Rule2021-13160
Elimination of the Requirement To Defibrinate Livestock Blood Saved as an Edible Product
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 24, 2021
Effective
August 23, 2021
Issuing agencies
Agriculture DepartmentFood Safety and Inspection Service
Abstract
The Food Safety and Inspection Service (FSIS) is removing from the Federal meat inspection regulations a requirement for the defibrination of livestock blood saved as an edible product. Defibrination is the process for removing the protein fibrin, which causes blood to clot. Removal of the defibrination requirement will not affect food safety, but it will allow the industry to meet a demand for non-defibrinated blood products.
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<title>Federal Register, Volume 86 Issue 119 (Thursday, June 24, 2021)</title>
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[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Rules and Regulations]
[Pages 33085-33088]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-13160]
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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: Final rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is removing from
the Federal meat inspection regulations a requirement for the
defibrination of livestock blood saved as an edible product.
Defibrination is the process for removing the protein fibrin, which
causes blood to clot. Removal of the defibrination requirement will not
affect food safety, but it will allow the industry to meet a demand for
non-defibrinated blood products.
DATES: This rule is effective August 23, 2021.
FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Assistant
Administrator, Office of Policy and Program Development, FSIS;
Telephone: (202)-205-0495.
SUPPLEMENTARY INFORMATION:
Background
On June 1, 2020, FSIS proposed to remove from the Federal meat
inspection regulations a provision requiring the defibrination of
livestock blood saved as edible product (85 FR 33031). The Agency
stated in the proposed rule that eliminating the requirement, along
with its associated costs to industry, would not affect food safety,
but would enable industry to meet a demand for non-defibrinated blood
products.
FSIS noted in the proposal that, before 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.
Also, FSIS explained in the proposed rule that there had been no
substantive changes governing the saving of livestock blood since 1974.
Since that time, 9 CFR 310.20 has allowed 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 to prevent its becoming
adulterated under the FMIA.
FSIS examined the peer-reviewed literature on 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.\2\
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\2\ 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 food
safety practices pertaining to the collection of edible blood.
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Furthermore, as is explained in the proposed rule, 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 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.
FSIS proposed to remove the defibrination requirement from the
Federal meat inspection regulations for many of the same reasons it
gave for eliminating the swine blood prohibition in 1974.
Final Rule
This final rule is consistent with the proposed rule. FSIS is
making no additional changes to the regulations in response to
comments. FSIS is removing the defibrination requirement from 9 CFR
310.20.
Specifically, FSIS is revising the codified regulations to remove
the word ``defibrinated''. Under this final rule, official
establishments will still have the option to defibrinate blood,
provided they meet all other requirements in 9 CFR 310.20. The
regulations will continue to prohibit the defibrination of blood by
hand. The regulations will also continue to require the use of
anticoagulants that meet cited requirements in title 9 and title 21 of
the Code of Federal Regulations.
Comments and Response
Comments: FSIS received two comments on the proposed rule. The
first, from an industry association, was in agreement with the Agency's
reasons for proposing to eliminate the blood defibrination requirement,
including the lack of a food-safety benefit from the requirement and
the fact that coagulated
[[Page 33086]]
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 Agency's 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 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.
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.
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\3\ 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 2, 2020.
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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.
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\4\ Sodium citrate prices were obtained from three laboratory
websites, <a href="https://www.jorvet.com/">https://www.jorvet.com/</a>, <a href="https://www.rpicorp.com/">https://www.rpicorp.com/</a>, <a href="https://www.tocris.com/">https://www.tocris.com/</a>. 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.
\5\ 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 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. AG-3A94-B-13-0003.
The order number is AG-3A94-K-14-0056. Table 2-5. Available at
<a href="http://www.fsis.usda.gov/wps/wcm/connect/0cdc568e-f6b1-45dc-88f1-45f343ed0bcd/Food-Safety-Costs.pdf?MOD=AJPERES">http://www.fsis.usda.gov/wps/wcm/connect/0cdc568e-f6b1-45dc-88f1-45f343ed0bcd/Food-Safety-Costs.pdf?MOD=AJPERES</a>.
\7\ 426 gallons multiplied by $1.47, the sodium citrate cost per
gallon of blood, equals $626. Costs are rounded to the nearest
dollar.
\8\ 1,065 gallons multiplied by $1.47 equals $1,566. Costs are
rounded to the nearest dollar.
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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.
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\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 51-3023) in the Animal Slaughtering and Process
Industry (NAICS code 311600). <a href="https://www.bls.gov/oes/current/oes513023.htm">https://www.bls.gov/oes/current/oes513023.htm</a>. 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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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 1--Industry Annual Cost Savings Estimates
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Low Medium High
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Sodium Citrate Cost Savings/Year................................ $9,390 $16,440 $23,490
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Labor Cost Savings/Year......................................... 6,390 19,575 39,945
Total Cost Savings.......................................... 15,780 36,015 63,435
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Total Costs Savings annualized at a discount rate of 7% over 15,780 36,015 63,435
10 years...................................................
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Regulatory Flexibility Act Assessment
The FSIS Administrator has made a determination that this final
rule will 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 will benefit from the cost savings associated with this
final rule. However, the benefits to small and very small
establishments, as indicated by the total savings estimates in Table 1
($15,780 to $63,435 over 10 years), will not be significant. Of the 15
establishments that submitted askFSIS questions about defibrination
from October 2015 to December 2, 2020, about 67 percent were classified
as small, by Hazard Analysis and Critical Control Point (HACCP) size,
and 33 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.
Paperwork Reduction Act
There are no new paperwork or recordkeeping requirements associated
with this final rule under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3520).
Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
the Office of Information and Regulatory Affairs designated this rule
as not a ``major rule,'' as defined by 5 U.S.C. 804(2).
Environmental Impacts
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 final rule, which removes the
defibrination requirement from 9 CFR 310.20, will not create any
extraordinary circumstances that would result in this normally excluded
action's 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(6) 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
In accordance with Federal civil rights law and U.S. Department of
Agriculture (USDA) civil rights regulations and policies, the USDA, its
Agencies, offices, and employees, and institutions participating in or
administering USDA programs are prohibited from discriminating based on
race, color, national origin, religion, sex, gender identity (including
gender expression), sexual orientation, disability, age, marital
status, family/parental status, income derived from a public assistance
program, political beliefs, or reprisal or retaliation for prior civil
rights activity, in any program or activity conducted or funded by USDA
(not all bases apply to all programs). Remedies and complaint filing
deadlines vary by program or incident.
Persons with disabilities who require alternative means of
communication for program information (e.g., Braille, large print,
audiotape, American Sign Language, etc.) should contact the responsible
Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or
contact USDA through the Federal Relay Service at (800) 877-8339.
Additionally, program information may be made available in languages
other than English.
To file a program discrimination complaint, complete the USDA
Program Discrimination Complaint Form, AD-3027, found online at <a href="https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint">https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint</a> and
at any USDA office or write a letter addressed to USDA and provide in
the letter all of the information requested in the form. To request a
copy of the complaint form, call (866) 632-9992. Submit your completed
form or letter to USDA by: (1) Mail: U.S. Department of Agriculture,
Office of the Assistant Secretary for Civil Rights, 1400 Independence
Avenue SW, Washington, DC 20250-9410; (2) fax: (202) 690-7442; or (3)
email: <a href="/cdn-cgi/l/email-protection#a2d2d0cdc5d0c3cf8ccbccd6c3c9c7e2d7d1c6c38cc5cdd4"><span class="__cf_email__" data-cfemail="e090928f8792818dce898e94818b85a095938481ce878f96">[email protected]</span></a>.
USDA is an equal opportunity provider, employer, and lender.
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:
<a href="https://www.fsis.usda.gov/federal-register">https://www.fsis.usda.gov/federal-register</a>.
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: <a href="https://www.fsis.usda.gov/subscribe">https://www.fsis.usda.gov/subscribe</a>. Options range from recalls to
export information, regulations, directives, and notices. Customers can
add or delete subscriptions themselves and have the
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option to password-protect their accounts.
List of Subjects in 9 CFR Part 310
Meat and meat products, Blood.
For the reasons set forth in the preamble, FSIS amends 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.
0
2. Revise Sec. 310.20 to read as follows:
Sec. 310.20 Saving of blood from livestock as an edible product.
Blood may be saved for edible purposes at official establishments
provided it is derived from livestock, the carcasses of which are
inspected and passed, and the blood is collected and handled in a
manner so as not to render it adulterated under the Federal Meat
Inspection Act and regulations issued pursuant thereto. The
defibrination of blood intended for human food purposes shall not be
done with the hands. Anticoagulants may be used in accordance with 21
CFR chapter I, subchapter A and subchapter B, or by regulation in 9 CFR
chapter III, subchapter A or subchapter E.
Done, at Washington, DC.
Paul Kiecker
Administrator.
[FR Doc. 2021-13160 Filed 6-23-21; 8:45 am]
BILLING CODE 3410-DM-P
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