Plant Records To Include Grade Label Butterfat Testing

<RULE> DEPARTMENT OF AGRICULTURE <SUBAGY>Agricultural Marketing Service</SUBAGY> <CFR>7 CFR Part 58</CFR> <DEPDOC>[Doc. No. AMS-DA-22-0064]</DEPDOC> <RIN>RIN 0581-AE20</RIN> <SUBJECT>Plant Records To Include Grade Label Butterfat Testing</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Agricultural Marketing Service, USDA. <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This final rule is effective February 18, 2025. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> 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: <E T="03">Whitney.Rick@usda.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> The Secretary of Agriculture is authorized by the Agricultural Marketing Act (AMA) of 1946, as amended (7 U.S.C. 1621, <E T="03">et seq.</E> ), 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 <E T="04">Federal Register</E> on August 15, 2023 (88 FR 55426). Copies of the proposed rule 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 ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 20k characters. 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