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Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Rules and Regulations their current practices. We do not estimate costs for changing manufacturing practices in ways that would be newly permitted by the final rule as costs of the final rule.
The three provisions that we estimate will require some small firms to change their current practices are:
1. The requirement that yogurt have either a titratable acidity of not less than 0.7 percent expressed as lactic acid or a pH of 4.6 or lower Acidity Requirement.
2. The requirement that yogurt bearing optional labeling statements such as contains live and active cultures must contain a minimum of 107 CFU/g of live and active cultures at the time of manufacture with a reasonable expectation that the yogurt will contain live and active cultures at a level of 106 CFU/g through the manufacturers assigned shelf life of the product, as well as the requirement that yogurt that is treated after culturing bear on its label the statement does not contain live and active cultures Claims Requirements.
3. The revocation of the standards of identity for lowfat yogurt 131.203
and nonfat yogurt 131.206
Standards of Identity Revocation.
The following analysis estimates the costs of each provision to small manufacturers.

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1. The Acidity Requirement The final rule requires that yogurt have either a titratable acidity of not less than 0.7 percent expressed as lactic acid or a pH of 4.6 or lower. We stated that we believed that all or nearly all yogurt currently on the market had a titratable acidity above the then-proposed minimum cutoff of 0.7 percent, usually in the range of 1.0 to 1.3 percent, and a pH level below the proposed maximum level of 4.6, usually ranging from 4.1 to 4.3. At the time, we estimated that the proposed acidity requirements would generate minimal or no compliance costs. We received no comments on this.
In the final rule, we require that yogurt have either a titratable acidity of not less than 0.7 percent expressed as lactic acid or a pH of 4.6 or lower. We still believe that all or nearly all yogurt currently on the market has a titratable acidity above the minimum cutoff of 0.7
percent titratable acidity, usually ranging from 1.0 to 1.3 percent, and a pH level below the proposed maximum level of 4.6, usually ranging from 4.1 to 4.3. We estimate that the Acidity Requirement would generate minimal or no compliance costs.

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2. The Claims Requirements Yogurt manufacturers who want to include the optional statement contains live and active cultures or similar claims on labels will be required to show that their yogurt contains at least 107 CFU/g of live and active cultures at the time of manufacture of the yogurt using analytical testing methods. Otherwise, such a claim cannot be made. In addition, yogurt products that are treated to inactivate viable microorganisms after culturing but do not currently bear the claim does not contain live and active cultures will be required to add this claim to labels. This was modified for clarity as the proposed rule would require yogurt products that are heattreated after culturing to bear the claim heat-treated after culturing on their label and it would advise, but not require, that such yogurt products also bear the claim does not contain live and active cultures on their label.
Based on an analysis of yogurt UPCs using the online grocery shopping platform Peapod, approximately 85
percent of yogurt UPCs currently make a contains live and active cultures or similar claim. Approximately 15 percent of yogurt UPCs make no such claims.
We estimate that approximately 1,972
UPCs manufactured by small yogurt manufacturers, or equivalently 8 small yogurt manufacturers, will be affected by the Claims Requirement related to the contains live and active cultures or similar claim Claims Requirement A and approximately 348 UPCs manufactured by small yogurt manufacturers, or equivalently 1 small yogurt manufacturer, will be affected by the Claims Requirement related to the does not contain live and active cultures claim Claims Requirement B.
Based on further analysis of yogurt UPCs using Peapod, 56 percent of yogurt UPCs that make a contains live and active cultures or similar claim also make a claim that they meet the NYA standard for live and active cultures. The NYAs standard of at least 108 CFU/g at the time of manufacture is higher than our standard of at least 107
CFU/g. We estimate that approximately 1,105 of the 1,972 UPCs that are affected by Claims Requirement A and are manufactured by small yogurt manufacturers will only need to incur analytical testing costs related to this Claims Requirement.
We do not know how many of the remaining 868 small manufacturer yogurt UPCs that are affected by Claims Requirement A meet this Claims Requirement. Therefore, we
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conservatively estimate that none do, so that some of these UPCs will need to incur analytical testing costs and reformulation costs to prove that they meet the 107 live and active cultures standard. Others will need to incur relabeling costs associated with removing the contains live and active cultures or similar claims from labels.
As we are not aware of data on these proportions, we estimate an even split between these possibilities, with approximately 434 UPCs incurring analytical testing and reformulation costs and approximately 434 UPCs incurring relabeling costs. Finally, we do not know how many of the 348 small manufacturer yogurt UPCs that do not make any kind of a contains live and active cultures or similar claim undergo heat treatment after culturing and would be subject to Claims Requirement B. Therefore, we conservatively estimate that all undergo heat treatment after culturing and estimate the relabeling costs associated with adding the phrase does not contain live and active cultures to their labels.
We estimate analytical testing costs using information on formula and UPC
counts from 2014 Nielsen Scantrack data, as well as information gathered on published prices from various testing laboratories. This information was gathered by RTI International as part of its development of the FDA Labeling Cost Model. We estimate that the total number of yogurt formulas is approximately 6,070 and the total number of yogurt UPCs is approximately 8,002, yielding a formula-to-UPC ratio of 0.759 6,070/
8,002 = 0.759. The total number of UPCs that will require analytical testing is approximately 1,539 and the total number of formulas subject to analytical testing is approximately 1,167.
Analytical tests designed to detect pathogens in food cost between $25.72
and $60.81 in 2019 dollars per formula.
These costs represent an estimate of the costs of measuring the amount of CFU/
g in yogurt. We estimate that two samples per formula are tested and that labor costs to prepare samples are approximately $29.58 and shipping costs related to shipping the samples to the testing laboratory are approximately $70.81 in 2019 dollars. Therefore, we estimate analytical testing costs to be between approximately $177,206 and $259,105 per year.
The number of small yogurt UPCs that will reformulate related to Claims Requirement A is approximately 434
and the total number of formulas subject to reformulation is approximately 329.
We estimated reformulation costs by
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