was to ``require 
appropriate training for supervisors and workers to ensure that they 
have the necessary knowledge and expertise in food hygiene, food 
protection, employee health and personal hygiene to produce safe food 
products. This training must be delivered in a manner that can be 
easily understood by the worker. Food processors must maintain a record 
of this training for each worker'' (Ref. 1). Our analysis of recalls 
also indicates that ineffective employee training was a root cause of 
32 percent of CGMP-related recalls in the 1999-2003 analysis (Ref. 58); 
deficiencies in training were identified as a contributing factor in 24 
percent of CGMP-related primary recalls in the 2008-2009 analysis (Ref. 
59). In addition, as discussed with respect to the proposed definition 
of preventive controls (see section X.C.4 of this document), section 
418(o)(3) of the FD&C Act recognizes the importance of both training 
and CGMPs in preventing hazards from occurring in foods in its 
definition of preventive controls, which identifies supervisor, 
manager, and employee hygiene training (Sec.  418(o)(3)(B)) and CGMPs 
under part 110 (Sec.  418(o)(3)(F)) as some of the procedures, 
practices, and processes that may be included as preventive controls.
    The vast majority of costs related to a mandatory education and 
training program would be for the time that workers would be training 
rather than in production. We estimate that a requirement for education 
and training, when implemented as part of a preventive approach, could 
impose an incremental annual cost of $1,000-$25,000 per facility based 
on size (number of employees) to facilities that do not already conduct 
training. This would result in an estimated aggregate cost of $93 
million for domestic facilities and an estimated aggregate cost of 
$101,300,000 for foreign facilities. This estimate assumes that both 
qualified and nonqualified facilities would be required to perform the 
training. Further details are provided in the ``Consideration of Other 
Provisions'' section of the RIA.
    We request comment on how best to revise current Sec.  110.10(c) in 
light of section 418(o)(3) of the FD&C Act and the recommendations of 
the CGMP Working Group with respect to training. Should we replace the 
current recommendations for personnel education and experience with 
requirements? Doing so would be consistent with the emphasis in section 
418(o)(3) of the FD&C Act on the importance of both training and CGMPs 
in preventing hazards from occurring in foods in its definition of 
preventive controls and with the recommendation in the CGMP Working 
Group Report. If so, what is the appropriate level of specificity? For 
example, should we simply replace the ``shoulds'' in current Sec.  
110.10(c) with ``musts''? This would provide flexibility for each 
establishment to determine the type and frequency of education and 
training appropriate for its personnel.
    FDA also requests comment on whether more detail would be 
appropriate, by, for example:
     Specifying that each person engaged in food manufacturing, 
processing, packing, or holding (including temporary and seasonal 
personnel and supervisors) receive training as appropriate to the 
person's duties;
     Specifying the frequency of training (e.g., upon hiring 
and periodically thereafter);
     Specifying that training include the principles of food 
hygiene and food safety, including the importance of employee health 
and personal hygiene, as applied at the facility; and
     Specifying that records document required training of 
personnel and, if so, specifying minimum requirements for the 
documentation (e.g., the date of the training, the type of training, 
and the person(s) trained).
    We also request comment on whether to establish some or all of the 
potential requirements for education and training in subpart B, subpart 
C, or both. If we establish a requirement for education and training in 
subpart B, that requirement would apply to all persons who manufacture, 
process, pack or hold food, with the exceptions of persons who would be 
exempt from subpart B (i.e., under proposed Sec.  117.5(k), a 
requirement in subpart B would not apply to ``farms'', activities of 
``farm mixed-type facilities'' that fall within the definition of 
``farm,'' or the holding or transportation of one or more RACs). On the 
other hand, if we establish a requirement for education and training in 
subpart C, that requirement would not apply to persons who would be 
exempt from the requirements of proposed subpart C (e.g., qualified 
facilities and persons conducting activities subject to HACCP 
regulations for juice or seafood).

[[Page 3730]]

N. Request for Comment on Additional CGMP Requirements

    We request comment on any additional proposed revisions or 
clarifications to our CGMP regulations that should be included in 
subpart B, including whether to further implement the ``opportunities'' 
for CGMP modernization identified by the CGMP Working Group or to 
enhance the CGMP regulations in some other way. For example, we request 
comment on whether a final rule based on this proposed rule should 
include CGMP requirements for environmental monitoring for L. 
monocytogenes, and whether such requirements should include other 
environmental pathogens such as Salmonella spp. If so, we also request 
comment on what such requirements should be. For additional information 
on environmental monitoring for L. monocytogenes and Salmonella spp., 
see sections I.D and I.E of the Appendix to this document.

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

A. Proposed Sec.  117.126--Requirement for a Food Safety Plan

1. Requirements of Section 418 of the FD&C Act
    Section 418(h) of the FD&C Act requires that the owner, operator, 
or agent in charge of a facility shall prepare a written plan that 
documents and describes the procedures used by the facility to comply 
with the requirements of section 418 of the FD&C Act, including 
analyzing the hazards under section 418(b) of the FD&C Act and 
identifying the preventive controls adopted under section 418(c) of the 
FD&C Act to address those hazards. Section 418(h) of the FD&C Act also 
requires that such written plan, together with the documentation 
described in section 418(g) of the FD&C Act, shall be made promptly 
available to a duly authorized representative of the Secretary upon 
oral or written request.
2. Proposed Sec.  117.126(a)--Requirement for a Food Safety Plan
    Proposed Sec.  117.126(a) would require that the owner, operator, 
or agent in charge of a facility prepare, or have prepared, and 
implement a written food safety plan. We use the term ``written food 
safety plan'' in proposed Sec.  117.126(a) to mean the ``written plan'' 
referred to in section 418(h) of the FD&C Act. To make clear that the 
written plan is related to food safety rather than to other plans a 
facility may have (such as quality control plans or food defense 
plans), we have designated the ``written plan'' to be a ``food safety 
plan.''
    Proposed Sec.  117.126(a) would require that the plan be written as 
is expressly required by section 418(h). A written food safety plan is 
essential for the facility to implement the plan consistently, train 
its employees, and periodically reanalyze and update the plan. It is 
also essential to a facility's food safety team, to auditors, and to 
inspectors. Proposed Sec.  117.126(a) would implement section 418(h) of 
the FD&C Act and is consistent with the NACMCF HACCP guidelines, the 
Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, 
and meat and poultry. The recordkeeping provisions of the NACMCF HACCP 
guidelines recommend that the HACCP plan include a list of the HACCP 
team and assigned responsibilities; a description of the food, its 
distribution, intended use, and consumer; a verified flow diagram; a 
HACCP Plan Summary Table that includes information for steps in the 
process that are CCPs, the hazard(s) of concern, critical limits, 
monitoring, corrective actions, verification procedures and schedule, 
and record-keeping procedures (Ref. 34). The Codex HACCP Annex 
recommends that HACCP procedures be documented, including the hazard 
analysis, and determinations of CCPs and critical limits (Ref. 35). 
Federal HACCP regulations for seafood, juice, and meat and poultry 
require a written plan (Sec. Sec.  123.6(b)) and 120.8(a) and 9 CFR 
417.2(b), respectively).
    Proposed Sec.  117.126(a) would provide flexibility for the owner, 
operator, or agent in charge of the facility to either prepare the 
written food safety plan or have that plan prepared, in whole or in 
part, on its behalf. This flexibility is consistent with the NACMCF 
HACCP guidelines (Ref. 34), which advise that a HACCP team may need 
assistance from outside experts who are knowledgeable in the hazards 
associated with the product and the process. This flexibility also is 
consistent with the Codex HACCP Annex, which acknowledges that small 
and/or less developed businesses do not always have the resources and 
the necessary expertise on site for the development and implementation 
of an effective HACCP plan and recommends that expert advice be 
obtained when necessary from other sources, such as trade and industry 
associations, independent experts and regulatory authorities. In 
addition, proposed Sec.  117.126 would provide flexibility for 
facilities in the development of their food safety plans by allowing 
facilities to group food types or production method types if the 
hazards, control measures, parameters, and required procedures such as 
monitoring are essentially identical.
    Proposed Sec.  117.126(a) would require that the owner, operator, 
or agent in charge of a facility implement the written food safety 
plan. Although section 418(h) of the FD&C Act is silent with respect to 
implementation of the required written plan, other provisions of 
section 418 address implementation. For example, section 418(c) of the 
FD&C Act requires, in relevant part, that the owner, operator, or agent 
in charge of a facility both establish and implement preventive 
controls (emphasis added). In addition, other provisions of section 418 
(e.g., section 418(d) regarding monitoring, section 418(e) regarding 
corrective actions, and section 418(f) regarding verification) all 
establish requirements related to the preventive controls required 
under section 418(c). As discussed immediately below, the written food 
safety plan would include the hazard analysis required under section 
418(b) of the FD&C Act, the preventive controls required under section 
418(c) of the FD&C Act, the monitoring procedures required under 
section 418(d) of the FD&C Act, the corrective action procedures 
required under section 418(e) of the FD&C Act, the verification 
procedures required under section 418(f) of the FD&C Act, and the 
recall plan as authorized by section 418(o)(3)(E) of the FD&C Act. 
Specific provisions for implementing these sections of the statute 
would be established throughout proposed subpart C.
3. Proposed Sec.  117.126(b)--Contents of a Food Safety Plan
    Proposed Sec.  117.126(b)(1) through (6) would require that the 
contents of a food safety plan include:
     The written hazard analysis as required by proposed Sec.  
117.130(a)(2);
     The written preventive controls as required by proposed 
Sec.  117.135(b);
     The written procedures, and the frequency with which they 
are to be performed, for monitoring the implementation of the 
preventive controls as required by proposed Sec.  117.140(a);
     The written corrective action procedures as required by 
proposed Sec.  117.145(a)(1);
     The written verification procedures as required by 
proposed Sec.  117.150(e); and
     The written recall plan as required by Sec.  117.137(a).
    Section 418(h) requires that the written plan document and describe 
the

[[Page 3731]]

procedures used by the facility to comply with the requirements of 
section 418, ``including analyzing the hazards under [section 418(b) of 
the FD&C Act] and identifying the preventive controls adopted under 
[section 418(c) of the FD&C Act] to address those hazards'' (emphasis 
added). Although section 418(h) of the FD&C Act explicitly references 
sections 418(b) and (c), the term ``including,'' indicates that the 
contents of a food safety plan need not be limited to the provisions of 
sections 418(b) and (c) of the FD&C Act.
    FDA interprets the requirement in section 418(h) of the FD&C Act 
that the written plan document and describe the procedures used by the 
facility to comply with the requirements of section 418 of the FD&C Act 
to mean that the written food safety plan would include all procedures 
required under section 418 of the FD&C Act. As discussed in sections 
XII.E.6.a, XII.F.2, XII.G.6, and XII.D.2 of this document, the proposed 
rule would require written procedures for monitoring the implementation 
of the preventive controls (proposed Sec.  117.140(a)); written 
corrective action procedures (proposed Sec.  117.145(a)(1)); written 
procedures for some verification activities (proposed Sec.  
117.150(e)); and a written recall plan (proposed Sec.  117.137(a)).
    FDA interprets the requirement in section 418(h) that the written 
plan describe the procedures used by the facility to comply with the 
requirements of section 418, including analyzing the hazards and 
identifying the preventive controls adopted to address those hazards, 
to mean that the contents of the food safety plan must include the 
hazard analysis conducted by the facility and the preventive controls 
that a facility must establish for hazards that its hazard analysis 
identifies as reasonably likely to occur, rather than procedures for 
analyzing the hazards and procedures for identifying the preventive 
controls. The general requirement in section 418(a) of the act is 
directed, in relevant part, to evaluating the hazards that could affect 
food manufactured, processed, packed, or held by a facility, and 
identifying and implementing preventive controls to significantly 
minimize or 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. Review of 
the evaluation of hazards in the hazard analysis is sufficient to 
determine the adequacy of the hazard analysis. Written procedures for 
conducting the hazard analysis are not necessary. Similarly, the 
preventive controls identified by the facility can be reviewed fully 
for adequacy without having a separate procedures document.
    Under our interpretation of section 418(h) of the FD&C Act, 
proposed Sec.  117.126(b)(1) and (2) are consistent with the NACMCF 
HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations 
for seafood, juice, and meat and poultry. The NACMCF HACCP guidelines 
recommend that a HACCP plan include the hazards of concern (which are 
the end product of the hazard analysis), the CCPs (which are the steps 
at which control can be applied and which are essential to prevent or 
eliminate a food safety hazard or reduce it to an acceptable level), 
and critical limits (which are the maximum or minimum values 
established at a CCP to control a hazard) (Ref. 34). The Codex HACCP 
Annex (Ref. 35) recommends that the HACCP plan include documentation of 
the hazard analysis and determinations of CCPs and critical limits. 
Federal HACCP regulations for seafood, juice, and meat and poultry all 
require that the HACCP plan list the food [safety] hazards that are 
reasonably likely to occur (Sec. Sec.  123.6(c)(1) and 120.8(b)(1) and 
9 CFR 417.2(c)(1), respectively), the CCPs (Sec. Sec.  123.6(c)(2) and 
120.8(b)(2) and 9 CFR 417.2(c)(2), respectively), and critical limits 
(Sec. Sec.  123.6(c)(3) and 120.8(b)(3) and 9 CFR 417.2(c)(3), 
respectively). The FSIS HACCP regulation for meat and poultry further 
requires that the written hazard analysis be maintained as part of the 
documentation for the establishment's HACCP plan (9 CFR 417.5(a)(1)). 
None of these documents recommends or requires that the HACCP plan 
include the procedures for analyzing the hazards or procedures for 
identifying the CCPs and critical limits. Rather, these documents are 
clear that it is the outcomes rather than the procedures for conducting 
the hazard analysis and identifying the preventive controls that are 
part of the plan.
4. Proposed Sec.  117.126(c)--Preparation of the Food Safety Plan by a 
Qualified Individual
    Proposed Sec.  117.126(c) would require that the food safety plan 
be prepared by (or its preparation overseen by) a qualified individual. 
(See the discussion in section XII.H of this document regarding the 
qualifications of a qualified individual as would be established in 
proposed Sec.  117.155(b)). Section 418 of the FD&C Act requires that 
firms identify and implement preventive controls and that facilities 
monitor and verify the effectiveness of the preventive controls. A 
qualified individual must develop the food safety plan in order to 
ensure the preventive controls are effective. The plan must be designed 
to identify and to significantly minimize or prevent hazards in order 
to prevent illness or injury. Designing a plan requires an individual 
who is knowledgeable in the concepts of preventive controls, the 
hazards associated with a product and process, the appropriate 
preventive controls, with associated monitoring and corrective actions 
for those hazards, and appropriate verification activities for the 
applicable preventive controls. Such knowledge requires scientific and 
technical expertise developed through training, experience, or both.
    Section 418 of the FD&C Act does not address the qualifications of 
the individual who would prepare the food safety plan. However, 
proposed Sec.  117.126(c) is consistent with the NACMCF HACCP 
guidelines, the Codex HACCP Annex, and Federal regulations for seafood, 
juice, and meat and poultry. The NACMCF HACCP guidelines recommend 
that, because of the technical nature required for the hazard analysis, 
experts who are knowledgeable in the food process either participate in 
or verify the hazard analysis and the HACCP plan (Ref. 34). Our HACCP 
regulations for seafood and juice require that the individual 
developing the HACCP plan complete training in the application of HACCP 
principles to juice or seafood processing under a standardized 
curriculum or be qualified through job experience that provides 
knowledge at least equivalent to that provided through the standardized 
curriculum (Sec. Sec.  123.10 and 120.13, respectively). The FSIS HACCP 
regulation for meat and poultry requires that the individual developing 
the HACCP plan complete training in the application of HACCP principles 
to meat or poultry product processing (9 CFR 417.7).
    One way to comply with proposed Sec.  117.126(c) could be for a 
team of individuals (for example, a ``HACCP team'' or a ``food safety 
team'') to develop the food safety plan under the oversight of a 
qualified individual. Each member of a HACCP or food safety team 
generally brings specific expertise important in developing the plan. 
For example, a microbiologist could provide knowledge of microbial 
hazards, an engineer could establish the critical parameters for 
delivery of heat treatments, and a maintenance supervisor could 
identify sources of metal contamination. Proposed Sec.  117.126 would 
not require that all such members of a food safety team satisfy the 
requirements in proposed

[[Page 3732]]

Sec.  117.126(c) for a qualified individual. However, under proposed 
Sec.  117.126(c), a qualified individual must be responsible for 
ensuring that all components the food safety plan have been developed, 
including reviewing all information contained in the food safety plan, 
thereby verifying the hazard analysis and food safety plan developed by 
the food safety team.
5. Facility-Based Nature of the Written Food Safety Plan
    The overall framework of section 418 of the FD&C Act is directed to 
a facility rather than, for example, a corporate entity that may have 
multiple facilities. For example, under section 418(b) of the FD&C Act 
the owner, operator, or agent in charge of a facility must identify and 
evaluate known or reasonably foreseeable hazards that may be associated 
with the facility (emphasis added). Thus, proposed Sec.  117.126 
establishes a requirement for every facility to have its own written 
food safety plan. The facility-based nature of the written food safety 
plan that would be required by proposed Sec.  117.126 is consistent 
with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal 
HACCP regulations for seafood, juice, and meat and poultry. The NACMCF 
HACCP guidelines emphasize that it is essential that the unique 
conditions within each facility be considered during the development of 
all components of the HACCP plan (Ref. 34). The Codex HACCP Annex 
states that HACCP should be applied to each specific operation 
separately (Ref. 35). Federal HACCP regulations for seafood, juice, and 
meat and poultry require that HACCP plans be specific to each location 
where the product is processed (Sec. Sec.  123.6(b)(1) and 120.8(a)(1) 
for seafood and juice, respectively) or to ``every official 
establishment'' (9 CFR 417.2(a)) for meat and poultry).
    Federal HACCP regulations for seafood, juice, and meat and poultry 
allow the HACCP plan to group food types or production method types if 
the hazards, critical control points, critical limits and required 
procedures such as monitoring are essentially identical, provided that 
any required features of the plan that are unique to a specific product 
or production method are clearly delineated in the plan and are 
observed in practice (Sec. Sec.  123.6(b)(2) and 120.8(a)(2) and 9 CFR 
417.2(b)(2) for seafood, juice, and meat and poultry, respectively). 
This type of grouping would be allowed under proposed Sec.  117.126 
and, thus, would provide flexibility for facilities in the development 
of their HACCP plans.

B. Proposed Sec.  117.130--Hazard Analysis

1. Requirements of Section 418 of the FD&C Act
    Section 418(b)(1) of the FD&C Act specifies, in relevant part, that 
the owner, operator, or agent in charge of a facility shall identify 
and evaluate known or reasonably foreseeable hazards that may be 
associated with the facility, including (A) biological, chemical, 
physical, and radiological hazards, natural toxins, pesticides, drug 
residues, decomposition, parasites, allergens, and unapproved food and 
color additives; and (B) hazards that occur naturally, or may be 
unintentionally introduced. Section 418(b)(3) of the FD&C Act 
specifies, in relevant part, that the owner, operator, or agent in 
charge of a facility shall develop a written analysis of the hazards.
    As discussed in section II.B.2.f of this document, this rulemaking 
is not intended to address ``hazards that may be intentionally 
introduced, including by acts of terrorism.'' Therefore, we are not 
implementing section 418(b)(2) of the FD&C Act in this proposed rule.
    Section 418(c)(1) of the FD&C Act specifies that the owner, 
operator, or agent in charge of a facility shall identify and implement 
preventive controls, including at critical control points, if any, to 
provide assurances that hazards identified in the hazard analysis 
conducted under section 418(b)(1) of the FD&C Act will be significantly 
minimized or prevented. Section 418(c)(3) of the FD&C Act specifies 
that the food manufactured, processed, packed, or held by such facility 
will not be adulterated under section 402 of the FD&C Act or misbranded 
under section 403(w) of the FD&C Act.
    Sections 418(c)(1) and (c)(3) of the FD&C Act, which we will 
address more fully in section XII.C.1 of this document, are relevant to 
our discussion of proposed Sec.  117.130(a) regarding the purpose of 
the hazard analysis required by section 418(b) of the FD&C Act.
2. Proposed Sec.  117.130(a)--Hazard Analysis
    a. Proposed Sec.  117.130(a)(1)--Requirement to identify and 
evaluate hazards. Proposed Sec.  117.130(a)(1) would require that the 
owner, operator, or agent in charge of a facility identify and evaluate 
known or reasonably foreseeable hazards, for each type of food 
manufactured, processed, packed, or held at the facility to determine 
whether there are hazards that are reasonably likely to occur. As 
discussed more fully in the remainder of this section, proposed Sec.  
117.130(a)(1) would implement section 418(b)(1) of the FD&C Act.
    Proposed Sec.  117.130(a)(1) is consistent with the NACMCF HACCP 
guidelines, the Codex HACCP Annex, and Federal HACCP regulations for 
seafood, juice, and meat and poultry. The NACMCF HACCP guidelines 
describe a two-stage process for conducting a hazard analysis (Ref. 
34), i.e., hazard identification and hazard evaluation. Hazard 
identification has been described as a brainstorming session designed 
to facilitate the development of a list of potential hazards, including 
those known to be associated with a type of food or process and those 
known to have occurred in a particular facility, for consideration 
during the hazard evaluation step (Ref. 143). Hazard evaluation is 
conducted after development of the list of potential hazards associated 
with each step in the product's process. The Codex HACCP Annex 
recommends that the HACCP team list all of the hazards that may be 
reasonably expected to occur at each step from primary production, 
processing, manufacture, and distribution until the point of 
consumption and then conduct a hazard analysis to identify which 
hazards are of such a nature that their elimination or reduction to 
acceptable levels is essential to the production of a safe food (Ref. 
35). Our HACCP regulation for juice requires that a hazard analysis 
both identify hazards and evaluate whether they are reasonably likely 
to occur (Sec.  120.7(a)(1) and (2)). Federal HACCP regulations for 
seafood and meat and poultry require that a processor or establishment 
conduct, or have conducted for it, a hazard analysis to determine 
whether there are food safety hazards that are reasonably likely to 
occur (Sec.  123.6(a) and 9 CFR 417.2(a)).
    In considering the proposed requirement for a hazard analysis, we 
considered the language of section 418(b)(1) of the FD&C Act describing 
the hazards that a facility would identify and evaluate--i.e., ``known 
or reasonably foreseeable hazards that may be associated with the 
facility.'' We consider that the ``known or reasonably foreseeable 
hazards'' in section 418(b) of the FD&C Act are analogous to the 
``potential hazards'' discussed in the NACMCF HACCP guidelines, and the 
hazards that are required to be identified to determine if they are 
``hazards that may be reasonably expected to occur at each step'' in 
the Codex HACCP Annex, or ``reasonably likely to occur'' in Federal 
HACCP regulations for seafood, juice, and meat and poultry.

[[Page 3733]]

    Proposed Sec.  117.130(a)(1) would establish the requirement to 
identify and evaluate hazards by conducting a hazard analysis; we 
propose specific requirements for the hazard identification in proposed 
Sec.  117.130(b) (see section XII.B.3 of this document) and specific 
requirements for the hazard evaluation in proposed Sec.  117.130(c) 
(see section XII.B.4 of this document).
    Proposed Sec.  117.130(a)(1) would require that the identification 
and evaluation of hazards be done ``for each type of food manufactured, 
processed, packed, or held at the facility.'' In considering the 
proposed requirement for a hazard analysis, we considered the language 
of section 418(b)(1) of the FD&C Act. The purpose of sections 418(b)(1) 
appears clear--i.e., 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 food produced by the facility. The 
known or reasonably foreseeable hazards associated with the facility's 
food may differ based on the type of food and, thus, the NACMCF HACCP 
guidelines, the Codex HACCP Annex, and Federal HACCP regulations for 
seafood, juice, and meat and poultry all apply a hazard analysis to 
each type of food manufactured, processed, packed, or held at the 
facility. Proposed Sec.  117.130(a) would do likewise.
    The NACMCF HACCP guidelines (Ref. 34) and Codex HACCP Annex (Ref. 
35) describe several preliminary tasks that need to be accomplished 
before application of the HACCP principles to a specific product and 
process, including describing the food and its distribution, describing 
the intended use and consumers of the food, and developing a flow 
diagram for the process. Our HACCP regulations for seafood and juice 
require that the hazard analysis be conducted for each kind of fish or 
fishery product (or for each type of juice product) processed by the 
processor (Sec. Sec.  123.6(a) and 120.7(a)) but do not mandate any 
particular process for the hazard analysis. The FSIS HACCP regulation 
for meat and poultry requires that a flow chart be prepared describing 
the steps for each process and product flow in the establishment (9 CFR 
417.2(a)(2)) and also requires a HACCP plan for each product produced 
by the establishment whenever the hazard analysis reveals one or more 
hazards that are reasonably likely to occur (9 CFR 417.2(b)(1)).
    The process of identifying and evaluating the hazards that may 
occur for specific types of food handled in a facility provides an 
efficient means for keeping track of multiple hazards that may occur in 
a facility that handles several types of foods. Such a process also 
provides an efficient means for ensuring that preventive controls are 
applied to specific foods when required. Thus, a facility may need to 
conduct multiple hazard analyses. For example, a facility that produces 
tea-based beverages may package its products in both glass and plastic 
bottles at the same facility. Although these two products might contain 
similar ingredients, we would consider them to be different types of 
food under proposed Sec.  117.130(a)(1) because the two types of 
packaging entail significant differences in the handling of these 
products during processing. The hazard of glass particles resulting 
from glass container breakage during plant operations is a known hazard 
associated with glass-packaged products and, thus, should be identified 
and evaluated for the product packaged in glass but not for the product 
packaged in plastic.
    Proposed Sec.  117.130(a)(1) would identify the purpose of the 
hazard analysis--i.e., to determine whether there are hazards that are 
reasonably likely to occur. Although section 418(b)(1) of the FD&C Act 
does not explicitly identify the purpose of the hazard analysis, we 
interpret the combined requirements of sections 418(b), (c)(1) and 
(c)(3) of the FD&C Act to reflect a purpose, i.e., to enable the 
facility to identify and, where necessary, implement preventive 
controls to provide assurances that hazards identified in the hazard 
analysis will be significantly minimized or prevented and that the food 
manufactured, processed, packed or held by the facility will not be 
adulterated under section 402 of the FD&C Act or misbranded under 
section 403(w) of the FD&C Act. If, for example, the facility concludes 
during the hazard analysis that one or more (or even all) known or 
reasonably foreseeable hazards are not reasonably likely to occur in 
the facility for a certain type of food, the facility could conclude 
that there is no need to identify and implement preventive controls for 
those hazards. The purpose of the hazard analysis identified in 
proposed Sec.  117.130(a)(1) is consistent with the purpose identified 
in the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal 
HACCP regulations for seafood, juice, and meat and poultry. The NACMCF 
HACCP guidelines identify the purpose of the hazard analysis as the 
development of a list of hazards that are of such significance that 
they are reasonably likely to cause illness or injury if not 
effectively controlled (Ref. 34). The Codex HACCP Annex recommends that 
the HACCP team identify for the HACCP plan hazards that are of such a 
nature that their elimination or reduction to acceptable levels is 
essential to the production of a safe food (Ref. 35). The stated 
purpose of the hazard analysis in Federal HACCP regulations for 
seafood, juice and meat and poultry is, in relevant part, to determine 
whether there are food safety hazards that are reasonably likely to 
occur for each kind of product (Sec. Sec.  123.6(a) and 120.7(a), 
respectively, for seafood and juice) or in the production process for 
meat and poultry (9 CFR 417.2(a)).
    b. Proposed Sec.  117.130(a)(2)--Requirement for the hazard 
analysis to be written. Proposed Sec.  117.130(a)(2) would require that 
the hazard analysis be written, as required by section 418(b)(3) of the 
FD&C Act. A written hazard analysis can help the facility organize the 
scientific basis for the hazard analysis and would be essential to the 
facility's food safety team, to auditors, and to inspectors. The 
facility's food safety team needs to fully understand the nature of the 
hazards in order to produce a safe food. For example, although the 
facility's food safety plan would include corrective action procedures 
that address problems that can be anticipated, the food safety team 
will need to make decisions as to appropriate corrective actions when 
there is an unanticipated problem (see, e.g., the discussion of a 
proposed requirement (proposed Sec.  117.145(b)) for corrective actions 
when there is an unanticipated problem in section XII.F.3 of this 
document). The written hazard analysis would be useful at these times. 
Having a written hazard analysis available for auditors and for 
inspectors is essential for them to assess the adequacy of the hazard 
analysis. A written hazard analysis also would be essential during 
reanalysis and updates of the hazard analysis, as would be required by 
proposed Sec.  117.150(f) so that the person doing the reanalysis or 
update has a baseline from which to start. A written hazard analysis 
also would be useful for training purposes as a tool to make employees 
aware of food safety hazards that are reasonably likely to occur.
    The written hazard analysis includes the justification for whatever 
conclusion the owner, operator, or agent in charge of a facility 
reaches, including a conclusion that no hazards are reasonably likely 
to occur. Thus, proposed Sec.  117.130(a)(2) would not limit the 
requirement for a written hazard analysis to those circumstances where 
the owner, operator, or agent in charge of a facility identifies one or 
more hazards that are reasonably likely

[[Page 3734]]

to occur. Under proposed Sec.  117.130(a)(2), a written hazard analysis 
would be required even if the conclusion of the analysis is that there 
are no hazards reasonably likely to occur.
    Proposed Sec.  117.130(a)(2) is consistent with the NACMCF HACCP 
guidelines, the Codex HACCP Annex, and Federal HACCP regulations for 
juice, seafood, and meat and poultry. The NACMCF HACCP guidelines and 
the Codex HACCP Annex each specify that the hazard analysis be 
documented in the HACCP plan (Ref. 34) (Ref. 35). Our HACCP regulation 
for juice requires a written hazard analysis (Sec.  120.7(a)). Our 
HACCP regulation for seafood requires that the list of food safety 
hazards that are reasonably likely to occur, identified in the hazard 
analysis, be included in the written HACCP plan (Sec.  123.6(c)). The 
FSIS HACCP regulation for meat and poultry requires a written hazard 
analysis, including all supporting documentation (9 CFR 417.5(a)(1)).
3. Proposed Sec.  117.130(b)--Hazard Identification
    Proposed Sec.  117.130(b) would require that the hazard analysis 
consider hazards that may occur naturally or may be unintentionally 
introduced, including:
     Biological hazards, including microbiological hazards such 
as parasites, environmental pathogens, and other microorganisms of 
public health significance (proposed Sec.  117.130(b)(1));
     Chemical hazards, including substances such as pesticide 
and drug residues, natural toxins, decomposition, unapproved food or 
color additives, and food allergens (proposed Sec.  117.130(b)(2));
     Physical hazards (proposed Sec.  117.130(b)(3)); and
     Radiological hazards (proposed Sec.  117.130(b)(4)).
    Proposed Sec.  117.130(b) would implement section 418(b)(1) of the 
FD&C Act and would establish four groups of hazards (i.e., biological, 
chemical, physical, and radiological). Three of the proposed groups of 
hazards (i.e., biological, chemical, and physical) are the same as the 
groups of hazards in the NACMCF HACCP guidelines, the Codex HACCP 
Annex, and Federal HACCP regulations for juice, seafood, and meat and 
poultry; the proposed group ``radiological hazards'' would be in 
addition to the groups of hazards in those HACCP systems. The 
additional group of ``radiological hazards'' is required by section 
418(b)(1)(A) of the FD&C Act. The NACMCF HACCP guidelines and Codex 
HACCP Annex identify biological, chemical, and physical hazards as 
types of hazards in the definition of hazard (Ref. 34) (Ref. 35). 
Federal HACCP regulations for seafood, juice and meat and poultry 
identify biological, chemical, and physical hazards as types of hazards 
in the definition of ``food safety hazard'' (Sec.  123.3(f) and 9 CFR 
Sec.  417.1 for seafood and meat and poultry, respectively) or food 
hazard (Sec.  120.3(g) for juice). Federal HACCP regulations for 
seafood, juice, and meat and poultry identify as hazards 
microbiological contamination, parasites, chemical contamination, 
unlawful pesticide residues, decomposition, natural toxins, unapproved 
use of food or color additives and physical hazards (Sec. Sec.  
123.6(c)(1), 120.7(c), and 9 CFR 417.2(a)(3), respectively). Federal 
HACCP regulations for seafood and meat and poultry also identify as 
hazards drug residues (Sec.  123.6(c)(1)(v) and 9 CFR 417.2(a)(3)(v) 
for seafood and meat and poultry, respectively) and undeclared 
ingredients that may be allergens (Sec.  120.7(c)(8) for juice). The 
FSIS HACCP regulation for meat and poultry also identifies zoonotic 
diseases as a hazard (9 CFR 417.2(a)(3)).
Microbiological Hazards
    Proposed Sec.  117.130(b)(1) would include microbiological hazards 
within the category of biological hazards. Examples of microbiological 
hazards include:
     Parasites (which are required to be considered by section 
418(b)(1)(A) of the FD&C Act). A parasite is an organism that lives on 
or in an organism of another species (often called the host organism) 
and feeds off that other species. Cryptosporidium spp., Giardia 
intestinalis, and Toxoplasma gondii are examples of parasites.
     Environmental pathogens (e.g., Listeria monocytogenes and 
Salmonella spp.); and
     Other microorganisms of public health significance, 
including bacteria (e.g., Campylobacter spp., Clostridium perfringens, 
Shiga toxin-producing Escherichia coli (STEC) O157, STEC non-O157, 
Shigella spp., Staphylococcus aureus, Vibrio spp., and Yersinia 
enterocolitica) and viruses (e.g., hepatitis A virus and norovirus).
    As discussed in section II.D.1 of this document, CDC has estimated 
that the total burden of foodborne illness is 48 million cases, 128,000 
hospitalizations, and 3,000 deaths due to illnesses from both major 
pathogens and from unspecified agents (Ref. 45) (Ref. 46). Focusing 
only on the foodborne illnesses attributable to particular pathogens, a 
recent report estimated that 31 major pathogens (for which data for 
preparing national estimates are available, including those listed 
above) cause 9.4 million episodes of foodborne illness, 55,961 
hospitalizations and 1351 deaths in the United States each year (Ref. 
45). In addition to contaminating raw materials, some of these 
pathogens (e.g., Listeria monocytogenes and Salmonella spp.) are common 
pathogens of concern with respect to contamination from the processing 
environment for specific types of facilities (Ref. 144) (Ref. 145). 
(See sections I.D and I.E of the Appendix to this document for a 
discussion of testing programs for environmental pathogens). 
Contamination of food with some pathogens (e.g., Staphylococcus aureus 
and norovius) is often due to poor employee hygiene or practices.
Chemical Hazards
    Proposed Sec.  117.130(b)(2) would include substances such as 
pesticide and drug residues, natural toxins, decomposition, unapproved 
food or color additives, and food allergens (all of which are required 
to be considered by section 418(b)(1)(A) of the FD&C Act) within the 
category of chemical hazards. As discussed in section II.D.2.b of this 
document, pesticide residues may be present in food in the absence of 
or in excess of a tolerance established by EPA. Residues of drugs 
(e.g., antibiotics administered to dairy cows) may be present in food 
derived from the animal (such as milk) in the absence of or in excess 
of a tolerance or safe levels established and enforced by FDA (Ref. 
146). Natural toxins such as aflatoxin and patulin are well recognized 
as hazards in foods such as peanuts and apple juice products, 
respectively (Ref. 82) (Ref. 85). Decomposition products such as 
histamine, produced from the amino acid histidine when certain bacteria 
grow, can pose a risk to health. An undeclared food allergen (such as a 
peanut) can cause a life-threatening reaction (such as anaphylactic 
shock) in susceptible individuals (Ref. 147). Heavy metals (such as 
lead) can lead to impaired cognitive development in children (Ref. 88).
Physical Hazards
    Proposed Sec.  117.130(b)(3) would require that the hazard analysis 
consider physical hazards, which are required to be considered by 
section 418(b)(1)(A) of the FD&C Act. Examples of physical hazards 
include stones, glass, or metal fragments that could inadvertently be 
introduced into food. Physical hazards may be associated with raw 
materials, especially RACs. The facility and equipment can also be a 
source of

[[Page 3735]]

physical hazards, e.g., container glass and metal fragments such as 
nuts and bolts.
Radiological Hazards
    Proposed Sec.  117.130(b)(4) would require that the hazard analysis 
consider radiological hazards. As discussed in section II.D.2.e of this 
document, examples of radiological hazards include radionuclides such 
as radium-226, radium-228, uranium-235, uranium-238, strontium-90, 
iodine-131, and cesium-137. The NACMCF HACCP guidelines, the Codex 
HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat 
and poultry do not identify radiological hazards as a type of hazard to 
be considered in the hazard analysis. However, section 418(b)(1)(A) of 
the FD&C Act requires that radiological hazards be considered, and food 
may be subject to contamination with radiological hazards--e.g., if 
water used to manufacture a food contains a radionuclide. For 
additional information on how radiological hazards may contaminate 
food, see section III.D.2.e of this document and references discussed 
therein (Ref. 107) (Ref. 108) (Ref. 109).
4. Proposed Sec.  117.130(c)--Hazard Evaluation
    a. Proposed Sec.  117.130(c)(1)--Evaluation of whether a hazard is 
reasonably likely to occur, including an assessment of the severity of 
the illness or injury if the hazard were to occur. Proposed Sec.  
117.130(c)(1) would require that the hazard analysis include an 
evaluation of the hazards identified in Sec.  117.130(b) to determine 
whether the hazards are reasonably likely to occur, including an 
assessment of the severity of the illness or injury if the hazard were 
to occur. As discussed in more detail later in this section, proposed 
Sec.  117.130(c)(1) would implement sections 418(b)(1) and (c)(3) of 
the FD&C Act. Proposed Sec.  117.130(c)(1) is consistent with the 
NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP 
regulations for seafood, juice, and meat and poultry. The NACMCF HACCP 
guidelines define severity as the seriousness of the effects of a 
hazard. The severity of the illness or injury includes the magnitude 
and duration of the illness and impact of any sequelae (chronic 
conditions resulting from an illness, such as reactive arthritis 
following a Salmonella infection). The NACMCF HACCP guidelines also 
recommend considering the likelihood of an illness or injury (usually 
based upon a combination of experience, epidemiological data, and 
information in the technical literature) and the potential effects 
associated with both short-term and long-term exposure (Ref. 34). 
Likewise, the Codex HACCP Annex recommends that the hazard analysis 
consider the severity of the adverse health effects associated with the 
hazards (Ref. 35). Our juice HACCP regulation requires that the hazard 
evaluation include an assessment of the severity of the illness or 
injury if the hazard occurs (Sec.  120.7(a)(2)). The requirement for a 
hazard analysis in our seafood HACCP regulation does not specifically 
require an assessment of severity but addresses the potential for 
illness or injury in its definition of a food safety hazard, which 
refers to biological, chemical or physical properties that may cause a 
food to be unsafe for human consumption (Sec.  123.3(f)) and in the 
description of a food safety hazard that is reasonably likely to occur, 
which includes illness data as a basis for establishing controls (Sec.  
123.6(a)). Similarly, the FSIS HACCP regulation for meat and poultry 
does not specifically require an assessment of severity in the hazard 
analysis (9 CFR 417.2(a)), but its definition of a food safety hazard 
refers to biological, chemical or physical properties that may cause a 
food to be unsafe for human consumption (9 CFR 417.1(c)). In the final 
rule to establish our juice HACCP regulation, we agreed with the NACMCF 
approach to conducting the hazard analysis--i.e., that the process of 
evaluating food hazards to determine which potential hazards need to be 
addressed in the HACCP plan (i.e., those that are reasonably likely to 
occur) takes into account both the consequences of exposure (i.e., 
severity) and the probability of occurrence (i.e., frequency) of the 
health impact of the potential hazards in question (66 FR 6138 at 
6155).
    As discussed in section II.D.2.a of this document, contamination of 
food with biological hazards often leads to immediate or near-term 
onset of illness or injury (e.g., gastrointestinal illness). Exposure 
to some biological hazards may have long-term consequences as well 
(e.g., infections with Salmonella spp. may result in reactive 
arthritis). The effects of exposure to some biological hazards are 
severe (e.g., Hemolytic Uremic Syndrome (HUS) in individuals exposed to 
E. coli O157:H7 (63 FR 20450 at 20450) or invasive listeriosis in 
susceptible individuals exposed to L. monocytogenes in ready-to-eat 
foods (Ref. 55). Proposed Sec.  117.130(c)(1) would require that such 
biological hazards be considered to determine whether they are 
reasonably likely to occur even if the biological hazard occurs 
infrequently.
    As discussed in sections II.D.2.b and II.D.2.c of this document, 
contamination of food with chemical hazards may lead to immediate or 
near-term onset of illness--e.g., an allergic reaction to an undeclared 
peanut or to a residue in a milk product of penicillin used to treat 
the cow. In other instances the focus of the evaluation for chemical 
hazards is directed to their long term effects, such as impaired 
cognitive development in children exposed to lead in contaminated candy 
(Ref. 88) and liver cancer as the result of chronic exposure to the 
mycotoxin aflatoxin (Ref. 89) (Ref. 90). Proposed Sec.  117.130(c)(1) 
would require that such chemical hazards be considered to determine 
whether they are reasonably likely to occur even if the chemical hazard 
occurs infrequently.
    We discuss the regulatory framework under the FD&C Act (including 
premarket approval or registration by FDA or EPA) of food additives, 
color additives, new animal drugs, and pesticides in section II.D.2.b 
of this document. An additive, drug, or pesticide that has been 
approved for use in some foods, but not other foods, is deemed by the 
FD&C Act to be unsafe for use with those other foods. Proposed Sec.  
117.130(c)(1) would require that chemical hazards such as unapproved 
food additives, unapproved color additives, new animal drugs, and 
pesticides be considered to determine whether they are reasonably 
likely to occur.
    We provide information about natural toxins (such as aflatoxin and 
patulin), decomposition products (such as histamine and other biogenic 
amines), and heavy metals (such as lead) in section II.D.2.b of this 
document and references contained therein (Ref. 82) (Ref. 83) (Ref. 84) 
(Ref. 85) (Ref. 86) (Ref. 87) (Ref. 88) (Ref. 90). Proposed Sec.  
117.130(c)(1) would require that such chemical hazards be considered to 
determine whether they are reasonably likely to occur even if the 
chemical hazard occurs infrequently.
    Physical hazards such as hard and sharp foreign objects that may be 
present in food can pose a health risk (Ref. 148). Hard or sharp 
foreign objects in food may cause traumatic injury, including 
laceration and perforation of tissues of the mouth, tongue, throat, 
stomach and intestine as well as damage to the teeth and gums (Ref. 
148) (Ref. 149). Thus, even if physical hazards occur infrequently, 
under proposed Sec.  117.130(c)(1) the potential for severe 
consequences would require consideration of these physical hazards to 
determine whether they are

[[Page 3736]]

reasonably likely to occur. Factors relevant to an evaluation of the 
severity of a physical hazard include the potential size of the object, 
the nature of the food (e.g., RTE or required to undergo further 
processing), and whether intended consumers of the food include special 
risk groups (Ref. 148).
    Contamination of food with radiological hazards generally is 
evaluated for long-term effects such as the potential for cancer (Ref. 
150). A significant radiation dose could be received as a result of 
consumption of food contaminated as a result of an accident at a 
nuclear power plant or other types of accidents (Ref. 150; see also (63 
FR 43402, August 13, 1998)). Foods may contain unsafe levels of 
radionuclides (Ref. 151). Thus, although radiological hazards occur 
infrequently, under proposed Sec.  117.130(c)(1) the potential for 
severe consequences would require consideration of radiological hazards 
to determine whether they are reasonably likely to occur for a 
particular food or facility, especially when circumstances arise that 
could lead to contamination of food with radiological hazards.
    The purpose of sections 418(b)(1) and 418(c)(3) of the FD&C Act 
seems clear--i.e., that the owner, operator, or agent in charge of a 
facility identify and evaluate known or reasonably foreseeable hazards 
for the purpose of identifying and implementing preventive controls to 
provide assurances that identified hazards will be significantly 
minimized or prevented and that the food manufactured, processed, 
packed or held by the facility will not be adulterated under section 
402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act. 
The process of evaluating food hazards to determine which potential 
hazards require preventive controls must take into account the 
consequences of exposure (i.e., severity) as well as the probability of 
occurrence (i.e., frequency) to provide assurances that the food 
manufactured, processed, packed or held by the facility will not be 
adulterated under section 402 of the FD&C Act or misbranded under 
section 403(w) of the FD&C Act. Proposed Sec.  117.130(c)(1) would 
implement this statutory direction.
    b. Proposed Sec.  117.130(c)(2)--Requirement to evaluate 
environmental pathogens. Proposed Sec.  117.130(c)(2) would require 
that the hazard analysis include an evaluation of whether environmental 
pathogens are reasonably likely to occur whenever an RTE food is 
exposed to the environment prior to packaging. As noted in section 
II.D.2.a of this document, environmental pathogens can be a source of 
contamination of food. Examples of environmental pathogens that have 
contaminated foods (and, in particular, RTE foods) include Salmonella 
spp. and L. monocytogenes. Proposed Sec.  117.130(b)(1) would include 
environmental pathogens as one of the biological hazards that must be 
considered in identifying hazards for evaluation. Under proposed Sec.  
117.130(c)(2), a facility that produces an RTE food that is exposed to 
the environment would be required to identify environmental pathogens 
as a known or reasonably foreseeable hazard under proposed Sec.  
117.130(b) and evaluate whether contamination of RTE food with the 
environmental pathogen is reasonably likely to occur in the facility.
    c. Proposed Sec.  117.130(c)(3)--Consideration of specific factors 
relevant to the hazard evaluation. Proposed Sec.  117.130(c)(3) would 
require that, in conducting the hazard evaluation, consideration be 
given to the effect of several specific factors on the safety of the 
finished food for the intended consumer. We tentatively conclude that 
these are factors that a prudent person who manufactures, processes, 
packs, or holds foods would consider when evaluating identified hazards 
to determine whether they are reasonably likely to occur. As we 
indicated in proposing our HACCP regulation for juice, a prudent 
processor should consider factors such as these in doing a hazard 
analysis (63 FR 20450 at 20468).
    Proposed Sec.  117.130(c)(3)(i) would require that the hazard 
evaluation consider the formulation of the food. The addition of 
certain ingredients such as acids and preservatives may be critical to 
the safety of the food, since they may inhibit growth of, or even kill, 
microorganisms of public health significance. This could impact the 
evaluation at steps during production and storage with respect to the 
hazard of ``pathogen growth.'' A multi-component food may have 
individual ingredients that do not support growth of undesirable 
microorganisms (e.g., because of pH or aw), but when put 
together there may be an interface where the pH and aw 
changes (e.g., pies, layered breads). Under proposed Sec.  
117.130(c)(3)(i), the interaction of the individual ingredients must be 
evaluated as part of the formulation of the food. Proposed Sec.  
117.130(c)(3)(i) also would require that the hazard evaluation consider 
whether or not the formulation contains an ingredient (such as a 
flavoring, coloring, or incidental additive) that may contain an 
allergen.
    Proposed Sec.  117.130(c)(3)(ii) would require that the hazard 
evaluation consider the condition, function, and design of the facility 
and equipment. The condition, function, or design of a facility or its 
equipment could potentially result in the introduction of hazards into 
foods. For example, older equipment (e.g., older slicing, rolling and 
conveying equipment) may be more difficult to clean (e.g., with close 
fitting components or hollow parts) and, thus, provide more 
opportunities for pathogens to become established in a niche 
environment than modern equipment designed to address the problem of 
pathogen harborage in niche environments. Proposed Sec.  
117.130(c)(3)(ii) would require that facilities with such equipment 
consider the impact of the equipment on the potential for pathogens to 
be a hazard that is reasonably likely to occur; if so, a preventive 
control such as enhanced sanitation controls may be appropriate, 
particularly if the equipment is used in production of RTE food. 
Equipment designed such that there is metal-to-metal contact may 
generate metal fragments. Proposed Sec.  117.130(c)(3)(ii) would 
require that facilities with such equipment consider the impact of the 
equipment on the potential for generation of such metal fragments to be 
a hazard that is reasonably likely to occur; if so, a preventive 
control such as metal detectors may be appropriate. A facility that 
manufactures, processes, or packs soft, fresh cheese (such as queso 
fresco, which is consumed without cooking to adequately reduce 
pathogens) may have cold, moist conditions that are conducive to the 
development of a niche where the pathogen L. monocytogenes can become 
established and contaminate food-contact surfaces and, eventually, 
foods. Proposed Sec.  117.130(c)(3)(ii) would require that facilities 
with such conditions consider the impact of the conditions on the 
potential for whether development of a niche where the pathogen L. 
monocytogenes can become established is a hazard that is reasonably 
likely to occur; if so, enhanced sanitation controls may be 
appropriate. A facility design that has closely spaced equipment would 
provide more opportunities for cross-contact (such as from allergens in 
powdered milk or soy) from one line to another (e.g., through dust) 
than a facility that has more spacing between equipment. Proposed Sec.  
117.130(c)(3)(ii) would require that facilities with such closely 
spaced equipment consider the impact of the close spacing on the 
potential for cross-contact to be a hazard

[[Page 3737]]

that is reasonably likely to occur; if so, targeted food allergen 
controls may be appropriate.
    Proposed Sec.  117.130(c)(3)(iii) would require that the hazard 
evaluation consider raw materials and ingredients. Current Sec.  110.3 
defines ``food'' to mean food as defined in section 201(f) of the FD&C 
Act and includes raw materials and ingredients, and that definition 
would be retained (with no proposed revisions) in this proposed rule. 
As discussed in section IX.E of this document, there is an overlap 
between raw materials and ingredients; not all raw materials are 
ingredients. A food can become contaminated through the use of 
contaminated food ingredients. For example, in the past several years 
thousands of foods have been recalled as a result of contamination of 
food ingredients with pathogens such as Salmonella spp. and E. coli 
O157:H7. The ingredients included peanut-derived ingredients (Ref. 19) 
(Ref. 20), pistachio-derived ingredients (Ref. 152), hydrolyzed 
vegetable protein (Ref. 23) (Ref. 24) (Ref. 153)), instant nonfat dried 
milk, whey protein, and fruit stabilizers (Ref. 21) (Ref. 22), and 
bagged spinach (Ref. 154). In some cases, the contamination was 
discovered only after the ingredient was associated with an outbreak of 
foodborne illness (Ref. 19). In other cases, the contamination was 
discovered in a food and associated with a particular ingredient 
without any known incidence of foodborne illness (Ref. 152) (Ref. 155) 
(Ref. 22) (Ref. 154). Following some of these recalls, we issued 
guidance recommending that manufacturers of foods containing a 
particular type of ingredient either obtain the ingredients from 
suppliers with validated processes in place to adequately reduce the 
presence of the applicable pathogen, or ensure that their own 
manufacturing process would adequately reduce the presence of that 
pathogen (Ref. 6) (Ref. 156). Specific pathogens would be considered to 
be a hazard that is reasonably likely to occur for raw materials and 
ingredients that have been documented to be contaminated with such 
pathogens, as well as for ingredients with similar characteristics 
(because such contamination might be expected in ingredients that are 
produced in a similar manner).
    A food also may become contaminated through the use of contaminated 
raw materials that are not food ingredients. In the example of the 
manufacture of the food additive sucrose fatty acid esters (see 
discussion in section IX.E of this document), Sec.  172.859 establishes 
specifications for sucrose fatty acid esters, such as specifications 
that arsenic is not more than 3 parts per million, total heavy metal 
content (as lead) is not more than 50 parts per million, and lead is 
not more than 10 parts per million (Sec.  172.859(b)(6), (7), and (8)). 
The use of raw materials that are contaminated with arsenic, lead, or 
other heavy metals that would not be removed as part of the 
manufacturing process for sucrose fatty acid esters could lead to 
sucrose fatty acid esters that are contaminated with arsenic, lead, or 
other heavy metals such that they do not satisfy the specifications of 
the regulation.
    As noted for formulation in the discussion of proposed Sec.  
117.130(c)(3)(i), ingredients must be evaluated for ``hidden'' 
allergens such as may be present in flavorings, colorings, or 
incidental additives. Production and harvesting practices may impact 
whether raw materials and ingredients contain hazards. For example, 
machinery-harvested produce is more likely to be contaminated with 
physical hazards than hand-picked produce, because the machinery often 
picks up foreign material from the field.
    Proposed Sec.  117.130(c)(3)(iv) would require that the hazard 
evaluation consider transportation practices. A food may become unsafe 
as a result of poor transportation practices for incoming raw materials 
and ingredients or for outgoing finished product. For example, failure 
to adequately control temperature during transportation could make a 
food unsafe if the product requires time and temperature controls to 
ensure safety. Distributing a food in bulk without adequate protective 
packaging makes the product susceptible to contamination during 
transportation--e.g., from pathogens or chemicals present in an 
inadequately cleaned vehicle or from other inadequately protected foods 
that are being co-transported and are potential sources of 
contamination (Ref. 157). (For additional examples of food safety 
problems that could occur during transportation, see 75 FR 22713, April 
30, 2010).
    The Sanitary Food Transportation Act of 2005 (SFTA) gives FDA 
authority to require shippers, carriers by motor vehicle or rail 
vehicle, receivers, and other persons engaged in the transportation of 
food to use sanitary transportation practices to ensure that food is 
not transported under conditions that may render the food adulterated. 
In 2010, we published an Advance Notice of Proposed Rulemaking to 
request data and information on the food transportation industry and 
its practices and we expect to issue a separate proposed rule to 
implement the SFTA (75 FR 22713, April 30, 2010). We do not expect a 
future rulemaking implementing the SFTA to eliminate the need for the 
owner, operator, or agent in charge of a facility to consider 
transportation practices when determining whether a hazard is 
reasonably likely to occur.
    Proposed Sec.  117.130(c)(3)(v) would require that the hazard 
evaluation consider manufacturing/processing procedures. For example, 
hazards may arise from manufacturing/processing processes such as 
cooling or holding of certain foods due to the potential for 
germination of pathogenic sporeforming bacteria such as Clostridium 
perfringens and Bacillus cereus (which may be present in food 
ingredients) as a cooked product is cooled and reaches a temperature 
that will allow germination of the spores and outgrowth. Hazards also 
may arise from manufacturing/processing processes such as acidification 
due to the potential for germination of spores of C. botulinum, with 
subsequent production of botulinum toxin, if the acidification is not 
done correctly. Toxins can be produced by the bacteria Staphylococcus 
aureus or Bacillus cereus in a product that has been heated and held at 
room temperature during the manufacturing process if the product 
formulation supports growth and toxin formation by the bacteria and S. 
aureus or B. cereus is present in the ingredients of the product or is 
introduced by poor employee hygiene (e.g., S. aureus). Physical hazards 
may occur from metal fragments generated during the manufacture of food 
on equipment in which metal (e.g., wires, saw blades or knives) is used 
to cut products during manufacturing.
    Proposed Sec.  117.130(c)(3)(vi) would require that the hazard 
evaluation consider packaging activities and labeling activities. For 
example, as discussed earlier in this section XII.4.c the hazards that 
are reasonably likely to occur would be different depending on whether 
a product is packaged in glass bottles or in plastic bottles. A label 
on a food may direct consumers to cook a product to a certain 
temperature; the likelihood of consumers following those cooking 
instructions may vary depending on the type of food. For example, it is 
well known that consumers will eat raw cookie dough, even though the 
cookie dough is clearly intended to be cooked, and an outbreak of 
foodborne illness has been associated with the consumption of uncooked 
cookie dough (Ref. 77) (Ref. 76) (Ref. 78). Thus, although label 
information is a factor to consider, a hazard may be reasonably likely 
to occur even with

[[Page 3738]]

label information such as cooking instructions.
    Proposed Sec.  117.130(c)(3)(vii) would require that the hazard 
evaluation consider storage and distribution. For example, biological 
hazards are more likely to be a hazard that is reasonably likely to 
occur during storage and distribution in foods that require 
refrigerated storage to maintain safety than in shelf-stable foods. 
Shelf-stable foods are designed such that biological hazards are 
controlled.
    Proposed Sec.  117.130(c)(3)(viii) would require that the hazard 
evaluation consider intended or reasonably foreseeable use. An example 
of intended or reasonably foreseeable use is whether the food would be 
cooked by the consumer. In some cases, the intended use of a product 
may include uses where it would be cooked by the consumer, as well uses 
where it would not be cooked. For example, soup is generally cooked, 
but a dried soup mix is often used in RTE form as a component of a dip. 
For another example, see the discussion of consumption of raw cookie 
dough earlier in this section. When it is known or reasonably 
foreseeable that a food would be consumed in RTE form, hazards such as 
Salmonella spp., L. monocytogenes, and E. coli O157:H7 would need to be 
considered to determine if they are hazards reasonably likely to occur.
    Proposed Sec.  117.130(c)(3)(ix) would require that the hazard 
evaluation consider sanitation, including employee hygiene. Sanitation 
measures and practices can impact the likelihood of a hazard being 
introduced into a food. For example, the frequency with which a 
production line is shut down for a complete cleaning can impact the 
potential for food residues to transfer pathogens from equipment to 
foods (e.g., pathogens present on raw produce that could carry over 
into the next production cycle on a line). Practices directed at worker 
health and hygiene can reduce the potential for transfer of pathogens 
such as Salmonella spp., hepatitis A and norovirus.
    Proposed Sec.  117.130(c)(3)(x) would require that the hazard 
evaluation consider any other relevant factors that might potentially 
affect the safety of the finished food for the intended consumer. For 
example, an unexpected natural disaster could flood some or all of a 
facility, creating insanitary conditions and potentially contaminating 
the facility with harmful microorganisms or chemical residues. 
Following a natural disaster, environmental contaminants that could be 
brought into the facility could be a hazard reasonably likely to occur. 
As another example, when local water authorities advise the public to 
boil tap water for drinking, a facility should consider whether 
bacterial, viral or parasitic (e.g., Cryptosporidium and Giardia) 
contamination presents a hazard reasonably likely to occur as a result 
of the events that triggered the advisory (Ref. 158).
    Proposed Sec.  117.130(c)(3) is consistent with the NACMCF HACCP 
guidelines, the Hazards and Controls Guides we have issued regarding 
our HACCP regulations for juice and seafood, and the Hazards and 
Controls Guide FSIS has issued regarding the FSIS HACCP regulation for 
meat and poultry. The NACMCF HACCP guidelines note that hazards 
identified in one operation or facility may not be significant in 
another operation producing the same or a similar product--e.g., due to 
differences in equipment and/or maintenance programs (Ref. 34). 
Appendix C of the NACMCF HACCP guidelines provides examples of 
questions to be considered when conducting a hazard analysis and 
identifies factors to consider such as ingredients, formulation, 
processing procedures, design of facility, design and use of equipment, 
packaging, sanitation, worker health and hygiene, storage, intended 
use, and intended consumer. Our Hazards and Controls Guide for juice 
provides recommendations related to factors such as shelf life of the 
product, location of the processing, and type of processing, e.g., 
thermal or non-thermal processing (Ref. 4). Our Hazards and Controls 
Guide for seafood provides recommendations related to factors such as 
storage conditions (time and temperature), the role of manufacturing 
conditions in minimizing the potential for formation of C. botulinum 
toxin, manufacturing procedures (cooking and pasteurization) to control 
pathogenic bacteria, manufacturing procedures (such as high hydrostatic 
pressure processing, individual quick freezing with extended frozen 
storage, mild heat processing, and irradiation) designed to retain raw 
product characteristics, and the introduction of pathogenic bacteria 
after pasteurization and specialized cooking processes. The FSIS 
Hazards and Controls Guide for meat and poultry provides 
recommendations related to factors such as receiving, thawing, 
formulation, manufacturing procedures, packaging, storage and shipping 
(Ref. 159).

C. Proposed Sec.  117.135--Preventive Controls for Hazards That Are 
Reasonably Likely To Occur

1. Requirements of Section 418 of the FD&C Act
    Section 418(c)(1) of the FD&C Act, in relevant part, specifies that 
the owner, operator, or agent in charge of a facility shall identify 
and implement preventive controls, including at critical control 
points, if any, to provide assurances that hazards identified in the 
hazard analysis conducted under section 418(b)(1) of the FD&C Act will 
be significantly minimized or prevented. Section 418(c)(1)(3) of the 
FD&C Act), in relevant part, specifies that the food manufactured, 
processed, packed, or held by such facility will not be adulterated 
under section 402 of the FD&C Act or misbranded under section 403(w) of 
the FD&C Act.
    As discussed in section X.B.4 of this document, section 418(o)(3) 
of the FD&C Act defines preventive controls and proposed Sec.  117.3 
would include the statutory definition in proposed part 117. Under 
section 418(o)(3), the procedures, practices, and processes described 
in the definition of preventive controls may include the following:
     Sanitation procedures for food-contact surfaces and 
utensils and food-contact surfaces of equipment (section 418(o)(3)(A) 
of the FD&C Act);
     Supervisor, manager, and employee hygiene training 
(section 418(o)(3)(B) of the FD&C Act);
     An environmental monitoring program to verify the 
effectiveness of pathogen controls in processes where a food is exposed 
to a potential contaminant in the environment (section 418(o)(3)(C) of 
the FD&C Act);
     A food allergen control program (section 418(o)(3)(D) of 
the FD&C Act);
     A recall plan (section 418(o)(3)(E) of the FD&C Act);
     CGMPs under part 110 or any successor regulations (section 
418(o)(3)(F) of the FD&C Act); and
     Supplier verification activities that relate to the safety 
of food (section 418(o)(3)(G) of the FD&C Act).
    2. Proposed Sec.  117.135(a)--Requirement To Identify and Implement 
Preventive Controls for Hazards that Are Reasonably Likely To Occur
    Proposed Sec.  117.135(a) would require that the owner, operator, 
or agent in charge of a facility identify and implement preventive 
controls, including at CCPs, if any, to provide assurances that hazards 
identified in the hazard analysis as reasonably likely to occur will be 
significantly minimized or prevented and the food manufactured, 
processed, packed or held by such

[[Page 3739]]

facility will not be adulterated under section 402 of the FD&C Act or 
misbranded under section 403(w) of the FD&C Act.
    As discussed in section XII.B.2.a of this document, proposed Sec.  
117.130(a) would require that the owner, operator, or agent in charge 
of a facility conduct a hazard analysis to identify and evaluate known 
or reasonably foreseeable hazards for each type of food manufactured, 
processed, packed, or held at the facility to determine whether there 
are hazards that are ``reasonably likely to occur.'' Under proposed 
Sec.  117.135(a), a facility that determines through its hazard 
analysis that there are hazards that are reasonably likely to occur 
would then be required to identify and implement preventive controls 
for those hazards. Preventive controls would be required when 
applicable hazards are identified as reasonably likely to occur. As 
discussed in sections XII.B.2 through XII.C.10 of this document, the 
types of preventive controls implemented would depend on the facility 
and the food it produces. Most hazards would be addressed through 
process controls, food allergen controls, and sanitation controls. For 
any type of preventive control, a facility would have the flexibility 
to identify and implement preventive controls from among all 
procedures, practices, and processes available to it that would provide 
the assurances that would be required by proposed Sec.  117.135(a).
    Proposed Sec.  117.135(a) would implement section 418(c) of the 
FD&C Act and is consistent with the NACMCF HACCP guidelines, the Codex 
HACCP Annex, and Federal HACCP regulations for juice, seafood, and meat 
and poultry, although there are some differences between HACCP systems 
and the preventive control system established by section 418 of the 
FD&C Act. The NACMCF HACCP guidelines (Ref. 34), the Codex HACCP Annex 
(Ref. 35), and Federal HACCP regulations for seafood, juice, and meat 
and poultry (Sec. Sec.  123.6 and Sec.  120.7 and 9 CFR 417.2, 
respectively) direct a processor to address potential hazards that are 
reasonably likely to cause illness or injury in the absence of their 
control by determining CCPs and establishing critical limits for those 
CCPs. As discussed in section II.C.2 of this document, although 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. Under proposed Sec.  117.135(a), a processor could 
address hazards that are reasonably likely to occur through preventive 
controls that would be applied at CCPs, but doing so would not be the 
only option available to the facility in all circumstances. In some 
cases adequate assurances could be achieved via preventive controls 
implemented through other procedures and practices of a facility, such 
as its food allergen control program, which may not have specific CCPs. 
(For discussion of the food allergen control program that would be 
required by proposed Sec.  117.135(d)(2), see section XII.C.6 of this 
document.)
    Whatever types of preventive controls a facility chooses to apply 
in its operations, the requirement in proposed Sec.  117.135(a) would 
be risk based. Establishing risk-based preventive controls involves 
consideration of the available scientific data and information related 
to food safety risks. Typically, the hazard evaluation will enable the 
facility to determine appropriate risk-based preventive controls for 
the hazard based on the severity of the hazard and the likelihood of 
its occurrence.
    For example, as discussed in section I.D.6 of the Appendix to this 
document, L. monocytogenes is an environmental pathogen that can 
establish a harborage in the environment such as on a production line 
used in wet manufacturing. Once established, L. monocytogenes can 
intermittently contaminate products on the production line. When a 
hazard analysis identifies L. monocytogenes as a hazard that is 
reasonably likely to occur in a food, the facility would establish 
sanitation controls to prevent L. monocytogenes from establishing 
itself in a harborage site. In addition to such sanitation controls, a 
facility may consider applying a listericidal process step (i.e., a 
process control applied to adequately reduce levels of L. monocytogenes 
in RTE foods). As discussed in section II.D.2.a of this document, some 
RTE foods (like soft cheese) support the growth of L. monocytogenes, 
while others (like hard cheese) do not. The FAO/WHO Listeria risk 
assessment demonstrated that the risk of serious illness from 
consumption of RTE products contaminated with L. monocytogenes 
increases with the number of L. monocytogenes in an RTE food (Ref. 
160). Thus, as a risk-based approach to the control of the biological 
hazard L. monocytogenes, the facility may elect to apply a listericidal 
process step to those RTE foods that support growth of L. monocytogenes 
in addition to its sanitation controls, but not apply such a process to 
those RTE foods that do not support growth of L. monocytogenes.
3. Proposed Sec.  117.135(b)--Requirement for Written Preventive 
Controls
    Proposed Sec.  117.135(b) would require that preventive controls 
for hazards identified in the hazard analysis as reasonably likely to 
occur be written. Proposed Sec.  117.135(b) would implement section 
418(h) of the FD&C Act which, as discussed in section XII.A.2 of this 
document, requires that the owner, operator, or agent in charge of a 
facility prepare a written food safety plan that, among other things, 
identifies the preventive controls within the plan. Written preventive 
controls are essential for the facility to implement the preventive 
controls consistently and essential for the facility's food safety 
team, auditors, and inspectors. Written preventive controls also would 
be essential for training purposes and during reanalysis and updates of 
the preventive controls. Proposed Sec.  117.135(b) is consistent with 
our HACCP regulation for juice, which requires that the written hazard 
analysis identify control measures that the processor can apply to 
control the food hazards identified as reasonably likely to occur 
(Sec.  120.7(a)).
4. Proposed Sec.  117.135(c)--Requirement for Parameters Associated 
With the Control of Hazards That Are Reasonably Likely To Occur
    Proposed Sec.  117.135(c)(1) would require that preventive controls 
for hazards identified in the hazard analysis as reasonably likely to 
occur include, as appropriate to the facility and the food, parameters 
associated with the control of the hazard, such as parameters 
associated with heat processing, acidifying, irradiating, dehydrating, 
and refrigerating foods. Proposed Sec.  117.135(c)(1) would include 
examples of several measures identified in current Sec.  110.80(b)(4) 
(Manufacturing Operations) (proposed Sec.  117.80(c)(4)) that if used 
as a preventive control must be adequate when used to prevent 
adulteration, but would not establish an exhaustive list of such 
processes, just as current Sec.  110.80(b)(4) (proposed Sec.  
117.80(c)(4)) does not establish an exhaustive list of measures that 
must be adequate. Examples of other processes that would require the 
identification of parameters if used as a preventive control are 
brining, chilling, high pressure processing, treating with ultraviolet 
light, and washing with antimicrobial agents. The parameters are those 
factors that must be controlled to ensure the hazard will be 
significantly minimized or prevented. The specific parameters required, 
and how they would be controlled, would depend on

[[Page 3740]]

the facility and the food. For example, for a heat process, parameters 
such as temperature and time must be controlled. Temperature may be 
controlled through controls on product temperature (as when treating a 
fluid product in a heat exchanger) or through controls on oven 
temperature (as when heating product in an oven). Foods such as 
beverages lend themselves to a heat exchanger; foods such as baked 
goods lend themselves to an oven. Heating time may be controlled 
automatically by a pump setting that controls flow of the fluid through 
the heat exchanger and hold tube or manually by an operator recording 
the time a product is put in the oven and the time it is removed. 
Heating time may also be controlled by the belt speed for the conveyor 
on a continuous oven. A facility would have flexibility to establish 
controls on heating time through these or other mechanisms.
    Some preventive controls may not have specific parameters 
associated with them. For example, preventive controls for metal may 
include an equipment preventive maintenance program and a metal 
detector on the packaging line. These programs may not have specific 
factors that must be controlled to prevent metal contamination. 
Sanitation procedures may include scrubbing certain pieces of equipment 
by hand; this may not require the identification of specific 
parameters. Similarly, label controls for food allergens do not involve 
identification of specific parameters.
    Proposed Sec.  117.135(c)(2) would require that preventive controls 
for hazards identified in the hazard analysis as reasonably likely to 
occur include, as appropriate to the facility and the food, the maximum 
or minimum value, or combination of values, to which any biological, 
chemical, radiological, or physical parameter must be controlled to 
significantly minimize or prevent a hazard that is reasonably likely to 
occur. Some of the preventive controls a facility may implement may be 
based upon scientific studies or other information that demonstrate the 
effectiveness of the control measure at specific values of a physical, 
biological, radiological or chemical parameter, e.g., the application 
of heat to food at a specific time/temperature combination to 
adequately reduce pathogens. Proposed Sec.  117.135(c)(2) would require 
that a facility that establishes such a preventive control specify 
values of the essential parameters to be applied in implementing the 
control. Specifying these values would enable the facility to implement 
them consistently, would facilitate validation of the preventive 
controls as would be required by proposed Sec.  117.150(a), and would 
facilitate audits and inspection.
    Proposed Sec.  117.135(c)(1) and (2) would implement section 418(c) 
of the FD&C Act and are consistent with the NACMCF HACCP guidelines, 
the Codex HACCP Annex, and Federal regulations for seafood, juice, and 
meat and poultry, although there are some differences related to the 
differences between HACCP systems and the preventive control system 
established by section 418 of the FD&C Act. The NACMCF HACCP guidelines 
and the Codex HACCP Annex (Ref. 34) (Ref. 35) each specify that the 
critical limits be documented in the HACCP plan. Federal HACCP 
regulations for seafood, juice, and meat and poultry each require that 
HACCP plan list the critical limits that must be met at each of the 
CCPs (Sec. Sec.  123.6(c)(3) and 120.8(b)(3), and 9 CFR 417.2(c)(3), 
respectively). The NACMCF HACCP guidelines define ``critical limit'' to 
mean 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. The definition of ``critical limit'' in Federal HACCP 
regulations for seafood, juice, and meat and poultry are, for practical 
purposes, identical to the definition in the NACMCF HACCP guidelines 
(Sec. Sec.  123.3(c) and 120.3(e) and 9 CFR 417.1(b), respectively). 
The Codex HACCP Annex defines ``critical limit'' to mean a criterion 
which separates acceptability from unacceptability (Ref. 35).
    FSMA does not use the term ``critical limit.'' As discussed in 
section II.C.2 of this document, although 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. Critical 
limits may not be appropriate for preventive controls that are not 
applied at CCPs. Thus, proposed Sec.  117.135(c)(1) and (2) use a 
broader term--i.e., parameter--to encompass preventive controls that 
may or may not apply at CCPs. Consistent with the NACMCF HACCP 
guidelines, the Codex HACCP Annex, and Federal HACCP regulations for 
seafood, juice, and meat and poultry, proposed Sec.  117.135(c)(2) 
would require the maximum or minimum value, or combination of values, 
to which any physical, biological, radiological, or chemical parameter 
must be controlled to significantly minimize or prevent a hazard that 
is reasonably likely to occur. This is similar to requiring critical 
limits at CCPs but would apply to values set for parameters that apply 
to preventive controls, whether these apply at a CCP or not.
5. Proposed Sec.  117.135(d)(1)--Process Controls
    Proposed Sec.  117.135(d)(1) would require that preventive controls 
for hazards identified in the hazard analysis as reasonably likely to 
occur include process controls that include those procedures, 
practices, and processes performed on a food during manufacturing/
processing that are employed to significantly minimize or prevent 
hazards that are reasonably likely to occur. Process controls do not 
include those procedures, practices, and processes that are not applied 
to the food itself, e.g., controls of personnel or the environment that 
may be used to significantly minimize or prevent hazards that are 
reasonably likely to occur but are not applied to the food itself. 
Specifying that process controls are employed during manufacturing/
processing to significantly minimize or prevent hazards that are 
reasonably likely to occur would distinguish those controls applied in 
manufacturing/processing that significantly minimize or prevent hazards 
(e.g., cooking, cooling, irradiating, refrigerating, and reducing water 
activity) from other types of controls that may be applied in 
manufacturing/processing to provide the desired product (e.g., controls 
for product size and shape). Many process controls, such as the 
application of heat to a food to adequately reduce pathogens, are 
applied in the same manner and for the same purpose as control measures 
established within HACCP plans and applied at CCPs as recommended by 
the NACMCF HACCP guidelines (Ref. 34) and the Codex HACCP Annex (Ref. 
35) and as required by Federal regulations for seafood, juice, and meat 
and poultry (Sec. Sec.  123.6(c)(3) and 120.8(b)(3)) and 9 CFR 
417.2(c)(3), respectively).
    As discussed in section XII.C.4 of this document, proposed Sec.  
117.135(c)(2) would require that preventive controls for hazards 
identified in the hazard analysis as reasonably likely to occur 
include, when applicable, the maximum or minimum value, or combination 
of values, to which any physical, biological, radiological, or chemical 
parameter must be controlled. For process controls in particular, the 
term ``parameter'' used in proposed Sec.  117.135(c)(1), and the value 
associated with the parameter in proposed Sec.  117.135(c)(2), are 
associated with the term ``critical limit'' used in HACCP systems. We 
described the use of the

[[Page 3741]]

term ``critical limit'' in other contexts in the previous section of 
this document. Collectively, proposed Sec.  117.135(b), (c) and (d)(1) 
would require that a facility include in its written process controls 
information equivalent to that provided when listing critical limits 
that must be met at each of the CCPs, such as is required in our HACCP 
regulations for seafood and juice (Sec. Sec.  123.6(c)(3) and 
120.8((b)(3), respectively). However, the process controls may or may 
not apply at CCPs.
    For example, a facility that holds in-shell pistachios in bulk 
storage units for an extended time period until they are shelled and 
packaged may identify the potential for growth of aflatoxin-producing 
molds on the nuts as a hazard reasonably likely to occur. As a process 
control to prevent such molds from growing on the nuts during storage, 
the facility may elect to dry (dehydrate) the nuts to a specific 
moisture content (e.g., no more than seven percent) prior to placing 
them in storage. The process control would be ``drying'' and the 
associated parameter would be moisture level, with its maximum value, 
or limit, being seven percent.
    As another example, a facility that manufactures refrigerated deli 
salads may identify the potential for growth of L, monocytogenes in the 
salads as a hazard reasonably likely to occur. As a process control to 
prevent such growth, the facility may elect to add an acidifying agent 
during its process to ensure that the pH of the product does not exceed 
4.4. The process control would be ``acidifying'' and the associated 
parameter would be pH, with its maximum value, or limit, being 4.4.
    A facility that manufactures a deli salad product may establish 
refrigeration as a process control to prevent growth of pathogenic 
sporeformers such as B. cereus, if it determines this organism is a 
hazard reasonably likely to occur in the deli salads being produced. (A 
facility may conclude that refrigeration is not necessary to prevent 
the growth of pathogenic sporeformers if, for example, it controls this 
potential hazard through product formulation, such as pH.) The facility 
may also establish process controls addressing the amount of time that 
in-process materials are held above 4 [deg]C (40[emsp14][deg]F) during 
manufacturing and addressing their temperatures during this time 
period. If so, the process control would be ``manufacturing time'' and 
the associated parameters would be time and temperature, with the 
maximum time that in-process materials are held above 4 [deg]C 
(40[emsp14][deg]F) being specified.
6. Proposed Sec.  117.135(d)(2)--Food Allergen Controls
    Proposed Sec.  117.135(d)(2)(i) would require that food allergen 
controls include those procedures, processes, and practices employed 
for ensuring protection of food from cross-contact, including during 
storage and use. Examples of such controls include procedures for 
separating ingredients and finished products that contain allergens 
from those that do not contain allergens, and procedures for separating 
foods that contain different allergens. Such controls are essential to 
prevent the inadvertent incorporation of an allergen into a product for 
which it is not an ingredient. Examples of such procedures for 
controlling food allergens include procedures that:
     Provide physical barriers;
     Eliminate or minimize the formation of dust, aerosols, or 
splashes;
     Conduct manufacturing/processing of foods in different 
parts of a facility;
     Emphasize separation in time, such as by production 
sequencing or by cleaning equipment between production runs;
     Emphasize storage and handling appropriate to reduce the 
potential for cross-contact; and
     Control the movement of tools and personnel that might 
carry allergens when the same production lines are used for both foods 
that contain allergens and foods that do not, or when the same 
production lines are used for foods that contain different allergens.
    Proposed Sec.  117.135(d)(2)(ii) would require that food allergen 
controls include those procedures, practices, and processes employed 
for labeling the finished food, including ensuring that the finished 
food is not misbranded under section 403(w) of the act. Such controls 
can prevent application of the wrong label to a food, use of the wrong 
packaging, and use of packaging with an incorrect allergen declaration. 
Examples of such procedures for controlling food allergens include 
procedures that:
     Ensure that the food label correctly declares all of the 
food allergens present (including those contained in flavorings, 
colorings, and incidental additives);
     Ensure that the correct food label is applied to a food;
     Ensure that the correct food is in the correct package 
(e.g., by checking that the correct packaging is used for each food); 
and
     Review formulations and compare them to the labels 
(especially when new batches of labels are received).
    Proposed Sec.  117.135(d)(2) would implement sections 418(c)(1) and 
(3) of the FD&C Act and 418(o)(3) of the FD&C Act. Proposed Sec.  
117.135(d)(2) is consistent with our HACCP regulation for juice, which 
requires processors to consider whether the presence of undeclared 
ingredients that may be allergens is a hazard that is reasonably likely 
to occur (Sec.  120.7(c)(8)). Proposed Sec.  117.135(d)(2) also is 
consistent with the recommendations in the CGMP Working Group Report 
(Ref. 1) that food processing establishments that produce foods 
containing a major food allergen be required to have a food allergen 
control plan that addresses segregation of food allergens during 
storage and handling, prevention of cross-contact during processing, 
product label review, and label usage and control.
7. Proposed Sec.  117.135(d)(3)--Sanitation Controls
    Proposed Sec.  117.135(d)(3)(i)(A) and (B) would establish two 
requirements for sanitation controls where necessary to significantly 
minimize or prevent hazards that are reasonably likely to occur 
(including any environmental pathogen that is reasonably likely to 
occur in a ready-to-eat food that is exposed to the environment prior 
to packaging, any microorganism of public health significance that is 
reasonably likely to occur in a ready-to-eat food due to employee 
handling, and any food allergen hazard). Proposed Sec.  
117.135(d)(3)(i)(A) would require that sanitation controls include 
procedures for the cleanliness of food-contact surfaces, including 
food-contact surfaces of utensils and equipment. Such hazards would 
include any environmental pathogen that is reasonably likely to occur 
in a ready-to-eat food that is exposed to the environment prior to 
packaging and any food allergen hazard. (We would generally not expect 
that microorganisms of public health significance contaminating an RTE 
food due to employee handling would be a hazard relevant to procedures 
for cleaning food-contact surfaces.) Examples of sanitation controls 
related to the cleanliness of food-contact surfaces include cleaning 
and sanitizing procedures (including appropriate frequencies for these 
procedures, concentrations of cleaning and sanitizing compounds, method 
of application, and contact time). Such controls can prevent 
contamination of food with microorganisms of public health 
significance, including environmental pathogens, that result from 
inadequate cleaning of food-contact surfaces. Such controls also can 
prevent cross-contact that results from inadequate cleaning of food-
contact

[[Page 3742]]

surfaces or surfaces that transfer material to food-contact surfaces.
    Proposed Sec.  117.135(d)(3)(i)(B) would require that sanitation 
controls include procedures for the prevention of cross-contact and 
cross-contamination from insanitary objects and from personnel to food, 
food packaging material, and other food-contact surfaces and from raw 
product to processed product. Such hazards would include any 
environmental pathogen that is reasonably likely to occur in a ready-
to-eat food that is exposed to the environment prior to packaging, any 
microorganism of public health significance that is reasonably likely 
to contaminate food if employees are handling RTE food, and any food 
allergen hazard. Examples of sanitation controls to prevent cross-
contact include procedures for ensuring that production utensils and 
maintenance tools do not transfer an allergen from one product to 
another (e.g., by proper cleaning of utensils and maintenance tools 
between uses if it is not practical to dedicate utensils and tools to 
specific processing lines); procedures for ensuring that personnel 
practices do not result in transfer of allergens from one production 
line to another (e.g., by ensuring employees do not handle food 
containing an allergen and one that does not without washing hands and 
changing outer garments); and procedures for minimizing the transfer of 
dust containing allergens (e.g., by cleaning powder spills around 
dumping stations as they occur).
    Examples of sanitation controls to prevent cross-contamination 
include procedures for ensuring that personnel do not touch insanitary 
objects (e.g., waste, trash cans, the floor, and rest room fixtures or 
surfaces) and then food, food-contact surfaces, or food packaging 
material without first washing and sanitizing their hands; procedures 
for protecting food packaging material from environmental 
contamination; procedures for protecting exposed food products from 
contamination from the environment; and procedures for controlling 
traffic (including traffic of people and traffic of equipment such as 
forklifts) between the raw and finished sides of the operation.
    To make clear that sanitation controls are required when an 
environmental pathogen is a hazard that is reasonably likely to occur 
in an RTE food that is exposed to the environment prior to packaging, 
proposed Sec.  117.135(d)(3)(i) includes this circumstance as an 
example where sanitation controls would be required. Recent outbreaks 
of foodborne illness caused by environmental pathogens (e.g., 
Salmonella spp. and L. monocytogenes), as well as the scientific 
literature, emphasize the critical need for sanitation controls to 
minimize the potential for food, particularly RTE food, to become 
contaminated with environmental pathogens. (See sections I.D and I.E of 
the Appendix to this document for a discussion of the importance of 
controlling environmental pathogens.) Any time a food is exposed to the 
environment during a manufacturing, processing, packing, or holding 
activity, there is the potential for the food to be contaminated. 
Appropriate sanitation controls can minimize the presence and transfer 
of contaminants, including environmental pathogens, to food. The need 
for sanitation controls related to food workers has long been 
recognized; however, appreciation of the importance of sanitation 
controls in preventing contamination due to environmental pathogens is 
more recent. We request comment on whether proposed Sec.  117.135(d)(3) 
should be more explicit about the two most common environmental 
pathogens (i.e., Salmonella spp. and L. monocytogenes)--e.g., by 
including these two environmental pathogens as examples.
    To make clear that sanitation controls are required when a 
microorganism of public health significance is a hazard reasonably 
likely to occur in an RTE food due to employee handling, proposed Sec.  
117.135(d)(3)(i) includes this circumstance as an example where 
sanitation controls would be required. Sanitation controls have long 
been used to prevent cross-contamination with pathogens (such as 
Staphylococcus aureus or enteric pathogens such as Salmonella spp.) 
that may be introduced by workers. People are common carriers of S. 
aureus--at any time up to 50 percent of humans will be carriers of this 
organism (e.g., in the nose and on the skin) (Ref. 161). People are 
also a source of enteric pathogens, including both symptomatic and 
asymptomatic infected workers (Ref. 162). Workers can contaminate RTE 
foods during handling, which can result in foodborne illness, in 
particular if the food is then held at temperatures that support growth 
and, in the case of S. aureus, production of enterotoxin (Ref. 161) 
(Ref. 163). Appropriate sanitation controls can minimize the transfer 
of microorganisms of public health significance from workers to food.
    To make clear that sanitation controls are required when a food 
allergen hazard is reasonably likely to occur, proposed Sec.  
117.135(d)(3)(i) includes this circumstance as an example where 
sanitation controls would be required. As discussed in section IX.D of 
this document, cross-contact can occur in a facility that manufactures, 
processes, packs or holds a food that contains a major food allergen 
and other food that does not contain that allergen. Appropriate 
sanitation controls can minimize the transfer of food allergens that 
result in cross-contact.
    Proposed Sec.  117.135(d)(3)(i)(A) and (B) would implement section 
418(c) of the FD&C Act. Proposed Sec.  117.135(d)(3)(i)(A) also is 
consistent with the recommendation of the Food CGMP Working Group that 
food processors be required to develop and maintain, at a minimum, 
written sanitation procedures for all food-contact equipment and food-
contact surfaces (Ref. 1). Under proposed Sec.  117.135(b), the 
preventive controls for sanitation required by proposed Sec.  
117.135(d)(3)(i)(A) and (B) would have to be written.
    HACCP plans, as described in the NACMCF HACCP guidelines (Ref. 34), 
the Codex HACCP Annex (Ref. 35), and Federal HACCP regulations for 
seafood, juice, and meat and poultry (Sec.  123.6, Sec.  120.7, and 9 
CFR part 417, respectively) require that control measures be 
established at CCPs to address hazards that are reasonably likely to 
occur. Because sanitation covers the entire processing environment, not 
just at CCPs, and is not limited to hazards reasonably likely to occur, 
sanitation controls have been difficult to fit into HACCP plans and are 
often addressed using prerequisite programs (e.g., SSOPs). The NACMCF 
HACCP guidelines (Ref. 34) and the Codex HACCP Annex (Ref. 35) address 
sanitation measures as prerequisite programs and are silent on their 
inclusion in HACCP plans to address identified hazards. FSIS addresses 
sanitation controls for meat and poultry products in a separate 
sanitation regulation (9 CFR part 416), which is similar to our CGMPs 
in current part 110 except that it includes SSOP requirements that, 
unlike our SSOPs, require written sanitation procedures.
    In our HACCP regulations for seafood and juice, FDA provides 
processors with an option to include sanitation controls in their HACCP 
plans (Sec. Sec.  123.6(f) and 120.8(c), respectively). Our HACCP 
regulations require monitoring for eight specified sanitary conditions 
and practices (referred to as SSOPs) regardless of whether these 
conditions and practices are related to hazards that are reasonably 
likely to occur (Sec. Sec.  123.11(b) and 120.6(a) and (b), 
respectively). The eight conditions and practices are:

[[Page 3743]]

     Safety of the water that comes into contact with food or 
food-contact surfaces or that is used in the manufacture of ice;
     Condition and cleanliness of food-contact surfaces, 
including utensils, gloves, and outer garments;
     Prevention of cross contamination from insanitary objects 
to food, food packaging material, and other food-contact surfaces, 
including utensils, gloves, and outer garments, and from raw product to 
processed product;
     Maintenance of hand washing, hand sanitizing, and toilet 
facilities;
     Protection of food, food packaging material, and food-
contact surfaces from adulteration with lubricants, fuel, pesticides, 
cleaning compounds, sanitizing agents, condensate, and other chemical, 
physical, and biological contaminants;
     Proper labeling, storage, and use of toxic compounds;
     Control of employee health conditions that could result in 
the microbiological contamination of food, food packaging materials, 
and food-contact surfaces; and
     Exclusion of pests from the food plant.
    The PMO HACCP Appendix essentially includes the same requirements 
as described in the HACCP regulation for juice (part 120) with respect 
to the eight conditions and practices. However, in the PMO HACCP 
Appendix these conditions and practices are referred to as ``required 
prerequisite programs (PPs)'' rather than SSOPs.
    The eight areas for which sanitation monitoring is required in our 
HACCP regulations for seafood and juice are those elements of 
sanitation in current part 110 that we identified as the most likely to 
have an impact on the safety of food. FDA's HACCP regulations impose 
mandatory monitoring, corrective action and recordkeeping for these 
activities to provide a framework to help ensure that the provisions of 
current part 110 that relate to the eight specific elements of 
sanitation are addressed in a systematic way, resulting in greater 
compliance with those provisions.
    The HACCP regulation for seafood recommends but does not require 
that processors develop written SSOPs for the eight areas of sanitation 
(Sec.  123.11(a)). The HACCP regulation for juice requires that an SSOP 
be developed for these areas but does not require that it be written 
(Sec.  120.6(a)). In contrast, proposed Sec.  117.135(d) would require 
written procedures for identified areas of sanitation and, in addition 
to monitoring and corrective actions as required in seafood and juice 
HACCP for the eight areas of sanitation, proposed Sec.  117.135(d) 
would require monitoring procedures and verification activities.
    In considering the application of preventive controls to the eight 
sanitation controls and practices, we considered the different 
framework for sanitation controls under this regulation (e.g., the 
additional requirements) as compared to the juice and seafood HACCP 
regulations, the traditional role of SSOPs as part of prerequisite 
programs, and the broad diversity of the food industry covered by this 
regulation. We tentatively conclude that it is necessary to require 
that the two areas included in proposed Sec.  117.135(d)(3) be 
addressed as preventive controls under subpart C and therefore be 
subject to requirements such as mandatory written procedures. Further, 
we tentatively conclude that for each of the other six areas, the 
current CGMPs are sufficient to address any hazards and further 
requirements in subpart C are not necessary. For these six areas, the 
value of mandating written procedures and other additional requirements 
(e.g., written monitoring procedures and verification) would not be 
significant because the relevant CGMP provisions in essence serve as 
the written procedures to which the facility must adhere. Some 
facilities may find value in adding more detail to the material 
contained in subpart B, but FDA has tentatively concluded that that 
would not be necessary in order to ensure that the hazards that are 
reasonably likely to occur are significantly minimized or prevented.
    For example, one of the six areas of sanitation is the safety of 
water used in food operations. In many facilities, the water is 
supplied by a municipal water authority that monitors the water and 
alerts its customers of any safety problems. Where facilities use well 
water, monitoring usually consists of an annual collection and analysis 
of the water for microbiological (and sometimes also chemical and 
radiological) safety. Another of the six areas contains provisions that 
ill workers must be excluded from operations where their presence could 
lead to contamination of food. A requirement in this regulation to 
develop written procedures for ensuring that this condition is met does 
not appear to be necessary, given the rather straightforward and 
universal nature of the controls (i.e., observe employees for signs of 
illness and redirect their activities accordingly). Similarly, 
procedures for ensuring the cleanliness of rest rooms or checking for 
the presence of pests appear to be unnecessary, given the rather 
straightforward and universal nature of the controls.
    On the other hand, equipment cleaning procedures, as would be 
required by proposed Sec.  117.135(d)(3)(i)(A) are very specific to the 
construction of the equipment, the nature of the food, the physical 
characteristics of the water used, the concentration of cleaning and 
sanitizing chemicals, the method of application, and the cleaning and 
sanitizing interval, among other things. For this reason, the 
procedures must be clearly stated to ensure that they are consistently 
followed. Often these procedures are performed by contract staff, often 
during night shifts where management is less likely to be present. In 
these circumstances, explicit cleaning procedures are essential.
    Procedures to prevent cross-contact and cross-contamination, as 
required by proposed Sec.  117.135(d)(3)(i)(B) are similarly complex 
and very situational. Identifying product and traffic flow within the 
facility, employee hand washing and sanitizing, and employee garbing 
requirements is critical to ensure that employees are trained on the 
correct procedures to ensure product safety.
    Proposed Sec.  117.135(d)(3)(ii) would require that the owner, 
operator, or agent in charge of a facility take action to correct, in a 
timely manner, conditions and practices that are not consistent with 
the procedures that would be established in proposed Sec.  
117.135(d)(3)(i)(A) or (B). Proposed Sec.  117.135(d)(3)(ii) is 
consistent with our HACCP regulations for seafood and juice, which each 
require that the processor correct, in a timely manner, those 
sanitation conditions and practices that are not met (Sec. Sec.  
123.11(b) and 120.6(b), respectively). Proposed Sec.  117.135(d)(3)(ii) 
also is consistent with 9 CFR part 416, which requires, in general, 
that each establishment take appropriate corrective action(s) when the 
establishment's SSOPs or the implementation or maintenance of the 
SSOPs, may have failed to prevent direct contamination or adulteration 
of product(s); corrective actions must include procedures to ensure 
appropriate disposition of product(s) that may be contaminated, restore 
sanitary conditions, and prevent the recurrence of direct contamination 
or adulteration of product(s), including appropriate reevaluation and 
modification of the SSOPs or appropriate improvements in the execution 
of the SSOPs (9 CFR 416.15).
    Proposed Sec.  117.135(d)(3)(iii) would provide that the owner, 
operator, or

[[Page 3744]]

agent in charge of a facility is not required to follow the corrective 
actions that would be established in proposed Sec.  117.145(a) and (b) 
when the owner, operator, or agent in charge of a facility takes 
action, in accordance with proposed Sec.  117.135(d)(3)(ii), to correct 
conditions and practices that are not consistent with the procedures in 
proposed Sec.  117.135(d)(3)(i) (A) or (B). As discussed in sections 
XII.F.2 and XII.F.3 of this document, proposed Sec.  117.145(a) would 
require that the owner, operator or agent in charge of a facility 
establish and implement written corrective action procedures that must 
be taken if preventive controls are not properly implemented, and 
outlines specific components that must be included. Proposed Sec.  
117.145(b) would require specific actions in the event of an 
unanticipated problem when a preventive control is not properly 
implemented and a specific corrective action procedure has not been 
established or a preventive control is found to be ineffective. For 
sanitation controls, proposed Sec.  117.135(d)(3)(ii) would require 
that the owner, operator or agent in charge of a facility take action 
to correct, in a timely manner, conditions and practices that are not 
consistent with the established sanitation control practices.
    There are many different ways in which conditions and practices for 
sanitation can deviate from the established procedures. In many 
instances the actions taken will be the same, regardless of the 
deviation. The corrective actions will generally involve re-
establishing sanitary conditions (e.g., re-cleaning a piece of 
equipment) and/or retraining personnel to carry out the procedures 
correctly. In many instances the procedural deviations are not 
reasonably likely to impact product (e.g., insanitary food-contact 
surfaces are usually detected by a pre-production inspection of the 
equipment by plant personnel; deviations in cleaning solution strength 
rarely result in the production of unsafe product if other cleaning and 
sanitizing procedures were properly carried out). Thus, there is rarely 
a need to evaluate the impact of the sanitation failure on food and to 
prevent food from entering commerce, as would be required by proposed 
Sec.  117.145(a)(2)(ii) and (iii). Because the corrective actions that 
will need to be taken for most sanitation controls are so general, we 
see little benefit in requiring a facility to develop written 
corrective action procedures for the many sanitation deviations that 
could occur. We do expect the facility to take action to correct 
conditions and practices as appropriate to the situation as would be 
required by proposed Sec.  117.135(d)(3)(ii). The requirement in 
proposed Sec.  117.135(d)(3)(ii) to take action to correct, in a timely 
manner, sanitation conditions and practices that are not in accordance 
with procedures is consistent with proposed Sec.  117.145(a)(2)(i), 
which would require that appropriate action be taken to identify and 
correct a problem with implementation of a preventive control to reduce 
the likelihood that the problem will recur.
    Proposed Sec.  117.135(d)(3)(iv) would require that all corrective 
actions taken in accordance with proposed Sec.  117.135(d)(3)(ii) be 
documented in records that would be subject to verification in 
accordance with proposed Sec.  117.150(c) and records review in 
accordance with proposed Sec.  117.150(d)(2)(i). The records that 
document corrective actions would be used to verify that appropriate 
decisions about corrective actions are being made and appropriate 
corrective actions are being taken.
8. Proposed Sec.  117.135(d)(4)--Recall Plan
    Proposed Sec.  117.135(d)(4) would require that preventive controls 
include, as appropriate, a recall plan as would be required by proposed 
Sec.  117.137. Proposed Sec.  117.135(d)(4) would incorporate the 
statutory definition of ``preventive controls'' from section 
418(o)(3)(E) of the FD&C Act, which establishes that preventive 
controls may include a recall plan. We include the details of the 
recall plan in proposed Sec.  117.137 and discuss it in section XII.D 
of this document.
9. Proposed Sec.  117.135(d)(5)--Other Controls
    Proposed Sec.  117.135(d)(5) would require that preventive controls 
for hazards identified in the hazard analysis as reasonably likely to 
occur include any other controls necessary to satisfy the requirements 
of proposed Sec.  117.135(a)--i.e., to significantly minimize or 
prevent hazards identified in the hazard analysis and to provide 
assurance that the food manufactured, processed, packed or held by such 
facility will not be adulterated under section 402 of the FD&C Act or 
misbranded under section 403(w) of the FD&C Act. For example, if a 
facility produces a refrigerated product that could support the growth 
of pathogens if proper temperature is not maintained during 
transportation, the facility must consider the need to implement 
preventive controls to minimize or prevent the potential for pathogen 
growth due to failure to control the temperature of the product during 
transportation. Most instances of failing to control temperature result 
primarily in quality issues such as product degradation or shortened 
shelf life, rendering the product unpalatable and thus precluding 
consumption. However, it is not common that products reach high enough 
temperatures for sufficient time to become hazardous due to growth of 
pathogens that may be present. For products that present a risk that 
pathogens would grow and present a health hazard, preventive controls 
could include temperature monitoring during transportation or other 
procedures that would ensure that product was not exposed to 
temperature/time intervals during transportation that would result in 
increased product temperatures for sufficient time to result in a 
potential safety issue. Often such procedures involve the shipper 
ensuring that product temperature is controlled during loading of the 
transportation vehicle, use of temperature recording devices that 
record the temperature of the transportation compartment during 
transportation, and the receiver verifying the temperature of product 
during transit as displayed by the temperature device.
    FDA notes that some of the controls listed in section 418(o) of the 
FD&C Act are not explicitly identified in proposed Sec.  117.135. In 
section XII.J of this document, we request comment on an environmental 
monitoring program (which section 418(o)(3)(C) of the FD&C Act 
indicates is one of the procedures, practices, and processes that 
preventive controls may include, and which section 418(f)(4) of the 
FD&C Act identifies as a verification activity). In section XII.J of 
this document, we also request comment on a supplier approval and 
verification program as one of the procedures, practices, and processes 
that preventive controls may include (section 418(o)(3)(G)). In section 
XI.M, of this document, we request comment on supervisor, manager, and 
employee hygiene training. We discuss CGMPs in section XI of this 
document. Further, as discussed in section XII.C.7 of this document, 
training and CGMP controls are traditionally considered to be part of 
prerequisite programs, essential to effective preventive controls but 
often not part of them. FDA expects that compliance with those 
requirements in proposed part 117, subpart B will be sufficient. 
However, a facility may determine that in some circumstances it would 
be appropriate to include certain Current Good Manufacturing Practice 
provisions among their preventive

[[Page 3745]]

controls (i.e., as ``other controls'' in proposed Sec.  117.135(d)(6)).
10. Proposed Sec.  117.135(e)--Applicability of Monitoring, Corrective 
Actions, and Verification
    Proposed Sec.  117.135(e)(1)(i) through (iii) would specify that, 
except as provided by proposed Sec.  117.135(e)(2), the preventive 
controls required under this section would be subject to monitoring as 
would be required by proposed Sec.  117.140; corrective actions as 
would be required by proposed Sec.  117.145; and verification as would 
be required by proposed Sec.  117.150. Proposed Sec.  117.135(e)(1)(i) 
through (iii) would restate the requirements of proposed Sec. Sec.  
117.140, 117.145, and 117.150 to clearly communicate the applicability 
of proposed Sec. Sec.  117.140, 117.145, and 117.150 to the preventive 
controls that would be required under proposed Sec.  117.135 and would 
establish no new requirements.
    Proposed Sec.  117.135(e)(2) would provide that the recall plan 
that would be established in proposed Sec.  117.137 would not be 
subject to the requirements of proposed Sec.  117.135(e)(1). A recall 
plan would address food that had left the facility, whereas the 
proposed requirements for monitoring, corrective actions, and 
verification would all be directed at food while it remains at the 
facility. Thus, as proposed, the requirements for monitoring, 
corrective actions, and verification have limited applicability to a 
recall plan. However, a ``mock recall'' (i.e., a simulated recall 
situation) is a verification activity that could identify problems with 
a recall plan, enable a facility to correct the problems, and provide 
reasonable assurance that the recall plan would be effective in 
removing products from commerce. FDA requests comments on whether to 
include a requirement for a mock recall as verification activity in the 
final rule.

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

1. Requirements of Section 418 of the FD&C Act
    Section 418(c) of the FD&C Act specifies that the owner, operator, 
or agent in charge of a facility shall identify and implement 
preventive controls, including at critical control points, if any, to 
provide assurances that:
     Hazards identified in the hazard analysis conducted under 
section 418(b)(1) of the FD&C Act will be significantly minimized or 
prevented (section 418(c)(1) of the FD&C Act); and
     The food manufactured, processed, packed, or held by such 
facility will not be adulterated under section 402 of the FD&C Act or 
misbranded under section 403(w) of the FD&C Act (section 418(c)(3) of 
the FD&C Act).
    Under section 418(o)(3)(D), the procedures, practices, and 
processes described in the definition of preventive controls may 
include, in relevant part, a recall plan.
2. Proposed Sec.  117.137--Recall Plan for Food With a Hazard That is 
Reasonably Likely To Occur
    Proposed Sec.  117.137(a) would require that the owner, operator, 
or agent in charge of a facility establish a written recall plan for 
food in which there is a hazard that is reasonably likely to occur. 
Although a recall is different from other preventive controls in that 
it is carried out after a product is distributed, it shares the purpose 
of significantly minimizing or preventing hazards, which is 
accomplished by limiting consumption of the affected food. Time is 
critical during a recall. A written recall plan is essential to 
minimizing the time needed to accomplish a recall; additional time 
during which the food is on the market can result in additional 
consumer exposure. Following an existing plan that addresses all 
necessary elements of a recall helps minimize delay created by 
uncertainty as to the appropriate actions to take and helps ensure 
critical actions are not overlooked.
    Proposed Sec.  117.137(a) would implement sections 418(c)(1) and 
(3) of the FD&C Act and 418(o)(3)(E) of the FD&C Act and is consistent 
with the NACMCF HACCP guidelines and the Codex GPFH. The NACMCF HACCP 
guidelines recommend that a recall system be in place (Ref. 34). The 
GPFH recommends that managers ensure effective procedures are in place 
to enable the complete, rapid recall of any implicated lot of the 
finished food from the market (Ref. 44). Our HACCP regulations for 
seafood and juice do not include any requirements for a recall plan; 
recommendations for addressing a recall for food can be found in our 
general guidance on policy, procedures, and industry responsibilities 
regarding recalls in subpart C of part 7 (Sec. Sec.  7.40 through 
7.59). The guidance advises firms to prepare and maintain a current 
written contingency plan for use in initiating and effecting a recall 
(Sec.  7.59). Likewise, the FSIS HACCP regulation for meat and poultry 
does not require a recall plan; FSIS addresses recalls through guidance 
to industry.
    Proposed Sec.  117.137(b) would require that the recall plan 
include procedures that describe the steps to be taken, and assign 
responsibility for taking those steps, to perform the following 
actions:
     Directly notify the direct consignees of the product being 
recalled and how to return or dispose of the affected food (proposed 
Sec.  117.137(b)(1));
     Notify the public about any hazard presented by the food 
when appropriate to protect public health (proposed Sec.  
117.137(b)(2));
     Conduct effectiveness checks to verify that the recall is 
carried out (proposed Sec.  117.137(b)(3)); and
     Appropriately dispose of recalled food--e.g., through 
reprocessing, reworking, diverting to a use that does not present a 
safety concern, or destroying the food (proposed Sec.  117.137(b)(4)).
    Procedures that describe the steps to be taken would enable a 
facility to act promptly by following its plan when the facility 
determines that a recall is warranted rather than developing a plan of 
action after the need for a recall is identified. Procedures that 
assign responsibility for taking those steps would save the time needed 
to make such determinations during a recall and enable the owner, 
operator, or agent in charge of a facility to clearly communicate such 
responsibilities to applicable managers or staff so that such managers 
or staff can take action as soon as the decision to conduct a recall is 
made.
    Directly notifying direct consignees about the recall (proposed 
Sec.  117.137(b)(1)) is the most effective mechanism to ensure direct 
consignees know that the product is being recalled and is consistent 
with our general guidance on recall communications in Sec.  7.49(a). 
Further, instructing direct consignees how to return or dispose of an 
affected product minimizes the chance the affected product will be 
disposed of improperly and allows direct consignees to act quickly. 
Further, it is consistent with our guidance on the content of recall 
communications in Sec.  7.49(c)(4). We have provided guidance to 
industry on model recall letters (Ref. 164) (Ref. 165). This guidance 
may be useful in developing procedures for directly notifying direct 
consignees about the recall and on how to return or dispose of an 
affected product.
    Notification procedures could identify a variety of communication 
means, including email, telephone, fax, text messaging, and urgent mail 
delivery. Notification procedures that would establish only a general 
notification to the public (e.g., through a press release or through 
information posted on a facility's Web site), without procedures

[[Page 3746]]

for concurrent contact directly with direct consignees about how to 
access the general notification, would not satisfy proposed Sec.  
117.137(b)(1); a general notification to the public would rely on the 
chance that the direct consignees would see the information and may not 
be effective.
    Notifying the public about any hazard presented by the food when 
appropriate to protect public health is a common practice (e.g., see 
FDA's Web site that provides information gathered from press releases 
and other public notices about recalls of food (Ref. 166)). Notifying 
the public in such circumstances is consistent with our guidance on a 
recall strategy that the purpose of a public warning is to alert the 
public that a product being recalled presents a hazard to health (Sec.  
7.42(b)). Notifying the public, in addition to direct consignees, may 
not be necessary to protect the public if, for example, the food being 
recalled was all distributed to food service operations (who were 
notified as a direct consignee) and not distributed for retail sale. 
Procedures in the recall plan for notifying the public could include 
model press releases and procedures for disseminating information to 
the public though press releases or other means, such as by information 
posted on the facility's Web site or provided to consumers using social 
media. We have provided guidance to industry with examples of model 
press releases for the presence in food of undeclared food allergens 
and several foodborne pathogens, including Salmonella spp. and L. 
monocytogenes (Ref. 164) (Ref. 165) (Ref. 167) (Ref. 168) (Ref. 169).
    An effectiveness check is a procedure designed to verify that all 
notified consignees have received notification about the recall and 
have taken appropriate action; procedures to conduct effectiveness 
checks would be consistent with our guidance on a recall strategy in 
Sec.  7.42(c)(3). Procedures to conduct an effectiveness check could 
expand on the procedures used to directly contact consignees about the 
recall--e.g., to include forms for consignees to provide information 
about the amount of recalled product on hand, to include information on 
follow up contacts via phone or email, or to include personal visits to 
consignees by sales representatives. We have provided guidance to 
industry on conducting effectiveness checks (Ref. 164); this guidance 
includes a model effectiveness check letter (Ref. 170), a model 
effectiveness check response form that could be sent to a consignee 
(Ref. 171), and a model questionnaire to be used during effectiveness 
checks conducted by telephone or by personal visit (Ref. 172).
    A facility that receives recalled product from their customers must 
appropriately dispose of the product--e.g., through reprocessing, 
reworking, diverting to a use that does not present a safety concern, 
or destroying the product. These types of disposition actions are 
similar to the disposition actions that a facility would consider as a 
corrective action as a result of a problem that is discovered before 
the product leaves the facility (see, e.g., the discussion of 
corrective actions in the final rule to establish our HACCP regulation 
for seafood; 60 FR 65096 at 65127). Procedures for disposition of a 
product can help the facility ensure that disposition of recalled 
product will be appropriate and will not present a risk to consumers. 
Implementation of such procedures is part of determining whether a 
recall can be considered terminated. Thus, having procedures in place 
can result in more efficient completion of a recall. Under Sec.  7.55, 
appropriate disposition of recalled product is a consideration in 
determining whether a recall is terminated.
    We request comment on whether the procedures to be included in the 
recall plan (i.e., to directly notify consignees, to notify the public, 
to conduct effectiveness checks and to appropriately dispose of 
recalled product) are appropriate for all types of facilities or if 
they should be modified for certain facilities.
    We request comment on whether we should require a recall plan to 
include procedures and assignments of responsibility for notifying FDA 
of recalls subject to the plan. Notifying FDA could enhance the 
effectiveness of a recall by allowing FDA to take appropriate steps to 
minimize the risk of illness or injury related to recalled products. As 
discussed in section II.A.6 of this document, notifying FDA of a 
reportable food is required by section 417 of the FD&C Act. Reportable 
food reports include information about whether a reportable food is 
being recalled. Thus, in some cases, reporting a recall to FDA could be 
accomplished by submitting a reportable food report required under 
section 417. In other cases, facilities could notify the local FDA 
district office of the recall.

E. Proposed Sec.  117.140--Monitoring

1. Requirements of Section 418 of the FD&C Act
    Section 418(a) of the FD&C Act specifies that the owner, operator, 
or agent in charge of a facility shall monitor the performance of the 
preventive controls. Section 418(d) of the FD&C Act specifies that the 
owner, operator, or agent in charge of a facility shall monitor the 
effectiveness of the preventive controls implemented under section 
418(c) of the FD&C Act to provide assurances that the outcomes 
described in section 418(c)] shall be achieved. The outcomes relevant 
to this proposal are those that provide assurances that hazards 
identified in the hazard analysis will be significantly minimized or 
prevented and that food manufactured, processed, packed or held by a 
facility will not be adulterated under section 402 of the FD&C Act or 
misbranded under section 403(w) of the FD&C Act.
    Section 418(g) of the FD&C Act requires, in relevant part, that the 
owner, operator, or agent in charge of a facility maintain records 
documenting the monitoring of the preventive controls implemented under 
section 418(c) of the FD&C Act.
    Section 418(h) of the FD&C Act requires, in relevant part, that the 
owner, operator, or agent in charge of a facility prepare a written 
plan that documents and describes the procedures used by the facility 
to comply with the requirements of section 418 of the FD&C Act.
2. Monitoring in HACCP Systems
    Proposed Sec.  117.3 would define ``monitor'' to mean ``to conduct 
a planned sequence of observations or measurements to assess whether a 
process, point, or procedure is under control and to produce an 
accurate record for use in verification.'' We discussed this 
definition, and how it is used in HACCP systems, including in 
guidelines developed by NACMCF and Codex, in section X.B.4 of this 
document. Examples of monitoring activities include: visual observation 
and measurement of temperature, time, pH, and moisture level (Ref. 34). 
The NACMCF HACCP guidelines identify three purposes of monitoring (Ref. 
34). First, monitoring is essential to managing food safety because it 
facilitates tracking of the operation (i.e., the ``process, point or 
procedure'' that is being controlled). This provides ongoing 
information about whether the process, point or procedure is under 
control (i.e., operating according to plan), and can provide 
information about shifts away from control. If monitoring indicates 
that there is a trend towards loss of control, a facility can take 
action to bring the process back into control before a deviation from a 
critical limit occurs. For example, if the temperature needed to ensure 
safety of roasted nuts

[[Page 3747]]

is 290 [deg]F, and the procedure for roasting the nuts in an oil 
roaster calls for an operating temperature of 350 [deg]F, monitoring 
would detect that the temperature in the oil roaster was dropping and 
enable the facility to identify and fix the problem with temperature 
before the temperature drops to 290 [deg]F. Second, monitoring is used 
to determine when a deviation occurs at a critical control point (i.e., 
exceeding or not meeting a critical limit), indicating there is loss of 
control. In the previous example, there would be loss of control if the 
temperature drops to 289 [deg]F. When a deviation occurs, an 
appropriate corrective action must be taken--e.g., stop the roasting 
process until the temperature in the oil roaster can be maintained 
above 290 [deg]F and reprocess nuts that were not roasted at the 
appropriate temperature. Third, monitoring provides written 
documentation for use in verification. For example, if the facility 
monitors the temperature of the oil roaster continuously, using a 
temperature recording device, the output of the temperature recording 
device is available during the verification activity of review of 
records. Under this approach, monitoring is directed to evaluating 
implementation of the preventive controls, and the written 
documentation of the monitoring is then used in verification.
3. Verification in HACCP Systems
    Proposed Sec.  117.3 would define ``verification'' to mean ``those 
activities, other than monitoring, that establish the validity of the 
food safety plan and that the system is operating according to the 
plan.'' We discussed this definition, and how it is used in HACCP 
systems, in section X.B.4 of this document. The NACMCF HACCP guidelines 
identify several aspects of verification (Ref. 34). One aspect of 
verification is the initial validation of the HACCP plan to determine 
that the plan is scientifically and technically sound, that all hazards 
have been identified and that if the HACCP plan is properly implemented 
these hazards will be effectively controlled. Another aspect of 
verification is evaluating whether the facility's HACCP system is 
functioning according to the HACCP plan. Both of these aspects are 
directed at the effectiveness of a preventive control; they establish 
that the preventive control is scientifically valid for controlling the 
hazard and verify that the preventive control is accomplishing its 
intended purpose. The Codex HACCP Annex addresses verification as 
determining compliance with the HACCP plan and confirming that the 
HACCP system is working effectively (Ref. 35). Examples of verification 
activities include review of monitoring records and review of records 
for deviations and corrective actions. We discuss verification 
activities in more detail during our discussion of proposed Sec.  
117.150 (Verification) in section XII.G of this document.
4. Relationship Between Monitoring and Verification
    Monitoring and verification are closely related; both address the 
performance of preventive controls, and verification relies in part on 
monitoring records to establish that preventive controls developed to 
significantly minimize or prevent hazards are being implemented 
according to plan. Three provisions of section 418(f) of the FD&C Act 
(Verification) are particularly relevant when considering the role of 
monitoring. First, section 418(f)(1) of the FD&C Act requires that the 
owner, operator, or agent in charge of a facility verify that ``the 
preventive controls implemented * * * are adequate to control the 
hazards identified.* * *'' Second, section 418(f)(2) of the FD&C Act 
requires that the owner, operator, or agent in charge of a facility 
verify that ``the owner, operator, or agent is conducting monitoring.* 
* *'' Third, section 418(f)(4) of the FD&C Act requires that the owner, 
operator, or agent in charge of a facility verify that ``the preventive 
controls implemented * * * are effectively and significantly minimizing 
or preventing the occurrence of identified hazards.* * *''
5. Monitoring the Performance of Preventive Controls
    Section 418(a) requires monitoring the ``performance'' of 
preventive controls whereas section 418(d) requires monitoring their 
``effectiveness.'' We tentatively conclude that the language of section 
418 regarding monitoring is ambiguous and that it would be appropriate 
to require monitoring of the performance of preventive controls. 
``Performance'' means ``the execution or accomplishment of an action, 
operation, or process undertaken or ordered'' (Shorter Oxford English 
Dictionary, Fifth Ed. (2002), p. 2157) and is consistent with use of 
the term ``monitoring'' in traditional HACCP. Monitoring the 
performance of preventive controls would be undertaken to determine 
whether a facility is implementing its preventive controls and would 
generate records that would be used to verify implementation of the 
controls. For example, monitoring performance could include visual 
observations and measurements of temperature, time pH, and moisture 
level. In contrast, ``effectiveness'' refers to the quality of ``having 
an effect or result'' (Shorter Oxford English Dictionary, Fifth Ed. 
(2002), p. 794) and is not consistent with use of the term 
``monitoring'' in traditional HACCP. The term ``verification,'' not 
``monitoring'' is used to refer to effectiveness in traditional HACCP 
systems. Monitoring the effectiveness of preventive controls would 
evaluate whether the preventive controls were working.
    Requiring monitoring of the effectiveness of the preventive 
controls would be redundant with required verification activities. 
Section 418(f) requires verification that the preventive controls ``are 
effectively and significantly minimizing the occurrence of the 
identified hazards.* * *'' The activities necessary for such 
verification are the same as would be required for monitoring the 
effectiveness of the preventive controls. For example, because 
effectiveness addresses whether the hazard is controlled, monitoring 
the effectiveness could include testing for the presence of the hazard, 
such as testing for the presence of staphylococcal enterotoxin that can 
occur during cheese making if the pH does not drop to a low enough 
level in a short enough time. Further, requiring monitoring of 
effectiveness rather than performance of the preventive controls would 
create a significant gap in the preventive controls system if the 
factors that are critical to control of the hazard, e.g., pH of the 
cheese curd and time, are not monitored to ensure the process is 
implemented correctly. In contrast, monitoring the performance of 
preventive controls would provide evidence that the preventive controls 
established to control the identified hazards are implemented 
appropriately (e.g., pH of the cheese curd drops below 5.6 within 8 
hours) and thereby are effectively and significantly minimizing or 
preventing the hazards (e.g., staphylococcal enterotoxin).
    As discussed more fully in the next section of this document, this 
interpretation also is grounded in our existing HACCP regulations and 
guidance. Section 418(n)(5) of the FD&C Act directs the Secretary, in 
promulgating these regulations, to review hazard analysis and 
preventive control programs in existence to ensure that this regulation 
is consistent to the extent practicable with applicable domestic and 
internationally-recognized standards in existence. Requiring monitoring 
of the performance of preventive controls is consistent with

[[Page 3748]]

applicable domestic and internationally recognized standards.
    Therefore, we tentatively conclude that this interpretation is 
reasonable, and we propose to adopt it in the proposed requirements 
implementing section 418(d) of the FD&C Act. We request comment on this 
interpretation.
6. Proposed Sec.  117.140--Monitoring
    a. Proposed Sec.  117.140(a)--Requirement for written procedures 
for monitoring. Proposed Sec.  117.140(a) would require that the owner, 
operator, or agent in charge of a facility establish and implement 
written procedures, including the frequency with which they are to be 
performed, for monitoring the preventive controls. Proposed Sec.  
117.140(a) would implement sections 418(d) and (h) of the FD&C Act.
    Proposed Sec.  117.140(a) is consistent with the NACMCF HACCP 
guidelines, the Codex HACCP Annex, and Federal HACCP regulations for 
seafood, juice, and meat and poultry. We discuss the purposes that the 
NACMCF HACCP guidelines identify for monitoring under a HACCP system in 
section II.C.4.d of this document. Each of these purposes applies to 
preventive controls as well, and we tentatively conclude that these 
purposes would be achieved by proposed Sec.  117.140(a). Proposed Sec.  
117.140(a) would facilitate tracking the implementation of the 
preventive controls to provide assurance that they are consistently 
performed; if monitoring indicates that there is a trend towards loss 
of control, a facility can take action to bring the process back into 
control before a preventive control is not properly implemented and 
potentially unsafe product is produced. Further, if monitoring is 
conducted with sufficient frequency to ensure preventive controls are 
consistently performed, it will detect if a preventive control is not 
properly implemented (e.g., if the temperature of an oven falls below 
the temperature needed to ensure safety), indicating loss of control 
and signaling the need for an appropriate corrective action. Finally, 
the proposed monitoring requirement would result in written 
documentation for use in verification.
    The Codex HACCP Annex advises that monitoring procedures must be 
able to detect loss of control at the CCP and ideally should provide 
this information in time to make adjustments to ensure control of the 
process to prevent violating the critical limits. The Codex HACCP Annex 
also recommends that, where possible, process adjustments be made when 
monitoring results indicate a trend towards loss of control at a CCP, 
before a deviation occurs (Ref. 35). Federal HACCP regulations for 
seafood, juice, and meat and poultry require in the written HACCP plan 
monitoring of control measures to determine whether physical, chemical, 
or biological parameters are being met (i.e., monitoring of critical 
control points to ensure compliance with the critical limits) (Sec.  
123.6(b) and (c)(4)), Sec.  120.8(a) and (b)(4), and 9 CFR 417.2(b)(1) 
and (c)(4), respectively). Like the Federal HACCP regulations for 
seafood, juice, and meat and poultry, the requirements for monitoring 
in proposed Sec.  117.140(a) focus on evaluating performance of the 
preventive controls.
    Proposed Sec.  117.140(a) would require that the monitoring 
procedures be written. Under section 418(d) of the FD&C Act, the owner, 
operator, or agent in charge of a facility must monitor the 
effectiveness of the preventive controls implemented under section 
418(c) of the FD&C Act, and under section 418(h) of the FD&C Act the 
procedures used by the facility to comply with the requirements of 
section 418 of the FD&C Act must be included in the written plan. The 
NACMCF HACCP guidelines note under record-keeping and documentation 
procedures that the procedures for monitoring should be provided (Ref. 
34). The Codex HACCP Annex includes ``monitoring procedures'' in its 
example of a HACCP worksheet (Ref. 35). Federal HACCP regulations for 
seafood, juice and meat and poultry require that the HACCP plan be 
written (Sec. Sec.  123.6(b), 120.8(a), and 9 CFR 417.2(b)(1), 
respectively) and that procedures for monitoring be included in the 
written HACCP plan (Sec. Sec.  123.6(c)(4), 120.8(b)(4), and 9 CFR 
417.2(c)(4), respectively).
    Proposed Sec.  117.140(a) would require that the monitoring 
procedures include the frequency with which they are to be performed. 
We discuss the frequency of monitoring in the next section of this 
document. Briefly, the frequency of monitoring must be sufficient to 
ensure that the preventive control is consistently performed in order 
to help ensure that the preventive control is effective. The NACMCF 
HACCP guidelines note that the frequency of monitoring should be 
provided in the HACCP Plan Summary Table (Ref. 34). Federal HACCP 
regulations for seafood, juice and meat and poultry require that the 
written HACCP plan include the procedures, and frequency thereof, that 
will be used for monitoring (Sec. Sec.  123.6(c)(4), 120.8(b)(4), and 9 
CFR 417.2(c)(4), respectively).
    b. Proposed Sec.  117.140(b)--Frequency of monitoring. Proposed 
Sec.  117.140(b) would require that the owner, operator, or agent in 
charge of a facility monitor the preventive controls with sufficient 
frequency to provide assurance that they are consistently performed. 
Proposed Sec.  117.140(b) does not specify a single monitoring 
frequency applicable to all facilities and processes. Rather, it 
requires monitoring with ``sufficient frequency'' to assure that the 
preventive controls are consistently performed. Proposed Sec.  
117.140(b) would implement section 418(d) of the FD&C Act and is 
consistent with the NACMCF HACCP guidelines and the Codex HACCP Annex.
    The NACMCF guidelines recommend continuous monitoring where 
possible (Ref. 34). Continuous monitoring is possible with many types 
of physical and chemical parameters. For example, the temperature and 
time for many thermal processes can be recorded continuously on 
temperature recording charts. If the temperature falls below the 
scheduled temperature or the time is insufficient, as recorded on the 
chart, the affected product can be retained and evaluated to determine 
the appropriate disposition. Examples of other parameters that can be 
monitored continuously include pressure, flow rate and pH.
    However, the NACMCF guidelines acknowledge that continuous 
monitoring may not be possible, or even necessary, in all cases. For 
example, it may not be practical to continuously monitor the size of 
particles in a food to ensure they do not exceed the maximum dimensions 
that are required to ensure a process such as cooking, cooling, or 
acidification can be properly implemented. NACMCF states that if 
monitoring is not continuous it may be difficult to ensure that the 
preventive controls are consistently implemented and a problem has not 
occurred. Thus, according to NACMCF, the frequency of non-continuous 
monitoring must be sufficient to ensure that a critical control point 
(or, in the case of this proposed rule, a preventive control) is under 
control (Ref. 34). The Codex HACCP Annex also notes that, if monitoring 
is not continuous, then the amount or frequency of monitoring must be 
sufficient to guarantee the CCP is in control (Ref. 35). The frequency 
of non-continuous monitoring would depend on factors such as the 
proximity of operating conditions to the conditions needed to ensure 
safety and the variability of the process. For example, if the 
temperature needed to ensure safety of roasted nuts is 290 [deg]F, non-
continuous monitoring would need to be more frequent when an oil 
roaster for nuts is operated at 300 [deg]F than when the oil roaster is 
operated at 350 [deg]F. As another example, if temperatures vary

[[Page 3749]]

by 10-15 [deg]F during processing, monitoring would need to be more 
frequent than if the variation is only 1-2 degrees.
    As discussed in the previous section of this document, Federal 
HACCP regulations for seafood, juice, and meat and poultry require that 
the written HACCP plan include the procedures, and frequency thereof, 
that will be used for monitoring (Sec. Sec.  123.6(c)(4), 120.8(b)(4), 
and 9 CFR 417.2(c)(4), respectively). Our Fish and Fishery Products 
Hazards and Controls Guidance discusses the frequency of monitoring and 
notes that the frequency of monitoring depends upon the circumstances, 
with continuous monitoring being desirable; in some cases, continuous 
monitoring may be necessary, while in other cases, it may not be 
necessary or practical (Ref. 173). Our Juice HACCP Hazards and Controls 
Guidance provides examples of ``Summary HACCP Plans,'' which show how 
the frequency of monitoring would depend on the circumstances (Ref. 4).
    c. Proposed Sec.  117.140(c)--Requirement for records. Proposed 
Sec.  117.140(c) would require that all monitoring of preventive 
controls in accordance with proposed Sec.  117.140 be documented in 
records that are subject to verification in accordance with Sec.  
117.150(b) and records review in accordance with proposed Sec.  
117.150(d)(2)(i). Proposed Sec.  117.140(c) would implement section 
418(g) of the FD&C Act and is consistent with the NACMCF HACCP 
guidelines, the Codex HACCP Annex, and Federal HACCP regulations for 
seafood, juice, and meat and poultry. The NACMCF HACCP guidelines 
recommend that the records maintained for the HACCP system include 
records that are generated during the operation of the plan (Ref. 34). 
The Codex HACCP Annex gives records of CCP monitoring activities as an 
example of records (Ref. 35). Our HACCP regulations for seafood and 
juice require that the HACCP plan provide for a recordkeeping system 
that documents the monitoring of the critical control points 
(Sec. Sec.  123.6(c)(7) and 120.8(b)(7), respectively). The FSIS HACCP 
regulation for meat and poultry requires records documenting the 
monitoring of CCPs and their critical limits, including the recording 
of actual times, temperatures, or other quantifiable values.
    The monitoring records would be used to verify that the preventive 
controls are adequate, as would be required by proposed Sec.  
117.150(a), and to verify that the preventive controls are effectively 
and significantly minimizing or preventing the hazards that are 
reasonably likely to occur, as would be required by proposed Sec.  
117.150(d). This is further discussed in section XII.G.5.b of this 
document. Together, proposed Sec. Sec.  117.140(a), (b), and (c) and 
117.150(a), (b), and (d) would establish a system that would provide 
assurance that hazards identified in the hazard analysis conducted 
under section 418(b)(1) of the FD&C Act will be significantly minimized 
or prevented and that food manufactured, processed, packed or held by 
such facility will not be adulterated under section 402 of the FD&C Act 
or misbranded under section 403(w) of the FD&C Act.

F. Proposed Sec.  117.145--Corrective Actions

1. Requirements of Section 418 of the FD&C Act
    Section 418(h) of the FD&C Act, in relevant part, specifies that 
the owner, operator, or agent in charge of a facility shall prepare a 
written plan that documents and describes the procedures used by the 
facility to comply with the requirements of section 418 of the FD&C 
Act. Section 418(e) of the FD&C Act specifies that the owner, operator, 
or agent in charge of a facility shall establish procedures to ensure 
that, if the preventive controls implemented under section 418(c) of 
the FD&C Act are not properly implemented or are found to be 
ineffective:
     Appropriate action is taken to reduce the likelihood of 
recurrence of the implementation failure (section 418(e)(1) of the FD&C 
Act);
     All affected food is evaluated for safety (section 
418(e)(2) of the FD&C Act); and
     All affected food is prevented from entering into commerce 
if the owner, operator or agent in charge of such facility cannot 
ensure that the affected food is not adulterated under section 402 of 
the FD&C Act or misbranded under section 403(w) of the FD&C Act 
(section 418(e)(3) of the FD&C Act).
    Section 418(f)(4) of the FD&C Act requires, in relevant part, that 
the owner, operator, or agent in charge of a facility verify that the 
preventive controls implemented under section 418(c) of the FD&C Act 
are effectively and significantly minimizing or preventing the 
occurrence of identified hazards.
2. Proposed Sec.  117.145(a)--Corrective Action Procedures
    Proposed Sec.  117.145(a)(1) would require that the owner, 
operator, or agent in charge of a facility establish and implement 
written corrective action procedures that must be taken if preventive 
controls are not properly implemented. Having written procedures in 
place would enable facilities to act quickly and appropriately when 
preventive controls are not properly implemented--e.g., when a 
parameter associated with heat processing exceeds a maximum value or 
falls below a minimum value. Proposed Sec.  117.145(a)(1) would 
implement section 418(e) of the FD&C Act and is consistent with the 
NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP 
regulations for seafood, juice, and meat and poultry.
    The NACMCF HACCP guidelines define a corrective action as 
procedures followed when a deviation occurs at a CCP and recommend that 
specific corrective actions be developed in advance for each CCP and 
included in the HACCP plan (Ref. 34). The Codex HACCP Annex advises 
that specific corrective actions be developed for each CCP in the HACCP 
system (Ref. 35). Our HACCP regulations for seafood and juice require 
that processers take corrective action whenever a deviation from a 
critical limit occurs, either by following specific corrective action 
procedures specified in the regulation, or by following procedures in 
written corrective action plans that the processor develops (Sec. Sec.  
123.7 and 120.10, respectively). If the processor of a seafood or juice 
product covered by the applicable HACCP regulation develops such plans, 
they must be included in the written HACCP plan (Sec. Sec.  123.6(c)(5) 
and 123.7(b) and 120.8(b)(5), respectively). The FSIS HACCP regulation 
for meat and poultry requires that the written HACCP plan identify the 
corrective action to be followed in response to a deviation from a 
critical limit (9 CFR 417.3(a)).
    As discussed in section XII.C.4 of this document, the proposed rule 
would establish requirements for preventive controls (which may be at 
critical control points), and proposed Sec.  117.135(c)(2) would 
require that the preventive controls include, as appropriate to the 
facility and the food, the maximum or minimum value, or combination of 
values, to which any physical, biological, radiological, or chemical 
parameter must be controlled to significantly minimize or prevent a 
hazard that is reasonably likely to occur (which reflects the NACMCF 
definition of a critical limit). As already noted earlier in this 
section, if a parameter associated with heat processing falls below a 
minimum value, corrective action would be triggered. Thus, the concept 
in the proposed rule of taking corrective action when a preventive 
control is not properly implemented is

[[Page 3750]]

similar to the concept in HACCP systems of taking corrective action for 
a deviation from a critical limit at a critical control point.
    The benefits from identifying corrective action procedures in 
advance of the need to actually take corrective action largely derive 
from having the procedures in written form. Written corrective action 
procedures would be essential to the facility's food safety team, to 
auditors, and to inspectors. The facility's food safety team will be 
responsible for ensuring that appropriate corrective actions are taken 
if preventive controls are not properly implemented. Having access to 
appropriate, written corrective action procedures determined in advance 
of the need for such action can ensure that correct and complete 
actions are taken in a timely fashion without the need for the team to 
meet and decide on the appropriate action. Having written corrective 
action procedures available for auditors and for inspectors is 
essential for them to assess the adequacy of the food safety plan; the 
procedures a facility will use to address implementation failures are 
essential to the production of safe food, and without them a complete 
assessment cannot be made. Written corrective action procedures also 
would be useful for training purposes, so that employees who would need 
to implement the corrective action procedures will be prepared for what 
they would need to do.
    Proposed Sec.  117.145(a)(2) would implement section 418(e) of the 
FD&C Act (i.e., that the owner, operator, or agent in charge of a 
facility must establish corrective action procedures) and section 
418(h) of the FD&C Act (i.e., that the owner, operator, or agent in 
charge of a facility must prepare a written plan). Proposed Sec.  
117.145(a)(2) is consistent with the NACMCF HACCP guidelines, the Codex 
HACCP Annex, and with Federal HACCP regulations for seafood, and juice, 
and meat and poultry. The NACMCF HACCP guidelines recommend that 
specific corrective actions be included in the HACCP plan (Ref. 34). In 
its discussion of corrective actions, the Codex HACCP Annex advises 
that deviation and product disposition procedures be documented in the 
HACCP record keeping (Ref. 35). Our HACCP regulations for seafood and 
juice both require that the written HACCP plan include any corrective 
action plans that have been developed by the processor (Sec. Sec.  
123.6(c)(5) and 123.7(b) and 120.8(b)(5)). The FSIS HACCP regulation 
for meat and poultry requires that the written HACCP plan identify the 
corrective action to be followed in response to a deviation from a 
critical limit (9 CFR 417.3(a)).
    Proposed Sec.  117.145(a)(2) would require that corrective action 
procedures describe the steps to be taken to ensure that:
     Appropriate action is taken to identify and correct a 
problem with implementation of a preventive control to reduce the 
likelihood that the problem will recur (proposed Sec.  
117.145(a)(2)(i));
     All affected food is evaluated for safety (proposed Sec.  
117.145(a)(2)(ii)); and
     All affected food is prevented from entering into 
commerce, if the owner, operator or agent in charge of such facility 
cannot ensure that the affected food is not adulterated under section 
402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act 
(proposed Sec.  117.145(a)(2)(iii)).
    The hazard analysis and risk-based preventive controls in this 
proposed rule are designed to identify hazards that are reasonably 
likely to occur, and to significantly minimize or 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. However, a preventive controls system, 
similar to a HACCP system (Ref. 34), accounts for the possibility of 
implementation and effectiveness problems and includes procedures for 
addressing those problems and any affected food.
    Proposed Sec.  117.145(a)(2) would implement sections 418(e)(1)-(3) 
of the FD&C Act and is consistent with the NACMCF HACCP guidelines, the 
Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, 
and meat and poultry. The NACMCF HACCP guidelines recommend that 
corrective actions include elements to determine and correct the cause 
of non-compliance and to determine the disposition of non-compliant 
product (Ref. 34). The Codex HACCP Annex advises that the specific 
corrective actions must ensure that the CCP has been brought under 
control and that actions taken must also include proper disposition of 
the affected product (Ref. 35). Our HACCP regulations for seafood and 
juice establish that a corrective action plan that is appropriate for a 
particular deviation is one that describes the steps to be taken and 
assigns responsibility for taking those steps, to ensure that no 
product enters commerce that is either injurious to health or is 
otherwise adulterated as a result of the deviation, and the cause of 
the deviation is corrected (Sec. Sec.  123.7(b) and 120.10(a), 
respectively). The FSIS HACCP regulation for meat and poultry requires 
that the HACCP plan describe the corrective action to be taken, and 
assign responsibility for taking corrective action, to ensure: (1) The 
cause of the deviation is identified and eliminated; (2) the CCP will 
be under control after the corrective action is taken; (3) measures to 
prevent recurrence are established; and (4) no product that is 
injurious to health or otherwise adulterated as a result of the 
deviation enters commerce (9 CFR 417.3(a)).
    Section 418(e)(1) of the FD&C Act and proposed Sec.  
117.145(a)(2)(i) explicitly require that action be taken to reduce the 
likelihood of recurrence of the implementation failure. Although not 
prescribed by proposed Sec.  117.145(a)(2)(i), reducing the likelihood 
of recurrence of an implementation failure is best accomplished by 
identifying the root cause of failure and then taking action to address 
that root cause. If the root cause is not identified and corrected, it 
is more likely that the failure will recur. For example, if the 
temperature of a heat process cannot be maintained, a corrective action 
to raise the temperature using the controller may correct the problem 
short-term. However, if the root cause is a lack of boiler capacity to 
run multiple heating units at the same time, corrective action should 
address replacing the boiler to increase capacity. Similarly, if a 
facility cannot cool a food rapidly enough in a refrigerator to meet 
the cooling times and temperatures in its HACCP plan, the initial 
corrective action may be to move product into a freezer for cooling. If 
the root cause is determined to be that the product was filled too high 
in the cooling tray, the corrective action may be to include procedures 
to measure the depth of product in the tray. If the root cause is 
determined to be insufficient cooling capacity to remove heat from the 
amount of product being cooled, the corrective action may involve using 
a cooling unit with greater cooling capacity or changing the method of 
cooling, e.g., to a blast freezer.
    Proposed Sec.  117.145(a)(2)(ii) and (iii), would require that 
corrective action procedures include an evaluation of all food affected 
by a problem and procedures for ensuring that affected food is 
prevented from entering into commerce if the owner, operator or agent 
in charge of the facility cannot ensure that the affected food is not 
adulterated under section 402 of the FD&C Act or misbranded under 
section 403(w) of the FD&C Act. Such an evaluation is implicit in our 
HACCP regulations for seafood and juice (Sec. Sec.  123.7(b) and 
120.10(a)) in that these

[[Page 3751]]

sections do not explicitly require that food affected by the problem be 
evaluated, but do require that steps be taken to ensure that product 
that is injurious to health or otherwise adulterated does not enter 
commerce. Although our HACCP regulations for seafood and juice do not 
specify the steps that must be described in a corrective action plan, 
the regulations require that specific steps be taken when a deviation 
from a critical limit occurs and the processor does not have a 
corrective action plan that is appropriate for that deviation 
(Sec. Sec.  123.7(c) and 120.10(b), respectively). Under these 
regulations, required steps include segregating and holding effected 
product, performing or obtaining a review to determine the 
acceptability of the affected product for distribution and taking 
corrective action, when necessary, to ensure that no product enters 
commerce that is either injurious to health or is otherwise adulterated 
as a result of the deviation. FDA notes that the corrective action 
procedures in the HACCP regulations do not reference misbranding under 
section 403(w) of the FD&C Act. Section 403(w) of the FD&C Act was 
added to the FD&C Act by the Food Allergen Labeling and Consumer 
Protection Act of 2004 (Pub. L. 108-282, Title II), which was enacted 
after issuance of both the seafood and juice HACCP regulations. 
However, our HACCP regulation for juice includes the presence of 
undeclared ingredients that may be allergens as a potential hazard that 
must be considered in the hazard analysis (Sec.  120.7(c)(8)), and our 
Fish and Fishery Products Hazards and Controls Guidance (Fourth 
Edition) (Ref. 173) and Juice HACCP Hazards and Controls Guidance (Ref. 
4) both include recommendations directed to hazards from undeclared 
food allergens.
3. Proposed Sec.  117.145(b)--Corrective Action in the Event of an 
Unanticipated Problem
    Proposed Sec.  117.145(b)(1) would require that if a preventive 
control is not properly implemented and a specific corrective action 
has not been established, or a preventive control is found to be 
ineffective, the owner, operator, or agent in charge of a facility take 
corrective action to identify and correct the problem, evaluate all 
affected food for safety, and, as necessary, prevent affected food from 
entering commerce as would be done following a corrective action 
procedure under proposed Sec.  117.145(a)(2)(i)-(iii). However, a 
facility might not anticipate all of the problems that may occur, and a 
facility may experience an implementation failure for which a 
corrective action procedure has not been established. Regardless of 
whether a problem was anticipated and a corrective action procedure was 
developed in advance, corrective actions to accomplish the steps that 
would have been included in a corrective action procedure are 
necessary. Likewise, a facility might determine (e.g., as a 
verification activity in accordance with proposed Sec.  117.150(d), 
discussed in section XII.G.5 of this document), that a preventive 
control is ineffective. For example, detecting a pathogen in an RTE 
food may signal that preventive controls for that pathogen are 
ineffective. As in the case of an unanticipated implementation failure 
of a preventive control, corrective actions would be necessary if a 
preventive control is found to be ineffective.
    Proposed Sec.  117.145(b)(1) is consistent with Federal HACCP 
regulations for seafood, juice, and meat and poultry. Our HACCP 
regulations for seafood and juice require that, when a deviation from a 
critical limit occurs and the processor does not have a corrective 
action plan that is appropriate for that deviation, the processor 
segregate and hold the affected product; perform or obtain a review to 
determine the acceptability of the affected product for distribution; 
take corrective action, when necessary, with respect to the affected 
product to ensure that no product enters commerce that is either 
injurious to health or is otherwise adulterated as a result of the 
deviation; and take corrective action, when necessary, to correct the 
cause of the deviation (Sec. Sec.  123.7(c)(1)-(4) and 120.10(b)(1)-
(4), respectively). The FSIS HACCP regulation for meat and poultry (9 
CFR 417.3(b)) requires, in relevant part, that if a deviation not 
covered by a specified corrective action occurs, or if another 
unforeseen hazard arises, the establishment must: (1) Segregate and 
hold the affected product, at least until the requirements of 9 CFR 
417.3(b)(2) and (3) are met; (2) perform a review to determine the 
acceptability of the affected product for distribution; and (3) take 
action, when necessary, with respect to the affected product to ensure 
that no product that is injurious to health or otherwise adulterated, 
as a result of the deviation, enters commerce. The NACMCF HACCP 
guidelines and the Codex HACCP Annex are silent on the specific issue 
of taking corrective actions when a preventive control is not properly 
implemented and a specific corrective action has not been established 
or when a preventive control has been found to be ineffective. However, 
proposed Sec.  117.145(b)(1) is consistent with HACCP principles, 
discussed earlier in this section, recommended in the NACMCF HACCP 
guidelines and Codex HACCP Annex regarding the importance of corrective 
actions whenever there is a deviation from a critical limit. In each of 
the situations described (following an established corrective action, 
taking corrective action in the absence of a plan, or taking corrective 
action when the preventive control is found to be ineffective) the 
intent of taking corrective action is to restore control and to ensure 
that hazardous foods do not reach the consumer.
    Proposed Sec.  117.145(b)(2) would require that the owner, 
operator, or agent in charge of a facility reanalyze the food safety 
plan in accordance with proposed Sec.  117.150(f) to determine whether 
modification of the food safety plan is required if a preventive 
control is not properly implemented and a specific corrective action 
has not been established, or if a preventive control is found to be 
ineffective. (We use the term ``reanalyze'' when we refer to a 
reassessment of the validity of a preventive control or the food safety 
plan to control a hazard.) Under proposed Sec.  117.150(a), the 
verification required by section 418(f) of the FD&C Act would include 
validation of the food safety plan, referring to whether it is 
effectively controlling the hazards or ``working correctly.'' See 
section XII.G of this document for a discussion of proposed 
requirements for verification (including validation and reanalysis) 
under section 418(f) of the FD&C Act. Proposed Sec.  117.145(b)(2) 
would apply to unanticipated food safety problems, and the 
unanticipated nature of the problems is relevant to the reanalysis of 
the food safety plan. If the owner, operator, or agent in charge of a 
facility has assessed its procedures, practices, and processes and has 
not identified a specific failure as a foreseeable occurrence, the 
owner, operator, or agent in charge must assess whether the problem is 
simply an implementation failure that could be expected to occur in the 
normal course of manufacturing, processing, packing or holding the 
food, or the result of a system-wide problem that is not being properly 
addressed by the plan (e.g., ineffective preventive controls). If the 
problem is simply an implementation failure, and such a failure is now 
a foreseeable circumstance, reanalysis of the food safety plan would be 
necessary to determine whether a corrective action procedure should be 
established for that foreseeable failure. Likewise, if the

[[Page 3752]]

problem is the result of a system-wide problem that is not being 
properly addressed by the plan (or is otherwise a result of ineffective 
preventive controls), reanalysis of the food safety plan would be 
necessary to identify effective preventive controls. Either way, 
reanalyzing the food safety plan and modifying it as necessary would be 
necessary to reduce the risk of recurrence of the problem.
    Proposed Sec.  117.145(b)(2) is consistent with the NACMCF HACCP 
guidelines, the Codex HACCP Annex, and Federal HACCP regulations for 
seafood, juice, and meat and poultry. The NACMCF HACCP guidelines, in 
relevant part, recommend that validations (i.e., an assessment of the 
validity of the HACCP plan) be conducted when there is an unexplained 
system failure (e.g., an implementation failure or ineffective 
preventive controls) (Ref. 34). The Codex HACCP Annex, in relevant 
part, advises that verification procedures be used to determine if the 
HACCP system is working correctly (Ref. 35); such verification 
procedures would also be used if an unexpected implementation failure 
of a preventive control suggests that the system is not working 
correctly. Our HACCP regulations for seafood and juice, in relevant 
part, require that, when a deviation from a critical limit occurs and 
the processor does not have a corrective action plan that is 
appropriate for that deviation, the processor must perform or obtain 
timely reassessment or verification by a trained individual to 
determine whether modification of the HACCP plan is required to reduce 
the risk of recurrence of the deviation and to modify the HACCP plan as 
necessary (Sec. Sec.  123.7(c)(5) and 120.10(b)(5), respectively). The 
FSIS regulation for meat and poultry requires, in relevant part, that 
if a deviation not covered by a specified corrective action occurs, or 
if another unforeseen hazard arises, the establishment must perform or 
obtain reassessment to determine whether the newly identified deviation 
or other unforeseen hazard should be incorporated into the HACCP plan 
(9 CFR 417.3(b)(4)). (The FSIS HACCP regulation for meat and poultry 
uses the term ``reassessment'' much as this proposed rule would use the 
term ``reanalysis.'')
4. Proposed Sec.  117.145(c)--Documentation
    Proposed Sec.  117.145(c) would require that all corrective actions 
taken in accordance with this section be documented in records that are 
subject to verification in accordance with Sec.  117.150(c) and records 
review in accordance with Sec.  117.150(d)(2)(i). The records that 
document corrective actions would be used to verify that appropriate 
decisions about corrective actions are being made and appropriate 
corrective actions are being taken.

G. Proposed Sec.  117.150--Verification

1. Requirements of Section 418 of the FD&C Act
    Section 418(f) of the FD&C Act requires that the owner, operator, 
or agent in charge of a facility verify that:
     The preventive controls implemented under section 418(c) 
of the FD&C Act are adequate to control the hazards identified under 
[section 418(b) of the FD&C Act (section 418(f)(1) of the FD&C Act);
     The owner, operator, or agent is conducting monitoring in 
accordance with section 418(d) of the FD&C Act (section 418(f)(2) of 
the FD&C Act);
     The owner, operator, or agent is making appropriate 
decisions about corrective actions taken under section 418(e) of the 
FD&C Act (section 418(f)(3) of the FD&C Act);
     The preventive controls implemented under section 418(c) 
of the FD&C Act are effectively and significantly minimizing or 
preventing the occurrence of identified hazards, including through the 
use of environmental and product testing programs and other appropriate 
means (section 418(f)(4) of the FD&C Act); and
     There is documented, periodic reanalysis of the plan under 
section 418(i) of the FD&C Act to ensure that the plan is still 
relevant to the raw materials, conditions and processes in the 
facility, and new and emerging threats (section 418(f)(5) of the FD&C 
Act).
    In addition, section 418(g) of the FD&C Act specifies, in relevant 
part, that the owner, operator, or agent in charge of a facility shall 
maintain, for not less than 2 years, records documenting the monitoring 
of the preventive controls implemented under section 418(c) of the FD&C 
Act, instances of nonconformance material to food safety, the results 
of testing and other appropriate means of verification under section 
418(f)(4) of the FD&C Act, instances when corrective actions were 
implemented, and the efficacy of preventive controls and corrective 
actions.
    Further, section 418(i) of the FD&C Act specifies that the owner, 
operator, or agent in charge of a facility shall conduct a reanalysis 
under section 418(b) of the FD&C Act (the requirement to identify and 
evaluate known or reasonably foreseeable hazards) whenever a 
significant change is made in the activities conducted at a facility 
operated by such owner, operator, or agent if the change creates a 
reasonable potential for a new hazard or a significant increase in a 
previously identified hazard or not less frequently than once every 3 
years, whichever is earlier. Such reanalysis shall be completed and 
additional preventive controls needed to address the hazard identified, 
if any, shall be implemented before the change in activities at the 
facility is operative. The owner, operator, or agent shall revise the 
written plan required under section 418(h) of the FD&C Act if such a 
significant change is made or document the basis for the conclusion 
that no additional or revised preventive controls are needed. The 
Secretary may require a reanalysis under section 418(i) of the FD&C Act 
to respond to new hazards and developments in scientific understanding, 
including, as appropriate, results from the Department of Homeland 
Security biological, chemical, radiological, or other terrorism risk 
assessment.
2. Proposed Requirements for Validation
    a. Proposed Sec.  117.150(a)--Validation that preventive controls 
are adequate to control the hazard. Proposed Sec.  117.150(a) 
(Validation) would require that, except as provided by paragraph 
(a)(3), the owner, operator, or agent in charge of a facility validate 
that the preventive controls identified and implemented in accordance 
with Sec.  117.135 to control the hazards identified in the hazard 
analysis as reasonably likely to occur are adequate to do so. Proposed 
Sec.  117.150(a) would implement section 418(f)(1) of the FD&C Act and 
is consistent with the NACMCF HACCP guidelines, the Codex HACCP 
guidelines, and Federal HACCP regulations for seafood, juice, and meat 
and poultry. The NACMCF HACCP guidelines describe verification as 
activities that, in relevant part, determine the validity of the HACCP 
plan (Ref. 34). The NACMCF guidelines advise that an important aspect 
of verification is the initial validation of the HACCP plan to 
determine that the plan is scientifically and technically sound, that 
all hazards have been identified and that, if the HACCP plan is 
properly implemented, these hazards will be effectively controlled 
(Ref. 34). The Codex HACCP guidelines recommend that, where possible, 
validation activities include actions to confirm the efficacy of all 
elements of the HACCP system (Ref. 35). Our HACCP regulation for 
seafood does not specifically use the term ``validation,''

[[Page 3753]]

but it reflects the concept in requiring that every processor verify 
that the HACCP plan is adequate to control the hazards (Sec.  
123.8(a)). Our HACCP regulation for juice addresses both validation of 
the HACCP plan (Sec.  120.11(b)) and the hazard analysis (Sec.  
120.11(c)). The regulation requires each processor to validate that the 
HACCP plan is adequate to control food hazards that are reasonably 
likely to occur at least once within 12 months after implementation and 
at least annually thereafter. (This annual validation is the same as 
reanalysis proposed in Sec.  117.150(f) and discussed in section 
XII.G.7 of this document. The requirement for validation of the hazard 
analysis in Sec.  120.11(c) aligns more with a requirement for 
reanalysis and is discussed in section XII.G.2.a of this document). The 
FSIS HACCP regulation for meat and poultry (9 CFR 417.4(a)) requires 
that every establishment validate the HACCP plan's adequacy in 
controlling the food safety hazards identified during the hazard 
analysis. The regulations and guidelines described above reflect the 
widespread recognition of the importance of ensuring that preventive 
controls, if properly implemented, will adequately control the hazards.
    b. Proposed Sec.  117.150(a)(1)--Validation by a qualified 
individual prior to implementation and on reanalysis. Proposed Sec.  
117.150(a)(1) would require that the validation of the preventive 
controls be performed by (or overseen by) a qualified individual. The 
preventive controls must be adequate to control the hazards identified 
in the hazard analysis as reasonably likely to occur. Determining 
whether specific preventive controls are adequate requires an 
individual who is knowledgeable in the hazards associated with a 
product and process and the appropriate preventive controls for those 
hazards. Such knowledge requires scientific and technical expertise 
developed through training, experience or both.
    Proposed Sec.  117.150(a)(1)(i) would require that validation occur 
prior to implementation of the food safety plan or, when necessary, 
during the first six weeks of production. The validation of preventive 
controls includes collecting and evaluating scientific and technical 
information (or, when such information is not available or is 
insufficient, conducting studies), as discussed in the next section of 
this document. The collected data or information, or the studies, would 
establish a scientific and technical basis for the preventive controls 
used, in particular those that involve critical control points. This 
scientific and technical basis largely must be established prior to 
producing a product to ensure that the food produced using those 
preventive controls will be safe. However, as a practical matter, the 
scientific and technical basis for some aspects of a preventive control 
may require production conditions and, thus, would be established by 
the collection of data or information during, rather than before, 
producing a product. For example, ensuring that limits for control 
parameters can be met during production would be done under production 
conditions. FDA tentatively concludes that preventive controls that 
require the collection of data or information, or studies, during 
production conditions are part of validation, and, thus proposed Sec.  
117.150(a)(1)(i) would require that the validation of preventive 
controls be performed, when necessary, during the first six weeks of 
production. We selected six weeks as a time interval that would be 
adequate to allow facilities to methodically collect data and 
information during production, yet would be close to implementation of 
a preventive control.
    The NACMCF HACCP guidelines recommend that initial validation be 
conducted prior to and during initial implementation of the plan (Ref. 
34). A Codex document entitled ``Guidelines for the Validation of Food 
Safety Control Measures'' (hereinafter the Codex validation guidelines) 
recommends that validation of control measures be performed, whenever 
possible, before their full implementation (Ref. 127). Codex also 
includes as a validation measure the collection of data, e.g., product 
and/or environmental sampling and testing, during operating conditions 
in the food operation for a specified period (e.g., 3-6 weeks) (Ref. 
127). The HACCP regulation for juice requires that validation of HACCP 
plans be conducted once during the year after implementation and at 
least annually thereafter (Sec.  120.11(b)). The FSIS HACCP regulation 
for meat and poultry (9 CFR 417.4(a)) requires that initial validation 
be conducted upon completion of the hazard analysis and development of 
the HACCP plan to determine that the HACCP plan is functioning as 
intended (9 CFR 417.4(a)(1)). During the HACCP plan validation period, 
the meat or poultry establishment must repeatedly test the adequacy of 
the CCPs, critical limits, monitoring and recordkeeping procedures, and 
corrective actions set forth in the HACCP plan (9 CFR 417.4(a)(1)).
    FDA requests comment on whether the proposed time frame for 
validation should be shorter or longer. Comments should provide the 
basis for an alternative time frame.
    Proposed Sec.  117.150(a)(1)(ii) would require that the validation 
of the preventive controls be performed whenever a reanalysis of the 
food safety plan reveals the need to do so. The circumstances under 
which a reanalysis would be required are addressed in proposed Sec.  
117.150(f). Proposed Sec.  117.150(f)(1)(ii) would require that the 
owner, operator, or agent in charge of a facility complete such 
reanalysis and implement any additional preventive controls needed to 
address the hazard identified, if any, before the change in activities 
at the facility is operative, or, when necessary, during the first six 
weeks of production. All preventive controls established to address a 
hazard identified as reasonably likely to occur must have a scientific 
and technical basis; establishing that scientific and technical basis 
is a validation activity regardless of whether the preventive control 
is established in the facility's initial food safety plan or as a 
result of reanalysis of the food safety plan.
    c. Proposed Sec.  117.150(a)(2)--Validation based on scientific and 
technical information. Proposed Sec.  117.150(a)(2) would require that, 
except as provided by paragraph (a)(3) of this section, the validation 
of preventive controls include collecting and evaluating scientific and 
technical information or, when such information is not available or is 
insufficient, conducting studies to determine whether the preventive 
controls, when properly implemented, will effectively control the 
hazards that are reasonably likely to occur. The NACMCF HACCP 
guidelines note that information needed to validate the HACCP plan 
often includes (1) expert advice and scientific studies and (2) in-
plant observations, measurements and evaluations (Ref. 34). The Codex 
validation guidelines address several approaches for validating control 
measures, including (1) reference to scientific or technical 
literature, previous validation studies or historical knowledge, (2) 
scientifically valid experimental data, (3) collection of data during 
operating conditions, (4) mathematical modeling, and (5) surveys, and 
note that these may be used individually or in combination (Ref. 127).
    The scientific and technical information that would be evaluated to 
determine whether preventive controls effectively control the hazards 
that are

[[Page 3754]]

reasonably likely to occur may include scientific publications, 
government documents, predictive mathematical models and other risk-
based models, and technical information from equipment manufacturers, 
trade associations, and other sources. If the qualified individual 
conducting the validation relies on sources such as scientific 
publications, the qualified individual would need to ensure during 
validation that the conditions used by the facility are consistent with 
those described in the publication that is being used to support the 
adequacy of the preventive control measure to control the hazard. For 
example, if a study demonstrates adequate inactivation of Salmonella 
spp. in peanuts using a roasting process, conditions such as roaster 
temperature, heating time, bed depth and humidity that were critical to 
achieving inactivation in the study must be the same when the facility 
roasts peanuts (or any change in the critical parameters must be such 
that the same or greater lethality is achieved). Documents published by 
FDA, such as the Food Code (Ref. 174), the Pasteurized Milk Ordinance 
(Ref. 37), and the Fish and Fisheries Products Hazards and Controls 
Guidance (Ref. 173) may provide scientific and technical information 
useful in establishing the validity of a preventive control measure, 
such as times and temperatures for cooling foods in which bacterial 
pathogen growth may occur or minimum water activities, minimum pH 
values, and minimum and maximum temperatures for growth of a variety of 
pathogens.
    Predictive mathematical models that describe the growth, survival, 
or inactivation of microorganisms in foods may provide scientific and 
technical information useful in determining whether a process would be 
adequate to reduce microorganisms of public health concern (Ref. 34) 
(Ref. 127). Other risk-based models may examine the impact of a control 
measure on a hazard and may be useful if appropriately validated for a 
specific food. If the model is for a different food, it may still 
provide useful validation information that could be supplemented by 
additional data. For example, there are many mathematical models for 
thermal resistance of Salmonella spp. If a model for the thermal 
resistance of Salmonella spp. is developed for the same type of food as 
the food being produced, and the food being produced has the same 
critical parameters such as pH and aw that were used in 
developing the thermal resistance model, then heat processes based on 
the model would generally be considered validated. For example, if a 
model for the thermal resistance of Salmonella spp. is developed in 
tomatoes with a pH of 4.3, the model would be considered valid for 
tomatoes with a pH of 4.3 or below, but not for tomatoes with a higher 
pH. If, however, the model is for thermal resistance of Salmonella spp. 
in a type of food that is only similar to the food being produced, or 
has different critical parameters than were used in developing the 
thermal resistance model, it would be necessary to conduct additional 
thermal resistance studies in the food being produced to provide the 
data needed to show that a heat process adequately reduces Salmonella 
spp. in that food and to establish the critical parameters for the 
process. For example, a model for thermal resistance of Salmonella spp. 
on almonds may not apply to hazelnuts, even though the foods are 
similar in that both are tree nuts. The extent of such studies would, 
however, be less than the extent of such studies if there were no data 
on the heat resistance of Salmonella spp. in a similar food. For 
example, if the thermal resistance of Salmonella spp. in initial 
studies with hazelnuts is similar to that for almonds, then a thermal 
resistance study used to develop data for hazelnuts could investigate 
fewer times and temperatures, or use fewer replicates, than would be 
the case in the absence of the information about the thermal resistance 
of Salmonella spp. in almonds.
    A process validation study would establish the relationship between 
parameters such as process times and temperatures and other factors and 
the rate at which pathogens are reduced, and a prevalence study would 
determine the levels at which pathogens may occur in the raw material, 
ingredient, or food product to establish the cumulative amount of 
pathogen reduction that would be required to adequately reduce the risk 
of illness from that pathogen. Such studies are typically published or 
otherwise broadly disseminated within the scientific community and, 
when properly designed and carried out, are generally regarded by 
experts as scientifically definitive with respect to the matters 
addressed by the study. However, if scientific and technical 
information is not available or is insufficient to support the adequacy 
of a preventive control measure to control the hazard, the owner, 
operator or agent in charge of a facility would need to conduct 
controlled scientific studies to establish that a preventive control 
measure is adequate to control the hazard. As an example, a facility 
that wants to use propylene oxide (PPO) to inactivate enteric pathogens 
such as E. coli O157:H7 on shelled hazelnuts would need to conduct 
studies to establish that PPO could significantly minimize the hazard 
because no such studies currently exist in the public domain. Such 
studies would also establish the critical parameters and limits (e.g., 
critical limits at a CCP) that the facility would need to use to 
effectively control the hazard. For the hazelnut example, the critical 
factors might include amount of PPO, temperature of the nuts to be 
treated, treatment time, chamber temperature, PPO vaporizer 
temperature, chamber vacuum, and post-treatment hold time and 
temperature. Studies on inactivation of Salmonella spp. on almonds 
could provide information about appropriate parameters to investigate 
for the inactivation of E. coli O157:H7 on shelled hazelnuts, but 
additional studies would be needed to establish the specific values for 
those parameters in the inactivation of E. coli O157:H7 on shelled 
hazelnuts.
    Information is available in the literature that can assist in the 
design of studies to support the adequacy of preventive control 
measures. For example, NACMCF has published information on ``Parameters 
for Determining Inoculated Pack/Challenge Study Protocols'' (Ref. 175) 
and ``Requisite Scientific Parameters for Establishing the Equivalence 
of Alternative Methods of Pasteurization'' (Ref. 176). Studies to 
validate preventive control measures must be conducted by persons with 
experience and expertise relevant to the product, process and hazard to 
be controlled. Under proposed Sec.  117.150(a)(1)), any studies needed 
to provide the scientific and technical information to establish the 
validity of the plan would either be conducted by a qualified 
individual (as would be defined in proposed Sec.  117.3) or would be 
overseen by a qualified individual. In other words, the qualified 
individual need not have the experience and expertise to conduct 
validation studies, but must have sufficient expertise in risk-based 
preventive controls to understand the studies and how they support the 
validity of the preventive controls with respect to the hazard of 
concern.
    d. Proposed Sec.  117.150(a)(3)--Preventive controls for which 
validation is not required. Proposed Sec.  117.150(a)(3)(i) through 
(iii) would provide that validation need not address:

[[Page 3755]]

     The food allergen controls that would be established in 
proposed Sec.  117.135(d)(2);
     The sanitation controls that would be established in 
proposed Sec.  117.135(d)(3); and
     The recall plan that would be established in proposed 
Sec.  117.137.
    According to NACMCF, verification involves activities to determine 
the validity of the HACCP plan and that the system is operating 
according to the plan (Ref. 34). Thus, validation is a verification 
activity. The purpose of validation is to provide the scientific and 
technical basis for ensuring that the preventive controls implemented 
are adequate to control the hazards identified as reasonably likely to 
occur. FDA tentatively concludes that validation, i.e., the evaluation 
of scientific and technical information, is either not an essential 
activity, is not practical or is not relevant, for the controls 
identified in proposed Sec.  117.150(a)(3).
Food Allergen Controls
    As discussed in section XII.C.6 of this document, proposed Sec.  
117.135(d)(2)(i) would require that food allergen controls include 
those procedures, practices, and processes employed for ensuring 
protection of food from cross-contact, including during storage and 
use. Examples of such procedures, practices, and processes include 
providing physical barriers between sections of a facility, conducting 
manufacturing/processing of foods in different parts of a facility, and 
controlling the movement of tools and personnel that might carry 
allergens when the same production lines are used for both foods that 
contain allergens and foods those that do not, or when the same 
production lines are used for foods that contain different allergens. 
These types of controls generally are not evaluated through scientific 
studies or by the collection of technical information as would be 
required under proposed Sec.  117.150(a)(2). Instead, monitoring (e.g., 
by visual observation) that these activities do not result in cross-
contact provides sufficient assurance that the controls are functioning 
as intended to prevent the hazard of undeclared allergens in the food 
due to cross-contact. Examples of such visual observations include 
observations that bags of allergenic foods (such as soy flour) are 
stored in sealed containers, that spills of allergen powders are 
promptly cleaned, and that equipment is cleaned between manufacturing/
processing of different foods. Thus, FDA tentatively concludes that 
this proposed rule should not propose to require validation of the 
adequacy of the food allergen cross-contact controls that would be 
established in proposed Sec.  117.135(d)(2)(i). We request comment on 
this approach.
    As discussed in section XII.C.6 of this document, proposed Sec.  
117.135(d)(2)(ii) would require that food allergen controls include 
those procedures, practices, and processes employed for labeling the 
finished food, including, including ensuring that foods are not 
misbranded under section 403(w) of the FD&C Act. Examples of such 
procedures, processes, and practices include ensuring that the food 
label correctly declares all of the food allergens present (including 
those contained in flavorings, colorings, and incidental additives), 
ensuring that the correct food label is applied to a food, and ensuring 
that the correct food is in the correct package (e.g., by checking that 
the correct packaging is used for each food). These types of controls 
generally are not evaluated through scientific studies or by the 
collection of technical information as would be required under proposed 
Sec.  117.150(a)(2). Instead, verifying that labels contain appropriate 
information and monitoring that the correct label is being applied to 
the product provide sufficient assurance that the controls are 
functioning as intended to prevent the hazard of undeclared allergens 
in the food due to incorrect labels. Thus, FDA tentatively concludes 
that this proposed rule should not propose to require validation of the 
adequacy of the food allergen labeling controls that would be required 
by proposed Sec.  117.135(d)(2)(ii). We request comment on this 
approach.
Sanitation Controls
    As discussed in section XII.C.7 of this document, proposed Sec.  
117.135(d)(3)(i)(A) would require that, where relevant to hazards that 
are reasonably likely to occur, sanitation controls include procedures 
for the cleanliness of food-contact surfaces, including food-contact 
surfaces of utensils and equipment. Traditionally, sanitarians employed 
by the facility or experts employed by companies that supply cleaning 
and sanitizing compounds will establish critical parameters and 
associated limits for cleaning and sanitation, including the choice and 
strength of the cleaning and sanitizing chemicals, contact time, and 
temperature requirements, based on studies conducted by the 
manufacturers of the products. Antimicrobial solutions applied to food 
processing equipment and utensils to sanitize such objects after they 
have been washed are included in the definition of ``pesticide 
chemical'' and therefore, are subject to regulation by EPA under 
section 408 of the FD&C Act (Ref. 118). Chapter 4 (Additional 
Considerations for Antimicrobial Products) of EPA's ``Pesticide 
Registration Manual'' (Ref. 177) outlines EPA's requirements and 
recommendations for registration of antimicrobial substances, including 
testing against a validated protocol to be granted EPA-registered 
claims for pathogen reduction. Thus, FDA tentatively concludes that 
this proposed rule should not propose to require validation of the 
adequacy of the sanitation controls that would be required by proposed 
Sec.  117.135(d)(3)(i)(A). Monitoring activities to ensure the 
procedures are followed will provide assurance that the controls are 
functioning as intended to prevent hazards from insanitary food-contact 
surfaces. We request comment on this approach.
    As discussed in section XII.C.7 of this document, proposed Sec.  
117.135(d)(3)(i)(B) would require that, where relevant to hazards that 
are reasonably likely to occur, sanitation controls include procedures 
for the prevention of cross-contact and cross-contamination from 
insanitary objects and from employees to food, food packaging material, 
and other food-contact surfaces and from raw product to processed 
product. As already discussed with respect to proposed Sec.  
117.135(d)(3)(i)(A), sanitation controls to prevent cross-contamination 
can be established by sanitarians or by companies that supply cleaning 
and sanitizing compounds without the need for validation by the 
facility. Cleaning procedures established by sanitation experts should 
also be adequate to remove allergens from equipment and the environment 
in facilities where raw materials or ingredients containing allergens 
are used. Although it is prudent to validate the efficacy of cleaning 
with respect to allergens, appropriate allergen test methods may not be 
available at present for this purpose in all situations (Ref. 124). For 
example, when the same equipment is used to make milk-based and soy-
based beverages, the availability of analytical methods that can detect 
milk protein and soy protein may make it practical to clean the 
equipment and then test a water rinse of the system to determine 
whether milk or soy proteins can be detected in the rinse water. 
However, this may not be the case when equipment used to make breaded 
shrimp is subsequently used to make breaded fish. We tentatively 
conclude

[[Page 3756]]

that validation by the facility to demonstrate that sanitation controls 
adequately protect against cross-contact is not feasible for all 
situations at this time.
    Regardless of whether this proposed rule would require the specific 
verification activity of validation to demonstrate that sanitation 
controls adequately protect against cross-contact, proposed Sec.  
117.135(d)(3)(i)(A) would require that the owner, operator, or agent in 
charge of a facility establish appropriate allergen sanitation 
procedures to ensure that products do not contain undeclared allergens 
from other products. Cleaning procedures established to remove food 
residues and verification that food residues have been removed (e.g., 
by visual inspection) should significantly minimize or prevent the 
presence of undeclared food allergens. When appropriate tests are 
available, we recommend that facilities use testing as well as visual 
inspection to verify that procedures have been done adequately. We 
request comment on this approach. We also request comment on whether we 
should require validation of sanitation controls to protect against 
cross-contact in those situations where appropriate analytical methods 
for use in validation studies are currently available, even if such 
methods are not available for all major food allergens.
Recall Plan
    As discussed in section XII.C.8 of this document, a recall plan can 
significantly minimize or prevent hazards by limiting consumption of 
affected food during a recall. Following an existing plan that 
addresses all necessary elements of a recall helps minimize delay 
created by uncertainty as to the appropriate actions to take and helps 
ensure critical actions are not overlooked. The proposed requirement to 
validate a preventive control by collecting and evaluating scientific 
and technical information or by conducting studies simply does not 
apply to such a plan. Thus, FDA tentatively concludes that this 
proposed rule should not propose to require validation of the recall 
plan that would be required by proposed Sec.  117.137.
3. Proposed Sec.  117.150(b)--Verification of Monitoring
    Proposed Sec.  117.150(b) would require that the owner, operator, 
or agent in charge of a facility verify that monitoring is being 
conducted, as would be required by proposed Sec.  117.140. One example 
of verification that monitoring is being conducted is a periodic 
observation of the monitoring activity, e.g., by a supervisor. Another 
example of such a verification activity is an independent test made by 
a person other than the person doing the monitoring. For example, if 
the line operator is verifying the operation of a metal detector by 
running test pieces through the metal detector every two hours to 
verify it rejects them, a quality assurance technician could 
periodically run a similar test--e.g., once per shift. Proposed Sec.  
117.150(b) does not address the review of monitoring records, which 
would be required under proposed Sec.  117.150(d)(2)(i) (see the 
discussion in section XII.G.5.b of this document).
    Proposed Sec.  117.150(b) would implement section 418(f)(2) of the 
FD&C Act and is consistent with the FSIS HACCP regulation for meat and 
poultry, which requires direct observations of monitoring activities as 
an ongoing verification activity (9 CFR 417.4(a)(2)(ii)). Proposed 
Sec.  117.150(b) would differ from the NACMCF HACCP guidelines (Ref. 
34), the Codex HACCP guidelines (Ref. 35), and FDA's HACCP regulations 
for seafood and juice (Sec. Sec.  123.8(a)(3)(i) and 
120.11(a)(1)(iv)(A), respectively), which address verification of 
monitoring through the review of records (which would be required by 
proposed Sec.  117.150(d)(2)(i)) but do not otherwise address 
verification activities for monitoring.
    Proposed Sec.  117.150(b) would not specify the verification 
activities that must be conducted for monitoring. We request comment on 
whether proposed Sec.  117.150(b) should do so, and if so, what 
verification activities should be required.
4. Proposed Sec.  117.150(c)--Verification of Corrective Actions
    Proposed Sec.  117.150(c) would require that the owner, operator, 
or agent in charge of a facility verify that appropriate decisions 
about corrective actions are being made, as would be required by 
proposed Sec.  117.145 and by proposed Sec.  117.135(d)(3)(ii). An 
example of verification that appropriate decisions about corrective 
actions are being made is observation of the corrective actions being 
taken, e.g., by a supervisor. Proposed Sec.  117.150(c) would implement 
section 418(f)(3) of the FD&C Act and is consistent with the FSIS HACCP 
regulation for meat and poultry, which includes direct observations of 
corrective actions as an ongoing verification activity (9 CFR 
417.4(2)(ii)). Proposed Sec.  117.150(c) would differ from the NACMCF 
HACCP guidelines (Ref. 34), the Codex HACCP guidelines (Ref. 35), and 
FDA's HACCP regulations for seafood and juice (Sec. Sec.  
123.8(a)(3)(ii) and 120.11(a)(1)(iv)(B), respectively), which address 
verification of corrective actions through the review of records (which 
would be required by proposed Sec.  117.150(d)(2)(i)) but do not 
otherwise address verification activities for corrective actions.
    Proposed Sec.  117.150(c) would not specify the verification 
activities that must be conducted for corrective actions. We request 
comment on whether proposed Sec.  117.150(c) should do so, and if so, 
what verification activities should be required.
5. Proposed Sec.  117.150(d)--Implementation and Effectiveness
    Proposed Sec.  117.150(d) would require that the owner, operator, 
or agent in charge of a facility verify the preventive controls are 
consistently implemented and are effectively and significantly 
minimizing or preventing the hazards that are reasonably likely to 
occur. This must include the requirements in proposed Sec.  
117.150(d)(1) and (2), as appropriate to the facility and the food. 
Proposed Sec.  117.150(d) would implement section 418(f)(4) of the FD&C 
Act, which requires in relevant part verification by ``appropriate 
means'' that the preventive controls ``are effectively and 
significantly minimizing or preventing the occurrence of identified 
hazards.''
    a. Proposed Sec.  117.150(d)(1)--Calibration. Proposed Sec.  
117.150(d)(1) would require calibration of process monitoring 
instruments and verification instruments. As discussed in section 
II.D.3 of this document, the combination of monitoring (proposed Sec.  
117.140(a)), recordkeeping (proposed Sec.  117.175), and verification 
(proposed Sec.  117.150(a) and (d)) would establish a system that would 
provide assurance that hazards identified in the hazard analysis 
conducted under section 418(b)(1) of the FD&C Act would be 
significantly minimized or prevented and that food manufactured, 
processed, packed or held by such facility would not be adulterated 
under section 402 of the FD&C Act or misbranded under section 403(w) of 
the FD&C Act. In many instances, monitoring and verification activities 
rely on instruments (such as a pH meter or a thermometer) that must be 
calibrated. Calibration provides assurance that an instrument is 
measuring accurately. If these instruments are not properly calibrated, 
the values they provide may not provide the necessary assurance that 
hazards will be significantly minimized or prevented. If an instrument 
is calibrated against a known reference, the reference standard may 
also need periodic calibration (e.g., the standard reference 
thermometer used to calibrate a thermometer used in processing

[[Page 3757]]

equipment will itself also need to be calibrated periodically).
    Instrument calibration is performed on a regular or periodic basis 
based upon the type of instrument being used and its sensitivity to 
factors such as the operating environment and the wear and tear of 
ongoing use. The type of instruments used in a particular facility and 
the manner of their use will largely determine the need for, and the 
frequency of, calibration, and the frequency of calibration is often 
prescribed by the instrument manufacturer. Therefore, proposed Sec.  
117.150(d)(1) would not specify a frequency for calibration.
    b. Proposed Sec.  117.150(d)(2)--Records review. Proposed Sec.  
117.150(d)(2) would require a review of specific records related to 
monitoring, corrective actions and certain verification activities 
within specified time frames, by (or under the oversight of) a 
qualified individual, to ensure that the records are complete, the 
activities reflected in the records occurred in accordance with the 
food safety plan, the preventive controls are effective, and 
appropriate decisions were made about corrective actions. Proposed 
Sec.  117.150(d)(2)(i) would require review of the monitoring and 
corrective action records within a week after the records are made. 
Proposed Sec.  117.150(d)(2)(ii) would require review of the records 
related to calibration within a reasonable time after the records are 
made. (As discussed in section XII.I.2 of this document, proposed Sec.  
117.175 would list the records that facilities must establish and 
maintain, including records that document the monitoring of preventive 
controls as required by Sec.  117.140(c), corrective actions as 
required by Sec.  117.140(d), and verification activities as required 
by Sec.  117.150(g)).
    Proposed Sec.  117.150(d)(2) would implement section 418(f) of the 
FD&C Act and is consistent with the NACMCF HACCP guidelines, the Codex 
HACCP guidelines, and Federal HACCP regulations for seafood, juice, and 
meat and poultry. The NACMCF HACCP guidelines provide examples of 
verification activities, including review of the HACCP plan for 
completeness, review of monitoring records, and review of records for 
deviations and corrective actions (Ref. 34). The examples of 
verification activities in the Codex HACCP Annex include a review of 
the HACCP plan and its records (Ref. 35). Our HACCP regulations for 
seafood (Sec.  123.8(a)(3)(i) through (iii)) and juice (Sec.  
120.11(a)(1)(iv)(A) through (C)) require a review of the records that 
document the monitoring of critical control points, the taking of 
corrective actions, the calibrating of any process control instruments 
used at critical control points, and the performing of any periodic 
end-product or in-process testing that is part of the processor's 
verification activities. The FSIS HACCP regulation for meat and poultry 
requires a review of all required records (9 CFR 417(a)(2)(iii)).
    Proposed Sec.  117.150(d)(2) would establish that the purpose of 
the review of records would be to ensure that the records are complete, 
the activities reflected in the records occurred in accordance with the 
food safety plan, the preventive controls are effective, and 
appropriate decision were made about corrective actions. We tentatively 
conclude that review of the records required by proposed Sec.  
117.150(d)(2)(i) and (ii) would accomplish these purposes. Reviewing 
monitoring records can reveal whether they contain information on all 
the parameters that were to be monitored to determine whether a process 
is delivered in accordance with the food safety plan. For example, if 
both the size of food particles to be acidified and the pH of the food 
after acidification are critical to the safety of the food, review of 
the monitoring records would demonstrate whether both particle size and 
pH were monitored and whether the values were within specified 
parameter values. Reviewing monitoring records can reveal whether a 
process followed the procedures specified in the facility's food safety 
plan (e.g., if the monitoring records show the pH of every other batch 
of an acidified food when the plan specified the measurement of every 
batch). Review of monitoring records also can reveal whether any 
information is missing--e.g., a designated lot number--so that the 
missing information can be quickly identified and added to the record 
if necessary. We seek comment on this proposal.
    If the review of the records reveals that the records do not 
contain all information specified by the food safety plan, or that the 
procedure in the food safety plan was not followed, the facility will 
not be able to conclude that its preventive controls were implemented 
in accordance with its food safety plan for those activities. Because 
the food safety plan establishes the procedures needed to ensure 
preventive controls are effective, if the records review indicates that 
the plan is not being followed, e.g., the records are missing critical 
information or the activities were not performed as specified in the 
plan, the facility will not be able to conclude its preventive controls 
were effective. For example, if the records show that food particle 
size is not being determined or that the particles are too large, 
acidification of all parts of the particle may not occur rapidly enough 
to ensure control of pathogens such as C. botulinum. If the plan 
requires determination of the pH of each batch of product but the 
records do not show that the pH was measured on all batches, the 
facility cannot be sure that the pH of those batches is correct, again 
posing a potential risk from C. botulinum. As a result, the facility 
would not be able to verify that its preventive controls are 
effectively and significantly minimizing or preventing the occurrence 
of identified hazards as required by Section 418(f) of the FD&C Act.
    Review of records can also reveal whether appropriate decisions 
were made about corrective actions. The review should determine whether 
all the corrective action procedures required by proposed Sec.  
117.145(a)(3) have been followed, e.g., that actions are taken to 
prevent recurrence of the problem, that affected food has been 
evaluated for safety, and that affected food is prevented from entering 
commerce unless it can be determined that the food is not adulterated 
under section 402 of the FD&C Act or misbranded under section 403(w) of 
the FD&C Act. For example, a food safety plan may require that each 
package of product pass through a properly functioning metal detector 
and that the operator determine every two hours whether metal test 
pieces of a specified type and size are rejected when passed through 
the metal detector. If one of the test pieces was not rejected but 
production continued until a supervisor doing a verification check 
noted the problem, then corrective actions should have been taken and a 
corrective action record produced. A review of the corrective action 
records should reveal that all packages of product that passed through 
the metal detector since the last test showing the metal detector was 
functioning appropriately were held and passed through a functioning 
metal detector before being released into commerce. The records should 
also show that the metal detector was adjusted to reject the metal test 
pieces before it was used again to check product during production.
    Proposed Sec.  117.150(d)(2) would require that the review of 
records be performed by (or under the oversight of) a qualified 
individual (see the discussion in section XII.H of this document 
regarding the activities that must be performed (or overseen) by a 
qualified individual as would be established in proposed Sec.  
117.155). The review of records is critical to assessing

[[Page 3758]]

the facility's application of the preventive controls system and, thus, 
is fundamental to ensuring its successful operation. Our HACCP 
regulations for seafood (Sec.  123.8(a)(3)) and juice (Sec.  
120.11(a)(1)(iv)) require that the review of records be conducted by an 
individual who has successfully completed training in the application 
of HACCP principles to the processing of the applicable food product at 
least equivalent to that received under standardized curriculum 
recognized as adequate by FDA, or who is otherwise qualified through 
job experience to perform this function. The FSIS HACCP regulation for 
meat and poultry requires that records be reviewed, ``preferably'' by 
an individual trained by successfully completing a course of 
instruction in the application of the HACCP principles to meat or 
poultry product processing (9 CFR 417.5(c) and 417.7(b)). The NACMCF 
HACCP guidelines stress the role of qualified experts in the 
development and evaluation of a HACCP plan, and recommend periodic 
comprehensive verification of the HACCP system by an unbiased, 
independent authority, internal or external to the food operation, 
including review of appropriate records from operation of the plan 
(Ref. 34). The Codex HACCP Annex does not specifically address the need 
for a qualified individual to review the records other than to 
recommend that where certain verification activities cannot be 
performed in-house, verification be performed on behalf of the business 
by external experts or qualified third parties (Ref. 35).
    Proposed Sec.  117.150(d)(2)(i) would require review of the 
monitoring and corrective action records within a week after the 
records are made. Although proposed Sec.  117.150(d)(2)(i) would 
establish a more frequent review of these records than recommended in 
the NACMCF guidelines (which recommend monthly verification of 
monitoring records and corrective action records), it is consistent 
with our HACCP regulations for seafood (Sec.  123.8(a)(3)(i) and (ii)) 
and juice (Sec.  120.11(a)(1)(iv)(A) and (B)), which require that the 
review of monitoring records and corrective action records occur within 
one week of the day that the records are made. Even for shelf-stable 
foods (e.g., low-acid canned foods and acidified foods) our experience 
has demonstrated that review of these kinds of records is a critical 
verification tool (60 FR 65096 at 65133). We seek comment on the 
proposed one week timeline. The FSIS HACCP regulation for meat and 
poultry requires records to be reviewed prior to shipping product (9 
CFR 417.5(c). As discussed in the seafood HACCP final rule (60 FR 65096 
at 65132), review of records needs to occur with sufficient frequency 
so as to ensure that any problems in the design and implementation of 
the HACCP plan are uncovered promptly and to facilitate prompt 
modifications. The concept is roughly that of a ``feedback loop,'' with 
information coming out of the record review process in such a timely 
manner that it can have impact on the production of subsequent lots of 
the product. If a problem with product is discovered during a review of 
records, all product since the last review could be affected. Although 
verification prior to shipment provides a valuable added assurance, FDA 
explained in the preamble to the seafood HACCP final rule (60 FR 65096 
at 65132) that with highly perishable products this is not always 
possible and that a weekly review of monitoring and corrective action 
records would provide for timely feedback of information and limit the 
amount of product impacted by any problems identified during the review 
of the records.
    Proposed Sec.  117.150(d)(2)(ii) would require review of the 
records related to calibration within a reasonable time after the 
records are made. The review of calibration records will depend in part 
on the frequency with which calibrations occur, which will be 
established in the food safety plan. If calibrations occur daily, it 
would be reasonable to review these records weekly. Where several 
instruments are calibrated each month, a monthly review of all the 
calibrations would be reasonable. Consequently, FDA tentatively 
concludes that setting a specific frequency for review of these records 
is not warranted. Proposed Sec.  117.150(d)(2)(ii) is, in relevant 
part, consistent with our HACCP regulations for seafood (Sec.  
123.8(a)(3)(iii)) and juice (Sec.  120.11(a)(1)(iv)(C)), which require 
that the review of records of calibrating of any process control 
instruments used at critical control points occur within a reasonable 
time after the records are made.
    As noted previously, proposed Sec.  117.150(d)(2) would require a 
review of records in part to determine whether the preventive controls 
are effective. A review should determine whether monitoring and 
corrective actions have been done in accordance with the food safety 
plan and whether the instruments used in monitoring and verification 
were properly calibrated. If food safety activities appropriate to the 
facility have been conducted in accordance with the plan and this is 
reflected in the records, the facility thus verifies the preventive 
controls are effective, i.e., that its preventive controls are 
effectively and significantly minimizing or preventing the occurrence 
of identified hazards as required by Section 418(f) of the FD&C Act.
6. Proposed Sec.  117.150(e)--Written Procedures for Verification 
Activities
    Proposed Sec.  117.150(e) would require that the owner, operator, 
or agent in charge of a facility establish and implement written 
procedures for the frequency of calibrating process monitoring 
instruments and verification instruments. We are proposing to require 
written procedures for the frequency of calibration because the 
frequency of calibration will vary depending on the instrument and the 
process or verification activity that it pertains to.
    We are not proposing to require that written procedures be 
developed for all verification procedures. In some instances the 
records of verification activities provide the information needed to 
understand how the verification activity has been carried out and to 
assess whether the verification activity is adequately demonstrating 
that the preventive controls are effective in significantly minimizing 
or preventing the hazards reasonably likely to occur. For example, we 
are not proposing to require written procedures for validation, 
verification of monitoring and corrective actions, or calibration of 
process monitoring instruments and verification instruments (other than 
for the frequency of calibration). Validation involves a variety of 
procedures, including evaluation of scientific and technical 
information and conducting laboratory and in-plant studies that 
generally do not follow a standardized protocol or approach. Records of 
monitoring and corrective actions provide the information needed to 
understand how the verification activity was carried out. In many 
instances the calibration of process monitoring instruments and 
verification instruments will be done by contract with other entities 
and the facility would not have access to the procedures used; having 
instruments calibrated and documenting the calibration provides the 
necessary assurance that such instruments will be accurate. However, 
the frequency of calibration must be specified to ensure that the 
instruments are calibrated on a schedule appropriate to the instrument 
and the process it controls.
    Section 418(f) of the FD&C Act establishes certain requirements for 
verification, and section 418(h) of the

[[Page 3759]]

FD&C Act requires that the procedures used by the facility to comply 
with the requirements of section 418 be included in the written plan. 
Our HACCP regulations for seafood and juice both require that the HACCP 
plan be written (Sec. Sec.  123.6(b) and 120.8(a), respectively) and 
that procedures for verification be included in the written HACCP plan 
(Sec. Sec.  123.6(c)(6) and 120.8(b)(6), respectively). The FSIS HACCP 
regulation for meat and poultry requires that the establishment 
maintain a record of the written HACCP plan, including, in relevant 
part, documents supporting the verification procedures selected and the 
frequency of those procedures (9 CFR 417.5(a)(2)). Thus, requiring 
verification procedures to be written implements the requirements in 
section 418 of the FD&C Act and is consistent with the requirements in 
HACCP regulations for seafood, juice, and meat/poultry.
7. Proposed Sec.  117.150(f)--Reanalysis
    a. Proposed Sec.  117.150(f)(1)--Reanalysis on the initiative of 
the owner, operator, or agent in charge of a facility. Proposed Sec.  
117.150(f)(1)(i) would require that the owner, operator, or agent in 
charge of a facility conduct a reanalysis of the food safety plan:
     At least once every 3 years (proposed Sec.  
117.150(f)(1)(i)(A));
     Whenever a significant change is made in the activities 
conducted at a facility operated by such owner, operator, or agent in 
charge if the change creates a reasonable potential for a new hazard or 
a significant increase in a previously identified hazard (proposed 
Sec.  117.150(f)(1)(i)(B));
     Whenever such owner, operator or agent in charge becomes 
aware of new information about potential hazards associated with the 
food (proposed Sec.  117.150(f)(1)(i)(C));
     Whenever a preventive control is not properly implemented 
and a specific corrective action procedure has not been established 
(proposed Sec.  117.150(f)(1)(i)(D)); and
     Whenever a preventive control is found to be ineffective 
(proposed Sec.  117.150(f)(1)(i)(E)).
    For example, if a facility that bottles beverages develops a food 
safety plan for its products packaged in plastic bottles and 
subsequently introduces a glass bottling line, the facility would be 
required to reanalyze its food safety plan because the glass bottling 
line creates a reasonable potential for a new hazard, i.e., glass 
particles. Similarly, if a facility that conducts dry roasting 
operations for nuts makes design changes to its roasters to increase 
product throughput, the facility would be required to reanalyze its 
food safety plan because a design change to equipment that is used to 
control a hazard that is reasonably likely to occur would be a 
significant change in the activities conducted at the facility.
    The owner, operator or agent in charge of a facility may become 
aware of a problem due to the finding of a hazard in a food as the 
result of testing by a regulatory agency (Federal, State, tribal, or 
foreign government) that would require an analysis of the food safety 
plan to ensure the hazard is significantly minimized or prevented by 
appropriate preventive controls. In addition, new hazards can emerge--
e.g., as identified through the investigation of outbreaks of foodborne 
illness by CDC or other public health agencies. For example, L. 
monocytogenes was not recognized as a food safety hazard until a series 
of outbreaks of foodborne illness associated with the consumption of 
foods such as coleslaw and fresh soft cheese in the early 1980s (Ref. 
178). As another example, in 2006-2007 there was an outbreak of 
salmonellosis due to contamination of peanut butter with Salmonella 
Tennessee (Ref. 63). This was the first outbreak of foodborne illness 
caused by peanut butter consumption in the U.S. and it demonstrated the 
need for manufacturers to address the hazard of Salmonella spp. in this 
product. Information about outbreaks and ensuing product recalls is 
widely disseminated, including on FDA's Web site, and modern 
communication tools make it possible for the owner, operator, or agent 
in charge of a facility to receive such information automatically. For 
additional discussion related to the proposed requirement that the 
owner, operator, or agent in charge of a facility conduct a reanalysis 
whenever such owner, operator or agent becomes aware of new information 
about potential hazards associated with the food, see the discussion in 
section XII.G.7 of this document of proposed Sec.  117.150(f)(3), which 
would provide that FDA may require a reanalysis of the food safety plan 
to respond to new hazards and developments in scientific understanding.
    As noted in section XII.F.3, proposed Sec.  117.145(b)(2) would 
require that the owner, operator, or agent in charge of a facility 
reanalyze the food safety plan in accordance with proposed Sec.  
117.150(f) to determine whether modification of the food safety plan is 
required if a preventive control is not properly implemented or is 
found to be ineffective, and a specific corrective action has not been 
established. If the owner, operator, or agent in charge of a facility 
has not identified a specific failure as a foreseeable occurrence, the 
deviation may be the result of a system-wide problem that is not being 
properly addressed by the food safety plan (e.g., ineffective 
preventive controls). Thus, an unforeseen failure for which a 
corrective action was not identified may indicate an ineffective 
preventive control, and a reanalysis of the food safety plan is 
warranted. Similarly, when information arises indicating that the 
preventive control has not been effective in significantly minimizing 
or preventing a hazard from occurring, a reanalysis must be conducted 
to determine if the food safety plan should be modified to ensure that 
the preventive controls implemented are adequate to significantly 
minimize or prevent a hazard identified as reasonably likely to occur.
    Proposed Sec.  117.150(f)(1)(i) would implement sections 418(f)(5) 
and 418(i) of the FD&C Act and is consistent with the NACMCF HACCP 
guidelines, the Codex HACCP guidelines, the Codex validation 
guidelines, and Federal HACCP regulations for seafood, juice, and meat 
and poultry. FDA notes that the terminology used in relation to the 
concept of ``reanalysis'' varies in the regulations and guidelines 
(e.g., ``subsequent validation,'' ``re-validation,'' ``reassessment of 
the hazard analysis,'' and ``validation'' of the HACCP plan). The 
NACMCF HACCP guidelines include validation of a HACCP plan to ensure 
that the plan is scientifically and technically sound and that all 
hazards have been identified as an important verification activity, and 
advise a subsequent validation under circumstances such as an 
unexplained system failure; a significant product, process or packaging 
change; or the recognition of new hazards (Ref. 34). The NACMCF HACCP 
guidelines also discuss the need for a periodic comprehensive 
verification of the HACCP system, including a technical evaluation of 
the hazard analysis and each element of the HACCP plan, independent of 
other verification procedures to ensure that the HACCP plan is 
resulting in control of the hazards. If the results of the 
comprehensive verification identify deficiencies, the HACCP team 
modifies the HACCP plan as necessary (Ref. 34). Likewise, the Codex 
HACCP Annex recommends that the HACCP application be reviewed and 
necessary changes made when any modification is made in the product, 
process, or any step (Ref. 35). The Codex validation guidelines provide 
examples of situations that could lead to the need to

[[Page 3760]]

re-validate a control measure or combination of control measures, e.g., 
system failure, process changes, and new scientific or regulatory 
information (Ref. 127).
    Our HACCP regulation for seafood requires a reassessment of the 
adequacy of the HACCP plan whenever any changes occur that could affect 
the hazard analysis or alter the HACCP plan in any way, or at least 
annually (Sec.  123.8(a)(1)). Our HACCP regulation for juice requires 
an initial validation within 12 months after implementation and at 
least annually or whenever any changes in the process occur that could 
affect the hazard analysis or alter the HACCP plan in any way (Sec.  
120.11(b)). The FSIS HACCP regulation for meat and poultry requires 
that every establishment reassess the adequacy of the HACCP plan at 
least annually and whenever any changes occur that could affect the 
hazard analysis or alter the HACCP plan (9 CFR 417.4(a)(3)).
    In addition, Federal HACCP regulations for seafood, juice, and meat 
and poultry require a reassessment of the hazard analysis when a 
processor does not have a HACCP plan (because the hazard analysis 
revealed no hazards reasonably likely to occur) and there are changes 
that could affect whether a food safety hazard now exists (Sec. Sec.  
123.8(c) and 120.11(c), and 9 CFR 417.4(a)(4) for seafood, juice, and 
meat and poultry, respectively). Each of these HACCP regulations 
provides examples of changes that may be considered to reasonably 
affect whether a food safety hazard now exists and, thus, require 
reassessment of the adequacy of the hazard analysis (Sec. Sec.  
123.8(a)(1) and 120.11(b) and 9 CFR 417.4(a)(4)). Such changes include 
changes in raw materials or the source of raw materials; product 
formulation; processing methods or systems, including computers and 
their software; packaging; finished product distribution systems; the 
intended use or consumers of the finished product; and slaughter or 
processing methods or systems for meat or poultry.
    The requirement in proposed Sec.  117.150(f)(1)(i)(A) that the 
periodic reanalysis of the food safety plan occur at least once every 3 
years would be different from the current requirement in our HACCP 
regulations for seafood and juice and in the FSIS HACCP regulation for 
meat and poultry for reassessment (validation) of the adequacy of the 
HACCP plan to be done ``at least annually'' (Sec. Sec.  123.8(a)(1) and 
120.11(b) and 9 CFR 417.4(a)(3), respectively). The 3-year minimum 
frequency for the periodic reanalysis of the food safety plan is 
explicitly required by section 418(i) of the FD&C Act. We tentatively 
conclude that, as a practical matter, the proposed requirement for 
reanalysis whenever a significant change is made in the activities 
conducted at a facility if the change creates a reasonable potential 
for a new hazard or a significant increase in a previously identified 
hazard makes it likely that reanalysis would occur more frequently than 
every 3 years because such changes are likely to occur more frequently 
than every 3 years.
    Proposed Sec.  117.150(f)(1)(ii) would require that the owner, 
operator, or agent in charge of a facility complete the required 
reanalysis and implement any additional preventive controls needed to 
address the hazard identified, if any, before the change in activities 
at the facility is operative or, when necessary, during the first 6 
weeks of production. The purpose of the reanalysis is to identify the 
need for, and implement, preventive controls in light of a reasonable 
potential for a new hazard, or a significant increase in a previously 
identified hazard, that is reasonably likely to occur. It follows that 
the preventive controls must be in place before making the change that 
creates the potential for a new hazard or a significant increase in a 
previously identified hazard. As with initial validation in proposed 
Sec.  117.150(a)(1)(i), we are proposing to provide the first six weeks 
of production, when necessary, to implement any additional preventive 
controls to allow facilities to methodically collect data and 
information during production to ensure the needed change can be 
implemented in the facility. We seek comment on this timeframe. 
Proposed Sec.  117.150(f)(1)(ii) would implement section 418(i) of the 
FD&C Act. Although proposed Sec.  117.150(f)(1)(ii) has no explicit 
counterpart in the NACMCF HACCP guidelines, the Codex HACCP guidelines, 
or Federal HACCP regulations for seafood, juice, and meat and poultry, 
it is consistent with the importance placed on reanalysis of the HACCP 
plans in those guidelines and regulations and with requirements to 
modify the HACCP plan immediately whenever validation reveals the need 
to do so, as discussed immediately below.
    Proposed Sec.  117.150(f)(1)(iii) would require that the owner, 
operator, or agent in charge of a facility revise the written plan if a 
significant change is made or document the basis for the conclusion 
that no additional or revised preventive controls are needed. Proposed 
Sec.  117.150(f)(1)(iii) would implement section 418(i) of the FD&C 
Act, which requires that the written plan be revised ``if * * * a 
significant change is made or document the basis for the conclusion 
that no additional or revised preventive controls are needed.'' As 
discussed in section XII.B.2.b of this document, the written hazard 
analysis is required even if the conclusion of the analysis is that 
there are no hazards reasonably likely to occur. It is also important 
to document that a reanalysis has been conducted even if no change has 
been made, as required by section 418(i) of the FD&C Act. Such 
documentation demonstrates that a facility has considered all relevant 
information on the safety of the products being produced, including new 
information that has become available since the last analysis, and 
determined that current procedures for implementing preventive controls 
are adequate to significantly minimize or prevent hazards that are 
reasonably likely to occur. Our HACCP regulations for juice and 
seafood, and the FSIS regulation for meat and poultry, require that the 
HACCP plan be modified immediately whenever a validation/reassessment 
reveals that the plan is no longer adequate to fully meet the 
requirements of the HACCP regulations (Sec. Sec.  120.11(b) and 
123.8(a)(1) and 9 CFR 417.4(a)(3) for juice, seafood, and meat/poultry, 
respectively), although they do not explicitly require documentation of 
the basis for the conclusion that no additional or revised preventive 
controls are needed. Although proposed Sec.  117.150(f)(1)(iii) has no 
explicit counterpart in the NACMCF HACCP guidelines or the Codex HACCP 
guidelines, it is consistent with the importance placed on reanalysis 
of the HACCP plans in those guidelines and regulations, and with the 
written nature of the HACCP plan. The Codex validation guidelines 
indicate that if a system failure for which a process deviation cause 
cannot be identified occurs, re-validation may be needed (i.e., 
reanalysis is needed whenever a preventive control is found to be 
ineffective) (Ref. 127).
    b. Proposed Sec.  117.150(f)(2)--Requirement for a qualified 
individual. Proposed Sec.  117.150(f)(2) would require that the 
reanalysis be performed or overseen by a qualified individual. Proposed 
Sec.  117.150(f)(2) is consistent with proposed Sec. Sec.  117.126(c) 
which would require that the food safety plan be developed or overseen 
by a qualified individual. We tentatively conclude that the same 
qualifications are needed whether initially conducting a hazard 
analysis and establishing a food safety plan, or reanalyzing a hazard 
analysis and plan.

[[Page 3761]]

    c. Proposed Sec.  117.150(f)(3)--Reanalysis on the initiative of 
FDA. Proposed Sec.  117.150(f)(3) establishes that FDA may require a 
reanalysis of the food safety plan to respond to new hazards and 
developments in scientific understanding. This authority will be 
delegated to the Commissioner of Food and Drugs. Proposed Sec.  
117.150(f)(2) would implement section 418(i) of the FD&C Act, which 
provides in relevant part that ``[t]he Secretary may require a 
reanalysis * * * to respond to new hazards and developments in 
scientific understanding * * * .'' As discussed in section XII.G.7.a of 
this document, new hazards can emerge--e.g., as identified through the 
investigation of outbreaks of foodborne illness by CDC or other public 
health agencies. In addition, new developments can occur in the 
scientific understanding of existing or potential hazards--e.g., if 
scientists and food safety regulatory agencies develop a better 
understanding of the causes of these events. For example, the outbreak 
from Salmonella Tennessee in peanut butter resulted in a greater 
understanding of the risks posed by environmental contamination and the 
importance of control of water in facilities producing low-moisture 
foods (Ref. 145) (Ref. 179). Information submitted to the RFR--which is 
a relatively recent addition to the regulatory framework for food 
safety--has the potential to identify new hazards or routes of 
contamination even before outbreaks occur. For example, the January 
2011 RFR Annual Report (Ref. 60) identified a high number of primary 
reports involving Salmonella spp. in spices and seasonings, and we have 
requested comments and scientific data and information to assist us in 
our plans to conduct a risk profile for pathogens and filth in spices 
(75 FR 20615, April 20, 2010). The purpose of the risk profile is to 
ascertain the current state of knowledge about spices contaminated with 
microbiological pathogens and/or filth, and the effectiveness of 
current and potential new interventions to reduce or prevent illnesses 
from contaminated spices.
8. Proposed Sec.  117.150(g)--Requirement for Records for Verification
    Proposed Sec.  117.150(g) would require that all verification 
activities taken in accordance with this section be documented in 
records. Proposed Sec.  117.150(g) would implement section 418(g) of 
the FD&C Act and is consistent with the NACMCF HACCP guidelines, the 
Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, 
and meat and poultry. The NACMCF HACCP guidelines recommend that the 
records maintained for the HACCP system include records that are 
generated during the operation of the plan and includes verification 
records as an example of HACCP records in an appendix (Ref. 34). The 
Codex HACCP Annex gives records of verification procedures performed as 
an example of records (Ref. 35). Our HACCP regulations for seafood and 
juice require that recordkeeping include the calibration of process-
monitoring instruments (Sec. Sec.  123.8(d) and 120.11(a)(2), 
respectively). The FSIS HACCP regulation for meat and poultry requires 
records documenting the calibration of process-monitoring instruments, 
as well as verification procedures and results.

H. Proposed Sec.  117.155--Requirements Applicable to a Qualified 
Individual

    Proposed Sec.  117.155(a) would require that one or more qualified 
individuals prepare the food safety plan (proposed Sec.  117.126(c)), 
validate the preventive controls (proposed Sec.  117.150(a)(1)), review 
records for implementation and effectiveness of preventive controls 
(proposed Sec.  117.150(d)(2)), and perform reanalysis of the food 
safety plan (proposed Sec.  117.150(f)(2)). We have discussed the basis 
for requiring that a trained individual perform or oversee these 
functions in our discussion of each applicable proposed provision. We 
are listing the functions that must be performed by a trained 
individual in Sec.  117.155(a) for simplicity and are not imposing any 
additional requirement through this list. A single individual with 
appropriate qualifications could perform all of the listed functions, 
but there would be no requirement for the same individual to perform 
all the listed functions.
    Proposed Sec.  117.155(b) would establish the qualification 
requirements applicable to a qualified individual. To be qualified, an 
individual must have successfully completed training in the development 
and application of risk-based preventive controls at least equivalent 
to that received under a standardized curriculum recognized as adequate 
by the FDA, or be otherwise qualified through job experience to develop 
and apply a food safety system. Training or job experience is essential 
to the effective development and implementation of a hazard analysis 
and risk-based preventive controls. Only a trained individual or 
individual qualified by job experience is capable of effectively 
executing certain activities, such as identifying hazards that are 
reasonably likely to occur; identifying preventive controls that will 
address those hazards; evaluating scientific and technical information 
to determine whether the food safety plan, when properly implemented, 
will effectively control the hazards that are reasonably likely to 
occur; determining the maximum or minimum value, or combination of 
values, to which any biological, chemical, physical, or radiological 
parameter must be controlled to significantly minimize or prevent a 
hazard that is reasonably likely to occur; determining whether 
monitoring procedures and corrective action procedures are appropriate; 
and determining whether specific corrective actions have been 
appropriate and effective. In addition, the products produced by the 
food industry are diverse, and the hazards that are reasonably likely 
to occur in a particular facility depend on a range of factors that 
vary from one facility to the next. We seek comment on the scope of the 
qualifications identified.
    Proposed Sec.  117.155 is consistent with the NACMCF HACCP 
guidelines, our HACCP regulations for seafood and juice, and USDA's 
HACCP regulations for meat and poultry. The NACMCF HACCP guidelines 
recommend that experts who are knowledgeable in the food process either 
participate in or verify the completeness of the HACCP plan (Ref. 34). 
Our HACCP regulations for seafood and juice both require that only a 
trained individual be responsible for developing the hazard analysis 
(juice only), developing the HACCP plan, verifying and modifying the 
HACCP plan, and performing the record review (Sec. Sec.  123.10(a)-(c) 
and 120.13(a)(1)-(4), respectively). These regulations also provide 
that job experience will qualify an individual to perform these 
functions if it has provided knowledge at least equivalent to that 
provided through the standardized curriculum. USDA's HACCP regulations 
for meat and poultry require that only an individual who has completed 
a training course can conduct certain activities, such as development 
and modification of the HACCP plan (9 CFR Sec.  417.7).
    FDA did not conduct HACCP training for persons subject to our HACCP 
regulations for seafood or juice. However, when implementing those 
regulations, FDA worked with an alliance of representatives from 
Federal and State agencies, industry and academia, to create a uniform, 
core training program that serves as the standardized curriculum 
against which other course materials can be judged. FDA will be working 
with an alliance to develop such a standardized curriculum for any 
final rule establishing requirements for hazard analysis and risk-based 
preventive controls. Having a

[[Page 3762]]

standardized curriculum on which facilities, as well as private 
organizations and academia that conduct training, can base their 
materials and training would provide a framework to ensure minimum 
training requirements are met.
    Proposed Sec.  117.155(b) also would provide that the qualified 
individual may be, but is not required to be, an employee of the 
facility. FDA expects that some facilities may rely on assistance from 
qualified individuals that are not employees of the facility, such as 
individuals associated with universities, trade associations, and 
consulting companies. Proposed Sec.  117.155(b) is consistent with 
HACCP regulations for seafood and juice, which have virtually identical 
requirements (Sec. Sec.  123.10 and 120.13(b), respectively). The 
option in proposed Sec.  117.155(b) would provide flexibility to 
facilities subject to the rule. Such flexibility may be particularly 
important for those facilities that have limited technical expertise.
    Proposed Sec.  117.155(c) would require that all applicable 
training be documented in records, including the date of the training, 
the type of training, and the person(s) trained. Such records would be 
a simple mechanism to demonstrate that a person has successfully 
completed training in the development and application of risk-based 
preventive controls at least equivalent to that received under a 
standardized curriculum recognized as adequate by the FDA, as would be 
required under proposed Sec.  117.155(b) should the qualified 
individual not be otherwise qualified through job experience to develop 
and apply a food safety system.

I. Proposed Sec.  117.175--Records Required for Subpart C

1. Requirements of Section 418 of the FD&C Act
    Section 418(g) of the FD&C Act, in relevant part, specifies that 
the owner, operator, or agent in charge of a facility shall maintain, 
for not less than 2 years, records documenting the monitoring of the 
preventive controls implemented under section 418(c) of the FD&C Act, 
instances of nonconformance material to food safety, the results of 
testing and other appropriate means of verification under section 
418(f)(4) of the FD&C Act, instances when corrective actions were 
implemented, and the efficacy of preventive controls and corrective 
actions.
    Section 418(h) of the FD&C Act, in relevant part, specifies that 
the owner, operator, or agent in charge of a facility shall prepare a 
written plan that documents and describes the procedures used by the 
facility to comply with the requirements of section 418 of the FD&C 
Act, including analyzing the hazards under section 418(b) of the FD&C 
Act and identifying the preventive controls adopted under section 
418(c) of the FD&C Act to address those hazards. Section 418(h) of the 
FD&C Act also specifies that the written plan, together with the 
documentation described in Section 418(g) of the FD&C Act, shall be 
made promptly available to a duly authorized representative of the 
Secretary upon oral or written request.
2. Proposed Sec.  117.175--Records Required for Subpart C
    Proposed Sec.  117.175(a)(1) through (5) would require that the 
owner, operator, or agent in charge of a facility establish and 
maintain the following records:
     The written food safety plan, including the written hazard 
analysis, preventive controls, monitoring procedures, corrective action 
procedures, verification procedures, and recall plan;
     Records that document the monitoring of preventive 
controls;
     Records that document corrective actions;
     Records that document verification, including, as 
applicable, those related to validation; monitoring; corrective 
actions; calibration of process monitoring and verification 
instruments; records review; and reanalysis; and
     Records that document applicable training for the 
qualified individual.
    Proposed Sec.  117.175(a) would not establish any new requirements 
but merely make it obvious at a glance what records are required under 
proposed part 117, subpart C.
    Proposed Sec.  117.175(b) would provide that the records that the 
owner, operator, or agent in charge of a facility must establish and 
maintain are subject to the requirements of part 117, subpart F. As 
discussed in section XV of this document, proposed subpart F would 
provide the general requirements that apply to all records required to 
be established and maintained by part 117, including provisions for 
retention of records and for making records available for official 
review.

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

1. Overview
    As discussed in section II.B.2 of this document, section 418(n) 
requires FDA to establish science-based minimum standards for, among 
other things, implementing preventive controls. In addition, section 
418(f) requires certain verification of those preventive controls. In 
this section of the preamble, we discuss several preventive controls 
(i.e., supplier controls) and verification measures (i.e., 
environmental and product testing programs) that FDA is not including 
as provisions in proposed part 117, subpart C.
    As we have already discussed (see section XII.C.1 of this 
document), section 418(c) requires the owner, operator, or agent in 
charge of a facility to identify and implement preventive controls. 
Section 418(o)(3) defines ``preventive controls'' to mean ``those risk-
based, reasonably appropriate procedures, practices and processes that 
a person knowledgeable about the safe manufacturing, processing, 
packing, or holding of food would employ to significantly minimize or 
prevent [identified hazards] and that are consistent with current 
scientific understanding of safe food manufacturing, processing, 
packing, or holding * * * .'' Section 418(o)(3) indicates that those 
procedures, practices and processes may include environmental 
monitoring, supplier verification activities, certain sanitation 
controls, and allergen controls. In addition, environmental and product 
testing programs are set out in section 418(f)(4): Section 418(f)(4) 
requires that the owner, operator, or agent in charge of a facility 
``verify that * * * the preventive controls * * * are effectively and 
significantly minimizing or preventing the occurrence of identified 
hazards, including through the use of environmental and product testing 
programs and other appropriate means.''
    We believe that the preventive controls and verification measures 
discussed in this section are an important part of a modern food safety 
system. We believe that the preventive controls discussed in this 
section (i.e., a supplier approval and verification program), when 
implemented appropriately in particular facilities, are ``risk-based, 
reasonably appropriate procedures, practices and processes that a 
person knowledgeable about the safe manufacturing, processing, packing, 
or holding of food would employ to significantly minimize or prevent 
[identified hazards] and that are consistent with current scientific 
understanding of safe food manufacturing, processing, packing, or 
holding * * * '' The verification procedures discussed in this section 
(i.e., environmental and product testing programs), when implemented

[[Page 3763]]

appropriately in particular facilities, could be used to verify that 
the preventive controls are effectively and significantly minimizing or 
preventing the occurrence of identified hazards. The use of and need 
for these preventive controls and verification measures, which are 
science-based, are widespread and commonly accepted in many sectors of 
the food industry. We request comment on these conclusions.
    As discussed (see section I of this document), food safety is best 
assured if each facility understands the hazards that are reasonably 
likely to occur in its particular product and operation and puts in 
place scientifically sound preventive controls to significantly 
minimize or eliminate those hazards. From a regulatory perspective, 
specifying the circumstances and manner in which these controls and 
practices are to be applied must take into account the wide array of 
factors, including the diversity among food products, the wide variety 
of manufacturing and processing methods used to produce the food, the 
variety of sources for raw materials and ingredients, variations in the 
nature and types of hazards associated with manufacturing, processing, 
packing and holding human food, and the possibility that different 
mitigation methods may achieve the same end. Further, regulatory 
requirements should make clear when one of these preventive controls or 
verification measures is necessary yet also be sufficiently flexible to 
account for a vast number of food and facility combinations and 
circumstances.
    Although we are not including provisions for environmental and 
product testing programs or a supplier approval and verification 
program in this proposed rule, we recognize that these preventive 
controls and verification measures, when implemented appropriately in 
particular facilities, can play important roles in effective food 
safety programs. The role and need for these measures varies depending 
on the type of products and activities of the facility. To facilitate 
comment and share our current thinking, we discuss the topics of 
environmental and product testing programs and a supplier approval and 
verification program immediately below. See the Appendix to this 
document for additional background information relevant to these 
topics.
2. Product Testing
    As discussed in section XII.G.1 of this document, section 418(f)(4) 
of the FD&C Act states that the owner, operator, or agent in charge of 
a facility shall verify that ``the preventive controls implemented 
under [section 418(c) of the FD&C Act] are effectively and 
significantly minimizing or preventing the occurrence of identified 
hazards, including through the use of environmental and product testing 
programs and other appropriate means'' The statute does not indicate 
the specific circumstances where product testing would be required or 
the specific manner in which such testing should be performed. FDA 
believes that the role and need for these measures varies depending on 
the type of products and activities of a facility. FDA further believes 
that the owner, operator, or agent in charge of a facility could 
consider a number of factors to establish a product testing program.
    Although finished product testing is rarely considered a preventive 
control, it plays a very important role as a verification measure in 
ensuring the safety of food, when implemented appropriately in 
particular facilities. Similarly, testing of raw materials or 
ingredients by a facility that is receiving the product often plays an 
important role in verification of hazard control that is performed by 
their supplier. Thus, an important purpose of testing is to verify that 
preventive controls, including those related to suppliers and those 
related to environmental monitoring, are controlling the hazard (Ref. 
111) (Ref. 112). Testing is used in conjunction with other verification 
measures in the food safety system, such as audits of suppliers, 
observations of whether activities are being conducted according to the 
food safety plan, and reviewing records to determine whether process 
controls are meeting specified limits for parameters established in the 
food safety plan.
    Finished product testing is more important and useful when there is 
a reasonable probability that exposure to an identified hazard will 
result in serious adverse health consequences or death to humans or 
animals. FDA believes that there are certain situations in which 
finished product testing is particularly useful as a verification 
measure, including the following circumstances:
     The outcome of the hazard analysis conducted under 
proposed Sec.  117.130 is that a biological hazard is reasonably likely 
to occur in an ingredient and the preventive controls established and 
implemented under proposed Sec.  117.135 do not include a process 
control that will significantly minimize the hazard. Examples include 
cut raw vegetables (such as celery, onions, leafy greens and tomatoes) 
that may contain Salmonella spp. or L. monocytogenes and that are 
intended to be used in RTE foods; nutrition bars in which dry 
ingredients (such as fruits, nuts, dried milk, soy proteins and 
chocolate) that may contain Salmonella spp. are formed into a bar 
without a lethal step; and mixtures of shelled nuts in which the nuts 
may be contaminated with Salmonella spp.
     The outcome of the hazard analysis conducted under 
proposed Sec.  117.130 is that a biological hazard is reasonably likely 
to occur in an ingredient that is added during manufacturing after the 
stage that applies a process control to significantly minimize 
biological hazards. Examples include food (such as chips, nuts and 
cereals) in which untreated seasonings that may contain Salmonella spp. 
are applied after a heat treatment and food (such as ice cream) to 
which nuts or other ingredients are added to an ice cream mix that has 
been pasteurized.
     The outcome of the hazard analysis conducted under 
proposed Sec.  117.130 is that a biological hazard is reasonably likely 
to occur as a result of handling of a product or exposure of a product 
to the environment after a process control that significantly minimizes 
a hazard such that a hazard could be introduced or re-introduced into 
the product. Examples include the manufacture of nut butters from 
roasted nuts (where contamination with Salmonella spp. from the 
environment is a concern); the mixing of dried, treated spices and 
herbs (where contamination with Salmonella spp. from the environment is 
a concern); the addition of herbs or vegetables to products such as 
cream cheese or cottage cheese (where contamination with L. 
monocytogenes from the environment is a concern); and the manual 
assembly of sandwiches (where contamination with S. aureus, L. 
monocytogenes, and enteric pathogens such as Salmonella spp. is a 
concern).
    In addition, the frequency of testing and the number of samples 
tested must be determined and needs to take into account a variety of 
hazard/commodity/facility considerations. FDA believes that factors to 
consider include whether ingredients that may contain a hazard have 
been tested, the extent of any environmental monitoring program, and 
whether other programs established by the facility provide added 
assurance that the potential for hazards has been minimized. The 
frequency of testing and the number of samples tested should have a 
scientific basis. Sampling plans and their performance have been 
described in the literature (Ref. 180) (Ref. 181) (Ref. 182) and are 
included in several Codex documents (Ref. 52) (Ref. 183). We discuss 
likely considerations that could impact finished product

[[Page 3764]]

verification testing in more detail in section I.F of the Appendix to 
this document.
    Although we are not including a testing provision in this proposed 
rule, we estimate that a requirement for a finished product testing 
program, when implemented appropriately in particular facilities, could 
impose an incremental annual cost of $14,000-$813,000 per facility 
based on size (number of employees) that adopts a testing and holding 
regime. This would result in an estimated aggregate cost of $23,500,000 
for domestic facilities based on an average of a range of $12,000,000-
$35,000,000 (assuming between 25 and 75 percent of relevant facilities 
conducting testing) and an estimated aggregate cost of $25,600,000 for 
foreign facilities. (As described in the PRIA, foreign costs are 
estimated by multiplying the domestic per facility cost by the total 
number of foreign facilities. See section XIX of this document for a 
discussion of the PRIA.) These costs assume that facilities will take 5 
finished product samples per product line on a monthly basis. The 
facilities that would adopt a testing and holding regime are facilities 
producing products for which finished product testing would be 
particularly useful as a verification measure, e.g., the production 
process does not have a step that will eliminate or reduce hazards to 
an acceptable level. This estimate excludes facilities that would be 
exempt under this proposed rule (using a definition of $250,000 for a 
very small business) and facilities that are already conducting 
finished product testing. Further details are provided in the 
``Consideration of Other Provisions'' section of the PRIA.
    FDA requests comment on when and how product testing programs are 
an appropriate means of implementing the statutory directives set out 
above. Although we have not included these provisions in the proposed 
rule, we request comment on their inclusion in a final rule. Should a 
product testing program be limited to finished product testing or 
include raw material testing? What is the appropriate level of 
specificity for a product testing program? For example, should we 
simply require that the owner, operator, or agent in charge conduct, as 
appropriate to the facility and the food, finished product testing, 
when appropriate based on risk, to assess whether the preventive 
controls significantly minimize or prevent the hazards that are 
reasonably likely to occur? This would provide flexibility to account 
for the wide diversity of food and food manufacturing, processing, 
packing and holding systems subject to this rule and be consistent with 
the discussions within this proposed rule.
    FDA also requests comment on whether more detail would be 
appropriate, by, for example:
     Specifying particular hazards, situations or product types 
for which finished product testing would be required;
     Specifying the frequency of testing and, if so, whether 
this frequency should depend on the type of product;
     Identifying appropriate sampling plans for finished 
product testing;
     Requiring periodic testing for trend analysis and 
statistical process control; and
     Requiring written procedures for conducting finished 
product testing and, if so, also require that procedures for finished 
product testing be scientifically valid and include the procedures for 
sampling and the sampling frequency.
    FDA also requests comment on the impact of product testing 
requirements on small businesses and on whether any product testing 
verification requirements should differ based on the size of the 
operation.
3. Environmental Monitoring
    As discussed in section XII.G.1 of this document, section 418(f)(4) 
of the FD&C Act states that the owner, operator, or agent in charge of 
a facility shall verify that ``the preventive controls implemented 
under [section 418(c) of the FD&C Act] are effectively and 
significantly minimizing or preventing the occurrence of identified 
hazards, including through the use of environmental and product testing 
programs and other appropriate means''. In addition, section 418(o)(3) 
indicates that preventive controls may include environmental monitoring 
to verify the effectiveness of pathogen controls is an example of 
preventive controls. The statute does not indicate the specific 
circumstances where environmental testing would be required or the 
specific manner in which such testing should be performed. 
Nevertheless, FDA believes that this testing can form an important 
component of a modern food safety system. FDA believes that the role 
and need for these measures varies depending on the type of products 
and activities of a facility. FDA further believes that the performance 
of environmental monitoring, for an appropriate microorganism of public 
health significance or for an appropriate indicator organism, is 
particularly useful as a verification measure for preventive controls 
(i.e., sanitation controls) when contamination of food with an 
environmental pathogen is a hazard reasonably likely to occur.
    As discussed in sections XII.B.3 and XII.B.4.b of this document, 
proposed Sec.  117.130(b) would require a hazard identification that 
must consider hazards that may occur naturally or may be 
unintentionally introduced; proposed Sec.  117.130(c)(2) would require 
that the hazard evaluation include an evaluation of whether 
environmental pathogens are reasonably likely to occur whenever a RTE 
food is exposed to the environment prior to packaging. The data from 
recalls and the RFR support a conclusion that Salmonella spp. is a 
hazard in low-moisture RTE food products (such as spices and 
seasonings, nuts and nut products, and seed products). When RTE foods 
such as these are exposed to the environment, FDA believes that most 
facilities producing such foods would identify Salmonella spp. as a 
known or reasonably foreseeable hazard under proposed Sec.  117.130(b) 
and evaluate whether Salmonella spp. contamination from the environment 
is reasonably likely to occur in the facility under proposed Sec.  
117.130(c)(2). A robust environmental monitoring program for Salmonella 
spp. can verify the effectiveness of sanitation controls designed to 
prevent Salmonella spp. from contaminating food-contact surfaces and 
food (Ref. 184).
    Likewise, the data from recalls and the RFR support a conclusion 
that L. monocytogenes is a hazard in refrigerated or frozen RTE food 
products (such as dairy products, fresh-cut produce, prepared foods 
such as sandwiches, and frozen foods). When RTE foods such as these are 
exposed to the environment, FDA believes that most facilities producing 
such foods would identify L. monocytogenes as a potential hazard under 
proposed Sec.  117.130(b) and evaluate whether L. monocytogenes is 
reasonably likely to occur in the facility under proposed Sec.  
117.130(c)(2). A robust environmental monitoring program for L. 
monocytogenes can verify the effectiveness of sanitation controls 
designed to prevent L. monocytogenes from contaminating food-contact 
surfaces and food (Ref. 52) (Ref. 144) (Ref. 185) (Ref. 186).
    As discussed in section A.5.c of the Appendix to this document, 
FDA's current thinking is that Listeria spp. may be an appropriate 
indicator organism for L. monocytogenes, because tests for Listeria 
spp. will detect multiple species of Listeria, including L. 
monocytogenes. However, FDA's current thinking is that there are no 
currently available indicator organisms for Salmonella spp. We request

[[Page 3765]]

comment on these findings and conclusions.
    Although we are not including an environmental testing provision in 
this proposed rule, we estimate that an environmental monitoring 
program for Salmonella spp., when implemented appropriately in 
particular facilities, could impose an incremental annual cost of 
$3,000-$6,000 per facility. These costs assume that facilities will 
take 5-15 environmental samples per month, based on facility size, and 
send the samples to an outside laboratory for testing. This would 
result in an estimated aggregate cost of $4,000,000 for domestic 
facilities based on an average of a range of $3,000,000-$5,000,000 
(assuming between 50 and 75 percent of relevant facilities conducting 
testing) and an estimated aggregate cost of $4,400,000 for foreign 
facilities.
    Similarly, we estimate that a requirement for an environmental 
monitoring program for Listeria, when implemented appropriately in 
particular facilities, could impose an incremental annual cost of 
$3,000-$6,000 per facility. These costs assume that facilities will 
take 5-15 environmental samples per month, based on facility size, and 
send the samples to an outside laboratory for testing. This would 
result in an estimated aggregate cost of $5,000,000 for domestic 
facilities based on an average of a range of $4,000,000-$6,000,000 
(assuming between 50 and 75 percent of relevant facilities conducting 
testing) and an estimated aggregate cost of $5,400,000 for foreign 
facilities. (As described in the PRIA, foreign costs are estimated by 
multiplying the domestic per facility cost by the total number of 
foreign facilities. See section XIX of this document for a discussion 
of the PRIA.)
    The facilities that could adopt environmental monitoring programs 
are facilities producing ready-to-eat products exposed to the 
environment whereby they may become contaminated and for which such 
testing would be particularly useful as a verification measure for 
sanitation controls. These estimates exclude facilities that would be 
exempt under this proposed rule (using a definition of $250,000 for a 
very small business) and facilities that are already conducting 
finished product testing. Further details are provided in the 
``Consideration of Other Provisions'' section of the PRIA.
    FDA requests comment on when and how environmental testing is an 
appropriate means of implementing the statutory directives set out 
above. Although we have not included these provisions in the proposed 
rule, we request comment on their inclusion in a final rule. If they 
are included, what is the appropriate level of specificity? For 
example, should we simply require the performance of environmental 
monitoring, for an appropriate microorganism of public health 
significance or for an appropriate indicator organism, if contamination 
of food with an environmental pathogen is a hazard reasonably likely to 
occur? FDA also requests comment on whether more detail would be 
appropriate, by, for example:
     Specifying the environmental pathogen or the indicator 
organism for which the samples must be tested;
     Specifying the corrective actions that should be taken if 
environmental testing identifies the presence of an environmental 
pathogen, such as;
     Conducting microbial sampling and testing of surrounding 
surfaces and areas to determine the extent of the contamination and the 
potential source of the contamination;
     Cleaning and sanitizing the contaminated surfaces and 
surrounding areas to eliminate the test organism;
     Conducting additional microbial sampling and testing to 
determine whether the contamination has been eliminated; and
     Conducting finished product testing.
     Specifying the locations within the facility at which 
samples must be collected;
     Specifying the frequency of collection of environmental 
samples (e.g., weekly or monthly depending on risk). For example, 
should the frequency of collection:
     Be greatest for foods that are likely to be consumed as 
RTE or consumed after a minimal treatment that may not adequately 
reduce the environmental pathogen?
     Be greater for an environmental pathogen that is 
frequently introduced into a facility (e.g., L. monocytogenes which is 
ubiquitous in the environment and can be continually introduced into a 
facility from many routes, including ingredients, people and objects 
(Ref. 144) than for an environmental pathogen that is less frequently 
introduced?
     Be greater for refrigerated or frozen RTE food products 
that support growth of L. monocytogenes than for those that do not?
     Be greater if there is greater risk of a negative impact 
on public health (e.g., the product is specifically intended for a 
sensitive population such as infants) than if there is a lesser risk of 
a negative impact on public health?
     Be greater for products that undergo significant handling 
and exposure to the environment than for products that undergo limited 
or no handling or have little exposure to the environment?
     Increase as a result of finding the environmental pathogen 
or an indicator of the environmental pathogen or as a result of 
situations that pose an increased risk of contamination, e.g., 
construction? (Ref. 52) (Ref. 185) (Ref. 184) (Ref. 187).
     Requiring written procedures for conducting environmental 
testing and, if so, also requiring that procedures for environmental 
testing be scientifically valid and include the procedures for sampling 
and the sampling frequency;
     Requiring data analysis to detect trends.
    In addition, with respect to environmental testing for L. 
monocytogenes, FDA requests comment on whether it would be appropriate 
to distinguish between environmental testing for RTE foods depending on 
whether the food supports the growth of L. monocytogenes. We also 
request comment on whether there are appropriate indicator organisms 
for any environmental pathogen other than L. monocytogenes. We further 
request comment on whether there is benefit in conducting routine 
environmental monitoring for other organisms in addition to, or instead 
of, the environmental pathogen of concern.
4. Supplier Approval and Verification Program
    Section 418(c) of the FD&C Act specifies, in relevant part, that 
the owner, operator, or agent in charge of a facility shall identify 
and implement preventive controls, including at critical control 
points, if any, to provide assurances that:
     Hazards identified in the hazard analysis conducted under 
section 418(b)(1) of the FD&C Act will be significantly minimized or 
prevented; and
     The food manufactured, processed, packed, or held by such 
facility will not be adulterated under section 402 of the FD&C Act or 
misbranded under section 403(w) of the FD&C Act.
    Section 418(o)(3)(G) of the FD&C Act indicates that the procedures, 
practices, and processes described in the definition of preventive 
controls may include supplier verification activities that relate to 
the safety of food. While FSMA refers only to supplier verification 
activities, supplier approval, together with supplier verification, is 
widely accepted in the domestic and international food safety 
community. The development of a

[[Page 3766]]

supplier approval and verification program can be part of a preventive 
approach. The NACMCF HACCP guidelines describe supplier controls as one 
of the common prerequisite programs for the safe production of food 
products and recommend that each facility assure that its suppliers 
have in place effective CGMP and food safety programs (Ref. 34). 
Likewise, Codex addresses the safety of ingredients in the GPFH and 
recommends that, where appropriate, specifications for raw materials be 
identified and applied and laboratory tests be conducted to establish 
fitness for use (Ref. 44).
    Because many facilities acting as suppliers procure their raw 
materials and ingredients from other suppliers, there is often a chain 
of suppliers before a raw material or other ingredient reaches the 
manufacturer/processor. Using a preventive approach, a facility 
receiving raw materials or ingredients from a supplier can help ensure 
that the supplier (or a supplier to the supplier) has implemented 
preventive controls to significantly minimize or prevent hazards that 
the receiving facility has identified as reasonably likely to occur in 
that raw material or other ingredient unless the receiving facility 
will itself control the identified hazard.
    A supplier approval and verification program can help ensure that 
raw materials and ingredients are procured from those suppliers that 
can meet company specifications and have appropriate programs in place 
to address the safety of the raw materials and ingredients. A supplier 
approval program can ensure a methodical approach to identifying such 
suppliers. A supplier verification program can help provide initial and 
ongoing assurance that suppliers are complying with practices to 
achieve adequate control of hazards in raw materials or ingredients.
    The statute does not indicate the specific circumstances where 
supplier verification would be required or the specific manner in which 
supplier verification should be performed, and FDA is not including 
provisions for such verification in this proposed rule. FDA believes 
that the role and need for these measures varies depending on the type 
of products and activities of a facility. FDA further believes that the 
owner, operator, or agent in charge of a facility could consider a 
number of factors to determine the specific circumstances and manner 
where it would be appropriate to perform supplier verification. FDA 
believes that factors to consider include:
     The nature of the adverse consequences associated with the 
hazard, such as whether consumption of food containing the hazard may 
result in serious adverse health consequences or death; and
     The establishment that would be controlling the hazard 
associated with the raw material or ingredient (e.g., the facility that 
receives the raw material or ingredient, the supplier of that raw 
material or ingredient, or even a supplier to the supplier of the raw 
material or ingredient).
    The vast majority of costs related to a supplier approval and 
verification program are due to verification activities such as audits 
and testing of raw materials and ingredients, which would likely be 
selected based on the hazard associated with the raw material or 
ingredient and where the hazard is controlled. Although we are not 
including a provision for such a program in this proposed rule, we 
estimate that a requirement for a supplier approval and verification 
program, if implemented as part of a preventive approach, could impose 
an incremental annual cost of $0-$5,000 per supplier facility based on 
size (number of employees) that undergoes an annual audit. This would 
result in an estimated aggregate cost of $11,000,000 for domestic 
facilities and an estimated aggregate cost of $12,000,000 for foreign 
facilities. (As described in the PRIA, foreign costs are estimated by 
multiplying the domestic per facility cost by the total number of 
foreign facilities. See section XIX of this document for a discussion 
of the PRIA.). We estimate that a requirement for a supplier approval 
and verification program could impose an incremental annual cost of 
$7,000-$90,000 per facility based on size (number of employees) for 
testing of raw materials and ingredients. This would result in an 
estimated aggregate cost of $5,000,000 for domestic facilities and an 
estimated aggregate cost of $5,400,000 for foreign facilities. This 
estimate excludes facilities that would be exempt under this proposed 
rule (using a definition of $250,000 for a very small business) and 
facilities that are already doing such supplier verification 
activities. Further details are provided in the ``Consideration of 
Other Provisions'' section of the PRIA.
    FDA requests comment on when and how supplier approval and 
verification is an appropriate means of implementing the statutory 
directives set out above. Although we have not included these 
provisions in the proposed rule, we request comment on their inclusion 
in a final rule. If they are included, what is the appropriate level of 
specificity? Should the requirement be very general, for example, 
requiring a supplier approval and verification program as appropriate 
to the facility and the food, when appropriate based on risk? FDA also 
requests comment on who a supplier approval and verification program 
should apply to--e.g., should it apply to all facilities that 
manufacture, process, pack or hold food, or be limited (such as to 
facilities that manufacture or process food)?
    FDA also requests comment on whether more detail would be 
appropriate, by, for example:
     Requiring that the supplier approval and verification 
program include a written list of approved suppliers;
     Requiring that, in determining appropriate verification 
activities, the owner, operator, or agent in charge of a facility 
consider relevant regulatory information regarding the supplier, 
including whether the raw material or ingredient is the subject of an 
FDA warning letter or import alert relating to the safety of the food.
     Specifying circumstances when a supplier approval and 
verification program would not be required--e.g., when the preventive 
controls at the receiving facility are adequate to significantly 
minimize or prevent each of the hazards the receiving facility has 
identified as reasonably likely to occur; or when the receiving 
facility obtains from its customer written assurance that the customer 
has established and is following procedures that will significantly 
minimize or prevent the hazard.
     Specifying that the type of verification activity be 
linked to the seriousness of the hazard--e.g., whether to:
     Require an onsite audit when there is a reasonable 
probability that exposure to the hazard will result in serious adverse 
health consequences or death to humans;
     Provide more flexibility with respect to hazards for which 
there is not a reasonable probability that exposure to the hazard will 
result in serious adverse health consequences or death to humans--e.g., 
periodic onsite audits, periodic or lot-by-lot sampling and testing of 
the raw material or ingredient, and periodic review of the supplier's 
food safety records;
     Specifying requirements for audits--e.g., the 
qualifications (including training, experience, and conflict of 
interest) for persons who conduct audits; content of an audit (such as 
compliance with applicable food safety regulations and, when 
applicable, compliance with a facility's food safety plan);

[[Page 3767]]

     Specifying the frequency of verification activities (e.g., 
initially, annually, or periodically);
     Specifying whether, for some hazards, it will be necessary 
to conduct more than one verification activity to provide adequate 
assurances that the hazard is significantly minimized or prevented;
     Providing for alternative requirements if a supplier is a 
qualified facility--e.g., documenting that the supplier is a qualified 
facility and obtaining written assurance that the supplier is producing 
the raw material or ingredient in compliance with sections 402 and 
403(w) of the FD&C Act;
     Specifying those records that would be appropriate for a 
supplier approval and verification program.
     Providing for substitution of a regulatory inspection 
(e.g., by FDA or a comparable State regulatory agency or foreign food 
safety authority), for an onsite audit; and
     Specifying that a receiving facility take appropriate 
action (e.g., discontinuing use of a supplier) if the facility 
determines that the supplier is not controlling hazards that the 
receiving facility has identified as reasonably likely to occur.
    FDA is aware that many firms that could be affected by supplier 
verification may be importing their ingredients. We believe that these 
firms are interested in how a supplier verification component of 
preventive controls will interface with the regulations FDA is required 
to issue to implement foreign supplier verification under new section 
805 of the FD&C Act. Section 805 requires FDA to issue regulations to 
require importers to implement foreign supplier verification programs 
(FSVPs) that are adequate to provide assurances that the importer's 
foreign suppliers produce food in compliance with processes and 
procedures, including risk-based preventive controls, that provide the 
same level of public health protection as those required under sections 
418 (concerning hazard analysis and preventive controls) and 419 
(concerning produce safety) of the FD&C Act, and in compliance with 
sections 402 (concerning adulteration) and 403(w) (concerning 
misbranding regarding allergen labeling) of the FD&C Act.
    FDA intends to issue proposed regulations implementing section 805 
in the near future. FDA intends to align regulations implementing 
supplier verification under section 418 and regulations implementing 
FSVP under section 805 to the fullest extent so we do not impose 
duplicative or unjustified requirements under those two regulations. 
For example, if a facility imports ingredients, we would not want to 
subject it to duplicative requirements under a supplier verification 
provision and an FSVP regulation.
    Likewise, FDA is aware that there is great interest from our 
trading partners on, among other things, the potential overlap between 
the supplier verification requirements in preventive controls and in 
FSVP. FDA believes that the approach to harmonization between supplier 
verification and FSVP described above would adequately address this and 
comports with our obligations under the World Trade Organization (WTO) 
trade agreements, including adherence to the principles of the Sanitary 
and Phytosanitary (SPS) Agreement.
    FDA is committed to meeting the requirements of the SPS Agreement 
and to complying with our obligations under that Agreement as we 
implement FSMA. In enacting FSMA, Congress explicitly recognized the 
importance of compliance with international agreements by providing in 
section 404 of FSMA that ``[n]othing in [FSMA] shall be construed in a 
manner inconsistent with the agreement establishing the World Trade 
Organization or any other treaty or international agreement to which 
the United States is a party.'' While the statutory provisions in FSMA 
governing supplier verification by domestic facilities and foreign 
supplier verification by importers differ in some respects, they are 
based on common risk-based principles. Implementation of these risk-
based principles will assure a general consistency of approach with 
respect to foreign and domestic facilities regarding, for example, when 
on-site audits are required. Implementation of FSMA's risk-based 
principles will also ensure that measures applicable to imports are not 
more trade-restrictive than required to achieve the appropriate level 
of sanitary or phytosanitary protection of the United States, taking 
into account technical and economic feasibility, as required by 
paragraph 6 of Article 5 of the SPS Agreement.
    FDA intends to publish in the very near future a proposed rule to 
implement FSMA's foreign supplier verification program requirement. FDA 
will align the comment periods on that proposed rule and the preventive 
controls rule addressed in this document so that interested parties in 
the United States and other countries will be able to assess how they 
will work together in practice. We invite comments to assist FDA in 
issuing final rules that protect public health and satisfy both FSMA 
and our international obligations.

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

1. Overview
    This section discusses two measures (review of consumer, customer, 
and other complaints, and submission of a food safety profile) that FDA 
is not proposing as specific provisions in proposed part 117, subpart 
C. Although these measures are not explicitly included in section 418, 
we believe that the preventive controls and verification measures 
discussed in this section are an important part of a modern food safety 
system.
2. Complaints
    The role of consumer complaints in evaluating the effectiveness of 
a food safety plan is reflected in our HACCP regulations for seafood 
and juice. Our HACCP regulation for seafood (Sec.  123.8(a)(2)(i)) 
requires that verification activities include a review of any consumer 
complaints that have been received by the processor to determine 
whether they relate to the performance of critical control points or 
reveal the existence of unidentified critical control points. Our HACCP 
regulation for juice (Sec.  120.11(a)(1)(i)) requires that verification 
activities include a review of any consumer complaints that have been 
received by the processor to determine whether the complaints relate to 
the performance of the HACCP plan or reveal the existence of 
unidentified critical control points. FDA notes that the role of 
consumer complaints is not discussed in the NACMCF guidelines or the 
Codex guidelines, and their review is not required by the FSIS HACCP 
regulation for meat and poultry. However, as we discussed in the 
seafood HACCP proposed rule (59 FR 4142 at 4157), no system is 
foolproof, and consumer complaints may be the first alert for a 
processor that deviations are occurring and are not being prevented or 
uncovered by the processor's HACCP controls.
    Further, although most consumer complaints will be related to 
quality issues, recent experience has demonstrated the value that 
consumer and customer complaints can provide in bringing attention to 
possible problems within a facility's preventive controls activities. 
FDA has received a number of submissions to the Reportable Food 
Registry (Ref. 60) that have suggested that environmental pathogens or 
food

[[Page 3768]]

allergen hazards were not adequately addressed in a supplier's food 
safety plan. Some of these were identified through customer 
verification testing and others through complaints from consumers to a 
facility. A facility may also receive alerts as a result of state 
surveillance and testing programs. (For a discussion of such programs, 
see section II.A.6.e of this document). Many recall notices identify 
the results of a state surveillance and testing program as the trigger 
for a recall (Ref. 188) (Ref. 189) (Ref. 190).
    Although this proposed rule does not include a provision regarding 
a review of complaints, we estimate that a requirement that facility 
personnel review consumer, customer or other complaints could impose an 
incremental annual cost of $0- $6,000 per facility based on size 
(number of employees). This would result in an estimated aggregate 
annual cost of $11,500,000 for domestic facilities and an estimated 
aggregate cost of $12,500,000 for foreign facilities.
    We request comment on whether and how a facility's review of 
complaints, including complaints from consumers, customers, or other 
parties, should be required as a component of its activities to verify 
that its preventive controls are effectively minimizing the occurrence 
of hazards.
3. Submission of a Facility Profile to FDA
    Proposed Sec.  117.126 would require that the owner, operator, or 
agent in charge of a facility prepare, or have prepared, a written food 
safety plan. The food safety plan would include the hazard analysis, 
preventive controls, and other records. Currently, information of this 
type is not reviewed by FDA investigators until they are physically 
present at a facility and have begun an inspection. In light of the 
large number of facilities that would be covered by this proposal, FDA 
recognizes several potential benefits to having a facility's food 
safety plan in advance of an inspection, if we were to require 
facilities to do so. Having such plans could aid in the efficient 
oversight of preventive controls by allowing FDA to better target 
inspectional activities to facilities that produce foods that have an 
increased potential for contamination (particularly with biological 
hazards) and to improve on-site inspections by focusing attention on 
hazards and preventive controls for which the facility appears to have 
deficiencies. Facilities would benefit from our advance preparation 
through interaction with better-informed investigators and potentially 
reduced inspection time. We could also more quickly identify facilities 
that had not established preventive controls for specific hazards of 
concern to the agency and advise them to fill such gaps to prevent a 
problem before it occurs. Also, FDA could use the plans in evaluating 
the need for guidance on specific hazards or controls and prioritizing 
guidance to areas where it is needed most.
    FDA believes that there are significant obstacles to realizing 
these benefits from submission of food safety plans, however. The 
agency would expect to receive a very large number of plans. Further, 
these plans would be expected to vary significantly in content and 
format. Assimilating the underlying information in a way that would be 
useful to the agency would be an immense challenge. Moreover, not all 
of the information in such plans may be essential to realizing the 
potential benefits described above. Therefore, to most efficiently 
realize the potential benefits of having certain information prior to 
an inspection, we request comment on whether to require submission to 
FDA of a subset of the information that would be in a food safety plan. 
This information, which could be referred to as a ``facility profile,'' 
could be submitted through an electronic form using a menu selection 
approach. The use of an electronic form would enhance our ability to 
store the information in a searchable form. Ideally, a searchable 
electronic system could allow FDA to assess information when a problem 
occurs with certain types of foods or controls, so that we could target 
inspections to facilities that manufacture, process, or pack, foods 
that are at increased risk for a food safety problem; to facilities 
that appear to have insufficient controls to prevent a problem; or to 
facilities using a control we conclude is ineffective at controlling 
hazards. The data elements for a facility profile could include some or 
all of the following:
     Contact information;
     Facility type;
     Products;
     Hazards identified for each product;
     Preventive controls established for each of the identified 
hazards;
     Third-party audit information (have you had one and which 
audit firm(s));
     Preventive control employee training conducted;
     Facility size (square footage);
     Full time operation or seasonal;
     Operations schedule;
    This information could be submitted at the same time as facility 
registration and updated biennially simultaneously with the required 
biennial update of the food facility registration. FDA requests comment 
on the utility and necessity of such an approach and on the specific 
types of information that would be useful in developing a facility 
profile. We also request comment on any additional benefits that might 
be obtained from using such an approach and any potential concerns with 
this approach.
    We have previously announced an opportunity for public comment on 
the proposed collection of additional food facility profile information 
on a voluntary basis from firms that complete the FDA food facility 
registration process (Federal Register of May 11, 2012, 77 FR 27779). 
In that notice, we noted that FSMA added section 421 of the FD&C Act 
(21 U.S.C. 350j), which directed FDA to allocate resources to inspect 
facilities according to the known safety risks of the facilities. We 
also noted that food facility profile information voluntarily provided 
to FDA will help us to determine whether a firm is high-risk or non-
high-risk and that we will use the profile information to assist us in 
determining the frequency at which we will inspect the firm. In 
contrast to the voluntary submission of food facility profile 
information described in that notice, in this document we are 
requesting comment on whether the submission of such information should 
be required.

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

    FSMA provides for the establishment of modified requirements for 
certain facilities under certain circumstances. In this section of this 
document, we propose such modified requirements.

A. Proposed Sec.  117.201--Modified Requirements That Apply to a 
Qualified Facility

1. Requirements of Section 418(l) of the FD&C Act
    Section 418(l) of the FD&C Act establishes modified requirements 
for ``qualified facilities.'' As discussed in section II.B.1.b of this 
document, section 418(l)(1) of the FD&C Act establishes the conditions 
for a facility to be a ``qualified facility'' based on either business 
size (section 418(l)(1)(B) of the FD&C Act) or a combination of the 
average monetary value of the food sold and the value of food sold to 
qualified end users as compared to all other purchasers (section 
418(l)(1)(C) of the FD&C Act), and proposed Sec.  117.3 would establish 
a definition for ``qualified facility'' based on section 418(l)(1).

[[Page 3769]]

    Sections 418(l)(2)(A) and (B) of the FD&C Act provide that a 
qualified facility is exempt from the requirements of sections 418(a) 
through (i) and (n) of the FD&C Act (i.e., the requirements for hazard 
analysis and risk-based preventive controls), but must instead submit 
two types of documentation to the Secretary of HHS. The first type of 
required documentation relates to food safety practices at the 
facility, and section 418(l)(2)(B)(i) provides two options for 
satisfying this documentation requirement. Under section 
418(l)(2)(B)(i)(I), the qualified facility may choose to submit 
documentation that demonstrates that the owner, operator, or agent in 
charge of the facility has identified potential hazards associated with 
the food being produced, is implementing preventive controls to address 
the hazards, and is monitoring the preventive controls to ensure that 
such controls are effective. Alternatively, under section 
418(l)(2)(B)(i)(II), the qualified facility may choose to submit 
documentation (which may include licenses, inspection reports, 
certificates, permits, credentials, certification by an appropriate 
agency (such as a State department of agriculture), or other evidence 
of oversight), as specified by the Secretary of HHS, that the facility 
is in compliance with State, local, county, or other applicable non-
Federal food safety law.
    The second type of required documentation relates to whether the 
facility satisfies the definition of a qualified facility. Under 
section 418(l)(2)(B)(ii) of the FD&C Act, the facility must submit 
documentation, as specified by the Secretary of HHS in a guidance 
document, that the facility is a qualified facility under section 
418(l)(1)(B) of the FD&C Act or section 418(l)(1)(C) of the FD&C Act.
    Section 418(l)(7)(A) of the FD&C Act requires that a qualified 
facility that is exempt from the requirements under sections 418 (a) 
through (i) and subsection (n), and that does not prepare documentation 
under section 418(l)(2)(B)(i)(I), provide notification to consumers by 
one of two procedures, depending on whether a food packaging label is 
required on the food. With respect to a food for which a food packaging 
label is required by the Secretary of HHS under any other provision of 
the FD&C Act, section 418(l)(7)(A)(i) of the FD&C Act requires that a 
qualified facility include prominently and conspicuously on such label 
the name and business address of the facility where the food was 
manufactured or processed. With respect to a food for which a food 
packaging label is not required by the Secretary of HHS under any other 
provisions of the FD&C Act, section 418(l)(7)(A)(ii) of the FD&C Act 
requires that a qualified facility prominently and conspicuously 
display, at the point of purchase, the name and business address of the 
facility where the food was manufactured or processed, on a label, 
poster, sign, placard, or documents delivered contemporaneously with 
the food in the normal course of business, or, in the case of Internet 
sales, in an electronic notice.
2. Proposed Sec.  117.201(a)--Documentation to be Submitted
    a. Proposed Sec.  117.201(a)(1)--Documentation that the facility is 
a qualified facility. Proposed Sec.  117.201(a)(1) would require that a 
qualified facility submit to FDA documentation that the facility is a 
qualified facility. Consistent with the conditions in section 418(l)(1) 
of the FD&C Act for a facility to be a qualified facility, and our 
proposed definition (proposed Sec.  117.3) of ``qualified facility,'' 
the documentation would be directed to either the status of the 
facility as a very small business (as would be defined in proposed 
Sec.  117.3) or the applicability of conditions for average annual 
monetary value and the value of food sold to qualified end users as 
compared to other purchasers (as would be included in the definition of 
qualified facility in proposed Sec.  117.3). As discussed further in 
section XIII.A.5, FDA tentatively concludes that a statement from the 
owner, operator, or agent in charge of a qualified facility certifying 
that the facility is a very small business, otherwise meets the 
definition of a qualified facility under proposed Sec.  117.3, or both, 
would be acceptable for the purposes of satisfying the requirements 
that would be established in proposed Sec.  117.201(a)(1). We would 
not, for example, require that a facility submit financial information 
to FDA demonstrating its total sales or to the proportion of sales to 
qualified end users.
    Proposed Sec.  117.201(a)(1) also would establish that, for the 
purpose of determining whether a facility satisfies the definition of 
qualified facility, the baseline year for calculating the adjustment 
for inflation is 2011. The conditions related to average annual 
monetary value established in section 418(l)(1)(C) of the FD&C Act, and 
the definition of very small business in proposed Sec.  117.3, allow 
adjustment for inflation. To establish a level playing field for all 
facilities that may satisfy definition of a qualified facility, we are 
proposing to establish the baseline year for the calculation in 
proposed Sec.  117.201(a)(1). We are proposing to establish 2011 as the 
baseline year for inflation because 2011 is the year that FSMA was 
enacted into law. We tentatively conclude that because Congress 
provided a specific dollar amount in section 418(l)(1)(C)(ii)(II)--
i.e., $500,000--and it provided that the dollar amount should be 
adjusted for inflation, it is reasonable to establish the baseline year 
as the year that the law was enacted.
    b. Proposed Sec.  117.201(a)(2)--Documentation related to food 
safety practices at a facility. Proposed Sec.  117.201(a)(2) would 
provide two options for satisfying the documentation requirement in 
section 418(l)(2)(B)(i) of the FD&C Act related to food safety 
practices at the facility. Proposed Sec.  117.201(a)(2)(i) would allow 
qualified facilities to submit documentation to demonstrate that the 
owner, operator, or agent in charge of the facility has identified the 
potential hazards associated with the food being produced, is 
implementing preventive controls to address the hazards, and is 
monitoring the performance of the preventive controls to ensure that 
such controls are effective to satisfy this requirement.
    Proposed Sec.  117.201(a)(2)(i) would implement the provisions of 
section 418(l)(2)(B)(i)(I) of the FD&C Act, except that proposed Sec.  
117.201(a)(2)(i) would specify monitoring the performance of the 
preventive controls to ensure that such controls are effective 
(emphasis added). As discussed in section II.B.1.a of this document, 
under the overall framework of the proposed requirements that would be 
established in subpart C, monitoring is directed to performance of 
preventive controls. Thus, proposed Sec.  117.201(a)(2)(i) is 
consistent with the statute and the overall framework of this proposed 
rule.
    Proposed Sec.  117.201(a)(2)(ii) would provide another option for 
satisfying the documentation requirement in section 418(l)(2)(B)(i) of 
the FD&C Act related to food safety practices at the facility by 
allowing qualified facilities to submit documentation (which may 
include licenses, inspection reports, certificates, permits, 
credentials, certification by an appropriate agency (such as a State 
department of agriculture), or other evidence of oversight), that the 
facility is in compliance with State, local, county, or other 
applicable non-Federal food safety law, including relevant laws and 
regulations of foreign countries. Proposed Sec.  117.201(a)(2)(i) would 
implement the provisions of section 418(l)(2)(B)(i)(II) of the FD&C 
Act.

[[Page 3770]]

    As discussed further in section XIII.A.5 of this document, FDA 
tentatively concludes that a statement from the owner, operator, or 
agent in charge of a qualified facility certifying that the facility 
(1) has identified the potential hazards associated with the food being 
produced, is implementing preventive controls to address the hazards, 
and is monitoring the implementation of the preventive controls to 
ensure that such controls are effective; or (2) that the facility is in 
compliance with State, local, county, or other applicable non-Federal 
food safety law, including relevant laws and regulations of foreign 
countries, would be acceptable for the purposes of satisfying the 
requirements that would be established in proposed Sec.  117.201(a)(2). 
We would not, for example, require that a facility submit documentation 
to FDA demonstrating the content of their hazard identification, 
preventive controls, or monitoring of the implementation of preventive 
controls; or copies of their non-Federal licenses, inspection reports, 
certificates, permits, credentials, or certifications.
3. Proposed Sec.  117.201(b)--Procedure for Submission
    Proposed Sec.  117.201(b) would require that qualified facilities 
submit the documentation that would be required by proposed Sec.  
117.201(a) by one of two procedures. Proposed Sec.  117.201(b)(1) would 
provide an option to submit documentation electronically at http://www.access.fda.gov by following the instructions to be provided on that 
Web page. Proposed Sec.  117.201(b)(1) would inform facilities that 
this Web site is available from wherever the Internet is accessible, 
including libraries, copy centers, schools, and Internet cafes. 
Although electronic submission is not required, proposed Sec.  
117.201(b)(1) would encourage electronic submission, which is efficient 
for FDA and should also be efficient for facilities. Electronic 
submission generally would be available 24 hours a day, 7 days a week, 
unless the Web site is experiencing technical difficulties or is 
undergoing maintenance.
    Proposed Sec.  117.201(b)(1) would provide an option to submit 
documentation by mail. A qualified facility would have the option to 
submit documents in a paper format or in an electronic format on a CD-
ROM, by mail to the U.S. Food and Drug Administration, ATTN: Qualified 
Facility Coordinator, 10903 New Hampshire Ave., Silver Spring, MD 
20993. ``Mail'' would include the U.S. mail and businesses that can 
deliver documents to the address provided. We would recommend that an 
owner, operator or agent in charge of a qualified facility submit by 
mail only if the qualified facility does not have reasonable access to 
the Internet. It is not efficient for FDA to receive such documents by 
mail.
    We are not proposing to provide for submission by fax. We expect 
that there may be technical difficulties or loss or mix-up of some 
submitted information if we were to allow for submission by fax.
    In section XIII.A.5 of this document, we discuss the information 
that would be submitted.
4. Proposed Sec.  117.201(c)--Frequency of Submission
    Proposed Sec.  117.201(c)(1) would require that the documentation 
that would be required by section Sec.  117.201(a) be submitted to FDA 
initially within 90 days of the applicable compliance date of the rule. 
As discussed in section VII of this document, the compliance date for a 
small business would be 2 years after the date of publication of the 
final rule and the compliance date for a very small business would be 3 
years after the date of publication of the final rule.
    Proposed Sec.  117.201(c)(2) would require that the documentation 
that would be required by proposed Sec.  117.201(a) also must be 
resubmitted to FDA at least every 2 years, or whenever there is a 
material change to the information that would be described in proposed 
Sec.  117.201(a). For the purposes of proposed Sec.  117.201, a 
material change would be one that changes whether or not a facility is 
a ``qualified facility.'' The status of a facility as a qualified 
facility has the potential to change materially on an annual basis. For 
example, if a facility reports that it is a very small business (e.g., 
under one option identified in proposed Sec.  117.3, has less than 
$250,000 in total annual sales of food, adjusted for inflation), its 
total annual sales of food likely would change on an annual basis, and 
could change so as to exceed $250,000. Likewise, if a facility reports 
that it otherwise satisfies the definition of a qualified facility, its 
total annual sales of food and value of food sold to qualified end 
users as compared to other purchasers likely would change on an annual 
basis, and could change so as to no longer satisfy the definition of a 
qualified facility.
5. Information That Would Be Submitted
    Consistent with section 418(l)(2)(B)(ii) of the FD&C Act, we intend 
to issue guidance regarding documentation that would be submitted under 
proposed Sec.  117.201(a)(1) to demonstrate that a facility is a 
qualified facility. As discussed in sections XIII.A.2.a and XIII.A.2.b 
of this document, we tentatively conclude that certified statements 
from the owner, operator, or agent in charge of a qualified facility 
would be acceptable for the purposes of satisfying the requirements 
that would be established in proposed Sec.  117.201(a)(1) and (2).
    To inform the guidance required under section 418(l)(2)(B)(ii) of 
the FD&C Act and any other guidance that may be useful in addressing 
questions regarding submission of documentation under this subpart, in 
this document we request comment on an option we are considering 
regarding the submission of documentation. Specifically, we request 
comment on the efficiency and practicality of submitting the required 
documentation using the existing mechanism for registration of food 
facilities, with added features to enable a facility to identify 
whether or not the facility is a qualified facility. A facility that 
does not identify itself as a qualified facility would not be prompted 
to provide additional information under proposed Sec.  117.201(a).
    A facility that identifies itself as a qualified facility would be 
prompted to provide the following information by checking items that 
apply. Such items could include:

 Whether the facility satisfies the conditions for a qualified 
facility:
     As a very small business as that term would be defined in 
proposed Sec.  117.3;
     As a facility that otherwise satisfies the definition of 
qualified facility in proposed Sec.  117.3 based on average monetary 
value of sales and value of food sold to qualified end users as 
compared to other purchasers; or
     Both of the above.

 Whether the facility:
     Has identified the potential hazards associated with the 
food being produced, is implementing preventive controls to address the 
hazards, and is monitoring the implementation of the preventive 
controls to ensure that such controls are effective;
     Is in compliance with State, local, county, or other 
applicable non-Federal food safety law, including relevant laws and 
regulations of foreign countries; or
     Both of the above.

    In essence, such a system would provide for self-certification that 
the

[[Page 3771]]

facility has appropriate information demonstrating that the facility is 
a qualified facility and either has identified the potential hazards 
associated with the food being produced, is implementing preventive 
controls to address the hazards, and is monitoring the implementation 
of the preventive controls to ensure that such controls are effective; 
or is in compliance with State, local, county, or other applicable non-
Federal food safety law, including relevant laws and regulations of 
foreign countries. Such a system may include a statement reminding 
submitters that anyone who makes a materially false, fictitious, or 
fraudulent statement to the U.S. Government is subject to criminal 
penalties under 18 U.S.C. 1001. Using such a system, a qualified 
facility could update the documentation required by proposed Sec.  
117.201(a) during the biennial registration required by section 
415(a)(3) of the FD&C Act.
6. Proposed Sec.  117.201(d)--Notification to Consumers
    Proposed Sec.  117.201(d) would require that a qualified facility 
that does not submit the type of documentation directed to food safety 
practices described in Sec.  117.201(a)(2)(i) provide notification to 
consumers as to the name and complete business address of the facility 
where the food was manufactured or processed (including the street 
address or P.O. box, city, state, and zip code for domestic facilities, 
and comparable full address information for foreign facilities) 
consistent with section 418(l)(7) of the FD&C Act. If a food packaging 
label is required, proposed Sec.  117.201(d)(1) would require that the 
required notification appear prominently and conspicuously on the label 
of the food. If a food packaging label is not required, proposed Sec.  
117.201(d)(2) would require that the required notification appear 
prominently and conspicuously, at the point of purchase, on a label, 
poster, sign, placard, or documents delivered contemporaneously with 
the food in the normal course of business, or in an electronic notice, 
in the case of Internet sales.
    Proposed Sec.  117.201(d) would enable consumers to contact the 
facility where a food was manufactured or processed (e.g., if the 
consumer identifies or suspects a food safety problem with a product) 
irrespective of whether the food product bears a label. The use of the 
term ``business address'' in section 418(l)(7) of the FD&C Act 
contrasts with Congress' use of a different term, ``place of 
business,'' in section 403(e) of the FD&C Act (21 U.S.C. 343(e)). 
Section 403(e) provides that foods in package form are misbranded 
unless the product label bears the name and place of business of the 
manufacturer, packer, or distributor of the food. Our regulations 
interpret ``place of business'' as requiring only the firm's city, 
state, and zip code to appear on the product label, as long as the 
firm's street address is listed in a current telephone directory or 
other city directory (21 CFR 101.5(d)). We tentatively conclude that 
the use of the term ``business address'' in section 418(l)(7) 
demonstrates Congress' intent to require the facility's full address, 
including the street address or P.O. box, to appear on labels or other 
required notifications when the facility has opted to not submit 
documentation directed to food safety practices under section 
418(l)(2)(B)(i)(I) of the FD&C Act. If Congress had considered the less 
complete address already required under section 403(e)(1) of the FD&C 
Act and the ``place of business'' labeling regulation (Sec.  101.5(d)) 
to be adequate for notification to consumers for foods required to bear 
labels, there would have been no need to impose a new, more specific 
requirement in section 418(l)(7) for the facility's ``business 
address'' to appear on the food label. Requiring the complete business 
address for this purpose is consistent with our guidance to industry on 
the labeling of dietary supplements as required by the Dietary 
Supplement and Nonprescription Drug Consumer Protection Act (Ref. 130). 
When proposed Sec.  117.201(d) would apply to a food for which a food 
packaging label is required under any other provision of the FD&C Act, 
the complete business address would substitute for the ``place of 
business'' required under section 403(e)(1) of the FD&C Act and 21 
C.F.R. 101.5(d) and would not impose any requirement for a label that 
would be in addition to any label required under any other provision of 
the FD&C Act. We seek comment on this interpretation.
7. Records
    Proposed Sec.  117.201(e)(1) would require that a qualified 
facility maintain records relied upon to support the documentation that 
would be required by Sec.  117.201(a). Proposed Sec.  117.201(a) would 
not require that a qualified facility establish any new records, but 
merely retain those that the facility relied upon to support the 
documentation that would required by proposed Sec.  117.201(a). 
Proposed Sec.  117.201(e)(2) would establish that the records that a 
qualified facility must maintain are subject to the requirements of 
subpart F of part 117. As discussed in section XV of this document, 
proposed subpart F would provide the general requirements that apply to 
all records required to be established and maintained by proposed part 
117, including provisions for retention of records and for making 
records available for official review. Together, proposed Sec.  
117.201(a) and (b) would make the underlying records qualified 
facilities would rely on to support their self-certifications available 
to FDA upon request. We tentatively conclude that it is appropriate to 
require that the records relied upon to support a self-certified 
statement be retained and made available to FDA upon request.

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

1. Requirements of Section 418 of the FD&C Act
    Briefly, as relevant to proposed Sec.  117.206, specific provisions 
of section 418 of the FD&C Act require, in relevant part, 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 and develop a written 
analysis of the hazards (section 418(b) of the FD&C Act);
     Identify and implement preventive controls to provide 
assurances that hazards identified in the hazard analysis will be 
significantly minimized or prevented and the food manufactured, 
processed, packed, or held by such facility will not be adulterated 
under section 402 of the FD&C Act (section 418(c) of the FD&C Act);
     Monitor the effectiveness of the preventive controls 
implemented under section 418(c) of the FD&C Act to provide assurances 
that the outcomes described in section 418(c) shall be achieved 
(section 418(d) of the FD&C Act);
     Establish procedures to ensure that, if the preventive 
controls implemented under section 418(c) of the FD&C Act are not 
properly implemented or are found to be ineffective * * * appropriate 
action is taken to reduce the likelihood of recurrence of the 
implementation failure; all affected food is evaluated for safety; and 
all affected food is prevented from entering into commerce if the 
owner, operator or agent in charge of such facility cannot ensure that 
the affected food is not adulterated under section 402 of the FD&C Act 
(section 418(e) of the FD&C Act);

[[Page 3772]]

     Verify that the preventive controls are adequate to 
control the hazards the owner, operator, or agent is conducting 
monitoring and is making appropriate decisions about corrective actions 
and the preventive controls are effectively and significantly 
minimizing or preventing the occurrence of identified hazards and there 
is documented, periodic reanalysis of the plan under section 418(i) of 
the FD&C Act to ensure that the plan is still relevant to the raw 
materials, conditions and processes in the facility, and new and 
emerging threats (section 418(f) of the FD&C Act);
     Maintain, for not less than 2 years, records documenting 
the monitoring of the preventive controls instances of nonconformance 
material to food safety and instances when corrective actions were 
implemented (section 418(g) of the FD&C Act);
     Prepare a written plan that documents and describes the 
procedures used by the facility to comply with the requirements of 
section 418 of the FD&C Act, including analyzing the hazards and 
identifying the preventive controls adopted to address those hazards 
(section 418(h) of the FD&C Act);
     Conduct a reanalysis under section 418 (b) of the FD&C Act 
whenever a significant change is made in the activities conducted at a 
facility operated by such owner, operator, or agent if the change 
creates a reasonable potential for a new hazard or a significant 
increase in a previously identified hazard or not less frequently than 
once every 3 years, whichever is earlier (section 418(i) of the FD&C 
Act).
    In addition to these requirements directed to the owner, operator, 
or agent in charge of a facility, section 418(m) of the FD&C Act 
provides, in relevant part, that the Secretary may, by regulation, 
exempt or modify the requirements for compliance under section 418 of 
the FD&C Act with respect to facilities that are solely engaged in the 
storage of packaged foods that are not exposed to the environment.
2. Approach to Modified Requirements Under Section 418(m) of the FD&C 
Act
    As discussed in section X.D.4 of this document, proposed Sec.  
117.7 would both provide that subpart C does not apply to a facility 
solely engaged in the storage of packaged food that is not exposed to 
the environment (proposed Sec.  117.7(a)) and establish that such a 
facility is subject to modified requirements in proposed Sec.  117.206 
(proposed Sec.  117.7(a)). In the remainder of our discussion of these 
modified requirements, we refer to ``packaged food that is not exposed 
to the environment'' as ``unexposed packaged food,'' and we refer to 
``unexposed refrigerated packaged food that requires time/temperature 
control for safety'' as ``unexposed refrigerated packaged TCS food.'' 
As noted in section X.D.2 of this document, we consider ``not exposed 
to the environment'' and ``unexposed'' to mean that the food is in a 
form that prevents any direct human contact with the food. The modified 
requirements in proposed Sec.  117.206 would apply to unexposed 
refrigerated packaged TCS food. In essence, proposed Sec.  117.7 
distinguishes between unexposed packaged food and unexposed 
refrigerated packaged TCS food. This distinction is based on hazards 
that are reasonably likely to occur during the storage of unexposed 
refrigerated packaged TCS food, but are not reasonably likely to occur 
during the storage of unexposed packaged food that does not require 
time/temperature control for safety.
    When an unexposed packaged food is a refrigerated TCS food, the 
principal hazard for the unexposed refrigerated packaged TCS food is 
the potential for the growth of, or toxin production by, microorganisms 
of public health significance. Information about this hazard for TCS 
foods in general (i.e., not limited to unexposed packaged food) is 
widely available (Ref. 137) (Ref. 138) (Ref. 139) (Ref. 140). In brief, 
the need for time/temperature control is primarily determined by (1) 
the potential for contamination with microorganisms of public health 
significance and (2) the potential for subsequent growth and/or toxin 
production. Refrigeration has long been used to retard deterioration of 
the flavor, color, and texture of foods. More importantly, 
refrigeration helps maintain the microbiological safety of potentially 
hazardous foods (62 FR 8248, February 24, 1997).
    Failure to maintain foods at appropriate temperatures may result in 
the growth of microorganisms that may have contaminated the foods 
before, or at the time of, harvest or during processing, handling, or 
storage. The rate of growth of these microorganisms is reduced as the 
storage temperature is lowered. Proper refrigeration, therefore, 
prevents or slows the growth of human pathogens and spoilage 
microorganisms and reduces the likelihood of foodborne illness (62 FR 
8248). A review of the factors that influence microbial growth and an 
analysis of microbial hazards related to time/temperature control of 
foods for safety can be found in a report (issued by the Institute of 
Food Technologists (IFT) under contract to FDA) on the Evaluation and 
Definition of Potentially Hazardous Foods (Ref. 140) (the IFT report). 
The IFT report describes properties of common food commodities and the 
microbiological hazards that may occur from consuming particular food 
commodities, emphasizing microbial concerns that would be associated 
with temperature abuse of the products. The IFT report discusses foods 
for which time/temperature control may be necessary for safety (Ref. 
140). Most foods that are stored refrigerated have not been processed 
to eliminate pathogenic sporeformers, including Clostridium botulinum, 
Bacillus cereus and C. perfringens. If refrigerated foods are exposed 
to high enough temperatures for sufficient time, these sporeformers may 
begin to grow and produce toxins. Some strains of C. botulinum and B. 
cereus can grow at refrigeration temperatures, e.g., some strains of B. 
cereus grow at 39 [deg]F (4 [deg]C) and some strains of C. botulinum 
grow at 38 [deg]F (3.3 [deg]C) (Ref. 173).
    Examples of refrigerated foods that are capable of supporting the 
growth of pathogenic sporeformers such as B. cereus, C. botulinum and 
C. perfringens include many prepared soups, filled pastas, and sauces. 
In addition, some foods may be contaminated with L. monocytogenes, 
which, as described in section II.D.2.a, can also grow at refrigeration 
temperatures. Examples of foods that support the growth of L. 
monocytogenes include milk and soft cheese. Producers of refrigerated 
foods minimize the contamination of foods with pathogens to the extent 
possible, particularly if the pathogen can grow under refrigeration 
conditions. Growth of pathogens is very slow under refrigeration, and 
the lower the temperature the longer the time for growth (Ref. 140). 
Conversely, as refrigeration temperature increases, the growth rate of 
strains of pathogens that grow slowly under refrigeration increases and 
food temperatures may get high enough that pathogens that cannot grow 
at normal refrigeration temperatures (generally in the range of 41-45 
[deg]F (5 [deg]C-7 [deg]C)) begin to grow (Ref. 140). For example, the 
strains of C. botulinum that have caused most of the outbreaks in the 
United States do not grow and produce toxin until the temperature 
reaches 50 [deg]F (10 [deg]C) (Ref. 3). Additional information about 
the time/temperature control of food to address the potential for 
microorganisms of public health significance to grow or produce toxins 
is available in books on food microbiology that are available for 
purchase.

[[Page 3773]]

    Such information is sufficiently well-known and accepted that we 
tentatively conclude that the outcome of each individual hazard 
analysis for an unexposed refrigerated packaged TCS food, conducted by 
the owner, operator, or agent in charge of each individual facility 
solely engaged in the storage of unexposed packaged food, would be the 
same. That outcome would be that the potential for the growth of, or 
toxin production by, microorganisms of public health significance is a 
hazard reasonably likely to occur in any unexposed refrigerated 
packaged TCS food. Likewise, information about appropriate preventive 
controls for this hazard is widely available (Ref. 191) (Ref. 139). 
Such information is sufficiently well-known and accepted that we 
tentatively conclude that the appropriate preventive control selected 
by each individual facility solely engaged in the storage of unexposed 
packaged food would be adequate controls on the temperature of any 
unexposed refrigerated packaged TCS food.
    In light of the general recognition of the hazard that is 
reasonably likely to occur in a refrigerated packaged TCS food and the 
appropriate preventive control for that hazard, we tentatively conclude 
that it is appropriate to specify the hazard and appropriate preventive 
control in the regulation. Under this approach, it would not be 
necessary for each individual facility solely engaged in the storage of 
unexposed packaged food to conduct its own hazard analysis and reach 
its own conclusion about the hazard and the appropriateness of 
temperature control to significantly minimize or prevent the growth of, 
or toxin production by, microorganisms of public health significance. 
Instead, what would remain for the facility to do to comply with 
section 418 of the FD&C Act for the activity of storing an unexposed 
refrigerated packaged TCS food would be a subset of the requirements 
for hazard analysis and risk-based preventive controls that would be 
established in proposed subpart C to implement section 418 of the FD&C 
Act. None of these requirements would require a qualified individual. 
This subset of requirements would be to:
     Implement temperature controls (section 418(c) of the FD&C 
Act);
     Monitor temperature (section 418(d) of the FD&C Act);
     Take appropriate corrective actions when there is a 
problem with temperature control (section 418(e) of the FD&C Act);
     Conduct applicable verification activities (review of 
records) (section 418(f) of the FD&C Act); and
     Establish and maintain certain records (section 418(g) of 
the FD&C Act). We seek comment on the proposed list of modified 
requirements.
    We also tentatively conclude that it would not be necessary for 
each individual facility solely engaged in the storage of unexposed 
packaged food to conduct the reanalysis specified in section 418(i) of 
the FD&C Act with respect to storing an unexposed refrigerated packaged 
TCS food. As discussed in section XII.G.6 of this document, reanalysis 
would apply in determining whether to apply any additional preventive 
controls and in determining whether to update the written plan. Under 
our approach, it is FDA who has identified the preventive control, and 
it would be FDA's responsibility, through rulemaking, to require any 
additional preventive control. Likewise, under our approach, the 
facility would not be required to develop a food safety plan and, 
therefore, would not need to update the plan. If, for example, the 
facility changes its procedures for temperature control, the specific 
activities that the facility would be required to conduct (monitoring 
temperature; taking appropriate corrective actions if there is a 
problem with temperature control; conducting applicable verification 
activities; and establishing and maintaining appropriate records) would 
be adequate to address the change in procedure for temperature control.
3. Proposed Sec.  117.206--Modified Requirements That Apply to a 
Facility Solely Engaged in the Storage of Packaged Food that Is Not 
Exposed to the Environment
    Proposed Sec.  117.206(a) would require that the owner, operator or 
agent in charge of a facility solely engaged in the storage of packaged 
food that is not exposed to the environment conduct certain activities 
for any such refrigerated packaged food that requires time/temperature 
control to significantly minimize or prevent the growth of, or toxin 
production by, microorganisms of public health significance. Briefly, 
those activities would encompass:
     Establishing and implementing temperature controls 
(proposed Sec.  117.206(a)(1));
     Monitoring the temperature controls (proposed Sec.  
117.206(a)(2));
     If there is a problem with the temperature controls for 
such refrigerated packaged food, taking appropriate corrective actions 
(proposed Sec.  117.206(a)(3));
     Verifying that temperature controls are consistently 
implemented (proposed Sec.  117.206(a)(4)); and
     Establishing and maintaining certain records (proposed 
Sec.  117.206(a)(5)).
    More specifically, proposed Sec.  117.206(a)(1) would require that 
the owner, operator, or agent in charge of a facility subject to 
proposed Sec.  117.206 establish and implement temperature controls 
adequate to significantly minimize or prevent the growth of, or toxin 
production by, microorganisms of public health significance in an 
unexposed refrigerated packaged TCS food. There are two fundamental 
questions that the owner, operator, or agent in charge of a facility 
subject to proposed Sec.  117.206 would need to know the answers to in 
order to comply with proposed Sec.  117.206 for any given unexposed 
refrigerated packaged food:
     Is the food a TCS food?
     If the food is a TCS food, what is the appropriate 
temperature for storage of the food?
    The two primary ways in which the owner, operator, or agent in 
charge of a facility subject to proposed Sec.  117.206 can obtain the 
answers to these questions are: (1) through information provided by the 
manufacturer, processor, or packer of the food, either in documents 
exchanged between the parties in the course of business or by label 
statements placed on the food by the manufacturer, processor, or packer 
of the food; and (2) through applicable scientific and technical 
support literature.
    As discussed in section X.D.2 of this document, a citizen petition 
submitted to FDA (Docket No. FDA-2011-P-0561) asserted that facilities 
work closely with the food manufacturers to understand the conditions 
and controls that need to be utilized to ensure the quality of the 
foods they store and distribute and, in many cases, those conditions 
and controls are formalized in written contracts. If the conditions for 
storage are not formalized in written contracts or by other means 
(e.g., through documents of the trade that travel with a food product 
when it moves within the supply chain), information relevant to safe 
storage of the food may be provided by the manufacturer, processor, or 
packer of the food on the food label. For example, in 1997 FDA 
published guidelines for labeling food that needs refrigeration by 
consumers due to the potential for the food to be rendered unsafe due 
to the growth of infectious or toxigenic microorganisms if 
``temperature abused'' (62 FR 8248,

[[Page 3774]]

February 24, 1997). FDA recommended that foods requiring refrigeration 
by the consumer for safety be labeled ``IMPORTANT Must be Kept 
Refrigerated to Maintain Safety'' (62 FR 8248 at 8251) and that foods 
that are intended to be refrigerated but that do not pose a safety 
hazard if temperature abused be labeled more simply--e.g.; ``Keep 
refrigerated.'' Such labeling can provide facilities with the 
information to identify TCS foods. We tentatively conclude that it 
would be rare for a facility solely engaged in the storage of unexposed 
packaged food to not have information regarding whether a refrigerated 
packaged food requires time/temperature control for safety and, if so, 
what specific temperature controls are necessary for safe storage of 
the food. We request comment on this tentative conclusion.
    In a situation where the owner, operator or agent in charge of a 
facility does not have information from the manufacturer, processor, or 
packer of the food about whether an unexposed refrigerated packaged 
food requires time/temperature control for safety and, if so, what 
specific temperature controls are necessary for safe storage of the 
food, the owner, operator, or agent in charge of the facility could 
either consult the scientific and technical literature to determine 
whether a particular food is a TCS food or assume that any unexposed 
refrigerated packaged food is a TCS food. Information about foods that 
are TCS foods, and about the appropriate temperatures to address the 
potential for microorganisms of public health significance to grow, or 
produce toxin, in food are well-established in the scientific 
literature. Documents prepared by or on behalf of FDA regarding 
appropriate time/temperature controls for safety (Ref. 173) (Ref. 140) 
provide numerous references to the primary scientific literature and 
serve as the basis for time/temperature controls for a variety of 
foods. The two temperatures commonly cited in these documents as 
maximum temperatures for safe storage of refrigerated food are 41 
[deg]F (5 [deg]C) and 45 [deg]F (7 [deg]C). The cited maximum 
temperature depends on the food; in some cases, a maximum storage 
temperature is established through rulemaking in a regulation. For 
example:
     Our regulations for the prevention of Salmonella 
Enteritidis in shell eggs during production, storage, and 
transportation (Sec.  118.4(e)) and for refrigeration of shell eggs 
held for retail distribution (Sec.  115.50(b)(2)) require that eggs be 
held and transported at a temperature not to exceed 45[deg]F (7[deg]C).
     The PMO provides for pasteurized Grade ``A'' milk and milk 
products to be held at 45[deg]F (7[deg]C) (Ref. 37).
     The FDA Food Code, which has been widely adopted in state 
laws, recommends holding most potentially hazardous (TCS) food at 
41[deg]F (7[deg]C) or lower (Ref. 191).
    Storage of refrigerated food at or below one of these two 
temperatures (i.e., 41 [deg]F (5 [deg]C) or 45 [deg]F (7 [deg]C)) 
consistent with storage temperatures required by regulation or 
recommended in widely adopted documents such as the PMO and the FDA 
Food Code would satisfy proposed Sec.  117.206(a).
    We consider frozen food to be a subset of refrigerated food. The 
temperature and time required for a frozen food to become unsafe would 
result in significant quality issues for such food. Although there have 
been occasional problems with frozen food being subject to temperatures 
that allow some thawing in storage and distribution, we are not aware 
of situations in which frozen foods have been associated with the food 
becoming unsafe. Thus, we tentatively conclude that it would be rare 
for an unexposed frozen packaged food to be a TCS food.
    Proposed Sec.  117.206(a)(2) would require that the owner, 
operator, or agent in charge of a facility solely engaged in the 
storage of unexposed packaged food monitor the temperature controls 
established for unexposed refrigerated packaged TCS food with 
sufficient frequency to provide assurance that they are consistently 
performed. Monitoring can be done by use of a continuous temperature-
recording device (e.g., a recording thermometer) that indicates and 
records the temperature accurately within the refrigeration compartment 
with a visual check of the recorded data at least once per day. 
Monitoring as would be required by proposed Sec.  117.206(a)(2) would 
provide the owner, operator, or agent in charge of the facility with 
factual information with which to judge whether the temperature control 
is operating as intended. Proposed Sec.  117.206(a)(2) is modified 
relative to the analogous monitoring requirement that would be 
established in proposed Sec.  117.140(a) in subpart C in that proposed 
Sec.  117.206(a)(2) would not require written procedures for 
monitoring. The records of monitoring (which would be required by 
proposed Sec.  117.206(a)(5)(i)) would demonstrate the frequency of 
monitoring. We request comment on whether there would be a benefit to 
requiring a facility to develop written procedures for monitoring 
temperature.
    Proposed Sec.  117.206(a)(3) would require that, if there is a 
problem with the temperature controls for unexposed refrigerated 
packaged TCS food, the owner, operator, or agent in charge of a 
facility solely engaged in the storage of unexposed packaged food take 
appropriate corrective actions to correct a problem with the control of 
temperature for any refrigerated packaged food and reduce the 
likelihood that the problem will recur (proposed Sec.  
117.206(a)(3)(i)); evaluate all affected food for safety (proposed 
Sec.  117.206(a)(3)(ii)); and prevent the food from entering commerce, 
if the owner, operator, or agent in charge of a facility cannot ensure 
the affected food is not adulterated under section 402 of the FD&C Act 
(proposed Sec.  117.206(a)(3)(iii)). Such corrective actions would be 
necessary if, for example, there was a failure to maintain adequate 
temperature control. Proposed Sec.  117.206(a)(3) is modified relative 
to the analogous proposed requirement for corrective actions that would 
be established in proposed Sec.  117.145(a) in subpart C in that 
proposed Sec.  117.206(a)(3) would not require written procedures for 
corrective actions. In essence, there is a single action to correct the 
problem (i.e., to restore temperature control), followed by the need to 
evaluate the food for safety and to prevent food from entering commerce 
when appropriate. The corrective actions taken, including information 
to document that product was not exposed to temperatures and times that 
would compromise the safety of the product, would be documented in 
records subject to agency review. It may be necessary for the owner, 
operator, or agent in charge of the facility to consult with the 
applicable manufacturer, processor, or packer of the food to determine 
the appropriate disposition of the food.
    Proposed Sec.  117.206(a)(4)(i) would require that the owner, 
operator, or agent in charge of a facility solely engaged in the 
storage of unexposed packaged food verify that temperature controls are 
consistently implemented by calibrating temperature monitoring and 
recording devices. As discussed in section XII.G.5.a of this document, 
calibration provides assurance that an instrument is measuring 
accurately. If these instruments are not properly calibrated, the 
values they provide may not provide the necessary assurance 
temperatures are adequate to significantly minimize or prevent the 
growth of, or toxin production by, microorganisms of public health 
significance in an unexposed

[[Page 3775]]

refrigerated packaged TCS food. Proposed Sec.  117.206(a)(4)(i) is 
analogous to proposed Sec.  117.150(d)(2) in subpart C, which would 
establish a verification requirement for calibration of process 
monitoring instruments and verification instruments.
    Proposed Sec.  117.206(a)(4)(ii) would require that the owner, 
operator, or agent in charge of a facility solely engaged in storage of 
unexposed packaged food verify that temperature controls are 
consistently implemented by reviewing records of calibration within a 
reasonable time after the records are made. As discussed in section 
XII.G.5.b of this document, the purpose of the review of records would 
be to ensure that the records are complete and that the preventive 
controls are effective. If temperature monitoring and recording devices 
are not properly calibrated, the temperature controls may not be 
effective. As discussed in section XII.G.5.b of this document, the 
review of calibration records will depend in part on the frequency with 
which calibrations occur.
    Proposed Sec.  117.206(a)(4)(iii) would require that the owner, 
operator, or agent in charge of a facility solely engaged in storage of 
unexposed packaged food verify that temperature controls are 
consistently implemented by reviewing the records of monitoring and 
actions taken to correct a problem with the control of temperature 
within a week after the records are made. As discussed in section 
XII.G.5.b of this document, the purpose of the review of records would 
be to ensure that the records are complete, that the temperatures 
recorded were adequate to significantly minimize or prevent the growth 
of, or toxin production by, microorganisms of public health 
significance in an unexposed refrigerated packaged TCS food, and that 
appropriate actions were taken to correct any problem with the control 
of temperature for any unexposed refrigerated packaged TCS food. A 
weekly review of monitoring and corrective action records would provide 
for timely feedback of information and limit the amount of product 
impacted by any problems identified during the review of the records. 
Proposed Sec.  117.206(a)(4)(iii) is analogous to proposed Sec.  
117.150(d)(2)(ii) in subpart C, which would establish a verification 
requirement for review of records of monitoring and corrective action 
records within a week after the records are made.
    Proposed Sec.  117.206(a)(4) is modified relative to the analogous 
proposed verification requirements in proposed Sec.  117.150 in that 
proposed Sec.  117.206(a)(4) would not require validation or 
reanalysis. There is a single control to verify, which limits the need 
for many of the verification procedures that might otherwise apply. As 
noted above, the temperatures to control growth of microbial pathogens 
are well documented and do not require validation that they are 
effective in controlling the potential for microorganisms of public 
health significance to grow, or produce toxin, in food. The reasons for 
not requiring reanalysis were discussed in section XIII.B.2. Proposed 
Sec.  117.206(a)(4) also is modified relative to the analogous proposed 
verification requirements in proposed Sec.  117.150 in that proposed 
Sec.  117.206(a)(4) would not require that a qualified individual 
perform or oversee the review of records of calibration or records of 
monitoring and actions taken to correct a problem with the control of 
temperature. The nature of these records does not require the 
qualifications that would be required under proposed Sec.  117.155(b).
    Proposed Sec.  117.206(a)(5) would require that the owner, 
operator, or agent in charge of a facility solely engaged in storage of 
unexposed packaged food establish and maintain records documenting the 
monitoring of temperature controls for any unexposed refrigerated 
packaged TCS food (proposed Sec.  117.206(a)(5)(i)); records of 
corrective actions taken when there is a problem with the control of 
temperature for any unexposed refrigerated packaged TCS food (proposed 
Sec.  117.206(a)(5)(ii)); and records documenting verification 
activities (proposed Sec.  117.206(a)(5)(iii)). The records that 
document monitoring would be used to verify that the temperature 
controls are effectively and significantly minimizing or preventing the 
growth of, or toxin production by, microorganisms of public health 
significance. The records that document corrective actions would be 
used to verify that appropriate decisions about corrective actions are 
being made and appropriate corrective actions are being taken. The 
records that document verification activities would be used to document 
that this key element of a food safety plan has been implemented. These 
records would be necessary to demonstrate compliance with the 
requirements and as such would be useful to inspectors and auditors. 
Proposed Sec.  117.206(a)(5) is analogous to provisions in proposed 
Sec. Sec.  117.140(c), 117.145(d), and 117.150(f) in subpart C, which 
would require documentation of monitoring, corrective actions, and 
verification activities, respectively.
    Proposed Sec.  117.206(b) would establish that the records that a 
facility must establish and maintain under proposed Sec.  117.206(a)(5) 
are subject to the requirements of proposed subpart F. Proposed subpart 
F would establish requirements that would apply to all records that 
would be required under proposed part 117. We describe the requirements 
of proposed subpart F in section XV of this document. Proposed Sec.  
117.206(b) is analogous to proposed Sec.  117.175(b) in subpart C.

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

    Section 418(l)(3)(A) of the FD&C Act specifies that, in the event 
of an active investigation of a foodborne illness outbreak that is 
directly linked to a qualified facility subject to an exemption under 
section 418(l) of the FD&C Act, or if the Secretary determines that it 
is necessary to protect the public health and prevent or mitigate a 
foodborne illness outbreak based on conduct or conditions associated 
with a qualified facility that are material to the safety of the food 
manufactured, processed, packed, or held at such facility, the 
Secretary may withdraw the exemption provided to such facility under 
section 418(l) of the FD&C Act. Section 418 does not expressly 
prescribe the procedures for withdrawing an exemption provided to a 
qualified facility under section 418(l). We tentatively conclude that 
it is appropriate to be transparent about the process we would use to 
withdraw an exemption and that we should include the process in the 
proposed rule.

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

1. Proposed Sec.  117.251(a)--Withdrawal of an Exemption in the Event 
of an Active Investigation of a Foodborne Illness Outbreak
    Proposed Sec.  117.251(a) would provide that FDA may withdraw the 
exemption that would be applicable to a qualified facility under 
proposed Sec.  117.5(a) in the event of an active investigation of a 
foodborne illness outbreak that is directly linked to the qualified 
facility. Proposed Sec.  117.251(a) would implement the statutory 
language of section 418(l)(3)(A) of the FD&C Act. As discussed in 
section II.A.6.c of this document, an outbreak of foodborne illness is 
the occurrence of two or more

[[Page 3776]]

cases of a similar illness resulting from the ingestion of a common 
food. Food can become contaminated 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. When foodborne illness 
is associated with food, a traceback investigation may enable us to 
directly link the illness to the facility or facilities that 
manufactured, processed, packed, and/or held the food.
    For example, in February 2007, CDC notified FDA of a multi-state 
outbreak of Salmonella Tennessee infections associated with the 
consumption of peanut butter (73 FR 55115 at 55118, September 24, 
2008). Peanut butter is a non-perishable packaged food, sold in jars. 
Consumers who became ill had open jars of peanut butter available for 
testing. Investigators were able to test samples of peanut butter taken 
from the jars and confirm the presence of Salmonella Tennessee in the 
peanut butter. Investigators were able to identify the manufacturer 
through information required to be on the label of the jars (21 CFR 
101.5(a)) and through a product code the manufacturer had voluntarily 
placed on the jars. This information made it possible for FDA to visit 
the manufacturing facility the day after we learned of the outbreak 
from CDC. Investigators were able to use the product code to look in 
the manufacturing facility for unopened jars of peanut butter 
manufactured at the same time as the jars available from consumers. 
Investigators took samples of peanut butter from these unopened jars 
and confirmed the presence of Salmonella Tennessee in those samples. 
Because investigators uncovered conditions at the manufacturer's 
facility that were likely to have caused the contamination and obtained 
a positive environmental sample, investigators saw no need to further 
trace the peanuts back to the farm where the peanuts were grown (73 FR 
55115 at 55118). In circumstances such as the 2007 peanut butter 
outbreak, the available data and information from the investigation 
directly linked the outbreak of foodborne illness to the manufacturing 
facility.
2. Proposed Sec.  117.251(b)--Withdrawal of an Exemption Based on 
Conduct or Conditions Associated With a Qualified Facility
    Proposed Sec.  117.251(b) would provide that FDA may withdraw the 
exemption applicable to a qualified facility under proposed Sec.  
117.5(a) if FDA determines that it is necessary to protect the public 
health and prevent or mitigate a foodborne illness outbreak based on 
conduct or conditions associated with a qualified facility that are 
material to the safety of the food manufactured, processed, packed, or 
held at such facility. As an example, we may receive reports to the 
Reportable Food Registry under section 417 of the FD&C Act about 
contamination of a food, and the reports may lead us to investigate a 
qualified facility that manufactured, processed, packed or held the 
food. If our investigation finds conduct or conditions associated with 
the facility that are material to the safety of the food (for example, 
conduct or conditions that likely led to the contamination of the 
food), we would consider withdrawing the exemption applicable to the 
facility under proposed Sec.  117.5(a) if doing so would be necessary 
to protect the public health and prevent or mitigate a foodborne 
illness outbreak. Likewise, if during a routine inspection of a 
qualified facility, we discover conditions and practices that are 
likely to lead to contamination of food with microorganisms of public 
health significance, we would consider withdrawing the exemption 
provided to the facility under proposed Sec.  117.5(a) if doing so 
would be necessary to protect the public health and prevent or mitigate 
a foodborne illness outbreak.

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

    Proposed Sec.  117.254(a) would provide that, if FDA determines 
that an exemption applicable to a qualified facility under proposed 
Sec.  117.5(a) should be withdrawn, any officer or qualified employee 
of FDA may issue an order to withdraw the exemption. We intend to 
create and maintain a written record of a determination that the 
withdrawal of an exemption is warranted and to include the basis for 
the determination in the written record.
    Proposed Sec.  117.254(b) would require that an FDA District 
Director in whose district the qualified facility is located (or, in 
the case of a foreign facility, the Director of the Office of 
Compliance in the Center for Food Safety and Applied Nutrition), or an 
FDA official senior to such Director, must approve an order to withdraw 
the exemption as part of the withdrawal determination procedure before 
the order is issued. A Regional Food and Drug Director is an example of 
an FDA official senior to a District Director. The Deputy Director and 
Director of the Center for Food Safety and Applied Nutrition are 
examples of an FDA official senior to the Director of the Office of 
Compliance. Requiring prior approval of a withdrawal order by a 
District Director or an FDA official senior to a District Director is 
consistent with the approval requirement for a detention order in part 
1, subpart K (Administrative Detention of Food for Human or Animal 
Consumption). Requiring prior approval of a withdrawal order by the 
Director of the Office of Compliance in the Center for Food Safety and 
Applied Nutrition is consistent with current FDA practices when dealing 
with foreign firms.
    Proposed Sec.  117.254(c) would require that FDA issue an order to 
withdraw the exemption to the owner, operator, or agent in charge of 
the qualified facility. The requirements of section 418 of the FD&C Act 
are directed to the owner, operator, or agent in charge of a facility. 
We tentatively conclude that the statutory language of section 418 
enables FDA to issue an exemption withdrawal order to any of these 
persons.
    Proposed Sec.  117.254(d) would require that FDA issue an order to 
withdraw the exemption in writing, signed and dated by the officer or 
qualified employee of FDA who is issuing the order.

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

    Proposed Sec.  117.257(a) through (i) would require that an order 
to withdraw an exemption applicable to a qualified facility under Sec.  
117.5(a) include the following information:
     (a) The date of the order (proposed Sec.  117.257(a));
     (b) The name, address and location of the qualified 
facility (proposed Sec.  117.257(b));
     (c) A brief, general statement of the reasons for the 
order, including information relevant to:
     (1) An active investigation of a foodborne illness 
outbreak that is directly linked to the facility; or
     (2) Conduct or conditions associated with a qualified 
facility that are material to the safety of the food manufactured, 
processed, packed, or held at such facility (proposed Sec.  
117.257(c)).
     (d) A statement that the facility must comply with subpart 
C of this part on the date that is 60 calendar days after the date of 
the order (proposed Sec.  117.257(d));
     (e) The text of section 418(l) of the Federal Food, Drug, 
and Cosmetic Act and of this subpart E (proposed Sec.  117.257(e));
     (f) A statement that any informal hearing on an appeal of 
the order must be conducted as a regulatory hearing

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under part 16 of this chapter (21 CFR part 16), with certain exceptions 
described in proposed Sec.  117.270 (proposed Sec.  117.257(f));
     (g) The mailing address, telephone number, email address, 
and facsimile number of the FDA district office and the name of the FDA 
District Director in whose district the facility is located (or, in the 
case of a foreign facility, the same information for the Director of 
the Office of Compliance in the Center for Food Safety and Applied 
Nutrition); (proposed Sec.  117.257(g)); and
     (h) The name and the title of the FDA representative who 
approved the order (proposed Sec.  117.257(i)).
    FDA tentatively concludes that the requirements that we propose in 
Sec.  117.257 would provide the owner, operator, or agent in charge of 
a qualified facility subject to a withdrawal with adequate notice of 
the basis for our determination to withdraw the exemption and of their 
opportunity to appeal our determination and to request an informal 
hearing. The proposed notification procedures are similar to and 
consistent with the notification requirements in other regulations 
involving administrative action, such as administrative detention of 
food under Sec.  1.393 orders for diversion or destruction of shell 
eggs under the PHS Act under Sec.  118.12(a)(i), and with procedures 
for an informal hearing in part 16.

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

    Proposed Sec.  117.260(a) would require that the owner, operator, 
or agent in charge of a qualified facility that receives an order under 
Sec.  117.251 to withdraw an exemption applicable to that facility 
under Sec.  117.5(a) either comply with applicable requirements of this 
part within 60 calendar days of the date of the order; or appeal the 
order within 10 calendar days of the date of the order in accordance 
with the requirements of Sec.  117.264. We tentatively conclude that 
either of the two circumstances that could result in our determination 
that an exemption should be withdrawn (as described in proposed Sec.  
117.251) warrant prompt compliance with the rule in the interest of 
public health. We tentatively conclude that ten calendar days for the 
submission of an appeal from the date of the receipt of a withdrawal 
order is appropriate for purposes of the efficient adjudication of the 
appeal of a withdrawal order and would provide reasonable due process 
that comes to closure sufficiently in advance of the effective date of 
the order to provide an opportunity for the facility to come into 
compliance if we deny the appeal.
    Proposed Sec.  117.260(b) would establish that submission of an 
appeal, including submission of a request for an informal hearing, will 
not delay or stay any administrative action, including enforcement 
action by FDA, unless the Commissioner of Food and Drugs, as a matter 
of discretion, determines that delay or a stay is in the public 
interest. For example, the submission of an appeal of a withdrawal 
order with a request for an informal hearing under proposed Sec.  
117.260(b) would not prevent FDA from simultaneously detaining food 
from the facility under section 304(h) of the FD&C Act, seizing food 
from the facility under section 304(a) of the FD&C Act, or seeking or 
enforcing an injunction under section 302 of the FD&C Act.
    Proposed Sec.  117.260(c) would require that, if the owner, 
operator, or agent in charge of the qualified facility appeals the 
order, and FDA confirms the order, the owner, operator, or agent in 
charge of the facility must comply with applicable requirements of this 
part within 60 calendar days of the date of the order. Proposed Sec.  
117.260(c) would make clear that the 60 calendar day time frame for 
compliance applies regardless of whether the owner, operator, or agent 
in charge of a facility requests, and FDA grants, a hearing. As already 
discussed, FDA tentatively concludes that the circumstances that lead 
to a determination that an exemption should be withdrawn warrant prompt 
compliance in the interest of public health.

F. Proposed Sec.  117.264--Procedure for Submitting an Appeal

    Proposed Sec.  117.264(a) would require that, to appeal an order to 
withdraw an exemption applicable to a qualified facility under Sec.  
117.5(a), the owner, operator, or agent in charge of the facility must 
(1) submit the appeal in writing to the FDA District Director in whose 
district the facility is located (or, in the case of a foreign 
facility, the same information for the Director of the Office of 
Compliance in the Center for Food Safety and Applied Nutrition), at the 
mailing address, email address, or facsimile number identified in the 
order within 10 calendar days of the date of the order; and (2) respond 
with particularity to the facts and issues contained in the order, 
including any supporting documentation upon which the owner, operator 
or agent in charge of the facility relies.
    Allowing the owner, operator, or agent in charge of the facility to 
submit an appeal in person, by mail, email, or fax would provide for 
flexibility as well as speed. For example, submitting in person would 
give the owner, operator, or agent in charge direct knowledge that the 
request for appeal had been delivered and received. Email and fax are 
instantaneous, and overnight mail delivery services are readily 
available to those who choose to use them; however, the ten day time 
frame for appeal of the order would not require the use of overnight 
mail delivery. For clarity, proposed Sec.  117.264(a) would repeat the 
10 calendar day time frame that would be established in proposed Sec.  
117.260(a)(2) and would not establish any new requirement. Any appeal 
would need to be written in order for FDA to evaluate the basis for the 
appeal. We are proposing that a written appeal would need to address 
with particularity all of the issues raised in the withdrawal order and 
include all supporting documentation so that we would be able to issue 
a final determination as to the disposition of the appeal solely on the 
basis of the materials submitted as part of the written appeal.
    Proposed Sec.  117.264(b) would provide that, in a written appeal 
of the order withdrawing an exemption provided under Sec.  117.5(a), 
the owner, operator, or agent in charge of the facility may include a 
written request for an informal hearing as provided in Sec.  117.267. 
Requesting an informal hearing does not mean that a hearing will be 
held, because we may deny the request (see discussion of proposed Sec.  
117.267(b) in the next section of this document). However, if the 
owner, operator, or agent in charge of the facility does not request an 
informal hearing at the time the written appeal is submitted, the 
owner, operator, or agent in charge of the facility will not be 
entitled to an informal hearing. Instead, FDA will make a final 
decision based on the written appeal and its supporting materials.

G. Proposed Sec.  117.267--Procedure for Requesting an Informal Hearing

    Proposed Sec.  117.267(a)(1) would provide that, if the owner, 
operator, or agent in charge of the facility appeals the order, the 
owner, operator, or agent in charge of the facility may request an 
informal hearing. Proposed Sec.  117.267(a)(1) would restate an option 
that would be included in proposed Sec.  117.264(b) to highlight the 
opportunity to request an informal hearing. Proposed Sec.  
117.267(a)(2) would require that, if the owner, operator, or agent in 
charge of the facility appeals the order, the owner, operator, or agent 
in charge of the

[[Page 3778]]

facility must submit any request for an informal hearing together with 
its written appeal submitted in accordance with Sec.  117.