[Federal Register Volume 66, Number 4 (Friday, January 5, 2001)]
[Rules and Regulations]
[Pages 1190-1204]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-95]
[[Page 1189]]
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Part II
Department of Agriculture
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Agricultural Marketing Service
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7 CFR Part 54
Regulations Governing the Certification of Sanitary Design and
Fabrication of Equipment Used in the Processing of Livestock and
Poultry Products; Final Rule
Federal Register / Vol. 66 , No. 4 / Friday, January 5, 2001 / Rules
and Regulations
[[Page 1190]]
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DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 54
[Docket No. LS-98-09]
RIN 0581-AB69
Regulations Governing the Certification of Sanitary Design and
Fabrication of Equipment Used in the Processing of Livestock and
Poultry Products
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
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SUMMARY: The Agricultural Marketing Service (AMS) has developed a
voluntary, user-fee-funded program under the provisions of the
Agricultural Marketing Act of 1946 to inspect and certify equipment and
utensils used to process livestock and poultry products. Livestock and
poultry processing equipment and utensils inspected and certified by
AMS to voluntary consensus standards for sanitary design will provide a
third party assurance that they meet minimum requirements for
cleanability, suitability of materials used in construction, durability
and inspectability.
EFFECTIVE DATE: January 8, 2001.
FOR FURTHER INFORMATION CONTACT: Barry Carpenter, Deputy Administrator,
Livestock and Seed Program, by telephone at (202) 720-5705 or by Fax at
(202) 720-3499.
SUPPLEMENTARY INFORMATION: The information that follows has been
divided into three sections. The first one provides background
information including a summary of the history of this rulemaking
process. The second section provides a summary of the comments received
in response to the proposed rule published in the Federal Register on
June 6, 2000, and the Agency's responses to these comments including
changes made in this final rule as a result of the comments. The last
section provides the impact analysis section that addresses various
requirements including the Regulatory Flexibility Act, the Paperwork
Reduction Act, Civil Rights Review, and the relevant Executive Orders.
I. Background
Provisions of the Agriculture, Rural Development, Food and Drug
Administration, and Related Agencies Appropriations Act, 2001, (Pub. L.
106-387, sec. 729) require AMS to develop a voluntary, user-fee-funded
program to inspect and certify equipment and utensils used to process
livestock and poultry products. Prior to this amendment, similar
language appeared in appropriations acts for fiscal year 1999 (Pub. L.
105-277, sec. 747) and fiscal year 2000 (Pub. L. 106-78, sec. 734). The
program will be conducted under the provisions of the Agricultural
Marketing Act (AMA) of 1946 (7 U.S.C. 1621 et seq.). From 1975 to 1997,
a similar function was carried out by USDA on a mandatory prior
approval basis by USDA's Food Safety and Inspection Service (FSIS) as a
prerequisite for equipment use in federally inspected meat and poultry
packing and processing establishments. The FSIS Equipment Branch
formally evaluated equipment and utensils proposed by manufacturers or
suppliers before they could be used in official establishments to
assure they could be maintained in a sanitary condition. The program
focused on identifying and correcting problems during the initial
development of equipment and utensils.
FSIS's acceptance of new, modified, or reconditioned equipment and
utensils for use in federally inspected meat and poultry establishments
was a two-step process. First, FSIS Equipment Branch personnel
evaluated the design and construction of equipment by reviewing
assembly-type drawings and corresponding parts and material lists
submitted to the Branch by the equipment manufacturer. Then, if
necessary, FSIS inspectors reviewed the in-establishment operation of
the equipment and reported their findings to the Equipment Branch.
Commercially available equipment was accepted and listed in an FSIS
reference guide, ``Accepted Meat and Poultry Equipment.'' Once
equipment was listed in this reference as acceptable, no further
approval was needed on an establishment basis.
FSIS continues to ensure that equipment and utensils used in
federally inspected facilities are of such material and construction as
will facilitate their thorough cleaning and operational cleanliness,
and not adulterate edible product. Also, FSIS still requires that
equipment and utensils used in federally inspected establishments are
constructed, maintained, and used in a manner that does not interfere
with inspection. However, in an effort to remove ``command and
control'' regulations that were contrary to FSIS' commitment to the
Hazard Analysis and Critical Control Point approach to Federal meat
inspection, and to provide federally inspected establishments with the
flexibility to use equipment and utensils designed in the manner they
deem to best maintain a sanitary environment for food production
without having to seek prior approval, FSIS discontinued the mandatory
prior approval program for equipment and utensils on September 24, 1997
(62 FR 45016).
At the time FSIS announced that it was discontinuing its prior
approval program, equipment and utensil manufacturers and processors of
livestock and poultry products expressed their desire to either
continue the FSIS program or develop a new program through AMS on a
voluntary, user-fee-funded basis to inspect and certify equipment and
utensils used to process livestock and poultry products to a sanitary
standard. Subsequently, provisions of the fiscal year 1999
appropriations required development of such a program by the Secretary
of Agriculture under the authority AMA of 1946.
Accordingly, on July 16, 1999, AMS published in the Federal
Register (64 FR 38315) an advance notice of proposed rulemaking (ANPRM)
and notice of public meeting to assist the Agency in the development of
a complete inspection and certification program for equipment and
utensils used to process livestock and poultry products.
Through the ANPRM and the public meeting, AMS sought information
which would enable the Agency to develop an efficient and cost-
effective program for inspecting and certifying equipment and utensils
used to process livestock and poultry products. Specifically, AMS
requested comments concerning: initiatives underway in the industry to
develop a voluntary, consensus sanitary standard for the design and
manufacture of equipment and utensils used to process livestock and
poultry products; the validity and usability of standards presented to
AMS for consideration for adoption; criteria to be used by AMS to
select a sanitary standard; and any other information which would aid
AMS in administering the program.
The ANPRM solicited comments on the issue for a 60-day period
ending September 14, 1999. The public meeting was held on August 10,
1999, in Room 107-A at the USDA Jamie L. Whitten Building, 12th and
Jefferson Drive, SW., Washington, DC.
To assist interested parties in obtaining information on the
proposed program and in reviewing comments as AMS received them, the
Agency launched a website at www.ams.usda.gov/lsg/equip.htm. Contained
on this website were electronic versions of the AMS press releases
related to the development of
[[Page 1191]]
the program, the ANPRM, complete transcripts of the August 10, 1999,
public meeting, and all comments received.
The public meeting was attended by 42 representatives of the meat
and poultry packing and processing industry, equipment and utensil
manufacturing industry, trade and professional associations, standards
developers, and other interested parties. Twelve individuals provided
prepared remarks at the meeting. AMS received 51 comments during the
comment period for the ANPRM.
On June 6, 2000, AMS published in the Federal Register (65 FR
35857), a proposed rule which responded to the ANPRM comments and
solicited additional public comment. AMS received 100 comments during
the comment period which ended August 7, 2000. The regulatory text of
this final rule incorporates changes made in response to these comments
and upon further review by AMS.
II. Comments and Responses
General Program Comments
Support for Program
Summary of Comments: Forty-one commenters expressed general support
of the development of the program as presented in the proposed rule
which included the standards developed by the NSF/3-A Joint Committee
on Food Processing Equipment, the voluntary aspects of the service, and
the use of Federal employees to provide the service. Thirty-three of
these commenters specifically supported AMS as the certifying agency.
Agency Response: AMS has considered these comments in support of
the program as it has contemplated changes from the proposed rule to
this final rule.
Program Would Become Mandatory Requirement
Summary of Comments: Three commenters expressed concern that this
program would become a ``de-facto'' mandatory requirement and that AMS
should clearly state in the final rule that equipment manufacturers
remain free to obtain other third party certifications or can ``self-
certify'' that equipment is sanitarily designed and manufactured.
Agency Response: Throughout the development of these regulations
and this program, AMS has maintained that the service to be implemented
is voluntary and user-fee-funded. Accordingly, no equipment fabricator
or user is required to participate in this program. Private
certification providers can propose and offer other services to the
livestock and poultry industries without restriction by these
regulations. Therefore, equipment fabricators and users may use
whatever means they desire, including ``self certification'', as
suggested by commenters, to market or represent their products.
Comments Referring to AMS Providing the Inspection and Certification
Service
Competition With the Private Sector
Summary of Comments: Five commenters generally opposed AMS
providing the certification service because of concerns over public-
private competition. One commenter also asserted that the Office of
Management and Budget (OMB), Circular A-76 requires Federal agencies to
use private sector services rather than offer duplicative services.
Agency Response: The comments received during the comment periods
for the both ANPRM and the proposed rule indicate a clear desire by the
livestock and poultry industry that this voluntary certification
service be provided by AMS using government employees. These final
regulations establish a voluntary, third-party evaluation service
administered by AMS which is consistent with other, similar services
provided by AMS for the inspection and grading of agricultural
products, for laboratory services, for the evaluation of the sanitary
design of equipment used in the dairy industry, and for the display of
official identification marks. As such, no equipment fabricator or user
is required to participate in this AMS service and equipment
manufacturers and other users may choose any other voluntary, private
certification service available to them. Furthermore, the regulations
do not prevent, exclude or limit any private organization from
independently offering a certification service of their own design to
the livestock and poultry industry. With regard to concerns over the
regulation's conformance with OMB Circular A-76, it is our view that
this rule is consistent with the provisions of the Circular.
Effect of Program on Private Certification Providers
Summary of Comments: One commenter stated that AMS failed to
consider the potential effects of the regulation upon private
certification providers.
Agency Response: AMS did consider potential effects upon third
parties. The service to be implemented by AMS is voluntary and user-
fee-funded. As already stated, no equipment fabricator or user is
required to participate in this program. Private certification
providers may offer their services to the livestock and poultry
industries without restriction by these regulations. Therefore,
equipment fabricators and users may use whatever means they desire to
demonstrate that their products are suitable for use.
Reexamine Alternatives to Proposed Program
Summary of Comments: One commenter asked AMS to reexamine
alternatives under the agricultural appropriations act considering
programs already implemented or publicly contemplated by AMS and offer
an accreditation service for conformity assessment organizations in
lieu of a certification service.
Agency Response: The Act provides that USDA develop a voluntary,
user-fee-funded program to inspect and certify equipment used to
process livestock and poultry products. Accordingly, the Agency
examined alternatives, including the alternative suggested by the
commenter. Additionally, AMS evaluated comments received in response to
the ANPRM and the proposed rule as the alternatives were considered.
The alternative option to develop a third-party certifier accreditation
service was evaluated and rejected by AMS. The statutory language
provides that the Secretary inspect and certify agricultural processing
equipment. Further, a significant number of comments during the comment
periods for the ANPRM and proposed rule which supported an AMS provided
service staffed by Federal employees to conduct the evaluations.
Conformance of Program to ISO and ANSI Standards for Third Party
Certification Bodies
Summary of Comments: Two commenters stated the proposed program did
not conform to ISO or American National Standards Institute (ANSI)
provisions or standards for third party certification bodies.
Agency Response: It has never been the objective or intent that the
certification service provided by AMS would conform to ISO or ANSI
provisions or standards for third party certification bodies. AMS
intends to operate this program consistent with other voluntary, user-
fee-funded inspection and certification services already provided by
the Agency. AMS believes that this decision is consistent with the
intent of Congress and the expectation of equipment manufacturers and
meat and poultry processors who requested AMS develop the service.
[[Page 1192]]
Continued Compliance with NSF/3-A Standards
Summary of Comments: Two commenters stated that the proposed
program did not provide for continued compliance with the NSF/3-A
Standard and that the regulations need to offer interested parties the
opportunity to question the appropriateness of an AMS certification of
compliance. Additionally, one commenter asked what would happen to
those manufacturers who do not report a change in the design of their
equipment to AMS, and how would AMS verify if a change had occurred and
was not reported.
Agency Response: After a review of the proposed regulations, AMS
believes these comments have merit. Accordingly, Sec. 54.1019 has been
modified to require a manufacturer of any equipment or utensil which
has been issued a report or certification of compliance to resubmit for
evaluation any change in materials of construction, design, or
fabrication which may impair the cleanability or hygienic design of the
equipment or utensil. Similarly, AMS encourages interested parties to
contact AMS if they have any questions regarding the appropriateness of
an AMS certification of compliance. AMS can use this feedback as a
basis for initiating a review to ensure that equipment marketed as
certified through this program comply with the standards.
Recertification of Equipment
Summary of Comments: Seventy-two commenters requested AMS clarify
or streamline the process for recertification of equipment. The
commenters expressed confusion as to AMS' intent behind the wording
used in the proposal stating that recertification by AMS was required
after ``any'' change to the design was made. Commenters generally
favored AMS only requiring recertification of equipment when a change
of design is made that may affect the hygienic, cleanliness, or
sanitary aspects of the equipment.
Agency Response: AMS agrees and has revised Sec. 54.1019 in these
regulations to clarify that only changes which impair the cleanability
or hygienic design of the equipment or utensil need to be submitted for
recertification.
Independent Audits
Summary of Comments: One commenter stated that the program did not
provide for independent audits of the manufacturing facility.
Agency Response: The regulations do not provide for such audits as
such audits are not intended to be a part of this service. AMS believes
a requirement in these regulations for independent audits of the
equipment or utensil manufacturers' facilities is not necessary. The
addition of an AMS audit requirement of the manufacturer's facilities
would substantially increase the cost of this voluntary program and the
Agency believes the marginal benefit of such audits would be
unwarranted. Additionally, the FSIS inspection program continues to be
responsible for ensuring that equipment and utensils used in federally
inspected facilities are of such material and construction as will
facilitate their through cleaning and operational cleanliness, and not
adulterate edible product. AMS believes the service to be provided by
these regulations, particularly those in Secs. 54.1019, contain
sufficient internal controls to protect the integrity of its
evaluations and certifications.
Requiring Samples, Material Lists and On-site Audits
Summary of Comments: One commenter objected to the program not
requiring examination of samples, materials lists, or on-site audits.
Three additional commenters requested clarification on the issue of
when an on-site audit is required.
Agency Response: In order to allow for the greatest flexibility for
applicants to apply for this service, AMS does not require blueprints,
samples, and materials list be submitted with the application for all
pieces of equipment and utensils. However, if sufficient information is
unavailable for AMS to accurately evaluate the design of a specific
piece of equipment or utensil, which could include the materials used
in construction, a report or certification of acceptance will not be
granted until such information that is required to perform the
inspection is provided.
With respect to on-site audits, the evaluation and certification
process includes the fabrication of the equipment or utensil. The only
means available to AMS to accurately determine that acceptable
fabrication techniques have been accomplished is to evaluate the
completed piece of equipment or utensil. Depending upon the size and
complexity of the equipment or utensil, this determination can only be
accomplished with an on-site evaluation. Once a report or certificate
of acceptance has been issued, additional on-site evaluations would be
necessary only if the fabricator modified the design and requests a
recertification under the provisions of Sec. 54.1019. As appropriate to
the review and evaluation process, AMS will conduct on-site reviews of
the actual equipment at the point of fabrication or where installed.
Section 54.1014 provide the regulatory language outlining the
requirements for accessability of the equipment for evaluation.
Because AMS believes that blueprints, material lists and on-site
audits will be required in virtually every instance envisioned by the
Agency, the cost burden estimates for this program put forward in the
Impact Analysis section of this rule assume all applicants will submit
such documentation and will receive an on-site audit.
Model Lines
Summary of Comments: Ten commenters requested clarification of how
AMS would process equipment which is part of a model line.
Specifically, they requested clarification as to whether each member of
the model line needed to be submitted for evaluation and certification.
Agency Response: AMS agrees that a clarification is needed.
Accordingly, Sec. 54.1006 has been modified by adding the wording,
``Equipment or utensils having an identical design, materials of
construction, and fabrication, except for scaling up or down in size,
may be submitted for evaluation as a model line or series.''
Four Year Certification Review
Summary of Comments: Three commenters objected to the requirement
that certification must be reviewed every 4 years.
Agency Response: AMS disagrees. Based on experience, AMS believes
equipment design and fabrication change frequently to meet the demands
and needs of the equipment users. Section 54.1019 provides the
requirements for these changes to be accommodated within the evaluation
and certification process. For those types of equipment or utensil
which change infrequently or not at all, the regulations provide for a
simple procedure whereby the fabricator can state that no changes in
the design or fabrication have occurred. AMS continues to support the
need for these provisions as program integrity safeguards that the
certifications issued by AMS are valid and that the four year
recertification cycle is appropriate for AMS needs while not being
overly restrictive to the livestock and poultry industries.
[[Page 1193]]
Comments Referring to the Selection of Standards That AMS Will Inspect
and Certify Equipment To
Support for Adoption of NSF/3-A Standards
Summary of Comments: Twenty-two commenters supported the adoption
of the standards developed by the NSF/3-A Joint Committee on Food
Processing Equipment.
Agency Response: AMS has adopted these standards as the basis of
this certification program.
Incorporation of NSF/3-A Standards
Summary of Comments: Sixty-nine commenters stated opposition to the
way AMS incorporated the NSF/3-A standard in the proposed regulations.
Commenters requested any changes to the standards be made through
notice and comment in the Federal Register. One of the commenters
stated AMS failed to follow OMB Circular A-119 made in the proposed
rule.
Agency Response: As stated in the proposed rule, AMS will inspect
and certify equipment and utensils to standards developed by the NSF/3-
A Joint Committee on Food Processing Equipment. NSF is an ANSI
Designated Audited Certifier. As such, NSF follows all ANSI procedures
for standards development and the final published standards will be
ANSI/NSF/3-A standards consistent with the provisions of OMB Circular
A-119. AMS believes that these ANSI procedures provide for the required
participation by all interested parties during all phases of the
standards development process to ensure all points of view or concerns
are considered before publication of the final standard. However, apart
from the ANSI procedures for standards development, AMS encourages
public comment on all of its services, and the standards the Agency
uses as the basis of its services, including this program. To ensure
that public comment is received prior to changes in the standards AMS
uses, AMS will provide notice of pending changes in the standards to
encourage interested parties to provide AMS with feedback and so they
may also comment directly to the NSF/3-A Joint Committee.
Enforcement of the Worker Safety Provisions of the NSF/3-A Standards
Summary of Comments: Seventy-two commenters requested the program
not enforce the worker safety provisions of the NSF/3-A standards
adopted.
Agency Response: The scope of the NSF/3-A standards apply only to
the hygienic requirements of the equipment or utensil design and had
not intended to evaluate or comment on worker or occupational safety
issues. Similar comments were also made to the NSF/3-A Joint Committee.
In August 2000, the Joint Committee published NSF/3-A 14159-1, Draft
7.0 which included modified wording to delete the references to worker
and occupational safety from application to livestock and poultry
processing equipment and utensils. In view of the changes to the
standards effected by the NSF/3-A Joint Committee, AMS believes the
concerns raised by the commenters has been resolved and no additional
action is needed by AMS.
Opposition to Use of Draft Standards
Summary of Comments: Two commenters objected to the use of the NSF/
3-A standard because it is a draft standard.
Agency Response: At the time of the publication of the proposed
rule the NSF/3-A standard was a draft standard, however the final ANSI/
NSF/3-A standard has now been published and accepted as an American
National Standard.
AMS Proposing One or Many Standards
Summary of Comments: One commenter was confused whether AMS was
proposing one standard or many standards.
Agency Response: AMS will inspect and certify equipment and
utensils to standards developed by the NSF/3-A Joint Committee on Food
Processing Equipment. This Joint Committee will develop a wide-range of
standards dealing with the hygienic design of equipment. As already
stated, one standard has been completed by the Joint Committee and the
committee is in the process of developing additional consensus
standards. It is the intent of AMS to inspect and certify equipment and
utensils to all standards finalized by the Joint Committee that are
appropriate to the livestock and poultry industries. As standards are
developed, this may result in the application of multiple standards by
AMS to the appropriate pieces of equipment and utensils, as well as to
the appropriate segments of the industry.
AMS Should Develop Its Own Standards
Summary of Comments: One commenter stated that they would have
preferred that AMS write its own standards.
Agency Response: AMS disagrees. As already stated, AMS will inspect
and certify equipment and utensils to standards developed by the NSF/3-
A Joint Committee on Food Processing Equipment. AMS does not believe
that the development of a new AMS standards would improve the service
or provide users with any benefits.
Use of ISO Standards
Summary of Comments: One commenter recommended that any third party
certifier should use International Organization for Standardization
(ISO) standards.
Agency Response: The primary purpose of the regulations is to
provide a third party certification that equipment meet specified
standards. The service developed by AMS is intended to meet the needs
expressed by the domestic livestock and poultry industries for a third
party evaluation of the sanitary design of processing equipment
according to specified standards. However, during development of the
service, AMS did evaluate and consider international harmonization and
compatibility with appropriate ISO standards. The standards developed
by the NSF/3-A Joint Committee on Food Processing Equipment, which will
be used by AMS, are based on the corresponding ISO standard, ISO/DIS
14159:1997 Safety of Machinery--Hygiene requirements for the design of
machinery.
Representation of Manufacturers in NSF/3-A Standards Development
Process
Summary of Comments: Two commenters objected to the use of the NSF/
3-A standards because ``manufacturers were not represented''.
Agency Response: Equipment manufacturers are represented on the
Joint Committee and the technical working groups. Further, the ANSI
procedures followed by the Joint Committee for the development of
standards requires that all interested parties be included in the
development process.
Support for Other Standards
Summary of Comments: One commenter requested AMS adopt the ANSI/UL
2128--Meat and Poultry Plant Equipment Standard developed by the
Underwriters Laboratories, Inc., instead of the NSF/3-A standard
because the ANSI/UL 2128 standard is the American National Standard.
Agency Response: Since publication of the proposed rule, the NSF/3-
A Joint Committee has now finalized their deliberation and published
the draft standard that was proposed in final form. Accordingly, the
NSF/3-A standard is now an American National Standard.
[[Page 1194]]
Suggested Revisions to NSF/3-A Standards
Summary of Comments: Thirteen commenters provided specific
revisions that they would like made to the hygienic portions of the
NSF/3-A draft standards.
Agency Response: AMS appreciates this feedback and will use it as
it evaluates revisions that may need to be made to the NSF/3-A
standards. AMS also recommends the commenters direct their specific
revision changes to the NSF/3-A Joint Committee, NSF International, P.
O. Box 130140, 789 N. Dixboro Rd., Ann Arbor, MI 48105.
As already stated, AMS encourages public comment on all of its
services, and the standards the Agency uses as the basis of its
services, including this program. To ensure that public comment is
received prior to changes in the standards AMS uses, AMS will provide
notice of pending changes in the standards to encourage interested
parties to provide AMS with feedback and so they may also comment
directly to the NSF/3-A Joint Committee.
Comments Referring to Administrative Issues
Grandfathering of Equipment Approved Under the Former FSIS Program
Summary of Comments: Two commenters requested that equipment
approved under the former FSIS prior-approval program be
``grandfathered'' under this program.
Agency Response: AMS disagrees. The standards applicable under the
two programs are different. It would be inappropriate for AMS to
``grandfather'' equipment that did not meet the standards proposed
under this service that would then compete in the market place with
equipment fabricators complying with the new standards.
AMS Work With Industry Associations
Summary of Comments: One commenter requested we inform the industry
associations about what we are doing.
Agency Response: AMS agrees. AMS has participated in a number of
informational meetings with all of the major industry trade
associations whose members use AMS programs and services.
Keep Program Simple and Straightforward
Summary of Comments: One commenter requested we keep the program as
``simple and straightforward'' as possible.
Agency Response: AMS agrees. It is the goal of AMS in these
regulations to provide a voluntary, user-fee-funded evaluation and
certification program that meets the needs of the livestock and poultry
industries, and is carried out in a manner as simple, straightforward,
efficiently and cost effective as possible.
Marketing Claims
Summary of Comments: Nine commenters expressed concern over
language in the proposed rule restricting the use of marketing claims
on promotional literature for equipment not approved by this program.
Additionally, commenters requested that approval letters from the
former FSIS prior-approval program be allowed to be used and that such
equipment be allowed to be marketed with the claim ``USDA accepted
equipment'' and ``USDA approved.''
Agency Response: AMS disagrees. The standards and procedures
provided for in these regulations are different than those implemented
by the FSIS prior-approval program. As such, it would be unfair to
participants in the this new program to have to compete with claims of
manufacturers sanctioned under the former FSIS program which have not
participated in this new AMS service. FSIS discontinued the mandatory
prior approval program for equipment and utensils on September 24, 1997
(62 FR 45016). Since that time, there has been no procedure available
to assure that the equipment or utensils covered by letters issued
during the former FSIS program accurately represent the current
equipment design or that such equipment even still meet current FSIS
requirements.
Program Budgeting and Appropriations by Congress
Summary of Comments: One commenter stated their belief that the new
service would be subject to congressional budgeting and appropriations.
Agency Response: The commenter is not correct. This service is
fully user-fee supported.
AMS Staffing Levels and Certification Turnaround Times
Summary of Comments: Four commenters expressed concern over AMS
staffing levels and turnaround times on certifications. Two of the
commenters specifically asked that AMS include a maximum certification
turnaround time in the regulations (30 and 60 days).
Agency Response: AMS will staff the program with sufficient
personnel to accomplish the goals of the program using the best
estimates available to AMS while still operating the program in an
efficient and cost effective manner. AMS disagrees with the suggestion
of commenters to include a maximum turnaround time in the regulations.
Due to the complexity and sophistication of many of the designs
eligible for evaluation and certification, turnaround time restrictions
could be unrealistic and ultimately detrimental to the evaluation
process.
Rejections of Applications
Summary of Comments: One commenter objected to AMS being able to
reject an application based on ``administrative reasons such as the
non-availability of personnel to perform the service.''
Agency Response: AMS disagrees. While AMS intends to provide
service to applicants consistent with this subpart, there may be
instances where such service may not be provided. Accordingly, the
provision will remain unchanged.
Acceptance of Program by FSIS
Summary of Comments: One commenter requested AMS work to ensure
this program is accepted by FSIS.
Agency Response: AMS has worked to ensure FSIS is fully aware of
the services being developed by AMS. Additionally, AMS has informed
FSIS of our availability to provide information about this service to
their management or employees.
Third-party Appeal of Certification
Summary of Comments: One commenter requested that a section be
added to the final rule allowing for users or other third-parties to
question AMS certifications.
Agency Response: As already stated, AMS encourages interested
parties to contact AMS if they have any questions regarding the
appropriateness of an AMS certification of compliance. AMS can use this
feedback as a basis for initiating a review to ensure that equipment
marketed as certified through this program comply with the standards.
The Agency believes this addresses the concern of the commenter
sufficiently without the need for the insertion of a new section in the
regulations. Accordingly, the regulations will remain unchanged.
Concurrent Reviews for Dairy and Meat and Poultry Equipment
Summary of Comments: One commenter requested that to improve
efficiency, dairy and meat and poultry equipment reviews be done
concurrently.
[[Page 1195]]
Agency Response: Although these regulations do not specifically
provide for a ``concurrent'' review of equipment to be accepted for use
under both this and the dairy equipment acceptance program, reviews
will be conducted concurrently to all applicable standards upon the
request of an applicant using the joint form used for both programs,
DA-162, Equipment Review Request.
AMS Accepted Equipment Symbol Confusing
Summary of Comments: One commenter objected to the AMS symbol as
confusing and leading observers to believe that the equipment bearing
the symbol has the endorsement of FSIS.
Agency Response: AMS disagrees. These regulations are intended to
meet the needs expressed by the domestic livestock and poultry
industries for a third party evaluation of the sanitary design of
processing equipment according to specified standards. These
regulations and the services they provide for do not obligate or
require any action on the part of FSIS. AMS believes these regulations
can be used by the livestock and poultry industries to demonstrate they
have had a third party evaluation of the hygienic design and
fabrication of processing equipment according to specified standards.
The symbol clearly references only AMS as the agency within USDA
certifying acceptance. There is no reference, intended or implied, in
these regulations of FSIS sanction of the symbol or the acceptance it
represents. FSIS regulations specifically identify their responsibility
for ensuring all Federally inspected meat and poultry establishments
produce safe and wholesome products, regardless of whether the
equipment and utensils used to process the products were certified by
AMS under the provisions of this regulation.
Size and Format of AMS Accepted Equipment Symbol
Summary of Comments: Four commenters expressed concern over the
size and format of the USDA ``Accepted Equipment'' symbol.
Agency Response: AMS agrees that the regulations were not
sufficiently clear on the intended size of the symbol. Section 54.1018
has been revised to include subsection (c) recommending at least a 3/4
by 3/4 inch size for the official AMS symbol, but also allowing for
smaller sizes to be used provided they are sufficiently large to be
identifiable and legible. Accordingly, symbols of varying size could be
used to be compatible with the use and location of the symbol on either
the equipment or promotional materials. The use of the official AMS
symbol for this program is consistent with the use of other official
identification marks used within other AMS programs.
Comments Referring to Rulemaking Issues
Extension of Comment Period Accompanying the Proposed Rule
Summary of Comments: One commenter requested the comment period be
extended.
Agency Response: AMS disagrees. The 60 day comment period which
accompanied the ANPRM and the 60 day comment period which accompanied
the proposed rule were sufficient to obtain the public comment required
to develop the program.
Implement Program on a Trial Basis
Summary of Comments: One commenter requested the program be
implemented as a 3-year pilot program.
Agency Response: AMS disagrees. Because this is a voluntary, user-
fee-funded service there is no benefit to the program being implemented
on a trial basis.
III. Impact Analysis
Executive Order 12866 and the Regulatory Flexibility Act
This proposed rule has been reviewed under Executive Order 12866.
The rule has been determined to be not significant for the purposes of
Executive Order 12866 and, therefore, has not been reviewed by the
Office of Management and Budget.
Pursuant to the requirements set forth in the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), AMS has considered the
economic impact of this proposed rule on small entities. The purpose of
the RFA is to fit regulatory actions to the scale of businesses subject
to such action so that small businesses would not be disproportionally
burdened. Accordingly, we have prepared this regulatory flexibility
analysis.
Development of this program is required by the Agriculture, Rural
Development, Food and Drug Administration, and Related Agencies
Appropriations Act, 2001, (Pub. L. 106-387, sec. 729). The program will
be conducted under the provisions of the Agricultural Marketing Act of
1946 (7 U.S.C. 1621 et seq.).
AMS is establishing these regulations to conduct a voluntary, user-
fee-funded inspection and certification program for equipment and
utensils that are used to process livestock and poultry products. Under
this proposed program, manufacturers of new, modified, or reconditioned
equipment and utensils designed to process livestock and poultry
products who want to have the equipment and utensils they manufacture
officially inspected and accepted by AMS as meeting the NSF/3-A
standards which outline minimum requirements for cleanability,
suitability of materials used in construction, inspectability and
durability would apply to AMS.
Under this equipment and utensil acceptance program, equipment and
utensil manufacturers seeking AMS acceptance and certification may
apply to AMS for an evaluation of their equipment and utensils.
Although AMS does not require the drawings, blueprints and a material
list for all pieces of equipment or utensils upon application, such
blueprints and lists must be submitted as will facilitate the
inspection and certification process. Additionally, some equipment and
utensils will require AMS to conduct an on-site review at the point of
fabrication or where installed and operating in an establishment to
fully evaluate the design and construction and execute final
acceptance.
To maintain acceptance and certification, these regulations require
any manufacturer whose equipment or utensil has been accepted to
resubmit the design and fabrication details of the accepted equipment
or utensils whenever a change of design or fabrication which may impair
the cleanability or hygienic design of the equipment or utensil occurs.
Barring changes in equipment or utensil design and fabrication,
acceptance is granted for a four year period. When equipment or utensil
acceptance nears expiration at the end of the four year period,
manufacturers may send a letter stating that no design changes have
been made to receive an additional four year acceptance renewal.
This action will benefit manufacturers of equipment and utensils
used for processing meat and poultry products and the purchasers of
such equipment and utensils by providing AMS certification that the
equipment and utensils meet the minimum requirements of voluntary
consensus standards for sanitary design. Acceptance by AMS will provide
manufacturers and buyers assurance that equipment and utensils can be
cleaned, are constructed of suitable materials, are durable, and can be
inspected.
This equipment and utensil inspection and certification program
affects manufacturers or other vendors of equipment and utensils. The
[[Page 1196]]
equipment and utensil manufacturers range in size from small to large
concerns. According to the Standard Industrial Classification (SIC) (13
CFR 121.201) which are used by the Small Business Administration to
identify small businesses, a small business equipment and utensil
manufacturer is defined as a firm with less than 500 employees (SIC
Division D. Major Group 20). According to the most complete data
available to AMS, it is estimated that there are about 2000 equipment
and utensil manufacturers, about 90 percent of these can be classified
as small entities.
Previously, FSIS maintained a mandatory prior approval program for
equipment and utensil inspection as a prerequisite for use in Federally
inspected meat and poultry packing and processing establishments that
affected these same entities. Under FSIS' former mandatory prior
approval program for equipment, an estimated 2,500 applications for
equipment approval were received each year. Evaluation and
certification of equipment and utensils is based on the complexity and
sophistication of the design and fabrication of the equipment or
utensil being evaluated.
The paperwork burden that may be imposed on equipment and utensil
manufacturers by this proposed action is further discussed in the
section entitled Paperwork Reduction Act that follows.
In addition, we have not identified any relevant Federal rules that
are currently in effect that duplicate, overlap, or conflict with this
rule. Further, as discussed below, this program will be operated by the
AMS Dairy Programs using its relevant fee structure.
Provisions of the Agriculture, Rural Development, Food and Drug
Administration, and Related Agencies Appropriations Act, 2001, require
AMS to develop a voluntary, user-fee-funded program to inspect and
certify equipment and utensils used to process livestock and poultry
products. Prior to this amendment, similar language appeared in the
appropriations acts for fiscal year 1999 (Pub. L. 105-277, sec. 747)
and fiscal year 2000 (Pub. L. 106-78, sec. 734). The program will be
conducted under the provisions of the Agricultural Marketing Act (AMA)
of 1946. Under the AMA of 1946, AMS is required to collect reasonable
fees for providing official services provided under this proposed
equipment and utensil certification program, to cover as nearly as
practicable AMS costs for performing the service, including related
administrative and supervisory costs. Since the procedures used to
inspect and certify equipment and utensils used to process livestock
and poultry products are similar to those used to inspect and certify
dairy processing equipment, AMS has decided to charge the same hourly
fees for inspecting and certifying equipment used to process livestock
and poultry products. Inspection and certification services are based
on the hourly rate for applicants who request services on an hourly
basis and appear at 7 CFR Part 58 as published in the Federal Register
at 62 FR 66258 on December 18, 1997. The current base hourly rate for
such service is $56 per hour for service performed between 6 a.m. and 6
p.m. and $61.60 for service performed between 6 p.m. and 6 a.m., for
the time required to perform the service calculated to the nearest 15-
minute period, including the time required for preparation of
certificates and reports and the travel time of the equipment review
specialist in connection with the performance of the service. A minimum
charge of one-half hour will be made for the service pursuant to each
request or certificate issued. If an applicant requests that
certification service be performed on a holiday, Saturday, or Sunday or
in excess of each 8-hour shift Monday through Friday, the applicant
would be charged such service at a rate of 1\1/2\ times the rate which
would be applicable for such service if performed during normal working
hours.
AMS estimates that the time required to review and accept an
initial submission for simple designs would be 1 hour. For complex
designs, AMS estimates that the time required to review and accept an
initial submission would be 8 hours. Based on the proposed AMS base
hourly fee for service of $56 per hour, an initial submission of
assembly type drawings and corresponding parts and material lists
should range from $56 to $448. However, the final cost for equipment or
utensil inspection and certification would be contingent on a final on-
site review of the equipment or utensil at the point of fabrication or
under conditions of actual use. The cost of this on-site review would
include associated travel and per diem costs in addition to the hourly
fee for service. AMS estimates the average time to perform a on-site
review for a piece of equipment or utensil to be 12 hours.
The cost for evaluation of equipment or utensils would depend on
the complexity of design, location of the equipment or utensil to be
evaluated on-site, and whether the manufacturer has provided resource
materials that would facilitate inspection of the equipment or utensil
by AMS to determine acceptance. AMS estimates the average total costs
to process and in-plant review a piece of equipment or utensil to be
$1,120 plus added travel costs for the required on-site review.
Assuming all equipment and utensil manufacturers would use an AMS
equipment and utensil certification program to the extent they used the
FSIS program, it is estimated that the total cost to the industry under
an AMS program would be about $2,800,000 plus travel costs for on-site
reviews annually. Since approximately 90 percent of equipment and
utensil manufacturers are small businesses, the estimated share of the
total annual industry burden directly affecting small businesses would
be $2,520,000.
As stated in the previous section pertaining to the comments
received in response to the proposed rule and the Agency's responses to
them, the Act provides that USDA develop a voluntary, user-fee-funded
program to inspect and certify equipment used to process livestock and
poultry products. Accordingly, the Agency examined alternatives in
developing such a program, including an alternative that would have
allowed AMS to accredit third-party certifiers to act as agents of AMS,
as well as the alternative to allow equipment and utensil manufacturers
to self certify their equipment to AMS standards.
AMS considered these alternatives as it evaluated comments received
in response to the ANPRM and the proposed rule as the alternatives were
considered. The alternative options were rejected by AMS. The statutory
language provides that the Secretary inspect and certify agricultural
processing equipment. Further, a significant number of comments during
the comment periods for the ANPRM and proposed rule which supported an
AMS provided service staffed by Federal employees to conduct the
evaluations.
In assessing alternatives to the scheme provided for in these
regulations, we believe that the provisions contained herein will best
accomplish the purpose of the program and at the same time minimize any
burden that might be placed upon affected parties.
Executive Order 12988
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform and is not intended to have a retroactive effect. This
rule would not preempt any State or local laws, regulations, or
policies, unless they present an irreconcilable conflict with this
rule. Further, section 729 of the
[[Page 1197]]
Agriculture, Rural Development, Food and Drug Administration, and
Related Agencies Appropriations Act, 2001, (Pub. L. 106-387) states
that the provision does not affect the authority of the Secretary to
carry out the Federal Meat Inspection Act (21 U.S.C. 601 et seq.); the
Poultry Products Inspection Act (21 U.S.C. 451 et seq.); or the Egg
Products Inspection Act (21 U.S.C. 1031 et seq.). There are no
administrative procedures that must be exhausted prior to any judicial
challenge to the provisions of this final rule.
Paperwork Reduction Act Requirements
The proposed rule (65 FR 35857) contained paperwork submission
requirements that were subject to public comment and to review by the
Office of Management and Budget under the Paperwork Reduction Act of
1995 (PRA) (44 U.S.C. Chapter 35). In accordance with 5 CFR Part 1320,
we included the description of the reporting requirements and an
estimate of the annual burden on manufacturers of equipment and
utensils used to process livestock and poultry products. As identified
in Sec. 54.1004 of these final regulations, the Certification of
Sanitary Design and Fabrication of Equipment Used in the Slaughter,
Processing, and Packaging of Livestock and Poultry Products service
would be administered by AMS. During the administration of the service,
AMS will expand the use of existing forms currently used by AMS and
approved by OMB under 7 CFR part 58, subpart A, Regulations Governing
the Inspection and Grading of Manufactured or Processed Dairy Products.
The Agency published a Federal Register Notice 65 FR 2370, dated
January 14, 2000, that expanded the use of these forms and allowed for
a 60-day comment period. Additionally, the proposed rule for this
action published in the Federal Register, 65 FR 35857, dated June 6,
2000, solicited comments from all interested parties concerning the
information collection requirements contained in this proposed rule.
Comments were specifically invited on the following: (1) The accuracy
of the agency's burden estimate of the proposed collection of
information including the validity of the methodology and assumptions
used; (2) ways to minimize the burden of the collection of information
on those who would respond, including through the use of appropriate
electronic collection methods; (3) whether the proposed collection of
information is sufficient or necessary for the proper performance of
the functions of the agency to perform this program; and (4) ways to
enhance the quality, utility, and clarity of the information to be
collected.
Of the one hundred comments received for the proposed rule only one
comment referenced the Paperwork Reduction Act requirements. This one
commenter stated AMS substantially underestimated the number of
applications per respondent. The commenter based the comment on the
history of their company's applications under the former FSIS prior
approval program. The AMS published estimates are based on the expected
average number of respondents. Any one applicant may exceed the number
of applications submitted based on their voluntary participation in the
service provided. However, AMS believes that the published average
number of applications is accurate for the program and has not revised
its estimates.
OMB Number: 0581-0126.
Expiration Date of Approval: August 31, 2003.
Abstract: The dairy grading program is a voluntary, user-fee-funded
program. In order for a voluntary inspection program to perform
satisfactorily with a minimum of confusion, there must be written
requirements and rules for both Government and industry. The
information collections are essential to carry out and administer the
inspection and grading program. The information requested is used to
identify the product offered for grading, to identify a request from an
equipment manufacturer of equipment used in the dairy, meat or poultry
industries for evaluation for sanitary design and construction, to
identify and contact the party responsible for payment of the
inspection, grading or equipment evaluation fee and expense, to
identify applicants who wish to be authorized for the display of
official identification on product packaging materials, equipment,
utensils, or on descriptive or promotional materials.
The equipment and utensil inspection and certification proposed
herein would use the forms described above in a program that would be
conducted by AMS on a voluntary, fee-for-service basis. Manufacturers
of new, modified, or reconditioned equipment and utensils designed to
process livestock and poultry products who want to have the equipment
or utensils they manufacture officially inspected and accepted by AMS
as meeting the NSF/3-A standards which outline minimum requirements for
cleanability, suitability of materials used in construction,
inspectability and durability would apply to AMS.
For the purposes of the burden estimate, AMS estimated that the
hourly wage for those submitting information would be $20 per hour. To
have equipment and utensils accepted under this program, equipment and
utensil manufacturers would submit an application to AMS requesting
evaluation of equipment or utensils (Form DA-162). AMS estimates that
of the 2000 livestock and poultry equipment and utensil manufacturers,
AMS will receive approximately 2500 applications per year or, on
average, 1.25 applications from each manufacturer. Form DA-162 requires
0.038 hours to complete. The total annual burden on the industry for
this proposed collection of information would be 95 hours or $1,900
annually. Since AMS does not require the drawings, blueprints and a
material list to be submitted, they have not been included in this
burden estimate.
Manufacturers whose equipment or utensil receives AMS acceptance
may, upon request, be issued an official certificate as proof that the
equipment or utensil meets NSF/3-A standards and is therefore accepted.
Since completion of this certificate is performed by AMS, it has also
not been included in this burden estimate. Upon written application
(Form DA-155 and Form DA-156), manufacturers of accepted equipment or
utensils may receive permission to display the official mark of
acceptance on equipment and utensils, or in promotional literature as
illustrated in the regulatory text (Figure 1). Form DA-155 is a one-
time application from each manufacturer and, therefore, has been
estimated to only be sent by a respondent once in every four-year cycle
of equipment and utensil approval. The estimate of the total annual
burden of this collection of information is 10.5 hours or $210
annually. Form DA-156 is submitted by a manufacturer each time there is
a request to use the symbol on a piece of equipment or utensil, or in
promotional literature. AMS estimates that it would receive one request
each year to use the symbol on equipment or utensils, or in promotional
material for each piece of equipment or utensil accepted. Therefore,
AMS estimates that the total annual burden for this collection of
information would be 42.5 hours or $850 annually.
Manufacturers whose equipment or utensil does not meet the design
and fabrication requirements of the NSF/3-A standards and does not
receive acceptance by AMS may appeal AMS' determination. The
manufacturers would make a request for appeal service with the Chief,
Dairy Grading Branch by completing and submitting a request for service
(Form DA-162) to have
[[Page 1198]]
equipment or utensils reevaluated. The appeal process is set forth in
sections Sec. 54.1020 through Sec. 54.1027 of the proposed regulations.
As the AMS Dairy Program has never received an appeal for service under
its current equipment acceptance program, AMS has estimated that 1% of
applicants will appeal service in this estimate of the burden of the
collection of information. Accordingly, with 2500 applications per year
and Form DA-162 requiring 0.038 hours to complete and an estimate of
only 1 percent of applicants requiring an appeal, the total annual
burden on the industry for this proposed collection of information
would be 0.95 hours or $19 annually.
Any manufacturer whose equipment or utensil has been certified
shall resubmit the design and fabrication details of the certified
equipment or utensil whenever a change of design or fabrication has
occurred. Certification of equipment or utensils that have not changed
remains in effect for a period of four years. If no changes in
equipment or utensil design or fabrication have occurred over the four
year period since the last certification was made, manufacturers must
submit a certificate of conformance signed by the chief engineering
officer and chief executive officer of the company stating that no
design changes have been made to receive certification renewal. AMS
estimates that it would receive one such request every four years for
each piece of equipment or utensil accepted. AMS estimates that the
total annual burden for this collection of information would be 52
hours or $1,040 annually.
Collectively, AMS estimated that the total annual burden for the
collection of information would be 200.95 hours or $4019 annually.
1. Equipment Review Request--Form DA-162
Estimate of Burden: Public reporting burden for this collection of
information is estimated to average 0.038 hours per response.
Respondents: Manufacturers of equipment and utensils used to
process livestock and poultry products.
Estimated Number of Respondents: 2000.
Estimated Number of Responses per Respondent: 1.25.
Estimated Total Annual Burden on Respondents: 95 hours.
Total Cost: $1,900.
2. Application To Use official ID--Form DA-155
Estimate of Burden: Public reporting burden for this collection of
information is estimated to average 0.021 hours per response.
Estimated Number of Respondents: 2000.
Estimated Number of Responses per Respondent: 0.250.
Estimated Total Annual Burden on Respondents: 10.5 hours.
Total Cost: $210.
3. Request To Display Official ID--Form DA-156
Estimate of Burden: Public reporting burden for this collection of
information is estimated to average 0.017 hours per response.
Estimated Number of Respondents: 2000.
Estimated Number of Responses per Respondent: 1.25.
Estimated Total Annual Burden on Respondents: 42.5 hours.
Total Cost: $850.
4. Appeal--Equipment Review Request--Form DA-162
Estimate of Burden: Public reporting burden for this collection of
information is estimated to average 0.038 hours per response.
Respondents: Manufacturers of equipment and utensils used to
process livestock and poultry products.
Estimated Number of Respondents: 2000.
Estimated Number of Responses per Respondent: 0.0125.
Estimated Total Annual Burden on Respondents: 0.95 hours.
Total Cost: $19.
5. Letter Requesting Renewal of Acceptance
Estimate of Burden: Public reporting burden for this collection of
information is estimated to average 0.083 hours per response.
Estimated Number of Respondents: 2000.
Estimated Number of Responses per Respondent: 0.313.
Estimated Total Annual Burden on Respondents: 52 hours.
Total Cost: $1,040.
Estimated Total Annual Burden on Respondents: 200.95 hours total or
0.1 hours per respondent.
Estimated Total Annual Costs: $4,019 or $2 per respondent.
It is found that good cause exists for not postponing the effective
date of this rule until 30 days after publication in the Federal
Register (5 U.S.C. 553) because this (1) is a voluntary, user-fee-
funded program; (2) equipment manufacturers are aware of the provisions
of this rule, which a 60-day comment period was provided for in the
proposed rule; and (3) have already begun to request this service.
List of Subjects in 7 CFR Part 54
Food Grades and standards, Food labeling, Meat and meat products.
For the reasons set forth in the preamble 7 CFR Part 54 is amended
as follows:
PART 54--MEATS, PREPARED MEATS, AND MEAT PRODUCTS (GRADING,
CERTIFICATION, AND STANDARDS)
1. The authority citation for part 54 continues to read as follows:
Authority: 7 U.S.C. 1621-1627; Pub. L. 106-387, sec. 729.
2. In Part 54 a new Subpart C consisting of Secs. 54.1001 through
54.1034 is added to read as follows.
Subpart C--Regulations Governing the Certification of Sanitary
Design and Fabrication of Equipment Used in the Slaughter,
Processing, and Packaging of Livestock and Poultry Products
Sec.
54.1001 Meaning of words.
54.1002 Terms defined.
54.1003 Designation of official certificates, memoranda, marks,
and other identifications for purposes of the Agricultural Marketing
Act of 1946.
54.1004 Administration and implementation.
54.1005 Basis of service.
54.1006 Kind of service.
54.1007 Availability of service.
54.1008 How to obtain service.
54.1009 Order of furnishing service.
54.1010 When request for service deemed made.
54.1011 Withdrawal of application or request for service.
54.1012 Authority of agent.
54.1013 When an application may be rejected.
54.1014 Accessibility of equipment and utensils; access to
establishments.
54.1015 Official reports, forms, and certificates.
54.1016 Advance information concerning service rendered.
54.1017 Authority to use official identification.
54.1018 Form of official identification and approval for use.
54.1019 Renewal of Acceptance Certification.
54.1020 Appeal service; marking equipment or utensils on appeal;
requirements for appeal; certain determinations not appealable.
54.1021 Request for appeal service.
54.1022 When request for appeal service may be withdrawn.
54.1023 Denial or withdrawal of appeal service.
54.1024 Who shall perform appeal service.
54.1025 Appeal reports.
54.1026 Superseded reports.
54.1027 Application of other regulations to appeal service.
[[Page 1199]]
54.1028 Fees and other charges for service.
54.1029 Payment of fees and other charges.
54.1030 Identification.
54.1031 Errors in service.
54.1032 Denial or withdrawal of service.
54.1033 Confidential treatment.
54.1034 OMB control numbers assigned pursuant to the Paperwork
Reduction Act.
Subpart C--Regulations Governing the Certification of Sanitary
Design and Fabrication of Equipment Used in the Slaughter,
Processing, and Packaging of Livestock and Poultry Products
Sec. 54.1001 Meaning of words.
For the purposes of the regulations in this subpart, words in the
singular form shall be deemed to impart the plural and vice versa, as
the case may demand.
Sec. 54.1002 Terms defined.
Act. The Agricultural Marketing Act of 1946, as amended (7 U.S.C.
1621 et seq.).
Administrator. The Administrator of the Agricultural Marketing
Service (AMS), United States Department of Agriculture, or the
representative to whom authority has been delegated to act in the stead
of the Administrator.
Agricultural Marketing Service (AMS). The Agricultural Marketing
Service of the United States Department of Agriculture.
Applicant. Any person who applies for service under the regulations
in this subpart.
Branch. The Dairy Grading Branch, Dairy Programs, Agricultural
Marketing Service.
Chief. The Chief of the Dairy Grading Branch, Dairy Programs,
Agricultural Marketing Service, or the representative to whom authority
has been delegated to act in the stead of the Chief.
Compliance. Conformity of a processing system, piece of processing
equipment, or a utensil to identified standards.
Department. The United States Department of Agriculture.
Deputy Administrator. The Deputy Administrator of the Dairy
Programs of the Agricultural Marketing Service or any officer or
employee of the Dairy Programs to whom authority has heretofore been
delegated, or to whom authority may hereafter be delegated to act in
the stead of the Deputy Administrator.
Design Review Specialist. An employee of the Branch who determines
and certifies or otherwise evaluates the compliance of equipment or
utensils under the regulations.
Design Evaluation and Certification Service. The service
established and conducted under the regulations for the evaluation and
certification or other identification of the compliance of equipment or
utensils used for the slaughter, processing or packaging of livestock
and poultry products (Referred to hereinafter as ``equipment'' or
``utensils'') with sanitary specifications or standards.
Fabricator. Commercial entity engaged in the manufacture or
assembly of equipment or utensils.
Financially interested person. Any person having a financial
interest in the equipment or utensils involved, including but not
limited to the designer, fabricator, or user of the equipment or
utensils.
Legal Holiday. Those days designated as legal public holidays in
Title 5, United States Code, section 6103(a).
Person. Any individual, partnership, corporation, or other legal
entity, or Government agency.
Processing. Cooking, baking, curing, heating, drying, mixing,
grinding, churning, separating, extracting, cutting, fermenting,
eviscerating, preserving, dehydrating, freezing, or otherwise
manufacturing, and includes the packaging, canning, jarring, or
otherwise enclosing in a container.
Program. The Dairy Programs of the Agricultural Marketing Service.
Standards. The most recent version of standards for equipment and
utensils formulated by the NSF/3-A Joint Committee on Food Processing
Equipment (Referred to hereinafter as ``NSF/3-A'').
The regulations. The regulations in this Subpart.
Sec. 54.1003 Designation of official certificates, memoranda, marks,
and other identifications, for purposes of the Agricultural Marketing
Act.
Subsection 203(h) of the Agricultural Marketing Act of 1946, as
amended provides criminal penalties for various specified offenses
relating to official certificates, memoranda, and marks or other
identifications, issued or authorized under section 203 of said Act,
and certain misrepresentations concerning the inspection or grading of
agricultural products under said section. For the purposes of said
subsection and the provisions in this subpart, the terms listed in
paragraphs (a) through (c) of this section shall have the respective
meanings specified:
(a) ``Official certificate'' means any form of certification,
either written or printed, used under the regulations to certify with
respect to the evaluation, review, condition, or acceptance of
equipment or utensils (including the compliance of equipment or
utensils with applicable standards).
(b) ``Official memorandum'' means any initial record of findings
made by an authorized employee of the Dairy Grading Branch in the
process of determining compliance, evaluating, or reviewing equipment
or utensils pursuant to the regulations, any processing or in plant-
operation report made by an authorized Dairy Grading Branch employee in
connection with determining compliance, evaluating, or reviewing
equipment or utensils under the regulations, and any report made by an
authorized employee of the Dairy Grading Branch of any other services
performed pursuant to the regulations.
(c) ``Official mark'' or ``other official identification'' means
any form of mark or other identification, including those prescribed in
Sec. 54.1018; used under the regulations in marking any equipment or
utensils or displayed as an indication that the equipment or utensils
has been evaluated by AMS (including the compliance of the equipment or
utensils with applicable standards).
Sec. 54.1004 Administration and implementation.
The Administrator designates the administration and implementation
of the Certification of Sanitary Design and Fabrication of Equipment
Used in the Processing of Livestock and Poultry Products service to the
Dairy Grading Branch, Dairy Programs, Agricultural Marketing Service.
The Chief is charged with the administration, under the general
supervision and direction of the Deputy Administrator, of the
regulations and the Act insofar as they relate to equipment or utensils
used to process livestock and poultry products.
Sec. 54.1005 Basis of service.
(a) Certification of Sanitary Design and Fabrication of Equipment
Used in the Slaughter, Processing, and Packaging of Livestock and
Poultry Products service shall be performed in accordance with the
provisions of this subpart, the instructions and guidelines issued or
approved by the Chief and the applicable standards developed by the
NSF/3-A.
(b) Copies of standards developed by NSF/3-A that AMS will inspect
and certify to are available, for a nominal fee, from NSF International
at www.nsf.org or contact Techstreet, 310 Miller Avenue, Ann Arbor, MI
48103; Phone (800) 699-9277. Copies of all other instructions and
guidelines can be obtained from, and copies of standards developed by
NSF/3-A may be inspected at, the U.S. Department of Agriculture,
Agricultural Marketing Service, Dairy Programs, Dairy Grading Branch;
Room 2746-S; 1400
[[Page 1200]]
Independence Ave., SW., Washington, DC 20250-6456.
(c) All services provided in accordance with the regulations shall
be rendered without discrimination on the basis of race, color,
national origin, gender, religion, age, disability, political beliefs,
sexual orientation, or marital or family status.
Sec. 54.1006 Kind of service.
Certification of Sanitary Design and Fabrication of Equipment Used
in the Slaughter, Processing, and Packaging of Livestock and Poultry
Products service under the regulations shall consist of the evaluation,
certification and/or identification, upon request by the applicant, of
the adherence of the design and fabrication of equipment and utensils
to sanitary principles and criteria under applicable standards
identified in this subpart. Equipment or utensils having an identical
design, materials of construction, and fabrication, except for scaling
up or down in size, may be submitted for evaluation as a model line or
series. Determination as to equipment or utensils compliance with
standards for materials of fabrication or method of fabrication may be
based upon information received from the fabricator.
Sec. 54.1007 Availability of service.
Service under these regulations may be made available to the
designers, fabricators, users, or other interested person or party, of
the equipment or utensils. Subject to the provisions of this subpart,
services shall be performed only when a qualified design review
specialist is available, and when the location of the equipment or
utensils, evaluation facilities and conditions, as determined by the
Chief, are suitable for conducting such service.
Sec. 54.1008 How to obtain service.
(a) Application. Any person may apply to the Chief for service
under the regulations with respect to equipment or utensils in which
the applicant is financially interested. The application shall be made
on a form approved by the Chief. In any case in which the service is
intended to be furnished at an establishment not operated by the
applicant, the applicant shall be responsible for obtaining approval
for accessability of the equipment or utensil from the operator of such
establishment and such approval shall constitute an authorization for
any employees of the Department to enter the establishment for the
purpose of performing their functions under the regulations. The
application shall state:
(1) The name and address of the establishment at which service is
desired;
(2) The name and post office address of the applicant;
(3) Identification of the party that will be responsible for
payment of all services rendered in response to the request;
(4) The type of equipment or utensil presented for evaluation;
(5) The date(s) on which service is requested to be performed; and
(6) The signature of the applicant (or the signature and title of
the applicant's representative) and date of the request.
(b) Notice of eligibility for service. The applicant for service
will be notified whether the applicant's application is approved.
Sec. 54.1009 Order of furnishing service.
Service under the regulations shall be furnished to applicants,
insofar as practicable and subject to the availability of a qualified
design review specialist, in the order in which requests therefor are
received, insofar as consistent with good management, efficiency and
economy. Precedence will be given, when necessary, to requests made by
any government agency and to requests for appeal service under
Sec. 54.1021.
Sec. 54.1010 When request for service deemed made.
A request for service under the regulations shall be deemed to be
made when received by the Branch. Records showing the date and time of
the request shall be maintained.
Sec. 54.1011 Withdrawal of application or request for service.
An application or a request for service under the regulations may
be withdrawn by the applicant at any time before the application is
approved or prior to performance of service. The applicant shall be
responsible for payment, in accordance with Sec. 54.1028 and
Sec. 54.1029, of any expenses already incurred by the Agricultural
Marketing Service in connection therewith.
Sec. 54.1012 Authority of agent.
Proof of the authority of any person making an application or a
request for service under the regulations on behalf of any other person
may be required at the discretion of the Deputy Administrator or Chief
or other employee receiving the application or request under
Sec. 54.1008.
Sec. 54.1013 When an application may be rejected.
(a) An application or a request for service may be denied by the
design review specialist, with the concurrence of the Deputy
Administrator or Chief when:
(1) For administrative reasons such as the non-availability of
personnel to perform the service;
(2) The application or request relates to equipment or utensils
which are not eligible for service under Sec. 54.1006;
(3) The applicant fails to meet either the application requirements
prescribed in this subpart or the conditions for receiving such
service;
(4) The equipment or utensil is owned by, or located on the
premises of, a person currently denied the benefits of the Act;
(5) The applicant has substantial financial ties to a person who is
currently denied the benefits of the Act, or who has been adjudged, in
an administrative or judicial proceeding, responsible in any way for a
current denial of benefits of the Act to any other person.
(6) The applicant is currently denied services under the Act.
(7) Any fees billed to the applicant are not paid within 30 days;
or
(8) The applicant has failed to comply with the Act or this subpart
or with the instructions or guidelines issued hereunder.
(b) The Chief shall provide notice to an applicant whose
application is rejected, and shall explain the reason(s) for the
rejection. If such notification is made verbally, written confirmation
may be provided.
Sec. 54.1014 Accessibility of equipment and utensils; access to
establishments.
(a) The applicant shall cause equipment and utensils to be made
easily accessible for examination and to be so placed, with adequate
illumination to facilitate evaluation for compliance. The applicant
shall furnish or make available any necessary tools; such as boroscope,
profilometer, disassembly tools, ladders, radius gauges, and the like;
necessary to complete the evaluation.
(b) Supervisors of USDA design review specialists responsible for
maintaining uniformity and accuracy of service under the regulations
shall have access to all parts of establishments covered by approved
applications for service under the regulations, for the purpose of
examining all equipment or utensils in the establishments which have
been or are to be evaluated for compliance with standards or which bear
any marks of compliance.
Sec. 54.1015 Official reports, forms, and certificates.
(a) Report. The design review specialist shall prepare, sign, and
issue
[[Page 1201]]
a narrative report covering the observations, comments and
recommendations based on the evaluation for conformance with standards
of equipment and utensils as provided for in Sec. 54.1005 and indicate
the fees and other charges incurred for the services rendered.
(b) Forms. Form DA-161 is the official certificate for equipment or
utensils evaluated and is accepted under the regulations. Issuance of
this certificate is optional at the request of the applicant.
(c) Distribution. The original report and official certificate (if
requested) shall be delivered or mailed to the applicant or other
persons designated by the applicant. Other copies shall be forwarded as
required by agency, program, and branch instructions. Additional copies
will be furnished to any person financially interested in the equipment
or utensil involved with the concurrence of the applicant and upon
payment of fees, as provided in Sec. 54.1028 and Sec. 54.1029.
Sec. 54.1016 Advance information concerning service rendered.
Upon request of any applicant, all or any part of the contents of
any report issued to the applicant under the regulations, or other
notification concerning the determination of compliance of equipment or
utensils for such applicant may be transmitted by facsimile
transmission to the applicant, or to any person designated by the
applicant at the applicant's expense.
Sec. 54.1017 Authority to use official identification.
The Chief may authorize an applicant or any persons designated by
the applicant to use the official identification symbol to mark
equipment or utensils, or for display in descriptive or promotional
materials providing the equipment or utensils is evaluated pursuant to
this subpart and found to be in compliance.
Sec. 54.1018 Form of official identification and approval for use.
(a) The official identification symbol approved for use on
equipment, utensils, or descriptive or promotional materials shall
appear in the form and design shown in Figure 1.
(b) The official identification symbol on equipment or utensils
shall be displayed by etching or the placement of a non-removable
sticker located in close proximity to the equipment identification
plate.
(c) The official identification symbol is recommended to be at
least 3/4 inch by 3/4 inch in size. Symbols which are smaller in size
will be considered provided they are sufficiently large to be
identifiable and legible.
(d) The official identification symbol shall not be used in
descriptive and promotional materials without prior approval by the
Chief. The official identification symbol, if used, on the descriptive
or promotional materials shall be printed as part of the text or
format.
(e) An applicant shall submit to the Chief of the Dairy Grading
Branch, Dairy Programs, Agricultural Marketing Service, U.S. Department
of Agriculture, P.O. Box 96456, Washington, D.C. 20090-6456, an
application, if one is not on file, requesting approval to use the
official identification symbol on officially accepted equipment and in
descriptive or promotional materials.
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Sec. 54.1019 Renewal of acceptance certification.
The manufacturer of any equipment or utensil which has been issued
a report or certification stating acceptance of compliance shall
resubmit the design and fabrication details of any change in materials
of construction, design, or fabrication which may impair the
cleanability or hygienic design of the equipment or utensil. If no
change in materials of construction, design, or fabrication which may
impair the cleanability or hygienic design of the equipment or utensil
has occurred during the period of four years after the date of the most
recent report stating acceptance of compliance or if no design or
fabrication changes have been made, the applicant may submit a
certificate of conformance signed by the chief engineering officer and
the chief executive officer of the company stating that no design
changes have been made to the specified equipment or utensil.
Sec. 54.1020 Appeal service; marking equipment or utensils on appeal;
requirements for appeal; certain determinations not appealable.
(a) Appeal service is a re-evaluation of the compliance of a piece
of equipment, portion of a piece of equipment, or utensil to design or
fabrication criteria according to the standards prescribed by this
subpart.
(b) Only the original applicant or their representative may request
appeal service requesting a reevaluation of the original determination
of the design and fabrication of the equipment or utensil for
compliance with the standards specified in this subpart.
(c) Appeal service will not be furnished for:
(1) A piece of equipment, portion of a piece of equipment, or
utensil which has been altered or has undergone a material change since
the original service.
(2) For the purpose of obtaining an up-to-date report or
certificate which does not involve a question as to the correctness of
the original service for the piece of equipment, portion of a piece of
equipment, or utensil.
Sec. 54.1021 Request for appeal service.
(a) Except as otherwise provided in Sec. 54.1020, an applicant or
their representative may request appeal service when the applicant or
their representative disagree with the determination as to compliance
with the standard of the piece of equipment, portion of a piece of
equipment, or utensil as documented in the applicable report.
(b) A request for appeal service shall be filed with the Chief,
directly or through the design review specialist who performed the
original service. The request shall state the reasons for the
disagreement with the original determination and may be accompanied by
a copy of any previous certificate or report, or any other information
which the applicant may have received regarding the piece of equipment,
portion of a piece of equipment, or utensil at the time of the original
service. Such request may be made orally (including by telephone) or in
writing (including by facsimile transmission). If made orally, the
Dairy Grading Branch employee receiving the request may require that it
be confirmed in writing.
Sec. 54.1022 When request for appeal service may be withdrawn.
A request for appeal service may be withdrawn by the applicant at
any time before the appeal service has been performed, upon payment of
any expenses already incurred under the regulations by the Branch in
connection therewith.
Sec. 54.1023 Denial or withdrawal of appeal service.
A request for appeal service may be rejected or such service may be
otherwise denied to or withdrawn from any person in accordance with the
procedure set forth in Sec. 54.1013(a), if it appears that the person
or product involved is not eligible for appeal service under
Sec. 54.1020, or that the identity of the piece of equipment, portion
of a piece of equipment, or utensil has been lost; or for any of the
causes set forth in Sec. 54.1032.
Sec. 54.1024 Who shall perform appeal service.
Appeal service for equipment or utensils shall be performed by the
Chief or a design review specialist designated by the Chief. No design
review specialist may perform appeal service for any piece of
equipment, portion of a piece of equipment or utensil for which the
original design review specialist performed the initial evaluation
service.
Sec. 54.1025 Appeal reports.
After appeal service has been performed for any piece of equipment,
portion of a piece of equipment or utensils, an official report shall
be prepared, signed, and issued referring specifically to the original
report and stating the determination of the re-evaluation of compliance
of the piece of equipment, portion of a piece of equipment or utensil.
Sec. 54.1026 Superseded reports.
The appeal report shall supersede the original report which,
thereupon, shall become null and void for all or a portion of the
report pertaining to the appeal service and shall not thereafter be
deemed to show the compliance of the equipment or utensils described
therein. However, the fees charged for the original service shall not
be remitted to the applicant who filed the appeal.
Sec. 54.1027 Application of other regulations to appeal service.
The regulations in this subpart shall apply to appeal service
except insofar as they are inapplicable.
Sec. 54.1028 Fees and other charges for service.
Fees and other charges equal as nearly as may be to the cost of the
services rendered shall be assessed and collected from applicants in
accordance with the provisions for Fees and Charges set forth in 7 CFR
part 58, Subpart A, Regulations Governing the Inspection and Grading
Services of Manufactured or Processed Dairy Products, sections
Secs. 58.38, 58.39, 58.41, 58.42, and 58.43, as appropriate.
Sec. 54.1029 Payment of fees and other charges.
Fees and other charges for service shall be paid upon receipt of
billing for fees and other charges for service. The applicant shall
remit by check, draft, or money order, made payable to the Agricultural
Marketing Service, USDA, payment for the service in accordance with
directions on the billing, and such fees and charges shall be paid in
advance if required by the official design review specialist or other
authorized official.
Sec. 54.1030 Identification.
All official design review specialists and supervisors shall have
their Agricultural Marketing Service identification cards in their
possession at all times while they are performing any function under
the regulations and shall identify themselves by such cards upon
request.
Sec. 54.1031 Errors in service.
When a design review specialist, supervisor, or other responsible
employee of the Branch has evidence of inaccurate evaluation, or of
incorrect certification or other incorrect determination or
identification as to the compliance of a piece of equipment or utensil,
such person shall report the matter to the Chief. The Chief will
investigate the matter and, if deemed advisable, will report any
material errors to the owner or the owner's agent. The Chief shall take
appropriate action
[[Page 1204]]
to correct errors found in the determination of compliance of equipment
or utensils, and the Chief shall take adequate measures to prevent the
recurrence of such errors.
Sec. 54.1032 Denial or withdrawal of service.
(a)(1) Bases for denial or withdrawal. An application or a request
for service may be rejected, or the benefits of the service may be
otherwise denied to, or withdrawn from, any person who, or whose
employee or agent in the scope of the person's employment or agency:
(i) Has wilfully made any misrepresentation or has committed any
other fraudulent or deceptive practice in connection with any
application or request for service under the regulations;
(ii) has given or attempted to give, as a loan or for any other
purpose, any money, favor, or other thing of value, to any employee of
the Department authorized to perform any function under the
regulations;
(iii) has interfered with or obstructed, or attempted to interfere
with or to obstruct, any employee of the Department in the performance
of duties under the regulations by intimidation, threats, assaults,
abuse, or any other improper means;
(iv) has knowingly falsely made, issued, altered, forged, or
counterfeited any official certificate, memorandum, mark, or other
identification;
(v) has knowingly uttered, published, or used as true any such
falsely made, issued, altered, forged, or counterfeited certificate,
memorandum, mark or identification;
(vi) has knowingly obtained or retained possession of any such
falsely made, issued, altered, forged, or counterfeited certificate,
memorandum, mark or identification, or of any equipment or utensil
bearing any such falsely made, issued, altered, forged, or
counterfeited mark or identification;
(vii) has applied the designation ``USDA Accepted Equipment'',
``AMS Accepted Equipment'', ``USDA Approved Equipment'', ``AMS Approved
Equipment'', ``Approved By USDA'', ``Approved By AMS'', ``Accepted By
USDA'', ``Accepted By AMS'', ``USDA Approved'', ``USDA Accepted'',
``AMS Approved'', ``AMS Accepted'', or any other variation of wording
which states or implies official sanction by the United States
Department of Agriculture by stamp, or brand directly on any equipment
or utensil, or used as part of any promotional materials which has not
been inspected and deemed in compliance with this subpart; or,
(viii) has in any manner not specified in this paragraph violated
subsection 203(h) of the AMA: Provided, That paragraph (a)(1)(vi) of
this section shall not be deemed to be violated if the person in
possession of any item mentioned therein notifies the Deputy
Administrator or Chief without such delay that such person has
possession of such item and, in the case of an official identification,
surrenders it to the Chief, and, in the case of any other item,
surrenders it to the Deputy Administrator or Chief or destroys it or
brings it into compliance with the regulations by obliterating or
removing the violative features under supervision of the Deputy
Administrator or Chief: And provided further, That paragraphs (a)(1)
(ii) through (vii) of this section shall not be deemed to be violated
by any act committed by any person prior to the making of an
application of service under the regulations by the principal person.
An application or a request for service may be rejected or the benefits
of the service may be otherwise denied to, or withdrawn from, any
person who operates an establishment for which such person has made
application for service if, with the knowledge of such operator, any
other person conducting any operations in such establishment has
committed any of the offenses specified in paragraphs (a)(1) (i)
through (vii) of this section after such application was made.
Moreover, an application or a request for service made in the name of a
person otherwise eligible for service under the regulations may be
rejected, or the benefits of the service may be otherwise denied to, or
withdrawn from, such a person:
(A) In case the service is or would be performed at an
establishment operated:
(1) By a corporation, partnership, or other person from whom the
benefits of the service are currently being withheld under this
paragraph; or
(2) By a corporation, partnership, or other person having an
officer, director, partner, or substantial investor from whom the
benefits of the service are currently being withheld and who has any
authority with respect to the establishment where service is or would
be performed; or
(B) In case the service is or would be performed with respect to
any product in which any corporation, partnership, or other person
within paragraph (a)(1)(viii)(A)(1) of this section has a contract or
other financial interest.
(2) Procedure. All cases arising under this paragraph shall be
conducted in accordance with the Rules of Practice Governing Formal
Adjudicatory Proceedings Instituted by the Secretary Under Various
Statutes set forth in 7 CFR Secs. 1.130 through 1.151 and the
Supplemental Rules of Practice in part 50, 7 CFR Sec. 50.1 et seq.
(b) Filing of records. The final orders in formal proceedings under
paragraph (a) of this section to deny or withdraw the service under the
regulations (except orders required for good cause to be held
confidential and not cited as precedents) and other records in such
proceedings (except those required for good cause to be held
confidential) shall be filed with the Hearing Clerk and shall be
available for inspection by persons having a proper interest therein.
Sec. 54.1033 Confidential treatment.
Every design review specialist providing service under these
regulations shall keep confidential all information secured and not
disclose such information to any person except an authorized
representative of the Department.
Sec. 54.1034 OMB control numbers assigned pursuant to the Paperwork
Reduction Act.
The following control number has been assigned to the information
collection requirements in 7 CFR Part 54, Subpart C, by the Office of
Management and Budget pursuant to the Paperwork Reduction Act of 1995
(44 U.S.C. Chapter 35).
------------------------------------------------------------------------
Current OMB
7 CFR section where requirements are described control No.
------------------------------------------------------------------------
54.1008(a)................................................. 0581-0126
54.1017.................................................... 0581-0126
54.1018(e)................................................. 0581-0126
54.1019.................................................... 0581-0126
54.1020.................................................... 0581-0126
54.1021.................................................... 0581-0126
------------------------------------------------------------------------
Dated: December 27, 2000.
Barry L. Carpenter,
Deputy Administrator, Livestock and Seed Program.
[FR Doc. 01-95 Filed 1-4-01; 8:45 am]
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