[Federal Register Volume 84, Number 214 (Tuesday, November 5, 2019)]
[Rules and Regulations]
[Pages 59678-59682]
From the Federal Register Online via the Government Publishing Office [http://www.gpo.gov/]
[FR Doc No: 2019-24055]



[[Page 59677]]

Vol. 84

Tuesday,

No. 214

November 5, 2019

Part II





Department of Agriculture





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Food Safety and Inspection Service





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9 CFR Part 557





Eligibility of the People's Republic of China, Socialist Republic of 
Vietnam, and Thailand To Export Siluriformes Fish and Fish Products to 
the United States; Final Rules

Federal Register / Vol. 84 , No. 214 / Tuesday, November 5, 2019 / 
Rules and Regulations

[[Page 59678]]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 557

[Docket No. FSIS-2018-0030]
RIN 0583-AD73


Eligibility of the People's Republic of China To Export 
Siluriformes Fish and Fish Products to the United States

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the 
Siluriformes fish inspection regulations to list the People's Republic 
of China (PRC) as a country eligible to export Siluriformes fish and 
fish products to the United States. FSIS has reviewed the PRC's laws, 
regulations, and inspection system as implemented and has determined 
that the PRC's Siluriformes fish inspection system is equivalent to the 
system that the United States has established under the Federal Meat 
Inspection Act (FMIA) and its implementing regulations. Under this 
final rule, only raw Siluriformes fish and fish products produced in 
certified PRC establishments are eligible for export to the United 
States. All such products are subject to re-inspection at U.S. points-
of-entry by FSIS inspectors.

DATES: Effective Date: December 5, 2019.

FOR FURTHER INFORMATION CONTACT: Terri Nintemann, Assistant 
Administrator, Office of Policy and Program Development, Food Safety 
and Inspection Service, U.S. Department of Agriculture; Telephone: 
(202) 205-0495.

SUPPLEMENTARY INFORMATION:

Background

    On September 19, 2018, FSIS proposed to amend its regulations at 9 
CFR 557.2(b)(1) to add the PRC as a country eligible to export 
Siluriformes fish to the United States (83 FR 47524) (for convenience, 
in this final rule, ``Siluriformes fish and fish products'' will be 
shortened to ``Siluriformes fish''). Although the PRC has been allowed 
to export these products to the United States under the conditions 
described in the proposed rule (83 FR 47524), the PRC is not currently 
listed in the Code of Federal Regulations (CFR) as eligible to export 
Siluriformes fish to the United States. FSIS proposed to add the PRC to 
the regulations as eligible to export such products after the Agency 
conducted a documentary review of the PRC's laws, regulations, and 
Siluriformes fish inspection system, as well as an in-country audit of 
the system, and determined that the PRC's Siluriformes fish inspection 
system is equivalent to the U.S. system established under the FMIA and 
its implementing regulations. This final rule is consistent with the 
provisions of the proposed rule.

Statutory and Regulatory Basis for Final Action

    As explained in the proposed rule (83 FR 47524), Siluriformes fish 
are an amenable species under the FMIA (21 U.S.C. 601(w)(2)). The FMIA 
prohibits importation into the United States of adulterated or 
misbranded meat and meat food products (21 U.S.C. 620). Under the FMIA 
and its implementing regulations, Siluriformes fish imported into the 
United States must be from foreign countries that maintain an 
inspection system that ensures compliance with requirements equivalent 
to the inspection, sanitary, quality, species verification, and residue 
standards in the United States, and all other provisions of the FMIA 
that are applied to official establishments in the United States. The 
regulatory requirements for foreign countries to become eligible to 
export Siluriformes fish to the United States are provided in 9 CFR 
557.2, which cross-references 9 CFR 327.2, the regulations for the 
import of other products also subject to the FMIA.
    Section 557.2(a) (cross-referencing 9 CFR 327.2(a)(1), (a)(2)(i), 
(a)(2)(ii)(C)-(I), (a)(2)(iii)-(iv), and (a)(3)), requires a foreign 
country's inspection system be authorized by legal authority that 
imposes requirements equivalent to those of the United States, 
specifically with respect to: (1) Official controls by the national 
government over establishment construction, facilities, and equipment; 
(2) direct official supervision of the preparation of product to assure 
that product is not adulterated or misbranded; (3) separation of 
establishment operations for product certified for export from product 
that is not certified; (4) requirements for sanitation at certified 
establishments and for the sanitary handling of product; (5) official 
controls over condemned materials; (6) a Hazard Analysis Critical 
Control Point (HACCP) system; and (7) any other requirements found in 
the FMIA and its implementing regulations.
    In addition to a foreign country's legal authority and regulatory 
requirements, the inspection program must achieve a level of public 
health protection equivalent to that achieved by the U.S. inspection 
program. Specifically, the inspection program organized and 
administered by the national government must impose requirements 
equivalent to those of the United States with respect to: (1) 
Organizational structure and staffing, so as to ensure uniform 
enforcement of the requisite laws and regulations in all certified 
establishments; (2) ultimate control and supervision by the national 
government over the official activities of employees or licensees; (3) 
competent, qualified inspectors; (4) enforcement and certification; (5) 
administrative and technical support; (6) inspection, sanitation, 
quality, species verification, and residue standards; and (7) any other 
inspection requirements required by the regulations in Subchapter F--
Mandatory Inspection of Fish of the Order Siluriformes and Products of 
Such Fish, which cross-references 9 CFR 327.2(a)(2)(i).
    Annually, the foreign country certifies the establishments as 
having met the required standards and notifies FSIS about 
establishments that are certified or removed from certification (9 CFR 
557.2, cross-referencing 9 CFR 327.2(a)(3)).

Evaluation of the PRC Siluriformes Fish Inspection System

    As discussed in the proposed rule (83 FR 47524), in March 2017, 
based on the PRC's request, FSIS conducted a document review of the 
PRC's Siluriformes fish inspection system to determine whether that 
system was equivalent to that of the United States. Based on its review 
of the submitted documentation, which included the PRC's laws, 
regulations, and inspection procedures, FSIS concluded that the PRC's 
inspection system is equivalent to those of the United States for raw 
Siluriformes fish products, specifically Siluriformes fish that fall 
within the FSIS product categories ``Raw Product--Intact'' and ``Raw 
Product--Non-Intact.'' Both product categories are defined in the 
``FSIS Product Categorization'' document, which was developed to assist 
foreign governments in accurately identifying the type of meat and 
poultry products exported to the U.S. This document can be found on the 
FSIS website at: https://www.fsis.usda.gov/shared/PDF/FSIS_Product_Categorization.pdf.
    Accordingly, from May 28 to June 4, 2018, FSIS proceeded with an 
initial on-site audit of the PRC's Siluriformes fish inspection system. 
The purpose of the on-site audit was to verify whether the PRC's 
General Administration of Customs (GACC), the Central Competent 
Authority (CCA) for food inspection, effectively implemented a 
Siluriformes fish inspection system equivalent to that

[[Page 59679]]

of the United States. The PRC currently exports only raw Siluriformes 
fish to the United States.
    The audit did not identify any deficiencies that represented an 
immediate threat to public health, but did identify deficiencies that 
could lead to product contamination if not adequately addressed. In the 
audit exit meeting, GACC committed to address the findings as 
presented. For more detailed information on FSIS's evaluation of the 
PRC's Siluriformes fish inspection system see the proposed rule (83 FR 
47524) and for the full audit report, go to: https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/eligible-countries-products-foreign-establishments/foreign-audit-reports.
    From November 26 through December 13, 2018, FSIS performed a 
follow-up audit in response to the deficiencies identified in the 
initial on-site audit. During the initial audit, FSIS was only able to 
observe processing in two out of the six audited establishments. In the 
follow-up audit, the FSIS auditors visited seven out of ten 
establishments exporting products to the United States at that time. At 
the time of the follow-up audit, all seven establishments were 
processing Siluriformes fish. The FSIS auditors observed the production 
of Siluriformes fish, in addition to the implementation of corrective 
actions to the inspection system deficiencies noted during the initial 
on-site audit. FSIS did not identify any deficiencies that represented 
an immediate threat to public health and has determined that the 
proposed corrective actions are adequate. For the full audit report, go 
to: https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/eligible-countries-products-foreign-establishments/foreign-audit-reports.

Final Rule

    After considering the comments received on the proposed rule, 
discussed below, FSIS concludes that the PRC's Siluriformes fish 
inspection system is equivalent to the United States inspection. 
Therefore, FSIS is amending its Siluriformes fish inspection 
regulations to list as the People's Republic of China as a country 
eligible to export Siluriformes fish to the United States. As stated 
above, under FSIS's Siluriformes fish import regulations, the PRC must 
certify to FSIS that those establishments that wish to export 
Siluriformes fish to the United States are operating under requirements 
equivalent to those of the United States (9 CFR 557.2(a)).
    Although a foreign country may be listed in FSIS regulations as 
eligible to export Siluriformes fish to the United States, the 
exporting country's products must also comply with all other applicable 
requirements of the United States. Accordingly, Siluriformes fish 
exported to the United States from the PRC will continue to be subject 
to re-inspection by FSIS at U.S. points-of-entry for, but not limited 
to, transportation damage, product and container defects, labeling, 
proper certification, general condition, and accurate count. In 
addition, FSIS will continue to conduct other types of re-inspection 
activities, such as taking product samples for laboratory analysis to 
detect drug and chemical residues and pathogens, as well as to identify 
product species and composition. Products that pass re-inspection will 
be stamped with the official mark of inspection and allowed to enter 
U.S. commerce. If they do not meet U.S. requirements, they will be 
refused entry and within 45 days must be exported to the country of 
origin, destroyed, or converted to animal food (subject to approval of 
the U.S. Food and Drug Administration (FDA)), depending on the 
violation. FSIS import re-inspection activities can be found on the 
Agency's website at: http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/port-of-entry-procedures.

Responses to Comments

    FSIS received 29 comments from individuals, Siluriformes fish and 
fish product producers from the PRC and the United States, trade 
associations, a commercial workers union, a frozen storage corporation, 
and a consumer interest group. The issues raised in the comments and 
the Agency responses are summarized below.

The Effectiveness of the PRC's Inspection System and Ongoing 
Verification of Compliance

    Comment: Comments from six individual consumers, a U.S. 
Siluriformes fish and fish products producer, a labor group, two trade 
associations, and a consumer group questioned whether the PRC's 
Siluriformes fish inspection system was truly equivalent to that of the 
United States, and whether Siluriformes fish processed under that 
system would be safe for consumption in the United States. One of the 
two trade association that questioned whether the PRC's regulatory and 
inspections systems are equivalent to that of the United States 
submitted peer-reviewed articles concerning the use of antibiotics in 
aquaculture.
    Response: FSIS made its equivalence determination for the PRC's 
Siluriformes fish inspection system based on sound science and in 
accordance with U.S. international obligations and its own equivalence 
process. FSIS has an in-depth and rigorous equivalence process, through 
which it systematically determines whether a foreign country's 
inspection system achieves a level of public health protection 
equivalent to that achieved by the U.S. inspection system. Accordingly, 
the equivalence process does not require the exporting country to 
develop and implement the same procedures as those of the United 
States. Once a country is considered to have an equivalent food safety 
inspection system, the FSIS equivalence process includes performing an 
annual records review and on-going on-site audits of the country's 
inspection system at least every three years to verify whether the 
country's inspection system continues to be equivalent to FSIS's 
inspection system.
    Regarding antibiotic residues as discussed above, FSIS performs an 
annual records review for each country that has been deemed to have an 
equivalent inspection system to that of the United States which 
includes, in part, a review of the country's sampling and testing for 
residues; in short, FSIS annually verifies the adequacy of each 
equivalent country's reside testing program. In addition, FSIS conducts 
point-of-entry re-inspection of all imported Siluriformes fish, which 
can include product sampling and testing for microbial, chemical and 
other hazards. FSIS may conduct laboratory analysis for the detection 
of chemical residues that may result from the use of drugs and 
pesticides, or from incidents involving environmental contaminants. 
FSIS analyzes imported Siluriformes fish for over 100 chemical 
compounds, which include drugs, aminoglycosides, antifungal drugs, 
metals and pesticides. Products that pass re-inspection are stamped 
with the official mark of inspection and allowed to enter U.S. 
commerce. If they do not meet U.S. requirements, they are refused entry 
into U.S. commerce and must be re-exported, destroyed, or converted to 
animal food.

On-Site Audit

    Comment: The commercial workers union and the consumer interest 
group expressed concerns over the deficiencies found during the initial 
on-site audit and the number of PRC establishments audited.

[[Page 59680]]

    Response: The results of the initial on-site audit, conducted from 
May 28 through June 4, 2018, were shared with the PRC's CCA. The CCA 
provided corrective actions to address the deficiencies that were 
deemed adequate by FSIS.
    On November 26 through December 13, 2018, FSIS performed a follow-
up audit of the PRC's food safety system governing fish and fish 
products of the order Siluriformes, in response to the deficiencies 
identified during the initial on-site audit (May 28 through June 4, 
2018). During the initial audit, FSIS was only able to observe 
processing of Siluriformes fish in two out of the six audited 
establishments. In the follow-up audit, the FSIS auditors visited seven 
out of the ten establishments that then exported products to the United 
States. At the time of this audit, all seven establishments were 
processing Siluriformes fish. The FSIS auditors observed the processing 
of Siluriformes fish products, in addition to the implementation of 
corrective actions to the inspection system deficiencies noted during 
the initial on-site audit. FSIS did not identify any deficiencies that 
represented an immediate threat to public health and determined that 
the proposed corrective actions were adequate.
    It is important to note that FSIS equivalence determinations are 
based on the foreign country's inspection system, not on an individual 
establishment's system. To be eligible to export Siluriformes fish to 
the United States, the foreign country's inspection system must ensure 
that establishments preparing these products for export to the United 
States comply with requirements equivalent to those of the FMIA and 
supporting regulations. The PRC's inspection system meets these 
requirements. The foreign country certifies the establishments as 
meeting the required standards and notifies FSIS about establishments 
that are certified or removed from certification. The PRC's inspection 
system currently meets all these requirements. FSIS will verify that 
the system continues to meet requirements through annual CCA 
submissions, on-going audits, and point-of-entry re-inspection and 
sampling and testing.

Executive Orders (E.O.s) 12866 and 13563

    E.O. 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 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 under E.O. 12866.

Expected Costs of the Final Rule

    This final regulatory impact analysis updates the preliminary 
regulatory impact analysis by including the most recent year's (2018) 
trade data. As shown in Table 1, in 2018, the PRC accounted for 
approximately 5.9 percent of Siluriformes fish imports and represented 
only 3.6 percent of Siluriformes fish consumption in the United States. 
The final rule is not expected to change the PRC's market share or to 
impose any cost on industry or consumers, because the final rule will 
maintain historical trade.

                                                         Table 1--Summary of Siluriformes Sales *
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                                                               2014            2015            2016            2017            2018       5 Year average
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                                                                                                Millions of Dollars
                                                         -----------------------------------------------------------------------------------------------
Total U.S. Imports \1\..................................         $346.66         $351.13         $405.61         $381.89         $547.10         $406.48
Total U.S. Domestic Production \2\......................         $351.94         $363.61         $385.99         $379.71         $360.40         $368.33
Total U.S. Exports \1\..................................           $4.00           $4.95           $4.80           $6.18           $3.89           $4.76
Total U.S. Consumption \3\..............................         $694.60         $709.79         $786.80         $755.43         $903.61         $770.04
Total U.S. Imports from the PRC \1\.....................          $36.19          $32.06          $37.46          $38.35          $32.20          $35.25
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The PRC as % of U.S. Imports............................           10.4%            9.1%            9.2%           10.0%            5.9%            8.7%
The PRC as % of U.S. Domestic Production................           10.3%            8.8%            9.7%           10.1%            8.9%            9.6%
The PRC as % of U.S. Consumption........................            5.2%            4.5%            4.8%            5.1%            3.6%            4.6%
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Data Source: U.S. Census Bureau Trade Data.
* Numbers in table may not sum to totals due to rounding.
\1\Import and Export Data Accessed from USDA Foreign Agricultural Service: Global Agricultural Trade System: https://apps.fas.usda.gov/gats/default.aspx/
  .
\2\ U.S. Production Data Accessed from USDA National Agricultural Statistics Service: Quick Stats: https://quickstats.nass.usda.gov/results/6F6BAB14-7014-365B-ACEA-CA35C184329B?pivot=short_desc.
\3\ U.S. Consumption data is assumed to equal Imports + Domestic Production - Exports.

Expected Benefits of the Final Rule

    This final rule will maintain the Siluriformes fish trade between 
the United States and the PRC and its associated benefits. As shown in 
Table 2, the United States is the PRC's largest foreign customer of 
Siluriformes fish, purchasing on average 60 percent of their total 
frozen catfish and frozen catfish fillets exports from 2016 to 2018. As 
shown in Table 1, the U.S. consumes more Siluriformes fish than it 
produces. U.S. production meets approximately half of U.S. total 
demand. Maintaining current trade flows will help keep consumer prices 
for Siluriformes fish affordable and meet the large U.S. demand for 
these products. Additionally, the PRC provides several species of 
Siluriformes fish that are not produced domestically, allowing for 
greater product diversity and consumer choice.

[[Page 59681]]



                                              Table 2--Chinese Siluriformes Export Market Share by Country
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                                                                          USD in millions                                  Percent share
                     Partner country                     -----------------------------------------------------------------------------------------------
                                                               2016            2017            2018            2016            2017            2018
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World...................................................          $50.43          $41.34          $28.74             100             100             100
United States...........................................           35.92           27.32           11.98              71              66              42
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Data Source: Global Trade Atlas--International Import and Export Commodity Trade Data (Numbers reported by Chinese Customs) Commodity: 030324--Catfish,
  Frozen and 030462--Catfish Fillets, Frozen.
FSIS downloaded the data from https://www.gtis.com/, and it will be available upon request.

Regulatory Flexibility Act Assessment

    The FSIS Administrator certifies that, for the purposes of the 
Regulatory Flexibility Act (5 U.S.C. 601 et seq.), this final rule will 
not have a significant economic impact on a substantial number of small 
entities in the United States, because, as stated above, the final rule 
will maintain existing trade. The trade volume is expected to remain 
within historical bounds, with little or no effect on U.S. 
establishments, regardless of size.

Executive Order (E.O.) 13771

    Consistent with E.O. 13771 (82 FR 9339, February 3, 2017), this 
final rule facilitates regulatory cooperation with foreign governments. 
Therefore, this final rule is an E.O. 13771 deregulatory action.

Paperwork Reduction Act

    No new paperwork requirements are associated with this final rule. 
Foreign countries wanting to export Siluriformes fish to the United 
States are required to provide information to FSIS certifying that 
their inspection system provides standards equivalent to those of the 
United States, and that the legal authority for the system and the 
implementing regulations are equivalent to those of the United States. 
FSIS provided the PRC with a questionnaire, referred to as the Self 
Reporting Tool (SRT), asking for detailed information about the 
country's inspection practices and procedures to assist the country in 
organizing its materials. This information collection was approved 
under OMB number 0583-0153. The rule contains no other paperwork 
requirements.

Executive Order (E.O.) 12988, Civil Justice Reform

    This final rule has been reviewed under E.O. 12988, Civil Justice 
Reform. Under this rule: (1) All State and local laws and regulations 
that are inconsistent with this rule will be preempted; (2) no 
retroactive effect will be given to this rule; and (3) no 
administrative proceedings will be required before parties may file 
suit in court challenging this rule.

E-Government Act

    FSIS and USDA are committed to achieving the purpose 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 citizens access to Government 
information and services, and for other purposes.

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 will also announce and provide a link to it through the FSIS 
Constituent Update, which is used to provide information regarding FSIS 
policies, procedures, regulations, Federal Register notices, FSIS 
public meetings, and other types of information that could affect or 
would be of interest to our constituents and stakeholders. The 
Constituent Update is available on the FSIS web page. Through the web 
page, FSIS is able to provide information to a much broader, more 
diverse audience. In addition, FSIS offers an email subscription 
service which provides automatic and customized access to selected food 
safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export 
information, regulations, directives, and notices. Customers can add or 
delete subscriptions themselves, and have the option to password 
protect their accounts.

USDA Non-Discrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds 
of race, color, national origin, religion, sex, gender identity, sexual 
orientation, disability, age, marital status, family/parental status, 
income derived from a public assistance program, or political beliefs, 
exclude from participation in, deny the benefits of, or subject to 
discrimination any person in the United States under any program or 
activity conducted by the USDA.

How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program 
Discrimination Complaint Form, which may be accessed online at: http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your 
authorized representative.
    Send your completed complaint form or letter to USDA by mail, fax, 
or email:
    Mail: U.S. Department of Agriculture, Director, Office of 
Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410.
    Fax: (202) 690-7442.
    Email: [email protected].
    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.), should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

List of Subjects in 9 CFR Part 557

    Imported products.

    For the reasons set out in the preamble, FSIS amends 9 CFR part 557 
as follows:

PART 557--IMPORTATION

0
 1. The authority citation for part 557 continues to read as follows:

    Authority: 21 U.S.C. 601-602, 606-622, 624-695; 7 CFR 2.7, 2.18, 
2.53.

0
 2. In Sec.  557.2, revise paragraph (b)(1) to read as follows:


Sec.  557.2  Eligibility of foreign countries for importation of fish 
and fish products into the United States.

* * * * *
    (b)(1) It has been determined that fish and fish products from the 
following countries covered by foreign inspection certificates of the 
country of origin as required by Sec.  557.4, are eligible under the 
regulations in this subchapter for entry into the United States after 
inspection and marking as required by

[[Page 59682]]

the applicable provisions of this part: People's Republic of China.
* * * * *

    Done at Washington, DC.
Carmen M. Rottenberg,
Administrator.
[FR Doc. 2019-24055 Filed 11-4-19; 8:45 am]
BILLING CODE 3410-DM-P