[Federal Register Volume 86, Number 192 (Thursday, October 7, 2021)]
[Notices]
[Pages 55799-55803]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21889]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS-2015-0042]
Eligibility of the Republic of Poland To Export Poultry and
Poultry Products to the United States
AGENCY: Food Safety and Inspection Service, USDA
ACTION: Notice and response to comments
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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing
that the Republic of Poland (Poland) is eligible to export poultry
products to the United States. FSIS has reviewed Poland's poultry laws,
regulations, and inspection system, as implemented, and has determined
that they are equivalent to the Poultry Products Inspection Act (PPIA),
the regulations implementing this statute, and the United States food
safety inspection system for poultry products. Therefore, poultry
products derived from poultry slaughtered and processed in certified
Polish establishments are now eligible for export to the United States.
All such products will be subject to reinspection at United States
points-of-entry by FSIS inspectors.
Applicable: Poland's poultry products eligible for import to the
United States will be added to the FSIS Import Library (https://www.fsis.usda.gov/importlibrary) on October 7, 2021.
FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Assistant
Administrator, Office of Policy and Program Development by telephone at
(202) 205-0495.
SUPPLEMENTARY INFORMATION:
Background
On April 20, 2016, FSIS published a proposed rule in the Federal
Register (81 FR 23194) to add Poland to the list of countries in the
regulations eligible to export poultry products to the United States.
Between the publication of the proposed rule concerning Poland's
eligibility and this Federal Register notice, FSIS finalized rulemaking
(84 FR 65265; November 27, 2019) to remove the lists of foreign
countries eligible to export meat, poultry, and egg products to the
United States from its regulations and instead maintain a single list
of eligible countries on FSIS' website at: https://www.fsis.usda.gov/importlibrary. This change allows FSIS to better provide the public
with the most accurate and current information. In addition, the final
rule affected FSIS' process for implementing equivalence
determinations. Instead of publishing proposed and final rules in the
Federal Register, FSIS now implements equivalence determinations
through Federal Register notices. The criteria FSIS uses to evaluate
whether a foreign country is eligible to export meat, poultry, or egg
products have not
[[Page 55800]]
changed. FSIS continues to provide an opportunity for public comment
when proposing through Federal Register notices to list new countries
as eligible to export products to the United States or to list existing
countries as eligible to export certain new products.
As explained in the 2016 proposed rule to list Poland as eligible
to export poultry products to the United States (81 FR 23194, April 20,
2016), under the PPIA and implementing regulations, poultry products
imported into the United States must be produced under standards for
safety, wholesomeness, and labeling accuracy that are equivalent to
those of the United States (21 U.S.C. 466). Section 381.196 of Title 9
of the Code of Federal Regulations (CFR) sets out the procedures by
which foreign countries may become eligible to export poultry products
to the United States.
Paragraph 9 CFR 381.196(a) requires that the standards of a foreign
country's poultry inspection system, its legal authority for the
inspection system, and the regulations implementing the system be
equivalent to those of the United States.
The country's inspection program must also impose requirements
equivalent to those of the United States.
Evaluation of the Polish Poultry Inspection System
On April 20, 2016, FSIS published a proposed rule to determine,
based on the results of audits in 2011 and 2014, that Poland's poultry
inspection system is equivalent to the United States system and,
therefore, to add Poland to the list of countries eligible to export
poultry products to the United States in the regulations. For more
detailed information on the FSIS evaluation of the Polish poultry
inspection system see the 2016 Poland proposed rule (81 FR 23194, April
20, 2016), and for the full 2011 and 2014 audit reports, go to: https://www.fsis.usda.gov/federal-register/rules/eligibility-republic-poland-export-poultry-products-united-states.
On August 21, 2014, FSIS published the final rule Modernization of
Poultry Slaughter Inspection (79 FR 49566, August 21, 2014). The rule
created regulatory changes that apply to all poultry slaughter
establishments and established a new optional post-mortem inspection
system, the New Poultry Inspection System (NPIS). In 2016 and 2017,
Poland sent letters to FSIS outlining the changes that were made to
Poland's poultry inspection system to achieve equivalence with the new
U.S. regulations. These included requirements that establishments have
procedures to ensure that carcasses with visible fecal contamination do
not enter the chiller and procedures to prevent contamination of
carcasses and parts by enteric pathogens and visible fecal material
throughout the entire slaughter and dressing operation. FSIS reviewed
the submitted letters and additional information and determined on
December 29, 2017, that Poland's poultry slaughter inspection system is
equivalent to the U.S. system regarding the requirements in the final
rule ``Modernization of Poultry Slaughter Inspection.''
Poland also is eligible to ship meat products to the United States.
After the publication of the 2016 proposed rule concerning Poland's
equivalence for poultry, FSIS conducted an onsite audit in September
2017 to verify the ongoing equivalence of Poland's meat inspection
system. Poland's 2017 onsite audit identified a finding related to
government inspection personnel in certified establishments producing
meat products for export to the United States and indicated that
additional information was needed before making a final conclusion
about whether Poland's meat products inspection system remained
equivalent to that of the United States. Consequently, in 2018 during
the review of Poland's comprehensive corrective action plans to address
the 2017 audit finding, Poland's General Veterinary Inspectorate (GVI),
which is Poland's central competent authority (CCA) in charge of food
inspection, confirmed that the same inspection arrangement was used in
poultry establishments that expressed interest in exporting to the
United States. FSIS was concerned that contract personnel, rather than
government personnel, may have been conducting inspection. In response
to this information, in 2018 and 2019, Poland submitted corrective
action plans that addressed FSIS' findings and ensured that government
inspectors will be performing inspection activities at all slaughter
and processing establishments that are eligible to export products to
the United States. FSIS conducted an onsite audit from July 15 through
August 1, 2019 and concluded that Poland had satisfactorily implemented
the corrective action plans that it had submitted in response to the
2017 audit. For the most recent full audit reports, go to: https://www.fsis.usda.gov/news-events/publications/poland-foreign-audit-report.
FSIS' Equivalence Determination
After considering the comments received on the proposed rule,
discussed below, FSIS concludes that Poland's poultry inspection system
is equivalent to the United States' inspection system for poultry
products. Therefore, FSIS is announcing that Poland is eligible to
export poultry products to the United States (9 CFR 381.196(b)). FSIS
has added Poland to its list of eligible countries to export poultry
products to the United States on its website at: http://www.fsis.usda.gov/importlibrary.
Polish poultry products will be eligible for importation into the
United States only if they are from birds slaughtered on or after the
publication date of this Federal Register notice. Under FSIS' import
regulations, the government of Poland must certify to FSIS that those
establishments requesting to export poultry products to the United
States are operating under requirements equivalent to those of the
United States (9 CFR 381.196(a)).
Upon publication of this Federal Register notice, Poland is
eligible to export to the United States raw and processed poultry
products derived from birds slaughtered in Poland. The eligible
processing categories include: Heat Treated--Shelf Stable, Not Heat
Treated--Shelf Stable, Fully Cooked--Not Shelf Stable, and Thermally
Processed--Commercially Sterile. Poland would need to submit additional
information for FSIS to review and may need to undergo an additional
audit before FSIS would allow Poland to export other raw and processed
poultry products to the United States not listed above. FSIS maintains
a country-specific web page \1\ on FSIS' website with a list of the
process categories and the product groups Poland is eligible to export
to the United States.
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\1\ See: https://www.fsis.usda.gov/inspection/import-export/import-export-library/poland.
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Although a foreign country may be listed on FSIS' website as
eligible to export poultry products to the United States, the exporting
country's products must also comply with all other applicable
requirements of the United States, including those of USDA's Animal and
Plant Health Inspection Service (APHIS). These requirements include
restrictions under 9 CFR part 94 of the APHIS regulations, which
regulate the importation of poultry products from foreign countries
into the United States to control the spread of specific animal
diseases.
All poultry products exported to the United States from Poland will
be subject to reinspection by FSIS at United States points-of-entry
for, but not limited to, transportation damage, product and container
defects, labeling,
[[Page 55801]]
proper certification, general condition, and accurate count.
FSIS also will conduct other types of reinspection activities, such
as physical inspection and incubation of thermally processed,
commercially sterile (canned) products to ensure product safety and
taking product samples for laboratory analysis to detect any drug or
chemical residues or pathogens that may render the product unsafe or
any species or product composition violations that would render the
product economically adulterated. Products that pass reinspection will
be stamped with the official mark of inspection and allowed to enter
United States commerce. If a product does not meet United States
requirements, it will be refused entry and within 45 days will have to
be returned to the country of origin, destroyed, or converted to animal
food (subject to approval of the Food and Drug Administration (FDA)),
depending on the violation. The import reinspection activities can be
found on the FSIS website at: https://www.fsis.usda.gov/inspection/import-export/import-guidance.
Finally, within one year of the publication date of this Federal
Register notice, FSIS will conduct an on-site audit of Poland's poultry
inspection system to verify ongoing equivalence. During the audit, FSIS
auditors will verify that Poland's CCA has implemented its food safety
inspection system as described in the Self-Reporting Tool (SRT) and
supporting documentation. FSIS will audit government offices,
establishments, and laboratories to verify that the CCA has implemented
its inspection system as documented and verify that the country's
system of controls remains equivalent to the U.S. inspection system.
Summary of Comments and Responses
FSIS received two comments in response to the proposed rule. The
government of Poland supported the proposed rule and one consumer
advocacy organization opposed it. The following is a brief summary of
the relevant issues raised in the comments and FSIS' responses.
New Poultry Inspection System (NPIS)
Comment: A consumer advocacy group requested more information on
how Poland demonstrated equivalence with the United States' regulatory
requirements in the final rule ``Modernization of Poultry Slaughter
Inspection'' (79 FR 49566, Aug. 21, 2014). Additionally, the consumer
advocacy group questioned whether Poland would implement an inspection
system similar to NPIS.
Response: As stated earlier, in 2016 and 2017, Poland sent letters
to FSIS outlining the changes that were made to Poland's poultry
inspection system to achieve equivalence with the FSIS' new
regulations. These included requirements that establishments have
procedures to ensure that carcasses with visible fecal contamination do
not enter the chiller and procedures to prevent contamination of
carcasses and parts by enteric pathogens and visible fecal material
throughout the entire slaughter and dressing operation. FSIS reviewed
the submitted letters and additional information from Poland and
determined on December 29, 2017, that Poland's poultry slaughter
inspection system is equivalent to the U.S. system regarding the
requirements in the final rule, ``Modernization of Poultry Slaughter
Inspection.'' Poland also explained in the letters that it does not
plan to implement an inspection system like NPIS in any of its
establishments. If Poland later chooses to implement NPIS, Poland will
need to implement regulations for that inspection system equivalent to
United States' NPIS regulations.
Audit Report Findings
Comment: The consumer advocacy organization expressed concern
regarding the two audits of Poland's poultry inspection system. The
organization argued that the 2011 audit revealed major issues with
Poland's poultry inspection system that prevented FSIS from moving
forward with rulemaking. According to the organization, the issues
found in the 2014 audit are recurring problems from the 2011 audit.
Response: Poland responded to the FSIS' 2011 audit findings with
comprehensive corrective action plans that addressed all of FSIS' audit
findings. Consequently, FSIS conducted a follow-up initial equivalence
audit in 2014 to assess the effectiveness of the implemented corrective
actions. The FSIS auditors verified that Poland had effectively
implemented the proffered comprehensive corrective action plan and that
Poland met the equivalence criteria for all six components. The
evaluation of all data collected before, during, and after the onsite
audit shows that Poland's poultry inspection system is equivalent to
the United States' inspection system for poultry.
Comment: The consumer advocacy organization also expressed concern
regarding establishment-level findings during the second initial onsite
audit. The consumer advocacy group stated that: (1) In one of the
slaughter facilities, a Polish inspector was not performing post-mortem
inspection of all carcasses for pathology, food safety issues, and
defects; (2) in one of the slaughter facilities, blood was accumulating
on the kill floor, leading to unsanitary conditions; (3) in one of the
processing facilities, exposed product came into contact with the sides
of a transporting cart and the floor; and (4) in one of the
establishments, Polish inspection personnel did not issue non-
compliance reports for the facility's failure to maintain verification
records that meet HACCP recordkeeping requirements.
Response: The FSIS auditors deemed each of the findings highlighted
by the consumer advocacy organization to be isolated incidents that
have been addressed and resolved. In each case, the GVI ordered
immediate corrective actions to address the findings. The CCA verified
that the establishments made the necessary adjustments and provided
supporting documents during and after the audit exit meeting. The
auditors verified that the GVI had adequately and effectively
implemented its corrective action plan and addressed the audit findings
with immediate corrective action and preventive measures. FSIS'
evaluation of Poland's proffered corrective actions and related
implementation records provided to FSIS after the exit meeting, found
that all audit findings were properly addressed.
Sample Size
Comment: The consumer advocacy organization questioned why FSIS
visited only two poultry slaughter and processing establishments, two
poultry processing (raw and ready-to-eat) establishments, and one
poultry canning facility during the 2014 audit. According to the
commenter, the number of establishments the auditor visited during the
2014 audit was not sufficient to verify that Poland addressed the
findings from the 2011 audit.
Response: During onsite verification audits, FSIS visits foreign
sites associated with the system that provides government oversight and
inspection, including the establishments interested in exporting
products to the United States, government offices, and government
laboratories. The purpose of the audit is to verify that the
implementation of the equivalence components of the country's food
safety inspection system are consistent with its design documented by
the CCA in the SRT. FSIS assesses the food safety inspection system as
a whole, by verifying controls and by recognizing
[[Page 55802]]
that any findings identified during the audit need to be considered in
the context of the overall food safety inspection system. In the 2011
Poland audit, FSIS audited two processing facilities and one cold
storage facility. During the 2014 audit, FSIS audited five poultry
establishments, which were all the establishments intending to export
product to the United States at that time. These establishments
included two slaughter and processing establishments, and three
processing only establishments, including the canning facility that
FSIS audited in 2011. Because of the number and types of establishments
audited during the 2014 audit, FSIS is confident that the number of
establishments audited was sufficient to verify that Poland had
addressed the findings from the 2011 audit.
Time Between Final Audit and Publication of the Proposed Rule
Comment: The consumer advocacy organization questioned the accuracy
of the information presented in the proposed rule because, according to
the commenter, too much time passed between the final audit and
publication of the proposed rule.
Response: The time between the final audit (2014) and the proposed
rule is consistent with that for other equivalence determinations since
2007. Further, FSIS intends to conduct an audit of Poland within one
year of its equivalence becoming effective. FSIS will continue to
conduct annual records reviews of Poland's poultry inspection system
and all imported product from Poland will be reinspected once it enters
the United States. Therefore, FSIS will effectively ensure Poland meets
equivalence requirements on an ongoing basis.
Trade
Comment: The consumer advocacy group stated that the proposed rule
was one piece of the larger Transatlantic Trade and Investment
Partnership (TTIP) negotiations and that the safety of U.S. consumers
was being sacrificed for expanded trade.
Response: FSIS makes determinations of equivalence by evaluating
whether foreign food inspection systems attain an equivalent level of
protection provided to our domestic system; FSIS determinations for
Poland are documented in this Federal Register notice. Thus, the TTIP
negotiations had no relationship to Poland's food regulatory system or
this Federal Register notice.
Expected Costs
FSIS updated the expected costs and benefits sections of this
notice to reflect more recent trade data than FSIS used for the
preliminary regulatory impact analysis (81 FR 23194, April 20, 2016).
Poland is the largest poultry producer within the European Union (EU).
From 2006 to 2019, Poland sharply increased its poultry production and
exports. According to USDA's Foreign Agricultural Service, Poland's
poultry exports exceeded 1.3 million metric tons in 2019, a 12-percent
increase over 2018.\2\ In 2019, a high pathogenic avian influenza
(HPAI) outbreak led to several countries imposing import bans on Polish
poultry, adversely affecting Polish poultry exports in 2020. Thus, the
Government of Poland is trying to ``open new market opportunities,
including United States market access.'' \3\
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\2\ See: USDA FAS GAIN Report: Poultry and Products Annual,
Poland. March 26, 2020. Report Number PL2020-0012 Prepared by Piotr
Rucinski at: https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=PoultryandProductsAnnual_Warsaw_Poland_03-18-2020.
\3\ Ibid.
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Poland's poultry production consists of 85 percent young chickens
(``broilers''), 14 percent young turkey, and about one percent other
poultry species such as duck and geese.\4\ \5\ Currently, almost 70
percent of Polish chicken meat exports go to neighboring EU markets,
particularly to the United Kingdom, Germany, and France.\6\ For Poland
to export poultry to the United States, it must be export-eligible,
export-capable, and price-competitive. After comparing Poland's price
competitiveness with the United States, Chile, and Canada, FSIS
estimated that the maximum potential Polish poultry products exports to
the United States is expected to be between 19,400 MT to 31,600 MT.\7\
This means, at a maximum, the total United States poultry supply will
increase only between 0.10 percent and 0.16 percent (19,400 MT to
31,600 MT from Poland compared to a United States slaughter volume of
20.1 million MT in 2020) \8\, leaving the total United States poultry
supply almost unchanged. Thus, Poland's poultry exports to the United
States are expected to minimally change domestic poultry prices, not
enough to alter the United States poultry market.
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\4\ Ibid.
\5\ Ibid.
\6\ Ibid.
\7\ FSIS estimated the maximum potential Polish poultry products
by identifying poultry products imported from Canada and Chile
(these two countries account for more than 97% of the poultry
products imported to the United States). FSIS assumed the potential
volume of Polish poultry products that would be exported to the U.S.
was equal to the volume of Polish poultry products that had a unit
price lower than Chile's and Canada's poultry products unit prices
(from 2018 and a 3-year average).
FSIS then used the volume of U.S. imports for these products
(based on 2018 data and a 3-year average) to estimate the maximum
potential Polish poultry exports.
\8\ USDA, Foreign Agricultural Service, Production, Supply and
Distribution. https://apps.fas.usda.gov/psdonline/app/index.html#/app/advQuery.
For 2020 U.S. Production, please see November 2020 WASDE Report
at: https://www.usda.gov/oce/commodity/wasde. The numbers have been
converted to Metric Ton.
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The above cost analysis is based on Poland's maximum potential
poultry exports. Currently, however, 24 establishments in Poland intend
to export poultry products to the United States.\9\ The total
processing capacity of these 24 establishments is far less than
Poland's total poultry export capacity. With minimal price changes
expected in United States poultry products markets, Poland's
eligibility to export poultry products to the United States should not
have a negative effect on United States consumers.
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\9\ Source: Correspondence with the government of Poland.
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Expected Benefits
The volume of trade stimulated by Poland's eligibility to export
poultry products to the United States is likely to be small and is
expected to have little or no effect on United States poultry supplies
or poultry prices. United States consumers, however, are expected to
enjoy more choices when purchasing poultry products. This equivalence
determination will, therefore, expand choices for United States
consumers and promote economic competition.
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, FSIS will announce this Federal
Register publication online 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
can provide information to a much broader, more diverse audience. In
addition, FSIS offers an email subscription service which provides
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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 option to password protect their
accounts.
Congressional Review Act
Pursuant to the Congressional Review Act at 5 U.S.C. 801 et seq.,
the Office of Information and Regulatory Affairs has determined that
this notice is not a ``major rule,'' as defined by 5 U.S.C. 804(2).
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.
Paul Kiecker,
Administrator.
[FR Doc. 2021-21889 Filed 10-6-21; 8:45 am]
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