Rules and Regulations. Proposed rule; reopening of the comment period

Agency: Food and Drug Administration, HHS
Action: Proposed rule; reopening of the comment period
Citation: FR Doc. 2020-07749 · Docket No. FDA-2008-P-0086 · 21 CFR 133

Summary

The Food and Drug Administration (FDA or we) is reopening the comment period for the proposed rule, published in the Federal Register of October 19, 2005, entitled “Cheeses and Related Cheese Products; Proposal to Permit the Use of Ultrafiltered Milk.” The proposed rule would amend our regulations to provide for the use of fluid ultrafiltered (UF) milk in the manufacture of standardized cheeses and related cheese products. FDA is reopening the comment period to update comments and to receive any new information.

Dates

FDA is reopening the comment period on the proposed rule published on October 19, 2005 (70 FR 60751), for which we had reopened the comment period as recently as December 30, 2019 (84 FR 71834). The reopened comment period ended on March 30, 2020. Through this document, we are reopening the comment period again. Submit either electronic or written comments by August 13, 2020.

Supplementary Information

In the Federal Register of October 19, 2005, we proposed to amend our regulations to provide for the use of fluid UF milk in the manufacture of standardized cheeses and related cheese products. Specifically, the proposed rule, if finalized, for standardized cheeses and related cheese products, would: (1) Amend the definitions of “milk” and “nonfat milk” in § 133.3 (21 CFR 133.3) to provide for ultrafiltration of milk and nonfat milk and (2) define ultrafiltered milk and ultrafiltered nonfat milk in § 133.3 as raw or pasteurized milk or nonfat milk that is passed over one or more semipermeable membranes to partially remove water, lactose, minerals, and water-soluble vitamins without altering the casein-to-whey protein ratio of the milk or nonfat milk and resulting in a liquid product. FDA also proposed that the name of such treated milk be “ultrafiltered milk” or “ultrafiltered nonfat milk,” as appropriate. Consequently, when this type of milk is used, it would be declared in the ingredient statement of the finished food as “ultrafiltered milk” or “ultrafiltered nonfat milk.” This proposal was issued in response to citizen petitions from the American Dairy Products Institute and the National Cheese Institute, the Grocery Manufacturers of America, Inc., and the National Food Processors Association. Interested persons were originally given until January 17, 2006, to comment. We subsequently reopened the comment period to seek further comment on two specific issues raised by the comments concerning the proposed ingredient declaration (72 FR 70251, December 11, 2007); the reopened comment period was scheduled to end on February 11, 2008. In the Federal Register of February 11, 2008 (73 FR 7692), we extended the comment period until April 11, 2008. In the Federal Register of August 14, 2017 (82 FR 37815), we announced the availability of a guidance for industry entitled “Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese Products.” In the guidance, we notified manufacturers who wish to use UF milk or UF nonfat milk in the production of standardized cheeses and related cheese products of our intent to exercise enforcement discretion regarding the use of fluid UF milk and fluid UF nonfat milk in the production of standardized cheeses and related cheese products, provided that the physical, chemical, and organoleptic properties of the cheese or cheese product are not affected. We also stated our intent to exercise enforcement discretion with respect to the labeling of fluid UF milk and fluid UF nonfat milk in recognition of the costs and logistics involved in label changes; however, we encouraged industry to identify these ingredients as “ultrafiltered milk” and “ultrafiltered nonfat milk” to the extent feasible and appropriate. We further explained that we intend to exercise enforcement discretion until we have completed a rulemaking process amending our regulations with respect to the issues covered by the guidance or announced our determination not to proceed with such a rulemaking. In the Federal Register of December 30, 2019, we announced another reopening of the comment period to receive information and further comment on current industry practices regarding the use of fluid UF milk and fluid UF nonfat milk in the manufacture of standardized cheeses and related cheese products, and the declaration of fluid UF milk and fluid UF nonfat milk when used as ingredients in standardized cheeses and related cheese products. The reopened comment period ended on March 30, 2020. Following publication of the December 30, 2019, document reopening the comment period for the proposed rule, we received requests to allow interested persons additional time to comment. In conjunction with the requests, we are providing an additional 120 days for persons to respond fully to FDA's specific requests for comments and to allow potential respondents to thoroughly evaluate and address pertinent issues. Therefore, we are reopening the comment period until August 13, 2020. Dated: April 7, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020-07749 Filed 4-14-20; 8:45 am]