SUPPLEMENTARY INFORMATION:

I. Background

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.

II. Additional Issues for Consideration

To inform our decision on whether to proceed with the rulemaking initiated in the October 19, 2005, proposal, we seek new information and public 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 in the labeling of these products when used as ingredients. Of particular interest, we seek comment on the following questions:

1. We would like to understand whether there is variable use of fluid UF milk or fluid UF nonfat milk in the production of standardized cheeses and related cheese products. For example, if a company uses fluid UF milk in the production of a standardized cheese, does the amount of fluid UF milk remain constant, or does the amount vary depending on certain factors (such as the cost of fluid UF milk)? Please explain whether the amount of fluid UF milk or fluid UF nonfat milk varies for specific standardized cheeses and related cheese products and the factors that influence the variability. To maintain the essential characteristics of the standardized cheese or cheese product, is the amount of fluid UF milk or fluid UF nonfat milk limited to a range ( i.e., a minimum and maximum amount)? Please identify the specific standardized cheese or cheese product and provide any ranges or amounts and explain your reasoning.

2. (a) We invite comment on why manufacturers may sometimes produce their particular brands of standardized cheeses and related cheese products with fluid UF milk or fluid UF nonfat milk and sometimes without fluid UF milk or fluid UF nonfat milk. Please explain your reasoning.

(b) Given that manufacturers may sometimes choose to produce these products with or without fluid UF milk or fluid UF nonfat milk, we are interested in how ingredient labeling of these standardized cheeses and related cheese products could be addressed.

Our understanding is that fluid UF milk and fluid UF nonfat milk, when used as ingredients in cheese, are always used in lesser amounts by weight than milk and nonfat milk in order to avoid affecting the physical, chemical, and organoleptic properties of the cheese. For example, a manufacturer might use milk and fluid UF milk, but our understanding is that the amount of fluid UF milk will be less than that of milk. As such, milk would be the predominant ingredient and declared first in the ingredient statement, per FDA's regulations that require ingredients to be declared by their common or usual names in descending order of predominance by weight (21 CFR 101.4(a)). Fluid UF milk, if used, would be declared thereafter.

Based on our understanding, we are considering whether, when fluid UF milk and fluid UF nonfat milk are sometimes used as ingredients, the labeling of standardized cheeses and cheese products may alternatively declare “milk or milk and ultrafiltered ( printed page 71836) milk” or “nonfat milk or nonfat milk and ultrafiltered nonfat milk” in the ingredient statements. We invite comment on this consideration and whether such declarations would indicate that fluid UF milk or fluid UF nonfat milk may be an ingredient, but not as predominant as milk or nonfat milk, and also enable manufacturers to avoid relabeling costs if they use varying amounts of fluid UF milk or fluid UF nonfat milk. Please discuss whether such declarations would be informative (or, conversely, potentially misleading to consumers) and please explain your reasoning.

3. We also are interested in issues related to the costs of printing different product labels and the logistics involved in label changes when fluid UF milk and fluid UF nonfat milk are sometimes used as ingredients in the production of a manufacturer's standardized cheese or cheese product. For example, what impacts, if any, would a label statement of “milk or milk and ultrafiltered milk” or “nonfat milk or nonfat milk and ultrafiltered nonfat milk” have on labeling costs? How would these costs compare if fluid UF milk and fluid UF nonfat milk are declared only when used in the standardized cheese or cheese product? Please explain your reasoning.

4. Ultrafiltered milk is being used in a greater number of food products than in the past. There are dairy products in the marketplace, which appear to have gained consumer acceptance, where “ultrafiltered milk” has appeared in the statement of identity or declared in the ingredient statement on the product label. Are there any situations where retailers or consumers would not purchase standardized cheeses or cheese products labeled as containing “ultrafiltered milk” as an ingredient? Please describe such situations and provide any recent consumer data or market analyses you may have to explain your reasoning.

84 FR 71834