Voglio sapere a riguardo di…

31132

Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Rules and Regulations
jbell on DSKJLSW7X2PROD with RULES

130.10b requires nutrients to be added to restore nutrient levels so that the product is not nutritionally inferior to the standardized food as defined in 21 CFR parts 131 to 169. As discussed in the proposed rule, lowfat yogurt and nonfat yogurt have a lower vitamin A
content than yogurt and therefore would be required under 130.10b to be fortified with vitamin A to the same level as yogurt.
Comment 32 One comment supported nutritional equivalence of lowfat yogurt and nonfat yogurt with yogurt under 130.10b, noting that the requirement would make these foods consistent with other foods modified under the general definition and standard. Another comment opposed mandatory fortification of lowfat yogurt and nonfat yogurt with vitamin A based on the costs of compliance for industry.
Response 32 Requiring vitamin A
fortification of lower-fat yogurt products under 130.10b would not necessarily make these products consistent with other modified dairy foods. FDA has not enforced 130.10b with respect to vitamin A fortification of lower-fat milk products covered under the general definition and standard see South Mt.
Creamery, LLC v. United States FDA, 438 F. Supp. 3d 236 2020. Moreover, as noted in the proposal, the contribution of yogurt to daily vitamin A intake is not expected to be altered significantly if the nutritional equivalency requirement in 130.10b were to apply to lowfat yogurt and nonfat yogurt. Although yogurt consumption has increased in recent years, the contribution of vitamin A that would result from fortification of lowerfat yogurt products remains insignificant Ref. 21. Thus, in light of our enforcement policy regarding vitamin A fortification of lower-fat milk products and the lack of public health impact from vitamin A fortification of yogurt, we are amending 130.10b to exempt lower-fat yogurt products from vitamin A fortification.
This final rule revises 130.10b to provide for the exemption.
Manufacturers may choose to fortify lowfat yogurt and nonfat yogurt with vitamin A to the level in yogurt;
however, they are not required to do so.
If they choose to fortify with vitamin A
under 130.10b, then vitamin A must be declared in the ingredient statement.
L. Incorporation by Reference The final rule incorporates two references. As we explained in part IV.G, FDA is incorporating by reference three methods from the Official Methods of Analysis of AOAC
International, 21st edition 2019. You
VerDate Sep<11>2014

17:30 Jun 10, 2021

Jkt 253001

may purchase a copy of the material from AOAC INTERNATIONAL, 2275
Research Blvd., Suite 300, Rockville, MD 208503250, USA, 3019247077
ext. 170. https www.aoac.org/officialmethods-of-analysis-21st-edition-2019/.
The AOAC Methods have undergone rigorous scientific review and validation to determine the performance characteristics for the intended analytical application and fitness for purpose. Each of the following three methods includes specific instructions for performing the chemical analysis of a substance in a particular matrix.
AOAC Official Method 947.05, Acidity of Milk Titrimetric Method, 21st edition, 2019, Vol. 1.
AOAC Official Method 989.05, Fat in Milk Modified Mojonnier Ether Extraction Method, 21st edition, 2019, Vol. 1.
AOAC Official Method 990.21, Solids-Not-Fat in Milk by Difference between Total Solids and Fat Contents, 21st edition, 2019, Vol. 1.
Also, FDA is incorporating by reference the International Organization for Standardization 7889:2003E/
International Dairy Federation 117:2003E ISO 7889:2003EIDF
117:2003E, YogurtEnumeration of Characteristic MicroorganismsColonyCount Technique at 37 C, First edition, 20030201. You may purchase a copy of the material from the International Organization for Standardization, ISO
Central Secretariat, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland. +41 22 749 01 11.
central@iso.org. ISO 7889IDF 117:2003
specifies a method for the enumeration of characteristic microorganisms in yogurt by means of the colony-count technique at 37 degrees Celsius. The method is applicable to yogurts in which both characteristic microorganisms L. delbrueckii subspecies bulgaricus and S.
thermophilus are present and viable.
V. Economic Analysis of Impacts This rule is issued in accordance with the formal rulemaking provisions of 5
U.S.C. 556 and 557, and is, therefore, exempt from the economic analysis requirements of Executive Order E.O.
12866 and E.O. 13563. We have examined the economic implications of this rulemaking on small businesses.
Regulatory Flexibility Analysis The Regulatory Flexibility Act 5
U.S.C. 601612 requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this rule may generate compliance costs for some small firms, we believe that this rule
PO 00000

Frm 00046

Fmt 4700

Sfmt 4700

would have a significant economic impact on a substantial number of small entities and is therefore subject to a final regulatory flexibility analysis 5 U.S.C.
604. The following analysis, in conjunction with the remainder of the preamble, constitutes our final regulatory flexibility analysis.
One requirement of the Regulatory Flexibility Act is a succinct statement of any objectives of the rule. As stated previously in the preamble, with this rule, we intend to amend the yogurt standard of identity and revoke the lowfat yogurt and nonfat yogurt standards of identity to promote honesty and fair dealing in the interest of consumers. The amendments are intended to modernize the current yogurt standard and allow for lowfat yogurt and nonfat yogurt to be covered under the general definition and standard to permit flexibility and provide for technological advances in yogurt production, while preserving the basic nature and essential characteristics of yogurt, lowfat yogurt, and nonfat yogurt consistent with consumer expectations and protecting consumer interests.
This rule would affect yogurt manufacturing firms in the Standard Industrial Classification SIC code 20260208 Yogurt Manufacturing.
The equivalent North American Industry Classification System NAICS
code is 311511 Fluid Milk Manufacturing. The Small Business Administration SBA defines a small business in NAICS code 311511 as a business with 500 or fewer employees.
This rule will not affect firms that manufacture products such as frozen yogurt, dried yogurt-style mixes, or products that contain yogurt as an ingredient.
We searched the Dun and Bradstreet database for U.S. firms in SIC code 20260208 Yogurt Manufacturing and identified 450 firms. To exclude firms not engaged in the manufacture of yogurt, we performed an internet search of the name of each firm and identified frozen yogurt manufacturers. After excluding frozen yogurt manufacturers, we estimate that there are approximately 31 U.S. yogurt manufacturers, of which approximately 9, or 29 percent = 31 0.29, are small businesses per SBA definition.
We expect that three provisions of the final rule may require some small firms to change their current activity. The other provisions of the final rule provide additional flexibility to firms beyond that available under current requirements. For this analysis, we estimate costs for those provisions that may require some small firms to change
E:FRFM11JNR1.SGM

11JNR1