[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

[[Page 55803]]

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]
BILLING CODE 3410-DM-P