Rule2025-00760
Plant Records To Include Grade Label Butterfat Testing
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 16, 2025
Effective
February 18, 2025
Issuing agencies
Agriculture DepartmentAgricultural Marketing Service
Abstract
This final rule adopts amendments to the plant records requirement for the Agricultural Marketing Service (AMS) Dairy Grading and Inspection Program. The amendments allow butterfat tests to be performed at an in-house or approved third party laboratory and add a requirement for plants to maintain and make such records available for examination by a United States Department of Agriculture (USDA) inspector. These amendments increase efficiency by conforming to current industry practice.
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 10 (Thursday, January 16, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 10 (Thursday, January 16, 2025)]
[Rules and Regulations]
[Pages 4585-4587]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-00760]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
========================================================================
Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 /
Rules and Regulations
[[Page 4585]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 58
[Doc. No. AMS-DA-22-0064]
RIN 0581-AE20
Plant Records To Include Grade Label Butterfat Testing
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule adopts amendments to the plant records
requirement for the Agricultural Marketing Service (AMS) Dairy Grading
and Inspection Program. The amendments allow butterfat tests to be
performed at an in-house or approved third party laboratory and add a
requirement for plants to maintain and make such records available for
examination by a United States Department of Agriculture (USDA)
inspector. These amendments increase efficiency by conforming to
current industry practice.
DATES: This final rule is effective February 18, 2025.
FOR FURTHER INFORMATION CONTACT: Whitney Rick, Grading and
Standardization Division, Dairy Program, Agricultural Marketing
Service, U.S. Department of Agriculture, Room 2530-South Building Mail
Stop 0225, 1400 Independence Avenue SW, Washington, DC 20250-0230:
Telephone: (202) 236-8241; Email: <a href="/cdn-cgi/l/email-protection#6a3d02031e040f1344380309012a1f190e0b440d051c"><span class="__cf_email__" data-cfemail="5f0837362b313a26710d363c341f2a2c3b3e71383029">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The Secretary of Agriculture is authorized
by the Agricultural Marketing Act (AMA) of 1946, as amended (7 U.S.C.
1621, et seq.), to provide voluntary Federal dairy inspection and
grading services that enables consumers to purchase high quality dairy
products and facilitates orderly marketing. Plants participating in the
voluntary, fee-based AMS Dairy Grading and Inspection Program process
milk into dairy foods that enter commerce as retail products,
ingredients for further processing, purchases for Federal food
assistance programs, and exports to other countries. Services provided
by the program enhance the marketability and add value to dairy
products and foods that contain dairy. Dairy products manufactured in
plants complying with the USDA inspection requirements are eligible to
be graded against official quality standards and specifications
established by AMS. Dairy products tested and graded by AMS have
certificates issued describing the product's quality and condition.
When the Grading and Inspection Program was implemented, the
quality of butter was inconsistent, and quality-control testing by USDA
was necessary to ensure a consistent product for the market. Today,
plants more consistently manufacture high-quality butter products and
maintain the butterfat standard necessary to be granted a USDA grade
label for butter.
Currently, USDA inspectors or designated plant personnel perform
tests of butter samples that have been selected by a USDA inspector for
quality control on randomized batches of finished product pursuant to 7
CFR 58.338. Testing frequency varies by the volume of butter processed
and whether a batch is randomly selected. Typically, USDA conducts
monthly or weekly testing depending on the volume of butter processed.
It is also current industry practice for plants to perform routine
internal tests on their butter products to ensure quality and
compliance with composition standards. Specific requirements for these
tests are outlined in 7 CFR 58.336.
During manufacturing it is normal to have fluctuations in butterfat
composition at different stages in butter making and, consequently,
test results may not be consistent throughout the process. Therefore,
butter processing plants continually monitor butterfat composition
throughout production and make necessary adjustments to maintain the 80
percent butterfat required for butter (7 CFR 58.305). The plant
maintains these monitoring records as part of its internal quality
program and testing procedures.
Under the current Dairy Grading and Inspection Program, USDA
conducts a single butterfat test at the time of grading, which provides
a limited perspective on overall butterfat composition of butter
manufactured by the plant.
The amendments will provide plants an alternative to butterfat
testing administered by a USDA inspector and allow in-plant quality
control testing to satisfy butterfat testing requirements. This final
rule authorizes a review of a plant's testing records performed by AMS
as an alternative to testing performed by a USDA inspector at the time
of grading. A records review of a plant's routine testing rather than a
single-point test provides a more accurate picture of whether the
plant's butter products meet quality standards. It also reduces costs
to a plant by providing an alternative to duplicate butterfat testing
by a USDA inspector. As explained in the Regulatory Flexibility
Analysis below, AMS estimates authorizing an alternative records review
option will save participating plants $4,560 to $31,560 annually.
Currently, the final butter product must contain a minimum of 80
percent butterfat by weight for it to comply with the regulations. That
requirement will not change as a result of this final rule. However,
pursuant to this rule, AMS will annually review each plant's butterfat
test records to gauge the plant's compliance with the regulations.
Butterfat tests are already conducted as a normal, standard business
operating procedure by plants that manufacture butter. If a records
review reveals a plant is out of compliance, AMS will perform more
frequent reviews to determine what preventative and corrective actions
are being taken. As described below, failure to rectify the problem
over multiple consecutive reviews may result in ineligibility to use
the USDA Grade Label shield on products produced by the plant.
Records inspected include plant records of butterfat tests
performed as required under 7 CFR 58.336, and analysis of records. The
change to the recordkeeping requirements applies to records kept in the
regular course of business by the plant. As records will be reviewed
on-site by USDA inspectors, plants will not be required to submit
information to the agency.
A proposed rule was published in the Federal Register on August 15,
2023 (88 FR 55426). Copies of the proposed rule
[[Page 4586]]
were made available through the internet by the USDA and the Office of
the Federal Register. The rule provided a 60-day comment period which
ended October 16, 2023. Seven comments were received. Four of the
comments supported the proposed changes. The comments in support of the
rule noted the change will continue to promote high quality products
and will lower the cost to manufacturers, which will result in savings
to the consumer.
Of the four supportive comments, the American Butter Institute
(ABI) requested clarification on four items related to this rulemaking.
First, ABI asked which tests will be reviewed. The tests reviewed must
be sufficient to evaluate the plant's process to control quality and
adjust butterfat composition during manufacturing and ensure final
butterfat composition meets the 80 percent requirement. Tests may
include but are not limited to Kohman method or inline and benchtop
infrared analysis.
Second, ABI sought clarification on which records will be reviewed.
Records reviewed will vary by plant depending on which records are kept
by the individual plant in the normal course of business. Records
reviewed may include the plant's sample selection process, butterfat
testing methods, quality control of butterfat composition during
manufacturing, final butterfat results, management of out of
specification product, and training documentation. Review of records
will be on an annual basis.
Third, ABI sought clarification on accepted butterfat testing
methodologies. Acceptable testing methodologies include those that are
intended for the analysis of butterfat composition in butter. Testing
equipment may be calibrated using the Kohman or modified Kohman as a
reference testing method. Additional validated methodologies available
in the future may be considered provided the purpose of the test is for
the analysis of butterfat composition.
Fourth, ABI requested clarification on compliance and enforcement.
If during a normal review of records, a plant is found to have test
records demonstrating the plant's butter products did not meet
composition requirements, USDA will review additional documentation.
Such additional documentation will include the plant's policy to
maintain butterfat composition, corrective actions taken after product
was found to not meet the 80 percent requirement, and training and/or
preventative measures taken to reduce the occurrence of butter products
not meeting composition requirements.
If a plant fails to take corrective action as instructed by USDA
over the course of three consecutive reviews, or releases product not
meeting the composition requirement on three occasions, USDA may notify
the plant to discontinue use of the butter shield.
Two commenters opposing the proposed rule expressed concern that
allowing plants to forego a USDA inspection in favor of a records
review of an in-house or third-party testing regime could jeopardize
quality for consumers. An additional commenter expressed the change
would impact the value of the `Made in Wisconsin' butter symbol because
of what the commentor viewed as less regulatory oversight. The rule
does not lessen USDA's oversight of plants to ensure adherence to the
regulations and the quality standards set by USDA. USDA will conduct a
review of each butter manufacturing plant's quality production records
to verify the butterfat testing program meets regulatory requirements.
Additionally, third-party industry laboratory test experts routinely
audit and validate non-USDA-laboratory test procedures. The review of
records provided by this rule offers USDA a more thorough view of the
composition of a plant's butter products over time, rather than a
single point in time test, to ensure product is meeting the required
butterfat composition standard.
AMS is making no changes to the proposed rule based on these
comments.
Finally, this final rule corrects a misspelling in the regulations.
A revision to Sec. 58.336(a) replaces the word ``insure'' with
``ensure.'' ABI commented that the correction should also be made to
the new Sec. 58.336(b). AMS agrees and is making the corresponding
change.
Paperwork Reduction Act
In accordance with the Paperwork Reduction Act (PRA) of 1995 (44
U.S.C. chapter 35), AMS requested approval of new information
collection and recordkeeping requirements for the AMS Dairy Grading and
Inspection Program and comments were invited on this new information
collection. AMS received no public comments on the Office of Management
and Budget (OMB)-approved information collection portion of the final
rule.
Title: Regulations Governing the Review of Butterfat Testing
Records for the Dairy Grading and Inspection Butter Program.
OMB Number: 0581-0340.
Expiration Date of Approval: This is a NEW collection.
Type of Request: Approval of New Information Collection.
Abstract: The Dairy Grading and Inspection Program is a voluntary,
fee-based program authorized under the Agricultural Marketing Act (AMA)
of 1946 (7 U.S.C. 1621-1627). The regulations governing inspection and
grading services of manufactured or processed dairy products are
contained in 7 CFR part 58. Under the program, a plant can submit to
grading and inspection of its butter products by a USDA grader
following the U.S. Grade Standards to ensure each product meet the U.S.
grade requirements. This program provides uniform quality of dairy
products in the marketplace. The information collection requirements in
this request are essential to carry out the intent of the AMA--to
ensure that dairy products are produced under sanitary conditions and
buyers are purchasing a quality product.
Estimate of Burden: Public recordkeeping burden for this collection
of information is estimated to average 2.5 hours per year.
Recordkeepers: Butter manufacturers.
Estimated Number of Recordkeepers: 17.
Estimated Number of Hours per Recordkeeper: 2.5 hours.
Estimated Total Annual Burden on Recordkeepers: 42.5 hours.
Comments: No comments were received on the information collection
in the proposed rule.
The information collection adds an annual review of a plant's
butterfat testing records as an alternative to testing by USDA
inspectors. The review encompasses plant records of butterfat tests
performed as required under 7 CFR 58.336, and analysis of records.
Plants seeking USDA inspection for butter grading conduct their own
routine, audited, butterfat tests to ensure quality and compliance with
composition standards. The information sought in this collection is
contained in records kept in the regular course of business by the
inspected plant. Records will be reviewed on-site by a USDA inspector.
The plant will not be required to submit information to the agency.
E-Government Act
USDA is committed to complying with the E-Government Act (44 U.S.C.
3601, et seq.) by promoting the use of the internet and other
information technologies to provide increased opportunities for citizen
access to Government information and services, and for other purposes.
Executive Orders 12866 and 13563
USDA is issuing this rule in conformance with Executive Orders
12866 and 13563, which direct agencies
[[Page 4587]]
to assess all costs and benefits of available regulatory alternatives
and, if regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health, and safety effects; distributive impacts; and equity).
Executive Order 13563 emphasizes the importance of quantifying both
costs and benefits, reducing costs, harmonizing rules, and promoting
flexibility. This rule has been determined to be not significant for
purposes of Executive Order 12866; and therefore, has not been reviewed
by the Office of Management and Budget (OMB).
Executive Order 12988
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform. This rule is not intended to have a retroactive effect.
This rule will not preempt any State or local laws, regulations, or
policies unless they present an irreconcilable conflict with this rule.
Regulatory Flexibility Analysis
Pursuant to the requirements set forth in the Regulatory
Flexibility Act (5 U.S.C. 601-612), AMS has considered the economic
impact of the action on small entities. Accordingly, AMS has prepared
this Regulatory Flexibility Analysis (RFA).
The purpose of the RFA is to fit regulatory actions to the scale of
businesses subject to such actions so that small businesses will not be
unduly or disproportionately burdened. The Small Business
Administration's definition (13 CFR 121.201) of small agricultural
service firms, which includes dairy processors, varies based on the
type of dairy product manufactured. Small butter manufacturers
processors are defined as having 750 or fewer employees. Seventeen (17)
plants producing grade label butter in the U.S. participate in the
Grade Label Program. According to AMS calculations, about twelve (12),
or approximately two-thirds, are operated by dairy farmer cooperatives,
while the remaining five (5) are independently owned. AMS estimates
that six (6) of the seventeen (17) participating butter processors
would be considered small businesses.
AMS has determined that establishment of this proposal will not
have a significant economic impact on small entities. The Dairy Program
Grading and Inspection Program is a voluntary program. Small businesses
have the option to participate. The change will not unduly or
disproportionately burden small butter processing entities. It will
reduce costs to small businesses by providing an alternative to a
redundant butterfat test currently performed by USDA. AMS expects most
or all plants to choose a review of records. AMS estimates the cost to
plants for meeting USDA butterfat testing requirements ranges from
$5,000 to $32,000 annually. The significant cost difference depends on
whether the plant has an approved onsite laboratory or must ship
samples to an outside AMS laboratory, and the frequency of butterfat
samples submitted for testing.
The change will add a review of records of butterfat tests that
manufacturers currently conduct in the normal course of business to
ensure quality and compliance with composition standards as an
alternative to a USDA-inspector test. The plants will be charged for
the inspectors' time to conduct the records review, estimated to take
four hours annually. At an hourly rate of $110, a records review will
cost the plant approximately $440. This results in annual net saving to
plants ranging from $4,560 to $31,560.
Program provisions will be applied uniformly to both large and
small businesses and is not expected to burden small entities unduly or
disproportionately.
Executive Order 13175
This rule has been reviewed under E.O. 13175--Consultation and
Coordination with Indian Tribal Governments, which requires agencies to
consider whether their rulemaking actions would have Tribal
implications. AMS has determined that this rule is unlikely to have
substantial direct effects on one or more Indian Tribes, on the
relationship between the Federal Government and Indian Tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian Tribes.
List of Subjects in 7 CFR Part 58
Dairy product, Food grades and standards, Food labeling, Reporting
and recordkeeping requirements.
For reasons set forth in the preamble, the Agricultural Marketing
Service amends 7 CFR part 58 as follows:
PART 58--GRADING AND INSPECTION, GENERAL SPECIFICATIONS FOR
APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS
0
1. The authority for part 58 continues to read as follows:
Authority: 7 U.S.C. 1621-1627.
0
2. Amend Sec. 58.148 by adding paragraph (h) to read as follows:
Sec. 58.148 Plant records.
* * * * *
(h) Butterfat test records. Retain for 12 months.
0
3. Amend Sec. 58.336 by revising paragraphs (a) and (b) to read as
follows:
Sec. 58.336 Frequency of sampling for quality control of cream,
butter and related products.
(a) Microbiological. Samples shall be taken from churnings or
batches and should be taken as often as is necessary to ensure
microbiological control.
(b) Sampling and testing.--(1) Composition. Sampling and testing
for product composition shall be made on churns or batches as often as
is necessary to ensure adequate composition control. For in-plant
control, the Kohman or modified Kohman test may be used.
(2) Sampling. Butterfat sampling may be performed as part of an in-
plant quality program.
* * * * *
Erin Morris,
Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2025-00760 Filed 1-15-25; 8:45 am]
BILLING CODE 3410-02-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on January 16, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.