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Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Rules and Regulations
updated modified Mojonnier ether extraction method in section 33.2.26 of the AOAC Methods: Official Method 989.05. Thus, we have revised 131.200e1 by adding paragraph i to identify the AOAC Official Method 989.05 for milkfat content and renumbering the remaining paragraphs accordingly.
The proposed rule, at 131.200e1i and ii, would establish the methods of analysis for milk solids not fat and for titratable acidity, respectively.
We did not receive comments on these provisions. However, as explained previously, we have renumbered these provisions as 131.200e1ii and iii, respectively, because we have restored the inadvertent deletion of the method of analysis for milkfat at 131.200e1i.
Proposed 131.200e2 would adopt the potentiometric method for pH as described in 114.90a 21 CFR
114.90a.
We did not receive comments on the method for pH that indicated a need to change methodology, and we have finalized 131.200e2 without change.
Comment 25 Proposed 131.200e3 would discuss the measurement of live and active cultures and refer to the use of the aerobic plate count method described in Chapter 3 of FDAs Bacteriological Analytical Manual, January 2001 edition the BAM
method Ref. 13. Several comments objected to the use of the BAM method.
The comments indicated that the BAM
method is not appropriate for the accurate enumeration of live and active cultures in yogurt. The comments recommended that, for accuracy and repeatability, live and active cultures should be determined by the method described in the International Organization for Standardization ISO
7889/International Dairy Federation IDF 117:2003 ISO 7889/IDF
117:2003, Yogurt-Enumeration of characteristic microorganismscolony count-technique at 37 C Ref. 14.
Response 25 We evaluated the BAM
method and the ISO 7889/IDF 117:2003
method. We agree that the BAM method is a general reference for determining plate counts and is not designed specifically for the measurement of characterizing cultures in yogurt products. We also agree that the ISO
7889/IDF 117:2003 method, which is specifically designed to measure the characteristic microorganisms in yogurt, is the appropriate method. The ISO
7889/IDF 117:2003 method is also referenced as the appropriate method to enumerate characterizing
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microorganisms in yogurt in the Standard Methods for the Examination of Dairy Products Ref. 15. Therefore, we have revised 131.200e3 and replaced the proposed BAM method with the ISO 7889/IDF 117:2003 method incorporated by reference in the final rule.
Comment 26 One comment said that, for other safe and suitable organisms, individual yogurt manufacturers should bear the responsibility of using validated methods to enumerate such bacteria to substantiate label claims.
Response 26 We agree that manufacturers using other safe and suitable bacterial cultures have or should have the knowledge to determine the most appropriate method to enumerate these organisms.
Therefore, the final rule does not specify methods to measure other safe and suitable bacterial cultures to substantiate label claims.
H. Section 131.200fNomenclature The proposed rule would revise 131.200f by: 1 Stating that the word sweetened must accompany the name of the food wherever it appears on the principal display panel or panels if a sweetener rather than a nutritive carbohydrate sweetener is added without the addition of characterizing flavor; and 2 providing for the optional labeling of contains live and active cultures.
As discussed in responses 18, 19, and 20, we have decided to retain the term nutritive carbohydrate sweeteners in 131.200d2 instead of using the term sweeteners. Likewise, we have decided to retain nutritive carbohydrate sweetener in 131.200f1i rather than use the term sweetener. The requirement in 131.200f1i continues to apply only to nutritive carbohydrate sweeteners and is not amended under this final rule. Under 130.10, nonnutritive sweeteners can be used in the manufacture of yogurt products that deviate from the standard of identity for yogurt in order to meet an expressed nutrient content claim defined by regulation e.g., reduced calorie. The nutrient content claim is part of the name or the statement of identity of the food e.g., reduced calorie yogurt and signals to consumers that the food differs from yogurt and contains nonnutritive sweeteners.
As discussed in responses 27, 28, and 29 regarding the labeling of yogurt containing live and active cultures, the final rule revises the proposed nomenclature provisions relating to heat-treated yogurt. Changes in the final
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rule at 131.200a, b, c, and d necessitate additional changes in 131.200f regarding nomenclature provisions in the final rule.
Comment 27 Currently, 131.200f1ii requires that, if the yogurt product is heat-treated after culturing, the parenthetical phrase heat-treated after culturing must follow the name of the food wherever it appears on the principal display panel or panels of the label in letters not less than one-half of the height of the letters used in such name. The proposed rule would revise 131.200f1ii by requiring the parenthetical phrase heat-treated after culturing to appear after the name of the food if the dairy ingredients have been heat-treated after culturing.
One comment opposed modifying the labeling requirements for heat-treated yogurt. The comment also opposed the requirement of any phrase on the label of heat-treated yogurt that would classify it as one that does not contain live and active cultures, arguing that there is no difference in the effect on the human body between the consumption of yogurt with live and active cultures and those without. Other comments expressed concerns that consumers may not understand the statement heattreated after culturing, although one comment did agree with the proposed rule. Another comment cited a consumer survey that evaluated consumer understanding of the phrase heat-treated after culturing. The comment claimed that the cited survey indicated that the meaning of this phrase is not clear to most consumers and does not inform consumers that the treatment destroys some or all the bacterial cultures.
Many comments opposed heat treatment after culturing but said that, if heat treatment after culturing is allowed, the product should be clearly labeled see comment 7. One comment would require a statement on the package to indicate that the product does not contain live and active cultures.
Response 27 As discussed in response 7, many consumers are interested in knowing whether the yogurt product they purchase contains live and active cultures. The term used in the proposed rule heat-treated after culturing is a description of a manufacturing process and does not directly inform consumers how the manufacturing process affects the properties of finished yogurt product.
Apart from the nutritional aspect, the beneficial effect of yogurt or yogurt cultures is reportedly either lost Ref.
16 or reduced Refs. 17 to 20 when the
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