[Federal Register Volume 83, Number 30 (Tuesday, February 13, 2018)]
[Proposed Rules]
[Pages 6314-6361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00425]
[[Page 6313]]
Vol. 83
Tuesday,
No. 30
February 13, 2018
Part II
Department of Agriculture
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Food Safety and Inspection Service
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9 CFR Parts 416, 417, et al.
Egg Products Inspection Regulations; Proposed Rule
Federal Register / Vol. 83 , No. 30 / Tuesday, February 13, 2018 /
Proposed Rules
[[Page 6314]]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 416, 417, 500, 590 and 591
[Docket No. FSIS-2005-0015]
RIN 0583-AC58
Egg Products Inspection Regulations
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to
amend the egg products inspection regulations by requiring official
plants that process egg products (herein also referred to as ``egg
products plants'' or ``plants'') to develop and implement Hazard
Analysis and Critical Control Point (HACCP) Systems and Sanitation
Standard Operating Procedures (Sanitation SOPs) and to meet other
sanitation requirements consistent with the meat and poultry
regulations. FSIS is proposing to eliminate those current regulatory
provisions that are inconsistent with HACCP, Sanitation SOPs, and the
proposed sanitation requirements. FSIS is also proposing to specify in
the regulations that official plants are required to process egg
products to be edible without additional preparation to achieve food
safety.
In addition, FSIS is proposing to: Provide for generic approval as
part of the prior label approval system for egg products; make changes
to labeling requirements for shell eggs consistent with those in the
Food and Drug Administration's (FDA's) regulations; require special
handling instructions on egg products; eliminate the requirements for
prior approval by FSIS of egg products plant drawings, specifications,
and equipment; incorporate egg products plants into the coverage of the
``Rules of Practice'' that the Agency follows when initiating
administrative enforcement actions; and change the Agency's
interpretation of the requirement for continuous inspection in agency
law.
FSIS is also announcing that it is seeking public comment on draft
guidance designed to help small and very small plants producing egg
products to meet the new regulatory requirements being proposed in this
rulemaking. Should the rule become final, FSIS intends to finalize this
guidance.
DATES: Comments must be received on or before June 13, 2018. FSIS is
providing a longer comment period than typical for this proposed rule
because of the magnitude of the proposed action and the need to provide
for possible public meetings on the proposed action.
ADDRESSES: FSIS invites interested persons to submit comments on this
proposed rule and the draft guidance. Comments may be submitted by any
of the following methods:
Federal eRulemaking Portal: This website provides the
ability to type short comments directly into the comment field on this
web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the on-line instructions at that site for
submitting comments.
Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S.
Department of Agriculture, Food Safety and Inspection Service, Patriots
Plaza 3, 1400 Independence Avenue SW, Mailstop 3782, Room 8-163B,
Washington, DC 20250-3700.
Hand- or Courier-Delivered Submittals: Deliver to Patriots
Plaza 3, 355 E Street SW, Room 8-163B, Washington, DC 20250-3700.
Instructions: All items submitted by mail or electronic mail must
include the Agency name and docket number FSIS-2005-0015. Comments
received in response to this docket will be made available for public
inspection and posted without change, including any personal
information, to http://www.regulations.gov.
Docket: For access to background documents or comments received, go
to the FSIS Docket Room at Patriots Plaza 3, 355 E Street SW, Room 8-
164, Washington, DC 20250-3700 between 8:00 a.m. and 4:30 p.m., Monday
through Friday.
FOR FURTHER INFORMATION CONTACT: Victoria A. Levine, Program Analyst,
Issuances Staff, Office of Policy and Program Development, Food Safety
and Inspection Service, U.S. Department of Agriculture, 1400
Independence Avenue SW, Room 6079, South Agriculture Building,
Washington, DC 20250-3700; telephone (202) 720-5627; fax (202) 690-
0486.
SUPPLEMENTARY INFORMATION:
Executive Summary
FSIS is proposing to amend the egg products inspection regulations
(9 CFR part 590) to require that official plants \1\ that process egg
products develop and implement Hazard Analysis and Critical Control
Points (HACCP) systems and Sanitation Standard Operating Procedures
(Sanitation SOPs), in accordance with the regulations in 9 CFR parts
416 and 417, and to meet proposed sanitation requirements (proposed 9
CFR part 591). The Agency is proposing to eliminate those regulations
that are incompatible with the regulations for HACCP and Sanitation
SOPs and to convert prescriptive, command-and-control requirements to
general sanitation standards.
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\1\ As defined in the Egg Products Inspection Act (21 U.S.C.
1031 et seq.). Exempted plants, as defined in 9 CFR 590.5, are also
official plants, per the statute.
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Existing regulations that FSIS is proposing to revise or eliminate
include those relating to egg products plant grounds and pest
management; plant sanitation; plant construction, including rooms,
doors, and windows; lighting; ventilation and odors; plumbing; sewage
disposal; water supply and solution re-use; and dressing rooms,
lavatories, and toilets. The Agency is proposing to replace all of
these with general sanitation requirements, as it has previously done
with the requirements on the same subjects in the meat and poultry
products regulations.
The Agency is also proposing to specify in the regulations that
official plants are required to process egg products to be edible
without additional preparation to achieve food safety (proposed 9 CFR
590.570). This will ensure that the products are free of detectable
pathogens. The proposed regulations will require egg product plants to
maintain control of egg products that have been sampled and tested for
public health hazards, e.g., Salmonella, until the test results become
available (proposed amendments to 9 CFR 590.504). The proposed amended
regulations will provide for the use of irradiated shell eggs in the
processing of egg products and food products containing them (proposed
9 CFR 590.590).
The Agency is proposing to make the egg products labeling and
``other consumer protection'' requirements, including requirements for
generically approved labeling, more like the labeling requirements for
meat and poultry products (proposed 9 CFR 590.412).
FSIS is proposing to align the import requirements for eggs and egg
products more closely with the import requirements for meat and poultry
products (proposed 9 CFR 590, Subpart B).
FSIS is proposing to change organizational terms and job titles
that appear in the regulations but that are no longer used in FSIS
(proposed amendment of 9 CFR 590.5).
FSIS is also proposing to change the Agency's interpretation of the
requirement for continuous inspection in 21 U.S.C. 1034(a). Inspection
will no
[[Page 6315]]
longer be conducted during all processing operations, but may instead
be provided at least once per shift.
Finally, FSIS is proposing to replace the rules of practice
governing enforcement procedures for egg product plants with those that
apply to meat and poultry product establishments (proposed amendments
to 9 CFR part 500).
Costs attributable to the proposed rule are those associated with
the development and implementation of HACCP plans and Sanitation SOPs
and the need for new product labels with safe-handling instructions.
The impact of the costs is somewhat mitigated by the fact that 93
percent of egg products plants already use a written HACCP plan to
address at least one production step in their process.
FSIS will continue to test for Salmonella and Listeria
monocytogenes (Lm) in egg products. If FSIS detects the pathogens in
the product, under HACCP, plants will be required to take corrective
actions to prevent recurrence of the problem, if the plant has
determined the pathogen is reasonably likely to occur in its production
process (9 CFR 417.3(a)). If FSIS detects the pathogen and the plant
has not determined that the hazard is reasonably likely to occur, the
plant will be required to take corrective actions and also will be
required to reassess its HACCP plan (9 CFR 417.3(b)). FSIS also will
continue to require that egg product plants test pasteurized egg
products for pathogens. Plants must ensure that egg products that test
positive for pathogens are condemned or reprocessed (9 CFR 590.422).
The proposed rule will provide greater flexibility and incentives
for innovation through reductions in paperwork and unnecessary
approvals. In addition, plants voluntarily meeting HACCP requirements
and also complying with current prescriptive regulations would reduce
costs because they would be operating entirely under HACCP
requirements.
Table 1--Summary of Estimated Costs and Benefits
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Discussion of benefits and costs
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Low Mid High
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Benefits ($1,000) \a\................ 5,585 5,585 5,585
Costs ($1,000)....................... 2,195.0 4,235.2 6,287.8
Net Benefits ($1,000)................ 3,389.7 1,349.5 -703.1
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Industry Benefits.................... Long-term efficiency gains, as shown in academic literature
derived from producing egg products in a HACCP system.
Less burdensome or elimination of waiver, blueprints, no
objection letter, changes to production equipment, and label approval
submissions to FSIS.
Cost savings from the elimination of overtime and holiday pay
paid to FSIS inspectors for inspection.
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Agency Benefits...................... Long-term benefits from improved inspection personnel coverage.
Egg products inspection personnel will now be trained under a HACCP
system and can be positioned for inspection in traditional meat and
poultry establishments.
Salary savings for the reduction in inspection at egg products
plants.
Savings from the reduction or elimination of waiver, blueprints,
no objection letter, changes to production equipment, and label approval
submissions to FSIS from industry.
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Industry Costs....................... Cost to the plant to create HACCP plans and Sanitation SOPs.
Costs to the plant for additional recordkeeping and monitoring.
Cost to the plant for training personnel in the HACCP system.
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Agency Costs......................... Costs for training inspection program personnel in HACCP and egg
products inspection.
Costs to the Agency to provide relief inspectors while egg
products plants inspectors are being trained.
Additional travel costs for inspection personnel on patrol
assignments in egg products plants.
Loss of overhead paid to the Agency by industry.
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\a\ Costs were annualized over 10 years at the 7 percent discount rate.
A copy of each document referenced in this notice of proposed
rulemaking is available for viewing in the FSIS Docket Room, on the
FSIS website as a related document associated with this docket, and on
www.regulations.gov, unless otherwise noted.
Table of Contents
I. Background
FSIS's Regulatory Jurisdiction Over Egg Products
1. What Products Are Covered Under the EPIA
2. Product Amenability Determinations Under the EPIA
II. Proposed Changes to Specific Regulations
A. Part 591
B. HACCP
C. Sanitation SOPs
D. Sanitation Requirements
E. Egg Products Are ``Ready-To-Eat''
F. Not Applying the Mark of Inspection Pending Test Results
G. Irradiated Shell Eggs
H. Preparing for Implementation of Regulatory Requirements
I. Labeling and Other Consumer Protection Regulatory
Requirements
J. Rules of Practice
K. Other Regulatory Changes
1. Elimination of Egg Products Plant Equipment and Facility
Prior Approval Requirements
2. Import Requirements
3. Changes to Defined Terms
4. Conditions for Receiving Inspection
5. Miscellaneous Changes
6. Reinterpreting the Requirement for Continuous Inspection in
21 U.S.C. 1034(a)
III. Executive Orders 12866 and 13563 and the Regulatory Flexibility
Act
IV. Paperwork Reduction Act
V. Executive Order 12988
VI. E-Government Compliance
[[Page 6316]]
VII. Executive Order 13175
VIII. USDA Nondiscrimination Statement
IX. Additional Public Notification
I. Background
FSIS's Regulatory Jurisdiction Over Egg Products
FSIS carries out its food safety responsibilities with respect to
eggs and egg products under the provisions of the Egg Products
Inspection Act (EPIA) (21 U.S.C. 1031-1056).
To prevent the entry into commerce of any egg product that is
capable of use as human food and is misbranded or adulterated, the
Secretary of Agriculture regulates the processing of egg products under
21 U.S.C. 1034. Section 1034(a) states that the Secretary ``shall,
whenever processing operations are being conducted, cause continuous
inspection to be made, in accordance with the regulations promulgated
under this Act, of the processing of egg products, in each plant
processing for commerce, . . . .'' Therefore, under FSIS's current
interpretation of the EPIA, an inspector needs to be on the premises
during all such operations. The Secretary has also been authorized to
make inspections, as appropriate, of the facilities of egg handlers
(including transport vehicles) to determine whether shell eggs destined
for the ultimate consumer are being held under refrigeration at an
ambient temperature of no greater than 45 degrees Fahrenheit after
packing and contain labeling that indicates that refrigeration is
required (21 U.S.C. 1034(e)).
Under 21 U.S.C. 1043, the Secretary of Agriculture has the
authority to promulgate such rules and regulations as he deems
necessary to carry out the purposes or provisions of the Act. The
Secretary is also responsible for the administration and enforcement of
the EPIA, except as otherwise provided in 21 U.S.C. 1034(d).
1. What Products Are Covered Under the EPIA
Under the EPIA, FSIS regulates egg products. FSIS also has been
delegated the authority to establish temperature and labeling
requirements applicable to shell eggs destined for the ultimate
consumer (see 21 U.S.C. 1034(e)(1)).
Under 21 U.S.C. 1033(f), the term ``egg product'' means any
``dried, frozen, or liquid eggs, with or without added ingredients,
excepting products which contain eggs only in a relatively small
proportion or historically have not been, in the judgment of the
Secretary, considered by consumers as products of the egg food
industry, and which may be exempted by the Secretary under such
conditions as he may prescribe to assure that the egg ingredients are
not adulterated and such products are not represented as egg
products.'' The EPIA does not define ``relatively small proportion,''
nor does it provide additional guidance as to what criteria the
Secretary should take into consideration when determining what egg
products consumers consider to be products of the egg food industry.
Under 21 U.S.C. 1034(a), the Secretary requires continuous
inspection to be made of the processing of egg products in each plant
processing for commerce. There are currently 77 such official plants
that are under FSIS jurisdiction. Under the EPIA, ``processing'' means
``manufacturing egg products, including breaking eggs or filtering,
mixing, blending, pasteurizing, stabilizing, cooling, freezing, drying,
or packaging egg products'' (21 U.S.C. 1033(w)). Thus, egg products
processing operations, such as mixing, pasteurizing, freezing,
packaging, or relabeling, must be conducted under continuous Agency
inspection.
The definition of ``egg product'' in the egg products inspection
regulations (9 CFR 590.5) includes a list of specific products that
have been exempted as not being ``egg products.'' These exempted
products include freeze-dried products; imitation egg products; egg
substitutes; dietary foods; dried no-bake custard mixes; egg nog mixes;
acidic dressings; noodles; milk and egg dip; cake mixes; French toast;
and sandwiches containing eggs or egg products. Such products must,
however, be prepared from inspected egg products or from eggs
containing no more restricted eggs than are allowed in the official
standards for U.S. Consumer Grade B shell eggs.\2\ Exempted products
are subject to the jurisdiction of the Food and Drug Administration
(FDA).
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\2\ See the United States Standards, Grades, and Weight Classes
for Shell Eggs, AMS 56.216(c). http://www.ams.usda.gov/sites/default/files/media/Shell_Egg_Standard%5B1%5D.pdf.
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As stated above, products that contain eggs only in a relatively
small proportion are exempted from the definition of ``egg product''
and thus not amenable under the EPIA. Several of the products listed in
the preceding paragraph have been exempted from the coverage of ``egg
products'' for this reason, including dried no-bake custard mixes; egg
nog mixes; acidic dressings; noodles; milk and egg dip; cake mixes; and
French toast. The egg product ingredients in these foods are not easily
distinguished in the food and are used simply to add flavor. Other
products that include eggs but are not subject to FSIS jurisdiction are
closed-face sandwiches containing eggs or egg products and balut, a
Philippine delicacy. These products are subject to the jurisdiction of
FDA.
Cooked egg products, such as cooked egg patties, cooked omelets,
and freeze-dried cooked eggs, also fall under FDA's jurisdiction
because they are produced from USDA-inspected and passed egg products.
To eliminate confusion as to who has statutory authority over these
types of products, FSIS is proposing to amend the definition of ``egg
product'' in 9 CFR 590.5 to include cooked egg products as not being
egg products under FSIS jurisdiction.
2. Product Amenability Determinations Under the EPIA
FSIS considers a product to be amenable under the EPIA if it
consists of dried, frozen, or liquid eggs, with or without added
ingredients. Examples include Pasteurized Frozen Whole Egg with citric
acid; plain Pasteurized Frozen Whole Egg without added ingredients;
Pasteurized Liquid Yolk with 10% salt; Pasteurized Frozen Scrambled Egg
Mix with Whole Egg and pepper, starch, and dried milk; Frozen Yolks
with 10% sugar added; Frozen Egg Whites with whipping aids (such as
sodium sulfate or triethyl citrate); Pasteurized Enzyme Modified Dried
Egg Product with Egg Yolks and xanthan gum and citric acid to preserve
color, and less than 1% silicon dioxide as an anticaking agent and
phospholipase; Spray Dried Albumin; and Spray Dried Egg Whites with
calcium citrate and salt (or other added ingredients).
FSIS has determined that some of the products on the list of
specific products that have been exempted as not being ``egg products''
are incorrectly categorized as such. FSIS believes that these products,
egg substitutes and freeze-dried egg products, are, in fact, egg
products, and should therefore no longer be exempt from inspection by
FSIS under the EPIA. FSIS is seeking comment on the number of
facilities that might become dual jurisdiction facilities, that is,
regulated by FSIS and FDA, if egg substitutes and freeze-dried egg
products are no longer exempt from FSIS inspection.
Egg Substitutes
Egg substitutes are low-cholesterol products that are characterized
by yolk replacement by other non-egg ingredients such as vegetable oil,
nonfat dry milk, soy protein, gums, food coloring, artificial flavors,
and vitamins and minerals (for nutritional fortification). The
fundamental ingredient in these products is egg white, but they may
also include added
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egg-white solids or a small amount of yolk. When the EPIA and the egg
products inspection regulations were written, the production of egg
substitutes was exempted from United States Department of Agriculture
(USDA) inspection in the egg products inspection regulations.
As a result, egg substitutes are under the jurisdiction of FDA. FDA
has overseen the formulation, packaging, labeling, storage, and
transportation of egg substitutes under the Federal Food, Drug, and
Cosmetic Act (FFDCA) (21 U.S.C. 301-399). Egg substitutes do not
undergo continuous inspection during processing (unless the starting
ingredient is unpasteurized egg white), and most egg substitutes do not
bear a USDA inspection legend.
However, FSIS tentatively finds that egg substitutes should no
longer be exempt from inspection by FSIS under the EPIA. Egg
substitutes are similar, if not identical, in some cases, in
formulation to egg products. Indeed, the egg product ingredient is
distinctive and significantly contributes to the basic nature of egg
substitutes by characterizing the food. The only substantive difference
among these categories of products is color and nutrients. When a color
additive is mixed with pasteurized egg whites, the resulting product is
called an ``egg substitute.'' The application of color to pasteurized
egg whites has generally not been conducted under FSIS inspection.
The processing of egg substitutes is also similar to that of other
egg products, and the contamination risks associated with these types
of products are the same. Egg products and egg substitutes are
manufactured using the same process, though egg substitutes processed
in an FDA facility do not have to re-pasteurized; where CCPs exist in
the manufacture of egg products, they exist in the production of egg
substitutes, e.g., during mixing, blending, pasteurization, if
applicable, cooling, and packaging. The fact that egg substitutes are
formulated with pasteurized egg whites does not mean that all food
safety risks associated with the products are eliminated. Some egg
substitutes are not re-pasteurized after production, even though they
have been further processed in the FDA facility. To produce egg
substitutes, manufacturers need to reprocess pasteurized egg whites
because of the risk of product contamination post-pasteurization.
Because the risks associated with egg substitutes are the same as
those associated with egg products, and because the reprocessing step
presents a point in the process where contamination of egg substitutes
might occur, under the EPIA, the processing of egg substitutes needs to
take place within the framework of HACCP and Sanitation SOP preventive
control measures. Furthermore, the addition of color and other
ingredients does not materially change the products such that the
jurisdiction over the inspection of the products should be different
than for other egg products. In an effort to be more transparent about
the roles and responsibilities of FSIS and FDA regarding eggs, and
after consulting with FDA, FSIS is proposing to assert jurisdiction
over egg substitutes.
In addition, FSIS is proposing to assert jurisdiction over freeze-
dried egg products. Under 9 CFR 590.5, these are exempted from being
egg products. However, FSIS tentatively finds this categorization to be
incorrect. Freeze-dried egg products are amenable under the EPIA
because they consist of a pasteurized egg product that is flash frozen
and placed in a vacuum chamber where ice particles are removed. The
food safety risks associated with freezing the product and contemplated
by the EPIA are the same whether the process takes place in an FSIS-
inspected egg products plant or an FDA-inspected facility. As a result,
if this proposal is adopted, freeze-dried egg products will no longer
be exempt and will be subject to FSIS's jurisdiction. Therefore, FSIS
is proposing to amend the list of products exempted as not being egg
products in 9 CFR 590.5 to eliminate freeze-dried products and egg
substitutes.
II. Proposed Changes to Specific Regulations
A. 9 CFR Part 591
Under proposed 9 CFR 591.1(a), all official plants will have to
comply with the requirements contained in 9 CFR parts 416, Sanitation,
and 417, HACCP Systems. For the purposes of these parts, as well as 9
CFR part 500, Rules of Practice, an ``official establishment'' or
``establishment'' will include a plant that processes egg products
(proposed 9 CFR 591.1(b)).
B. HACCP
FSIS is proposing to adopt HACCP as the organizing structure for
its egg products food safety program because HACCP has been proven to
be an optimal framework for building science-based process control into
food production systems to prevent food safety hazards. Under proposed
9 CFR 590.149(b) and 591.1(a), official plants will be required to
comply with 9 CFR part 417, the Agency's regulation on HACCP, as a
condition of receiving inspection.
HACCP is a flexible system that will enable official plants to
tailor their control systems to the needs of their particular plants
and processes. Under proposed 9 CFR 590.149(b)and 591.1 and 9 CFR part
417, each egg products plant will be required to develop and implement
a HACCP system for food safety that is designed to prevent, eliminate,
or reduce to an acceptable level the occurrence of biological,
chemical, and physical hazards that are reasonably likely to occur in
the plant's process. Plants will be responsible for developing and
implementing HACCP plans that incorporate the controls that are
necessary to produce safe egg products. Given the requirements in 9 CFR
part 417, FSIS is proposing to amend or eliminate many of the
processing and facility requirements contained in 9 CFR 590.500-575.
Under 9 CFR part 417, when developing a HACCP plan (9 CFR
417.2(b)), a plant conducts a hazard analysis to identify and list the
biological, chemical, or physical food safety hazards that are
reasonably likely to occur in its production process for a particular
product and the measures necessary to prevent, eliminate, or reduce the
occurrence of those hazards to an acceptable level. The plant then
identifies the points in each of its processes at which control is
necessary to achieve this goal (9 CFR 417.2(c)(2)). These points are
called ``critical control points'' (CCPs). The plant would have to
establish critical limits for the preventive measures associated with
each identified CCP. A critical limit is the maximum or minimum value
to which a hazard must be controlled at a CCP to prevent, eliminate, or
reduce to an acceptable level the occurrence of the identified food
safety hazard. Critical limits are most often based on process
parameters such as temperature, time, water activity, pH, or humidity.
FSIS is proposing to treat egg products similarly to the way it
treats ready-to-eat (RTE) meat and poultry products. FSIS will require
that official plants produce egg products to be edible without
additional preparation to achieve food safety. Pathogens detected in or
on RTE egg products would adulterate those egg products under 21 U.S.C.
1033(a)(1)) because they would contain a poisonous or deleterious
substance which may render them injurious to health.
For example, FSIS regards any amount of Lm in an RTE product as a
product adulterant (9 CFR 430.4). Because the product is RTE, it is
likely to be consumed without any effort to kill the pathogen, and the
presence of the pathogen may render the product
[[Page 6318]]
injurious to health (21 U.S.C. 601(m)(1), 453(g)(1)) and would cause
the product to be unhealthful.\3\ The same would be true of an RTE egg
product containing Salmonella or Lm. While egg products may receive
additional preparation for palatability or aesthetic, epicurean,
gastronomic, or culinary purposes, they are produced to be edible
without additional preparation to achieve food safety. The presence of
Salmonella or Lm, therefore, would render the product injurious to
health (21 U.S.C. 1033(a)(1)) and would cause it to be unhealthful.
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\3\ Control of Listeria monocytogenes in Ready-to-Eat Meat and
Poultry Products; Final Rule (68 FR 34208, Jun. 6, 2003).
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FSIS has also addressed shiga-toxin producing E. coli (STEC) in
certain raw beef products (non-intact or intended for non-intact use)
in this manner. FSIS considers an acceptable reduction for STEC to be a
reduction to an undetectable level (i.e., a level that would not be
detectable using the FSIS testing method or a method with a sensitivity
at least equivalent to FSIS's method).\4\ This means that an
establishment producing RTE meat or poultry products or certain raw
beef products needs to address the pathogens so that they will not be
detected by FSIS or other equivalent testing. FSIS has recommended that
establishments do their own testing to verify that their HACCP systems
address the pathogens of concerns.\5\ While establishments can use
their own testing methods, those methods should be at least as
sensitive as FSIS's.\6\ FSIS has also said that establishments can
address the pathogen in their HACCP plan or Sanitation SOPs or other
prerequisite program.\7\ This same guidance would apply to egg products
plants.
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\4\ E. coli O157:H7 Contamination of Beef Products (67 FR 62325,
October 7, 2002) (available at: http://www.fsis.usda.gov/wps/wcm/connect/ad259bcd-5b85-4696-9888-89872bee39ee/00-022N.pdf?MOD=AJPERES).
\5\ Control of Listeria monocytogenes in Ready-to-Eat Meat and
Poultry Products; Final Rule (68 FR 34214, Jun. 6, 2003).
\6\ FSIS. 2013. Establishment Guidance for the Selection of a
Commercial or Private Microbiological Testing Laboratory (available
at: http://www.fsis.usda.gov/wps/wcm/connect/464a4827-0c9a-4268-8651-b417bb6bba51/Guidance-Selection-Commercial-Private-Microbiological-Testing-lab-062013.pdf?MOD=AJPERES).
\7\ HACCP Systems Validation (80 FR 27557, May 14, 2015).
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Under the Agency's verification testing program, egg products are
broken into seven product categories--four liquid and three dried. Each
month, inspectors collect one egg product sample per process from each
plant that produces egg products. Thus, inspectors could sample an egg
products plant as many as seven times per month depending on the number
of plant production processes occurring during the month. After
inspectors collect the samples, FSIS Field Service Laboratories analyze
the samples for the presence of Salmonella and Lm using the protocols
listed in the Microbiology Laboratory Handbook.8 9
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\8\ Isolation and Identification of Salmonella from Meat,
Poultry, Pasteurized Egg, and Siluriformes (Fish) Products and
Carcass and Environmental Sponges. January 2, 2017 (available at:
https://www.fsis.usda.gov/wps/wcm/connect/700c05fe-06a2-492a-a6e1-3357f7701f52/MLG-4.pdf?MOD=AJPERES).
\9\ Isolation and Identification of Listeria Monocytogenes from
Red Meat, Poultry, Ready-To-Eat Siluriformes Fish and Egg Products,
and Environmental Samples January 2, 2017 (available at: https://www.fsis.usda.gov/wps/wcm/connect/1710bee8-76b9-4e6c-92fc-fdc290dbfa92/MLG-8.pdf?MOD=AJPERES).
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Once a plant has established critical limits for the measures
associated with each identified CCP, it will need to monitor the
identified CCPs to assess whether the CCP is within the established
critical limit (9 CFR 417.2(c)(4)). Monitoring is an integral part of
HACCP, and monitoring frequencies must be sufficient to ensure that
each CCP is under control. The plant's HACCP plan would also have to
include corrective action to be taken when monitoring indicates that
there is a deviation from a critical limit at a CCP, because the
existence of a HACCP plan does not guarantee that problems will not
arise (9 CFR 417.2(c)(5)). For example, corrective action plans must be
in place to identify and correct the cause of a deviation and to
determine the disposition of potentially adulterated product.
Plants will also have to develop and maintain effective
recordkeeping procedures that document the entire HACCP system (9 CFR
417.2(c)(6)). Finally, plants will need to list the verification
procedures, and the frequency with which those procedures will be
performed, that the plant will use to ensure that the HACCP system is
in compliance with the HACCP plan (9 CFR 417.2(c)(7)). Periodic
verification will help the plant to ensure that it is operating in
accordance with its HACCP plan. The occurrence of unforeseen hazards
evidences that the HACCP plan needs to be reassessed. If this proposal
is adopted, individuals developing, reassessing, and modifying HACCP
plans in accordance with 9 CFR 417.2(b) and 417.3 will have to have
successfully completed a course of instruction in the application of
the seven HACCP principles to meat, poultry, or egg products
processing, including a segment on the development of a HACCP plan for
a specific product and on record review (9 CFR 417.7(b)).
Under this proposal, if an egg products plant fails to develop and
implement a HACCP plan that complies with proposed 9 CFR 590.149(b) and
591.1 and 9 CFR 417.2, or to operate in accordance with other 9 CFR
part 417 requirements, FSIS is likely to file a complaint to withdraw
or refuse inspection services, pursuant to 9 CFR 500.6 or 500.7. As
with official meat and poultry products establishments, FSIS will
verify that the plant's HACCP plans comply with the requirements of
proposed 9 CFR 590.149(b) and 591.1 and 9 CFR part 417; that these
plans have been validated by the facility; and that plants are
producing egg products to be edible without additional preparation to
achieve food safety. In other words, these products must be free of
detectable pathogens.
Hazard Analysis
If this proposal is adopted, each egg products plant will be
required to conduct a hazard analysis to determine the food safety
hazards reasonably likely to occur in its production processes and to
identify the preventive measures that it needs to take to control those
hazards (proposed 9 CFR 590.149(b) and 591.2 and 9 CFR 417.2(a)(1)).
The analysis must include a flow chart that describes the steps of the
process and that identifies the intended use or consumers of the
finished product (9 CFR 417.2(a)(2)).
Contamination with Salmonella spp. can be a food safety hazard that
is reasonably likely to occur in the production of egg products.
Therefore, as part of its hazard analysis, each egg products plant
should consider addressing this food safety hazard in its HACCP system.
Consistent with the application of HACCP in meat and poultry
operations, plants may determine that the Sanitation SOP or a
prerequisite program is an appropriate and suitable means to
effectively prevent the occurrence of certain food safety hazards and
thus make them not reasonably likely to occur.
HACCP Plan
Under this proposed rule, each egg products plant will be required
to develop and implement a HACCP plan covering each product produced
whenever the hazard analysis reveals one or more food safety hazards
that are reasonably likely to occur. Note that a single HACCP plan may
encompass multiple products within a single processing category (see
proposed 9 CFR 590.149(b) and 591.2 and 9 CFR 417.2(b)(1)) if the food
safety hazards,
[[Page 6319]]
CCPs, critical limits, and procedures identified within are essentially
the same.
Once completed, the HACCP plan must be signed and dated by a
responsible official, that is, the individual with overall authority
on-site or a higher level official of the plant. This signature
signifies that the plant accepts and will implement the HACCP plan. The
HACCP plan must be signed and dated not only upon initial acceptance by
the processor but also upon any modification to the plan and at least
annually, as required by 9 CFR 417.4(a)(3) (9 CFR 417.2(d)).
Corrective Actions
Under this proposed rule, the HACCP plan must identify the
corrective actions that the plant will take when responding to a
deviation from a critical limit and assign responsibility for taking
corrective action. Corrective actions must ensure that no product that
is injurious to health or that is otherwise adulterated as a result of
the deviation enters commerce; that the cause of the deviation is
identified and eliminated; that the CCP will be under control after the
corrective action is taken; and that measures to prevent recurrence are
established (proposed 9 CFR 590.149(b) and 591.2 and 9 CFR 417.3).
Because pre-established corrective actions may not cover every
contingency, and unforeseen hazards or deviations may occur, 9 CFR
417.3(b) provides a series of steps that must be taken in such
situations. These steps include segregating and holding affected
product and conducting a review to determine the acceptability of the
product for distribution, ensuring that any adulterated product or
product otherwise injurious to health does not enter commerce, and
reassessing HACCP plans to determine whether any modification is
needed.
Validation, Verification, and Reassessment
Under this proposed rule, every egg products plant will be required
to validate its HACCP plan's adequacy in controlling the food safety
hazards identified during the hazard analysis. Once the plant has
determined that the HACCP plan is functioning as intended, it will have
to validate that the plan is being effectively implemented (proposed 9
CFR 590.149(b) and 591.1 and 9 CFR 417.4(a)).\10\ FSIS will provide
additional guidance to plants on how to validate their HACCP systems.
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\10\ On May 14, 2015, FSIS announced the availability of the
final revision of its Compliance Guideline for Hazard Analysis
Critical Control Point (HACCP) systems validation (80 FR 27557).
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Upon completion of the hazard analysis and the development of the
HACCP plan, the plant will conduct its initial validation, which
consists of the activities the plant must perform to determine whether
the plan is functioning as intended. During this initial validation,
the facility repeatedly tests the adequacy of the CCPs, critical
limits, monitoring and recordkeeping procedures, and corrective actions
set forth in the HACCP plan. Validation also encompasses reviews of the
records, routinely generated by the HACCP system, in the context of
other validation activities. Plants may use independent consultants,
process authorities, or employees trained in accordance with 9 CFR
417.7 for plan development and validation.
The data used to validate a HACCP plan may be derived from various
sources, including the scientific literature, product testing results,
experimental research results, scientifically-based regulatory
requirements, FSIS compliance guidelines, computer-modeling programs,
and data developed by process authorities (a process authority is a
person or organization with expert knowledge in the relevant products,
process controls, and regulations). However, validation data must
include at least 90 days of in-plant data or information reflecting the
plant's experience in implementing the HACCP plan during plant
operations. These data are needed because validation must demonstrate
not only that the HACCP plan is scientifically sound, but also that
this particular egg products plant can implement the HACCP plan and
make it work.
To ensure that the HACCP plan is functioning as intended on a
continual basis, the plant would conduct ongoing verification
activities (proposed 9 CFR 590.149 and 591.1 and 9 CFR 417.4(a)(2)).
Verification is intended to show that the HACCP system is working
effectively on a day-to-day basis, resulting in the production of safe
food. Verification is distinct from ongoing plant monitoring, which is
designed to provide a record showing that the written HACCP plan is
being followed.
Verification includes repeatedly reviewing and evaluating the
various components of the HACCP system. Verification activities should
provide practical results specific to the operation of the given HACCP
plan and could include, but would not be limited to, checking the
adequacy of critical limits; reviewing CCP-monitoring records;
reviewing monitoring and recordkeeping procedures; calibrating process-
monitoring instruments; collecting in-line or finished product samples
for biological (e.g. Salmonella spp.), chemical, or physical analysis;
and directly observing and evaluating the adequacy of corrective
actions.
Under this proposed rule, plants will also be required to reassess
the adequacy of their HACCP plans at least annually and whenever any
changes occur that could affect the hazard analysis or alter the HACCP
plan. Examples of such changes include changes in raw materials or the
source of raw materials; product formulation; production volume;
packaging; or the intended use or consumers of the finished product
(proposed 9 CFR 590.149, 591.1, and 591.2, and 9 CFR 417.4(a)(3)). This
reassessment must be conducted by an individual who has successfully
completed a course of instruction in the application of the seven HACCP
principles, including a segment on the development of a HACCP plan for
a specific product, for example, liquid egg product, and on record
review (9 CFR 417.7(b)).
By periodically monitoring its HACCP plan, a plant can ensure that
the plan is continuously effective in controlling and preventing food
safety hazards. It also provides a plant the opportunity to apply
relevant experiences to improving process controls.
Records
Under this proposed rule, plants will have to maintain records
regarding their operations under HACCP. These records include the
written hazard analysis and all supporting documentation, the written
HACCP plan and all decision-making documents associated with the
development of CCPs and critical limits, and documents supporting the
monitoring and verification procedures selected and the frequency of
those procedures. Records documenting the monitoring of CCPs and
critical limits, corrective actions, verification procedures and
results, product codes, and product name or identity will also have to
be maintained. Each entry on a record maintained under the HACCP plan
will have to be made at the time the specific event occurred and
include the date and time recorded, and be signed or initialed by the
employee making the entry.
Prior to shipping product, the plant will have to review the
processing and production records associated with the HACCP plan to
ensure that they are complete, all critical limits were met, and, if
applicable, that corrective actions were taken (proposed 9 CFR 590.149
and 591.1 and 9 CFR 417.5(c)).
[[Page 6320]]
This pre-shipment review will have to be conducted by someone other
than the person who produced the records, where practicable, and
preferably by an individual trained in accordance with 9 CFR 417.7 or
the responsible plant official.
C. Sanitation Standard Operating Procedures (Sanitation SOPs)
General
Proper sanitation is an important and integral part of every food
process and a fundamental requirement under the law. Insanitary
facilities and equipment, and poor food handling and personal hygiene
practices among employees, create an environment in which pathogens can
flourish. Furthermore, the law is quite clear: Eggs or egg products
that have been prepared, packed, or held under insanitary conditions
whereby they may have been contaminated with filth, or whereby they may
have been rendered injurious to health are deemed adulterated (21
U.S.C. 1033(a)(4)). FSIS inspection program personnel are expressly
charged with ensuring that product is produced and held under sanitary
conditions.\11\ For these reasons, FSIS is proposing to require that
all plants that process egg products develop, implement, and maintain
written Sanitation SOPs to prevent direct contamination or adulteration
of product before and during operations (9 CFR 416.11). Under this
proposed rule, plants will be required to maintain daily records to
document adherence to the SOPs (Sec. 416.16). FSIS is proposing to
cross-reference 9 CFR part 416 in 9 CFR 591.1 rather than duplicate the
regulatory text.
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\11\ Under 21 U.S.C. 1035, official plants must be operated in
accordance with such sanitary practices and have such premises,
facilities, and equipment as are required by regulations promulgated
by the Secretary to effectuate the purposes of the EPIA.
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Sanitation SOPs are necessary because they clearly define each
plant's responsibility to consistently follow effective sanitation
procedures to minimize the risk of direct product contamination and
adulteration. This proposal is based on FSIS's determination for meat
and poultry plants that effective sanitation is essential for food
safety and for the successful implementation of HACCP. FSIS is not
aware of any reason why the same determination should not be made for
egg products plants.
Well-run plants have effective quality control and sanitation
programs, including written Sanitation SOPs. Such programs are based,
in large part, on the plants' recognition of the link between the
existence of insanitary conditions during the processing and production
of egg products and the likelihood that bacteria, including pathogenic
bacteria, will contaminate the finished product. Some plants, however,
do not have adequate programs and do not consistently maintain good
sanitation. In fact, poor sanitation is the most frequently cited
problem identified by FSIS inspection program personnel in egg products
plants.
If FSIS finalizes this proposal, all official plants will be
required to develop, implement, and maintain written Sanitation SOPs,
as well as comply with the Sanitation requirements (9 CFR 416.1-6), in
accordance with 9 CFR part 416. As a result, FSIS is proposing to amend
or replace many of the current sanitary requirements contained in 9 CFR
590.500-575. The plant's Sanitation SOPs will need to describe all
procedures the plant conducts daily to prevent direct contamination or
adulteration of products (proposed 9 CFR 591.1(a) and 9 CFR 416.12(a)).
The Sanitation SOPs will also need to specify the frequency with which
each procedure in the Sanitation SOPs is to be performed and identify
the plant employees responsible for implementing and maintaining the
procedures (9 CFR 416.12(d)). The Sanitation SOPs will have to be
signed and dated, upon initiation and any modification, by ``the
individual with overall authority on-site or a higher level official of
the plant.'' The signature will signify that the plant will implement
and maintain the Sanitation SOPs in accordance with 9 CFR part 416
(proposed 9 CFR 591.1 and 9 CFR 416.12(b)). Official plants will also
have to identify their pre-operational sanitation procedures in their
written Sanitation SOPs, distinguishing them from sanitation activities
to be carried out during operations (proposed 9 CFR 591.1 and 9 CFR
416.12(c)).
Under this proposal, each plant will be required to conduct the
pre-operational and operational procedures as specified in the
Sanitation SOPs, monitor the conduct of the procedures, and routinely
evaluate the effectiveness of the SOPs and modify the Sanitation SOPs
as necessary, in light of changes to the facility, personnel, or
operations, to ensure that they remain effective in preventing direct
product contamination and adulteration (proposed 9 CFR 591.1 and 9 CFR
416.13 and 416.14).
Plants will have to take corrective action when either the plant or
FSIS determines that the Sanitation SOPs, or their implementation, may
have failed to prevent direct product contamination or adulteration (9
CFR 416.15(a)). Corrective actions 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 Sanitation SOPs and the procedures specified
therein . . .'' (proposed 9 CFR 591.1 and 9 CFR 416.15(b)).
If this proposed rule is adopted, plants will have to keep daily
records documenting that the sanitation and monitoring procedures
listed in the Sanitation SOPs are performed and maintain records
documenting any corrective actions taken to prevent direct
contamination or adulteration of products, or when the plant determines
or FSIS notifies it that its Sanitation SOPs are inadequate (proposed 9
CFR 591.1 and 9 CFR 416.16(a)). Under this proposal, records may be
maintained on a computer, provided that plants implement controls to
ensure the integrity of the electronic data (9 CFR 416.16(b)). Records
could be retained off-site, provided that they are not removed from the
plant for at least 48 hours following their completion, and that they
can be provided to FSIS personnel within 24 hours of being requested (9
CFR 416.16(c)).
Under the proposed Sanitation SOPs, FSIS inspection program
personnel will verify that plant management is conducting its
operations in a sanitary environment and manner. Failure to comply with
the Sanitation SOPs provides presumptive evidence of insanitation. As
is now the case, inspection program personnel will act to prevent a
facility from operating under insanitary conditions.
D. Sanitation Requirements
In addition to Sanitation SOP requirements, FSIS is proposing to
remove the current sanitation requirements discussed below for egg
products plants from its regulations. Some of the existing plant
sanitation requirements will no longer be needed in light of the
proposed HACCP and Sanitation SOP requirements. Further, some of the
existing plant sanitation requirements impede innovation and blur the
distinction between plant and inspector responsibilities for
maintaining sanitary conditions. Should these regulations become final,
they will provide official plants with more flexibility to innovate
with regard to facility design, construction, and operations.
[[Page 6321]]
The sanitation requirements proposed in this rule will not only
provide plants with the flexibility to innovate in facility design,
construction, and operations but will also articulate the standards for
good sanitation and for food product safety that must be met by egg
products processors. All sanitation requirements have the same intent:
A plant that processes egg products must operate under sanitary
conditions, in a manner that ensures that the product is not
adulterated and that does not interfere with FSIS inspection and its
enforcement of such standards. However, because the proposed sanitation
requirements define the results to be achieved by sanitation, but not
the specific means to achieve those results, plants can meet the
sanitation requirements in different ways. Regardless of the means by
which plants comply with the standards under this proposed rule, the
required results will be the same for all egg products plants.
FSIS is proposing to replace most of the current sanitation
regulations in 9 CFR 590.500 through 590.560 with the general
sanitation requirements set out in 9 CFR 416.1 through 416.6, which the
Agency is proposing to incorporate by reference (proposed 9 CFR
591.1(a)). This proposed change will significantly reduce the number of
egg and egg products sanitation regulations and consolidate most
sanitation requirements for eggs and egg products with those for meat
and poultry products.
General Sanitation--9 CFR 416.1 and Proposed 9 CFR 591.1
The current sanitation regulations for eggs and egg products
require that plants, including rooms, windows, and floors, be kept
clean and reasonably dry, and free from objectionable odors, flies,
insects, and rodents. Section 416.1 of 9 CFR, which applies to meat and
poultry establishments, provides greater flexibility: ``Each official
establishment must be operated and maintained in a sanitary manner
sufficient to ensure that product is not contaminated, adulterated, or
misbranded.'' Unlike command-and-control regulations, examples of which
are cited below, 9 CFR 416.1 will provide facilities with the maximum
possible flexibility to innovate in facility design, construction, and
operation.
Examples of current requirements to be replaced by the general
standards are: Sec. 590.500(d), which states that materials and
equipment not currently needed shall be handled or stored in a manner
so as not to constitute a sanitary hazard; Sec. 590.500(e), concerning
doors and windows leading to rooms where exposed edible product is
handled; Sec. 590.522(a) concerning breaking room operations; and
Sec. 590.539(a), concerning the defrosting of frozen egg product in a
sanitary manner.
The proposed rule would also provide flexibility to industry in
facility design, construction, and operation by the replacement of the
following regulations with the general standards in 9 CFR 416.1: Sec.
590.506(c), which requires the installation of an approved exhaust
system for the continuous removal directly to the outside of any steam,
vapors, odors, or dust in the candling and transfer room; Sec.
590.508(a), which states that candling and transfer rooms and equipment
shall be kept clean, free from cobwebs, dust, objectionable odors, and
excess packing materials; and Sec. 590.546(b), which requires that the
air intake source in albumen flake process drying facilities be free
from foul odors, dust, and dirt.
Establishment Grounds and Pest Management--9 CFR 416.2(a)
The current egg products plant requirements for facility grounds
are unnecessarily prescriptive. For example, 9 CFR 590.500(b) requires
that the premises be free from refuse, waste, and other materials and
conditions that constitute a source of odors or a harbor for insects,
rodents, and other vermin, while Sec. 590.500(g) states that drains
and gutters shall be properly installed with approved traps and vents.
Several other sections (Sec. Sec. 590.542(a), 547(a), and 548(a))
require that rooms be kept free of flies, insects, and rodents.
The other prescriptive establishment grounds regulations are 9 CFR
590.500(a) and (c), which require that the plant be free from
objectionable odors, dust, and smoke-laden air and state that the
buildings shall be of sound construction and kept in good repair to
prevent the entrance or harboring of vermin, and Sec. 590.522(a),
which states that the breaking room shall be kept in dust-free clean
condition and free from flies, insects, and rodents. In addition, 9 CFR
590.522(a) requires that the plant keep the floor clean and reasonably
dry during breaking operations and free of egg meat and shells.
The general sanitation requirements in 9 CFR 416.2(a) preserve the
intent of these requirements that grounds be maintained to prevent
conditions that could lead to the contamination or adulteration of
product, and that establishments implement and maintain an integrated
pest control program to eliminate the harborage of pests on the grounds
and within the plant facilities. This regulation, however, provides the
flexibility and leave to innovate that the Agency is proposing to
incorporate into the egg product regulations.
Establishment Construction--9 CFR 416.2(b)
The egg products inspection regulations concerning construction of
egg products plants are very prescriptive and inflexible. For example,
9 CFR 590.500 prescribes numerous, specific requirements for different
areas within an official plant, e.g., dressing rooms, toilet
facilities, and refuse rooms. Other regulations containing prescriptive
construction requirements include Sec. 590.506, candling and transfer-
room facilities and equipment; Sec. 590.520, breaking room facilities;
Sec. 590.546, albumen flake process drying operations, Sec. 590.560,
concerning personnel facilities; and Sec. 590.570(a), concerning
pasteurization facilities.
Section 416.2(b) of 9 CFR sets out construction sanitation
requirements that will allow for increased flexibility in regard to
facility operation construction and maintenance if adopted by reference
through proposed 9 CFR 591.1. Plants will be able to design facilities
and equipment in the manner that they deem best to maintain the
required sanitary environment for food production.
In addition to the six prescriptive egg products construction
regulations listed above, there are seven more construction
requirements that will be replaced by 9 CFR 416.2(b) if this proposal
is finalized. They are 9 CFR 590.146(b)(5) and (d), concerning the
requirements for floor plans and revised blueprints submitted prior to
receiving inspection service or making changes or revisions to an
official plant; Sec. 590.500(i), (j), (l), and (o), concerning
structure construction materials, maintenance requirements for rooms in
which shell eggs or egg products are handled, and toilet and refuse
room requirements; Sec. 590.532(a), concerning liquid egg holding tank
requirements; Sec. 590.534(a), concerning freezing room requirements;
Sec. 590.548(c), which addresses heat treatment room construction
requirements; Sec. 590.550, dealing with washing and sanitizing room
or area facility requirements; and Sec. 590.560(a) and (b), concerning
the health and hygiene of plant personnel and the construction of
personnel facilities.
Light--9 CFR 416.2(c)
The lighting requirements for breaking rooms in official plants in
Sec. 590.520(a) prescribe specific light intensities for all working
surfaces in the room and at breaking and inspection stations. For
example, all working
[[Page 6322]]
surfaces must have at least 30 foot-candles of light intensity, while
breaking and inspection stations must have at least 50 foot-candles of
light intensity. Other egg products regulations do not contain specific
lighting requirements, stating only that rooms shall be adequately or
well-lighted (see Sec. Sec. 590.500(l)(i), 548(a), and 550(a)).
The intent of the lighting requirements is to ensure that there is
enough light of adequate quality to monitor sanitary conditions and
processing operations and to examine product for evidence of
adulteration or misbranding. Section 416.2(c) of 9 CFR has codified
this intent as a general sanitation requirement, and it will be
applicable to plants that process egg products if this proposed rule is
finalized. Under 9 CFR 416.2, which requires that lighting be of good
quality and of sufficient intensity to ensure that sanitary conditions
are maintained, and that product is not adulterated, plants will have
the flexibility to determine what light intensities are appropriate to
ensure sanitation in different operational contexts. Therefore, FSIS is
proposing to remove Sec. Sec. 590.500(l)(1), 520(a), 548(a), and
550(a) from the egg products inspection regulations.
Ventilation--9 CFR 416.2(d)
The egg products inspection regulations addressing ventilation
generally require that ventilation provide for a positive flow of
outside filtered air through rooms and air of suitable working
temperature during operations, and that rooms be kept free from
objectionable odors and condensation (see Sec. Sec. 590.500,
590.504(p), 590.506(c), 590.520(d), 590.550(a)). Objectionable odors or
condensation are to be reduced to the extent possible or eliminated
because they can adulterate product. FSIS has codified a single
sanitation requirement, 9 CFR 416.2(d), which preserves the intent of
the current egg products regulations. This codification will simplify
FSIS's egg products ventilation regulations by consolidating them into
9 CFR 416.2(d).
In addition to the regulations discussed above, FSIS is proposing
to remove the following regulations from 9 CFR part 590 because they
will be replaced by proposed 9 CFR 416.2(d) if this rule is finalized:
9 CFR 590.435(d), which states that containers and packing or packaging
materials in which shell eggs are received into the official plant
shall be free from odors and materials which could contaminate or
adulterate the eggs or egg products; Sec. 590.508(b), requiring the
removal of containers for trash and inedible eggs at least once daily
and their cleaning and treatment in such a manner as to prevent odors
or objectionable conditions in the plant; Sec. 590.530(a), which
states that liquid egg storage rooms, including surface coolers and
holding tank rooms, shall be kept clean and free from odors and
objectionable odors and condensation; and Sec. 590.536(a), concerning
the conditions in which freezing rooms are to be kept.
Other regulations to be replaced by 9 CFR 416.2(d) will be: 9 CFR
590.540(d), which states that air drawn into the drier in spray process
drying facilities be free from foul odors, dust, and dirt; Sec.
590.546(b), requiring that intake air sources in albumen flake process
drying facilities be free from foul odors, dust, and dirt; Sec.
590.549, requiring that dried egg storage be sufficient to adequately
handle the production of the plant and be kept clean, dry, and free
from objectionable odors; and Sec. 590.560(b), requiring that toilets
and dressings be kept clean and that toilet rooms be ventilated to the
outside of the building.
Plumbing--9 CFR 416.2(e)
The design, installation, and maintenance of an adequate plumbing
system are key responsibilities of an egg products plant. Because
plumbing systems carry water into plants and convey water, sewage, and
other waste from plants, problems with plumbing systems can easily
cause product contamination or adulteration. The plumbing sanitation
requirements in 9 CFR 416.2(e) set out the essential condition plants
must achieve with their plumbing systems: plumbing systems cannot cause
adulteration of product and must ensure sanitary operating conditions.
Plants otherwise will be allowed to build plumbing systems suitable to
the nature and volume of their production. Therefore, FSIS is proposing
to eliminate the requirement in Sec. 590.500(g) that drains and
gutters with approved traps and vents be installed. The Agency is also
proposing to eliminate the prescriptive requirements regarding lavatory
accommodations in Sec. 590.500(l) and (m).
Sewage Disposal--9 CFR 416.2(f)
The current regulations require any person desiring to process egg
products under continuous inspection to submit drawings and
specifications before receiving approval of a plant and facilities as
an official plant. Information that must be submitted includes how the
plant intends to dispose of sewage (Sec. 590.146(b)(7)). Section
590.504(q) states that all liquid and solid material in the official
plant shall be disposed of in a manner approved by the Administrator to
prevent product contamination and in accordance with acceptable
environmental protection practices.
Section 416.2(f) of 9 CFR, sewage disposal, will replace both of
these regulations by requiring that sewage be disposed into a sewage
system separate from all other drainage lines or disposed of through
other means sufficient to prevent backup of sewage into areas where
product is processed, handled, or stored.
Water Supply and Reuse--9 CFR 416.2(g)
The current regulations regarding water supply and reuse in plants
require that the water supply be ample, clean, and potable, with
adequate pressure and facilities for its distribution throughout the
plant or portion thereof utilized for egg processing and handling
operations and protected against contamination and pollution (Sec.
590.500(h)). Section 590.500(h) also requires that the applicant for
inspection obtain and furnish to the Administrator, at the
Administrator's request, a water report, issued under the authority of
a State or municipal health authority, certifying to the potability of
the water supply. When ice is used as an emergency refrigerant by being
placed directly into the egg meat, Sec. 590.530(f) requires that the
source of the ice be certified by the local or State board of health
and that the ice be handled in a sanitary manner.
Section 416.2(g)(1) of 9 CFR sets out a transparent water supply
performance standard concerning potable water. The water must comply
with Environmental Protection Agency (EPA) National Primary Drinking
Water regulations. These EPA regulations are applicable to public water
systems. Because these regulations already apply to potable water used
by egg products plants, the reference in the sanitation requirements
would not constitute a new requirement for these plants. The sanitation
requirement also restates the current requirement that plants must make
available to FSIS, upon request, State or local certificates attesting
to water quality.
The egg products industry uses large quantities of water for
processing products and for cleaning. Water and water based (aqueous)
solutions are widely used for prewetting, washing, and rinsing eggs,
product formulation, and cleaning and sanitizing equipment. Reuse of
water solutions, therefore, can offer significant economic advantages.
Section 590.515(a), for example, sets forth the requirements for
washing shell
[[Page 6323]]
eggs to be presented for breaking. They include changing the wash water
every four hours or more often if needed to maintain sanitary
conditions and at the end of each shift (paragraph (a)(4)); adding
replacement water to the wash water of washers continuously to maintain
a continuous overflow (paragraph (a)(5)); piping waste water from the
egg washing operation directly to drains (paragraph (a)(6)); and
completing continuous washing operation as rapidly as possible
(paragraph (a)(7)). Section 590.516(a) requires that all shell eggs be
spray rinsed with potable water containing an approved sanitizer of not
less than 100 ppm but no more than 200 ppm of available chlorine or its
equivalent immediately prior to breaking.
Section 590.552 establishes cleaning and sanitizing requirements
for equipment used in egg processing operations that comes in contact
with liquid eggs or exposed edible products. While such equipment may
be cleaned by any sanitary means, it is preferable to use water to do
so. Paragraph (b)(2) requires that shell eggs that have been sanitized
and equipment that comes in contact with edible products be rinsed with
clean water after sanitizing if other than hypochlorites are used as
sanitizing agents.
Section 416.2(g)(2) through (6) of 9 CFR sets forth sanitation
requirements for the reuse of water in meat and poultry establishments.
If this proposal is adopted, plants will also be able to use reuse
water in their operations, as appropriate.
Prior to the implementation of 9 CFR 416.2(g), reuse water was
permitted in meat and poultry establishments only under certain
circumstances, and any other reuse situation had to be approved by the
Agency in advance. However, once technologies were developed that can
recondition water for safe and effective reuse in various applications,
the Agency recognized that reuse water may be used safely and
effectively in certain food processing situations.
Under 9 CFR 416.2(g), reuse water can be treated to render it free
of biological, chemical, and physical hazards. Some of the general
treatment options used include filtration, chlorination, ozonation,
ultraviolet (UV) radiation, and heating. Use of these procedures can
usually return water to a level of quality appropriate to its intended
use. After treatment, however, such water should be tested regularly to
ensure continual freedom from biological, chemical, or physical
hazards.
Depending upon the original use, the intended use, and the duration
of reuse, a wide range of acceptable biological, chemical, or physical
contaminant levels are possible in reuse water. The previous degree of
exposure or potential exposure to contaminants dictates the appropriate
reconditioning treatment and the allowable reuse.
FSIS requires official egg products plants to produce pasteurized,
RTE products that are free of pathogens. Therefore, reuse water that is
used to chill or cook pasteurized, RTE egg products must be free of
fecal coliforms because their presence would indicate that the water
was contaminated, possibly with pathogenic organisms (9 CFR
416.2(g)(2)). Other types of contamination will also have to be reduced
sufficiently to prevent adulteration of product.
Section 416.2(g)(3) of 9 CFR deals with the use and reuse of water,
ice, and solutions used to chill or wash raw product. In response to
questions raised at public meetings in Columbus, OH, and Sacramento,
CA, on March 30 and April 6, 2000, and Washington, DC, on July 31,
2001, held to obtain comments on FSIS's and FDA's thinking at the time
on approaches to ensure egg safety from farm to table, FSIS has
tentatively concluded that unprocessed shell eggs, i.e., eggs that have
not yet been washed, sized, or candled, are more like raw product than
RTE product. As a result, FSIS has determined that the provisions of 9
CFR 416.2(g)(3), which regulate the use of reuse water to wash raw
product, will apply to official plants. Consequently, water used to
wash unprocessed shell eggs may be reused for the same purpose,
provided that measures are taken to reduce biological, chemical, and
physical contamination so as to prevent contamination or adulteration
of the eggs. Such reused water from use on raw eggs may not come into
contact with processed shell eggs.
Paragraph (g)(4) of 9 CFR 416.2 will allow plants that recondition
their water through an advanced wastewater treatment facility to use
such reconditioned water on raw product, except in product formulation
and throughout the plant in edible and inedible production areas. This
water is not, however, potable, and it may not have ever contained
human waste. Product, facilities, and equipment coming in contact with
this water must undergo a separate final rinse with non-reconditioned
water that meets the criteria prescribed in 9 CFR 416.2(g)(1). The
reuse water described above would most likely be used to wash solid
waste from equipment and floors.
Paragraph (g)(5) of 9 CFR 416.2 will permit plants to use any water
for any purpose in edible or inedible product areas, provided that it
has never contained human waste, has been conditioned to be free of
pathogenic organisms, and does not contact edible product. Finally,
paragraph (g)(6) states that any water not meeting the conditions of 9
CFR 416.2(g)(1) through (5) may not be used, except in areas where no
edible product is handled or prepared, and may not be used in any
manner which would allow it to contaminate or adulterate edible
product.
Moving the egg products water supply and reuse regulations into 9
CFR 416.2(g) will consolidate them with those for meat and poultry. The
proposed sanitation requirements in 9 CFR 416.2(g) are intended to and
should account for every allowable water reuse situation in official
plants, including those covered by the following egg products
inspection regulations, which will be replaced by 9 CFR 416.2(g) if
this proposal is finalized: Sec. 590.520(e), which requires adequate
and easily accessible hand washing facilities in an official plant;
Sec. 590.539(d)(1), which permits frozen eggs packed in metal or
plastic containers to be placed in running tap water (70 degrees F or
lower) without submersion to speed defrosting; and Sec. 590.552(a) and
(b)(2), concerning equipment cleaning and sanitizing requirements.
Dressing Rooms, Lavatories, and Toilets--9 CFR 416.2(h)
The current regulations concerning dressing rooms, lavatories, and
toilets in egg products plants are highly prescriptive. For example,
Sec. 590.500(l)(2) provides a formula that serves as the basis for
determining the toilet facilities required in an official plant, the
intent being to ensure that plants provide an adequate number of toilet
bowls, thus maintaining related sanitary conditions. The sanitation
requirement in 9 CFR 416.2(h) gives plants the responsibility and
flexibility to determine how many dressing rooms, lavatories, and
toilets it needs. Of course, plants will have to meet any applicable
State and local codes concerning the number of lavatories and toilets
in the workplace.
There are also other requirements for dressing rooms, lavatories,
and toilets currently in the egg products regulations (see Sec.
590.520(e), concerning hand washing facilities in breaking rooms, Sec.
590.560(a) and (b), concerning health and hygiene of personnel, and
Sec. 590.146(b)(5), requiring floor plans to show the locations of
hand-washing facilities and toilets). The proposed sanitation
requirement in 9 CFR 416.2(h) eliminates the need for these
[[Page 6324]]
requirements because it renders them redundant.
Equipment and Utensils--9 CFR 416.3
The egg products inspection regulations concerning equipment and
utensils are unduly prescriptive and can deprive official plants of the
flexibility to innovate in regard to equipment and utensil sanitation.
The equipment and utensil sanitation requirement that FSIS is proposing
to adopt for plants not only provides flexibility but also clarifies
plant responsibility for selecting and maintaining equipment and
utensils in a manner that effectively prevents product contamination or
adulteration.
If this proposal is adopted, plants will no longer have to install
and use equipment that complies with the applicable 3-A or E-3-A
Sanitary Standards and accepted practices currently in effect for such
equipment (Sec. 590.502(b)). Instead, equipment and utensils used for
processing or otherwise handling edible product or ingredients will
only have to be of such material and construction as to facilitate
thorough cleaning and be durable and suitable for its intended use.
Plants will need to ensure that product is not contaminated,
adulterated, or misbranded during processing, handling, or storage.
Equipment and utensils will still need to be maintained in sanitary
condition so as not to contaminate or adulterate product. In addition
to 9 CFR 590.502(b), FSIS is also proposing to remove the following
sections from 9 CFR part 590 because 9 CFR 416.3 will make them
redundant:
Sec. 590.500(n), requiring suitable facilities for cleaning
and sanitizing utensils and equipment at convenient locations
throughout the plant
Sec. 590.504(f) and (n), requiring personnel handling
utensils or containers which may come into contact with egg products to
wash their hands and maintain them in a clean condition and requiring
most utensils and equipment to be clean and sanitized at the beginning
of processing operations and kept clean and sanitary during all
processing operations
Sec. 590.506(a), which states that the equipment shall be
arranged to facilitate cleaning and the removal of refuse and excess
packing material from the candling and transfer room
Sec. 590.508(c) and (d), requiring the handling of shell eggs
in a manner to minimize sweating prior to breaking and placing shell
eggs with extensively damaged shells, unless otherwise prohibited, into
leaker trays
Sec. 590.515(a)(1) and (b), requiring that shell egg cleaning
equipment be kept in good repair and be cleaned after each day's use or
more frequently, if necessary, and requiring that the temperature of
wash water be maintained at 90 degrees F or higher, and shall be at
least 20 degrees F warmer than the temperature of the eggs to be
washed, throughout the cleaning cycle
Sec. 590.520(g), states that a suitable container
conspicuously identified shall be provided for the disposal of rejected
liquid
Sec. 590.522(d), (h), (s), (t), (u), (v), (y), (aa)(1)-(3),
containing prescriptive requirements for the cleaning of breaking
machines and equipment, including mechanical breaking machines, as well
as other equipment used in the processing of egg products, such as
cups, knives, racks, etc., dump tanks, drawoff tanks, and churns,
strainers, filtering devices, etc., and containers used for
transporting liquid eggs products
Sec. 590.538, concerning the construction and cleaning of
defrosting facilities
Sec. 590.539(f), concerning the cleaning of crushers and
other equipment used in defrosting operations
Sec. 590.540(h), requiring the construction of powder
conveying equipment as will facilitate thorough cleaning
Sec. 590.542(b)(2) and (c)(1), requiring the sanitizing of
spray process drying equipment within 2 hours prior to resuming spray
drying operations and the clearing of sifters and conveyers used for
other than dried albumen powder when such equipment is not to be used
for 24 hours or longer
Sec. 590.548(b)(3)-(5), which requires that equipment and
utensils used in dried eggs be kept off the floor and be kept clean at
all times and whenever contaminated be cleaned and sanitized. It also
requires that all equipment used to mechanically package dried egg
products be vacuum cleaned daily
Sec. 590.560(c) and (d), prohibiting personnel affected with
any communicable disease in a transmissible stage or a carrier of such
disease, or affected by a list of other health conditions, from coming
into contact with equipment used to process eggs. Paragraph (d)
requires workers coming in contact with equipment to wear clean outer
uniforms
Food-Contact Surface Cleaning and Sanitation--9 CFR 416.4(a)
The egg products inspection regulations require that egg products
plants clean food contact surfaces at the start of processing
operations, and that they keep equipment and utensils clean and
sanitary during all processing operations (9 CFR 590.504(n)). Section
590.522(aa)(3) of 9 CFR states that mechanical egg breaking equipment
shall be clean and sanitized prior to use, and during operations the
machines shall be cleaned and sanitized approximately every 4 hours or
more often if needed to maintain them in a sanitary condition. It also
requires that the equipment be cleaned at the end of each shift. See
also 9 CFR 590.552(a).
The objective of the food-contact surface cleaning requirements has
always been to mitigate biological, chemical, and physical
contamination that could adulterate product. The proposed food-contact
surface cleaning sanitary operations requirement in 9 CFR 416.4(a)
embodies this objective and clarifies plant responsibility for
determining how best to achieve it. The advantage of this proposed
standard is that it would provide plants with the flexibility to
innovate when determining how to mitigate biological, chemical, and
physical contamination that could adulterate product. For this reason,
therefore, FSIS is proposing to remove the egg products inspection
regulations discussed above, as well as following sections, and replace
them with the sanitary operations requirement in 9 CFR 416.4(a):
Sec. 590.504(i) and (k), requiring the removal, cleaning, and
sanitizing of utensils and equipment that are contaminated during the
course of processing egg products and containing the admonition that
all reasonable precautions be taken to avoid soiling or contaminating
the surface of any package or container liner which is or will be in
direct contact with egg products
Sec. 590.515(a)(4), which states that wash water will be
changed every four hours or more often, if needed, to maintain sanitary
conditions and at the end of each shift
Sec. 590.522(x), (z), and (aa)(2), requiring that containers
for holding egg products variously be washed, rinsed, sanitized, and
drained immediately prior to use and cleaned after each use. The
pipelines of systems for pumping egg liquid directly from egg breaking
machines must be cleaner or flushed as often as necessary to maintain
them in a sanitary condition, and they must be cleaned and sanitized at
the end of each shift. Other pumping system equipment must be cleaned
and sanitized at least every four hours or sooner to maintain it in
sanitary condition
[[Page 6325]]
Sec. 590.539(e), which states that sanitary methods will be
used in handling containers and removing egg product
Sec. 590.542, which includes prescriptive requirements for
maintaining sanitary conditions in spray process drying operations
Sec. 590.544(c) and (d), which states that dry blending must
be done in accordance with Sec. 590.548 or in a closed blending system
and in accordance with clean, sanitary practices. Edible dried egg
powder may be reconstituted, repasteurized, and redried when
accomplished in a clean, sanitary manner
Sec. 590.548(b)(4), which includes prescriptive requirements
for maintaining sanitary conditions in drying, blending, packaging, and
heat treatment rooms and facilities.
Non-Food-Contact Surface Cleaning and Sanitation--9 CFR 416.4(b)
If this proposed rule (proposed 9 CFR 591.1) is adopted, official
plants that process egg products will have to keep, in accordance with
9 CFR 416.4(b), non-food-contact surfaces, such as floors and walls,
free of any biological contaminants, chemical contaminants, or physical
contaminants that could adulterate egg products. FSIS is proposing to
remove the following sections and replace them with the sanitary
operations requirement in 9 CFR 416.4(b) because this requirement will
give plants greater flexibility and responsibility for developing
sanitary procedures specific to the nature of their operations:
Sec. 590.500(j) and (l)(1), requiring rooms and compartments
in which shell eggs or egg products are handled or processed to be
maintained in a clean and sanitary condition
Sec. 590.504(g) and (h), prohibiting the storage of products
or materials that create objectionable conditions in any room,
compartment, or place where shell eggs or egg products are processed,
stored, or handled and permitting only compounds approved by the
Administrator that will not deleteriously affect shell eggs or egg
products when used in an approved manner to be used in an official
plant
Sec. 590.515(b), prohibiting shell eggs from being washed in
the breaking room or any room where edible products are processes
Sec. 590.522(m), stating that ingredients used in, or for,
processing egg products, must be handled in a clean and sanitary manner
Sec. 590.546(b), requiring that intake air sources be free
from foul odors, dust, and dirt
Sec. 590.548(b)(3), requiring that dry blending equipment and
supplies be kept off of the floor
Cleaning Compounds and Sanitizers--9 CFR 416.4(c)
Section 590.504(h) of 9 CFR requires that FSIS approve detergents,
wetting agents, or other similar compounds, among other things, before
they can be used within an official plant. Section 590.552(b) of 9 CFR
states that sanitizing shall be accomplished by such methods as
approved by the Administrator and requires the approval of chemicals
and compounds used for sanitizing by the Administrator before use.
These requirements are intended to ensure that egg products are not
adulterated with chemicals or any injurious substance.
FSIS is proposing to replace 9 CFR 590.504(h) and 552(b) with
proposed 9 CFR 591.1 and the single sanitary operations requirement in
9 CFR 416.4(c), which states that cleaning compounds and sanitizing
agents must be safe and effective under the conditions of use, and that
plants would not be required to obtain prior approval from FSIS. If
this proposed rule becomes final, plants that process egg products
would be able to use cleaning compounds and sanitizing agents that are
safe and effective under the conditions of use. They would have to use,
handle, and store them in a manner that would not adulterate product or
create insanitary conditions and maintain documentation to support that
these compounds and agents are safe and effective. Plants would,
however, have to meet the use requirements for the substances
promulgated by other regulatory agencies, such as FDA and EPA, who are
responsible for ensuring that these substances are safe for their
intended uses.
Operational Sanitation--9 CFR 416.4(d)
The egg products requirements for operational sanitation
(sanitation measures carried out during operations) are spread through
a number of regulations. (See 9 CFR 590.515 concerning egg cleaning
operations; Sec. 590.516 concerning sanitizing and drying of egg
shells prior to breaking; and Sec. 590.522 concerning breaking room
operations.)
These requirements are unnecessarily prescriptive. For example,
Sec. 590.515(a)(4) requires an official plant to change wash water
approximately every 4 hours or more often if needed to maintain
sanitary conditions and at the end of each shift. Section 590.522(s)
requires the cleaning and sanitizing of cups, knives, racks,
separators, trays, spoons, liquid egg pails, and other breaking
equipment every 2\1/2\ hours.
If adopted, the sanitary operations requirement in 9 CFR 416.4(d)
will consolidate the concepts in all of these operational sanitation
requirements (which are discussed in this preamble and are currently
spread throughout Sec. Sec. 590.500-575) in a single place and remove
them from the egg products inspection regulations. Plants will be
required to protect egg products from adulteration during processing,
handling, storage, loading, and unloading at and during transportation
from their premises.
Employee Hygiene--9 CFR 416.5(a)
The current egg products inspection regulations mandate specific
employee hygiene practices which egg products plants must adopt. For
example, plant personnel handling exposed edible product must wash
their hands before beginning work and upon returning to work after
leaving the work room (Sec. 590.560(e)). Section 590.560(f) states
that expectorating or other unsanitary practices are not permitted in
official plants.
The proposed sanitation requirement in 9 CFR 416.5(a) requires that
all persons working in contact with product, food-contact surfaces, and
product-packaging materials adhere to hygienic practices while on duty
to prevent adulteration of product and the creation of insanitary
conditions. It would, if adopted, allow plants to develop alternative
or innovative means to ensure that employee hygiene practices do not
result in product adulteration, without being as prescriptive and
restrictive as the current egg products inspection regulations.
Therefore, FSIS is proposing to remove Sec. 590.560 and replace it
with the proposed sanitation requirement in Sec. 416.5(a).
Employee Clothing--9 CFR 416.5(b)
The requirements regarding employee clothing are prescriptive. For
example, Sec. 590.560(d) states that workers coming into contact with
liquid or dried eggs, containers, or equipment shall wear clean outer
uniforms, while paragraph (h) of that section requires all persons in
breaking and packaging rooms to properly wear hair nets or caps.
Section 590.560(g) prohibits the use of tobacco in any form or the
wearing of jewelry, nail polish, or perfumes in any area where edible
products are exposed.
As stated in the previous section, FSIS is proposing to remove
Sec. 590.560 and replace it with the sanitation requirement in 9 CFR
416.5(b) and proposed 9 CFR 591.1(a). If the
[[Page 6326]]
proposed rule is finalized, cleanliness in employee hygiene would be
required without the prescriptiveness of Sec. 590.560. Under 9 CFR
416.5(b), aprons, frocks, and other outer clothing worn by persons in
plants processing egg products who handle product must be made of
material that is disposable or readily cleaned. Clean garments will
also have to be worn at the start of each working day, and garments
will have to be changed during the day as often as necessary to prevent
adulteration of product and creation of insanitary conditions.
Employee Disease--9 CFR 416.5(c)
The sanitation requirement in 9 CFR 416.5(c) is similar to the
requirements for employee health in Sec. 590.560(c) to prevent
transmission of communicable diseases. FSIS is proposing to remove
Sec. 590.560(c) and adopt proposed 9 CFR 591.1 and 416.5(c) for egg
products plants.
Tagging Insanitary Equipment, Rooms, or Compartments--9 CFR 416.6
Retention tags or other devices and methods as may be approved by
the Administrator are used for the control and identification of
equipment, utensils, rooms, or compartments in official plants that are
found to be unclean or otherwise in violation of the egg products
inspection regulations (Sec. 590.426). This requirement is similar to
the sanitation requirement articulated in 9 CFR 416.6, which requires
the attachment of a ``U.S. Rejected'' tag to any equipment, utensil,
room, or compartment at an official establishment that is insanitary,
or the use of which could cause the adulteration of product. Both
regulations prohibit the use of tagged equipment, utensils, rooms, or
compartments until they have been made acceptable and require the
removal of tags by program employees. Therefore, FSIS is proposing to
replace Sec. 590.426 with 9 CFR 416.5(c) and proposed 9 CFR 591.1.
This proposed sanitation requirement for plants that process egg
products would serve to provide consistency between the egg products
requirements and the meat and poultry requirements.
Sanitation Performance Standards Compliance Guide
To meet the sanitation requirements proposed in this document, egg
products plants may develop and employ sanitation or processing
procedures customized to the nature and volume of their production.
However, FSIS has developed a Sanitation Performance Standards
Compliance Guide (Compliance Guide) that presents or references methods
already proven to be effective in maintaining sanitary conditions in
meat and poultry products establishments, which is posted on the
Agency's web page: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index/sanitation-performance-standards. If this proposed rule is adopted, and before it takes
effect, FSIS will update the Compliance Guide to include methods that
are effective in maintaining sanitary conditions in egg products
plants. Past FSIS regulations and guidance, as well as recommendations
from the current Model Food Code issued by FDA and other technical
sources, will be included or cited.
Plants that follow the recommendations in the Compliance Guide
could be reasonably certain that they will be meeting the sanitation
requirements. They would need to be mindful, however, that each
processing environment is unique, and that in some cases, the methods
presented in the Compliance Guide might require validating the adequacy
to ensure sanitary conditions or to prevent the adulteration of egg
products.
E. Egg Products Are ``Ready-To-Eat''
21 U.S.C. 1036(a) requires that egg products inspected at an
official plant and found to be not adulterated be pasteurized before
they leave the official plant, except as otherwise permitted by the
regulations of the Secretary. Any detectable pathogen would adulterate
egg products under 21 U.S.C. 1033(a)(1) because it would contain a
poisonous or deleterious substance which may render them injurious to
health. Pasteurized egg products are ready-to-eat; that is, they have
been prepared so that they can be consumed as is, without any
additional cooking.
In 2005, FSIS undertook a quantitative microbial risk assessment to
assist Agency risk managers in evaluating possible pasteurization
performance standards for reducing the likelihood of Salmonella spp.
contamination in liquid and dried egg products, and, subsequently, for
reducing the risk of human illness, hospitalization, and death
associated with egg products.\12\ However, while the risk assessment
showed that pasteurization resulting in a 6-log10 reduction
of Salmonella was predicted to be effective for reducing illnesses from
Salmonella spp. in egg products, FSIS has chosen to propose a standard
for egg products that requires them to be produced to be edible without
additional preparation to achieve food safety. FSIS has chosen this
approach because in-plant inspectors cannot effectively verify whether
a plant has met a specific lethality standard. The Agency can, however,
effectively verify whether Salmonella is present in an egg product
through testing. Overall, this approach is simpler than that of
log10 pasteurization performance standards and is consistent
with the approach used by FSIS in establishing requirements for most
RTE meat and poultry products.
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\12\ FSIS. 2005. Risk Assessments of Salmonella Enteritidis in
Shell Eggs and Salmonella spp. in Egg Products. (http://www.fsis.usda.gov/wps/portal/fsis/topics/science/risk-assessments).
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Meat and poultry establishments produce the vast majority of their
RTE products without needing to meet FSIS-specified time and
temperature combinations or lethality performance standards codified in
the regulations. The only FSIS regulations that include specific times
and temperatures for ready-to-eat products are for cooked uncured meat
patties, which must meet or exceed the times and temperatures listed in
9 CFR 318.23, and for pork, and products containing pork, which must
meet or exceed the times and temperatures listed in 9 CFR 318.10.
Cooked beef and poultry products must meet the lethality performance
standards listed in 9 CFR 318.17 and 381.150. FSIS previously removed
prescriptive time and temperature requirements for other ready-to-eat
meat and poultry products from the meat and poultry regulations. Such
prescriptive time and temperature requirements are not necessary
because under the statutes, establishments need to produce ready-to-eat
products (including egg products) so that no detectable pathogens exist
in the final products.
Therefore, FSIS is proposing to amend the egg products inspection
regulations by removing the prescriptive regulations on the
pasteurization of egg products (9 CFR 590.570 and .575). If this
proposed rule is finalized, 9 CFR 590.570 would be replaced by a new
regulation specifying that egg products are ready-to-eat and do not
require additional steps to ensure food safety, consistent with the
definition of ``ready-to-eat'' product in 9 CFR 430. Egg products must
be produced such that the finished product is free of detectable
pathogens. In addition, egg products would not be required to bear a
safe-handling instruction or other labeling that directs that the
product must be cooked or otherwise treated for safety.
The current requirements for egg products mandate step-by-step
[[Page 6327]]
processing measures and specifically prescribe minimal time and
temperature combinations for the pasteurization treatment of various
egg products. Under HACCP, these prescriptive requirements are not
necessary. Under HACCP, egg products plants are required to produce
product by controlling, eliminating, or reducing microbial hazards so
that the finished product has no detectable pathogens.
Plants that choose not to develop new or modified procedures will
be able to continue to follow a set of pasteurization time and
temperature combinations for products that have been validated as
achieving the intended pathogen reduction, such as those in the current
regulations. FSIS has developed a draft compliance guideline document
that includes these procedures. The draft guideline document can be
found at: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index. An official plant would then need
to validate that it is properly applying the FSIS time and temperature
combinations provided in the guidance material and conduct monitoring
and verification activities to demonstrate proper execution of the
selected combinations.
The pasteurization time and temperature compliance guidelines
specifically will assist small and very small businesses in identifying
validated procedures. The materials will be posted on the Agency's
website.
F. Not Applying the Mark of Inspection Pending Test Results
As discussed previously, egg products inspected at an official
plant and found to be not adulterated must be pasteurized before they
leave the official plant, except as otherwise permitted by the
regulations of the Secretary. They must also bear the official
inspection legend and official plant number of the plant where the
products were processed.\13\
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\13\ 9 CFR 411(c)(5) requires that containers of product bearing
official identification display that identification and the plant
number. Official identification means the official inspection mark
or any other symbol prescribed by the regulations in part 590 to
identify the status of any article. See 9 CFR 590.5.
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9 CFR 590.504(o) requires that egg products be pasteurized in
accordance with the egg products inspection regulations before being
released into consuming channels, while paragraph (o)(1) requires that
they be sampled and tested for the presence of Salmonella to ensure
that they were adequately pasteurized. 9 CFR 590.580 sets forth the
specific testing requirements, and in this proposal, FSIS has rewritten
this section for clarity.
While FSIS does not require final product testing for Salmonella in
RTE meat and poultry products, the Agency is continuing to require
testing for Salmonella for RTE egg products by official plants. An egg
products plant's Salmonella testing data continues to be important in
monitoring process control.14 15 As part of its control
verification effort, FSIS also will continue to collect and analyze
samples from egg product processes for Salmonella and Lm.
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\14\ The current Salmonella sampling levels that egg products
plants must meet are provided in FSIS Directive 10,230.4, Salmonella
Surveillance Program for Liquid and Frozen Egg Products.
\15\ The USDA, FSIS Pasteurized Egg Products Lab (PEPRLab)
Program is a program for laboratories performing Salmonella analysis
on official surveillance samples of pasteurized egg products.
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While 9 CFR 590.504(o) states that egg products must be pasteurized
before being released into consuming channels, 9 CFR 590.504(d) does
permit inspection program personnel to allow egg products to be moved
from an official plant before the plant receives laboratory results for
Salmonella, or any other test results, if the plant retains control of
the product. The plant must ensure that the product will be returned to
the plant for reprocessing if the test results show that the product is
positive for Salmonella.
FSIS allows meat and poultry establishments to move product to
locations other than the production facility prior to the receipt of
FSIS test results so long as the establishment maintains control of the
product. It also permits them to package and label products sampled and
tested for adulterants with the mark of inspection pending negative
test results, provided those products do not enter commerce, i.e., the
products remain under the establishment's control until negative test
results become available. The product does not, however, actually
receive the mark of inspection until negative test results have been
returned.
The egg products regulations are the same. Egg products plants may
move product pending test results only under circumstances that will
ensure the return of the product to the plant for reprocessing, or
under such other conditions as the Administrator may determine to
ensure compliance with part 590. FSIS's practice of allowing egg
products to be moved pending receipt of results of tests done by FSIS
or the plant is codified in 9 CFR 590.504(d).
Failure of an egg products plant to hold or maintain control of
product pending Agency or plant test results endangers public health.
Therefore, FSIS is proposing to revise paragraph (e) to 9 CFR 590.504
to make clear that egg products plants that move product that has been
sampled by the Agency or the plant before receiving test results must
maintain control of the products represented by the sample pending the
test results.
The Agency is not requiring the use of any particular control
measures to ensure that product is not used or distributed for sale
before test results are known. Instead, egg products plants may
continue to use, or develop, their own new, effective methods of
control.
G. Irradiated Shell Eggs
Shell eggs that are subjected to ionizing radiation may be used in
the production of egg products because when applied at sufficient
doses, irradiation can be a means of destroying disease-producing
bacteria in food and result in a pasteurized product. Specifically,
food irradiation is the process of exposing food to high levels of
radiant energy. Forms of radiant energy include: Microwave and infrared
radiation that heat food during cooking; visible light or ultraviolet
light used to dry food or kill surface microorganisms; and ionizing
radiation, resulting from cobalt-60, cesium-137, x-ray machines, or
electron accelerators, that penetrates deeply into food, killing insect
pests and microorganisms without significantly raising the temperature
of the food. Food is most often irradiated commercially to extend shelf
life, eliminate insect pests, or reduce pathogenic microorganisms. Food
irradiation for these purposes is practiced in many countries,
including the United States.
Irradiation is subject to the food additive provisions of the
FFDCA. FDA has the primary responsibility for determining whether food
additives are safe for particular uses. FDA lists uses of food
additives it has concluded are safe in 21 CFR parts 172 through 179.
Under section 201(s) of the FFDCA (21 U.S.C. 321(s)), a source of
radiation used to treat food is defined as a food additive. A source of
radiation is used to process or treat food such that, analogous to
other food processes, its use can affect the characteristics of the
food.
In a notice published in the Federal Register on March 20, 1998 (63
FR 13675), FDA announced that a food additive petition (FAP 8M4584) had
been filed by Edward S. Josephson, University of Rhode Island, Food
Science and Nutrition Research Center, 530 Liberty Lane, West Kingston,
RI 02892-1802, to amend the food additive
[[Page 6328]]
regulations to provide for the safe use of ionizing radiation for the
reduction of Salmonella in fresh shell eggs.
The petitioner submitted published articles and other study reports
containing data and information related to eggs and other kinds of food
in the areas of radiation chemistry, nutrition, toxicology, and
microbiology. FDA considered the data and studies submitted in the
petition, as well as other information in its files relevant to the
safety and nutritional adequacy of eggs treated with ionizing
radiation.
Based on the totality of evidence from all evaluated data and
studies, FDA determined that: (1) The proposed use of irradiation on
fresh shell eggs at levels not to exceed 3.0 kGy is safe, (2) the
irradiation can achieve its intended technical effect of reducing the
numbers of Salmonella in fresh shell eggs, and, therefore, (3) it
should amend 21 CFR 179.26 to provide for the use of irradiation on
fresh shell eggs. Consequently, on July 21, 2000 (65 FR 45280), FDA
approved the use of ionizing radiation on eggs in the shell to reduce
the internal level of Salmonella. It also amended its regulations by
expanding the list of products (21 CFR 179.26(b)) for which ionizing
irradiation may be safely used to include fresh shell eggs. (While FDA
does not define the word ``egg,'' FSIS has included the definition
contained in the EPIA in 9 CFR 590.5.)
While the irradiation of fresh shell eggs at the doses approved by
FDA will reduce the level of microorganisms in shell eggs (65 FR 45281,
July 21, 2000), the irradiation treatment of shell eggs to be processed
as liquid egg product will not sufficiently eliminate pathogens of
public health concern from this form of egg. As a result, treating
shell eggs used to process egg products only with ionizing radiation
will not result in a final egg product that is completely pasteurized,
i.e., RTE. Because the irradiation treatment approved by FDA is
insufficient to produce a ready-to-eat product based on the maximum
approved irradiation dose specified in 21 CFR 179.26, it must be used
in combination with other lethality treatments to complete the total
lethality required to result in a pasteurized, RTE egg product.
Under proposed 9 CFR 590.590, the irradiation treatment must
precede the heat or other lethality treatment because FDA has not
approved the use of irradiation on egg products. Irradiated shell eggs
or the use of the irradiated contents of fresh shell eggs for inclusion
in pasteurized egg products must be reflected in the ingredient
statement on the finished product labeling (proposed 9 CFR
590.410(a)(3)).
H. Implementation of Regulatory Requirements Domestic Plants
All official plants will be subject to the requirements put forth
in this proposal if it is adopted. FSIS intends to phase in the HACCP
requirements in this proposal over a 2-year period after publication of
a final rule, both as a means to reduce the impact for small and very
small businesses and to ensure that FSIS inspection program personnel
are properly trained and equipped with the tools to carry out the new
requirements for inspection. FSIS intends to enforce the Sanitation SOP
measures and the sanitation requirements one year after publication of
a final rule because these regulations should involve less significant
changes for the plants, and these regulations provide the plant
increased flexibility.
FSIS intends to enforce the requirement that egg products be
processed to be edible without additional preparation to achieve food
safety on the effective date of the rule. This requirement is
consistent with current regulatory and statutory requirements; FSIS
tests samples from all egg products for Salmonella and Lm. FSIS will
continue to do so should this rule become final.
Under this proposal, FSIS would no longer control design
specifications for buildings and equipment. Instead, FSIS would focus
its regulatory attention on determining whether an official plant is
successfully meeting sanitation requirements. Should this rule become
final, plants would be required to ensure that the design of buildings
and equipment is appropriate for sanitary food production and for
maintaining good sanitary conditions in accordance with broad
sanitation principles. In addition, official plants adopting Sanitation
SOPs of their own design would identify the elements of good sanitation
required to prevent direct product contamination, carry out their
Sanitation SOPs on a daily basis, and achieve acceptable sanitation
results.
Foreign Plants
Under 9 CFR 590.910, to export egg products to the United States,
foreign countries will have to have a system of inspection that is
equivalent to the system in the United States. Should this rule become
final, as HACCP and other regulatory provisions are implemented in the
American domestic market, foreign countries that export egg products to
the United States would be evaluated to ascertain whether their
inspection systems provide equivalent food safety protection, including
adequate levels of enforcement.
I. Labeling and Other Consumer Protection Regulatory Requirements
Official plants are responsible for ensuring that labeling used on
egg products is truthful and not false or misleading (21 U.S.C. 1036).
They are also responsible for ensuring that all labeling complies with
the EPIA and the egg products inspection regulations. To ensure that
official plants comply with applicable statutory and regulatory
labeling requirements, FSIS conducts a prior approval program for
labels used on federally-inspected egg products (9 CFR 590.411).
Examples of label features that FSIS evaluates include the
standardized, common or usual, or descriptive name of the product; an
ingredients statement containing the common or usual name of each
ingredient listed in descending order of predominance; and handling
statements if the product is perishable.
To obtain label approval, egg products plants must submit sketch
labels to FSIS before they print the labels, containers, or packaging
materials that bear official identification (9 CFR 590.411(a)). The
information submitted is evaluated by the FSIS Labeling and Program
Delivery Staff (LPDS) for conformance with the EPIA and the regulations
adopted under it.
Before July 1996, FSIS conducted a prior approval program for meat
and poultry labels used on federally-inspected meat and poultry
products. As with egg products, the meat and poultry prior approval
program was intended to ensure that the labels applied to those
products complied with the labeling and standards requirements of the
Federal Meat Inspection Act, the Poultry Products Inspection Act, and
their implementing regulations.
Effective July 1, 1996, FSIS modified its prior label approval
program for meat and poultry products by eliminating the need for
submitting final labels to the Agency. The Agency changed the previous
program by requiring the submission of only sketch labels (i.e.,
printer's proofs) and by expanding the types of labels that are
generically approved and that could be applied to products in final
form without first submitting such labels to the Agency for evaluation
and approval (60 FR 67443, Dec. 29, 1995). FSIS took this action to
improve the label approval system by eliminating the need for industry
to re-submit sketches in final label form, thereby reducing the number
of labels being submitted to the Agency for approval.
[[Page 6329]]
On November 7, 2013, FSIS published a final rule that amended the
meat and poultry products inspection regulations to expand the
circumstances under which the labels of meat and poultry products would
be deemed to be generically approved by the Agency. Effective January
6, 2014, FSIS regulations only require four categories of meat and
poultry product labels to be submitted to LPDS for approval, as
described in 9 CFR 412.1. FSIS requires the submission of labels: (1)
Intended for temporary approval; (2) for products produced under
religious exemption; (3) for products for export with labeling
deviations; and (4) with special statements and claims as described in
Sec. 412.1(c). All labels that do not fit into one of the four
categories are eligible for generic approval.
As part of its effort to make the egg products inspection
regulations as consistent as possible with the Agency's meat and
poultry products regulations, FSIS is proposing to modify the prior
label approval program for egg products labeling. If finalized, the
program will be consistent with the prior label approval system that is
in place for meat and poultry products, including the regulations that
permit generically approved labeling. Under this system, only labeling
that meets the criteria described in 9 CFR 412.1 will have to be
submitted to FSIS for evaluation and approval.
Therefore, FSIS is proposing to revise 9 CFR 590.411 to require all
official plants, including those certified under a foreign inspection
system in accordance with 9 CFR 590.910, to comply with the
requirements contained in 9 CFR 412.1. As a result, egg products plants
will have to submit only four categories of product labels to FSIS for
approval, including labels: (1) Intended for temporary approval; (2)
for products produced under religious exemption; (3) for products for
export with labeling deviations; and (4) with special statements and
claims as described in 9 CFR 412.1(c).
In addition, FSIS is proposing to revise 9 CFR 590.412 to require
that all official plants, including those certified under a foreign
inspection system in accordance with Sec. 590.910, comply with the
requirements in 9 CFR 412.2. Under this section, egg products plants
would be authorized to use generically approved labels and thus would
be free to use such labels without submitting them to the Agency for
approval, provided the label displays all of the required mandatory
features in a prominent manner and is not otherwise false or misleading
in any particular.
As with meat and poultry products, FSIS would select samples of
generically approved labels from the records maintained by official
plants and plants certified under foreign inspection systems to
determine compliance with label requirements (9 CFR 412.2(a)(2)). If
the Agency finds that an official plant is using a false or misleading
label, it would institute the proceedings prescribed in 9 CFR 500.8 to
revoke the approval for the label.
Current 9 CFR 590.50 requires shell eggs that are packed into
containers destined for the ultimate consumer to be labeled to state
that refrigeration is required. However, on December 5, 2000, FDA
amended 21 CFR part 101 to require that all shell eggs bear a safe
handling statement. This statement, which is intended to inform
consumers that there may be a risk associated with the consumption of
eggs, and of the ways that they can properly handle and prepare eggs in
order to reduce such risks, specifically instructs consumers to keep
eggs refrigerated (21 CFR 101.17). As a result, FSIS's labeling
requirement essentially duplicates FDA's, which became effective on
September 4, 2001. Since it is FSIS's intention not to unnecessarily
burden any parties with its regulatory requirements, FSIS is proposing
to state in its regulations that shell eggs packed into containers
destined for the ultimate consumer must be labeled in accordance with
21 CFR 101.17(h).
Meat and poultry products that require special handling to maintain
their wholesome condition are required to bear handling statements. To
ensure that the egg products inspection regulations will be as
consistent as possible with the Agency's meat and poultry products
regulations, FSIS is proposing a similar requirement for certain egg
products, 9 CFR 590.410(a). Under this proposal, packaged egg products
that require special handling to maintain their wholesome condition
would have to bear the statement ``Keep Refrigerated,'' ``Keep
Frozen,'' ``Perishable Keep Under Refrigeration,'' or a similar
statement. This statement would have to be prominently displayed on the
principal display panel. Similarly, egg products that are distributed
frozen and thawed before or during display for sale at retail would
have to bear the statement ``Keep Frozen'' on the shipping container.
Consumer-sized containers for such egg products would have to bear the
statement ``Previously Handled Frozen for Your Protection, Refreeze or
Keep Refrigerated.''
J. Rules of Practice
Under the EPIA, FSIS ensures that egg products are wholesome, not
adulterated, and properly marked, labeled, and packaged. FSIS has broad
authority to issue regulations to carry out the provisions of the EPIA,
including the authority to prescribe terms and conditions under which
inspection will be provided and maintained (21 U.S.C. 1035(b) and
1043).
Currently, when FSIS refuses to inaugurate inspection in a plant,
seeks to withdraw inspection, or refuses to approve egg products
markings, labels, or containers, the Agency initiates an administrative
action under 9 CFR 590.160. FSIS is proposing to replace 9 CFR
590.160(a)-(c) and (f)(1) with the supplemental rules of practice
contained in 9 CFR part 500. These supplemental rules already apply to
meat and poultry products establishments. Should this proposed rule
become final, 9 CFR part 500, Rules of Practice, would apply to egg
products plants, as an official establishment or establishment would
include an official plant under proposed 9 CFR 591.1(b).
FSIS is proposing to amend 9 CFR 500.2(c) to add 9 CFR 590.310 to
the list of regulatory citations under which an establishment \16\ may
appeal a regulatory control action. FSIS is also proposing to amend 9
CFR 500.3(a)(7) to allow FSIS to take a withholding action or to impose
a suspension without providing an establishment prior notification
because the establishment did not destroy a condemned egg product that
has been found to be adulterated and has not been reprocessed, in
accordance with 9 CFR part 590, within three days of notification.
---------------------------------------------------------------------------
\16\ For the purposes of Part 500, Rules of Practice, an
official establishment or establishment includes an official plant.
See proposed Sec. 591.1(b).
---------------------------------------------------------------------------
FSIS is proposing to amend 9 CFR 500.5(a)(5) and (c) to add 9 CFR
590.310 to the list of regulatory citations under which it must advise
an establishment that it may appeal a withholding action or suspension,
and under which an establishment may appeal a withholding action or
suspension. FSIS is also proposing to amend 9 CFR 500.6 by adding
section 18 of the EPIA (21 U.S.C. 1047) to the statutory citations
under which the FSIS Administrator may file a complaint to withdraw a
grant of Federal inspection because a recipient of inspection, or
anyone responsibly connected to the recipient, is unfit to engage in
any business requiring inspection.
[[Page 6330]]
FSIS is proposing to amend paragraphs (a)(3) and (5) of 9 CFR 500.7
to permit the FSIS Administrator to refuse to grant Federal inspection
because an applicant has not demonstrated that adequate sanitary
conditions exist in the establishment as required by the egg products
inspection regulations, or because the applicant is unfit to engage in
any business requiring inspection as specified in 21 U.S.C. 1047. FSIS
is also proposing to amend 9 CFR 500.8(a) to allow FSIS to rescind or
refuse approval of false or misleading marks, labels, or sizes or forms
of any container for use with any egg product under sections 7 or 14 of
the EPIA (21 U.S.C. 1036 and 1043). If this proposal is adopted, 9 CFR
500.8(c) will provide for an opportunity for a hearing, in accordance
with the Uniform Rules of Practice, 7 CFR subtitle A, part 1, subpart
H, if FSIS rescinds or refuses approval of false or misleading marks,
labels, or sizes or forms of any container for use with any egg
product.
Should this rule become final, FSIS would take a withholding action
or impose a suspension without providing the plant prior notification
because: (1) The official plant does not have a HACCP plan as specified
in 9 CFR 417.2; (2) the official plant does not have Sanitation
Standard Operating Procedures as specified in accordance with 9 CFR
416.11 and 416.12; or (3) the official plant does not maintain sanitary
conditions (9 CFR 500.3(a)). FSIS would also take these actions when
facilities apply for a grant of inspection and the applicant or
recipient, or anyone responsibly connected with the applicant or
recipient, is unfit to engage in business because of prior criminal
convictions, or when plant personnel assault, intimidate, or interfere
with Federal inspection service (21 U.S.C. 1047).
The proposed rules of practice will ensure that enforcement
procedures are fair; identify situations that may lead FSIS to take
enforcement action that may include refusing to apply or withholding
the marks of inspection from product or suspending or withdrawing
inspection from facilities; provide an opportunity for official plants
to address and correct problems before the Agency files a formal
administrative complaint to suspend or withdraw inspection; establish
the procedures FSIS will follow in taking such actions; and consolidate
the rules of practice applicable to official plants with those
applicable to meat and poultry products establishments.
K. Other Regulatory Changes
1. Elimination of Official Egg Products Plant Equipment and Facility
Prior Approval Requirements
The egg products inspection regulations require that official egg
products plants applying for inspection submit to FSIS multiple sets of
drawings of and specifications for the facilities for approval before
inspection can be granted (Sec. 590.146). The regulations require
plans to be submitted to the Agency for approval before any remodeling
of facilities, and they require that prior approval by FSIS be obtained
for equipment and utensils proposed for use in preparing edible product
or product ingredients in official plants (Sec. Sec. 590.146(d),
590.502, 590.504).
The prior-approval process is a feature of the traditional
``command-and-control'' regulatory approach. While prior approval
provides assurance that equipment, facilities, and processes, as
designed, meet certain requirements that are intended to ensure food
safety or quality, it also reflects the emphasis of the current egg
products inspection system on dictating the way in which official
plants maintain sanitation and produce safe food. This feature of the
current system is inconsistent with FSIS's view of the appropriate
allocation of responsibility between the Agency and official plants. It
is an obstacle and too often a deterrent to innovation by official
plants seeking to improve operations, and it contributes to
unproductive use of FSIS resources both in managing the approval system
and policing official plants' compliance with approved facility and
equipment specifications.
Experience has shown that FSIS prior approvals are of limited value
in ensuring good sanitation. They are limited in both scope, in that
they deal only with official plant facilities as presented in drawings,
and time, in that they are given once, on the condition that official
plants will maintain a sanitary operating environment after their
facilities are approved. Ultimately, an official plant's implementation
of good Sanitation SOPs on a continuing basis is more critical than the
actual design of a facility. Plant-operated sanitation procedures will
achieve, without prior approval, the same objectives as the FSIS prior
approvals, thereby rendering the prior approval procedures unnecessary.
Thus, under HACCP-based inspection, the FSIS prior approvals could no
longer be considered an efficient and cost-effective means to achieve
sanitation objectives.
Under this proposal, although there will no longer be a requirement
for an official plant to submit facility drawings and specifications
when applying for a grant of inspection, FSIS will continue to use a
specific process to determine whether to grant inspection. This process
will still include an on-site review, or ``walk-through,'' of the
plant's facilities by FSIS inspection program personnel as part of the
pre-decisional review of the facility's capability to produce complying
product. However, the decision-making process will no longer include
the review and prior approval of facility blueprints and specifications
by the Agency. The on-site review will not involve matching items on
the blueprints with the actual facilities represented. Instead, the
focus of the review will be on the extent to which the facility is able
to maintain a sanitary environment for food production and not impede
government inspection.
Prior approval by FSIS of equipment and utensils proposed for use
in preparing edible egg products or product ingredients will also be
eliminated under this proposal. FSIS's one-time approval does not
address daily operational issues such as proper maintenance and
adjustment of equipment to prevent product contamination. Such issues
are covered by the requirement in 9 CFR 416.3 that equipment and
utensils be of such material and construction that they can be
thoroughly cleaned and sanitized, as well as by other general
sanitation requirements.
While facilities will be required to meet the general sanitation
requirements prescribed in the regulations, they will have the
flexibility to determine the specific steps to be taken to comply with
those requirements. Facilities will be able to use equipment based on
their own evaluation of their ability to utilize the equipment in a
sanitary way.
In its inspection activities, FSIS will verify that plant equipment
meets those general standards. FSIS inspection program personnel will
act if they find that the equipment that a facility is using creates an
insanitary condition that may render product injurious to health.
2. Eggs and Egg Products Import Requirements
FSIS is proposing to amend the regulations governing the
importation and inspection of foreign eggs and egg products to align
them more closely with the regulations governing the importation of
foreign meat and poultry products. Historically, significant
[[Page 6331]]
differences have existed in how FSIS makes determinations of
eligibility for the import of meat and poultry products to the United
States as opposed to determinations for imported egg products.
Similarly, requirements and procedures for the reinspection of imported
products presented for entry into domestic commerce have been applied
differently to meat and poultry products than to egg products. In this
proposal, therefore, to improve import program efficiency and food
safety controls, FSIS is seeking to harmonize the requirements and
procedures applicable to imported eggs and egg products with those
applicable to imported meat and poultry products.
FSIS is proposing to amend 9 CFR part 590 by adding a new subpart
B, Imports (9 CFR 590.900 et seq.), that will contain the imported egg
products regulations. FSIS is proposing to amend these regulations by
adding 9 CFR 590.900, which includes paragraphs that define certain
basic terms, Import (Imported) and Offered for entry, and for product
from eligible countries: Entry (Entered). FSIS is also proposing to add
the term Official Import Inspection Establishment consistent with the
definition in the meat inspection regulations.
FSIS is proposing to add a new 9 CFR 590.901 to 9 CFR part 590 to
establish the identity of inspected and passed imported egg products as
domestic products. In so doing, the Agency seeks to ensure that
imported egg products that bear the mark of inspection may be combined
with inspected and passed domestic products for purposes of further
processing or sale in domestic commerce.
FSIS is proposing to amend 9 CFR 590.910 to establish the process
and criteria that the Agency will follow to evaluate the equivalence of
the inspection programs of foreign countries interested in gaining
eligibility to export egg products to the United States. This section
also delineates the manner in which foreign governments will be
required to maintain the equivalence of their egg products inspection
programs, including their certification of eligible establishments,
separation of certified from uncertified establishments, and audits to
verify the on-going equivalence of food safety and HACCP controls in
certified establishments. FSIS is also proposing to prescribe the
manner in which foreign governments are to certify eligible
establishments to FSIS. Finally, proposed 9 CFR 590.910 includes
provisions for the public notification of determinations of equivalence
made by FSIS of foreign egg products inspection programs.
FSIS is addressing those circumstances in which a shipment of
imported egg products may be rejected for container defects, but are
otherwise found to be acceptable, by proposing to add a new paragraph
(d) to 9 CFR 590.945 to identify the conditions under which imported
egg products consignments with damaged containers may be reoffered for
inspection.
For the handling of imported egg products, FSIS is proposing to
amend 9 CFR 590.930 to require official import inspection
establishments that re-inspect egg products to meet the sanitation
requirements in 9 CFR part 416. The sanitation requirements in 9 CFR
part 416 address conditions within establishments, such as facility and
equipment sanitation, employee hygiene, and the development and
implementation of sanitation standard operating procedures and
associated recordkeeping requirements.
FSIS is proposing to amend 9 CFR 590.940 to establish official
inspection marks for imported egg products. Current regulations require
only that egg products found to be acceptable for importation be
properly labeled and bear the inspection mark of the country of origin.
FSIS is proposing that imported egg products bear the same mark of
inspection that is applied to imported meat and poultry products.
Additionally, this section outlines a procedure for the pre-stamping of
official marks of inspection on product containers prior to the
completion of an inspection assignment. These changes are intended to
help to facilitate the clearance of inspected product during the
examination process when the product is not being held pending the
receipt of laboratory test results.
FSIS is proposing to amend 9 CFR 590.945 to clarify the procedures
for the treatment and handling of imported egg products identified as
``U.S. Refused Entry.'' Paragraph (a)(5) of that section states that if
the owner or importer fails to take the required action within the time
specified under paragraph (a)(4) of this section, the Department will
take such actions as may be necessary to effectuate its order to have
the product destroyed for human food purposes. The Department shall
seek court costs and fees, storage, and proper expenses in the
appropriate forum.
FSIS is proposing to amend 9 CFR 590.955 to include shipping or
identification marks among the list of required items for the labeling
of imported egg products shipping containers. Shipping and
identification marks are identifiers included on product container
labels to distinguish product contained in a particular shipment from
other product shipped elsewhere from the same production lot. Including
shipping and identification marks on the shipping container labels
facilitates identification of the product in the event of a recall or
compliance investigation.
9 CFR 590.956 permits the relabeling of all egg products eligible
for importation with an approved label under the supervision of an FSIS
inspector at an official egg products plant or other location. Under
proposed 9 CFR 590.411(f)(1), if the Administrator has reason to
believe that any labeling, including the size or form of any container
in use or proposed for use, with respect to egg products is false or
misleading in any way, the Administrator may direct that such use be
withheld unless the labeling or container is modified so that it will
not be false or misleading, or the formulation of the product is
altered so that it is not adulterated or would not cause misbranding.
While 9 CFR 590.956 permits the relabeling of all egg products
eligible for importation with an approved label, proposed 9 CFR
590.411(f)(1) would permit only those products whose containers,
labels, or packaging materials are false or misleading to be modified
so that the containers or labels are not adulterated or would not be
misbranded. Therefore, FSIS is proposing to amend 9 CFR 590.956 to
permit only those egg products that have been refused entry into the
United States solely because of misbranding to be brought in compliance
with the labeling requirements of 9 CFR chapter III. An authorized
representative of the Secretary will have authority to supervise any
such compliance activities.
Under 9 CFR 590.965, egg products that have been inspected and
marked by USDA may be returned from foreign countries. They are not
considered importations within the meaning of 9 CFR part 590. Because
such products are inspected and passed U.S. product, they are handled
in the same manner as domestic products. FSIS is proposing to amend 9
CFR 590.965 to permit the re-entry of inspected and passed egg products
from foreign countries if they are not adulterated or misbranded at the
time of such return. The product may be subject to reinspection in an
official plant before it can be released into commerce. Such products
would be exempted from further requirements under 9 CFR part 590, and
returned shipments must be reported to the Administrator by letter
prior to their arrival at the United States port of entry. The proposed
language will be
[[Page 6332]]
consistent with that for returned United States inspected and marked
poultry products (9 CFR 381.209).
9 CFR 590.960 provides an exemption from foreign export
certification and import inspection requirements for imported egg
products that are intended for an importer's personal use, display, or
laboratory analysis or that are not intended for sale or distribution
in domestic commerce. FSIS is proposing to extend the 50 pound
exemption for dried egg products to liquid or frozen egg products,
which may currently not exceed 30 pounds in weight. This proposed
change is consistent with the personal exemption provisions for
imported meat and poultry products, which permit any product in a
quantity of 50 pounds or less which was purchased by the importer
outside of the United States for his/her own consumption to be imported
into the United States from any country without compliance with the
provisions of chapter III of title 9.
On September 19, 2014, FSIS published a final rule amending 9 CFR
590.915 and 590.920 to provide an electronic alternative to the paper-
based import inspection application and the foreign inspection and
foreign plant certificate processes (79 FR 56220). It also removed from
the regulations the discontinued ``streamlined'' import inspection
procedures for Canadian product. The Agency is reproducing the amended
regulatory text in the codified text of this rule for context and
clarity. It is not, however, amending that text.
3. Changes to Defined Terms
FSIS is proposing to amend the egg and egg products inspection
regulations by updating the terminology used to refer to Agency
personnel and the definitions of various terms. FSIS is proposing to
remove the undesignated paragraphs of 9 CFR 590.5 that define Chief of
the Grading Branch, Inspector/Grader, National Supervisor, Regional
Director, and Service because such positions/entities do not exist
within FSIS. As mentioned previously, FSIS assumed responsibility for
conducting the egg products inspection program from AMS on May 28,
1995. Therefore, 9 CFR part 590 references should refer to FSIS and its
officials. FSIS is also proposing to remove the term Sanitize from 9
CFR 590.5. As discussed earlier in this document, the Agency is
proposing to consolidate the current sanitation regulations applicable
to official plants into 9 CFR 590.1 and part 416. While not explicitly
defined, the concept underlying the term ``sanitize'' is explained in 9
CFR part 416. Therefore, to eliminate this difference between the meat
and poultry inspection regulations and the egg and egg products
inspection regulations, FSIS is proposing to remove the term Sanitize
from 9 CFR 590.5.
FSIS is also proposing to remove the definition for the term Eggs
of current production. ``Eggs of current production'' are those eggs
that have moved through the usual marketing channels since the time
they were laid and are not in excess of 60 days old.\17\ AMS uses the
concept of ``eggs of current production'' to maintain the integrity of
its quality standards and the AMS grade shield. It is a quality, not a
food safety, indicator. Therefore, FSIS is proposing to remove the term
because continued application of the regulatory requirement may unduly
restrict the availability of edible eggs. However, FSIS is requesting
comments on whether it should keep the term ``eggs of current
production,'' and any support that the term is still necessary.
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\17\ On April 19, 2006, AMS amended its definition of ``eggs of
current production'' to mean shell eggs that are no more than 21
days old (71 FR 20288).
---------------------------------------------------------------------------
Finally, FSIS is proposing to remove the definition for the term
``plant.'' Under this definition, the term ``plant'' can refer to an
exempted plant, i.e., a plant where the Administrator has determined
that the facilities and operating procedures meet the standards
prescribed in part 590, and where the eggs received or used in the
manufacture of egg products contain no more than restricted eggs than
are allowed by the official standards of U.S. Consumer Grade B for
shell eggs, and where an exemption has been granted, or an official
plant, which means any plant in which the plant facilities, methods of
operations, and sanitary procedures have been found suitable and
adequate for the continuous inspection of egg products in accordance
with part 590 and in which inspection service is carried on. FSIS is
proposing to remove this definition because it is proposing to
eliminate the exempted plant regulations, which is discussed later in
this document. FSIS is proposing to add, in alphabetical order, an
undesignated paragraph to 9 CFR 590.5 defining ``official plant.'' An
``official plant'' will be any plant in which the plant facilities,
methods of operation, and sanitary procedures have been found suitable
and adequate by the Administrator for the inspection of egg products
pursuant to the regulations in this part and in which inspection
service is carried on.
FSIS is proposing to revise the undesignated paragraphs of 9 CFR
590.5 that define the terms Administrator, Egg, Egg product,
Pasteurize, Processing, and Shell egg packer. FSIS is proposing to
revise the definition for the term Administrator to make reference to
the FSIS Administrator instead of the AMS Administrator. This change
reflects the fact that the authority for inspecting egg products under
the EPIA's food safety provisions was delegated by the Secretary of
Agriculture to FSIS from AMS in November 1994.
Because the term Dirty egg or Dirties is defined twice in 9 CFR
590.5, once as an undesignated stand alone term and once as a
definition under the term Egg (paragraph c)), FSIS is proposing to
eliminate this redundancy by removing the undesignated stand-alone term
and its definition of Dirty egg or Dirties. While the definition of
Dirty egg or Dirties in paragraph (c) of the term Egg is properly
located, FSIS is proposing to revise it. The definition includes
prominent stains as a criterion for classifying an egg as ``dirty,''
but the EPIA's definition of the term does not include this criterion
(21 U.S.C. 1033(g)(3)). In addition, rather than being called
``dirties,'' dirty eggs are referred to as ``dirts'' in 7 CFR 59.720,
which the Agency is proposing to add to the egg products inspection
regulations. Consequently, FSIS is proposing to delete the words
``prominent stains'' from the definition of Dirty egg or Dirties in the
regulations.
Also in 9 CFR 590.5, FSIS is proposing to replace the term Official
standard with the term Official standards, correcting a typographical
error made when the term was transferred from 7 CFR chapter 1, part 59
to 9 CFR chapter III, part 590 on December 31, 1998 (63 FR 72352).
FSIS is also proposing to amend the definition of Processing, to
make clear that official plants may not repackage pasteurized dried egg
products unless inspection program personnel are available to provide
inspection oversight during the process. FSIS is proposing to amend the
definition of Pasteurize to eliminate the requirement that only
lethality treatments prescribed in the egg products inspection
regulations may be used to destroy harmful viable microorganisms.
FSIS is also proposing to amend the term Shell egg packer (grading
station) by removing the phrase (grading station). Grading station is a
term used by AMS to differentiate between the two primary types of egg
handlers: (1) Producer-packers, who pack only their own production, and
(2) grading stations, which are all other facilities that segregate and
pack eggs. While FSIS also distinguishes between producer-packers and
all other packing facilities
[[Page 6333]]
in its regulations, the phrase (grading station), when included as part
of the defined term itself, causes confusion because FSIS does not
perform any grading functions.
FSIS is proposing to add to 9 CFR 590.5 an undesignated paragraph
that defines Program employee because it is specific to FSIS and refers
to Agency personnel. FSIS is also proposing to define the phrase
Shipped for retail sale. Shipped for retail sale means eggs that are
forwarded from the processing facility for distribution to the ultimate
consumer.
4. Conditions for Receiving Inspection
FSIS is proposing a 9 CFR 591.1(a) which, by cross-reference, will
require that official plants, before receiving Federal inspection,
develop written sanitation Standard Operating Procedures, in accordance
with 9 CFR part 416, conduct a hazard analysis, and develop and
implement a HACCP plan, in accord with 9 CFR part 417. Conditional
inspection may be provided for a period not to exceed 90 days, during
which period the plant will have to validate its HACCP plan.
5. Miscellaneous Changes
FSIS is proposing to amend the following egg products inspection
regulations to match the text in the meat and poultry products
inspection regulations:
9 CFR 590.118 Identification.
9 CFR 590.120 Financial interest of inspectors.
9 CFR 590.136 Accommodations and equipment to be furnished by
facilities for use of program employees in performing service.
9 CFR 590.146 Survey and grant of inspection.
9 CFR 590.310 Appeal inspections.
FSIS is also proposing to eliminate the issuance of appeal
certificates (9 CFR 590.360) and the cost of an appeal to a plant (9
CFR 590.370). Under current 9 CFR 590.300 and proposed 9 CFR 590.310,
official plants have the right to appeal inspection decisions.
6. Reinterpreting the Requirement for Continuous Inspection in 21
U.S.C. 1034(a)
The EPIA requires the continuous inspection of the processing of
egg products whenever processing operations are being conducted in each
plant processing egg products for commerce (21 U.S.C. 1034(a)). FSIS
has interpreted this to require the presence of inspection program
personnel at each egg products plant whenever the manufacturing of egg
products is being conducted, including breaking eggs or filtering,
mixing, blending, pasteurizing, stabilizing, cooling, freezing, drying,
or packaging egg products. This level of inspection coverage is similar
to that required at meat and poultry slaughter establishments, where
FSIS conducts inspection during all slaughter operations. In contrast,
at meat and poultry processing establishments, FSIS conducts inspection
at least once per shift.
Based on the Agency's experience inspecting egg products plants
since 1995, the Agency believes that egg products operations are more
similar to meat and poultry processing operations, and especially those
that produce ready-to eat products, than they are to meat and poultry
slaughter operations, where inspection is required for each meat or
poultry carcass. Like ready-to-eat meat and poultry processing
operations, the typical egg products processing operation is a
streamlined, automated process, with one or more lethality steps to
destroy pathogens of concern in the finished product. As a result, FSIS
is proposing to change the Agency's interpretation of ``continuous
inspection'' in 21 U.S.C. 1034(a). Therefore, FSIS now intends to
require inspection in egg products plants at least once per shift,
instead of during all processing operations. FSIS welcomes comment on
possible criteria the Agency might use in determining how inspection
will be specifically adjusted in egg products plants.
Section 590.100 provides exemptions from continuous inspection
under certain circumstances, provided that the conditions for exemption
and the provisions of the regulations are met. Paragraph (b) of 9 CFR
590.100 provides an exemption from continuous inspection at any plant
where the facilities, sanitation, and operating procedures are the same
as required in part 590 for official plants and where the eggs received
or used in the manufacture of egg products contain no more restricted
eggs than are allowed by the official standards for U.S. Consumer Grade
B shell eggs, and the egg products processed at such plant. Plants
granted an exemption under 9 CFR 590.100(b) are called ``exempted
plants.''
Instead of continuous inspection, exempted plants are subject to
periodic inspections, provided they have met the facility, operating
procedures and practices, and sanitation standards required for
official egg products plants as contained in 9 CFR 590.500-590.580.
They are also subject to other provisions applicable to official
plants, which includes maintaining records which must be made available
to duly authorized representatives of the Administrator for review.
Product from exempted plants may not bear official identification (9
CFR 590.680(a)). Exempted product labels must bear the statement,
``Exempted-E.P.I.A. Registration No. __.'' The registration number is
that assigned to the exempted plant as provided in 9 CFR 590.650.
The Agency's proposal to no longer require inspection coverage
during all processing operations removes the need for this exemption.
The circumstances provided by this exemption can be accommodated under
FSIS's changed interpretation of ``continuous inspection'' in 21 U.S.C.
1034(a) and would allow such exempted plants to bear official
identification. Therefore, FSIS is proposing to remove the specific
exemption from continuous inspection found in 9 CFR 590.100(b), as well
as the regulations in 9 CFR 590.600-590.680 authorizing these types of
exempted egg products plants. The other exemptions from inspection for
certain types of egg products processing, provided at 9 CFR 590.100(e)
and (g), would remain, but would be redesignated as paragraphs (b)(1)
and (2). Paragraph (f), now reserved, would be removed.
III. Executive Orders 12866, 13563, and 13771 and the Regulatory
Flexibility Act
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, or reducing costs, of harmonizing rules, and of promoting
flexibility. This proposed rule has been designated a ``significant''
regulatory action under section 3(f) of Executive Order 12866.
Accordingly, the rule has been reviewed by the Office of Management and
Budget under Executive Order (E.O.) 12866.
A. Need for Regulatory Action
The proposed rule will enable official plants to increase
efficiency from complying with less burdensome regulations. FSIS is
proposing that the current ``command and control'' egg products
inspection regulations be changed to more flexible regulatory
requirements. Under this proposed rule, egg products plants would be
required to develop and maintain HACCP systems. A HACCP system allows
greater flexibility for producers to
[[Page 6334]]
realize increased production efficiency. In addition, the proposed rule
will allow plants to use different pasteurization methods. With 93
percent of egg products plants already under a HACCP system,\18\ many
have incurred additional unnecessary costs from complying with FSIS
requirements in terms of ``command and control'' regulations and by
processing under their own HACCP systems. By operating under the HACCP
system alone, egg products plants can use plant resources in a more
efficient manner while controlling for hazards in innovative ways in
their HACCP plans.
---------------------------------------------------------------------------
\18\ RTI International. 2014. ``Survey of Egg Packing and Egg
Products Processing Plants.'' Revised Final Report. RTI Project no.
0211740.015.001. 3040 Cornwallis Rd., P.O. Box 12194 Research
Triangle Park, NC 27709-2194. OMB No. 0583-0162.
---------------------------------------------------------------------------
Furthermore, regulatory action is warranted by the non-negligible
public health risks associated with pasteurized egg products. The FSIS
2005 risk assessment estimated 5,500 cases of Salmonella per year due
to pasteurized liquid egg products. This represents 0.5% of the
approximately 1.03 million annual domestically acquired foodborne
illnesses caused by Salmonella estimated by Scallan et al. (2011,
Emerging Infectious Diseases 17(1):7-15). Gurtler et al. (2013,
Foodborne Pathogens and Disease, 10(6):492-499) identifies four
Salmonella outbreaks during 2007-2012 that were possibly caused by
contaminated pasteurized egg products. Also, process control failures
in the production of pasteurized egg products have the potential for
especially serious health outcomes because the Food Code recommends
pasteurized egg products for highly susceptible populations (FDA 2013
Food Code, Sec. 3-8).
Baseline of the Egg Products Industry
Currently, egg products are produced under FSIS jurisdiction by 77
egg products plants. Egg products include liquid, frozen, and dried
whole eggs, whites, yolks, and various blends with or without non-egg
ingredients. According to the FSIS Public Health Information System
(PHIS) Database, we estimate that the egg products industry produced
1.8 billion pounds of dried, frozen, and liquid egg products for
distribution in commerce and produced 4 billion pounds of liquid
unpasteurized product for further processing in 2014.\19\ Liquid egg
products are produced in 73 percent of plants and accounted for 19
percent of all egg products marketed as finished product in 2014.\20\
Liquid egg products represent the largest product type produced by egg
products plants.
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\19\ In the Fiscal Year 2014, the monthly average production
volume was used to calculate the annual estimate for 77 egg products
plants in the PHIS database.
\20\ In the Fiscal Year 2014, the monthly average production
volume was used to calculate the percentage for 77 egg products
plants in the PHIS database.
---------------------------------------------------------------------------
A survey by RTI International in 2014, Egg Products Industry
Survey,\21\ showed that 93 percent of egg products plants use a written
HACCP plan to address at least one production step in their
process.\22\ The remaining 7 percent would need to create HACCP plans
under this proposed rule, as well as any of the 93 percent of egg
products plants that have HACCP plans for some egg products, but not
for others.
---------------------------------------------------------------------------
\21\ RTI International. 2014. ``Survey of Egg Packing and Egg
Products Processing Plants.'' Revised Final Report. RTI Project no.
0211740.015.001. 3040 Cornwallis Rd., P.O. Box 12194 Research
Triangle Park, NC 27709-2194.
\22\ RTI International. 2014. ``Survey of Egg Packing and Egg
Products Processing Plants.'' Revised Final Report. RTI Project no.
0211740.015.001. 3040 Cornwallis Rd., P.O. Box 12194 Research
Triangle Park, NC 27709-2194.
---------------------------------------------------------------------------
This proposed rule would require that egg products plants maintain
sanitation SOPs equivalent to the specifications of FSIS. Ninety-one
percent of egg products plants already conduct sanitation procedures
for food contact surfaces either daily or more frequently and document
those procedures for sanitation standard operating procedures
(Sanitation SOPs).\23\
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\23\ Ibid.
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Egg products production is easily the least labor-intensive process
of the industries and products that FSIS regulates. Egg products plants
tend to be highly mechanized and staffed with relatively low numbers of
employees. Based on the results of a 2014 industry survey,\24\ no egg
products plants employ enough employees to be categorized as HACCP size
Large. Because of the high product volume output to low employee count
that egg products plants enjoy, nearly all plants that have less than
10 employees have over $2.5 million in annual sales, making them
ineligible for the HACCP size Very Small category. Therefore, the large
majority (98 percent) of egg products plants fall into the HACCP size
Small category. In this section, FSIS discusses the size of individual
plants. For a discussion of the size of egg products businesses under
the Small Business Administration's (SBA) definition, see the initial
Regulatory Flexibility Analysis section of this document.
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\24\ Under the HACCP size definitions, large establishments have
500 or more employees and small establishments have fewer than 500
but more than 10 employees. Very small establishments have fewer
than 10 employees or annual sales of less than $2.5 million. These
definitions are outlined in Pathogen Reduction: Hazard Analysis and
Critical Control Point (HACCP) Systems (61 FR 38806 (July 25, 1996)
available at: http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/93-016F.pdf.
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Table 2 displays plants and processes.
Table 2--Egg Products Plants and Total Processes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Plants Breaking Liquid Dried Total processes
--------------------------------------------------------------------------------------------------------------------------------------------------------
77.............................................................. 56 52 17 125
--------------------------------------------------------------------------------------------------------------------------------------------------------
FSIS inspection of egg products plants includes 95 inspection
program personnel (IPP), who conduct daily pre-operational sanitation
inspections and monitor sanitary conditions of the plant premises,
facilities, and equipment continually during operations at every egg
products plant in multiple shifts. FSIS IPP are responsible for
observing the cleanliness, type, and wholesomeness of raw materials and
finished products, the handling of ingredients, pasteurization,
packaging, labeling, freezing, storing, and all other operations
related to the processing and production of egg products. In the past,
FSIS has determined through regulation that, under the EPIA, IPP are
required to conduct continuous inspection at egg products plants. This
requirement means IPP must be on duty whenever eggs are broken; liquid
eggs arrive at the receiving plant; egg products are blended,
reconstituted, or reformulated; egg products are pasteurized or
packaged; and non-denatured inedible egg products arrive at, or are
shipped from, the plant.\25\
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\25\ U.S. Department of Agriculture, Egg Products Inspectors
Handbook. AMS PY-Instruction No. 910. January, 1975.
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Expected Cost of the Proposed Rule
Presented here are economic analyses for the breaking of shell
eggs, the production of pasteurized liquid egg
[[Page 6335]]
products (including frozen egg products), and the production of
pasteurized dried egg products. Also provided are estimated government
costs associated with this proposed regulation. All recurring and one-
time cost estimates are in 2016 dollars, and discount rates of 3
percent and 7 percent are used to calculate annualized costs over a 10-
year period. For the purposes of the cost estimate, FSIS did not
consider plant HACCP size because of the regularity in size explained
previously (98 percent small). FSIS does not anticipate costs
experienced by Very Small plants to differ greatly from those
experienced by Small plants, because this proposed rule does not
require any major capital, structural, or machinery investment or the
hiring of additional employees, which can impose a large burden on Very
Small plants.
Egg products plant personnel compensation (wages and benefits) that
plants would need to provide to their employees because of the proposed
regulation is derived using Bureau of Labor Statistics Occupational
Employment Statistics wage rates and National Compensation Survey
benefits percentages. The wage rate for a Quality Control (QC) manager
is estimated to be $51.47 per hour; for Supervisors or QC technicians,
$34.26 per hour; and for Production workers, $13.00 per hour.\26\
Plants may pay employees for benefits such as paid leave, health
insurance, and retirement and savings, and FSIS applied a benefits
factor \27\ of two to the hourly wage rate to estimate a total
compensation rate for a Quality Control (QC) manager at $102.94 per
hour; and for Supervisors or QC technicians at $68.52 per hour; and for
Production workers at $26.00 per hour.
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\26\ Estimates obtained from the Bureau of Labor Statistics May
2016 National Industry-Specific Occupational Employment and Wage
Estimates, for Management Occupations (Occupational Code 11-0000),
https://www.bls.gov/oes/current/oes113051.htm#ind, Food Scientists
and Technologists (19-1012), https://www.bls.gov/oes/current/oes191012.htm, and Production Occupations (51-0000) https://www.bls.gov/oes/current/oes513023.htm.
\27\ This analysis accounts for fringe benefits and overhead by
multiplying wages by a factor of two.
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Hazard Analysis & Critical Control Points (HACCP) Systems: The cost
estimates for HACCP implementation include costs associated with plan
development and reassessment, training, and monitoring and
recordkeeping costs. If egg products plants follow current time/
temperature regulations, FSIS would accept their approach, and FSIS
would not require that plants do a significant amount of analysis in
their HACCP plan. Upon completion of the hazard analysis and
development of the HACCP plans, plants are required to determine
whether their HACCP plans are functioning as intended. During the
initial validation period, plants are to test, repeatedly, the adequacy
of the CCPs, critical limits, monitoring and recordkeeping procedures,
and corrective actions identified in the HACCP plan.\28\ Plants are
also required to perform an annual reassessment of their HACCP plans.
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\28\ 9 CFR 417.4.
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HACCP Plan Development and Reassessment: Egg products plants
operate to produce a variety of products using a number of different
processing techniques. Under this proposed rule, each plant would be
required to evaluate its processes to determine the adequacy of
existing written HACCP plans and the number of plans that would need to
be created or modified to meet the requirements of the proposed rule. A
large number of egg products plants already have HACCP plans for their
processes. These plants will be required to validate and reassess their
HACCP plans annually, to ensure that their HACCP plans are consistent
with the regulations that FSIS is proposing in this document. For
plants that currently lack HACCP plans, FSIS estimated the cost of
initial plan development and validation and annual reassessment and
validation. Under this proposed rule, every egg products plant would be
required to reassess the adequacy of the HACCP plan at least annually
and whenever any changes occur that could affect the hazard analysis or
alter the HACCP plan. Such changes may include, but are not limited to,
changes in raw materials, source of raw materials, or product
formulation. For the purposes of estimating costs, FSIS simplified the
production of egg products into three processes: the breaking of shell
eggs, the production of pasteurized liquid egg products (including
frozen egg products), and the production of pasteurized dried egg
products.
Using these three process definitions and data from PHIS, FSIS
categorized plants by process. For reference, Table 2 above displays
plants and processes. Using results from the 2014 Egg Products Industry
Survey, FSIS applied a distribution, by process, of plants responding
affirmatively to having a written HACCP plan to the population of egg
products plants.\29\ Using this data, FSIS estimated the number of
processes in those plants that require a HACCP plan to be developed.
This information is displayed in Table 3.\30\
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\29\ See Appendix A, Section 4.
\30\ For the purposes of the table, the number of processes was
rounded to the nearest whole number. For the purposes of cost
calculations and to be more exact, the Agency kept the actual
figures, including digits past the decimal point, for instance, the
number of total processes is actually 24.2507 rather than 24. These
figures are not exact whole numbers because the Agency used the
survey participant responses for which processes they use, as
percentages of the total survey responses. These percentages were
used to derive the total number of establishments that use each
process applying that to the total population of egg products plants
in Agency data (please see appendix A).
Table 3--Processes Without Written HACCP Plans
------------------------------------------------------------------------
Total
Breaking Liquid Dried processes
------------------------------------------------------------------------
9................................... 12 3 24
------------------------------------------------------------------------
For plan development and reassessment, FSIS used the Cost of Food
Safety Investments \31\ final report, updated for inflation from 2014
to 2016 dollars using the Consumer Price Index (CPI) for Urban
Consumers, and, with the assumed benefits factor of two. FSIS estimates
the costs for plan development and reassessment using the low estimate,
(plan developed internally--low estimate--$17, 130), the high estimate
(plan developed with consultant--high estimate--$42,423), and the
average of the mid-estimates of the plan developed with a consultant
and internally ($31,271).\32\ FSIS also incorporated an initial
validation cost of $27,408 ($13,704-$41,112) and an ongoing (yearly)
reassessment cost of $28,188 ($14,094-$42,282) for all HACCP plans.
FSIS applied these estimates to the number of processes needing HACCP
plans to determine the cost of HACCP plan development, validation, and
reassessment, displayed in Table 4.
---------------------------------------------------------------------------
\31\ RTI International. Cost of Food Safety Investments Final
Report. Available at: https://www.fsis.usda.gov/wps/wcm/connect/0cdc568e-f6b1-45dc-88f1-45f343ed0bcd/Food-Safety-Costs.pdf?MOD=AJPERES. These cost figures were adjusted for
inflation using the average CPI-U from 2014 to 2016.
\32\ For plan development costs, in order to mitigate outliers,
the Agency selected the greater of the two lowest costs between
developing the plan internally and the cost for developing with a
consultant for the low estimate, and the lesser of the two highest
costs between developing the plan internally or with a consultant
for the high estimate.
[[Page 6336]]
Table 4--Estimated HACCP Plan Development, Validation, and Reassessment Costs
[$1,000s]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized cost--3% (low Annualized cost--7% (low
Cost component Initial cost (low estimate- Recurring cost (low estimate- estimate-high estimate) over estimate-high estimate) over
high estimate) high estimate) 10 10 years
--------------------------------------------------------------------------------------------------------------------------------------------------------
Development..................... 758.3 (415.4-1028.8) 0 86.3 (47.3-117.1) 100.9 (55.3-136.9)
Initial Validation * for 25 New 667.4 (332.3-997.0) 0 75.6 (37.8-113.5) 88.4 (44.2-132.7)
Plans..........................
Annual Reassessment **.......... 2,839.9 (1420.2-4,259.9) 3,523.5 (1,761.8-5,285.3) 3,445.7 (1,722.8-5,168.5) 3,432.5 (1,716.3-5,148.8)
--------------------------------------------------------------------------------------------------------------------------------------------------------
* These estimates are calculated using the actual number of unrounded processes or 24.2507 processes.
** ``Initially, plants with existing HACCP plans will begin reassessing in year 1. Plants without existing plans, after developing their plans in year
1, will begin reassessing their plans in the following years.
The above analysis does not include costs associated with taking a
corrective action when routine monitoring of a CCP detects a deviation
from an established critical limit. It is not possible to determine the
costs of these corrective actions, but we expect that, for well-
designed processes with HACCP, these costs would occur infrequently.
HACCP Training and Personnel: We assume that each egg products
plant will employ a QC manager and a QC technician to ensure compliance
with the proposed measures. Based on the 2014 Egg Products Industry
Survey final report, approximately 7 percent of plants do not employ
any HACCP plans.\33\ Thus, we assume 7 percent of plants (approximately
five) will need to obtain training for a QC manager, assuming one per
plant, and a QC technician and three production workers for each
processing operation shift (an average of 1.7 shifts per plant based on
the results of the Industry Survey).
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\33\ See Appendix A, Section 5.
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Although the HACCP system is different than the current system,
FSIS believes that in egg products plants, only a portion of production
employees, or a minimum number per shift, would actually receive
training, given that the duties for most of the production employees
will remain very similar or even the same when the plant operates under
HACCP. FSIS is seeking comment on its assumed staffing and training
cost estimates.
FSIS used initial and recurring annual refresher training cost
estimates (updated using the CPI for Urban Consumers from 2014 to 2016
dollars and the assumed benefit factor of two) and the number of hours
of training from the Cost of Food Safety Interventions \34\ final
report updated with the assumed benefit factor of two. QC Managers
would be trained initially at a cost of $3,991.29 (ranging from
$1,995.65 to $5,986.94), with an annual refresher at a cost of $205.88
($102.94 to $308.82). QC Technicians would be trained initially at a
cost of $3,165 ($1,583 to $4,748), with an annual refresher at a cost
of $137 ($69 to $206). An additional opportunity cost for training was
added to account for the time lost when employees were in training at
the per hour compensation rate (including wage and benefit factor) of
the employees being trained for the length of the training and for
replacement personnel to work covering the time of the training.
Production employees would also need to be trained; however, FSIS
assumed that this training would take place on the job, and therefore
would only impose opportunity costs. We use an annual turnover rate of
27.9 percent \35\ to estimate recurring costs due to employee
separation and the need to train new employees. These estimates are
displayed in Table 5.
---------------------------------------------------------------------------
\34\ RTI International. Cost of Food Safety Investments Final
Report. Available at: https://www.fsis.usda.gov/wps/wcm/connect/0cdc568e-f6b1-45dc-88f1-45f343ed0bcd/Food-Safety-Costs.pdf?MOD=AJPERES. These cost figures were adjusted for
inflation using the average CPI-U from 2014 to 2016.
\35\ Ibid.
Table 5--HACCP-Related Training Costs
[$1000s]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized cost--3% (low Annualized cost--7% (low
Plants Shifts Initial training costs (low Recurring training costs (low estimate-high estimate) over estimate-high estimate) over
estimate-high estimate) estimate-high estimate) 10 years 10 years
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
5..................................................... 9 78.9 (39.5-118.4) 27.9 (13.9-41.8) 33.7 (16.8-50.5) 34.7 (17.3-52)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
HACCP Recordkeeping: The proposal requires facilities to record
observations when monitoring CCPs and to document any deviations and
corrective actions. The rule requires that an employee not involved in
recording observations certify such records. Recordkeeping costs
include the time it takes to make observations and to record the
results of those observations, plus the cost of certifying and
maintaining records. The level and extent of recordkeeping for the
proposed rule should not change greatly for egg products plants already
using HACCP plans. Plants with existing HACCP plans are already
documenting CCPs, as well as documenting information for the current
regulations. For these plants, there will be a cost savings and
reduction in recordkeeping costs, because they are keeping records for
both a HACCP system and the current regulations.
FSIS used data from the 2014 Egg Products Industry Survey to
estimate how many plants do not have HACCP plans, and the number of
plans needed at these plants. FSIS also estimated the number of shifts
at those plants.\36\ The cost of recordkeeping is dependent on several
factors, each of which has to be documented in some manner, such as the
number of HACCP plans developed by each plant, the number of shifts
operated by each plant, the number of CCPs per HACCP plan, the number
of pre-shipment reviews conducted, and any decision-making for hazard
analysis that may require documentation.
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\36\ See Appendix A, Section 6.
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[[Page 6337]]
The numbers of CCPs in egg products plants likely vary considerably
across the industry. An FSIS technical expert \37\ suggested four to
six CCPs per HACCP plan, as an average. Therefore, we assumed that the
average number of CCPs is five per egg products plant, per plan. We
assumed 3 minutes (+/- 1 minute) for monitoring recordkeeping and 1
minute (+/- 30 seconds) for certifying per CCP.\38\ FSIS is seeking
comment on these time assumptions. From the above assumptions, we
estimate (Table 6) the annual cost of HACCP recordkeeping and
monitoring. The Agency seeks comment on the number of CCPs anticipated,
taking into account the variables listed above.
---------------------------------------------------------------------------
\37\ Curtis, P., North Carolina State University, Raleigh, NC.
October 5, 2001. Personal communication with Catherine Viator, RTI.
Reported in RTI International. 2002. ``Pathogen Reduction and Other
Technological Changes in the Meat, Poultry, and Egg Industries.''
RTI Project no. 07182.017. 3040 Cornwallis Rd., P.O. Box 12194
Research Triangle Park, NC 27709-2194
\38\ FSIS estimated these approximate time estimates by first
hand observation at egg products plants.
Table 6--Annual HACCP Recordkeeping and Monitoring Costs
[$1000s]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Effective Annualized--3% recordkeeping Annualized--7% recordkeeping Annualized--3% monitoring Annualized--7% monitoring
Plans annual costs (low estimate-high costs (low estimate-high costs (low estimate-high costs (low estimate-high
shifts estimate) over 10 years estimate) over 10 years estimate) over 10 years estimate) over 10 years
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
24...................................................... 10,509 68.3 (45.5-91.9) 68.3 (45.5-91.1) 60.0 (30.0-90.0) 60.0 (30.0-90.0)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Table 7 presents a summary of the total HACCP-related costs as a
result of the rule. These figures are annualized over 10 years at 3
percent and 7 percent discount rates.
Table 7--Total HACCP-Related Industry Costs
[$1000s] *
----------------------------------------------------------------------------------------------------------------
Annualized costs--3% (low Annualized costs--7% (low
Cost component estimate-high estimate) over estimate-high estimate) over
10 years 10 years
----------------------------------------------------------------------------------------------------------------
Plan Development and Reassessment................... 3,607.7 (1808.0-5399.1) 3,621.9 (1,815.8-5,418.4)
Training............................................ 33.7 (16.8-50.5) 34.7 (17.3-52.0)
Recordkeeping & Monitoring.......................... 128.3 (75.5-181.1) 128.3 (75.5-181.1)
-----------------------------------------------------------
Total........................................... 3,769.7 (1,900.3-5,630.7) 3,784.9 (1,908.6-5,651.5)
----------------------------------------------------------------------------------------------------------------
* Numbers in table may not sum to totals due to rounding.
Sanitation Standard Operating Procedures (Sanitation SOPs)
Plan Development: For the most part, plants already have plans for
sanitation insofar as FSIS already requires certain sanitation
procedures. FSIS used responses from the 2014 Egg Products Industry
Survey \39\, which describes the number of plants where they train
their employees on sanitation SOPs, to estimate the percentage of
plants that have sanitation SOPs. This accounts for approximately 91
percent of all egg products plants. FSIS assumed that if a plant is
training production employees, then it has a written plan in place that
the training is based on and would likely meet the requirements of the
proposed rule. FSIS then applied this percentage to determine the
number of plants that would need to develop written sanitation SOPs
(approximately 7). The current Sanitation SOP requirements for egg
products plants will not change greatly, because the basis and
standards for the sanitation of the plants will remain consistent with
the current guidelines. For the proposed rule, the Sanitation SOPs will
be created by the plant to meet FSIS standards under the HACCP system.
---------------------------------------------------------------------------
\39\ See Appendix A, Section 1.
---------------------------------------------------------------------------
FSIS used cost estimates from the Cost of Food Safety Interventions
\40\ final report, with labor costs updated for inflation from 2014 to
2016 dollars and for the benefit factor described previously. For plan
development, FSIS estimated costs using the low estimate (plan
developed internally--low estimate--$17,130), the high estimate (plan
developed with a consultant--high estimate, $31,018), and the average
of the mid-estimates of the plan developed internally and with a
consultant ($27,469).\41\ The costs of Sanitation SOP plan development
are displayed in Table 8.
---------------------------------------------------------------------------
\40\ RTI International. Cost of Food Safety Investments Final
Report. Available at: http://www.fsis.usda.gov/wps/wcm/connect/0cdc568e-f6b1-45dc-88f1-45f343ed0bcd/Food-Safety-Costs.pdf?MOD=AJPERES.
\41\ For plan development costs, in order to mitigate outliers,
the Agency selected the greater of the two lowest costs between
developing the plan internally and the cost for developing with a
consultant, and the lesser of the two highest costs between
developing the plan internally or with a consultant.
Table 8--Costs Associated With the Development of Sanitation SOPs
[$1,000s]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized cost--3% (low Annualized cost--7% (low
Cost component Initial cost (low estimate- Recurring cost (low estimate- estimate-high estimate) over estimate-high estimate) over
high estimate) high estimate) 10 years 10 years
--------------------------------------------------------------------------------------------------------------------------------------------------------
Development................. 185.5 (115.7-209.5) 0 21.1 (13.2-23.8) 24.7 (15.4-27.9)
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 6338]]
Recordkeeping: Under the proposed rule, plants would be required to
maintain daily records sufficient to document the implementation and
monitoring of sanitation SOPs. FSIS used data from the 2014 Egg
Products Industry Survey to estimate the proportion of plants keeping
sanitation records that would meet the requirements of the proposed
rule consisting of employee task performance and a log for deviations
and corrective actions.\42\ FSIS then determined how many of those
plants are completing recordkeeping tasks daily.\43\ Those plants that
are not conducting recordkeeping or are conducting inadequate
recordkeeping based on the proposed sanitation SOPs requirements will
incur costs to do so.
---------------------------------------------------------------------------
\42\ See Appendix A, Section 2.
\43\ At least 1 pre-operational sanitation inspection of product
contact zones per 9 CFR 416.13 and 416.12(c).
---------------------------------------------------------------------------
For plants that are not keeping adequate sanitation records, FSIS
estimated costs of recordkeeping based on the frequency of reported
recordkeeping tasks. FSIS assumed that each sanitation recordkeeping
task would be performed by a production employee and would take
approximately 15 minutes (+/-5 minutes) to complete. A sanitation
recordkeeping task would be performed daily, unless the plant reported
performing a task more than daily, in which case FSIS assumed there
would be one task per shift (an average of 1.7 shifts per plant based
on the results of the Industry Survey). The average number of shifts
was calculated using question 5.2 of the survey, which asks respondents
their total number of production shifts per day.\44\ The responses by
small and large plants to question 5.2 were combined along with the
total responses to get percentages for average number of shifts. The
calculation is 25% x 3 shifts + 18% x 2 shifts + 57% x 1 shift = 1.7
shifts.
---------------------------------------------------------------------------
\44\ Please see Appendix A.
---------------------------------------------------------------------------
FSIS further assumed that a QC technician would review records for
approximately 10 minutes (+/-5 minutes) once per day. FSIS used the
recordkeeping estimates and time assumptions to estimate the cost to
industry for Sanitation SOP recordkeeping, displayed in Table 9.
Table 9--Sanitation SOP Recordkeeping Costs
[$1,000s]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized--3% recordkeeping Annualized--7% recordkeeping
Current recordkeeping practices Recordkeeping Number of plants cost (low estimate-high cost (low estimate-high
frequency estimate) over 10 years estimate) over 10 years
--------------------------------------------------------------------------------------------------------------------------------------------------------
In compliance with proposed rule.......................... Daily * 17 0 0
Not in compliance with proposed rule...................... Daily 12 34.2 (22.8-45.7) 34.2 (22.8-45.7)
--------------------------------------------------------------------------------------------------------------------------------------------------------
* For number of plants, FSIS multiplies the percentages from the survey for each category by total number of plants (77). For the category >Daily, in
compliance, the calculation of 77 x 22.8% yields 17.56. This count was rounded down to 17 plants to be consistent with the total number of plants in
the analysis of 77.
Table 10--Sanitation SOP Monitoring Costs
[$1,000s]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized--3% monitoring Annualized--7% monitoring
Current recordkeeping practices Recordkeeping Number of plants cost (low estimate-high cost (low estimate-high
frequency estimate) over 10 years estimate) over 10 years
--------------------------------------------------------------------------------------------------------------------------------------------------------
In compliance with proposed rule.......................... Daily * 17 ............................ ............................
Not in compliance with proposed rule...................... Daily 12 36.1 (18.0-54.1) 36.1 (18.0-54.1)
--------------------------------------------------------------------------------------------------------------------------------------------------------
* For number of plants, FSIS multiplies the percentages from the survey for each category by total number of plants (77). For the category >Daily, in
compliance, the calculation of 77 x 22.8% yields 17.56. This count was rounded down to 17 plants to be consistent with the total number of plants in
the analysis of 77.
Training Costs: Egg products plants that are implementing new
sanitation SOPs and those not in compliance will also need to conduct
initial training for employees. Using data from the 2014 Egg Products
Industry Survey, FSIS estimated the number of plants that will need to
develop new sanitation SOPs (see Table 11) and the average number of
shifts at those plants.\45\ FSIS assumed that one QC Manager per plant,
and one QC Technician and three production employees per shift would be
trained.\46\ FSIS is seeking comment on these assumptions. FSIS assumed
the recurring training would occur for all 77 plants. FSIS used initial
and recurring annual refresher training cost estimates from the Cost of
Food Safety Interventions \47\ final report updated for inflation from
2014 to 2016 dollars and with the assumed benefit factor of two. QC
Managers would be trained initially at a cost of $2,756 ($1,378 to
$4,134) with an annual refresher at a cost of $205.98 ($102.94 to
$308.82). QC Technicians would be trained initially
[[Page 6339]]
at a cost of $2,342.97 (1,171.50 to 3,514.46) with an annual refresher
at a cost of $137 ($68.52 to $205.56). FSIS added an additional
opportunity cost to account for the lost hours when employees are in
training. Production employees would also need to be trained, however,
FSIS assumed that this training would take place on the job and
therefore would impose only opportunity costs.
---------------------------------------------------------------------------
\45\ See Appendix A, Section 3.
\46\ An FSIS expert has also agreed with the Industry Survey and
provided the likely staff needing training at a typical egg products
plant.
\47\ See Footnote 33.
---------------------------------------------------------------------------
FSIS included recurring training costs to account for labor
separation and the need to train new employees. To estimate these
ongoing costs, FSIS used an annual labor turnover rate of 27.9 percent
\48\ and applied that percentage to the initial training costs. The
Sanitation SOP-related training costs due to the rule are displayed in
Table 11.
---------------------------------------------------------------------------
\48\ Annual total separations rate for nondurable goods, Bureau
of Labor Statistics Job Openings and Labor Turnover Survey,
available at: http://www.bls.gov/news.release/jolts.t16.htm.
Table 11--One-Time and Recurring Sanitation SOP Training Costs
[$1000s]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized cost--3% (low Annualized cost--7% (low
Plants Shifts Initial training costs (low Recurring training costs (low estimate-high estimate) over estimate-high estimate) over
estimate-high estimate) estimate-high estimate) 10 years 10 years
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
34.................................................... 59 363.7 (214.7-545.6) 140.3 (79.3-225.2) 181.7 (103.8-287.3) 188.7 (107.9-297.8)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Table 12 presents a summary of the total sanitation SOPs-related
costs due to the rule annualized over 10 years at 3 percent and 7
percent discount rates.
Table 12--Total Sanitation SOPs-Related Industry Costs
[$1000s] *
----------------------------------------------------------------------------------------------------------------
Annualized costs--3% (low Annualized costs--7% (low
Cost component estimate-high estimate) over estimate-high estimate) over
10 years 10 years
----------------------------------------------------------------------------------------------------------------
Plan Development.................................... 21.1 (13.2-23.8) 24.7 (15.4-27.9)
Recordkeeping & Monitoring.......................... 171.0 (97.3-244.8) 171.0 (97.3-244.8)
Training............................................ 181.7 (103.8-287.3) 188.7 (107.9-297.8)
-----------------------------------------------------------
Total........................................... 373.9 (214.2-555.9) 384.5 (220.6-570.5)
----------------------------------------------------------------------------------------------------------------
* Numbers in table may not sum to totals due to rounding.
Special Handling Statements on Labels: The proposed egg products
rule requires ``Keep Refrigerated'' or ``Keep Frozen'' statements for
all egg products that require special handling to maintain their
wholesome condition. Plants currently include this information on egg
products labels; therefore, this new requirement for the industry
should not create additional costs.
Costs from Requiring Egg Products Plants to Produce Egg Products
That are Edible without Additional Preparation to Achieve Food Safety:
The proposed rule requires that egg products plants process egg
products that are edible without additional preparation to achieve food
safety. FSIS does not anticipate that these plants will need to change
their pasteurization practices to meet this requirement and therefore
will not incur additional costs, except as a part of their normal
operations in regards to complying with HACCP plan verification and
monitoring activities. These verification and monitoring activities are
discussed above as part of the HACCP costs of this proposed rule for
recordkeeping and monitoring. FSIS has developed a Compliance Guideline
for Small and Very Small Plants that produce ready-to-eat egg products.
This guidance document is designed to help small and very small plants
meet the proposed regulatory requirements by providing the best
practice recommendations by FSIS, based on the best scientific and
practical considerations. FSIS is seeking comment on this guidance
document, which is posted on the Agency's web page: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index.
Below, the total industry costs are presented:
Table 13--Total Industry Costs
[$1,000] *
----------------------------------------------------------------------------------------------------------------
Annualized costs--3% (low Annualized costs--7% (low
Cost component estimate-high estimate) estimate-high estimate)
----------------------------------------------------------------------------------------------------------------
HACCP............................................... 3,769.7 (1,900.3-5,630.7) 3,784.9 (1908.6-5651.5)
Sanitation SOPs..................................... 373.9 (214.2-555.9) 384.5 (220.6-570.5)
-----------------------------------------------------------
Total........................................... 4,143.6 (2,114.5-6,186.6) 4,169.4 (2,129.2-6,220.0)
----------------------------------------------------------------------------------------------------------------
* Numbers in table may not sum to totals due to rounding.
Agency Costs
Training and Personnel: FSIS employs 95 egg products inspectors
that exclusively inspect egg products plants. Some egg products plant
inspectors already have HACCP training from past inspection experience
in meat and poultry plants. For inspectors without prior experience,
FSIS will need to train them in the HACCP system. The long-term
objective of the Agency is to establish an inspection system where
inspection program personnel would be equally qualified to conduct
inspection
[[Page 6340]]
activities at meat or poultry establishments, and egg product plants.
The Agency anticipates that it will need to train 51 egg products
inspection personnel \49\ and 24 meat or poultry inspectors (non-egg
products inspectors). Fifty-one of these inspectors will require a 4-
week training course on HACCP methods called Inspection Methods
training, and 24 inspectors already trained in HACCP inspection will be
trained in egg product inspection. The inspection methods training for
egg products inspection personnel would be longer than for other plant
personnel because it includes additional topics (e.g., processing and
slaughter inspection in a HACCP environment, rules of practice, and
fundamental food microbiology) that not all egg products plant
personnel need to perform their job. The total costs (including travel,
lodging, per diem, and training program) for the 4-week training
program is approximately $6,000 \50\ per inspector, and the one-week
egg product inspection training is approximately $1,200 per inspector.
Therefore, the one-time Agency training costs total $334,800 (51 x
$6,000) + (24 x $1,200).
---------------------------------------------------------------------------
\49\ FSIS Policy Development Staff (PDS) provided the number of
personnel that will need training. PDS estimated this number by
contacting each district manager in the field where egg products
plants are located.
\50\ This figure is a mean estimate of training costs from FSIS/
OOEET Center for Learning.
---------------------------------------------------------------------------
Replacement inspectors will be required during periods when egg
products plant inspectors are being trained. The Agency's district
offices estimate the cost of replacement inspectors to be $2,800 per
person \51\ for inspection methods training and $700 per person for egg
products inspection training. Consequently, the one-time cost of
replacement inspectors is $159,600 derived from (51 x $2,800) and (24 x
$700). Thus, the total one-time cost of training inspectors at egg
products plants is $494,400. Table 14 provides the summary of the costs
associated with inspector training.
---------------------------------------------------------------------------
\51\ This is the average GSA per diem for meals and hotel
multiplied by the number of days replacement inspectors would be
needed to fill positions. http://www.gsa.gov/portal/content/104877.
Table 14--Inspection Program Training Costs at 3% and 7% Discount Rates Annualized Over 10 Years*
[$1,000]
----------------------------------------------------------------------------------------------------------------
Annualized Annualized
Cost component Number of IPP Cost per IPP One-time cost cost--3% over cost--7% over
10 years 10 years
----------------------------------------------------------------------------------------------------------------
Inspection Methods Training..... 51 6 306 34.8 40.7
Egg Products Inspection Training 24 1.2 28.8 3.3 3.8
Replacement IPP................. 75 .............. 159.6 18.2 21.2
-------------------------------------------------------------------------------
Total....................... .............. .............. 494.4 56.3 65.8
----------------------------------------------------------------------------------------------------------------
* Numbers in table may not sum to totals due to rounding.
Total Costs: Table 15 provides a summary of the estimated total
costs for the industry and Agency. The table includes annualized costs
over 10 years at discount rates of 3 percent and 7 percent.
Table 15--Total Costs
[$1,000] *
----------------------------------------------------------------------------------------------------------------
Annualized costs--3% (low Annualized costs--7% (low
Total costs estimate-high estimate) over estimate-high estimate) over
10 years 10 years
----------------------------------------------------------------------------------------------------------------
Industry:
HACCP........................................... 3,769.7 (1,900.3-5,630.7) 3,784.9 (1,908.6-5,651.5)
Sanitation SOPs................................. 373.9 (214.2-555.9) 384.5 (220.6-570.5)
Agency.......................................... ............................ ............................
IPP Training: 38.1 44.5
Replacement IPP................................. 18.2 21.2
-----------------------------------------------------------
Total....................................... 4,199.9 (2,170.8-6,242.9) 4,235.2 (2,195.0-6,287.8)
----------------------------------------------------------------------------------------------------------------
* Numbers in table may not sum to totals due to rounding.
The total annualized cost to the egg products industry of the
proposal is $0.002 per pound of aggregate egg products ($4,143,600/1.8
billion pounds) at the 3 percent discount rate. The cost of the
proposed rule to the egg products industry is minimal, and we do not
expect the costs from this rule to have impact on consumer prices.
Expected Benefits of the Proposed Rule
The proposed rule will provide firms in the egg products industry
greater flexibility and incentives for innovation. Firms derive
benefits from opportunities to innovate and employ more flexible
production methods over time.\52\ Many egg products plants have already
adopted the HACCP system for egg product processing. One reason for
this adoption is buyers of egg products (further egg processors or
retailers) require the production of egg products to be done under the
HACCP system. In addition, under a HACCP system, egg products plants
can attain quality accreditations such as one by the Safe Quality Food
Institute, which allows egg products plants to access different markets
inaccessible to non-HACCP
[[Page 6341]]
processors. Academic literature (please see next section) has also
shown that an egg products plant's choice to process under a HACCP
system as a management tool can also be internally driven by efficiency
gains.\53\
---------------------------------------------------------------------------
\52\ Coglianese, Cary & David Lazer. 2003. ``Management-Based
Regulation: Prescribing Private Management to Achieve Public
Goals''. Law & Society Review 37.
\53\ Kay Cao, Oswin Maurer, Frank Scrimgeour and Chris Drake.
2004. ``The Economics of HACCP (Hazard Analysis & Critical Control
Point): A Literature Review, Agribusiness Perspectives Papers'',
Paper 64, ISSN 1442-6951.
---------------------------------------------------------------------------
A number of studies in the last few decades have shown important
efficiency gains for food production industries after moving into a
HACCP system. In a study by Nganje and Mazzocco in 2003,\54\ individual
plants in the red meat industry benefited from implementing HACCP by
gaining efficiency in production. In a study by Henson et al. (2000)
\55\ on HACCP adoption in the UK dairy industry, the authors also
report similar benefits such as ``the reduction in wastage, increases
in product shelf life, and decreases in production costs.'' \56\
---------------------------------------------------------------------------
\54\ Nganje W.E. and Mazzocco M.A. 2003. ``The Impact of HACCP
on Factor Demand and Output Supply Elasticities of Red Meat''.
Journal of Agricultural and Resource Economics.
\55\ Henson, S., Holt, G., and Northen, J. (2000). ``Costs and
benefits of implementing HACCP in the UK dairy processing sector''.
In L.J. Unnevehr (Ed.), The economics of HACCP: Costs and benefits
(pp.347-363).
\56\ Kay Cao, Oswin Maurer, Frank Scrimgeour, and Chris Drake,
The Economics of HACCP (Hazard Analysis & Critical Control Point): A
Literature Review, Agribusiness Perspectives Papers 2004, Paper 64,
ISSN 1442-6951
---------------------------------------------------------------------------
HACCP systems also enable firms that purchase egg products plant
products to reduce costs of raw materials inspection, specification,
and inventory.\57\ Given the efficiency gains in different food
production facilities under FSIS jurisdiction by implementing HACCP,
FSIS reasonably expects that the egg products industry will gain some
efficiency from HACCP implementation.
---------------------------------------------------------------------------
\57\ Kay Cao, Oswin Maurer, Frank Scrimgeour and Chris Drake,
The Economics of HACCP (Hazard Analysis & Critical Control Point): A
Literature Review, Agribusiness Perspectives Papers 2004, Paper 64,
ISSN 1442-6951
---------------------------------------------------------------------------
Benefits from removing current regulations: A large benefit from
moving away from the current regulatory framework is the lessening of
administrative burdens on plants and plant personnel. With the movement
to a HACCP-based system, IPP will change how they inspect egg products
plants by ensuring that plants' HACCP systems are functioning as
intended rather than inspecting for compliance with current
specifications. This change in how inspection is done will allow for
improved allocation of resources to more food- safety tasks and
sanitary verifications both for the Agency and for egg products plants.
It also allows egg product plants to employ resources in a manner that
more efficiently produces safe product instead of allocating resources
just to comply with FSIS regulations. For instance, instead of sampling
product for time and temperature, a plant can design a system in which
its HACCP plan specifies sampling products at a more convenient time in
the process, allowing for better personnel resource management to
improve production efficiency.
Another aspect of the reduced administrative burden is a reduced
need for FSIS approval for changes to plant operations that deviate
from current regulations. For example, official plants will no longer
need to submit facility blueprints and specifications (plant changes)
to the Agency when applying for a grant of inspection, nor will they
need to obtain prior approval from FSIS for equipment and utensils
proposed for use in preparing edible product or product ingredients.
The approval process for a waiver to a regulation or for no objection
to production changes will also be eliminated if this proposed rule is
adopted. These changes provide cost savings to industry and the Agency
and are quantified below. It takes industry on average 100 hours to
make an industry submission as described above (waiver, plant
blueprint, no objection, or equipment use), including additional
correspondence with FSIS. The Agency spends an average of 69 hours to
review and approve each submission. FSIS is seeking comment on its
estimates of the time it takes industry to develop a submission and to
respond to FSIS requests in connection with the submission.
FSIS receives on average nine submissions per year from egg
products plants. The submission process involves an egg products
plant's QC technician providing the initial submission data and follow-
up correspondence with Agency personnel. This follow-up correspondence
includes responding to FSIS questions with supporting data. The QC
technician is paid an hourly wage of $68.52 per hour, which includes a
benefit rate of two.\58\ An Agency reviewer would have a General
Schedule 13 salary, step 3, at $94.20 per hour, which includes a
benefit factor of two.\59\ Eliminating these two submission processes
will save industry approximately $61,600 annually discounted over 10
years at the 7 percent rate. The Agency would save approximately
$58,498 annually discounted over 10 years at the 7 percent rate.
---------------------------------------------------------------------------
\58\ Estimates obtained from the Bureau of Labor Statistics May
2016 National Industry-Specific Occupational Employment and Wage
Estimates, for Management Occupations (Occupational Code 11-0000),
https://www.bls.gov/oes/current/oes113051.htm#ind, Food Scientists
and Technologists (19-1012), https://www.bls.gov/oes/current/oes191012.htm, and Production Occupations (51-0000) https://www.bls.gov/oes/current/oes513023.htm.
\59\ Hourly rate, Washington, DC, Office of Personel Management
https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2016/DCB_h.pdf.
Table 16--Industry and Agency Savings From the Elimination of Agency
Approval for Plant And Product Processing Changes
[$1,000s] *
------------------------------------------------------------------------
Annualized Annualized
Total savings savings--3% savings--7%
over 10 years over 10 years
------------------------------------------------------------------------
Industry................................ 61.6 61.6
Agency.................................. 58.5 58.5
Total................................. 120.1 120.1
------------------------------------------------------------------------
* Numbers in table may not sum to totals due to rounding.
The HACCP plan provision of the proposed rule will also give plants
flexibility to design their pasteurization and sampling procedures.
Ninety three percent of egg products plants have indicated that their
plants conduct microbiological testing in addition to those required by
regulation.\60\ By giving plants the option to sample as determined in
their HACCP plan, there may be a cost savings from sampling less. The
proposed rule specifies that the final product must be produced to be
edible without additional preparation to achieve food safety. This
standard provides flexibility to an egg products plant by giving it the
necessary end result of pathogen-free products without specifying
direct instructions on the processing method. This allows plants to
find the most efficient processing or sampling methods to best fit
their own production process and resources to produce a pathogen-free
product.
---------------------------------------------------------------------------
\60\ RTI International. 2014. ``Survey of Egg Packing and Egg
Products Processing Plants.'' Revised Final Report. RTI Project no.
0211740.015.001. 3040 Cornwallis Rd., P.O. Box 12194 Research
Triangle Park, NC 27709-2194.
---------------------------------------------------------------------------
Additional Benefits from Generic Labeling: Additional benefits
include cost reductions for the Agency and for the egg products plants
that submit labels for changes to an existing label or for new label
approvals. Currently, an egg products plant must submit a formal
application along with a sketch of a product label to FSIS personnel
for approval, regardless of the change (including a color or size
change to a label). If the proposed rule is finalized,
[[Page 6342]]
the approval process for certain labels will be streamlined, allowing
egg products plants to use certain labels without submitting an
application to FSIS because the labels will be generically
approvable.\61\ Labels that will not qualify for generic approval
include temporary approvals, labels for export only that bear labeling
deviations, or labels bearing special statements and claims. All other
label types can be generically approved. Presently, many egg products
plants use special claims on their labels (e.g., organic or free range)
and so those labels would not qualify for generic approval. The Agency
estimates that approximately 80 percent of labels have prior approval
for these claims.\62\ If these prior approved producers make other
changes to the labels not involving their pre-approved claims, they
could qualify for generic labeling.
---------------------------------------------------------------------------
\61\ As required by 9 CFR 412, the Labeling and Program Delivery
Staff (LPDS) evaluates certain sketch applications and all temporary
applications for meat and poultry products. All other meat and
poultry product label applications may be generically approved
without evaluation by LPDS.
\62\ This was an approximation made by a label reviewer in the
FSIS labeling group.
---------------------------------------------------------------------------
The number of egg products labels submitted in 2015 was
approximately 520, and in 2016, the number rose to 708 labels. FSIS
estimates that approximately 50 percent of these new labels would
qualify for generic label approval each year. Generic approval would
reduce the recordkeeping burden at the plant and Agency by about half
the current levels. In order to estimate cost savings through the
generic labeling process, the number of future label submissions was
estimated based on the annual historic increase in submissions. Using
the industry cost savings of $25.00 per label from the prior label
approval system: Generic Label Approval final rule,\63\ the proposed
generic label approval process for egg products could save industry
approximately $16,000 annually, discounted over 10 years at the 7
percent rate, from not submitting labels. The Agency would save
approximately $61,000 annually, given that on average the review
process takes approximately one hour, and a reviewer would have a
General Schedule 13 salary, step 3 with a benefit factor of two,\64\
having a total compensation of $94.20.
---------------------------------------------------------------------------
\63\ 78 FR 66826.
\64\ Estimates obtained from the Bureau of Labor Statistics May
2016 National Industry-Specific Occupational Employment and Wage
Estimates, for Management Occupations (Occupational Code 11-0000),
https://www.bls.gov/oes/current/oes113051.htm#ind, Food Scientists
and Technologists (19-1012), https://www.bls.gov/oes/current/oes191012.htm, and Production Occupations (51-0000) https://www.bls.gov/oes/current/oes513023.htm.
Table 17--Savings From Generic Labeling
[$1,000s] *
------------------------------------------------------------------------
Annualized Annualized
Total savings savings--3% savings--7%
over 10 years over 10 years
------------------------------------------------------------------------
Industry................................ 16 16
Agency.................................. 60.6 60.4
Total................................. 76.7 76.4
------------------------------------------------------------------------
* Numbers in table may not sum to totals due to rounding.
Better Agency Resource Coverage: Because all egg products plant
inspectors will now be trained in HACCP and can staff FSIS-regulated
establishments other than egg products plants, the Agency will
experience an improvement in inspection coverage. In the egg products
plants themselves, the Agency can also utilize HACCP trained inspectors
as relief inspectors. Currently, egg products inspectors can only work
in egg products plants.
Change in Inspector Coverage: Under the proposed rule, FSIS
inspectors would no longer provide inspection during all processing
operations at each egg products plant, but instead may be provided once
per shift. Therefore, under the proposal, inspectors may inspect
several plants within a reasonable commuting distance (i.e., patrol
assignments similar to meat and poultry processing inspection). The
Agency expects there to be salary savings associated with patrol
assignments through a 3-year change in staffing. The Agency expects to
reduce the number of egg products inspectors by 10 inspectors in year
1, 10 inspectors in year 2, and 10 inspectors in year 3, for a total
reduction of 30 egg products inspectors through attrition and movement
of inspectors to other positions in the Agency.
In addition to Agency savings, there would be cost savings to
industry because there would be a reduction in egg products inspector
overtime and holiday hours, which industry pays for, due to patrol
assignments.
The Agency will incur costs for the additional travel inspectors
will incur on patrol assignments, and the loss of overhead industry
paid to the Agency for overtime and holiday hours worked. Agency travel
costs include mileage increases for existing patrol assignments and GSA
cars for new patrol assignments. Please see table 18 for a summary of
total savings from the proposed changes in inspection coverage.
Table 18--Total Net Savings From Changes in Egg Products Inspection
[$1,000] *
----------------------------------------------------------------------------------------------------------------
Annualized estimate--3% over Annualized estimate--7% over
Agency 10 years 10 years
----------------------------------------------------------------------------------------------------------------
Costs:
Changes in inspection coverage.............. 1,421 1,421
Savings:
Reduction in salaries due to changes in (2,046) (2,005)
inspection coverage........................
---------------------------------------------------------------
Agency Net Budget Impact................ (625) (548)
----------------------------------------------------------------------------------------------------------------
Industry
----------------------------------------------------------------------------------------------------------------
Savings:
Elimination of inspection payments for (4,803) (4,803)
overtime and holidays......................
---------------------------------------------------------------
Grand Total Net Savings................. (5,428) (5,388)
----------------------------------------------------------------------------------------------------------------
* Numbers in table may not sum to total due to rounding.
[[Page 6343]]
In summary, the benefits from this proposed rule include
improvements in product quality, lower transaction costs, plant
innovation, and generally lower operational costs. Additionally, the
egg products plants will not have to comply with the current ``command
and control'' regulations. By eliminating regulations, administrative
burdens will be lessened, including those associated with submitting
documentation to FSIS for changes to the plant and plant processes,
waivers, and most egg products labels, resulting in cost savings.
Industry will also benefit from the reduction in overtime and holiday
pay paid for the inspection of egg products plants. Table 19 summarizes
the quantified costs and cost savings to industry and the Agency if the
proposed rule is implemented. The rule provides a net cost savings of
between $1.3 million and $1.4 million annualized over 10 years at the 7
percent and 3 percent rates.
Table 19--Total Costs and Net Benefits
[$1,000s] *
----------------------------------------------------------------------------------------------------------------
Annualized 3% mid estimate Annualized 7% mid estimate
Costs (low estimate-high estimate) (low estimate-high estimate)
over 10 years over 10 years
----------------------------------------------------------------------------------------------------------------
Industry:
HACCP....................................... 3,769.7 (1,900.3-5,630.7) 3,784.9 (1,908.6-5,651.5)
Sanitation SOPs............................. 373.9 (214.2-555.9) 384.5 (220.6-570.5)
Agency:
IPP Training................................ 38.1 44.5
Replacement IPP............................. 18.2 21.2
---------------------------------------------------------------
Total Costs............................. 4,199.9 (2,170.8 to 6,242.9) 4,235.2 (2,195.0 to 6,287.8)
----------------------------------------------------------------------------------------------------------------
Savings
----------------------------------------------------------------------------------------------------------------
Industry:
Reduced Plant Approval Processes............ -61.6 -61.6
Generic Labeling............................ -16 -16
Changes in inspection coverage.............. -4,803 -4,803
Agency:
Reduced Plant Approval Processes............ -58.5 -58.5
Generic Labeling............................ -60.6 -60.4
Changes in inspection coverage.................. -625 -585
---------------------------------------------------------------
Total Savings............................... -5,625 -5,585
---------------------------------------------------------------
Grand Total Net Benefits Mid (low to 1,424.8 (-618.2 to 3,453.9) 1,349.5 (-703.1 to 3,389.7)
high) savings minus costs..............
----------------------------------------------------------------------------------------------------------------
* Numbers in table may not sum to totals due to rounding.
Uncertainty Surrounding Public Health Impacts: Currently, the
regulations require specific times and temperatures for egg products
pasteurization. If a plant wishes to employ an alternative time and
temperature combination, the Agency reviews scientific research or data
validating other methods of pasteurization (9 CFR 590.570(b)) and
issues a ``No Objection'' letters (NOL) approving its use. The proposed
rule will eliminate the codified time and temperature regulations and
will require egg products plants to process egg products in a way that
will ensure that the products are free of detectable pathogens. Due to
a lack of data, FSIS is currently unable to compare food safety
performance in egg products plants operating under the current
regulations to those plants operating in a HACCP system under NOLs with
differing pasteurization times and temperatures from those prescribed
in the current regulations.
Under HACCP, an egg products plant would be required to conduct a
hazard analysis to identify and list the biological, chemical, or
physical food safety hazards that are reasonably likely to occur in its
production process for a particular product and the measures to
prevent, eliminate, or reduce the occurrence of those hazards to an
acceptable level. The plant would also be required to identify the
points in each of its processes at which control is necessary to
achieve this goal (9 CFR 417.2(c)(2)). These points are called
``critical control points'' (CCPs). The plant would have to establish
critical limits for the preventive measures associated with each
identified CCP. Plants would also be required to validate that their
process works as intended (9 CFR 417.4). The HACCP and Sanitation SOP
framework will make FSIS inspection more efficient and effective,
because the egg products plant would be required to prevent food safety
problems rather than react to problems without preventing recurrence.
FSIS has developed a Compliance Guideline for Small and Very Small
Plants that produce ready-to-eat egg products. This document updates
the current time and temperature regulations based on the best
available scientific information.\65\ It provides ``safe harbors'' for
egg products plants that FSIS considers as recognized procedures that
can be employed without any further validation studies. However, the
plant would need to validate that it is properly applying the FSIS time
and temperature combinations provided in the guidance material and
conduct monitoring and
[[Page 6344]]
verification activities in the plant's operating environment.
---------------------------------------------------------------------------
\65\ Gurtler, J.B., Marks, H.M., Bailey, R.B, Juneja, V. and
Jones, D.R. 2013. Kinetics Model Comparison for the inactivation of
Salmonella Enteritidis and Oranienburg in 10% salted liquid whole
egg. Foodborne Pathogens and Disease. 10:492-499.
Gurtler, J.B., Marks, H.M., Jones, D.R, Bailey, R.B, and Bauer,
N.E. 2011. Modeling the thermal inactivation kinetics of heat-
resistant Salmonella Enteritidis and Oranienburg in 10 percent
salted liquid egg yolk. J. Food Prot. 74:882-892.
Jordan, S.S., Gurtler, J.B., Marks, H.M., Jones, D.R. and Shaw,
W.K. 2011. A mathematical model of inactivation kinetics for a four-
strain composite of Salmonella Enteritidis and Oranienburg in
commercial liquid egg yolk. Food Micro. 28:67-75.
---------------------------------------------------------------------------
FSIS will continue to test egg products for Salmonella and Lm. If
FSIS detects pathogens in the product, plants that have identified the
pathogen as reasonably likely to occur in the HACCP hazard analysis
will be required to take corrective actions to ensure that they
identify problems that led to production of contaminated product,
ensure no adulterated product is in commerce, and take measures to
prevent recurrence. Plants that have not identified the pathogen as
reasonably likely to occur would need to take corrective actions and
reassess their HACCP plans in accordance with 9 CFR 417.3(b).
Currently, when FSIS detects positives in egg products plants, the
Agency response is limited to preventing the product from which the
sample was collected from entering commerce or requesting that the
producer recall its products. FSIS inspectors currently repeatedly
issue noncompliance reports at egg products plants with limited
improvements in operations. Therefore, it is possible that the HACCP
regulations will improve the operations of egg products plants.
Alternative Regulatory Approaches
The Agency considered two alternatives designed to achieve the
regulatory objective outlined in the Need for the Rule section.
However, this proposed rule was chosen as the least burdensome,
technically acceptable regulatory approach.
Voluntary HACCP regulatory program: A voluntary HACCP system would
be very close to the current system. In the current system, 93 percent
of egg products plants already have implemented HACCP systems
integrated into their processing. Because many plants have already
changed to a HACCP system, the Agency does not foresee any non-HACCP
operations voluntarily implementing HACCP that have not already done
so. These plants would stay at status quo. Therefore, this regulatory
option would not lead to a significant change in current egg products
plants processing practices. However, there would be additional costs,
such as inspector HACCP training and the costs of inspecting a dual
system. Also, under the current regulations, continuous inspection
prevents inspectors from working patrol assignments, which would save
industry overtime costs and Agency resources. These savings would not
be fully realized in a dual system. For the plants not operating under
HACCP, there are possible consumer benefit losses as some plants may
fail to innovate and might continue to comply with current regulation,
passing production costs on to consumers. Therefore, FSIS rejected this
alternative.
HACCP for large volume egg products plants: In this alternative,
only plants with a large production volume would be required to
implement HACCP. This alternative would save Agency HACCP training
costs for inspection personnel, who inspect small production plants.
Small volume plants would be allowed to stay in a non-HACCP system,
lowering industry costs. This alternative would need to have certain
volume definitions to distinguish the type of plant considered in the
alternative. A difficulty associated with the size definition process
is that an egg products plant's volume may change depending on the
season or from changes in its source eggs. These changes could affect
the classification system, which is based on volume, and could create
difficulties in identifying the plants most likely to be designated as
large volume. Another drawback to this alternative is the possible
costs to the small producer in the long run. Although the low-
production egg products plants may save initially on costs by not
implementing HACCP, this alternative may hurt the plants' long-run
efficiencies and competiveness because they would not be gaining the
flexibility to innovate that they would by producing under the HACCP
system.
Table 20--Regulatory Alternatives Considered
------------------------------------------------------------------------
Alternative Costs Benefits
------------------------------------------------------------------------
(1) Existing Voluntary Additional costs No additional
Recordkeeping. for the Agency. benefits.
(2) HACCP only for large In the long run, Small volume
volume egg products plants. small plants producers would save
would incur more on costs from not
costs from the having to change
lack of their production
efficiency gains process and develop
associated with the requisite
HACCP. Sanitation SOP and
HACCP plans. Large
volume producers
would acquire
benefits from
implementing HACCP.
(3) The Proposed Rule......... ($1.34 million Achievement of
\66\) annual regulatory objective
cost savings to of regulations
industry and to consistent with
the Agency. other FSIS
regulations, clear
responsibility of
Agency vs. industry,
and additional
flexibility for
industry.
------------------------------------------------------------------------
Initial Regulatory Flexibility Analysis: The FSIS Administrator has
made a preliminary determination that this proposed rule would not have
a significant economic impact on a substantial number of small entities
in the United States, as defined by the Regulatory Flexibility Act (5
U.S.C. 601 et seq.).
---------------------------------------------------------------------------
\66\ This cost is annualized at the 7 percent discount rate over
10 years.
---------------------------------------------------------------------------
There are 77 federally-inspected plants. We estimate that at least
12 are large businesses or companies with multiple egg products
plants.\67\ We estimate that approximately 46 plants are part of these
larger companies, leaving 31 plants that could be considered small
businesses. In the cost analysis above, FSIS estimated that the cost
savings for the industry is approximately 733 thousand (7 percent, 10
years).
---------------------------------------------------------------------------
\67\ These figures differ from the number of plants in HACCP
size categories for small and large as mentioned earlier in the
document, because the sizes are derived from the HACCP size rather
than a business size. In this section, FSIS does not need HACCP
sizes for egg products plants for the Regulatory Flexibility
Analysis. Instead, FSIS must analyze egg products company or firm
sizes instead of an egg products establishment sizes. The HACCP size
of an establishment alone is not enough to verify whether it's part
of a larger business. To determine whether a business is small, FSIS
analyzed whether egg products establishments were part of larger
companies.
---------------------------------------------------------------------------
This results in an average cost savings to a plant of ($9,200/
plant) annualized (7 percent, 10 years). The average revenue for egg
products plants is approximately $104.4 million.\68\ Therefore, FSIS
believes that the total cost savings to revenue ratio per plant is .01
percent. FSIS is seeking public comment on its conclusion of no
significant impact on small entities.
[[Page 6345]]
FSIS has developed a Compliance Guideline for Small and Very Small
Plants that produce ready-to-eat egg products. This guidance document
is designed to help small and very small plants meet the proposed
regulatory requirements by providing the best practice recommendations
by FSIS, based on the best scientific and practical considerations.
FSIS is seeking comment on this guidance document, which is posted on
the Agency's web page: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index.
---------------------------------------------------------------------------
\68\ Derived from the RTI Industry Survey, Q.5.11, the weighted
average of the midpoints of the respondents' answers to the level of
annual revenue earned in the year prior to the survey. Q.5.11 What
was the approximate value of egg product sales during the past year?
---------------------------------------------------------------------------
Appendix A to Executive Orders 12866 and 13563 and the Regulatory
Flexibility Act Analysis \69\
---------------------------------------------------------------------------
\69\ This Appendix describes how the Agency used the 2014 Egg
Products Industry Survey conducted and published by RTI
International to gather information on egg products plants relating
to the cost section of this proposed rule. Specifically, this
Appendix outlines how the survey questions were used to estimate the
number of egg products plants that have Sanitation SOPs, HACCP
plans, training, number of shifts, and record keeping.
Section (1) describes egg products plants' use of Sanitation
SOPs. Section (2) outlines the estimates for egg product plants'
recordkeeping for Sanitation SOPs. Section (3) describes egg
products plants' training for Sanitation SOPs. Section (4) describes
the type of product produced by egg products plants and their use of
HACCP plans. Section (5) describes the number of egg products plants
with HACCP plans. Section (6) estimates the average number of shifts
for egg products plants without HACCP plans.
---------------------------------------------------------------------------
The 2014 Egg Products Industry Survey, conducted and published by
RTI International, surveyed approximately 57 egg products plants with
questions in regard to plants' use of HACCP plans, Sanitation SOPs, the
number of plant personnel, hours of operation and the number of shifts,
and current sampling practices. The survey design involved
collaboration between FSIS personnel and RTI International. The full-
scale data collection took place over a 16-week period from February
17, 2014, to June 9, 2014. The survey included 18 questions. The survey
also provided information on production volume, types of product, and
production processes. The survey was considered to be a census of the
industry because all 77 egg products plants currently regulated by FSIS
were contacted and asked to respond. The response rate to the survey
was 72 percent. Fifty seven egg products plants completed the survey.
Of these, 26 (46 percent) completed the survey via mail and 31 (54
percent) completed the Web survey. FSIS used the survey results to
supplement the information that FSIS maintains in the Public Health
Information System. The responses to the survey were masked so that
individual plants could not be identified, so FSIS applied response
distributions to the larger population of egg products plants to
approximate baseline industry characteristics. In order to describe the
egg products plants, which are under FSIS's jurisdiction, brief
discussions of the major findings of the survey have been placed
throughout this Executive Order 12866 and 13563 discussion and the
regulatory flexibility analysis and footnoted accordingly. Please find
the link to the survey here: http://www.fsis.usda.gov/wps/wcm/connect/df3e0400-aaa7-423f-bb11-ff080fc8ce2b/Survey-Egg-Products-09302014.pdf?MOD=AJPERES.
Section 1 Sanitation SOPs
FSIS estimated the percentage of plants that train production
employees for Sanitation SOPs using question 4.5: During the past year,
what types of food safety training did permanent employees of this
plant receive? A plant was considered to train production employees if
it responded affirmatively to choice b. Sanitation SOPs. 91.2 percent
of respondents answered that employees receive Sanitation SOPs
training.
Section 2 Recordkeeping for Sanitation SOPs
FSIS estimated the percentage of plants that currently meet the
proposed recordkeeping requirements using survey question 2.2: ``Which
of the following records that are not required by FSIS does this plant
maintain?'' A plant was considered to meet both if it answered
affirmatively to choices 1--``Employee task performance log
verification'' and 2--``Deviation and corrective action log.''
FSIS then determined the frequency at which sanitation tasks are
performed using question 2.6: ``How frequently does this plant conduct
sanitation inspections of product contact zones?'' If a plant responded
affirmatively to choice 1--``More than once per shift,'' it was
considered to be conducting sanitation tasks at a frequency greater
than daily. If it responded affirmatively to choice 2--``Once per shift
before shift operations begin,'' and operates more than one shift daily
(determined with question 5.2), then it was also considered to be
conducting sanitation tasks at a frequency greater than daily. If it
responded affirmatively to choice 2 and operates a single shift per
day, or if it responded affirmatively to choice 3--``Once per day
before daily operations begin,'' it was considered to be conducting
sanitation tasks at a daily frequency. If it answered affirmatively to
any other option, it was considered to conduct sanitation tasks less
than daily.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Records in compliance Records not in compliance
--------------------------------------------------------------------------------------------------------------------------------------------------------
Daily Daily
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.8%............................................................... 33.3% 22.8% 3.5% 15.8% 15.8%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 3 Training for Sanitation SOPs
FSIS used the training estimates from Section 1 and assumed that
any plant which did not provide training for Sanitation SOPs did not
have a written plan. Then, FSIS estimated the number of shifts of
employees needing training for Sanitation SOPs by averaging the
reported number of shifts from question 5.2--``How many production
shifts are operated each day at this plant?'' Only those plants that do
not provide HACCP training were included in the average.
----------------------------------------------------------------------------------------------------------------
No sanitation Needed
Plants SOPs training sanitation SOPs Average sifts Total shifts
----------------------------------------------------------------------------------------------------------------
77.......................................... 8.8% 7 1.7 8
----------------------------------------------------------------------------------------------------------------
[[Page 6346]]
Section 4 Use of HACCP Plans
To determine the percentage of plants which have written HACCP
plans in place for their respective processes, FSIS used the survey to
first determine which respondents produced products corresponding to
the three main processes.
For breaking, FSIS considered all plants that responded to question
1.1: ``Which statement below describes how this plant receives egg
inputs?'' and answered affirmatively to choice 1--This plant receives
shell eggs only''--or to choice 2--This plant receives both shell eggs
and liquid or dried eggs.''
For dried eggs, FSIS considered all plants that responded to
question 1.11: ``Does this plant produce this egg product form?'' and
answered affirmatively to choice e--``Dried''--or to choice f--
``Blended and dried.''
For liquid eggs, FSIS considered all plants that which responded to
question 1.11: ``Does this plant produce this egg product form?'' and
answered affirmatively to choice a--``Liquid''; to choice b--``Blended
and liquid''; to choice c--``frozen''; to choice d--``Blended and
frozen''; or g--``Extended shelf life liquid''.
Next, for each process, FSIS determined if the respondent had a
written HACCP plan using question 2.1: ``What production steps are used
by this plant, and if used, is the step addressed in a written plan?''
Specifically, FSIS considered the plan acceptable if the plant
responded affirmatively to option 3--``Used and Addressed in a Written
HACCP Plan'' for option j--``Breaking shell eggs''; option m--``Drying
egg products''; or option n--``Pasteurizing dried egg whites''; and
option l--``Pasteurizing liquid eggs for breaking, dried, and liquid
processes, respectively.''
------------------------------------------------------------------------
Breaking w/ HACCP Dried w/ HACCP Liquid w/ HACCP
------------------------------------------------------------------------
84.6%................................. 80.0% 76.5%
------------------------------------------------------------------------
Finally, FSIS applied these percentages to PHIS egg products plants
production data (see Table below) to estimate the number of processes
currently operating without HACCP plans.
----------------------------------------------------------------------------------------------------------------
Plants Breaking Dried Liquid Total processes
----------------------------------------------------------------------------------------------------------------
77.......................................... 56 17 52 125
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Total processes
Breaking w/o HACCP Dried w/o HACCP Liquid w/o operating w/o
HACCP HACCP
----------------------------------------------------------------------------------------------------------------
9............................................................ 3 12 24
----------------------------------------------------------------------------------------------------------------
Section 5 Plants With HACCP Plans
FSIS used the results to question 2.1: ``What production steps are
used by this plant, and if used, is the step addressed in a written
plan?'' to determine the percentage of plants with no HACCP plans.
Specifically, a plant was considered to have no HACCP plans if it did
not respond with option 3--``Used and Addressed in a Written HACCP Plan
for any of the following: j. Breaking shell eggs, l. Pasteurizing
liquid eggs, m. Drying egg products, or n. Pasteurizing dried egg
whites.''
------------------------------------------------------------------------
Number of plants
Percent with no HACCP (approximate)
with no HACCP
------------------------------------------------------------------------
7.%................................................... 5 *
------------------------------------------------------------------------
* The number of plants was rounded down.
Section 6 Shifts for Plants Without HACCP Plans
To estimate the number of shifts at plants without any HACCP
systems in place, FSIS averaged the responses to question 5.2: ``How
many production shifts are operated each day at this plant?'' for those
respondents determined to not have HACCP plans as described in Section
5. This average (1.7 shifts) was then applied to the total number of
plants estimated to be without HACCP systems.
Executive Order 13771
This proposed rule, if finalized as proposed, is expected to be an
E.O. 13771 deregulatory action. We have estimated that this proposed
rule would yield cost savings. Assuming a 7 percent discount rate and a
perpetual time horizon and a starting year of 2018, the proposed rule
would yield approximately $1.29 million (2016$) in annualized cost
savings. Assessment of the specific costs and cost savings may be found
in the preceding economic analysis.
IV. Paperwork Reduction Act
FSIS has reviewed the paperwork and recordkeeping requirements in
this proposed rule in accordance with the Paperwork Reduction Act (44
U.S.C. 3501, et seq.) and has determined that the paperwork
requirements constitute new information collections.
Title: Egg Products Hazard Analysis and Critical Control Point
(HACCP) Systems and Sanitation Standard Operating Procedures (SOPs).
Type of Collection: New.
Abstract: Under this proposed rule, FSIS is requiring official
plants to develop and maintain HACCP and Sanitation SOP records and
plans, as well as various transaction records. The egg products
industry's documentation of its processes, first in a plan and
thereafter in a continuous record of process performance, will be a
more effective food safety approach than the sporadic generating of
information by inspection program personnel. This documentation gives
inspection program personnel a much broader picture of production than
they can generate and provides them additional time to perform higher
priority tasks. At the same time, it gives plant managers a better view
of their own process and more opportunity to adjust it to prevent
safety defects.
Sanitation SOPs
To meet the proposed regulation's sanitation requirements, each
processor will develop and maintain a Sanitation SOP. The Sanitation
SOP would specify the cleaning and sanitizing procedures for all
equipment and facilities involved in the production of every product.
As part of the Sanitation SOP, a plant employee will record results of
daily sanitation checks at the frequencies stated in the Sanitation
SOP.
The burden of documenting the adherence to Sanitation SOPs is based
on three factors: Recording, reviewing, and storage. Recording
encompasses conducting and inscribing the finding
[[Page 6347]]
from an observation and filing of the document produced.
HACCP
Under this proposal, the requirements for the implementation of
HACCP in official plants will be the same as those being met by meat
and poultry products establishments operating under HACCP. The plant
will maintain on file the name and a brief resume of the HACCP-trained
individuals who participate in the hazard analysis and subsequent
development of the HACCP plans. Plants will develop written HACCP plans
that include: Identification of hazards reasonably likely to occur in
the production process; identification and description of the CCP for
each identified hazard; specification of the critical limit which may
not be exceeded at the CCP, and, if appropriate, a target limit;
description of the monitoring procedure or device to be used;
description of the corrective action to be taken if the limit is
exceeded; description of the records which would be generated and
maintained regarding this CCP; and description of the facility
verification activities and the frequency at which they are to be
conducted. Critical limits that are currently a part of FSIS
regulations must be included. The adequacy of a plant's HACCP plan must
be reassessed at least annually and whenever changes occur that could
affect the hazard analysis or alter the HACCP plan.
The HACCP records should be reviewed by a plant employee other than
the one whom produced the record, before the product is distributed in
commerce. If a HACCP-trained individual is on-site, that person should
be the reviewer. The reviewer would sign the records. Lastly, HACCP
records generated by the processor would be retained on site for at
least 1 year.
Labeling
Under this proposal, official plants will be authorized to use
generically approved labels without specific evaluation by LPDS. In
addition, frozen and refrigerated egg products will be required to bear
labels that say, ``Keep Frozen'' or ``Keep Refrigerated.'' Plants
already use special handling statements, when appropriate, under
general Agency policy governing special handling statements. Therefore,
the Agency has already accounted for the labeling paperwork burden.
Estimate of Burden: FSIS estimates that each respondent will spend
927.58 hours per year on this information collection.
Respondents: Official egg products plants.
Estimated Number of Respondents: 77.
Estimated Number of Responses per Respondent: 927.58.
Estimated Total Annual Burden on Respondents: 71,424 hours.
Copies of this information collection assessment can be obtained
from Gina Kouba, Paperwork Reduction Act Coordinator, Food Safety and
Inspection Service, USDA, Room 6065-S, South Agriculture Building, 1400
Independence Avenue SW, Washington, DC 20250; (202) 720-5627.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of FSIS's
functions, including whether the information will have practical
utility; (b) the accuracy of FSIS's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; ways to
minimize the burden of the collection of information on those who are
to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques,
or other forms of information technology. Comments may be sent to both
Gina Kouba, Paperwork Reduction Act Coordinator, at the address
provided above, and the Desk Officer for Agriculture, Office of
Information and Regulatory Affairs, Office of Management and Budget,
Washington, DC 20253.
All responses to this notice will be summarized and included in the
request for OMB approval. All comments will also become a matter of
public record.
V. Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. Under this rule: (1) All State and local laws and
regulations that are inconsistent with this rule will be preempted; (2)
no retroactive effect will be given to this rule; and (3) no
administrative proceedings will be required before parties may file
suit in court challenging this rule.
VI. E-Government Act Compliance
FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et seq.) by, among other things,
promoting the use of the internet and other information technologies
and providing increased opportunities for citizen access to government
information and services, and for other purposes.
VII. Executive Order 13175
This rule has been reviewed in accordance with the requirements of
Executive Order 13175, ``Consultation and Coordination with Indian
Tribal Governments.'' E.O. 13175 requires Federal agencies to consult
and coordinate with tribes on a government-to-government basis on
policies that have tribal implications, including regulations,
legislative comments or proposed legislation, and other policy
statements or actions that have substantial direct effects on one or
more Indian tribes, on the relationship between the Federal Government
and Indian tribes or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.
FSIS has assessed the impact of this rule on Indian tribes and
determined that this rule does not, to our knowledge, have tribal
implications that require tribal consultation under E.O. 13175. If a
Tribe requests consultation, the Food Safety and Inspection Service
will work with the Office of Tribal Relations to ensure meaningful
consultation is provided where changes, additions and modifications
identified herein are not expressly mandated by Congress.
VIII. USDA Nondiscrimination Statement
No agency, officer, or employee of the USDA shall, on the grounds
of race, color, national origin, religion, sex, gender identity, sexual
orientation, disability, age, marital status, family/parental status,
income derived from a public assistance program, or political beliefs,
exclude from participation in, deny the benefits of, or subject to
discrimination any person in the United States under any program or
activity conducted by the USDA.
How To File a Complaint of Discrimination
To file a complaint of discrimination, complete the USDA Program
Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your
authorized representative.
Send your completed complaint form or letter to USDA by mail, fax,
or email:
Mail: U.S. Department of Agriculture, Director, Office of
Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410.
Fax: (202) 690-7442.
IX. Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, FSIS will
[[Page 6348]]
announce this Federal Register publication on-line through the FSIS web
page located at: http://www.fsis.usda.gov/federal-register.
FSIS also will make copies of this publication available through
the FSIS Constituent Update, which is used to provide information
regarding FSIS policies, procedures, regulations, Federal Register
notices, FSIS public meetings, and other types of information that
could affect or would be of interest to our constituents and
stakeholders. The Update is available on the FSIS web page. Through the
web page, FSIS is able to provide information to a much broader, more
diverse audience. In addition, FSIS offers an email subscription
service which provides automatic and customized access to selected food
safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export
information, regulations, directives, and notices. Customers can add or
delete subscriptions themselves, and have the option to password
protect their accounts.
List of Subjects
9 CFR Part 416
Meat inspection, Poultry and poultry products, Sanitation.
9 CFR Part 417
Meat inspection, Poultry and poultry products, Record and
recordkeeping requirements, Hazard Analysis and Critical Control Point
(HACCP) Systems.
9 CFR Part 500
Administrative practice and procedure, Meat inspection, Poultry and
poultry products, Rules of practice.
9 CFR Part 590
Eggs and egg products, Exports, Food grades and standards, Food
labeling, Imports, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, FSIS proposes to amend 9
CFR chapter III as follows:
0
1. Revise the heading of subchapter E to read as follows:
SUBCHAPTER E--REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT INSPECTION
ACT, THE POULTRY PRODUCTS INSPECTION ACT, AND THE EGG PRODUCTS
INSPECTION ACT
PART 416--SANITATION
0
2. Revise the authority citation for part 416 to read as follows:
Authority: 21 U.S.C. 451-470, 601-695, 1031-1056; 7 U.S.C. 450,
1901-1906; 7 CFR 2.18, 2.53.
PART 417--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP)
SYSTEMS
0
3. Revise the authority citation for part 417 to read as follows:
Authority: 21 U.S.C. 451-470, 601-695, 1031-1056; 7 U.S.C. 450,
1901-1906; 7 CFR 2.18, 2.53.
0
4. In Sec. 417.7, revise paragraph (b) to read as follows:
Sec. 417.7 Training.
* * * * *
(b) The individual performing the functions listed in paragraph (a)
of this section shall have successfully completed a course of
instruction in the application of the seven HACCP principles to meat,
poultry, or egg products, including a segment on the development of a
HACCP plan for a specific product and on record review.
PART 500--RULES OF PRACTICE
0
5. Revise the authority citation for part 500 to read as follows:
Authority: 21 U.S.C. 451-470, 601-695, 1031-1056; 7 U.S.C. 450,
1901-1906; (33 U.S.C. 1251 et seq.); 7 CFR 2.18, 2.53.
0
6. Amend Sec. 500.2 by revising paragraph (c) to read as follows:
Sec. 500.2 Regulatory control action.
* * * * *
(c) An establishment may appeal a regulatory control action, as
provided in Sec. Sec. 306.5, 381.35, and 590.310 of this chapter.
0
7. Amend Sec. 500.3 by revising paragraphs (a)(1) and (a)(7) to read
as follows:
Sec. 500.3 Withholding action or suspension without prior
notification.
(a) * * *
(1) The establishment produced and shipped adulterated or
misbranded product as defined in 21 U.S.C. 453, 21 U.S.C. 602, or 21
U.S.C. 1033;
* * * * *
(7) The establishment did not destroy a condemned meat or poultry
carcass, or part or product thereof, or egg product, that has been
found to be adulterated and that has not been reprocessed, in
accordance with part 314 or part 381, subpart L, or part 590 of this
chapter within three days of notification.
* * * * *
0
8. Amend Sec. 500.5 by revising paragraphs (a)(5) and (c) to read as
follows:
Sec. 500.5 Notification, appeals, and actions held in abeyance.
(a) * * *
(5) Advise the establishment that it may appeal the action as
provided in Sec. Sec. 306.5, 381.35, and 590.310 of this chapter.
* * * * *
(c) An establishment may appeal the withholding action or
suspension, as provided in Sec. Sec. 306.5, 381.35, and 590.310 of
this chapter.
* * * * *
0
9. In Sec. 500.6:
0
a. Redesignate paragraphs (a) through (i) as paragraphs (a)(1) through
(9).
0
b. Designate the introductory text as paragraph (a).
0
c. Revise newly redesignated paragraph (a)(9).
0
d. Add reserved paragraph (b).
The revision and addition read as follows:
Sec. 500.6 Withdrawal of inspection.
(a) * * *
(9) A recipient of inspection or anyone responsibly connected to
the recipient is unfit to engage in any business requiring inspection
as specified in section 401 of the FMIA, section 18(a) of the PPIA, or
section 18 of the EPIA.
(b) [Reserved]
0
10. In Sec. 500.7, revise paragraphs (a)(3) and (5) to read as
follows:
Sec. 500.7 Refusal to grant inspection.
(a) * * *
(3) Has not demonstrated that adequate sanitary conditions exist in
the establishment as required by part 308, subpart H of part 381, part
416, or part 590 of this chapter;
* * * * *
(5) Is unfit to engage in any business requiring inspection as
specified in section 401 of the FMIA, section 18(a) of the PPIA, or
section 18 of the EPIA.
* * * * *
0
11. In Sec. 500.8, revise paragraphs (a) and (c) to read as follows:
Sec. 500.8 Procedures for rescinding or refusing approval of marks,
labels, and containers.
(a) FSIS may rescind or refuse approval of false or misleading
marks, labels, or sizes or forms of any container for use with any
meat, poultry, or egg product, under section 7 of the FMIA, under
section 8 of the PPIA, or under sections 7 or 14 of the EPIA.
* * * * *
(c) If FSIS rescinds or refuses approval of false or misleading
marks, labels, or sizes or forms of any container for use with any
meat, poultry, or egg product, an opportunity for a hearing will be
provided in accordance with the Uniform Rules of Practice, 7 CFR
subtitle A, part 1, subpart H.
[[Page 6349]]
PART 590--INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS
INSPECTION ACT)
0
12. The authority citation for part 590 is revised to read as follows:
Authority: 21 U.S.C. 1031-1056; 7 CFR 2.18, 2.53.
Sec. Sec. 590.1 through 590.860 [Designated as Subpart A]
0
13. Designate Sec. Sec. 590.1 through 590.860 as subpart A and add a
heading for subpart A to read as follows:
Subpart A--GENERAL
0
14. Amend Sec. 590.5 by:
0
a. Revising the definition of Administrator.
0
b. Removing the definition of Chief of the Grading Branch and Dirty egg
or Dirties.
0
c. Revising paragraph (c) of the definition of Egg and the definition
of Egg product.
0
d. Removing the definition of Eggs of current production, Inspector/
Grader, and National Supervisor.
0
e. Adding, in alphabetical order, the definition of Official plant.
0
f. Removing the definition of Official Standard.
0
g. Adding, in alphabetical order, the definition of Official standards.
0
h. Revising the definition of Pasteurize.
0
i. Removing the definition of Plant.
0
j. Revising the definition of Processing.
0
k. Adding, in alphabetical order, the definition of Program employee.
0
l. Removing the definitions of Regional Director, Sanitize, and
Service.
0
m. Revising the definition of Shell egg packer.
0
n. Adding, in alphabetical order, the definition of Shipped for retail
sale.
The revisions and additions read as follows:
Sec. 590.5 Terms defined.
* * * * *
Administrator means the Administrator of the Food Safety and
Inspection Service or any officer or employee of the Department of
Agriculture to whom authority has been delegated or may be delegated to
act in his or her stead.
* * * * *
Egg * * *
(c) Dirty egg or Dirt means an egg that has a shell that is
unbroken and has adhering dirt or foreign material.
* * * * *
Egg product means any dried, frozen, or liquid eggs, with or
without added ingredients, excepting products which contain eggs only
in a relatively small proportion or historically have not been, in the
judgment of the Secretary, considered by consumers as products of the
egg food industry, and which may be exempted by the Secretary under
such conditions as the Secretary may prescribe to assure that the egg
ingredients are not adulterated and such products are not represented
as egg products. For the purposes of this part, the following products,
among others, are exempted as not being egg products: Cooked egg
products, imitation egg products, dietary foods, dried no-bake custard
mixes, egg nog mixes, acidic dressings, noodles, milk and egg dip, cake
mixes, French toast, and sandwiches containing no more restricted eggs
than are allowed in the official standards for U.S. Consumer Grade B
shell eggs. Balut and other similar ethnic delicacies are also exempted
from inspection under this part.
* * * * *
Official plant means any plant in which the plant facilities,
methods of operation, and sanitary procedures have been found suitable
and adequate by the Administrator for the inspection of egg products
pursuant to the regulations in this part and in which inspection
service is carried on.
Official standards means the standards of quality, grades, and
weight classes for eggs.
* * * * *
Pasteurize means the subjecting of each particle of egg products to
heat or other treatments to destroy harmful viable microorganisms.
* * * * *
Processing means manufacturing of egg products, including breaking
eggs or filtering, mixing, blending, pasteurizing, stabilizing,
cooling, freezing or drying, or packaging or repackaging egg products
at official plants.
* * * * *
Program employee means any inspector or other individual employed
by the Department or any cooperating agency who is authorized by the
Secretary to do any work or perform any duty in connection with the
Program.
* * * * *
Shell egg packer means any person engaged in the sorting of shell
eggs from sources other than or in addition to the person's own
production into their various qualities, either mechanically or by
other means.
Shipped for retail sale means eggs that are forwarded from the
processing facility for distribution to the ultimate consumer.
* * * * *
0
15. Amend Sec. 590.10 by revising the third sentence to read as
follows:
Sec. 590.10 Authority.
* * * The Food Safety and Inspection Service and its officers and
employees will not be liable in damages through acts of commission or
omission in the administration of this part.
Sec. Sec. 590.17 and 590.22 [Removed]
0
16. Remove Sec. Sec. 590.17 and 590.22.
0
17. Revise Sec. 590.28 to read as follows:
Sec. 590.28 Other inspections.
Inspection program personnel will make periodic inspections of
business premises, facilities, inventories, operations, transport
vehicles, and records of egg handlers, and the records of all persons
engaged in the business of transporting, shipping, or receiving any
eggs or egg products.
* * * * *
0
18. Revise Sec. 590.40 to read as follows:
Sec. 590.40 Egg products not intended for human food.
Periodic inspections will be made at any plant processing egg
products which are not intended for use as human food of its operations
and records to ensure compliance with the Act and the regulations in
this part. Egg products not intended for use as human food shall be
denatured or decharacterized prior to being offered for sale or
transportation unless shipped under seal as authorized in Sec.
590.504(c) and identified as prescribed by the regulations in this part
to prevent their use as human food.
0
19. Revise Sec. 590.50 to read as follows:
Sec. 590.50 Egg temperature and labeling requirements.
(a) All shell eggs packed into containers destined for the ultimate
consumer must be stored and transported under refrigeration at an
ambient temperature of no greater than 45[deg] F (7.2[deg] C) and must
bear a safe handling label in accordance with 21 CFR 101.17(h).
(b) Any producer-packer with an annual egg production from a flock
of 3,000 or fewer hens is exempt from the temperature and labeling
requirements of this section.
0
20. Revise Sec. 590.100 to read as follows:
Sec. 590.100 Specific exemptions.
(a) [Reserved]
(b) The following are exempt, to the extent prescribed, from the
continuous inspection of egg products processing operations in section
5(a) of the Act (21 U.S.C. 1034(a)), provided the conditions
[[Page 6350]]
for exemption and the provisions of these regulations are met:
(1) The processing and sale of egg products by any poultry producer
from eggs of his own flock's production when sold directly to a
household consumer exclusively for use by the consumer and members of
the household and its nonpaying guests and employees.
(2) The processing in non-official plants, including but not
limited to bakeries, restaurants, and other food processors, of certain
categories of food products which contain eggs or egg products as an
ingredient, as well as the sale and possession of such products. Such
products must be manufactured from inspected egg products processed in
accordance with the regulations in this part and 9 CFR part 591 or from
eggs containing no more restricted eggs than are allowed in the
official standards for U.S. Consumer Grade B shell eggs.
Sec. 590.105 [Removed]
0
21. Remove Sec. 590.105 and undesignated center heading ``Performance
of Service''.
Sec. Sec. 590.112, 590.114 and 590.116 [Removed]
0
22. Remove Sec. Sec. 590.112, 590.114 and 590.116.
0
23. Add an undesignated center heading above Sec. 590.118 and revise
Sec. 590.118 to read as follows:
Performance of Service
Sec. 590.118 Identification.
Each program employee will be furnished with a numbered official
badge that will be carried in a proper manner at all times while on
duty. This badge will be sufficient identification to entitle the
program employee entry at all regular entrances and to all parts of the
official plant and premises to which the program employee is assigned.
Sec. 590.119 [Removed]
0
24. Remove Sec. 590.119.
0
25. Revise Sec. 590.120 to read as follows:
Sec. 590.120 Financial interest of inspectors.
(a) No program employee will inspect any product in which the
employee, the employee's spouse, minor child, partner, organization in
which the employee is serving as officer, director, trustee, partner,
or employee, or any other person with whom the program employee is
negotiating or has any arrangements concerning prospective employment,
has a financial interest in the product.
(b) All program employees are subject to statutory restrictions
with respect to political activities; e.g., 5 U.S.C. 7324 and 1502.
(c) Violation of the provisions of paragraph (a) of this section or
the provisions of applicable statutes referenced in paragraph (b) of
this section will constitute grounds for dismissal.
(d) Program employees are subject to all applicable provisions of
law and regulations and instructions of the Department and the Food
Safety and Inspection Service concerning employee responsibilities and
conduct. The setting forth of certain prohibitions in this part in no
way limits the applicability of such general or other regulations or
instructions.
0
26. Revise Sec. 590.134(b) to read as follows:
Sec. 590.134 Accessibility of product and cooler rooms.
* * * * *
(b) The perimeter of each cooler room used to store eggs must be
made accessible in order for the Secretary's representatives to
determine the ambient temperature under which shell eggs packed into
containers destined for the ultimate consumer are stored.
0
27. Revise Sec. 590.136 to read as follows:
Sec. 590.136 Accommodations and equipment to be furnished by
facilities for use of program employees in performing service.
(a) Program employee's office. Office space, including, but not
limited to, furnishings, light, heat, and janitor service, will be
provided without cost in the official plant for the use of program
employees for official purposes. The room or space set apart for this
purpose must meet the approval of the Food Safety and Inspection
Service and be conveniently located, properly ventilated, and provided
with lockers or file cabinets suitable for the protection and storage
of supplies and with accommodations suitable for program employees to
change clothing. At the discretion of the Administrator, small official
plants requiring the services of less than one full-time program
employee need not furnish accommodations for program employees as
prescribed in this section where adequate accommodations exist in a
nearby convenient location.
(b) Accommodations and equipment. Such accommodations and equipment
must include, but not be limited to, a room or area suitable for
sampling product and a stationary or adequately secured storage box or
cage (capable of being locked only by the program employee) for holding
official samples.
0
28. Revise Sec. 590.140 to read as follows:
Sec. 590.140 Application for grant of inspection.
The proprietor or operator of each official plant and official
import inspection establishment must make application to the
Administrator for inspection service unless exempted by Sec. 590.100.
The application must be made in writing on forms furnished by the
inspection service. In cases of change of name or ownership or change
of location, a new application must be made.
0
29. Revise Sec. 590.142 to read as follows:
Sec. 590.142 Filing of application.
An application for inspection service will be regarded as filed
only when it has been:
(a) Filled in completely;
(b) Signed by the applicant; and
(c) Received in the appropriate District Office.
0
30. Revise Sec. 590.146 to read as follows:
Sec. 590.146 Survey and grant of inspection.
(a) Before inspection is granted, FSIS will survey the official
plant to determine if the construction and facilities of the plant are
in accordance with the regulations in this part. FSIS will grant
inspection, subject to 9 CFR 500.7, when these requirements are met and
the requirements contained in Sec. 590.149 are met.
(b) FSIS will give notice in writing to each applicant granted
inspection and will specify in the notice the official plant, including
the limits of the plant's premises, to which the grant pertains.
Sec. 590.148 [Removed]
0
31. Remove Sec. 590.148.
0
32. Add Sec. 590.149 to read as follows:
Sec. 590.149 Conditions for receiving inspection.
(a) Before receiving Federal inspection, a plant must have
developed written sanitation Standard Operating Procedures, in
accordance with part 416 and Sec. 591.1(a)(1) of this chapter.
(b) Before receiving Federal inspection, a plant must conduct a
hazard analysis, and develop and implement a HACCP plan, in accord with
part 417 and Sec. 591.1(a)(1) of this chapter. Conditional inspection
may be provided for a period not to exceed 90 days, during which period
the facility must validate its HACCP plan.
(c) Before producing new product for distribution in commerce, a
plant must conduct a hazard analysis and develop a HACCP plan
applicable to that
[[Page 6351]]
product, in accordance with Sec. 417.2 of this chapter. During a
period not to exceed 90 days after the date the new product is produced
for distribution in commerce, the plant must validate its HACCP plan,
in accordance with Sec. 417.4 of this chapter.
0
33. Revise Sec. 590.160 to read as follows:
Sec. 590.160 Clean Water Act; refusal, suspension, or withdrawal of
service.
(a) Any applicant for inspection at a plant where the operations
thereof may result in any discharge into the navigable waters in the
United States is required by subsection 401(a)(1) (33 U.S.C. 1341) of
the Clean Water Act as amended (86 Stat. 816, 91 Stat. 1566, 33 U.S.C.
1251 et seq.), to provide the Administrator with a certification, as
prescribed in said subsection, that any such discharge will comply with
the applicable provisions of sections 301, 302, 303, 306, and 307 of
the Act (33 U.S.C. 1311, 1312, 1313, 1316, and 1317). No grant of
inspection can be issued unless such certification has been obtained,
or is waived, because failure of refusal of the State, interstate
agency, or the Administrator of the Environmental Protection Agency to
act on a request for certification within a reasonable period (which
should not exceed 1 year after receipt of such a request). Further,
upon receipt of an application for inspection and a certification as
required by subsection 401(a)(1) of the Clean Water Act, the
Administrator (as defined in Sec. 590.5) is required by subparagraph
(2) of said subsection to notify the Administrator of the Environmental
Protection Agency for proceedings in accordance with that subsection.
No grant of inspection can be made until the requirements of 401(a)(1)
and (2) have been met.
(b) Inspection may be suspended or revoked and plant approval
terminated as provided in subsection 401(a)(4) and (5) of the Clean
Water Act, as amended (33 U.S.C. 1341(a)(4) and (5)).
0
34. Revise Sec. 590.200 to read as follows:
Sec. 590.200 Records and related requirements.
(a) Persons engaged in the transporting, shipping, or receiving of
any eggs or egg products in commerce, or holding such articles so
received, and all egg handlers, except producer-packers with an annual
egg production from a flock of 3,000 hens or fewer, must maintain
records documenting, for a period of 2 years, the following, to the
extent applicable:
(1) The date of lay, date and time of refrigeration, date of
receipt, quantity and quality of eggs purchased or received, and from
whom (including a complete address, unless a master list is
maintained). Process records documenting that the temperature and
labeling requirements in Sec. 590.50(a) have been met must also be
kept;
(2) The date of packaging, ambient air temperature surrounding
product stored after processing, quantity and quality of eggs delivered
or sold, and to whom (including a complete address, unless a master
list is maintained);
(3) If a consecutive lot numbering system is not employed to
identify individual eggs, containers of eggs, or egg products, record
the alternative code system used, in accordance with Sec.
590.411(c)(3);
(4) The date of disposal and quantity of restricted eggs, including
inedible egg product or incubator reject product, sold or given away
for animal food or other uses or otherwise disposed of, and to whom
(including a complete address, unless a master list is maintained);
(5) The individual or composite (running tally) record of
restricted egg sales to household consumers. Records should show number
of dozens sold on a daily basis. The name and address of the consumer
is not required;
(6) The date of production and quantity of egg products delivered
or sold, and to whom (including a complete address, unless a master
list is maintained);
(7) The date of receipt and quantity of egg products purchased or
received, and from whom (including a complete address, unless a master
list is maintained);
(8) The production records by categories of eggs such as graded
eggs, nest-run eggs, dirties, checks, etc.; bills of sale, inventories,
receipts, shipments, shippers, receivers, dates of shipment and
receipt, carrier names, etc.
(b) All records required to be maintained by this section must be
made available to an authorized representative of the Secretary for
official review and copying.
(c) Records of all labeling, along with the product formulation and
processing procedures as prescribed in Sec. Sec. 590.410 through
590.412 of this chapter, must be kept by every person processing,
except processors exempted under Sec. 590.100 of this chapter.
0
35. Revise Sec. 590.300 to read as follows:
Sec. 590.300 Appeal inspections.
Any person receiving inspection service may, if dissatisfied with
any decision of an inspector related to any inspection, file an appeal
from such decision.
0
36. Revise Sec. 590.310 to read as follows:
Sec. 590.310 Appeal inspections; how made.
Any appeal from the inspection decision of any program employee
must be made to his or her immediate supervisor having jurisdiction
over the subject matter of the appeal.
0
37. Revise Sec. 590.320 to read as follows:
Sec. 590.320 How to file an appeal inspection or decision review.
The request for an appeal inspection or review of a program
employee's decision may be made orally or in writing. If made orally,
written confirmation may be required. The applicant must clearly
identify the product involved, the decision being appealed, and the
reasons for requesting the appeal.
0
38. Revise Sec. 590.340 to read as follows:
Sec. 590.340 Who must perform the appeal inspection or decision
review.
An appeal inspection or review of a program employee's decision, as
requested in Sec. 590.310, must be performed by a program employee of
FSIS other than the one who made the initial decision.
0
39. Revise Sec. 590.350 to read as follows:
Sec. 590.350 Appeal samples.
An appeal sample will consist of product taken from the original
sample containers plus an equal number of containers selected at
random. A condition appeal cannot be made unless all originally sampled
containers are available.
Sec. Sec. 590.360 and 590.370 [Removed]
0
40. Remove Sec. Sec. 590.360 and 590.370.
0
41. Revise Sec. 590.410 to read as follows:
Sec. 590.410 Egg products required to be labeled.
(a)(1) Packaged egg products that require special handling to
maintain their wholesome condition must have the statement ``Keep
Refrigerated,'' ``Keep Frozen,'' ``Perishable Keep Under
Refrigeration,'' or such similar statement prominently displayed on the
principal display panel.
(2) Egg products that are distributed frozen and thawed prior to or
during display for sale at retail must bear the statement ``Keep
Frozen'' on the shipping container. Consumer-sized containers for such
egg products must bear the statement ``Previously Handled Frozen for
Your Protection, Refreeze or Keep Refrigerated.''
[[Page 6352]]
(3) The labels of packages of egg products produced from shell eggs
that have been treated with ionizing radiation must reflect that
treatment in the ingredient statement on the finished product labeling.
(b) Containers, portable tanks, and bulk shipments of edible egg
products produced in official plants must be labeled in accordance with
Sec. Sec. 590.411 through 590.415 and must bear the official
identification shown in Figure 1 of Sec. 590.413.
(c) Bulk shipments of unpasteurized egg products produced in
official plants must bear a label containing the words ``date of
loading,'' followed by a suitable space in which the date the
container, tanker truck, or portable tank is loaded must be inserted.
The label must be conspicuously located, and printed and affixed on
material that cannot be detached or effaced due to exposure to weather.
Before the truck or tank is removed from the place where it is
unloaded, the carrier must remove or obliterate the label. Such
shipments must also bear the official identification shown in Figure 2
of Sec. 590.415.
0
42. Revise Sec. 590.411 to read as follows:
Sec. 590.411 Label approval.
(a) All official plants, including official plants certified under
a foreign inspection system in accordance with Sec. 590.910, must
comply with the requirements contained in 9 CFR 412.1, except as
otherwise provided in this part.
(b) For the purposes of 9 CFR 412.2, an official establishment or
establishment certified under a foreign inspection system includes an
official plant.
(c) Labels, containers, or packaging materials of egg products must
show the following information, as applicable, on the principal display
panel (except as otherwise permitted in this part), in accordance with
the requirements of this part, or if applicable, 21 CFR 101.17(h):
(1) A statement showing by the common or usual names, if any, of
the kinds of ingredients comprising the product. Formulas are to be
expressed in terms of a liquid product except for product that is dry-
blended. Also, for product to be dried, the label may show the
ingredients in order of descending proportions by weight in the dried
form. However, the formula submitted must include the percentage of
ingredients in both liquid and dried form. If the product is comprised
of two or more ingredients, such ingredients must be listed in the
order of descending proportions by weight in the form in which the
product is to be marketed (sold), except that ingredients in dried
product (other than dry blended) may be listed in either liquid or
dried form. When water (excluding that used to reconstitute dehydrated
ingredients back to their normal composition) is added to a liquid or
frozen egg product or to an ingredient of such products (in excess of
the normal water content of that ingredient), the total amount of water
added, including the water content of any cellulose or vegetable gums
used, must be expressed as a percentage of the total product weight in
the ingredient statement on the label;
(2) The name, address and zip code of the distributor; qualified by
such terms as ``distributed by,'' or ``distributors'';
(3) The lot number or an alternative code indicating the date of
production, in accordance with Sec. 590.200(a);
(4) The net content;
(5) An official inspection symbol and the number of the official
plant in which the product was processed under inspection as set forth
in Sec. 590.413;
(6) Egg products processed from edible eggs of the turkey, duck,
goose, or guinea must be clearly and distinctly labeled as to the
common or usual name of the product indicating the type of eggs or egg
products used in the product, e.g., ``Frozen whole turkey eggs,''
``Frozen whole chicken and turkey eggs.'' Egg products labeled without
qualifying words as to the type of egg used in the product must be
produced only from the edible egg of the domesticated chicken or the
egg products produced from such eggs.
(d) Liquid or frozen egg products identified as whole eggs and
processed in other than natural proportions as broken from the shell
must have a total egg solids content of 24.20 percent or greater.
(e) Nutrition information may be included on labels used to
identify egg products, providing such labeling complies with the
provisions of 21 CFR part 101, promulgated under the Federal Food,
Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. Since
these regulations have different requirements for consumer packaged
products than for bulk packaged egg products not for sale or
distribution to household consumers, label submission must be
accompanied with information indicating whether the label covers
consumer packaged or bulk packaged products. Nutrition labeling is
required when nutrients, such as proteins, vitamins, and minerals are
added to the product, or when a nutritional claim or information is
presented on the labeling, except for the following, which are exempt
from nutrition labeling requirements:
(1) Egg products shipped in bulk form for use solely in the
manufacture of other food and not for distribution to household
consumers in such bulk form or containers.
(2) Products containing an added vitamin, mineral, or protein, or
for which a nutritional claim is made on the label, or in advertising,
which is supplied for institutional food use only, provided that the
manufacturer or distributor provides the required nutrition information
directly to those institutions.
(3) Any nutrients included in the product solely for technological
purposes may be declared solely in the ingredients statement, without
complying with nutrition labeling, if the nutrient(s) is otherwise not
referred to in labeling or in advertising. All labels showing nutrition
information or claims are subject to review by the Food and Drug
Administration prior to approval by the Department.
(f)(1) No label, container, or packaging material may contain any
statement that is false or misleading. If the Administrator has reason
to believe that a statement or formulation shows that an egg product is
adulterated or misbranded, or that any labeling, including the size or
form of any container in use or proposed for use, with respect to eggs
or egg products, is false or misleading in any way, the Administrator
may direct that such use be withdrawn unless the labeling or container
is modified in such a manner as the Administrator may prescribe so that
it will not be false or misleading, or the formulation of the product
is altered in such a manner as the Administrator may prescribe so that
it is not adulterated or would not cause misbranding.
(2) If the Administrator directs that the use of any label,
container, or packaging material be withdrawn because it contains any
statement that is false or misleading, an opportunity for a hearing
will be provided in accordance with Sec. 500.8(c) of this chapter.
Sec. 590.412 [Redesignated as Sec. 590.413]
0
43. Redesignate Sec. 590.412 as Sec. 590.413.
0
44. Add a new Sec. 590.412 to read as follows:
Sec. 590.412 Approval of generic labels.
(a) All official plants, including official plants certified under
a foreign inspection system in accordance with Sec. 590.910, must
comply with the
[[Page 6353]]
requirements in 9 CFR 412.2, except as otherwise provided in this part.
(b) For the purposes of 9 CFR 412.2, an official establishment or
establishment certified under a foreign inspection system includes an
official plant.
0
45. Revise newly redesignated Sec. 590.413 to read as follows:
Sec. 590.413 Form of official identification symbol and inspection
mark.
(a) The shield set forth in Figure 1 of this section containing the
letters ``USDA'' must be the official identification symbol used in
connection with egg products to denote that the official plant receives
official inspection service. The inspection mark used on containers of
edible egg products is set forth in Figure 1 of this section, except
that the plant number may be preceded by the letter ``G'' in lieu of
the word plant. The plant number may also be omitted from the official
mark if applied on the container's principal display panel or other
prominent location and preceded by the letter ``G.''
[GRAPHIC] [TIFF OMITTED] TP13FE18.000
(b) [Reserved]
0
46. Revise Sec. 590.415 to read as follows:
Sec. 590.415 Use of other official identification.
All unpasteurized egg products shipped from an official plant must
be marked with the identification set forth in Figure 2 of this
section. Such product must meet all requirements for egg products that
are permitted to bear the official inspection mark shown in Sec.
590.413, except for pasteurization, heat treatment, or other method of
treatment sufficient to reduce Salmonella. Such product must not be
released into consumer channels until it has been subjected to
pasteurization, heat treatment, or other method of treatment sufficient
to reduce Salmonella. After pasteurization or treatment, the product
may bear the official inspection mark as shown in Sec. 590.413.
[GRAPHIC] [TIFF OMITTED] TP13FE18.001
[[Page 6354]]
Sec. 590.418 [Amended]
0
47. Amend Sec. 590.418 by removing paragraphs (a) and (c) and
redesignate paragraph (b) as an undesignated paragraph.
0
48. Revise Sec. 590.420(a) and (b) to read as follows:
Sec. 590.420 Inspection.
(a) Inspection shall be made, pursuant to the regulations in this
part, of the processing of egg products in each official plant
processing egg products for commerce, unless exempted under Sec.
590.100. Inspections, certifications, or specification-type gradings,
and other inspections which may be requested by the official plant and
are in addition to the normal inspection requirements and functions for
the processing, production, or certification for a wholesome egg
product under this part, shall be made pursuant to the voluntary egg
products inspection regulations (part 592 of this chapter).
(b) Any food manufacturing establishment or institution which uses
any eggs that do not meet the requirements of 21 U.S.C. 1044(a)(1) in
the preparation of any articles for human food shall be deemed to be a
plant processing egg products requiring inspection under the
regulations in this part.
* * * * *
Sec. 590.422 [Amended]
0
49. Amend Sec. 590.422 by removing the last sentence of the section.
0
50. Amend Sec. 590.430 by revising paragraph (b) to read as follows:
Sec. 590.430 Limitation on entry of material.
* * * * *
(b) Inedible egg products may be brought into an official plant for
storage, processing, and reshipment provided it is handled in such a
manner that adequate segregation and inventory controls are maintained
at all times. The processing of inedible egg products must be done
under conditions that will not affect the processing of edible
products, such as processing in separate areas or at times when no
edible products are being processed. If the same equipment or areas are
used to process both inedible and edible eggs, then the equipment and
processing areas used to process inedible eggs must be thoroughly
cleaned and sanitized prior to processing any edible egg products.
0
51. Revise Sec. 590.435 to read as follows:
Sec. 590.435 Use of food ingredients and approval of materials.
(a)(1) No substance may be used in the processing of egg products,
for any purpose, unless its use is authorized under 21 CFR as a direct
food additive (part 172), a secondary direct food additive (part 173),
an indirect food additive (parts 174-178), a source of radiation (part
179), an interim-listed direct food additive (part 180), a prior-
sanctioned substance (part 181), a Generally Recognized As Safe (GRAS)
substance (parts 182 or 184), or by 21 CFR 160.185, or by regulation in
this chapter. Substances and ingredients used in the processing of egg
products capable of use as human food must be clean, wholesome, and
unadulterated.
(2) No substance which is intended to impart color in any egg
product may be used unless such use is authorized under 21 CFR as a
color additive (parts 73, 74, or 81) or by regulation in this chapter.
(b) Substances permitted for use in egg products under 21 CFR will
be permitted for such use under this chapter, subject to declaration
requirements in 9 CFR 424.22(c) and 9 CFR 590.411, unless precluded
from such use or further restricted in this chapter. Such substances
must be safe and effective under conditions of use and not result in
the adulteration of product. The Administrator may require, in addition
to listing the ingredients, a declaration of the additive and the
purpose of its use.
(c) Chemical additives to be used in the processing of egg products
must be safe under the conditions of their intended use and in amounts
sufficient to accomplish their intended purpose. Chemical additives may
not promote deception or cause the product to be otherwise adulterated
or unwholesome. Scientific data showing the additive meets the above
specified criteria must be maintained and made available to FSIS
program employees.
0
52. Revise Sec. 590.440(c) to read as follows:
Sec. 590.440 Processing ova.
* * * * *
(c) All products containing ova must be labeled in accordance with
Sec. 590.411.
Sec. Sec. 590.500 and 590.502 [Removed]
0
53. Remove Sec. Sec. 590.500 and 590.502.
0
54. Revise Sec. 590.504 to read as follows:
Sec. 590.504 General operating procedures.
(a) Operations involving the processing, storing, and handling of
eggs, ingredients, and egg products must be strictly in accordance with
clean and sanitary methods and must be conducted as rapidly as
practicable.
(b)(1) Egg products are subject to inspection in each official
plant processing egg products for commerce.
(2) Any egg products not processed in accordance with the
regulations in this part or part 591 or that are not otherwise fit for
human food will be removed and segregated.
(c)(1) All loss and inedible eggs or inedible egg products must be
placed in a container clearly labeled ``inedible'' and containing a
sufficient amount of denaturant or decharacterant, such as an
acceptable FD&C color additive, suspended in the product. Eggs must be
crushed and the substance dispersed through the product in amounts
sufficient to give the product a distinctive appearance or odor.
Inedible product may be held in containers clearly labeled ``inedible''
which do not contain a denaturant as long as such inedible product is
properly packaged, labeled and segregated, and inventory controls are
maintained. Such inedible product must be denatured or decharacterized
before being shipped from a facility.
(2) Denatured or decharacterized inedible egg products may be
shipped from an official plant for industrial use or animal food,
provided that it is properly packaged, labeled, and segregated, and
inventory controls are maintained.
(d)(1) Egg products must be processed to meet the standard set out
in Sec. 590.570.
(2) Unpasteurized egg products may be shipped from an official
plant to another official plant only when they are to be pasteurized,
heat treated, or treated using other methods of treatment sufficient to
reduce Salmonella in the second official plant. Shipments of
unpasteurized egg products shipped from one official plant to another
for pasteurization or treatment must be sealed in cars or trucks and
labeled in accordance with Sec. 590.410(c). Containers of
unpasteurized egg product must be marked with the identification mark
shown in Figure 2 of Sec. 590.415.
(e) When inspection program personnel do not suspect noncompliance
by an official plant with any provisions of this part, they may permit
that plant to move egg products that have been sampled and analyzed for
Salmonella, or any other reason, before receiving the test results so
long as the plant maintains control of the products represented by the
sample pending test results.
Sec. 590.506 [Removed]
0
55. Remove Sec. 590.506.
0
56. Revise Sec. 590.508 to read as follows:
[[Page 6355]]
Sec. 590.508 Candling and transfer-room operations.
Eggs must be handled in a manner that minimizes sweating prior to
breaking or processing.
0
57. Amend Sec. 590.510 by revising paragraphs (a) introductory text,
(c)(1) and (3), and (d) introductory text to read as follows:
Sec. 590.510 Classifications of eggs used in the processing of egg
products.
(a) The eggs must be sorted and classified into the following
categories:
* * * * *
(c)(1) When presented for breaking, eggs must have an edible
interior quality and the shell must be sound and free of adhering dirt
and foreign material. However, checks and eggs with a portion of the
shell missing may be used when the shell is free of adhering dirt and
foreign material and the shell membranes are not ruptured.
* * * * *
(3) Eggs with meat or blood spots may be used if the spots are
removed.
(d) All loss or inedible eggs must be placed in a designated
container and handled as required in Sec. 590.504(c). Eggs extensively
damaged during breaking, whether not completely cracked open
mechanically or in the movement of trays of eligible eggs for hand
breaking, must be broken promptly. For the purpose of this section and
Sec. 590.522, inedible and loss eggs include crusted yolks, filthy and
decomposed eggs, and the following:
* * * * *
0
58. Amend Sec. 590.516 by revising the section heading and paragraph
(a) to read as follows:
Sec. 590.516 Cleaning of eggs prior to packaging, breaking, or
pasteurizing.
(a) All eggs, except as provided in Sec. 590.801, must be clean
prior to packaging, breaking, or pasteurizing. If a sanitizer is used,
it must be used in accordance with FDA requirements for the intended
use.
* * * * *
Sec. 590.520 [Removed]
0
59. Remove Sec. 590.520.
0
60. Revise Sec. 590.522 to read as follows:
Sec. 590.522 Egg products processing room operations.
Eggs used in processed egg products must be broken in a sanitary
manner and examined to ensure that the contents are acceptable for
human consumption.
Sec. Sec. 590.530 and 590.532 [Removed]
0
61. Remove Sec. Sec. 590.530 and 590.532.
0
62. Revise Sec. 590.534 to read as follows:
Sec. 590.534 Freezing facilities.
Freezing rooms, either on or off the premises, must be capable of
solidly freezing, or reducing to a temperature of 10[emsp14][deg]F or
lower, all liquid egg products.
Sec. Sec. 590.536, 590.538 through 590.540, 590.542, 590.544, 590.546
through 590.550, 590.552 and 590.560 [Removed]
0
63. Remove Sec. Sec. 590.536, 590.538 through 590.540, 590.542,
590.544, 590.546 through 590.550, 590.552 and 590.560.
0
64. Revise Sec. 590.570 to read as follows:
Sec. 590.570 Control of pathogens in egg products.
Egg products must be produced to be edible without additional
preparation to achieve food safety and may receive additional
preparation for palatability or aesthetic, epicurean, gastronomic, or
culinary purposes. Egg products are not required to bear a safe-
handling instruction or other labeling that directs that the product
must be cooked or otherwise treated for safety.
Sec. 590.575 [Removed]
0
65. Remove Sec. 590.575.
0
66. Revise Sec. 590.580 to read as follows:
Sec. 590.580 Pathogen reduction standards testing.
(a) Official plants must test to determine that the production of
egg products is in compliance with the Act and the egg products
inspection regulations.
(b) To ensure adequate pasteurization:
(1) Pasteurized liquid, frozen, and dried egg products, and heat
treated dried egg whites must be sampled and analyzed for the presence
of Salmonella spp. Such testing must be performed in a manner
sufficient such that it is possible for the official plant to verify
that the system is capable of eliminating Salmonella spp. at the time
that the annual reassessment occurs, and as regularly as necessary
between annual reassessments, to show that the system, when tested, is
working.
(2) Samples must be analyzed for the presence of Salmonella spp.
with such sequence, with such frequency, and using such laboratory
methods as is sufficient to ensure that product is not adulterated.
(3) Samples must be drawn from the final packaged form.
(c) Results of all partial and completed analyses performed under
paragraph (b) of this section must be provided to inspection program
personnel promptly upon receipt by the official plant. Positive test
results must be provided to inspection program personnel immediately
upon receipt by the official plant.
0
67. Add Sec. 590.590 to read as follows:
Sec. 590.590 Use of irradiated shell eggs to produce egg products.
Irradiated shell eggs used to produce pasteurized egg products must
be used in conjunction with heat or another lethality treatment to
produce a ready-to-eat product. Unless otherwise approved by FDA, the
irradiation treatment of the shell eggs must precede the heat or other
lethality treatment applied to the egg products.
Sec. Sec. 590.600 through 590.680 [Removed]
0
68. Remove the undesignated center heading ``Exempted Egg Products
Plants'' and Sec. Sec. 590.600 through 590.680.
0
69. Add an undesignated center heading and Sec. 590.700 to read as
follows:
Inspection and Disposition of Restricted Eggs
Sec. 590.700 Prohibition on disposition of restricted eggs.
(a) No person may buy, sell, or transport, or offer to buy or sell,
or offer or receive for transportation in any business in commerce any
restricted eggs capable of use as human food, except as authorized in
Sec. Sec. 590.100 and 590.720.
(b) No egg handler may possess with the intent to use, or use, any
restricted eggs in the preparation of human food, except as provided in
Sec. Sec. 590.100 and 590.720.
0
70. Add Sec. 590.720 to read as follows:
Sec. 590.720 Disposition of restricted eggs.
(a) Except as exempted in Sec. 590.100, eggs classified as checks,
dirts, incubator rejects, inedibles, leakers, or loss must be disposed
of by one of the following methods at the point and time of
segregation:
(1) Checks and dirts must be labeled in accordance with Sec.
590.800 and shipped to an official plant for segregation and
processing. Inedible and loss eggs must not be intermingled in the same
container with checks and dirts.
(2) By destruction in a manner that clearly identifies the products
as being inedible and not for human consumption, such as crushing and
denaturing or decharacterizing in accordance with Sec. 590.504(c). The
products must also be identified as ``Inedible Egg Product--Not To Be
Used As Human Food.''
(3) Processing for industrial use or for animal food. Such products
must be
[[Page 6356]]
denatured or decharacterized in accordance with Sec. 590.504(c) and
identified as provided in Sec. Sec. 590.840 and 590.860, or properly
handled in a manner that clearly identifies the products as being
inedible and not for human consumption and does not adulterate egg
product intended for human consumption. Notwithstanding the foregoing,
product which was produced under official supervision and transported
for industrial use or animal food need not be denatured or
decharacterized if it is shipped under Government seal and received by
a program employee as defined in this part.
(4) By coloring the shells of loss and inedible eggs with a
sufficient amount of FD&C color to give a distinct appearance, or
applying a substance that will penetrate the shell and decharacterize
the contents of the egg. However, lots of eggs containing significant
percentages of eggs having small to medium blood spots or meat spots,
but no other types of loss or inedible eggs, may be shipped directly to
official plants, provided they are conspicuously labeled with the name
and address of the shipper and the wording ``Spots--For Processing Only
In Official Egg Products Plants.''
(5) Incubator rejects must be broken or crushed and denatured or
decharacterized in accordance with Sec. 590.504(c) and labeled as
required in Sec. Sec. 590.840 and 590.860.
(b) Eggs that are packed for the ultimate consumer and have been
found to exceed the tolerance for restricted eggs permitted in the
official standards for U.S. Consumer Grade B but have not been shipped
for retail sale must be identified as required in Sec. Sec. 590.800
and 590.860 and must be shipped directly or indirectly:
(1) To an official plant for proper segregation and processing; or
(2) Be re-graded so that they comply with the official standards;
or
(3) Used as other than human food.
(c) Records must be maintained as provided in Sec. 590.200 to
ensure proper disposition.
0
71. Add Sec. 590.801 to read as follows:
Sec. 590.801 Nest-run or washed ungraded eggs.
Nest-run or washed ungraded eggs are exempt from the labeling
provisions in Sec. 590.800. However, when such eggs are sold to
consumers, they may not exceed the tolerance for restricted eggs for
U.S. Consumer Grade B shell eggs.
Sec. Sec. 590.900 through 590.970 [Removed]
0
72. Remove undesignated center heading ``Imports'' and Sec. Sec.
590.900 through 590.970.
0
73. Add subpart B, consisting of Sec. Sec. 590.900 through 590.965, to
read as follows:
Subpart B--Imports
Sec.
590.900 Definitions; requirements for importation into the United
States.
590.901 Egg products offered for entry and entered to be handled and
transported as domestic; entry into official plants; transportation.
590.905 Importation of restricted eggs.
590.910 Eligibility of foreign countries for importation of eggs and
egg products into the United States.
590.915 Imported products; foreign inspection certificates required.
590.920 Import inspection application.
590.925 Inspection of eggs and egg products offered for entry.
590.930 Eggs and egg products offered for entry, retention in
customs custody; delivery under bond; movement prior to inspection;
handling; equipment and assistance.
590.935 Means of conveyance and equipment used in handling egg
products offered for entry to be maintained in sanitary condition.
590.940 Identification of egg products offered for entry; official
import inspection marks and devices.
590.945 Eggs and egg products offered for entry; reporting of
findings to customs; handling of articles refused entry; appeals,
how made; denaturing procedures.
590.950 Labeling of immediate containers of egg products offered for
entry.
590.955 Labeling of shipping containers of egg products offered for
entry.
590.956 Relabeling of imported egg products.
590.960 Small importations for importer's personal use, display, or
laboratory analysis.
590.965 Returned to the United States inspected and identified
covered products; exemption.
Subpart B--Imports
Sec. 590.900 Definitions; requirements for importation into the
United States.
(a) When used in this subpart, the following terms will be
construed to mean:
(1) Import (Imported). To bring within the territorial limits of
the United States, whether that arrival is accomplished by land, air,
or water.
(2) Offer(ed) for entry. The point at which the importer presents
the imported product for reinspection.
(3) Entry (entered) means the point at which imported product
offered for entry receives reinspection and is marked with the official
mark of inspection, as required by Sec. 590.940.
(4) Official Import Inspection Establishment. This term means any
establishment, other than an official establishment as defined in 9 CFR
301.2, where inspections are authorized to be conducted as prescribed
in Sec. 590.925 of this subchapter.
(b) No egg products may be imported into the United States unless
they are healthful, wholesome, fit for human food, not adulterated, and
contain no dye, chemical, preservative, or ingredient which renders
them unhealthful, unwholesome, unadulterated, or unfit for human food.
Such products must also comply with the regulations prescribed in this
subpart to ensure that they adhere to the standards provided for in the
Act. The provisions of this subpart will apply to these products only
if they are capable for use as human food.
(c) Approval for Federal import inspection must be in accordance
with Sec. Sec. 590.140 through 590.149.
(d) Egg products may be imported only if they are processed solely
in the countries listed in Sec. 590.910(b).
Sec. 590.901 Egg products offered for entry and entered to be handled
and transported as domestic; entry into official plants;
transportation.
(a) All egg products, after entry into the United States in
compliance with this subpart, will be deemed and treated and, except as
provided in Sec. Sec. 590.935 and 590.960, will be handled and
transported as domestic product, and will be subject to the applicable
provisions of this part and to the provisions of the Egg Products
Inspection Act and the Federal Food, Drug, and Cosmetic Act.
(b) Imported egg products entered in accordance with this subpart
may, subject to the provisions of the regulations, be taken into
official plants and be mixed with or added to egg products that are
inspected and passed or exempted from inspection in such plants.
(c) Imported egg products that have been inspected and passed under
this subpart may be transported in commerce only upon compliance with
the applicable regulations.
Sec. 590.905 Importation of restricted eggs.
(a) No containers of restricted eggs other than checks or dirties
will be imported into the United States. The shipping containers of
such eggs shall be identified with the name, address, and country of
origin of the exporter, and the date of pack and the quality of the
eggs (e.g., checks of dirties) preceded by the word ``Imported'' or the
statement ``Imported Restricted Eggs-For Processing Only In An Official
USDA Plant,'' or ``Restricted Eggs--Not To Be Used As Human Food.''
Such identification shall be legible and conspicuous.
[[Page 6357]]
(b) For properly sealed and certified shipments of shell eggs for
breaking at an official egg products plant, the containers need not be
labeled, provided that the shipment is segregated and controlled upon
arrival at the destination breaking plant.
Sec. 590.910 Eligibility of foreign countries for importation of eggs
and egg products into the United States.
(a)(1) Whenever it is determined by the Administrator that the
system of egg products inspection maintained by any foreign country,
with respect to plants preparing products in such country for export to
the United States, insures compliance of such plants and their products
with requirements equivalent to all the inspection, building
construction standards, and all other provisions of the Act and the
regulations in this part which are applied to official plants in the
United States, and their products, and that reliance can be placed upon
certificates required under this part from authorities of such foreign
country, notice of that fact will be given by including the name of
such foreign country in paragraph (b) of this section. Thereafter,
products prepared in such plants which are certified and approved in
accordance with paragraph (a)(3) of this section, will be eligible so
far as this part is concerned for importation into the United States
from such foreign country after applicable requirements of this part
have been met.
(2) The determination of acceptability of a foreign egg products
inspection system for purposes of this section must be based on an
evaluation of the foreign program in accordance with the following
requirements and procedures:
(i) The system must have a program organized and administered by
the national government of the foreign country. The system as
implemented must provide standards equivalent to those of the Federal
system of egg products inspection in the United States with respect to:
(A) Organizational structure and staffing, so as to insure uniform
enforcement of the requisite laws and regulations in all plants
throughout the system at which products are prepared for export to the
United States;
(B) Ultimate control and supervision by the national government
over the official activities of all employees or licensees of the
system;
(C) The assignment of competent, qualified inspectors;
(D) Authority and responsibility of national inspection officials
to enforce the requisite laws and regulations governing egg products
inspection and to certify or refuse to certify products intended for
export;
(E) Adequate administrative and technical support;
(F) The inspection and residue standards applied to egg products
produced in the United States.
(G) Other requirements of adequate inspection service as required
by the regulations in this part.
(ii) The legal authority for the system and the regulations
thereunder must impose requirements equivalent to those governing the
system of egg products inspection organized and maintained in the
United States with respect to:
(A) Official controls by the national government over plant
construction, building and facilities, and equipment;
(B) Official supervision of the processing of egg products in
plants by the assignment of inspectors to plants certified under
paragraph (a)(2)(iv) of this section to ensure that adulterated or
misbranded product is not prepared for export to the United States;
(C) Any product that is prepared under inspection in a plant must
be inspected in such a plant as often as the inspector deems necessary
in order to ascertain if the product is unadulterated, wholesome,
properly labeled, and fit for human food at the time it leaves the
plant. Upon any such inspection, if any product or portion thereof is
found to be adulterated, unwholesome, or otherwise unfit for human
food, such product or portion thereof must be condemned and must
receive such treatment as provided in Sec. 590.504(c);
(D) Complete separation of plants certified under paragraph
(a)(2)(iv) of this section from plants not certified, and the
maintenance of a single standard of inspection and sanitation
throughout all certified plants;
(E) Requirements for sanitation at certified plants and for
sanitary handling of egg products;
(F) Official controls over condemned material until destroyed or
removed and thereafter excluded from the plant;
(G) A Hazard Analysis and Critical Control Point (HACCP) system, as
set forth in part 417 of this chapter; and
(H) Other matters for which requirements are contained in the Act
or regulations in this part.
(iii) Countries desiring to establish eligibility for the
importation of egg products into the United States may request a
determination of eligibility by presenting copies of the laws and
regulations on which the foreign egg products inspection system is
based and such other information as the Administrator may require with
respect to matters enumerated in paragraphs (a)(2)(i) and (ii) of this
section. Determination of eligibility is based on a study of the
documents and other information presented and an initial review of the
system in operation by a representative of the Department using the
criteria listed in paragraphs (a)(2)(i) and (ii) of this section.
Maintenance of eligibility of a country for importation of egg products
into the United States depends on the results of periodic reviews of
the foreign egg products inspection system in operation by a
representative of the Department, and the timely submission of such
documents and other information related to the conduct of the foreign
inspection system, including information required by paragraph (e) of
section 20 of the Act, as the Administrator may find pertinent to and
necessary for the determinations required by this section of the
regulations.
(iv) The foreign inspection system must maintain a program to
assure that the requirements referred to in this section, equivalent to
those of the Federal system of egg products inspection in the United
States, are being met. The program as implemented must provide for the
following:
(A) Periodic supervisory visits by a representative of the foreign
inspection system to each plant certified in accordance with paragraph
(a)(3) of this section to ensure that requirements referred to in
paragraphs (a)(2)(ii)(A) through (H) of this section are being met:
Provided, that such visits are not required with respect to any plant
during a period when the plant is not operating or is not engaged in
producing products for exportation to the United States;
(B) Written reports prepared by the representative of the foreign
inspection system who has conducted a supervisory visit, documenting
his or her findings with respect to the requirements referred to in
paragraphs (a)(2)(ii)(A) through (H) of this section, copies of which
must be made available to the representative of the Department at the
time of that representative's review upon request by that
representative to a responsible foreign meat inspection official:
Provided, that such reports are not required with respect to any plant
during a period when the plant is not operating or is not engaged in
producing products for exportation to the United States; and
(C) Random sampling and testing at the point of production, for
residues identified by the exporting country's inspection authorities
or by this Agency as potential contaminants, in accordance with
sampling and
[[Page 6358]]
analytical techniques approved by the Administrator, provided that such
testing is required only on samples taken of egg products intended for
importation into the United States.
(3) Only those plants that are determined and certified to the
Agency by a responsible official of the foreign egg products inspection
system as fully meeting the requirements of paragraphs (a)(2)(i) and
(ii) of this section are eligible to have their products imported into
the United States. Plant eligibility is subject to review by the Agency
(including observations of the plants by official program personnel
representatives at times prearranged with the foreign egg products
inspection system officials). Foreign plants certifications must be
renewed annually. Notwithstanding certification by a foreign official,
the Administrator may terminate the eligibility of any foreign plant
for the importation of its products into the United States if it does
not comply with the requirements listed in paragraphs (a)(2)(i) and
(ii) of this section, or if current plant information cannot be
obtained. The Administrator will provide reasonable notice to the
foreign government of the proposed termination of any foreign plant,
unless a delay in terminating its eligibility could result in the
importation of adulterated or misbranded product.
(i) For a new plant, or any plant for which information from last
year's electronic certification or paper certificate has changed, the
certification or certificate must contain: The date; the foreign
country; the foreign plant's name, address, and foreign plant number;
the foreign official's title and signature (for paper certificates
only); the type of operations conducted at the plant (e.g., processing,
storage, exporting warehouse); and the plant's eligibility status
(e.g., new or relisted (if previously delisted)). Processing plant
certifications must address the type of products produced at the plant
(e.g., the process category).
(ii) If the plant information provided on the preceding year's
electronic foreign plant certification or paper certificate, as
required in paragraph (a)(3)(i) of this section, has not changed, the
certification or certificate must contain: The date, the foreign
country, the foreign plant's name, and the foreign official's title and
signature (for paper certificates only).
(4) Egg products from foreign countries not listed in paragraph (b)
of this section are not eligible for importation into the United
States, except as provided by Sec. Sec. 590.960 and 590.965. The
listing of any foreign country under this section may be withdrawn
whenever it is determined by the Administrator that the system of egg
products inspection maintained by such foreign country does not assure
compliance with requirements equivalent to all the inspection, building
construction standards, and other requirements of the Act and the
regulations in this part as applied to official plants in the United
States; or that reliance cannot be placed upon certificates required
under this part from authorities of such foreign country; or that, for
lack of current information concerning the system of egg products
inspection being maintained by such foreign country, such foreign
country should be required to reestablish its eligibility for listing.
(b) It has been determined that egg products from the following
countries covered by foreign egg products inspection certificates of
the country of origin as required by Sec. 590.915 are eligible under
the regulations in this part for entry into the United States after
inspection and marking as required by the applicable provisions of this
part: Canada, The Netherlands.
Sec. 590.915 Imported products; foreign inspection certificates
required.
(a) Except as provided in Sec. 590.960, each consignment imported
into the United States must have an electronic foreign inspection
certification or a paper foreign inspection certificate issued by an
official of the foreign government agency responsible for the
inspection and certification of the product.
(b) An official of the foreign government agency must certify that
any product described on any official certificate was produced in
accordance with the regulatory requirements of Sec. 590.910.
(c) The electronic foreign inspection certification must be in
English, be transmitted directly to FSIS before the product's arrival
at the official import inspection establishment, and be available to
import inspection personnel.
(d) The paper foreign inspection certificate must accompany each
consignment; be submitted to import inspection personnel at the
official import inspection establishment; be in English; and bear the
official seal of the foreign government responsible for the inspection
of the product, and the name, title, and signature of the official
authorized to issue the inspection certificates for products imported
into the United States.
(e) The electronic foreign inspection certification and paper
foreign inspection certificate must contain:
(1) The date;
(2) The foreign country of export and the producing foreign
establishment number;
(3) The species used to produce the product and the source country
and foreign establishment number, if the source materials originate
from a country other than the exporting country;
(4) The product's description including the process category, the
product category, and the product group;
(5) The name and address of the importer or consignee;
(6) The name and address of the exporter or consignor;
(7) The number of units (pieces or containers) and the shipping or
identification mark on the units;
(8) The net weight of each lot; and
(9) Any additional information the Administrator requests to
determine whether the product is eligible to be imported into the
United States.
Sec. 590.920 Import inspection application.
(a) Applicants must submit an import inspection application to
apply for the inspection of any product offered for entry. Applicants
may apply for inspection using a paper or electronic application form.
(b) Import inspection applications for each consignment must be
submitted (electronically or on paper) to FSIS in advance of the
shipment's arrival at the official import establishment where the
product will be reinspected, but no later than when the entry is filed
with U.S. Customs and Border Protection.
(c) The provisions of this section do not apply to products that
are exempted from inspection by Sec. Sec. 590.960 and 590.965.
Sec. 590.925 Inspection of eggs and egg products offered for entry.
(a)(1) Except as provided in Sec. Sec. 590.960 and 590.965 and
paragraph (b) of this section, egg products offered for entry from any
foreign country must be reinspected at an official import inspection
establishment or official plant by a program inspector before they may
be allowed entry into the United States.
(2) Every lot of product must routinely be given visual
reinspection by a program inspector for appearance and condition and be
checked for certification and label compliance as provided in
Sec. Sec. 590.915, 590.950, and 590.955.
(3) Program inspectors must consult the electronic inspection
system for reinspection instructions. The electronic inspection system
will assign
[[Page 6359]]
reinspection levels and procedures based on established sampling plans
and established product and plant history.
(b) Official program personnel may take, without cost to the United
States, from each consignment of egg product offered for entry, such
samples of the products as are deemed necessary to determine the
eligibility of the products for entry into the commerce of the United
States.
Sec. 590.930 Eggs and egg products offered for entry, retention in
customs custody; delivery under bond; movement prior to inspection;
handling; equipment and assistance.
(a) No egg products required by this subpart to be inspected will
be released from customs custody prior to required inspections, but
such product may be delivered to the importer, or his agent, prior to
inspection, if the importer furnishes a bond, in a form prescribed by
the Secretary of the Treasury, on the condition that the product must
be returned, if demanded, to the collector of the port where the
product was offered for clearance through customs.
(b) Notwithstanding paragraph (a) of this section, no product
required by this subpart to be inspected will be moved prior to
inspection from the port of arrival where first unloaded, and if
arriving by water from the wharf where first unloaded at such port, to
any place other than the place designated in accordance with this part
as the place where the product must be inspected; and no product will
be conveyed in any manner other than in compliance with this subpart.
(c) The importer, or his agent, must furnish such equipment and
must provide such assistance for handling and inspecting, where
applicable, egg products offered for entry as the program inspector may
require.
(d) Official import inspection establishments must provide
buildings and equipment that meet the sanitation requirements contained
in 9 CFR part 416.
Sec. 590.935 Means of conveyance and equipment used in handling egg
products offered for entry to be maintained in sanitary condition.
(a) Compartments of steamships, railroad cars, and other means of
conveyance transporting any egg products to the United States, and all
chutes, platforms, racks, tables, tools, utensils, and all other
devices used in moving and handling any egg products offered for entry
into the United States, must be maintained in accordance with 9 CFR
416.4.
(b) All conveyances containing imported liquid egg products must be
sealed by inspection authorities in the exporting country. Seals may be
broken at U.S. port-of-entry for purposes of inspection by official
program personnel or customs officers.
Sec. 590.940 Identification of egg products offered for entry;
official import inspection marks and devices.
(a) Except for products offered for entry from Canada, egg products
that upon reinspection are found to be acceptable for entry into the
United States must be identified as ``U.S. Inspected and Passed''
product. The official inspection legend shown in paragraph (b) of this
section will identify product only after completion of official import
inspection and product acceptance.
(b) The official mark for identifying egg products offered for
entry as ``U.S. Inspected and Passed'' must be in the following form,
and any device approved by the Administrator for applying such mark
must be an official device.\1\
---------------------------------------------------------------------------
\1\ The number ``I-38'' is given as an example only. The plant
number of the official plant, facility, or official import
inspection establishment where the product was inspected must be
shown on each stamp impression.
[GRAPHIC] [TIFF OMITTED] TP13FE18.002
(c) Owners or operators of plants, other than official plants, who
want to have import inspections made at their plants, must apply to the
Administrator for approval of their establishments for such purpose.
Application must be made on a form furnished by the Program, Food
Safety and Inspection Service, U.S. Department of Agriculture,
Washington, DC, and must include all information called for by that
form.
(d) No brand manufacturer or other person will cast or otherwise
make, without an official certificate issued by official program
personnel, a brand or other marking device containing an official
inspection legend, or simulation thereof, as shown in Sec. 590.940(b).
(e) The inspection legend may be placed on containers of product
before completion of the official import inspection if the containers
are being inspected by an import inspector who reports directly to a
program supervisor, the product is not required to be held at the
official import inspection establishment pending receipt of laboratory
test results, and a written procedure for the controlled stamping,
submitted by the official import inspection establishment and approved
by the Food Safety and Inspection Service, is on file at the import
inspection location where the inspection is to be performed.
(f)(1) The written procedure for the controlled release and
identification of product should be in the form of a letter and must
include the following:
(i) That stamping under this subpart is limited to those lots of
product that can be inspected on the day that certificates for the
product are examined;
(ii) That all products that have been pre-stamped will be stored in
the facility where the import inspection will occur;
(iii) That inspection marks applied under this part will be removed
from any lot of product subsequently refused entry on the day the
product is rejected; and
(iv) That the establishment will maintain a daily stamping log
containing the following information for each lot of product: The date
of inspection, the country of origin, the foreign establishment number,
the product name, the number of units, the shipping container marks and
foreign inspection certificate number covering the product to be
inspected. The daily log must be retained by the establishment in
accordance with Sec. 590.200.
(2) An establishment's controlled program privilege may be
cancelled orally or in writing by the inspector who is supervising its
enforcement whenever the inspector finds that the establishment has
failed to comply with the provisions of this subpart or any conditions
imposed pursuant thereto. If the cancellation is oral, the decision and
the reasons for it must be confirmed in writing, as promptly as
circumstances allow. Any person whose controlled pre-stamping program
privilege has been cancelled may appeal the decision to the
Administrator, in writing, within ten (10) days after receiving written
notification of the cancellation. The appeal must state all of the
facts and reasons upon which the person relies to show that the
controlled program was wrongfully cancelled. The Administrator will
grant or deny the appeal, in writing, stating the reasons
[[Page 6360]]
for such decision, as promptly as circumstances allow. If there is a
conflict as to any material fact, a hearing must be held to resolve
such conflict. Rules of practice concerning such a hearing will be
adopted by the Administrator. The cancellation of the controlled pre-
stamping privilege will be in effect until there is a final
determination of the preceding.
Sec. 590.945 Eggs and egg products offered for entry; reporting of
findings to customs; handling of articles refused entry; appeals, how
made; denaturing procedures.
(a)(1) Official program personnel must report their findings as to
any product that has been inspected in accordance with this subpart to
the Director of Customs at the original port of entry where the same is
offered for clearance through Customs inspection.
(2) When product is refused entry into the United States, the
official mark to be applied to the product refused entry must be in the
following form:
[GRAPHIC] [TIFF OMITTED] TP13FE18.003
(3) When product has been identified as ``U.S. Refused Entry,''
official program personnel must request the Director of Customs to
refuse admission of such product and to direct that it be exported by
the owner or importer within the time specified in this section, unless
the owner or importer, within the specified time, causes it to be
destroyed by disposing of it under the supervision of official program
personnel so that the product can no longer be used as human food, or
by converting it to animal food uses, if permitted by the Food and Drug
Administration. The owner or importer of the refused entry product must
not transfer legal title to such product, except to a foreign importer
for direct and immediate exportation, or to an end user, e.g., an
animal food manufacturer or a renderer, for destruction for human food
purposes. ``Refused entry'' product must be delivered to and used by
the manufacturer or renderer within the 45-day time limit provided in
paragraph (a)(4) of this section. Even if such title is illegally
transferred, the subsequent purchaser will still be required to export
the product or have it destroyed under paragraph (a)(4) of this
section.
(4) The owner or importer will have 45 days after notice is given
by FSIS to the Director of Customs at the original port of entry to
take the action required in paragraph (a)(3) of this section for
``refused entry'' product. An extension beyond the 45-day period may be
granted by the Administrator when extreme circumstances warrant it,
e.g., a dock workers' strike or an unforeseeable vessel delay.
(5) If the owner or importer fails to take the required action
within the time specified under paragraph (a)(4) of this section, the
Department will take such actions as may be necessary to effectuate its
order to have the product destroyed for human food purposes. The
Department will seek court costs and fees, storage, and proper expenses
in the appropriate forum.
(6) No egg product that has been refused entry and exported to
another country pursuant to paragraph (a)(3) of this section may be
returned to the United States under any circumstances. Any such product
so returned to the United States will be subject to administrative
detention in accordance with section 1048 of the Act and seizure and
condemnation in accordance with section 1049 of the Act.
(7) Egg products that have been refused entry solely because of
misbranding may be brought into compliance with the requirements of
this chapter under the supervision of an authorized representative of
the Administrator.
(b) Upon the request of the Director of Customs at the port where
an egg product is offered for clearance through the customs, the
importer of the product must, at the importer's own expense,
immediately return to the Director any product that has been delivered
to the importer under this subpart and subsequently designated ``U.S.
Refused Entry'' or found in any request not to comply with the
requirements in this part.
(c) Except as provided in Sec. 590.930(a) or (b), no person will
remove or cause to be removed from any place designated as the place of
inspection of egg products that the regulations in this part require to
be identified in any way, unless the same has been clearly and legibly
identified in compliance with this part.
(d) Any person receiving inspection services may, if dissatisfied
with any decision of an inspector relating to any inspection, file an
appeal from such decision. Any such appeal from a decision of an
inspector must be made to the inspector's immediate supervisor having
jurisdiction over the subject matter of the appeal, and such supervisor
must determine whether the inspector's decision was correct. Review of
such an appeal determination, when requested, must be made by the
immediate supervisor of the Department employee making the appeal
determination. The egg products involved in any appeal must be
identified by U.S. retained tags and segregated in a manner approved by
the inspector pending completion of an appeal inspection.
(e) All loss or inedible eggs, or inedible egg products must be
disposed of in accordance with Sec. 590.504(c)(1).
Sec. 590.950 Labeling of immediate containers of egg products offered
for entry.
(a) Immediate containers of product offered for entry into the
United States must bear a label, printed in English, showing:
(1) The name of the product;
(2) The name of the country of origin of the product, and for
consumer packaged products, preceded by the words ``Product of,'' which
statement must appear immediately under the name of the product;
(3) [Reserved];
[[Page 6361]]
(4) The word ``Ingredients'' followed by a list of the ingredients
in order of descending proportions by weight;
(5) The name and place of business of the manufacturer, packer, or
distributor, qualified by a phrase which reveals the connection that
such person has with the product;
(6) An accurate statement of the quantity;
(7) The inspection mark of the country of origin;
(8) Plant number of the plant at which the egg products were
processed; and
(9) The date of production and plant number of the plant at which
the egg products were processed or packed.
(b) For properly sealed and certified shipments of shell eggs for
breaking at an official plant, the immediate containers need not be
labeled, provided that the shipment is segregated and controlled upon
arrival at the destination breaking plant.
(c) The labels must not be false or misleading in any respect.
Sec. 590.955 Labeling of shipping containers of egg products offered
for entry.
Shipping containers of imported egg products are required to bear
in a prominent and legible manner the name of the product, the name of
the country of origin, the foreign inspection system plant number of
the plant in which the product was processed, shipping or
identification marks, production codes, and the inspection mark of the
country or origin. Labeling on shipping containers must be examined at
the time of inspection in the United States and if found to be false or
misleading, the product must be refused entry.
Sec. 590.956 Relabeling of imported egg products.
(a) Egg products eligible for importation may be relabeled with an
approved label under the supervision of an inspector at an official
plant or official import inspection establishment. The new label for
such product must indicate the country of origin, except for egg
products that are processed (repasteurized or, in the case of dried
product, dry blended with product produced in the United States) in an
official plant.
(b) Egg products that have been refused entry into the United
States solely because of misbranding may be brought into compliance
with the labeling requirements of this chapter.
(c) The label for relabeled products must state the name, address,
and zip code of the distributor, qualified by an appropriate term such
as ``packed for'', ``distributed by'', or ``distributors''.
Sec. 590.960 Small importations for importer's personal use, display,
or laboratory analysis.
Egg products (other than those that are forbidden entry by other
Federal law or regulation) from any country, that are exclusively for
the importer's personal use, display, or laboratory analysis, and not
for sale or distribution; that are sound, healthful, wholesome, and fit
for human food; and that are not adulterated and do not contain any
substance not permitted by the Act or regulations, may be admitted into
the United States without a foreign inspection certificate. Such
products are not required to be inspected upon arrival in the United
States and may be shipped to the importer without further restriction
under this part, except as provided in 9 CFR 590.925(b), provided that
the Department may, with respect to any specific importation, require
that the importer certify that such product is exclusively for said
importer's personal use, display, or laboratory analysis and not for
sale or distribution. The amount of liquid, frozen, or dried egg
products imported must not exceed 50 pounds.
Sec. 590.965 Returned to the United States inspected and identified
covered products; exemption.
U.S. inspected and passed and so marked egg products exported to
and returned from foreign countries will be admitted into the United
States without compliance with this part upon notification to and
approval of the Food Safety and Inspection Service, in specific cases.
SUBCHAPTER I--EGG PRODUCTS INSPECTION ACT
0
74. Add part 591 to read as follows:
PART 591--SANITATION REQUIREMENTS AND HAZARD ANALYSIS AND CRITICIAL
CONTROL POINT SYSTEMS
Sec.
591.1 Basic requirements.
591.2 Hazard analysis and HACCP plan.
Authority: 21 U.S.C. 1031-1056; 7 CFR 2.18, 2.53.
Sec. 591.1 Basic requirements.
(a) All official plants must comply with the requirements contained
in 9 CFR parts 416, Sanitation, and 417, Hazard Analysis and Critical
Control Point (HACCP) Systems, except as otherwise provided in this
chapter.
(b) For the purposes of 9 CFR parts 416, Sanitation, 417, Hazard
Analysis and Critical Control Point (HACCP) Systems, and 500, Rules of
Practice, an official establishment or establishment includes an
official plant.
Sec. 591.2 Hazard analysis and HACCP plan.
Pursuant to 21 U.S.C. 1035 and 1043, the failure of an official
plant to develop and implement a HACCP plan that complies with 9 CFR
part 417, or to operate in accordance with the requirements in this
part, may render the products produced under those conditions
adulterated.
Done at Washington, DC, on: January 9, 2018.
Paul Kiecker,
Acting Administrator.
[FR Doc. 2018-00425 Filed 2-12-18; 8:45 am]
BILLING CODE 3410-DM-P