Elimination of the Requirement To Defibrinate Livestock Blood Saved as an Edible Product, 33085-33088 [2021-13160]
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Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Rules and Regulations
whichever you report on your acreage
report and for which you qualify; or
(ii) At any time after the acreage
reporting date, your unit structure will
be one enterprise unit for all acreage of
the crop in the county provided you
meet the requirements in section
34(a)(4). Otherwise, we will assign the
basic unit structure for all acreage of the
crop in the county.
(4) If you elected an enterprise unit
for only one type and we discover you
do not qualify for an enterprise unit for
that type and such discovery is made:
(i) On or before the acreage reporting
date, your unit division for all acreage
of the crop in the county will be based
on basic or optional units, whichever
you report on your acreage report and
for which you qualify; or
(ii) At any time after the acreage
reporting date, we will assign the basic
unit structure for all acreage of the crop
in the county.
(c) In addition to, or instead of,
establishing optional units as provided
in section 34(c) in the Basic Provisions,
a separate optional unit may be
established for each bean type
(designated in actuarial documents and
including any type insured by written
agreement).
(d) Enterprise and optional units by
type may be further divided by acreage
of contract seed beans if the seed bean
processor contract specifies the number
of acres under contract. Contract seed
beans produced under a seed bean
processor contract that specifies only an
amount of production or a combination
of acreage and production, are not
eligible for separate enterprise or
optional units.
*
*
*
*
*
Richard Flournoy,
Acting Manager, Federal Crop Insurance
Corporation.
[FR Doc. 2021–13115 Filed 6–23–21; 8:45 am]
BILLING CODE 3410–08–P
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 310
[Docket No. FSIS–2020–0005]
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RIN 0583–AD81
Elimination of the Requirement To
Defibrinate Livestock Blood Saved as
an Edible Product
Food Safety and Inspection
Service, USDA.
ACTION: Final rule.
AGENCY:
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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 nondefibrinated 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:
SUMMARY:
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., nondefibrinated, 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
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33085
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
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
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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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 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.
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 1—INDUSTRY 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 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 https://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 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 $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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Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Rules and Regulations
33087
TABLE 1—INDUSTRY ANNUAL COST SAVINGS ESTIMATES—Continued
Low
High
Labor Cost Savings/Year .............................................................................................................
Total Cost Savings ...............................................................................................................
6,390
15,780
19,575
36,015
39,945
63,435
Total Costs Savings annualized at a discount rate of 7% over 10 years ...........................
15,780
36,015
63,435
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).
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Medium
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
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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 EGovernment 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
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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 https://
www.usda.gov/oascr/how-to-file-aprogram-discrimination-complaint 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: program.intake@usda.gov.
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: https://
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: https://
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
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
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.
■
2. Revise § 310.20 to read as follows:
§ 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
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA–2021–0093; Project
Identifier MCAI–2020–01213–T; Amendment
39–21535; AD 2021–10–02]
RIN 2120–AA64
Airworthiness Directives; Bombardier,
Inc., Airplanes
Federal Aviation
Administration (FAA), Department of
Transportation (DOT).
ACTION: Final rule.
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AGENCY:
The FAA is adopting a new
airworthiness directive (AD) for all
Bombardier, Inc., Model BD–700–1A10
and BD–700–1A11 airplanes. This AD
was prompted by reports indicating that
the left- and right-hand elevator torque
tube bearings were contaminated with
SUMMARY:
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sand and corrosion, restricting free
rotation. This AD requires repetitive
general visual inspections of the leftand right-hand elevator torque tube
bearings for any sand, dust, or
corrosion; repetitive functional tests of
the elevator control system; and
replacement of the elevator torque tube
bearings if necessary. The FAA is
issuing this AD to address the unsafe
condition on these products.
DATES: This AD is effective July 29,
2021.
The Director of the Federal Register
approved the incorporation by reference
of certain publications listed in this AD
as of July 29, 2021.
ADDRESSES: For service information
identified in this final rule, contact
Bombardier, Inc., 200 Coˆte-Vertu Road
West, Dorval, Que´bec H4S 2A3, Canada;
North America toll-free telephone 1–
866–538–1247 or direct-dial telephone
1–514–855–2999; email ac.yul@
aero.bombardier.com; internet https://
www.bombardier.com. You may view
this service information at the FAA,
Airworthiness Products Section,
Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For
information on the availability of this
material at the FAA, call 206–231–3195.
It is also available on the internet at
https://www.regulations.gov by
searching for and locating Docket No.
FAA–2021–0093.
Examining the AD Docket
You may examine the AD docket on
the internet at https://
www.regulations.gov by searching for
and locating Docket No. FAA–2021–
0093; or in person at Docket Operations
between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
The AD docket contains this final rule,
any comments received, and other
information. The address for Docket
Operations is U.S. Department of
Transportation, Docket Operations,
M–30, West Building Ground Floor,
Room W12–140, 1200 New Jersey
Avenue SE, Washington, DC 20590.
FOR FURTHER INFORMATION CONTACT:
Siddeeq Bacchus, Aerospace Engineer,
Mechanical Systems and Administrative
Services Section, FAA, New York ACO
Branch, 1600 Stewart Avenue, Suite
410, Westbury, NY 11590; telephone
516–228–7362; fax 516–794–5531; email
9-avs-nyaco-cos@faa.gov.
SUPPLEMENTARY INFORMATION:
Background
Transport Canada Civil Aviation
(TCCA), which is the aviation authority
for Canada, has issued TCCA AD CF–
2020–29, dated August 21, 2020
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(referred to after this as the Mandatory
Continuing Airworthiness Information,
or the MCAI), to correct an unsafe
condition for all Bombardier, Inc.,
Model BD–700–1A10 and BD–700–
1A11 airplanes. You may examine the
MCAI in the AD docket on the internet
at https://www.regulations.gov by
searching for and locating Docket No.
FAA–2021–0093.
The FAA issued a notice of proposed
rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would
apply to all Bombardier, Inc., Model
BD–700–1A10 and BD–700–1A11
airplanes. The NPRM published in the
Federal Register on February 24, 2021
(86 FR 11180). The NPRM was
prompted by reports indicating that the
left- and right-hand elevator torque tube
bearings were contaminated with sand
and corrosion, restricting free rotation.
The NPRM proposed to require
repetitive general visual inspections of
the left- and right-hand elevator torque
tube bearings for any sand, dust, or
corrosion; repetitive functional tests of
the elevator control system; and
replacement of the elevator torque tube
bearings if necessary. The FAA is
issuing this AD to address sand
contamination and corrosion of the
elevator torque tube bearings, which
could lead to binding or seizure of the
bearings, and potentially lead to a
reduction in or loss of airplane pitch
control. See the MCAI for additional
background information.
Comments
The FAA gave the public the
opportunity to participate in developing
this final rule. The FAA received no
comments on the NPRM or on the
determination of the cost to the public.
Conclusion
The FAA reviewed the relevant data
and determined that air safety and the
public interest require adopting this
final rule as proposed, except for minor
editorial changes. The FAA has
determined that these minor changes:
• Are consistent with the intent that
was proposed in the NPRM for
addressing the unsafe condition; and
• Do not add any additional burden
upon the public than was already
proposed in the NPRM.
Related Service Information Under 1
CFR Part 51
Bombardier has issued the following
service information.
• Bombardier Service Bulletin 700–
1A11–27–041, Revision 1, dated
December 7, 2020.
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]]>Agencies
[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 [www.gpo.gov]
[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, 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.
\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
https://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.
\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). 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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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
[[Page 33087]]
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 https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint 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: [email protected].
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:
https://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: https://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
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]
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