This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

31054 

Vol. 79, No. 104 

Friday, May 30, 2014 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

9 CFR Parts 101 and 113 

[Docket No. APHIS–2013–0034] 

RIN 0579–AD86 

Viruses, Serums, Toxins, and 

Analogous Products; Standard 

Requirements; Addition of 

Terminology To Define Veterinary 

Biologics Test Results 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Proposed rule. 

SUMMARY: We are proposing to amend 

the veterinary biological product 

regulations by defining the terms used 

for reporting the results of tests 

performed on veterinary biological 

products. Licensees and permittees of 

veterinary biological products must 

conduct these tests and report the 

results to the Animal and Plant Health 

Inspection Service so that the Agency 

can determine if the products are 

eligible for release. Defining these terms 

would clarify the circumstances under 

which the results of a prescribed test 

can be reported as satisfactory, 

unsatisfactory, inconclusive, or a No 

Test. We are also proposing to remove 

several obsolete testing standard 

requirements from part 113. These 

changes would update our regulations 

and improve communication between 

regulators and product licensees and 

permittees with respect to reporting test 

results. 

DATES: We will consider all comments 

that we receive on or before July 29, 

2014. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/

#!docketDetail;D=APHIS-2013-0034. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2013–0034, Regulatory Analysis 

and Development, PPD, APHIS, Station 

3A–03.8, 4700 River Road, Unit 118, 

Riverdale, MD 20737–1238. 

Supporting documents and any 

comments we receive on this docket 

may be viewed at http://

www.regulations.gov/

#!docketDetail;D=APHIS-2013-0034 or 

in our reading room, which is located in 

Room 1141 of the USDA South 

Building, 14th Street and Independence 

Avenue SW., Washington, DC. Normal 

reading room hours are 8 a.m. to 4:30 

p.m., Monday through Friday, except 

holidays. To be sure someone is there to 

help you, please call (202) 799–7039 

before coming. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Donna Malloy, Operational Support 

Section, Center for Veterinary Biologics 

Policy, Evaluation, and Licensing, VS, 

APHIS, 4700 River Road, Unit 148, 

Riverdale, MD 20737–1231; (301) 851– 

3426. 

SUPPLEMENTARY INFORMATION: 

Background 

The Animal and Plant Health 

Inspection Service (APHIS) administers 

and enforces the Virus-Serum-Toxin Act 

(21 U.S.C. 151 et seq.). Under the VirusSerum-Toxin Act, a veterinary 

biological product must be shown to be 

pure, safe, potent, and efficacious before 

a veterinary biological product license 

may be issued. The regulations in 9 CFR 

part 113, ‘‘Standard Requirements’’ 

(referred to below as the regulations), 

prohibit the release of biological 

products prior to the completion of tests 

identified in the regulations and in the 

Outline of Production, a document 

submitted by the licensee that explains 

how a serial of product is formulated, 

tested, packaged, dated, and 

recommended for use. 

The results of these tests must be 

reported in accordance with 9 CFR part 

116. Specifically, § 116.7 requires 

veterinary biologics licensees to submit 

summaries of all tests conducted on 

each serial and subserial of product 

using APHIS Form 2008 or an 

acceptable equivalent form prior to 

release of each serial or subserial. This 

form lists four terms to designate test 

results: ‘‘Satisfactory,’’ ‘‘unsatisfactory,’’ 

‘‘inconclusive,’’ and ‘‘No Test.’’ The 

terms ‘‘satisfactory,’’ ‘‘unsatisfactory,’’ 

and ‘‘inconclusive’’ are not defined in 

the regulations. Section 101.5(l) of the 

regulations currently defines the term 

‘‘No Test’’ as a test that produces 

inconclusive or invalid results and, 

therefore, cannot be used to evaluate a 

biological product. Section 113.5(d) of 

the regulations indicates that when an 

initial or subsequent test is declared a 

No Test, the reasons must be reported in 

the test records, the results will not be 

considered as final, and the test may be 

repeated. 

We are proposing to add definitions of 

the terms used to designate test results, 

‘‘satisfactory,’’ ‘‘unsatisfactory,’’ and 

‘‘inconclusive,’’ to § 101.5(l) and to 

revise the definition of ‘‘No Test’’ 

currently in that section. Defining these 

testing terms will align the regulations 

in 9 CFR part 113 with current industry 

standards and practices. 

We propose to revise paragraph (l) in 

section 101.5 to define the testing terms 

in new subparagraphs (1) through (4). 

Paragraph (l)(1) will provide a revised 

definition of ‘‘No Test.’’ The term ‘‘No 

Test’’ would now be defined as the test 

designation used when a deficiency in 

the test system has rendered a test 

unsuitable for drawing a valid 

conclusion. For example, the deficiency 

can be the result of a failure to meet the 

test’s internal validity requirements 

established in the filed Outline of 

Production or standard requirements, or 

be caused by an uncontrollable 

occurrence such as a power outage 

affecting incubators or other equipment. 

A No Test is considered an intermediate 

designation and cannot be used to 

evaluate a biological product. A further 

process is then required to determine a 

final test conclusion of satisfactory or 

unsatisfactory, which will be based on 

the filed Outline of Production or 

standard requirements. 

Paragraph (l)(2) would define the term 

‘‘satisfactory’’ as the final, conclusive 

designation given to a valid test with 

results that meet the release criteria 

stated in the filed Outline of Production 

or Standard Requirement. 

Paragraph (l)(3) would define the term 

‘‘unsatisfactory’’ as the final, conclusive 

designation given to a valid test with 

results that do not meet the release 

criteria stated in the filed Outline of 

Production or Standard Requirement. 

Paragraph (l)(4) would define the term 

‘‘inconclusive’’ as the test designation 

used for an initial test when a sequential 

test design established in the filed 

Outline of Production or Standard 

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Federal Register / Vol. 79, No. 104 / Friday, May 30, 2014 / Proposed Rules 31055 

Requirement allows further testing if a 

valid initial test is not satisfactory. 

We are also proposing to revise 

§ 113.5(d), which indicates that, when 

the initial or any subsequent test is 

declared a No Test, the reasons must be 

reported in the test records, the results 

will not be considered as final, and the 

test may be repeated. We would explain 

to licensees and permittees what the 

status of the product serial or subserial 

would be when the result of the test is 

designated as satisfactory, 

unsatisfactory, or inconclusive. When a 

test is declared satisfactory or 

unsatisfactory, the test designation 

would be considered a final conclusion. 

When the initial or any subsequent test 

is declared inconclusive, the reasons 

would have to be reported in the test 

records, the result would not be 

considered as a final conclusion, and 

the test could be repeated. If a test 

designated inconclusive is not 

performed again, it would be considered 

concluded and the final result reported 

as unsatisfactory. 

The definitions we propose are 

intended to clarify the circumstances 

under which the results of prescribed 

tests can be reported as satisfactory, 

unsatisfactory, inconclusive, or No Test. 

In some cases, the proposed definitions 

would change how the test results are 

reported by licensees and permittees on 

APHIS Form 2008. We have identified 

more than 50 specific instances of tests 

in the regulations in which results 

designated as inconclusive would be 

redesignated as No Test based on the 

proposed definition. As one example, 

§ 113.44(b) outlines the swine safety test 

procedure and interpretation of the test 

results: 

(b) Interpretation. If unfavorable 

reactions attributable to the product 

occur in either of the swine during the 

observation period, the serial or 

subserial is unsatisfactory. If 

unfavorable reactions which are not 

attributable to the product occur, the 

test shall be declared inconclusive and 

may be repeated; Provided, That, if the 

test is not repeated, the serial or 

subserial shall be declared 

unsatisfactory. 

As a result of our proposed changes 

to this and other tests in part 113, the 

term ‘‘inconclusive’’ in the paragraph 

above would be replaced by the term 

‘‘No Test.’’ The procedural steps in 

many part 113 tests differ depending on 

whether the test is initially reported as 

a No Test or is inconclusive. A No Test 

indicates an invalid test that can be 

repeated without regard to the initial 

test. On the other hand, an inconclusive 

initial test result cannot be disregarded. 

The interpretation of any subsequent 

testing outcomes takes into account the 

initial inconclusive test result, for 

example by averaging its results with 

subsequent tests and using the average 

to complete subsequent tests. 

For a list of instances where we are 

proposing to redesignate test outcomes 

from inconclusive to No Test, please see 

the proposed amendatory text below. 

We are also proposing to remove 

§§ 113.201, 113.202, 113.203, 113.211, 

113.213, and 113.214 from the 

regulations. These standards, which 

involve testing on live animals, are no 

longer used by the industry because 

newer testing methods are available. 

Executive Order 12866 and Regulatory 

Flexibility Act 

This proposed rule has been 

determined to be not significant for the 

purposes of Executive Order 12866 and, 

therefore, has not been reviewed by the 

Office of Management and Budget. 

In accordance with the Regulatory 

Flexibility Act, we have analyzed the 

potential economic effects of this action 

on small entities. The analysis is 

summarized below. Copies of the full 

analysis are available by contacting the 

person listed under FOR FURTHER

INFORMATION CONTACT or on the 

Regulations.gov Web site (see 

ADDRESSES above for instructions for 

accessing Regulations.gov). 

APHIS is proposing to amend the 

regulations in order to better define the 

terminology used when reporting the 

results of tests performed on veterinary 

biological products, thereby bringing the 

regulations up to date with current 

industry standards. 

The proposed changes would clarify 

when the results of a prescribed test can 

be reported as satisfactory, 

unsatisfactory, inconclusive, or can be 

designated as a No Test. The 

definitional changes would improve 

communication between APHIS and the 

regulated industry, and enable APHIS to 

more efficiently process the release of a 

tested product using current industry 

standards for reporting of test results. 

There are about 330 firms in the 

United States that manufacture 

biological products. It is not known how 

many of these firms are engaged in 

manufacturing biologic products 

specifically for veterinary purposes. The 

Small Business Administration (SBA) 

standard for a small business in this 

industry is a firm with not more than 

500 employees; the average firm in this 

industry has 93 employees. While most 

firms that would be affected by this rule 

are small, the proposed changes would 

not impose a financial burden on them, 

but rather help make the product 

approval process timelier. 

Under these circumstances, the 

Administrator of the Animal and Plant 

Health Inspection Service has 

determined that this action would not 

have a significant economic impact on 

a substantial number of small entities. 

Executive Order 12372 

This program/activity is listed in the 

Catalog of Federal Domestic Assistance 

under No. 10.025 and is subject to 

Executive Order 12372, which requires 

intergovernmental consultation with 

State and local officials. (See 7 CFR part 

3015, subpart V.) 

Executive Order 12988 

This proposed rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. It is not intended to 

have retroactive effect. This rule would 

not preempt any State or local laws, 

regulations, or policies where they are 

necessary to address local disease 

conditions or eradication programs. 

However, where safety, efficacy, purity, 

and potency of biological products are 

concerned, it is the Agency’s intent to 

occupy the field. This includes, but is 

not limited to, the regulation of labeling. 

Under the Act, Congress clearly 

intended that there be national 

uniformity in the regulation of these 

products. There are no administrative 

proceedings which must be exhausted 

prior to a judicial challenge to the 

regulations under this rule. 

Paperwork Reduction Act 

This proposed rule contains no new 

information collection or recordkeeping 

requirements under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

et seq.). 

List of Subjects 

9 CFR Part 101 

Animal biologics. 

9 CFR Part 113 

Animal biologics, Exports, Imports, 

Reporting and recordkeeping 

requirements. 

Accordingly, we propose to amend 9 

CFR parts 101 and 113 as follows: 

PART 101—DEFINITIONS 

■ 1. The authority citation for part 101 

continues to read as follows: 

Authority: 21 U.S.C. 151–159; 7 CFR 2.22, 

2.80, and 371.4. 

■ 2. In § 101.5, paragraph (l) is revised 

to read as follows: 

§ 101.5 Testing terminology. 

* * * * * 

(l) Test results. Terms used to 

designate testing results are as follows: 

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31056 Federal Register / Vol. 79, No. 104 / Friday, May 30, 2014 / Proposed Rules 

(1) No Test. Designation used when a 

deficiency in the test system has 

rendered a test unsuitable for drawing a 

valid conclusion. 

(2) Satisfactory. Designation is a final 

conclusion given to a valid test with 

results that meet the release criteria 

stated in the filed Outline of Production 

or Standard Requirement. 

(3) Unsatisfactory. Designation is a 

final conclusion given to a valid test 

with results that do not meet the release 

criteria stated in the filed Outline of 

Production or Standard Requirement. 

(4) Inconclusive. Designation used for 

an initial test when a sequential test 

design established in the filed Outline 

of Production or Standard Requirement 

allows further testing if a valid initial 

test is not satisfactory. 

* * * * * 

PART 113—STANDARD 

REQUIREMENTS 

■ 3. The authority citation for part 113 

continues to read as follows: 

Authority: 21 U.S.C. 151–159; 7 CFR 2.22, 

2.80, and 371.4. 

■ 4. In § 113.5, paragraph (d) is revised 

to read as follows: 

§ 113.5 General testing. 

* * * * * 

(d) When the initial or any subsequent 

test is declared a No Test, the reasons 

shall be reported in the test records, the 

results shall not be considered as final, 

and the test may be repeated. When a 

test is declared satisfactory, the test 

designation is considered to be a final 

conclusion. When a test is declared 

unsatisfactory, the test designation is 

considered to be a final conclusion. 

When the initial or any subsequent test 

is declared inconclusive, the reasons 

shall be reported in the test records, the 

result shall not be considered as final, 

and the test may be repeated as 

established in the filed Outline of 

Production or Standard Requirement. If 

a test is designated inconclusive or No 

Test and the biological product is not 

further tested, the test designation of 

unsatisfactory is the final conclusion. 

* * * * * 

§§ 113.33, 113.36, 113.38, 113.39, 113.40, 

113.41, 113.44, 113.45, 113.47, 113.67, 

113.70, 113.71, 113.108, 113.109, 113.111, 

113.112, 113.116, 113.117, 113.118, 113.204, 

113.205, 113.207, 113.208, 113.215, 113.216, 

113.301, 113.302, 113.303, 113.304, 113.305, 

113.306, 113.310, 113.311, 113.313, 113.314, 

113.315, 113.316, 113.317, 113.318, 113.326, 

113.327, 113.328, 113.329, 113.330, 113.331, 

113.332, 113.406, 113.450, 113.454, and 

113.455 [Amended] 

■ 5. Sections 113.33, 113.36, 113.38, 

113.39, 113.40, 113.41, 113.44, 113.45, 

113.47, 113.67, 113.70, 113.71, 113.108, 

113.109, 113.111, 113.112, 113.116, 

113.117, 113.118, 113.204, 113.205, 

113.207, 113.208, 113.215, 113.216, 

113.301, 113.302, 113.303, 113.304, 

113.305, 113.306, 113.310, 113.311, 

113.313, 113.314, 113.315, 113.316, 

113.317, 113.318, 113.326, 113.327, 

113.328, 113.329, 113.330, 113.331, 

113.332, 113.406, 113.450, 113.454, and 

113.455 are amended by removing the 

word ‘‘inconclusive’’ each time it occurs 

and by adding the words ‘‘a No Test’’ in 

its place. 

§§ 113.109, 113.111, and 113.112 

[Amended] 

■ 6. Section 113.109, 113.111, and 

113.112 are amended by removing the 

word ‘‘invalid’’ each time it occurs and 

adding the words ‘‘a No Test’’ in its 

place. 

§§ 113.201, 113.202, 113.203, 113.210, 

113.211, 113.213, and 113.214 [Removed 

and Reserved] 

■ 7. Sections 113.201, 113.202, 113.203, 

113.211, 113.213, and 113.214 are 

removed and reserved. 

§ 113.210 [Amended] 

■ 8. In § 113.210, paragraphs (d)(1) and 

(d)(2) are amended by removing the 

word ‘‘inconclusive’’ each time it occurs 

and replacing it with the words ‘‘a No 

Test’’. 

§ 113.212 [Amended] 

■ 9. Section 113.212 is amended as 

follows: 

■ a. In paragraph (b), by removing the 

word ‘‘inconclusive’’ and replacing it 

with the words ‘‘a No Test’’; and 

■ b. In paragraph (d)(1), by removing the 

word ‘‘inconclusive’’ and replacing it 

with the words ‘‘a No Test’’. 

§ 113.325 [Amended] 

■ 10. Section 113.325 is amended as 

follows: 

■ a. By revising paragraph (b); and 

■ b. In paragraphs (c)(4), (d)(1), and 

(d)(2)(ii), by removing the word 

‘‘inconclusive’’ each time it occurs and 

replacing it with the words ‘‘a No Test’’. 

The revision reads as follows: 

§ 113.325 Avian Encephalomyelitis 

Vaccine. 

* * * * * 

(b) Each lot of Master Seed Virus shall 

be tested for pathogens by the chicken 

embryo inoculation test prescribed in 

§ 113.37, except that, if the test is a No 

Test because of a vaccine virus override, 

the test may be repeated and if the 

repeat test is inconclusive for the same 

reason, the chicken inoculation test 

prescribed in § 113.36 may be 

conducted and the virus judged 

accordingly. 

* * * * * 

Done in Washington, DC, this 23rd day of 

May 2014. 

Kevin Shea, 

Administrator, Animal and Plant Health 

Inspection Service. 

[FR Doc. 2014–12551 Filed 5–29–14; 8:45 am] 

BILLING CODE 3410–34–P 

FARM CREDIT ADMINISTRATION 

12 CFR Part 612 

RIN 3052–AC44 

Standards of Conduct and Referral of 

Known or Suspected Criminal 

Violations; Standards of Conduct 

AGENCY: Farm Credit Administration. 

ACTION: Proposed rule; reopening of 

comment period. 

SUMMARY: The Farm Credit 

Administration (FCA, we, or our) 

reopens the comment period on a 

proposed rule that would amend its 

regulations governing standards of 

conduct of directors, employees, and 

agents of Farm Credit System (System) 

institutions, excluding the Federal 

Agricultural Mortgage Corporation and 

clarify and strengthen reporting 

requirements and prohibitions, require 

institutions to establish a Code of 

Ethics, and enhance the role of the 

Standards of Conduct Official. 

Reopening the comment period will 

afford interested parties a new 

opportunity to comment on the 

proposed regulations. 

DATES: Comments on the proposed rule 

must be submitted on or before June 20, 

2014. 

ADDRESSES: We offer a variety of 

methods for you to submit your 

comments. For accuracy and efficiency 

reasons, commenters are encouraged to 

submit comments by email or through 

the FCA’s Web site. As facsimiles (fax) 

are difficult for us to process and 

achieve compliance with section 508 of 

the Rehabilitation Act, we are no longer 

accepting comments submitted by fax. 

Regardless of the method you use, 

please do not submit your comment 

multiple times via different methods. 

You may submit comments by any of 

the following methods: 

• Email: Send us an email at regcomm@fca.gov. 

• FCA Web site: http://www.fca.gov. 

Select ‘‘Public Commenters, ’’ then 

‘‘Public Comments’’ and follow the 

directions for ‘‘Submitting a Comment.’’ 

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