56914 Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Proposed Rules 

(b) Except as provided in paragraph 

(c) of this section, all breeding swine 

shall be tested for and show negative 

test results to brucellosis by a test 

prescribed in ‘‘Standard Agglutination 

Test Procedures for the Diagnosis of 

Brucellosis’’ or ‘‘Supplemental Test 

Procedures for the Diagnosis of 

Brucellosis.’’ The test results shall be 

classified negative in accordance with 

the provisions prescribed in the 

Recommended Brucellosis Eradication 

Uniform Methods and Rules, chapter 2, 

part II, G, 1, 2, and 3. 

(c) Breeding swine exported to a 

country that does not require breeding 

swine from the United States to be 

tested for brucellosis need not comply 

with the requirements of paragraph (b) 

of this section. 

(Approved by the Office of 

Management and Budget under control 

number 0579-0020) 

Done in Washington, DC, this 13th day 

of September 2010. 

Kevin Shea 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2010–23235 Filed 9–16–10: 8:45 am] 

BILLING CODE 3410–34–S 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

9 CFR Part 91 

[Docket No. APHIS-2009-0078] 

RIN 0579-AD25 

Removal of the List of Ports of 

Embarkation and Export Inspection 

Facilities from the Regulations 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Proposed rule. 

SUMMARY: We are proposing to amend 

the live animal export regulations by 

removing the list of designated ports of 

embarkation and their associated export 

inspection facilities. As a result of this 

rulemaking, those ports and facilities 

would henceforth be listed on the 

Internet rather than in the regulations, 

thus enabling us to amend the list, when 

necessary, in a timelier manner than we 

can now and allowing us greater 

flexibility in regulating animal exports. 

DATES: We will consider all comments 

that we receive on or before November 

16, 2010. 

ADDRESSES: You may submit comments 

by either of the following methods: 

∑ Federal eRulemaking Portal: Go to 

(http://www.regulations.gov/ 

fdmspublic/component/ 

main?main=DocketDetail&d=APHIS2009-0078) to submit or view comments 

and to view supporting and related 

materials available electronically. 

∑ Postal Mail/Commercial Delivery: 

Please send one copy of your comment 

to Docket No. APHIS-2009-0078, 

Regulatory Analysis and Development, 

PPD, APHIS, Station 3A-03.8, 4700 

River Road Unit 118, Riverdale, MD 

20737-1238. Please state that your 

comment refers to Docket No. APHIS2009-0078. 

Reading Room: You may read any 

comments that we receive on this 

docket in our reading room. The reading 

room 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) 690-2817 before 

coming. 

Other Information: Additional 

information about APHIS and its 

programs is available on the Internet at 

(http://www.aphis.usda.gov). 

FOR FURTHER INFORMATION CONTACT: Dr. 

Courtney Bronner Williams, Senior Staff 

Veterinarian, Technical Trade Services, 

National Center for Import and Export, 

VS, APHIS, 4700 River Road Unit 39, 

Riverdale, MD; 20737-1231; (301) 734- 

8364. 

SUPPLEMENTARY INFORMATION: 

Background 

The regulations in 9 CFR part 91, 

‘‘Inspection and Handling of Livestock 

for Exportation’’ (referred to below as 

the regulations), prescribe conditions for 

exporting animals from the United 

States. The regulations state, among 

other things, that all animals, except 

animals exported by land to Canada or 

Mexico, must be exported through 

designated ports of embarkation, unless 

the exporter can show that the animals 

would suffer undue hardship if they 

were required to be moved to a 

designated port of embarkation. 

Paragraph (a) of § 91.14 lists ports that 

have been designated by the Animal and 

Plant Health Inspection Service (APHIS) 

as having met the requirements for use 

as ports of embarkation. To receive such 

a designation from APHIS, a port must 

have an export inspection facility 

available for the inspection, holding, 

feeding, and watering of animals prior 

to exportation. Approved export 

inspection facilities, along with their 

contact information, are also listed in 

§ 91.14(a). Under the regulations, export 

inspection facilities must meet the 

standards contained in § 91.14(c) 

concerning physical construction 

requirements, facility size, inspection 

implements (e.g., pens and animal 

restraining devices), cleaning and 

disinfection, feed and water, access by 

inspectors, animal handling 

arrangements, testing and treatment of 

animals, facility location, disposal of 

animal wastes, lighting, office and 

restroom facilities, and walkways. 

Because the designated ports of 

embarkation and associated export 

inspection facilities are now listed in 

the regulations, the list can only be 

amended to add or remove ports or 

export inspection facilities or to update 

contact information by means of 

rulemaking. In order to allow for more 

timely changes, we are proposing to 

remove this list from the regulations. In 

its place, we would add a new 

paragraph (a) stating that all ports that 

have export inspection facilities that an 

APHIS veterinarian has determined 

satisfy the requirements of § 91.14(c) 

would be designated as ports of 

embarkation. The proposed paragraph 

would further state that the list of 

designated ports and inspection 

facilities can be obtained from an APHIS 

Veterinary Services area office or 

viewed on the Internet on the APHIS 

Web site. Finally, proposed paragraph 

(a) would provide, as does the 

introductory text of the existing 

paragraph (a), that all animals, except 

animals being exported by land to 

Mexico or Canada, must be exported 

through the listed ports or through other 

ports designated in special cases by the 

Administrator, as provided in § 91.14(b). 

We are also proposing some changes 

to § 91.14(d), which pertains to approval 

and denial, revocation, or suspension of 

approval of export inspection facilities. 

Currently, the paragraph states that 

approval of an export inspection facility 

will be denied or revoked if the facility 

fails to meet the standards contained in 

§ 91.14(c). The operator of the facility is 

notified in writing if approval is denied 

or revoked, in the latter case, at least 60 

days prior to the date of the proposed 

revocation. The written notice details 

the deficiencies of the facility, and the 

operator is given an opportunity to 

respond. Pending a final determination, 

approval of any facility may be denied 

or suspended by the Administrator 

when he has reason to believe that the 

facility does not meet the standards set 

forth in the regulations. 

The paragraph, as currently written, is 

somewhat ambiguous regarding the 

circumstances that may trigger a 

revocation of approval. In order to 

clarify the regulations and ensure that 

standards are being maintained at ports 


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Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Proposed Rules 56915 

and facilities covered under these 

regulations, we are proposing to amend 

paragraph (d) to require that designated 

ports of embarkation and export 

facilities be reevaluated annually for 

compliance with § 91.14(c) by means of 

an APHIS inspection. 

We would also remove the provisions 

pertaining to suspension and/or 

proposed revocation of approval, 

including the requirement that we 

notify the operator of the facility 60 

days prior to the latter. For purposes of 

enforcement, the existing categories of 

suspension and revocation are 

essentially the same: In either case, the 

port or facility loses its eligibility for use 

as a designated port of embarkation. 

Moreover, there is no distinction 

between the requirements for 

reinstatement of a facility that has had 

its approval suspended and one that has 

had its approval revoked. In both the 

former case and the latter, the facility is 

reinstated when it can demonstrate that 

it meets the requirements of § 91.14(c). 

The elimination of the category of 

suspension, therefore, would not change 

the way the regulations are enforced but 

would simplify them. Under our 

proposed paragraph (d), if a facility 

were to fail an annual compliance 

inspection, it would be removed 

immediately from the list of designated 

facilities. Proposed paragraph (d) would 

also clarify the procedure for 

reinstatement by indicating that 

operators of facilities that fail either an 

initial inspection or an annual 

compliance inspection would have the 

opportunity to request another 

inspection after remedying the 

deficiencies listed in the written notice 

from APHIS. The existing regulations do 

not address the issue of reinstatement 

directly. 

Finally, we would make minor 

editorial changes to §§ 91.14(b) and 

91.15(a), the current text of which 

contains references to the list of ports in 

current § 91.14(a). 

By eliminating the need for 

rulemaking each time the list of 

designated ports of embarkation and 

associated export inspection facilities 

needs to be changed, this proposed rule 

would allow revisions to that list to be 

made much more quickly than they can 

at present. Our ability to revise the list 

in a timely manner will make the 

process of regulating animal exports 

more flexible and efficient. 

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). 

This proposed rule would amend the 

live animal export regulations by 

removing the list of designated ports of 

embarkation and their associated export 

inspection facilities. As a result of this 

rulemaking, those ports and facilities 

would henceforth be listed on the 

Internet rather than in the regulations, 

allowing us to amend the list, when 

necessary, in a timelier manner than we 

can now. 

Those entities most likely to be 

economically affected by the rule would 

be exporters of live animals and 

domestic livestock producers. These 

entities either sell goods on their own 

account (import/export merchants) or 

arrange for the sale of goods owned by 

others (import/export agents and 

brokers). Affected entities could include 

beef cattle ranching and farming 

operations, dairy cattle and milk 

production operations, hog and pig 

farming operations, sheep and goat 

farming operations, and cattle feedlots. 

The Small Business Administration 

has established guidelines for 

determining which businesses are to be 

considered small. Based on the most 

recent data we have regarding annual 

receipts, it is likely that most of the 

entities that could be affected by this 

proposed rule are small. 

However, this proposal would only 

amend APHIS’ administrative process 

for changing the list of designated 

embarkation ports and associated export 

inspection facilities. The proposed 

action would not make any changes in 

the status of any designated 

embarkation port or associated export 

inspection facility, nor would it alter the 

technical criteria by which designated 

embarkation ports and associated export 

inspection facilities are added to or 

removed from this list. We expect that 

this proposed rule will have little effect 

on U.S. entities other than benefits they 

could derive from timelier changes to 

the list of designated ports of 

embarkation and associated export 

inspection facilities. 

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. If this proposed rule is 

adopted: (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) administrative proceedings 

will not be required before parties may 

file suit in court challenging this rule. 

Paperwork Reduction Act 

This proposed rule contains no 

information collection or recordkeeping 

requirements under the Paperwork 

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

seq.). 

List of Subjects in 9 CFR Part 91 

Animal diseases, Animal welfare, 

Exports, Livestock, Reporting and 

recordkeeping requirements, 

Transportation. 

■ Accordingly, we propose to amend 9 

CFR part 91 as follows: 

PART 91—INSPECTION AND 

HANDLING OF LIVESTOCK FOR 

EXPORTATION 

■ 1. The authority citation for part 91 

continues to read as follows: 

Authority: 7 U.S.C. 8301-8317; 19 U.S.C. 

1644a(c); 21 U.S.C. 136, 136a, and 618; 

46 U.S.C. 3901 and 3902; 7 CFR 2.22, 2.80, 

and 371.4. 

■ 2. Section 91.14 is amended by 

revising paragraphs (a), (b), and (d) to 

read as follows: 

§ 91.14 Ports of embarkation and export 

inspection facilities. 

(a) All ports that have export 

inspection facilities which an APHIS 

veterinarian has determined satisfy the 

requirements of paragraph (c) of this 

section are hereby designated as ports of 

embarkation. A list of designated ports 

of embarkation can be viewed on the 

Internet at (http://www.aphis.usda.gov/ 

regulations/vs/iregs/animals/) or 

obtained from a Veterinary Services area 

office. Information on area offices is 

available at (http://www.aphis.usda.gov/ 

animal_health/area_offices/). All 

animals, except animals being exported 


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56916 Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Proposed Rules 

by land to Mexico or Canada, shall be 

exported through said ports or through 

ports designated in special cases under 

paragraph (b) of this section. 

(b) In special cases, other ports may 

be designated as ports of embarkation by 

the Administrator, with the concurrence 

of the Commissioner of the Bureau of 

Customs and Border Protection, when 

the exporter can show to the satisfaction 

of the Administrator that the animals to 

be exported would suffer undue 

hardship if they are required to be 

moved to a port listed as a designated 

port of embarkation in accordance with 

paragraph (a) of this section. Ports shall 

be designated in special cases as ports 

of embarkation only if the inspection 

facilities are approved as meeting the 

requirements of paragraph (c) of this 

section. 

* * * * * 

(d) Approval and denial or revocation 

of approval. Approval of each export 

inspection facility for designation under 

paragraph (a) of this section, and in 

special cases under paragraph (b) of this 

section, shall be obtained from the 

Administrator. Approval of an export 

inspection facility under paragraph (a) 

or (b) will be denied or revoked for 

failure to meet the standards in 

paragraph (c) of this section. Designated 

ports of embarkation and export 

facilities shall be reevaluated annually, 

by means of an APHIS site inspection, 

for continued compliance with the 

standards contained in paragraph (c) of 

this section. If the port or facility fails 

to pass the annual inspection, its 

designation will be revoked, and it will 

be removed from the list of designated 

ports and facilities. A written notice of 

any proposed denial or revocation shall 

be given to the operator of the facility, 

and he will be given an opportunity to 

present his views thereon. Such notice 

shall list in detail the deficiencies 

concerned. After remedying the 

deficiencies, an operator may request 

another inspection. Approval of a port 

of embarkation in connection with the 

designation of an export inspection 

facility in special cases shall be limited 

to the special case for which the 

designation was made. 

* * * * * 

■ 3. In § 91.15, paragraph (a) is revised 

to read as follows: 

§ 91.15 Inspection of animals for export. 

(a) All animals offered for exportation 

to any foreign country, except by land 

to Mexico or Canada, shall be inspected 

within 24 hours of embarkation by an 

APHIS veterinarian at an export 

inspection facility at a port listed as a 

designated port of embarkation in 

accordance with § 91.14(a), or at a port 

or inspection facility designated by the 

Administrator in a special case under 

§ 91.14(b). 

* * * * * 

Done in Washington, DC, this 13th day 

of September 2010. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2010–23245 Filed 9–16–10: 8:45 am] 

BILLING CODE 3410–34–S 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

9 CFR Parts 101 and 114 

[Docket No. APHIS-2009-0028] 

RIN 0579-AD06 

Viruses, Serums, Toxins, and 

Analogous Products; Expiration Date 

Required for Serials and Subserials 

and Determination of Expiration Date 

of Product 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Proposed rule; withdrawal and 

reproposal. 

SUMMARY: We are proposing to amend 

the Virus-Serum-Toxin Act regulations 

concerning expiration dating to clarify 

that the expiration date of a serial or 

subserial of a veterinary biologic should 

be computed from the date of the 

initiation of the first potency test. We 

also propose to require the expiration 

dating period (stability) of a product to 

be confirmed by conducting a real-time 

stability study with a stabilityindicating assay; require stability 

monitoring of products after licensing; 

and specify a single standard for 

determining the expiration date for 

veterinary biologics in place of the 

current standard that specifies different 

procedures for products contingent 

upon whether they consist of viable or 

nonviable organisms. These 

amendments would update and clarify 

the regulations concerning expiration 

dating and establish a single uniform 

standard for determining the stability of 

veterinary biological products. This 

proposed rule replaces a previously 

published proposed rule, which we are 

withdrawing as part of this document. 

DATES: We will consider all comments 

that we receive on or before November 

16, 2010. 

ADDRESSES: You may submit comments 

by either of the following methods: 

∑ Federal eRulemaking Portal: Go to 

(http://www.regulations.gov/ 

fdmspublic/component/ 

main?main=DocketDetail&d=APHIS2009-0028) to submit or view comments 

and to view supporting and related 

materials available electronically. 

∑ Postal Mail/Commercial Delivery: 

Please send one copy of your comment 

to Docket No. APHIS-2009-0028, 

Regulatory Analysis and Development, 

PPD, APHIS, Station 3A-03.8, 4700 

River Road Unit 118, Riverdale, MD 

20737-1238. Please state that your 

comment refers to Docket No. APHIS2009-0028. 

Reading Room: You may read any 

comments that we receive on 

Regulations.gov (see the link above) or 

in our reading room. The reading room 

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) 690-2817 before 

coming. 

Other Information: Additional 

information about APHIS and its 

programs is available on the Internet at 

(http://www.aphis.usda.gov). 

FOR FURTHER INFORMATION CONTACT: Dr. 

Albert P. Morgan, Chief of Operational 

Support, Center for Veterinary 

Biologics, Licensing and Policy 

Development, VS, APHIS, 4700 River 

Road Unit 148, Riverdale, MD 20737- 

1231; (301) 734-8245. 

SUPPLEMENTARY INFORMATION: 

Background 

The Virus-Serum-Toxin Act 

regulations in 9 CFR part 114, 

‘‘Production Requirements for Biological 

Products’’ (referred to below as the 

regulations), include requirements 

applicable to computing expiration 

dates and determining expiration dating 

periods (stability) for veterinary 

biologics. Currently, § 114.12 of the 

regulations requires each serial or 

subserial of veterinary biological 

product prepared in a licensed 

establishment to be given an expiration 

date, and § 114.13 provides that the 

expiration date for each product shall be 

computed from the date of the initiation 

of the potency test. 

The computed expiration date of a 

serial or subserial of biological product 

is inextricably linked to the stability of 

such product. The expiration date of a 

veterinary biologic designates the end of 

the period during which such product, 

when properly stored and handled, can 

be expected with reasonable certainty to 


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