Voglio sapere a riguardo di…

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Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Rules and Regulations
blood is a key ingredient in certain ethnic cuisines.
The second comment, from an individual, supported the practice of saving undefibrinated livestock blood as an edible product. The comment also underscored the benefits from eliminating the unnecessary costs associated with the defibrination requirement. The commenter stated that although these costs, as calculated in the Agencys economic analysis, may seem minimal when viewing a single employee performing a single defibrination task, they add up in the course of a year and when considering the number of establishments affected.
Response: FSIS agrees with the commenters and appreciates their support for this deregulatory action.
Executive Orders E.O.s 12866 and 13563, and the Regulatory Flexibility Act E.O.s 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits including potential economic, environmental, public health and safety effects, distributive impacts, and equity. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This final rule has been designated as a non-significant regulatory action under section 3f of E.O. 12866. Accordingly, the rule has not been reviewed by the Office of Management and Budget OMB under E.O. 12866.
FSIS has updated the estimated benefits for this final rule from those published in the proposed rule based on
more recent data. The changes include:
A slight increase in the number of askFSIS questions and establishments;
updated wage rates for production employees; and updated anti-coagulant solution costs.
Baseline From October 2015 to December 2, 2020, FSIS received 16 askFSIS 3
questions about defibrination from 15
slaughter establishments. Therefore, FSIS assumes that at least 15
establishments will be affected by this final rule.
Expected Costs of the Final Rule There are no expected costs associated with this final rule. FSIS will allow coagulated blood to be saved for edible purposes.
Expected Benefits of the Final Rule This final rule will benefit slaughter establishments that manufacture livestock blood and processing establishments that use the blood in their products, such as blood sausage, blood tofu, and blood pudding. This final rule will allow slaughter establishments manufacturing livestock blood for edible purposes to package and sell the item in its customary coagulated form, enhancing the marketability for these niche products.
In addition, removing the unnecessary, prescriptive requirements will allow establishments additional flexibility to be innovative and to operate in the most efficient manner.
Removing the regulatory requirement for establishments to defibrinate livestock blood is expected to result in industry cost savings. Establishments will reduce anti-coagulant solution costs and labor costs associated with defibrination.

According to 9 CFR 424.21, sodium citrate is a FSIS-approved anti-coagulant that can be used to defibrinate blood.
FSIS estimates that the 2020 sodium citrate solution cost per gallon of blood is $1.47.4 Using askFSIS and Public Health Information System PHIS 5
data, FSIS determined that all 15
establishments that process edible blood are small or very small establishments.
FSIS experts estimated that small establishments that process edible blood products process two to five gallons of edible blood per production day. These establishments operate about 213 6
production days per year, which means that they each process an estimated 426
to 1,065 gallons of edible blood per year.
Each of these establishments will save approximately $1,096 per year, with a range of $626 7 to $1,566 8 if they no longer defibrinate blood.
Establishments that process edible blood will also benefit from labor cost savings. FSIS experts estimate that it takes one production worker two to five minutes to defibrinate one gallon of livestock blood. FSIS estimated the total compensation rate of a production employee is $28.46 9 per hour or approximately $0.50 10 per minute based on 2019 estimates from the Bureau of Labor Statistics. Each establishment will save approximately $1,305 in labor costs per year,11 with a range of $426 to $2,663 if they no longer defibrinate blood.
FSIS estimated that at least the 15
establishments that submitted askFSIS
questions about defibrination from October 2015 to December 2, 2020 will benefit from the cost savings associated with this final rule. The total estimated annual industry cost savings are detailed in Table 1.

TABLE 1INDUSTRY ANNUAL COST SAVINGS ESTIMATES
Low
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Sodium Citrate Cost Savings/Year
3 askFSIS is a web-based computer application designed to help answer technical and policyrelated questions from inspection program personnel, industry, consumer groups, other stakeholders, and the public. This data was received on December 2, 2020.
4 Sodium citrate prices were obtained from three laboratory websites, https www.jorvet.com/, https www.rpicorp.com/, https www.tocris.com/.
These websites were accessed on 11/30/2020.
The average sodium citrate price per milliliter was $0.08. This price was multiplied by the conversion rate of 3,785.412 ml per gallon to get the average sodium citrate price per gallon of $292.11.
According to 9 CFR 424.21, the sodium citrate solution cannot exceed 0.5 percent, based on the ingoing weight of the product. Therefore, the price of sodium citrate per gallon of blood would be $292.11 multiplied by .005 or $1.47.

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5 PHIS is FSISs electronic data analytic system, used to collect, consolidate, and analyze data in order to improve public health. FSIS used data from PHIS to identify these establishments by Hazard Analysis and Critical Control Point HACCP
category. This data was accessed on December 2, 2020.
6 Viator. C. et al. 2015. RTI International Costs of Food Safety Investments prepared by Catherine L. Viator, Mary K. Muth, and Jenna E. Brophy. The contract number is No. AG3A94B130003. The order number is AG3A94K140056. Table 25.
Available at http www.fsis.usda.gov/wps/wcm/
connect/0cdc568e-f6b1-45dc-88f1-45f343ed0bcd/
Food-Safety-Costs.pdf?MOD=AJPERES.
7 426 gallons multiplied by $1.47, the sodium citrate cost per gallon of blood, equals $626. Costs are rounded to the nearest dollar.

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Medium
$9,390

$16,440

High $23,490

8 1,065 gallons multiplied by $1.47 equals $1,566.
Costs are rounded to the nearest dollar.
9 Wage estimate of $14.23 obtained from the Bureau of Labor Statistics, May 2019 National Industry-Specific Occupational Employment and Wage Estimates for the Processing Workers Occupational Code 513023 in the Animal Slaughtering and Process Industry NAICS code 311600. https www.bls.gov/oes/current/
oes513023.htm. FSIS multiplied the mean hourly wage rate by a benefits factor of 2, to obtain a total compensation rate of $28.46 per hour.
10 $28.46 divided by 60 minutes equals $0.4743
rounded to the nearest tenth of a cent to $0.50.
11 3.5 2 + 5/2 minutes multiplied by the mid estimate of 3.5 2 + 5/2 gallons of blood per production day multiplied by 213 production days, multiplied by the labor cost per minute $0.50. The costs are rounded to the nearest dollar.

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