[Federal Register Volume 85, Number 105 (Monday, June 1, 2020)]
[Proposed Rules]
[Pages 33031-33034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11191]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
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 

  Federal Register / Vol. 85, No. 105 / Monday, June 1, 2020 / Proposed 
Rules  

[[Page 33031]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 310

[Docket No. FSIS-2020-0005]
RIN 0583-AD81


Elimination of the Requirement To Defibrinate Livestock Blood 
Saved as an Edible Product

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: The Food Safety and Inspection Service is proposing to remove 
a provision from the Federal meat inspection regulations that requires 
the defibrination of livestock blood saved as an edible product. This 
proposed action would eliminate a regulatory requirement and its 
associated costs to industry without affecting food safety. Moreover, 
it would allow industry to fulfill a demand for non-defibrinated blood 
products.

DATES: Comments must be received by July 31, 2020.

ADDRESSES: FSIS invites interested persons to submit comments on the 
proposed rule. Comments may be submitted by one of the following 
methods:
     Federal eRulemaking Portal: This website provides the 
ability to type short comments directly into the comment field on this 
web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the on-line instructions at that site for 
submitting comments.
     Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S. 
Department of Agriculture, Food Safety and Inspection Service, 1400 
Independence Avenue SW, Mailstop 3758, Room 6065, Washington, DC 20250-
3700.
     Hand- or courier-delivered submittals: Deliver to 1400 
Independence Avenue SW, Room 6065, Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2020-0005. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to http://www.regulations.gov.
    Docket: For access to background documents or comments received, 
call (202) 720-5627 to schedule a time to visit the FSIS Docket Room at 
1400 Independence Avenue SW, Room 6065, Washington, DC 20250-3700.

FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Acting Assistant 
Administrator, Office of Policy and Program Development, FSIS; 
Telephone: (202)-720-0399.

SUPPLEMENTARY INFORMATION:

Background

    FSIS administers a regulatory program under the Federal Meat 
Inspection Act (FMIA) (21 U.S.C. 601 et seq.) to protect the health and 
welfare of consumers. FSIS is responsible for ensuring that the 
nation's commercial supply of meat and meat food products is safe, 
wholesome, not adulterated, and correctly labeled and packaged. Under 
the FMIA, FSIS has broad authority to promulgate rules and regulations 
necessary to carry out this mission (21 U.S.C. 621). However, like all 
executive branch agencies, FSIS must also prudently manage the costs 
associated with governmental imposition of private expenditures 
required to comply with its regulations (Executive Order (E.O.) 13771). 
FSIS, therefore, has a responsibility to identify and eliminate 
burdensome regulations that are not necessary to ensure the safety of 
meat and meat food products.
    The Federal meat inspection regulations govern the saving of 
livestock blood for edible purposes (9 CFR 310.20). Prior to 1974, the 
regulations allowed establishments to collect edible blood from all 
livestock, except swine. However, in 1974, the Agency promulgated 9 CFR 
310.20, which removed the swine blood prohibition, finding that it was 
not necessary for food safety (39 FR 1973, January 16, 1974). In the 
1974 rule, the Agency also reasoned that the prohibition was 
burdensome, in that it denied specialty food producers a source of 
swine blood for their products.
    There have been no substantive changes governing the saving of 
livestock blood since 1974. Since that time, 9 CFR 310.20 allows 
establishments to save edible blood from all livestock, including 
swine, provided the animals' carcasses are inspected and passed and the 
blood is collected, defibrinated, and handled in a manner so as not to 
render it adulterated under the FMIA. Defibrination is the process of 
preventing fibrin from forming in blood--fibrin being an insoluble 
protein that causes blood to coagulate. Defibrination, therefore, 
results in blood that does not clot and remains in a liquid state. As 
explained below, FSIS is proposing to remove the defibrination 
requirement from the Federal meat inspection regulations for many of 
the same reasons it eliminated the swine blood prohibition in 1974.

Proposed Rule

    FSIS is proposing to remove the defibrination requirement from 9 
CFR 310.20. Blood collected from inspected and passed livestock 
carcasses and handled in a manner so as not to render it adulterated 
under the FMIA is safe for human consumption. FSIS conducted a review 
of the peer-reviewed literature regarding coagulated, i.e. non-
defibrinated, blood and did not identify any scientifically supportable 
food safety concerns. Thus, FSIS believes coagulated blood, like fluid 
blood, is safe for human consumption, provided the blood is saved from 
inspected and passed animals, and the blood is otherwise produced and 
prepared in compliance with all other FSIS regulations. Therefore, FSIS 
believes the defibrination requirement is not necessary to ensure food 
safety in accordance with the FMIA.\1\
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    \1\ FSIS Notice 22-19 instructs inspection program personnel on 
how to verify that edible blood, including coagulated blood, is 
collected and handled in a manner to be fit for use in human food. 
FSIS will periodically review data generated by such verification 
activities to ensure that establishments are following proper foods 
safety practices pertaining to the collection of edible blood.
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    Furthermore, FSIS has become aware that some establishments are 
interested in collecting coagulated blood for use in human food 
products, including specialty and ethnic food products that require 
coagulated blood as an ingredient. Such foods include

[[Page 33032]]

variations of blood sausage, blood pudding, and blood tofu. The current 
defibrination requirement denies specialty and ethnic food producers a 
source of coagulated blood, thereby placing an unnecessary economic 
burden on them and on the livestock slaughter establishments that could 
provide coagulated blood. This proposed rule would rectify that 
situation.
    FSIS is proposing to remove the word ``defibrinated'' from the 
codified regulations. Under the proposed rule, official establishments 
would still have the option to defibrinate blood, provided they meet 
all other requirements in 9 CFR 310.20. The regulations would continue 
to prohibit the defibrination of blood by hand. The regulations would 
also continue to require the use of anticoagulants that meet cited 
requirements in title 9 and title 21 of the Code of Federal 
Regulations.

Executive Orders 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 proposed rule 
has been designated as a ``non-significant'' regulatory action under 
section 3(f) of E.O. 12866. Accordingly, the rule has not been reviewed 
by the Office of Management and Budget (OMB) under E.O. 12866.

Baseline

    From October 2015 to December 3, 2019, FSIS received 15 askFSIS \2\ 
questions about defibrination from 14 slaughter establishments. 
Therefore, FSIS assumes that at least 14 establishments would be 
affected by this proposed rule.
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    \2\ askFSIS is a web-based computer application designed to help 
answer technical and policy-related questions from inspection 
program personnel, industry, consumer groups, other stakeholders, 
and the public. This data was received on December 4, 2019.
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Expected Costs of the Proposed Rule

    There are no expected costs associated with this proposed rule. If 
this proposed rule is finalized, FSIS would allow coagulated blood to 
be saved for edible purposes.

Expected Benefits of the Proposed Rule

    The proposed rule would 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 proposed rule would 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 would allow establishments additional 
flexibility to be innovative and to operate in the most efficient 
manner.
    Removing the regulation that requires establishments to defibrinate 
livestock blood is expected to result in industry cost savings. 
Establishments would 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 estimated that 
the 2019 sodium citrate solution cost per gallon of blood was $1.39.\3\ 
Based on askFSIS and Public Health Information System (PHIS) \4\ data, 
all 14 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 \5\ 
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 
establishment would save approximately $592 \6\ to $1,480 \7\ in anti-
coagulate solution cost per year if they no longer defibrinate blood.
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    \3\ 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 11/27/2019.
    The average sodium citrate price per milliliter was $0.07. 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 
$277.09. 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 $277.09 multiplied by .005 or $1.39.
    \4\ PHIS is FSIS's 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 received on December 10, 2019.
    \5\ 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. AG-3A94-B-13-0003. 
The order number is AG-3A94-K-14-0056. Table 2-5. Available at 
http://www.fsis.usda.gov/wps/wcm/connect/0cdc568e-f6b1-45dc-88f1-45f343ed0bcd/Food-Safety-Costs.pdf?MOD=AJPERES.
    \6\ 426 gallons multiplied by $1.39 sodium citrate cost per 
gallon of blood equals $592. Costs are rounded to the nearest 
dollar.
    \7\ 1,065 gallons multiplied by $1.39 equals $1,480. Costs are 
rounded to the nearest dollar.
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    Establishments that process edible blood would 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 was $27.36 \8\ per hour or approximately $0.50 \9\ per minute 
based on 2018 estimates from the Bureau of Labor Statistics. Each 
establishment would save approximately $1,305 in labor costs per 
year,\10\ with a range of $426 to $2,663 if they no longer defibrinate 
blood.
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    \8\ Wage estimate of $13.68 obtained from the Bureau of Labor 
Statistics, May 2018 National Industry-Specific Occupational 
Employment and Wage Estimates for the Processing Workers 
(Occupational Code 51-3023) 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 $27.36 
per hour.
    \9\ $27.36 divided by 60 minutes equals $0.456 rounded to the 
nearest tenth of a cent to $0.50.
    \10\ 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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    FSIS estimated that at least the 14 establishments that submitted 
askFSIS questions about defibrination from October 2015 to December 3, 
2019 would benefit from the cost savings associated with this proposed 
rule. The total estimated annual industry cost savings are detailed in 
Table 1. FSIS requests comments and data on the total number of 
establishments that save livestock blood for edible purposes.

[[Page 33033]]



                                      Table 1--Industry Annual Cost Savings
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                                                                                      Medium
                                                                   Low estimate      estimate      High estimate
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Sodium Citrate Cost Savings/Year................................          $8,288         $14,504         $20,720
Labor Cost Savings/Year.........................................           5,964          18,270          37,282
                                                                 -----------------------------------------------
    Total Cost Savings..........................................          14,252          32,774          58,002
                                                                 -----------------------------------------------
        Total Costs Savings annualized at a discount rate of 7%           14,252          32,774          58,002
         over 10 years..........................................
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Regulatory Flexibility Act Assessment

    The FSIS Administrator has made a preliminary determination that 
this proposed rule would not have a significant economic impact on a 
substantial number of small entities in the United States, as defined 
by the Regulatory Flexibility Act (5 U.S.C. 601). Small and very small 
establishments would benefit from the cost savings associated with this 
proposed rule. However, the benefits to small and very small 
establishments would not be significant based on the total savings 
estimates in Table 1 ($14,252 to $58,002 over 10 years). Of the 14 
establishments that submitted askFSIS questions about defibrination 
from October 2015 to December 3, 2019, about 64 percent were classified 
as Hazard Analysis and Critical Control Point (HACCP) size small and 36 
percent were HACCP size very small. Under the HACCP size definitions, 
large establishments have 500 or more employees and small 
establishments have fewer than 500 but more than 10 employees. Very 
small establishments have fewer than 10 employees or annual sales of 
less than $2.5 million.

Executive Order 13771

    Consistent with E.O. 13771 (82 FR 9339, February 3, 2017), FSIS has 
estimated that this proposed rule would yield cost savings. Assuming a 
7 percent discount rate, a perpetual time horizon, and a starting year 
of 2020, the proposed rule, if finalized, is estimated to yield 
approximately $25,003 (2016$) in annual cost savings. Therefore, if 
finalized as proposed, this rule would be an E.O. 13771 deregulatory 
action.

Paperwork Reduction Act

    There are no new paperwork or recordkeeping requirements associated 
with this proposed rule under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3520).

Expected Environmental Effects

    Each USDA agency is required to comply with 7 CFR part 1b of the 
Departmental regulations, which supplements the National Environmental 
Policy Act regulations published by the Council on Environmental 
Quality. Under these regulations, actions of certain USDA agencies and 
agency units are categorically excluded from the preparation of an 
Environmental Assessment (EA) or an Environmental Impact Statement 
(EIS) unless the agency head determines that an action may have a 
significant environmental effect (7 CFR 1b.4(b)). FSIS is among the 
agencies categorically excluded from the preparation of an EA or EIS (7 
CFR 1b.4(b)(6)).
    FSIS has determined that this proposed rule, which would remove the 
defibrination requirement from 9 CFR 310.20, would not create any 
extraordinary circumstances that would result in this normally excluded 
action having a significant individual or cumulative effect on the 
human environment. Therefore, this action is appropriately subject to 
the categorical exclusion from the preparation of an environmental 
assessment or environmental impact statement provided under 7 CFR 1b.4 
of the U.S. Department of Agriculture regulations.

E-Government Act

    FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et seq.) by, among other things, 
promoting the use of the internet and other information technologies 
and providing increased opportunities for citizen access to Government 
information and services, and for other purposes.

USDA Non-Discrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds 
of race, color, national origin, religion, sex, gender identity, sexual 
orientation, disability, age, marital status, family/parental status, 
income derived from a public assistance program, or political beliefs, 
exclude from participation in, deny the benefits of, or subject to 
discrimination any person in the United States under any program or 
activity conducted by the USDA.

How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program 
Discrimination Complaint Form, which may be accessed online at: http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your 
authorized representative. Send your completed complaint form or letter 
to USDA by mail, fax, or email:
    Mail: U.S. Department of Agriculture, Director, Office of 
Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410.
    Fax: (202) 690-7442.
    Email: [email protected].
    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.), should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication on-line through the FSIS web page located at: 
http://www.fsis.usda.gov/federal-register.
    FSIS also will make copies of this publication available through 
the FSIS Constituent Update, which is used to provide information 
regarding FSIS policies, procedures, regulations, Federal Register 
notices, FSIS public meetings, and other types of information that 
could affect or would be of interest to our constituents and 
stakeholders. The Constituent Update is available on the FSIS web page. 
Through the web page, FSIS is able to provide information to a much 
broader, more diverse audience. In addition, FSIS offers an email 
subscription service which provides automatic and customized access to 
selected food safety news and information. This service is available 
at: http://www.fsis.usda.gov/subscribe. Options range from recalls to 
export information, regulations, directives, and notices. Customers can 
add or delete subscriptions themselves and have the

[[Page 33034]]

option to password protect their accounts.

List of Subjects in 9 CFR Part 310

    Blood, Meat and meat products.

    For the reasons set forth in the preamble, FSIS is proposing to 
amend 9 CFR Chapter III as follows:

PART 310--POST-MORTEM INSPECTION

0
1. The authority citation for part 310 continues to read as follows:

    Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53


Sec.  310.20  [Amended]

0
2. In Sec.  310.20, remove ``, defibrinated,'' from the first sentence 
in the paragraph.

    Done, at Washington, DC
Paul Kiecker,
Administrator.
[FR Doc. 2020-11191 Filed 5-29-20; 8:45 am]
BILLING CODE 3410-DM-P