[Federal Register Volume 78, Number 11 (Wednesday, January 16, 2013)]
[Proposed Rules]
[Pages 3646-3824]
From the Federal Register Online via the Government Publishing 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, [email protected].
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
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Who or what would be exempt from the
requirements for hazard analysis and Notes
risk-based preventive controls
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``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
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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
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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
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(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);