[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]
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Proposed Rules
Federal Register
________________________________________________________________________
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
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Total Cost Savings.......................................... 14,252 32,774 58,002
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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
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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]
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