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Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Rules and Regulations
whether we performed sufficient evaluations to understand the safety and nutritional quality of MPC. The comment argued that, because MPC is not allowed in other standardized dairy foods, it should not be allowed in yogurt. Some comments indicated that MPC has not been classified as generally recognized as safe GRAS
21 CFR 170.3 and 170.30; sections 201s and 409 of the FD&C Act and that, according to a 2001 report from the U.S. Government Accountability Office, MPC is not nutritionally equivalent to fluid milk Ref. 10.
Response 14 Like any other food ingredient, optional milk-derived ingredients 131.200c used in yogurt must be safe and suitable. Section 130.3d 21 CFR 130.3 defines safe and suitable ingredients used in the manufacture of standardized foods. The safe and suitable ingredient must perform an appropriate function in the food when used 130.3d1 and be used at a level no higher than necessary to achieve its intended purpose in that food 130.3d2.
We disagree with the comments that only permitting the use of fluid milk or establishing a defined list of optional dairy milk-derived ingredients is necessary to manufacture the taste, aroma, appearance, and nutritional characteristics of yogurt. We do not find a technical reason to exclude one or more types of milk-derived ingredients as optional dairy ingredients if the use of these ingredients complies with all our applicable regulations, including 130.3d1 and 2.
We disagree with comments regarding safety or the GRAS status of MPC.
Under FDAs GRAS notification program, a person may notify FDA of a conclusion that a substance is GRAS
under the conditions of its intended use in human food 21 CFR part 170, subpart E. FDA has evaluated GRAS
notices for certain functional uses of MPC in food, including yogurt, and did not question the notifiers conclusion that these uses are GRAS Ref. 11. FDA
is not aware of any information at this time that calls into question the safety of the use of MPC in yogurt. We note that it is a manufacturers responsibility to ensure that food ingredients are safe and are otherwise in compliance with all applicable requirements.
Furthermore, any optional dairy ingredients, such as MPC, must be safe and suitable according to our regulations whether they are sourced domestically or imported. This means, in relevant part, that any use must be authorized under section 409 of the FD&C Act or be exempt from regulation as a food additive 130.3d.

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We likewise disagree with the comments position that MPC is a substandard ingredient. MPC and other non-milk dairy ingredients can be used as optional ingredients, provided the protein efficiency ratio of all protein present must not be decreased as a result of adding optional ingredients.
Milk protein concentrates are made by concentrating fluid skim milk using ultrafiltration and spray drying. Because both casein and whey proteins are concentrated in this process, the ratio of casein to whey protein remains nearly the same as the ratio of these components in fluid milk Ref. 12.
Although the comments provided no data to support that yogurt containing MPC in addition to the required dairy ingredients are less acceptable or differ in taste, flavor, or texture to yogurts produced with other optional dairy ingredients, the longtime use of MPC
and other optional dairy ingredients in yogurt throughout the marketplace indicates that the basic nature and essential characteristics of yogurt are maintained in producing acceptable and desired yogurt products.
Regarding the use of imported ingredients, we have programs in place, for example inspecting foods that are imported to the United States from other countries, to make sure they comply with government standards and meet the same safety requirements as foods produced within the United States. In general, a foreign or domestic facility that manufactures, processes, packs, or holds food for consumption in the United States and has to register with FDA under section 415 of the FD&C Act 21 U.S.C. 350d is subject to the requirements related to preventive controls of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule 21 CFR
part 117. Compliance with these regulations helps ensure that imported dairy ingredients, including imported MPC, are as safe as domestically produced dairy ingredients.
The comment stating that the use of MPC or whey products as an optional dairy ingredient in yogurt would have a negative economic impact on U.S. dairy farmers did not provide specific information as to how the use of these ingredients would have a negative economic impact. In addition, we note that Congress did not include economic consequences for industry such as suppliers or manufacturers as the statutory basis for establishing standards of identity. Section 401 of the FD&C Act permits FDA to establish food standards, and consequently to amend or revoke them, only when doing so
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promotes honesty and fair dealing in the interest of consumers.
Regarding the comment concerning MPCs effect on nutritional quality, the use of MPC does not diminish the nutritional quality of yogurt. Under the proposed rule, at 131.200c, the ratio of protein to total nonfat solids of the food and the protein efficiency ratio of all protein present in yogurt must not be decreased as a result of adding the optional dairy ingredients. This provision ensures that the milk protein amount and protein quality are not reduced after the addition of optional dairy ingredients and should address the other concerns regarding the use of MPC on nutritional quality. This provision is now codified at 131.200c in the final rule.
Although the proposed rule would require the minimum of 8.25 percent milk solids not fat at 131.200a, and as discussed in the preamble 74 FR
2443 at 2448, the proposed rule at 131.200c did not specify this minimum when describing other safe and suitable milk-derived ingredients that may be used to increase the nonfat solids content of the food. Thus, on our own initiative, for added clarity, in 131.200c we specify the minimum of 8.25 percent milk solids not fat above which other safe and suitable milk derived ingredients may be used to increase the milk solids not fat content of the food as required in 131.200a.
Additionally, we note that the phrase nonfat solids content in proposed 131.200c would mean the same as the phrase milk solids not fat in the proposed 131.200a. Therefore, to be consistent in the terms used, we have, on our own initiative, revised 131.200c to use the phrase milk solids not fat.
Comment 15 One comment said that the addition of optional dairy ingredients after culturing should not be permitted for safety concerns, such as microbial contamination. Other comments asked us to permit the addition of optional dairy ingredients after culturing if the optional dairy ingredients are pasteurized and handled in a manner to prevent postpasteurization contamination. The comments gave cottage cheese as an example of a standardized food in which optional dairy ingredients may be added after culturing; for example, pasteurized cottage cheese dressing is added to the cultured curd.
One yogurt producer stated that adding pasteurized milk-derived ingredients after culturing would conserve water and energy and would provide production flexibility. The comment stated that characterizing the
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