This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents.

Rules and Regulations Federal Register

41501 

Vol. 82, No. 169 

Friday, September 1, 2017 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

9 CFR Parts 300, 441, 530, 531, 532, 

533, 534, 537, 539, 540, 541, 544, 548, 

550, 552, 555, 557, 559, 560, and 561 

[Docket No. FSIS–2017–0003] 

Changes to the Inspection Coverage in 

Official Establishments That Slaughter 

Fish of the Order Siluriformes 

AGENCY: Food Safety and Inspection 

Service, USDA. 

ACTION: Response to comments; 

confirmation of implementation date. 

SUMMARY: The Food Safety and 

Inspection Service (FSIS) is confirming 

that on September 1, 2017, it will adjust 

inspection coverage at official 

establishments that slaughter fish of the 

order Siluriformes from all hours of 

operation to once per production shift. 

FSIS also is responding to comments 

received on the May 17, 2017 Federal 

Register document that announced 

these changes. 

DATES: FSIS will adjust inspection 

coverage at official establishments that 

slaughter Siluriformes fish from all 

hours of operation to once per 

production shift, beginning September 

1, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Edelstein, Deputy Assistant 

Administrator, Office of Policy and 

Program Development; Telephone: (202) 

205–0495, or by Fax: (202) 720–2025. 

Background 

On December 2, 2015, FSIS amended 

its regulations by publishing the final 

rule, ‘‘Mandatory Inspection of Fish of 

the Order Siluriformes and Products 

Derived from Such Fish’’ (80 FR 75590). 

Fish of the order Siluriformes include, 

but are not limited to, ‘‘catfish’’ (fish of 

the family Ictaluridae) and ‘‘basa’’ and 

‘‘swai’’ (fish of the family Pangasiidae). 

For convenience, this notice will use 

‘‘fish’’ to mean all fish of the order 

Siluriformes. 

Specifically, the final rule established 

regulations to implement the provisions 

of the 2008 and 2014 Farm Bills, which 

amended the Federal Meat Inspection 

Act (FMIA) to include fish as amenable 

and to provide for their inspection by 

FSIS. In the preamble to the final rule, 

FSIS stated that during an 18-month 

transitional period, it would assign 

inspection program personnel to be 

present during all hours of operation at 

domestic establishments that slaughter 

fish and, at the start of the period, assign 

inspection program personnel to 

conduct inspection at processing-only 

facilities at least quarterly. FSIS also 

stated that it might adjust inspection 

frequency in fish slaughter 

establishments in the future and, that at 

the end of the 18-month transitional 

period, inspection program personnel 

would be assigned at least once per day 

per shift at processing-only 

establishments (80 FR 75606). 

On May 17, 2017, FSIS announced 

and requested comment on its decision 

to adjust inspection coverage at fish 

slaughter establishments, starting 

September 1, 2017, from all hours of 

operation to once per production shift 

(82 FR 22609). This decision was based 

on the Agency’s experience inspecting 

official fish slaughter establishments 

since implementing the mandatory 

inspection program on March 1, 2016. 

FSIS found that the typical fish 

slaughter operation is a streamlined, 

automated process that combines 

slaughter with processing in the same 

continuous operation, more like meat 

processing-only operations than like 

slaughter operations for other species 

amenable to the FMIA. 

A consumer advocacy organization 

requested that FSIS extend the comment 

period by 30 days, so as to make 

informed comments. FSIS agreed and on 

June 16, 2017, extended the comment 

period until July 17, 2017 (82 FR 

27680). At the conclusion of the 

comment period, FSIS had received 

eight comments. After reviewing these 

comments, FSIS is affirming its plan to 

adjust inspection coverage at official 

fish slaughter establishments from all 

hours of operation to once per 

production shift, beginning September 

1, 2017. Issues raised by the comments 

received and FSIS’s responses follow. 

Comments and FSIS Responses 

FSIS received eight comments in 

response to its announced plans to 

adjust inspection coverage at official 

fish slaughter establishments. The 

comments were from two trade 

associations, one fish establishment, 

two FSIS inspectors, two consumer 

advocacy organizations and a foreign 

government. Four of the comments 

supported the change, agreeing that 

establishments that slaughter fish are 

most similar in operation and design to 

meat processing-only establishments 

and, therefore, should be inspected like 

a meat processing-only establishment, 

as opposed to meat slaughter 

establishments, i.e., once per production 

shift. 

The comment from the foreign 

government agreed with the rationale 

for the proposed change, but advocated 

for even less frequent inspection of fish, 

owing to its position that fish products 

pose little risk to the public health. As 

stated above, amendments to the FMIA 

in 2008 and 2014 directed FSIS to 

inspect the preparation of fish and fish 

products. USDA has historically 

interpreted the requirements in the 

FMIA for inspection of meat processing 

to mandate inspection at least once per 

production shift. Because FSIS has 

determined that operations in fish 

slaughter establishments are more like 

those in meat processing-only 

establishments, it is requiring 

inspection at a frequency of once per 

production shift there, as well. 

Several of the supportive comments 

expressed concern that the adjustment 

in inspection frequency would affect an 

establishment’s approved hours of 

operation (typically 8-hour shifts) and 

charges for inspection services outside 

these hours. It will not. The regulations 

at 9 CFR 307.4 through 307.6, and 

associated FSIS policies, regarding the 

provision of inspection services, would 

continue to apply to fish establishments. 

Official fish establishments should 

coordinate with their District Office to 

determine hours of operation and for 

clarification on what activities require 

inspection. 

Comments from the two consumer 

advocacy organizations and from an 

FSIS inspector opposed the change. One 

of the consumer advocacy organizations 

questioned the Agency’s 

implementation of inspection under 21 

U.S.C. 606, for both fish and other meat 


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41502 Federal Register / Vol. 82, No. 169 / Friday, September 1, 2017 / Rules and Regulations 

products, as allowing for inspection 

once per shift. This commenter further 

opined that Congress, in fact, intended 

for FSIS to ‘‘apply a greater care in 

inspecting catfish than with other meat 

food products,’’ because of the addition 

of paragraph (b) under this section, 

which directs USDA to consider the 

conditions under which fish is raised 

and transported. 

FSIS disagrees. A narrow 

interpretation of the language in 21 

U.S.C. 606, requiring that each unit of 

meat product be individually inspected 

by FSIS before movement in commerce, 

would create enormous costs without 

significantly increasing the effectiveness 

of inspection. USDA has never 

interpreted this language so narrowly in 

administration of the FMIA at meat 

processing-only establishments. In 

regard to the new section 21 U.S.C. 

606(b), FSIS has determined that this 

section grants the Agency authority to 

conduct verification activities regarding 

the raising or transport of fish, but does 

not address the frequency of inspection 

or verification activities regarding the 

preparation of fish. Again, FSIS believes 

that the risks associated with fish 

slaughter are more closely aligned with 

meat processing, as further confirmed 

by explicit Congressional exemption of 

fish from the ante-mortem and postmortem inspection provisions of the 

FMIA. 

When FSIS inspection program 

personnel visit meat processing-only 

establishments, they systematically 

verify compliance with the regulatory 

requirements. Inspectors routinely 

check the cleanliness of equipment and 

facilities, wholesomeness of incoming 

source materials, processing procedures, 

Hazard Analysis and Critical Control 

Point (HACCP) records, product labels, 

as well as other things. In addition, they 

submit samples for analysis, as directed 

in FSIS’s Public Health Information 

System. FSIS inspection program 

personnel assigned to official fish 

establishments will be instructed to 

follow the same procedures. Therefore, 

we believe this approach will provide a 

high level of assurance that the fish 

products are safe, wholesome, and 

properly packaged and labeled, and that 

the public health will continue to be 

effectively protected by the change in 

inspection coverage. 

Both comments from consumer 

advocacy organizations raise concerns 

about the effect of the adjustment in 

inspection frequency on the Agency’s 

programs to ensure the safety of 

imported fish and fish products. One 

comment contends that FSIS has not 

considered the conditions under which 

imported fish have been raised or 

transported. The other comment cites 

the number of shipments of foreign fish 

and fish products rejected by FSIS for 

import or recalled from commerce, 

because of violative residues found 

through FSIS testing, as evidence that 

foreign fish production, processing and 

inspection systems are inadequate. The 

commenter suggests that inspection 

during all hours of operation should be 

required for foreign slaughter and 

processing of fish intended for import to 

the United States. 

FSIS does consider the conditions 

under which imported fish are raised 

and transported through both the 

equivalence process and its testing of 

imported fish and fish products. When 

applying to export fish and fish 

products to the United States, a foreign 

country’s Central Competent Authority 

(CCA) must demonstrate to FSIS that it 

ensures fish for export are raised and 

transported under conditions that 

prevent product adulteration. For 

example, the CCA must provide 

information regarding how it ensures 

that fish are not grown or farmed under 

conditions that would cause them to be 

adulterated; details of its sampling of 

feed, fish or the body of water from 

which the fish are harvested; and 

information on its program for ensuring 

that fish are transported under sanitary 

conditions from harvest to processing 

establishments. A foreign country’s 

inspection program cannot be deemed 

equivalent unless the CCA demonstrates 

that it prevents the adulteration of fish 

during raising and transport. 

Additionally, FSIS tests fish and fish 

products collected during reinspection 

for chemical residues, Salmonella, and 

speciation. In regard to chemical 

residues, FSIS tests imported fish for 

veterinary drug residues, including 

nitrofurans and some fluoroquinolones; 

malachite green; gentian violet; metals 

and pesticides. This testing serves to 

verify that imported fish were raised 

under conditions to prevent product 

adulteration and keeps adulterated fish 

and fish products out of United States 

commerce. 

In regard to inspection frequency for 

imported fish and fish products, the 

FMIA and the regulations specifically 

require that imported products be held 

to the same standards as domestic 

products. The FMIA at 21 U.S.C. 620 

requires that no product may be 

imported into the United States unless 

it complies with all applicable 

provisions of the FMIA and the 

regulations issued thereunder. The fish 

import regulations at 9 CFR 557.3 

specifically require that no fish or fish 

product offered for importation from 

any foreign country shall be admitted 

into the United States if it is adulterated 

or misbranded or does not comply with 

all the requirements that would apply to 

it if it were a domestic product. 

Therefore, because FSIS will require 

government inspection of fish 

preparation at least once per production 

shift, to be determined equivalent, a 

foreign country’s fish inspection system 

must also provide government 

inspection at least once per production 

shift. FSIS sees no basis to impose 

inspection requirements for imported 

fish that are in addition to those applied 

to domestic fish. Food safety issues with 

imported fish can be addressed through 

import reinspection, enforcement and 

the equivalence process. 

Finally, one inspector opposed the 

change in inspection frequency at fish 

slaughter establishments, expressing 

concern that the change would result in 

increased workloads for inspectors that 

are currently assigned to these 

establishments. FSIS disagrees. The 

change in inspection frequency will 

simply place establishments that 

slaughter fish into ‘‘patrol assignments’’ 

including other meat and poultry 

processing establishments. The 

inspection workload for affected 

inspectors will be no different than the 

workload associated with current patrol 

assignments of processing 

establishments. 

USDA Nondiscrimination 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. 

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: program.intake@usda.gov. 

Persons with disabilities who require 

alternative means for communication 

(Braille, large print, audiotape, etc.) 


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Federal Register / Vol. 82, No. 169 / Friday, September 1, 2017 / Rules and Regulations 41503 

should contact USDA’s TARGET Center 

at (202)720–2600 (voice and TDD). 

Additional Public Notification 

FSIS will announce this notice online 

through the FSIS Web page located at 

http://www.fsis.usda.gov/federalregister. 

FSIS will also make copies of this 

Federal Register publication available 

through the FSIS Constituent Update 

(CU), 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 

constituents and stakeholders. The CU 

is communicated via Listserv, a free 

electronic mail subscription service for 

industry, trade groups, consumer 

interest groups, health professionals, 

and other individuals who have asked 

to be included. The CU is also available 

on the FSIS Web page. In addition, FSIS 

offers an electronic mail 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 

to regulations, directives, and notices. 

Customers can add or delete 

subscriptions themselves, and have the 

option to password protect their 

accounts. 

Done at Washington, DC on: August 29, 

2017. 

Paul Kiecker, 

Acting Administrator. 

[FR Doc. 2017–18591 Filed 8–31–17; 8:45 am] 

BILLING CODE 3410–DM–P 

DEPARTMENT OF ENERGY 

10 CFR Part 1016 

[Docket No. DOE–HQ–2015–0029–0001] 

RIN 1992–AA46 

Safeguarding of Restricted Data by 

Access Permittees 

AGENCY: Department of Energy. 

ACTION: Final rule. 

SUMMARY: The Department of Energy 

(DOE or Department) has revised its 

regulations governing the standards for 

safeguarding Restricted Data by access 

permittees. The previous version of this 

regulation was promulgated in 1983. 

Since 1983, changes in organizations, 

terminology, and DOE and national 

policies rendered portions of the 

previous regulation outdated. This 

version updates existing requirements. 

DATES: This rule is effective October 2, 

2017. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Linda Ruhnow, Office of Security Policy 

at (301) 903–2661; Security.Directives@

hq.doe.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

II. Section by Section Analysis 

III. Regulatory Review and Procedural 

Requirements 

A. Review Under Executive Order 12866 

B. Review Under the Regulatory Flexibility 

Act 

C. Review Under Paperwork Reduction Act 

D. Review Under the National 

Environmental Policy Act 

E. Review Under Executive Order 13132 

F. Review Under Executive Order 12988 

G. Review Under the Unfunded Mandates 

Reform Act of 1995 

H. Review Under Executive Order 13211 

I. Review Under the Treasury and General 

Government Appropriations Act of 1999 

J. Congressional Notification 

K. Approval by the Office of the Secretary 

I. Background 

The U.S. Department of Energy may 

issue an access permit to any person, as 

set forth in 10 CFR part 725, who 

requires access to Restricted Data 

applicable to civil uses of atomic energy 

for use in his/her business, trade or 

profession. 10 CFR part 725 specifies 

the terms and conditions under which 

the Department will issue an access 

permit and provides for the amendment, 

renewal, suspension, termination and 

revocation of an access permit. 

The regulations in 10 CFR part 1016 

establish requirements for the 

safeguarding of Secret and Confidential 

Restricted Data received or developed 

under an access permit. This part does 

not apply to Top Secret information 

because no such information may be 

provided to an access permittee within 

the scope of this regulation. The 

regulations in this part apply to all 

persons who may require access to 

Restricted Data used, processed, stored, 

reproduced, transmitted, or handled in 

connection with an access permit. 

The original regulations for the 

safeguarding of Restricted Data were 

Atomic Energy Commission regulations 

that were transferred to the Energy 

Research and Development 

Administration (ERDA) upon its 

formation in 1974 (Energy 

Reorganization Act of 1974; Pub. L. 93– 

438). The regulations were subsequently 

revised to conform to ERDA’s 

organization (41 FR 56775, 41 FR 

56785–56788, Dec. 30, 1976). The 

regulations were updated and 

transferred from 10 CFR part 795 to 10 

CFR part 1016 in Aug. 10, 1983 (48 FR 

36432). DOE has developed this version 

of 10 CFR part 1016 to reflect 

organizational, terminology and policy 

changes that have occurred since the 

regulations were last revised. 

DOE proposed changes to the 

regulations at 10 CFR part 1016 on 

November 16, 2016 (81 FR 80612). No 

comments were received. No changes 

were made to the proposed regulations 

except to modify the definition of an 

‘‘L’’ access authorization in § 1016.3, 

Definitions. 

II. Section by Section Analysis 

With the exception of the definition of 

an ‘‘L’’ access authorization in § 1016.3, 

Definitions, the modifications to 10 CFR 

part 1016 adopted in this final rule are 

described in the Section by Section 

Analysis in section II of DOE’s notice of 

proposed rulemaking published on 

November 16, 2016 (81 FR 80612). In 

§ 1016.3, Definitions, the definition of 

‘‘L’’ access authorization was modified 

from DOE’s proposed changes to update 

the type of background investigation 

required by DOE and national level 

directives. The reference to National 

Agency Checks with Local Agency 

Checks and Credit Check background 

investigation has been replaced with a 

Tier III background investigation. 

III. Rulemaking Requirements 

A. Review Under Executive Order 12866 

This action does not constitute a 

‘‘significant regulatory action’’ as 

defined in section 3(f) of Executive 

Order 12866, ‘‘Regulatory Planning and 

Review’’ (58 FR 51735). 

B. Review Under the Regulatory 

Flexibility Act 

The Regulatory Flexibility Act (5 

U.S.C. 601 et seq.) requires preparation 

of a regulatory flexibility analysis for 

any rule that by law must be proposed 

for public comment, unless the agency 

certifies that the rule, if promulgated, 

will not have a significant economic 

impact on a substantial number of small 

entities. As required by Executive Order 

13272, ‘‘Proper Consideration of Small 

Entities in Agency Rulemaking’’ (67 FR 

53461, Aug. 16, 2002), DOE published 

procedures and policies on February 19, 

2003, to ensure that the potential 

impacts of its rules on small entities are 

properly considered during the 

rulemaking process. DOE has made its 

procedures and policies available on the 

Office of the General Counsel’s Web site 

(www.gc.doe.gov). 

DOE has reviewed this rule under the 

Regulatory Flexibility Act and certifies 

that, as adopted, the rule would not 

have a significant impact on a 

substantial number of small entities. 


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