Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Rules and Regulations 52173 

the additional costs may be passed on 

to producers. However, these costs are 

offset by the benefits derived by the 

operation of the marketing order. 

In addition, the Committee’s meeting 

was widely publicized throughout the 

Colorado Area No. 3 potato industry and 

all interested persons were invited to 

attend the meeting and participate in 

Committee deliberations on all issues. 

Like all Committee meetings, the May 8, 

2008, meeting was a public meeting and 

all entities, both large and small, were 

able to express views on this issue. 

This rule imposes no additional 

reporting or recordkeeping requirements 

on either small or large Colorado Area 

No. 3 potato handlers. As with all 

Federal marketing order programs, 

reports and forms are periodically 

reviewed to reduce information 

requirements and duplication by 

industry and public sector agencies. 

AMS is committed to complying with 

the E-Government Act, to promote the 

use of the Internet and other 

information technologies to provide 

increased opportunities for citizen 

access to Government information and 

services, and for other purposes. 

As noted in the initial regulatory 

flexibility analysis, USDA has not 

identified any relevant Federal rules 

that duplicate, overlap, or conflict with 

this rule. 

A proposed rule concerning this 

action was published in the Federal 

Register on July 25, 2008 (73 FR 43375). 

Copies of the proposed rule were also 

mailed or sent via facsimile to all 

handlers. Finally, the proposal was 

made available through the Internet by 

USDA and the Office of the Federal 

Register. A 15-day comment period 

ending August 11, 2008, was provided 

for interested persons to respond to the 

proposal. No comments were received. 

A small business guide on complying 

with fruit, vegetable, and specialty crop 

marketing agreements and orders may 

be viewed at: http://www.ams.usda.gov/ 

AMSv1.0/ams.fetchTemplateData.do?

template=TemplateN&page=Marketing

OrdersSmallBusinessGuide. Any 

questions about the compliance guide 

should be sent to Jay Guerber at the 

previously mentioned address in the 

FOR FURTHER INFORMATION CONTACT

section. 

After consideration of all relevant 

material presented, including the 

information and recommendation 

submitted by the Committee and other 

available information, it is hereby found 

that this rule, as hereinafter set forth 

will tend to effectuate the declared 

policy of the Act. 

Pursuant to 5 U.S.C. 553, it is also 

found and determined that good cause 

exists for not postponing the effective 

date of this rule until 30 days after 

publication in the Federal Register 

because: (1) The 2008–2009 fiscal 

period began on July 1, 2008, and the 

marketing order requires that the rate of 

assessment for each fiscal period apply 

to all assessable potatoes handled 

during such fiscal period; (2) the 

northern Colorado potato shipping 

season began in July; (3) the Committee 

needs to have sufficient funds to pay for 

expenses which are incurred on a 

continuous basis; and (4) handlers are 

aware of this action which was 

recommended by the Committee at a 

public meeting and is similar to other 

assessment rate actions issued in past 

years. Also, a 15-day comment period 

was provided for in the proposed rule. 

List of Subjects in 7 CFR Part 948 

Marketing agreements, Potatoes, 

Reporting and recordkeeping 

requirements. 

■ For the reasons set forth in the 

preamble, 7 CFR part 948 is amended as 

follows: 

PART 948—IRISH POTATOES GROWN 

IN COLORADO 

■ 1. The authority citation for 7 CFR 

part 948 continues to read as follows: 

Authority: 7 U.S.C. 601–674. 

■ 2. In Part 948, the suspension of 

§ 948.215 is lifted. 

Dated: September 4, 2008. 

Lloyd C. Day, 

Administrator, Agricultural Marketing 

Service. 

[FR Doc. E8–20853 Filed 9–8–08; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

9 CFR Parts 71, 83, and 93 

[Docket No. APHIS–2007–0038] 

RIN 0579–AC74 

Viral Hemorrhagic Septicemia; 

Interstate Movement and Import 

Restrictions on Certain Live Fish 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Interim rule and request for 

comments. 

SUMMARY: We are establishing 

regulations to restrict the interstate 

movement and importation into the 

United States of live fish that are 

susceptible to viral hemorrhagic 

septicemia, a highly contagious disease 

of certain fresh and saltwater fish. In 

2005 and 2006, viral hemorrhagic 

septicemia was detected in freshwater 

fish in several of the Great Lakes and 

related tributaries. The disease has been 

responsible for several large-scale dieoffs of wild fish in the Great Lakes 

region. This action is necessary to 

prevent further introductions into, and 

dissemination within, the United States 

of viral hemorrhagic septicemia. 

DATES: Effective date: This interim rule 

is effective November 10, 2008. 

Comment dates: Comments on the 

interim rule are due on or before 

November 10, 2008. Comments on the 

environmental assessment are due on or 

before October 9, 2008. 

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=APHIS2007-0038 to submit or view comments 

and to view supporting and related 

materials available electronically. 

• Postal Mail/Commercial Delivery: 

Please send two copies of your comment 

to Docket No. APHIS–2007–0038, 

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. APHIS–

2007–0038. 

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. 

P. Gary Egrie, Senior Staff Veterinary 

Medical Officer, National Center for 

Animal Health Programs, VS, APHIS, 

4700 River Road Unit 46, Riverdale, MD 

20737–1231; (301) 734–0695; or Dr. 

Peter L. Merrill, Senior Staff 

Veterinarian, National Center for Import 

and Export, VS, APHIS, 4700 River 

Road Unit 39, Riverdale, MD 20737–

1231; (301) 734–8364. 

SUPPLEMENTARY INFORMATION: 


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Background 

Viral hemorrhagic septicemia (VHS) is 

a highly contagious disease of certain 

fresh and saltwater fish, caused by a 

rhabdovirus. It is listed as a notifiable 

disease by the World Organization for 

Animal Health (OIE). The pathogen 

produces variable clinical signs in fish 

including lethargy, skin darkening, 

exophthalmia, pale gills, a distended 

abdomen, and external and internal 

hemorrhaging. The development of the 

disease in infected fish can result in 

substantial mortality. Other infected fish 

may not show any clinical signs or die, 

but may be lifelong carriers and shed 

the virus. 

Four genotypes of VHS virus have 

been identified, and appear to be 

distributed geographically. Genotypes I, 

II, and III are mainly found in Europe or 

Asia and are highly pathogenic to 

rainbow trout. The fourth genotype, 

referred to as North American type IV, 

has been found in wild fish from the 

East and West coasts of North America 

periodically since 1988. This genotype 

is less virulent to commercially 

important fish stocks than the 

European/Asian VHS virus genotypes 

because it results in less morbidity and 

mortality than those genotypes. 

In 2005 and 2006, VHS outbreaks 

were reported in wild fish from the 

Great Lakes in both Canada and the 

United States. The mortality associated 

with numerous individual outbreaks 

ranged from just a few fish to many 

thousands per outbreak. 

The 2005 and 2006 VHS outbreaks 

were the first freshwater isolations of 

VHS virus in the United States. The 

strain of VHS virus isolated from all of 

these outbreaks, while similar to North 

American type IV found in saltwater, 

has been shown to be genetically 

distinct from other known strains of 

VHS virus, and is apparently capable of 

causing substantial morbidity and 

mortality in many native species of fish. 

It is currently believed that the 

saltwater-adapted type IV strain 

mutated into a strain that is affecting 

new host fish species in new 

environments in both Canada and the 

United States. The extent of VHS viral 

distribution is not yet known; however, 

reported epizootics attributable to VHS 

since 2005 have been limited to wild 

fish from the Great Lakes watershed. 

The emerging strain (tentatively 

called North American type IV(b) to 

differentiate it from what will likely be 

renamed type IV(a)) has caused a 

number of mass mortalities in wild fish 

populations, ranging up to many 

thousands of fish. Some outbreaks were 

reported to occur at temperatures that 

had not been previously associated with 

the development of VHS disease. Virus 

growth is generally inhibited when 

water temperatures are above 15 °C; 

however, this VHS virus appears to have 

a much wider temperature range. 

According to research conducted at the 

U.S. Geological Survey, type IV(b), in 

vitro, grows best at 15 °C and up to 20 

°C where growth begins to decline. Type 

IV(b) viral growth was inhibited at 25 

°C. Additionally, all the species of fish 

in the 2005 and 2006 North American 

outbreaks had not previously been 

known to be susceptible to VHS 

infection and/or disease. The list of fish 

species susceptible to VHS, as 

determined by the Animal and Plant 

Health Inspection Service (APHIS), 

currently includes 28 separate species. 

These species include baitfish, 

recreationally important fish, and food 

fish such as salmonids and catfish. 

Federal Order 

The Animal Health Protection Act 

(AHPA) authorizes the Secretary of 

Agriculture to prohibit or restrict the 

importation or movement in interstate 

commerce of any animal, article, or 

means of conveyance if the Secretary 

determines that the prohibition or 

restriction is necessary to prevent the 

introduction or dissemination of any 

pest or disease of livestock into or 

within the United States. 

In response to recent outbreaks of 

VHS in wild fish populations in the 

Great Lakes, the Administrator 

determined that it was necessary, in 

order to prevent the spread of VHS into 

aquaculture facilities, to prohibit or 

restrict the interstate movement and 

importation of VHS-regulated species of 

live fish. Accordingly, on October 24, 

2006, APHIS issued a Federal Order 

prohibiting the importation of VHSsusceptible species of live fish from two 

Canadian provinces (Ontario and 

Quebec) into the United States and the 

interstate movement of the same species 

of live fish from the eight States 

bordering the Great Lakes (Illinois, 

Indiana, Michigan, Minnesota, New 

York, Ohio, Pennsylvania, and 

Wisconsin). 

At the time the Federal Order was 

issued, only three States (Michigan, 

New York, and Ohio) had been affected 

by VHS within the jurisdictional 

borders of their States. Epidemiologic 

considerations such as the commonality 

of the Great Lakes watershed influenced 

APHIS’ decision to include all of the 

States within the Great Lakes watershed 

as ‘‘affected’’ or ‘‘at-risk.’’

In October 2006, APHIS held a 2-day 

meeting with Federal, State, Tribal, and 

industry representatives to discuss VHS 

and the Federal Order, and to obtain 

information regarding State regulations 

and diagnostic testing programs related 

to VHS. During this meeting, APHIS 

received several recommendations from 

participants regarding modifications to 

the Federal Order that could be made to 

alleviate impacts on industry and 

related businesses in the Great Lakes 

region while still protecting against the 

spread of VHS. 

APHIS also met with the Department 

of Fisheries and Oceans Canada (DFO) 

and the Canadian Food Inspection 

Agency (CFIA) in November 2006. At 

that time, Canada provided APHIS with 

information about its VHS testing 

program and requested that APHIS 

amend the Federal Order to allow the 

importation of fish that Canada certifies 

as VHS-free. 

Based on the information gathered at 

these meetings, on November 14, 2006, 

APHIS modified the Federal Order to 

allow VHS-susceptible species of live 

salmonid fish from the affected 

Canadian provinces to be imported into 

the United States if the shipment meets 

the regulations of the U.S. Fish and 

Wildlife Service (FWS) in 50 CFR 

16.13(a)(3) and 16.13(b). The FWS 

regulations in 50 CFR 16.13(a)(3) 

provide that live or dead uneviscerated 

salmonid fish are prohibited entry into 

the United States for any purpose except 

by direct shipment accompanied by a 

certification that: (1) The fish lots from 

which the shipments originated have 

been sampled; (2) viral assays have been 

conducted on the samples according to 

methods specified in the regulations; 

and (3) certain pathogens, including the 

virus causing VHS, have not been 

detected in the fish stocks from which 

the samples were taken. The FWS 

regulations further provide that live 

salmonid fish can be imported into the 

United States only with the written 

approval of the Director of FWS. The 

regulations in 50 CFR 16.13(b) set out 

the information that must be included 

in the certification statement required in 

§ 16.13(a)(3). 

The modified Federal Order also 

established conditions under which 

VHS-susceptible species of live fish 

could be moved from the eight States 

bordering the Great Lakes. Specifically, 

the Order provided that VHSsusceptible live fish may be moved 

interstate for slaughter if the fish are: (1) 

Intended for human consumption; (2) 

transported to a State-inspected 

slaughter facility that discharges waste 

water into a municipal sewage system 

that includes waste water disinfection, 

or disposes of waste water in a nondischarging settling pond or a settling 

pond that disinfects according to State 


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1We define anadromous fish as fish that are born 

and spawn in freshwater, but which spend part of 

their lifecycle in saltwater. 

and Federal requirements, and renders 

or composts offal, including carcasses; 

and (3) accompanied by a valid VS 

Form 1–27 issued by an APHIS area 

office if not tested for VHS. 

The Order also provided that VHSsusceptible fish may be moved interstate 

to research and diagnostic laboratories 

provided the fish are: (1) Accompanied 

by a valid VS Form 1–27 issued by an 

APHIS area office stating that the fish 

are destined for a research or diagnostic 

laboratory that has been approved by a 

State, Tribal, or Federal competent 

authority for aquatic animal health and 

(2) received at a laboratory where waste 

fluids and carcasses are considered 

medical waste and disposed of 

according to State and Federal 

requirements. Finally, the Order 

provided that VHS-susceptible fish may 

be moved interstate for purposes other 

than slaughter, research, or diagnostics 

provided the fish are transported with 

documentation from the appropriate 

State, Tribal, or Federal competent 

authority for aquatic animal health 

stating that the fish have tested negative 

for VHS virus under specific national 

and international standards. 

In January 2007, APHIS hosted public 

meetings in Lakewood, CO; Memphis, 

TN; Romulus, MI; and Coraopolis, PA. 

The purpose of the meetings was to 

present current information about the 

outbreaks of VHS and actions taken to 

prevent its spread, and to give interested 

stakeholders an opportunity to present 

data and views concerning the possible 

regulation of VHS by the Agency. 

On May 4, 2007, APHIS modified the 

Federal Order to allow for the catchand-release of VHS-susceptible 

regulated fish in waters that cross State 

and international boundaries. These 

activities include recreational fishing, 

tournaments, competitions, fishing 

derbies, or other types of contests where 

individuals catch, compare, and release 

live VHS-susceptible fish. However, 

catch-and-release fishing activities do 

not include the movement of VHSsusceptible fish intended to be used as 

live bait. Catch and release fishing 

activities are considered low risk for 

spreading VHS virus because fish are 

caught and released within the same 

body of water and within a limited 

geographic area over a limited time 

period. In contrast, the use of live bait 

is considered high risk for spreading 

VHS virus because the bait is used for 

fishing in multiple bodies of water over 

a broader geographic area. 

On November 8, 2007, APHIS 

modified the Federal Order by revising 

the list of VHS-susceptible species. We 

removed 12 species and added 2 new 

freshwater fish species that are 

susceptible to VHS. We also clarified 

the scientific names of several species. 

Currently, there are 28 separate species 

of fish listed. 

The original October 2006 Federal 

Order listed 37 species of VHSsusceptible fish, including all species 

listed by the OIE as susceptible to all 

known strains of VHS. The updated list 

includes only those species found in 

freshwater environments in the United 

States and Canada that have been 

infected by VHS under natural (i.e., 

nonexperimental) conditions of 

exposure and from which VHS virus has 

been isolated by cell culture, with 

confirmation of strain identity through 

molecular detection. Anadromous fish 

species 1 that have migrated into 

freshwater and from which VHS strain 

type IV(a) is isolated are excluded. 

Finally, on April 2, 2008, APHIS 

modified the Federal Order to allow 

VHS-susceptible species of live nonsalmonid fish from affected Canadian 

provinces to be imported into the 

United States for direct slaughter if 

accompanied by an APHIS permit. 

The Federal Order was issued in 

response to the rapid spread of VHS in 

the Great Lakes region and was designed 

to prevent the introduction of VHS into 

aquaculture facilities by controlling the 

movement of VHS-susceptible fish 

species while APHIS gathered more 

information about the disease and 

developed a regulatory program that 

would allow the interstate movement 

and importation of VHS-susceptible fish 

under certain conditions. Taking into 

consideration the information provided 

by States, Tribes, and other interested 

stakeholders, APHIS has now developed 

a regulatory framework for the interstate 

movement and importation of VHSsusceptible fish species. 

In the Federal Order, we used the 

terms ‘‘VHS-susceptible species’’ and 

‘‘VHS-affected or at-risk States or 

regions;’’ however, for the purposes of 

these regulations we will use the terms 

‘‘VHS-regulated species’’ and ‘‘VHSregulated areas or regions.’’

Accordingly, we are amending the 

interstate movement regulations in title 

9, subchapter C, by adding a new part 

83, ‘‘Viral Hemorrhagic Septicemia’’

(§§ 83.1 through 83.7). We are also 

amending 9 CFR part 71 to provide that 

fish affected with VHS may be moved 

interstate in accordance with part 83. 

Finally, we are amending the animal 

import regulations in 9 CFR part 93, 

subpart I, ‘‘Aquatic Animal Species’’

(§§ 93.900 through 93.916). The new 

interstate movement and importation 

requirements are discussed in detail 

below. 

As stated previously in this 

document, the AHPA authorizes the 

Secretary of Agriculture to prohibit or 

restrict the importation or movement in 

interstate commerce of any animal, 

article, or means of conveyance if the 

Secretary determines that the 

prohibition or restriction is necessary to 

prevent the introduction or 

dissemination of any pest or disease of 

livestock into or within the United 

States. Ballast water (i.e., water with its 

suspended matter taken on board a ship 

to control trim, list, draught, stability, or 

stresses of a ship) can be taken onto a 

ship in its port of origin and discharged 

into the water body of the ship’s 

destination port, making it a potential 

pathway for VHS virus. APHIS has 

neither the regulatory authority nor the 

technical expertise to safely regulate 

ballast water discharge. Therefore, we 

do not address ballast water in this 

interim rule. APHIS will assist the U.S. 

Coast Guard, which has clear regulatory 

authority for ballast water, in their 

development of ballast water discharge 

standards. 

Definitions (§§ 83.1 and 93.900) 

In §§ 83.1 and 93.900, we define the 

terms used in the regulations. In § 83.1, 

we set out the following standard terms 

and definitions, which are found 

throughout title 9, subchapter C: 

Accredited veterinarian, Administrator, 

Animal and Plant Health Inspection 

Service (APHIS), APHIS representative, 

Department, interstate, moved 

(movement), person, State, and State 

animal health official. These terms and 

their definitions are set out in the 

regulatory text at the end of this 

document. 

In both §§ 83.1 and 93.900, we define 

terms that are specific to VHS and 

aquatic animals. These terms are 

anadromous fish, catch-and-release 

fishing, cultured fish, secure water 

source, VHS virus, and viral 

hemorrhagic septicemia (VHS). These 

terms are defined as follows: 

Anadromous fish. Fish that are born 

and spawn in freshwater, but which 

spend part of their lifecycle in saltwater. 

Catch-and-release fishing. Fishing for 

pleasure or for recreational purposes, 

including tournaments, organized 

fishing competitions, fishing derbies, or 

other types of contests where 

individuals catch, compare, and release 

live VHS-regulated fish. This term 

excludes VHS-regulated fish used, or 

intended to be used, as live bait. 

Cultured fish. Fish of the same species 

and age class, originating from the same 


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broodstock and on the same water 

supply, whose care is partly or totally 

managed from the first life stage 

onwards. 

Secure water source. A biosecure 

water supply that does not contain 

pathogens or has not had the 

opportunity to be contaminated with 

pathogens. Biosecure water supplies 

include well, spring, or borehole water; 

surface water that does not contain fish 

populations; or water that has been 

treated to eliminate aquatic animal 

pathogens. 

VHS virus. Any North American (type 

IV) strain of VHS virus, a rhabdovirus of 

fish. 

Viral hemorrhagic septicemia (VHS). 

A disease caused by infection with VHS 

virus. 

Due to slight differences in 

terminology and program requirements, 

some VHS-specific terms are defined 

differently in §§ 83.1 and 93.900. These 

terms are approved laboratory, 

competent authority, VHS-regulated 

area, VHS-regulated region, and VHSregulated fish. 

In § 83.1, approved laboratory is 

defined as a laboratory authorized by a 

State, Tribal, or Federal competent 

authority for aquatic animal health to 

perform assays for the detection of VHS 

virus while, in § 93.900, approved 

laboratory is defined as a laboratory 

authorized by the competent authority 

of a country for aquatic animal health to 

perform assays for the detection of VHS 

virus. 

In § 83.1, we define competent 

authority as the State, Tribal, or Federal 

entity with the legal responsibility for 

ensuring or supervising the 

implementation of aquatic animal 

health measures. This definition is 

similar to the current definition for 

competent authority in § 93.900, which 

refers to the national veterinary services 

or other authority of a country 

responsible for aquatic animal health. 

In § 83.1, VHS-regulated area is 

defined as any State or portion of a State 

listed in accordance with § 83.4. Section 

93.900 defines VHS-regulated region as 

any region listed in accordance with 

§ 93.910. 

In § 83.1, we define VHS-regulated 

fish as any fish species listed in 

accordance with § 83.4 while, in 

§ 93.900, we define VHS-regulated fish 

as any fish species listed in accordance 

with § 93.910. 

Finally, in § 83.1, we define the term 

Interstate Certificate of Inspection (ICI). 

This term is specific to the interstate 

movement requirements in part 83 and 

is defined as an official document 

issued by an accredited veterinarian or 

a State, Tribal, or Federal competent 

authority in the originating State that 

certifies that the fish being moved 

interstate originated from a facility that 

has been found free of VHS virus. 

Interstate Movement 

General Restrictions; Conditions of 

Movement (§§ 83.2 and 83.3) 

Section 83.2 provides that live VHSregulated fish may not be moved 

interstate from a VHS-regulated area 

except in compliance with part 83. 

Section 83.3 sets forth the conditions 

under which live VHS-regulated fish 

may be moved interstate. 

Paragraph (a) of § 83.3 provides that, 

apart from the exceptions provided in 

paragraphs (b) through (e) of that 

section, live VHS-regulated fish, 

including fish moved to live fish 

markets, may only be moved interstate 

from a VHS-regulated area if the fish 

originated from a facility that has been 

found free of the VHS virus in 

accordance with § 83.6 and the fish are 

accompanied by an Interstate Certificate 

of Inspection (ICI) issued by an 

accredited veterinarian or a State, 

Tribal, or Federal competent authority 

for aquatic animal health. 

Paragraph (b) of § 83.3 provides that 

live VHS-regulated fish may be moved 

interstate directly to a slaughtering 

establishment provided the fish are 

transported in a sealed conveyance and 

accompanied by a VS Form 1–27. The 

VS Form 1–27 is available through 

APHIS’ Veterinary Services offices, and 

can be issued by a State, Tribal, Federal, 

or accredited veterinarian. The fish 

must be moved to a slaughtering 

establishment that discharges its waste 

water to a municipal sewage system that 

includes waste water disinfection 

sufficient to neutralize any VHS virus, 

or to either a non-discharging settling 

pond or a settling pond that disinfects, 

according to all applicable local, State, 

and Federal regulations, sufficiently to 

neutralize any VHS virus. In addition, 

any water used to transport the fish 

must be disposed of to a municipal 

sewage system that includes waste 

water disinfection sufficient to 

neutralize any VHS virus, or to either a 

non-discharging settling pond or a 

settling pond that disinfects, according 

to all applicable local, State, and 

Federal regulations, sufficiently to 

neutralize any VHS virus. These 

requirements are necessary to ensure 

that water waste discharged to the 

environment (or to a public waterway) 

does not contain any viable VHS virus. 

Offal, including carcasses, from the 

slaughtering establishment must be 

either rendered or composted. 

Paragraph (c) of this section extends 

these same provisions to fish moved for 

research or diagnostic purposes. 

Paragraph (d) specifies that live VHSregulated fish may be moved interstate 

during catch-and-release fishing. 

Finally, paragraph (e) provides that 

the Administrator may, on a case-bycase basis, permit the interstate 

movement of fish whose movement is 

not otherwise provided for in part 83, 

under such conditions as the 

Administrator may prescribe in each 

case to prevent the introduction and 

dissemination of VHS. 

VHS-Regulated Fish and VHS-Regulated 

Areas (§ 83.4) 

Paragraph (a) of § 83.4 provides that 

APHIS will list as a VHS-regulated fish 

any fish species found in freshwater to 

be susceptible to the North American 

(type IV) strain of VHS virus under 

natural (i.e., non-controlled) conditions 

of exposure and from which VHS virus 

has been isolated in cell culture or other 

assay determined by the Administrator 

to be adequate to detect VHS virus, with 

confirmation of strain identity through 

genetic sequencing. Anadromous fish 

that have migrated into freshwater and 

from which VHS strain type IV(a) has 

been isolated will not be considered 

VHS-regulated fish under this rule 

because this strain appears to be less 

pathogenic than type IV(b). Type IV(a) 

has been in the United States since at 

least 1988 and has not resulted in largescale fish mortalities across a broad 

range of species such as those that were 

associated with the outbreaks of type 

IV(b) in the Great Lakes. 

Paragraph (a) further provides that, 

when APHIS determines that a species 

meets the criteria of this paragraph and 

should be added to the list of VHSregulated fish, APHIS will publish a 

notice in the Federal Register 

announcing that determination. 

Paragraph (b) of this section provides 

that APHIS will list as a VHS-regulated 

area each State or portion of a State from 

which VHS virus has been detected in 

any VHS-regulated fish species (with or 

without clinical signs of disease) in a 

water source that is not a secure water 

source, or which the Administrator 

determines to be at risk of having VHS 

based on criteria such as inadequate 

surveillance or movement requirements, 

or other epidemiologic information. 

Paragraph (b) further provides that, if 

the Administrator determines that a 

State or portion of a State meets the 

criteria for a VHS-regulated area, APHIS 

will publish a notice of its decision in 

the Federal Register and take comments 

from the public. The designation as a 

VHS-regulated area will become 


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Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Rules and Regulations 52177 

effective upon publication of this notice. 

After reviewing the comments, APHIS 

will issue a second notice in the Federal 

Register announcing its decision on 

whether or not the designation as a 

VHS-regulated area will remain in 

effect. 

Paragraph (c) provides that these lists 

of VHS-regulated fish and VHSregulated areas will be maintained on 

the APHIS aquaculture Web site at 

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

animal_health/animal_dis_spec/ 

aquaculture. The purpose of 

maintaining the lists on the Web site is 

to maintain the most accurate, up-todate list possible in a location where 

affected parties can easily view recent 

changes. The Web site list should be 

particularly useful when a new area is 

added to the list, which occurs 

immediately after APHIS receives and 

confirms reports of a new outbreak. 

Changes to lists maintained in the 

regulations typically take several weeks, 

so maintaining the lists on the Web site 

will allow APHIS to communicate new 

developments and take prompt action as 

soon as it confirms an outbreak or 

identifies a new species of fish affected 

by VHS. 

Paragraph (c) also includes an address 

from which the lists of VHS-regulated 

fish and VHS-regulated areas may be 

obtained from APHIS. 

As of this rule’s effective date, the 

following fish species and areas are 

regulated because of VHS: 

VHS-Regulated Areas 

Illinois, Indiana, Michigan, 

Minnesota, New York, Ohio, 

Pennsylvania, Wisconsin. 

VHS-REGULATED FISH SPECIES

Black crappie ...... Pomoxis nigromaculatus. 

Bluegill ................ Lepomis macrochirus. 

Bluntnose minnow.Pimephales notatus. 

Brown bullhead .. Ameiurus nebulosus. 

Brown trout ......... Salmo trutta. 

Burbot ................. Lota lota. 

Channel catfish .. Ictalurus punctatus. 

Chinook salmon Oncorhynchus 

tshawytscha. 

Emerald shiner ... Notropis atherinoides. 

Freshwater drum Aplodinotus grunniens. 

Gizzard shad ...... Dorosoma cepedianum. 

Lake whitefish .... Coregonus clupeaformis. 

Largemouth bass Micropterus salmoides. 

Muskellunge ....... Esox masquinongy. 

Northern pike ...... Esox lucius. 

Pumpkinseed ...... Lepomis gibbosus. 

Rainbow trout ..... Oncorhynchus mykiss. 

Rock bass .......... Ambloplites rupestris. 

Round goby ........ Neogobius 

melanostomus. 

Shorthead 

redhorse.

Moxostoma 

macrolepidotum. 

Silver redhorse ... Moxostoma anisurum. 

VHS-REGULATED FISH SPECIES— 

Continued 

Smallmouth bass Micropterus dolomieu. 

Spottail shiner .... Notropis hudsonius. 

Trout-Perch ........ Percopsis omiscomaycus. 

Walleye ............... Sander vitreus. 

White bass ......... Morone chrysops. 

White perch ........ Morone americana. 

Yellow perch ....... Perca flavescens. 

This interim rule does not provide a 

process by which APHIS will remove 

areas from the list of VHS-regulated 

areas if the area petitions APHIS for a 

reassessment of its disease status. As 

discussed in more detail below under 

the heading ‘‘Related Issues on Which 

APHIS is Seeking Comment,’’ we 

particularly invite comments on which 

specific factors APHIS should consider 

before removing an area from the list of 

VHS-regulated areas. 

Interstate Certificate of Inspection (ICI) 

(§ 83.5) 

Paragraph (a) of § 83.5 requires that 

live VHS-regulated fish moved interstate 

in accordance with § 83.3(a) be 

accompanied by an ICI issued by an 

accredited veterinarian or a State, 

Tribal, or Federal competent authority 

for aquatic animal health. This 

paragraph further provides that an ICI 

will be valid for 30 days from the date 

of issuance. 

Paragraph (b) of this section requires 

that the ICI state that: (1) The live fish 

were inspected by the accredited 

veterinarian or a State, Tribal, or Federal 

competent authority for aquatic animal 

health within 72 hours prior to 

shipment and found to be free of any 

clinical signs of disease consistent with 

VHS, and (2) the live fish covered by the 

ICI originated in an area or facility that 

has demonstrated freedom from VHS in 

accordance with § 83.6. 

In addition, the section specifies that 

the ICI must contain the following 

information: 

• The name, address, and phone 

number of the owner or owner’s agent. 

• The name, address, and phone 

number of the facility in which the fish 

originated. 

• The name, address, and phone 

number of the person or facility who 

will receive the fish; or the State or 

other regulatory authority responsible 

for oversight of the environment in 

which the fish will be introduced. 

• The name, address, and phone 

number of the shipping or 

transportation company. 

• The species and number of the fish. 

• The lot (or other) identification of 

the shipment. 

• The name, address, and phone 

number of the approved laboratory that 

performed the testing required by § 83.6 

and the number of fish tested, the 

assay(s) used for testing, and the test 

results. 

• The date the certificate was issued. 

• The type of water source according 

to § 83.6(c). 

Requiring the issuance of an ICI will 

ensure that appropriate testing 

procedures were applied as well as 

allow for traceback should an inspector 

encounter a problem with or have 

questions about a shipment. 

Testing Requirements (§ 83.6) 

Paragraph (a) of § 83.6 provides that a 

facility can demonstrate freedom from 

VHS through negative testing results 

provided by an approved laboratory. 

Paragraph (a) also specifies that such 

testing must: 

• Be conducted with a testing sample 

size that provides for a 95 percent 

confidence level of detecting a 2 percent 

prevalence of infection in the facility. 

• Include virus isolation or other 

assay authorized by the Administrator, 

using appropriate cell lines to detect 

VHS virus, if present. All suspect VHS 

cytopathic effects must be positively 

identified as VHS through molecular 

assays and/or genetic sequencing. 

• Use proportional numbers of each 

VHS-regulated fish species which might 

be present in the facility. 

• Be conducted at water temperatures 

between 50 and 72 °F, or at other times 

or under environmental conditions 

when VHS is most likely to be detected, 

if present. 

Facilities with a history of negative 

testing results for VHS are assumed to 

have a lower risk of spreading VHS; 

therefore, we will decrease the number 

of fish required to be tested for such 

facilities. Specifically, paragraph (a)(1) 

of § 83.6 also provides that facilities 

with cultured fish of VHS-regulated 

species which can document a 2-year 

history of negative testing for VHS virus 

can conduct testing at a sampling level 

to provide for a 95 percent confidence 

level of detecting a 5 percent prevalence 

of infection in the facility. Facilities 

with cultured fish of VHS-regulated 

species which can document a 4-year 

history of negative testing for VHS virus 

can conduct testing at a sampling level 

to provide a 95 percent confidence level 

of detecting a 10 percent prevalence of 

infection in the fish facility. Such 

facilities must be on a secure water 

source, and testing must be conducted 

twice a year, with at least 3 months 

between tests. These facilities must also 

document that any VHS-regulated 

species in the facility that originated in 

VHS-regulated States or Canadian 


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provinces originate from facilities of the 

same or higher health status. 

Because this is an emerging disease, 

APHIS may update the list of VHSregulated fish species as our knowledge 

of species susceptibility increases. 

Paragraph (b) explains how facilities can 

maintain VHS-free status when new 

species are added to the list of VHSregulated fish species. Specifically, 

paragraph (b) provides that, when a new 

species is added to the list of VHSregulated fish, a facility that has been 

determined to be free of VHS must 

conduct additional testing on the newly 

listed species, if present in the facility, 

and the fish must be free of VHS virus 

in order for the facility to retain its free 

status. Paragraph (b) further provides 

that VHS testing must be conducted on 

each newly listed species with a sample 

size that provides for a 95 percent 

confidence level of detecting a 2 percent 

prevalence of infection in the fish 

facility in order to return the facility to 

the same health status that existed prior 

to the new listing of the VHS-regulated 

species. 

Paragraph (c) of this section specifies 

that the test results for fish maintained 

on a secure water source will be valid 

for 6 months from the date of sample 

collection provided no fish of a lesser or 

unknown health status are introduced 

into the facility. Test results for fish 

held on a water source that is not a 

secure water source will be valid for 30 

days from the date of sample collection. 

This will help to ensure that fish 

qualified to move interstate by virtue of 

a health certification program retain that 

qualification for a reasonable length of 

time while not compromising the health 

status of those fish through the 

introduction of additional fish of 

unknown or lesser VHS status, or 

introduction of VHS virus through the 

water source. 

Shipping Containers; Cleaning and 

Disinfection (§ 83.7) 

Paragraph (a) of § 83.7 requires that all 

live VHS-regulated fish that are to be 

moved interstate in accordance with 

§ 83.3(a) must be moved in new 

containers or containers that have been 

cleaned and disinfected to neutralize 

any VHS virus to which the shipping 

containers may have been exposed. 

Cleaning and disinfection must be 

monitored by the accredited 

veterinarian or State, Tribal, or Federal 

competent authority for aquatic animal 

health who issues the ICI. The cleaning 

and disinfection protocols used must be 

referenced in the ICI or in a separate 

cleaning and disinfection certificate 

accompanying the shipment. 

Import Restrictions 

General Restrictions; Exceptions 

(§ 93.910) 

As previously discussed, the Federal 

Order, as amended, allows VHSsusceptible species of live salmonid fish 

from the affected Canadian provinces to 

be imported into the United States if the 

shipment meets the FWS regulations in 

50 CFR 16.13(a)(3) and 16.13(b). This 

interim rule will continue to allow live 

salmonid VHS-regulated fish to be 

imported into the United States from 

VHS-regulated regions in accordance 

with the FWS regulations. In addition, 

this rule establishes conditions under 

which live non-salmonid VHS-regulated 

fish species may be imported into the 

United States from VHS-regulated 

regions. 

Specifically, paragraph (a) of § 93.910 

provides that no live VHS-regulated 

species of fish may be imported into the 

United States from VHS-regulated 

regions except in accordance with 

subpart I or the regulations of the FWS 

in 50 CFR 16.13(a)(3) and 16.13(b). This 

paragraph further provides that no such 

live VHS-regulated fish may be moved 

from the port of entry after arrival until 

released by an APHIS representative or 

FWS official. In addition, this paragraph 

specifies that the Administrator may, 

upon request in specific cases, allow the 

importation of live VHS-regulated fish 

into the United States under conditions 

other than those specifically set forth in 

the subpart when the Administrator 

determines that such movement will not 

result in the further introduction of VHS 

into the United States. 

Paragraph (b) of § 93.910 provides that 

APHIS will list as a VHS-regulated fish 

any fish species found in freshwater to 

be susceptible to the North American 

(type IV) strain of VHS virus under 

natural (i.e., non-controlled) conditions 

of exposure and from which VHS virus 

has been isolated in cell culture or other 

assay determined by the competent 

authority to be adequate to detect VHS 

virus, with confirmation of strain 

identity through genetic sequencing. As 

stated previously, anadromous fish that 

have migrated into freshwater and from 

which VHS strain type IV(a) has been 

isolated are not considered VHSregulated fish under this rule. Paragraph 

(b) further provides that, when APHIS 

determines that a species meets the 

criteria of this paragraph and should be 

added to the list of VHS-regulated fish, 

APHIS will publish a notice in the 

Federal Register announcing that 

determination. 

Paragraph (c) of this section provides 

that APHIS will list as a VHS-regulated 

region any region in which VHS virus 

has been officially reported to the OIE 

by the country’s competent authority for 

aquatic animal health from any fish 

species in a water source that is not a 

secure water source, or which the 

Administrator determines to be at risk of 

having VHS based on criteria such as 

inadequate surveillance, less restrictive 

import requirements, or other 

epidemiologic information. 

Paragraph (c) further provides that, if 

the Administrator determines that a 

region meets the criteria for a VHSregulated region, APHIS will publish a 

notice of its decision in the Federal 

Register and take comments from the 

public. The designation as a VHSregulated region will become effective 

upon publication of this notice. After 

reviewing the comments, APHIS will 

issue a second notice in the Federal 

Register announcing its decision on 

whether or not the designation as a 

VHS-regulated region will remain in 

effect. 

Paragraph (d) provides that these lists 

will be maintained on the APHIS 

aquaculture Web site at http:// 

www.aphis.usda.gov/animal_health/

animal_dis_spec/aquaculture. This 

paragraph further provides an address 

from which the lists of VHS-regulated 

fish and VHS-regulated regions may be 

obtained from APHIS. 

As of this rule’s effective date, only 

two Canadian Provinces (Ontario and 

Quebec) are listed as VHS-regulated 

regions. The current list of VHSregulated fish species is set out above 

under the heading ‘‘VHS-regulated fish 

and VHS-regulated areas (§ 83.4).’’

This interim rule does not provide a 

process by which APHIS will remove 

regions from the list of VHS-regulated 

regions if the area petitions APHIS for 

a reassessment of its disease status. As 

discussed in more detail below under 

the heading ‘‘Related Issues on Which 

APHIS Is Seeking Comment,’’ we 

particularly invite comments on which 

specific factors APHIS should consider 

before removing an area from the list of 

VHS-regulated regions. 

Paragraph (e) of § 93.910 provides that 

other provisions of part 93 relating to 

the importation of live VHS-regulated 

fish shall not apply to shipments of 

such fish imported from VHS-regulated 

regions if they are imported in 

accordance with the FWS regulations in 

50 CFR 16.13. As previously discussed, 

the FWS regulations pertain to live 

salmonid fish species to be imported 

into the United States. This paragraph 

makes it clear that live salmonid VHSregulated fish to be imported into the 

United States from VHS-regulated 

regions will be exempt from the other 

provisions in part 93 provided that the 


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fish are imported in accordance with the 

FWS regulations. 

Paragraph (f) of this section provides 

that other provisions of part 93 relating 

to the importation of live VHS-regulated 

fish shall not apply to shipments of 

such fish in transit through the United 

States, if an import permit has been 

obtained under § 93.912 and all 

conditions of the permit are observed, 

and if the live VHS-regulated fish 

species are handled as follows: 

• They are maintained under 

continuous confinement while in transit 

through the United States aboard an 

aircraft, ocean vessel, or other means of 

conveyance; or if they are unloaded in 

the course of such transit, they are 

placed in a holding facility that is 

provided by the carrier or its agent and 

has been approved by the Administrator 

as adequate to prevent the spread within 

the United States of any finfish 

pathogen; they are maintained there 

under continuous confinement until 

loaded aboard a means of conveyance 

for transportation from the United 

States; and they are maintained under 

continuous confinement aboard such 

means of conveyance until it leaves the 

United States. 

• They are moved in accordance with 

any additional conditions prescribed in 

the permit that the Administrator has 

determined to be necessary to ensure 

that the fish do not introduce VHS into 

the United States. 

For a holding facility to be approved 

by the Administrator, the following 

conditions must be met: 

• The holding facility must be 

sufficiently isolated to prevent direct or 

indirect contact of the live fish it 

contains with any other live VHSregulated fish species in the United 

States. 

• The holding facility must be 

constructed to provide adequate 

protection against environmental 

conditions and so that it can be 

adequately cleaned, washed, and 

disinfected. 

• Provision must be made for 

disposal of fish carcasses, shipping 

water, effluent, waste, and any 

associated shipping materials in a 

manner that will prevent dissemination 

of disease. 

• Provision must be made for 

adequate sources of feed and water and 

for attendants for the care and feeding 

of fish in the facility. 

• The holding facility must comply 

with all applicable local, State, and 

Federal requirements for environmental 

quality. 

• The holding facility must comply 

with any additional requirements that 

the Administrator may impose on a 

particular shipment in order to prevent 

the dissemination of VHS virus. 

Paragraph (g) provides that the 

provisions of the subpart relating to the 

importation of live VHS-regulated fish 

shall not apply to fish moved into the 

United States from VHS-regulated 

regions during catch-and-release fishing. 

Ports Designated for the Importation of 

Live VHS-Regulated Fish Species 

(§ 93.911) 

Section 93.911 designates ports 

through which live VHS-regulated fish 

from VHS-regulated regions may be 

imported into the United States without 

an import permit. To relieve some of the 

paperwork burden associated with 

import permits, we will allow VHSregulated fish species that have been 

tested in accordance with § 93.913(b) 

and found to be free of VHS virus to be 

imported through certain Canadian 

border ports without an import permit. 

We consider those ports to have 

adequate facilities and inspectors to 

perform the necessary inspections of 

shipments of live fish without advance 

notification of the arrival of a shipment 

that is associated with the application 

for and issuance of an import permit. As 

described later in this document in the 

section titled ‘‘Declaration and other 

documents (§ 93.914),’’ all importers 

must submit a declaration to Customs. 

The information included in the 

declaration will parallel the information 

required in an import permit, except 

that importers must indicate the route of 

travel in an import permit. APHIS asks 

for notice of a shipment’s route of travel 

in order to prevent transits of animals 

through countries subject to import 

restrictions because of certain animal 

disease risks. We typically do not 

require this information for shipments 

coming through land border ports 

because it is unlikely that a shipment 

entering the United States at a land 

border port would have traveled 

through any other countries. 

Paragraph (a) provides that VHSregulated fish species may be imported 

into the following Canadian border 

ports without an import permit: 

Eastport, ID; Houlton and Jackman, ME; 

Detroit, Port Huron, and Sault Ste. 

Marie, MI; Baudette, MN; Opheim, 

Raymond, and Sweetgrass, MT; 

Alexandria Bay, Buffalo, and 

Champlain, NY; Dunseith, Pembina, and 

Portal, ND; Derby Line and Highgate 

Springs, VT; and Oroville and Sumas, 

WA. 

Paragraph (b) provides that live VHSregulated fish may be imported into the 

United States with an import permit 

through the following ports: Anchorage, 

AK; Los Angeles and San Francisco, CA; 

Miami and Tampa, FL; Atlanta, GA; 

Honolulu, HI; Chicago, IL; Boston, MA; 

Newark, NJ; Jamaica and Newburgh, 

NY; Portland, OR; Memphis, TN, DallasFt. Worth, TX; Seattle, WA; and San 

Juan, PR. 

Paragraph (c) of this section also 

provides for other ports to be designated 

by the Administrator in specific cases 

with the concurrence of the Secretary of 

the Department of Homeland Security. 

Import Permits (§ 93.912) 

Paragraph (a) of § 93.912 requires that 

live VHS-regulated fish imported from 

VHS-regulated regions through a limited 

port listed in § 93.911(b) be 

accompanied by an import permit 

issued by APHIS and must be imported 

within 30 days of the proposed arrival 

date stated in the import permit. 

Paragraph (b) provides the address 

and APHIS Web site from which 

prospective importers may request 

import permit applications and to 

which completed applications should 

be sent. An application for an import 

permit must be submitted for each 

shipment of live VHS-regulated fish. 

Paragraph (c) of this section specifies 

the information that must be included 

on an import permit application. It 

states that the application must include 

the name and address of the exporter; 

the proposed date of shipment to the 

United States; the name and address of 

the importer; the species and number of 

live VHS-regulated fish to be imported 

into the United States; the purpose of 

the importation; the port of 

embarkation; the mode of 

transportation; the route of travel, 

including all carrier stops en route; the 

port of entry in the United States; the 

proposed date of arrival in the United 

States; and the name and address of the 

person to whom the live VHS-regulated 

fish will be delivered in the United 

States. 

APHIS needs this information to 

determine whether the live fish are 

eligible for importation, to respond to an 

applicant, to identify the shipment at 

the port of entry, to ensure that 

inspectors and facilities are available for 

inspection in the United States, and to 

contact appropriate persons if any 

questions arise concerning the 

importation. 

Finally, paragraph (d) explains what 

happens after we receive and review the 

permit application. This paragraph 

provides that, if following our review, 

we determine that the live VHSregulated fish are eligible for 

importation, we will issue an import 

permit. This paragraph also specifies 

that an import permit does not 

guarantee that any live fish will be 


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allowed entry into the United States; the 

VHS-regulated fish will be allowed to 

enter the United States only if they meet 

all applicable requirements of the 

regulations. 

Health Certificate (§ 93.913) 

Paragraph (a) of § 93.913 requires that 

all live VHS-regulated fish that are 

imported from VHS-regulated regions 

for other than immediate slaughter or 

research or laboratory use be 

accompanied by a health certificate. The 

health certificate must be in English or 

contain an English translation and must 

be issued by a full-time salaried 

veterinarian of the national government 

of the exporting country, or issued by a 

certifying official and endorsed by the 

competent authority of that country. 

The health certificate will be valid for 

30 days from the date of issuance. 

In addition, the health certificate must 

state that the shipment was inspected by 

the veterinarian or certifying official 

who issued the certificate within 72 

hours prior to shipment, and found to 

be free of any clinical signs of disease 

consistent with VHS; and the live fish 

covered by the health certificate 

originated in a region or facility that has 

demonstrated freedom from VHS 

through testing in accordance with 

paragraphs (b) and (c) of § 93.913. 

Paragraph (b) provides that a facility 

can demonstrate freedom from VHS 

through negative testing results by a 

pathogen detection laboratory approved 

for VHS viral assays by the competent 

authority. All viral testing must meet 

the following conditions: 

• Be conducted with a testing sample 

size that provides for a 95 percent 

confidence level of detecting a 2 percent 

prevalence of infection in the facility. 

• Include virus isolation or other 

assays authorized by the competent 

authority, using appropriate cell lines to 

detect VHS virus, if present. All suspect 

VHS cytopathic effects must be 

positively identified as VHS through 

molecular assays and/or genetic 

sequencing. 

• Test proportional numbers of each 

VHS-regulated fish species which might 

be present in a shipment, if applicable. 

• Be conducted at water temperatures 

between 50 and 72 °F, or at other times 

or under environmental conditions 

when VHS virus is most likely to be 

detected, if present. 

As stated previously in this 

document, facilities with a history of 

negative testing results for VHS are 

assumed to have a lower risk of 

spreading VHS; therefore, we will 

decrease the number of fish that are 

required to be tested for such facilities. 

Specifically, paragraph (b) of this 

section also allows facilities with 

cultured fish of VHS-regulated species 

which can document a 2-year negative 

testing history for VHS virus to conduct 

testing at a sampling level to provide a 

95 percent confidence level of detecting 

a 5 percent prevalence of infection in 

the facility and facilities with cultured 

fish of VHS-regulated species which can 

document a 4-year negative testing 

history for VHS virus to conduct testing 

at a sampling level to provide a 95 

percent confidence level of detecting a 

10 percent prevalence of infection in the 

fish facility. Such facilities must be on 

a secure water source, and testing must 

be conducted twice a year, with at least 

3 months between tests. The facilities 

must also document that any VHSregulated species in the facility that 

originated in VHS-regulated States or 

Canadian provinces originate from 

facilities of the same or higher health 

status. 

Paragraph (c) explains how facilities 

can maintain VHS-free status when new 

species are added to the list of VHSregulated fish species. Specifically, 

paragraph (c) provides that when a new 

species is added to the list of VHSregulated fish, a facility that has been 

determined to be free of VHS must 

conduct additional testing on fish of the 

newly listed species, if present in the 

facility, and the fish must be free of VHS 

virus in order for the facility to retain its 

free status. Paragraph (c) further 

provides that VHS testing must be 

conducted on each newly listed species 

with a sample size that provides for a 

95 percent confidence level of detecting 

a 2 percent prevalence of infection in 

the fish facility. 

Paragraph (d) of this section requires 

that, except as provided in § 93.910(e) 

through (g), all live fish be shipped in 

new containers or containers that have 

been cleaned and disinfected to 

neutralize any VHS virus to which the 

shipping containers may have been 

exposed. Cleaning and disinfection of 

shipping containers must take place 

under the supervision of the 

veterinarian or certifying official who 

issues the health certificate, and be 

sufficient to neutralize any VHS virus to 

which shipping containers may have 

been exposed. Cleaning and disinfection 

protocols must be referenced in the 

health certificate or in a separate 

cleaning and disinfection certificate 

accompanying the shipment to the U.S. 

port of entry. 

Declaration and Other Documents 

(§ 93.914) 

Section § 93.914 requires the importer 

or his or her agent to submit the 

following documents to the appropriate 

Customs and Border Protection officer 

for use by the port veterinarians: 

• All permits, certificates, or other 

documentation required under 

§§§ 93.912 and 93.913; and 

• Two copies of a declaration that 

lists the port of entry; the name and 

address of the importer; the name and 

address of the broker; the origin of the 

live fish; the number, species, and the 

purpose of the importation; the name of 

the person to whom the fish will be 

delivered; and the location of the place 

to which such delivery will be made. 

This information will allow for the 

traceback of shipments should any 

problems occur subsequent to entry into 

the United States. 

Inspection at the Port of Entry (§ 93.915) 

Section 93.915 sets forth requirements 

for port of entry inspections of 

shipments of live fish. Paragraph (a) 

provides that the shipments of live 

VHS-regulated fish must be presented 

for inspection at a port of entry 

designated under § 93.911. This 

paragraph also provides that the port 

veterinarian must be notified at least 72 

hours in advance of the arrival of the 

shipment in the United States for live 

fish of VHS-regulated species being 

imported through a limited port listed 

in § 93.911(c). It also provides that any 

shipment that does not meet the 

requirements of this subpart will be 

refused entry (e.g., lacking appropriate 

permits, declarations, and/or health 

certificates or exhibiting clinical signs 

consistent with VHS). 

Paragraph (b) states that shipments 

refused entry must be exported within 

a time fixed in each case by the 

Administrator, and in accordance with 

other provisions he or she may require 

in each case for their handling, or the 

shipment will be disposed of as the 

Administrator may direct. 

Special Provisions (§ 93.916) 

Section 93.916 sets forth requirements 

for importation for slaughter or for 

research or laboratory purposes. 

Paragraph (a) provides that live VHSregulated fish from VHS-regulated 

regions may be imported directly for 

slaughter under the following 

conditions: 

• An import permit has been obtained 

under § 93.912 and all conditions of the 

permit are observed. 

• An APHIS representative at the port 

seals the means of conveyance with 

official seals. 

• The shipment is moved directly 

from the port of entry to a slaughtering 

establishment that discharges its waste 

water to a municipal sewage system that 

includes waste water disinfection 


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sufficient to neutralize any VHS virus or 

to either a non-discharging settling pond 

or a settling pond that disinfects, 

according to all applicable local, State, 

and Federal regulations, sufficiently to 

neutralize any VHS virus. Offal, 

including carcasses, from the 

slaughtering establishment is either 

rendered or composted. 

• An APHIS representative unseals 

the vehicle upon arrival at the 

slaughtering establishment. 

• Any water used to transport the fish 

is disposed to a municipal sewage 

system that includes waste water 

disinfection sufficient to neutralize any 

VHS virus or to either a non-discharging 

settling pond or a settling pond that 

disinfects, according to all applicable 

local, State, and Federal regulations, 

sufficiently to neutralize any VHS virus. 

Paragraph (b) of this section provides 

that live non-salmonid VHS-regulated 

fish may be imported from a VHSregulated region for research or 

laboratory use under the following 

conditions: 

• An import permit has been obtained 

under § 93.912 and all conditions of the 

permit are observed. 

• The laboratory or research facility 

disposes of effluent to a municipal 

sewage system that includes waste 

water disinfection sufficient to 

neutralize any VHS virus or to either a 

non-discharging settling pond or a 

settling pond that disinfects, according 

to all applicable local, State, and 

Federal regulations, sufficiently to 

neutralize any VHS virus. 

• Carcasses must be rendered or 

composted. 

• Any water used to transport the fish 

is disposed to a municipal sewage 

system that includes waste water 

disinfection sufficient to neutralize any 

VHS virus or to either a non-discharging 

settling pond or a settling pond that 

disinfects, according to all applicable 

local, State, and Federal regulations, 

sufficiently to neutralize any VHS virus. 

These measures will ensure that VHS 

virus that may be present in such fish 

is effectively neutralized or that the fish 

are rendered incapable of infecting fish 

in other waters of the United States. 

Related Issues on Which APHIS Is 

Seeking Comment 

There are two additional issues 

related to VHS for which we are seeking 

public comment. This interim rule does 

not make any of the possible changes 

discussed below, because there are no 

immediate risks associated with them 

that would justify immediate action. 

However, we believe the following 

changes would improve the 

effectiveness of our programs to prevent 

the introduction of VHS and other fish 

pathogens and may include such 

changes in a subsequent rulemaking. 

As discussed above, the new lists of 

VHS-regulated areas and VHS-regulated 

regions will be maintained on the 

APHIS Web site, not in the regulations. 

We do not however, provide criteria for 

removing an area or region from those 

lists. At present, VHS occurs only in 

wild fish populations in the United 

States and Canada, making the disease 

difficult to contain and eradicate. For 

that reason, we do not believe any areas 

or regions that are currently on the lists 

of VHS-regulated areas or VHSregulated regions will be eligible for 

removal from those lists in the 

immediate future. Further, APHIS is 

still considering what information we 

would use in reassessing an area’s or 

region’s disease status and would find 

public input valuable. Specifically, 

APHIS seeks comments on what factors 

should be considered when removing 

areas and regions from the lists of VHSregulated areas and VHS-regulated 

regions. 

We recognize that gametes are a 

potential pathway for the spread of VHS 

due to the ability of the virus to survive 

in ovarian fluid. While the disinfection 

of salmonid eggs is common practice, no 

standardized protocols exist for 

disinfecting non-salmonid eggs. Further, 

there is not sufficient documented 

scientific evidence to support regulated 

egg treatment protocols for nonsalmonid eggs. APHIS seeks comment 

on what types of egg disinfection 

protocols, if any, should be considered 

for VHS-regulated non-salmonid 

species. 

User Fees 

APHIS user fees for processing permit 

applications and for inspecting animals 

at the port of entry will apply. The user 

fees are set forth in 9 CFR part 130. User 

fees for processing applications for 

permits to import certain animals and 

animal products are listed in the table 

in § 130.4. User fees for inspection at the 

port of entry and laboratory and facility 

inspections are the hourly rates set forth 

in § 130.30. 

Emergency Action 

The Administrator of the Animal and 

Plant Health Inspection Service has 

determined that there is good cause for 

publishing this interim rule without 

prior opportunity for public comment. 

Immediate action is necessary to 

prevent the introduction of VHS into 

aquaculture facilities by controlling the 

movement of live fish at risk of 

harboring VHS virus. Despite its current 

VHS-free status for farmed fish, the 

United States remains unprotected from 

continuing introductions of VHSinfected non-salmonid fish imported 

from Canada, since there are a number 

of exporters of VHS-regulated fish 

species in VHS-regulated areas in 

Canada, and pretesting of these fish is 

not currently required. Additionally, 

although VHS outbreaks have so far 

been limited to States within the Great 

Lakes watershed, there are no 

standardized restrictions in place other 

than those specified in the FWS 

regulations in title 50 and the existing 

APHIS Federal Order to prevent the 

further spread of VHS into new 

watersheds or areas by the transfer of 

live salmonid or non-salmonid VHSregulated species. Therefore, it is 

necessary to implement regulations that 

will restrict such movements in as 

timely a manner as possible. 

We will consider comments we 

receive during the comment periods for 

this interim rule and the environmental 

assessment (see DATES above). After the 

comment period closes, we will publish 

another document in the Federal 

Register to notify the public of our 

decision regarding the environmental 

assessment. We will also publish a 

document in the Federal Register that 

will include a discussion of any 

comments we receive and any 

amendments we are making to the rule. 

Executive Order 12866 and Regulatory 

Flexibility Act 

This rule has been reviewed under 

Executive Order 12866. The 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. 

We have prepared an economic 

analysis for this interim rule. It provides 

an initial regulatory flexibility analysis, 

which considers the potential economic 

effects of this proposed rule on small 

entities, as required by the Regulatory 

Flexibility Act, as well as a cost-benefit 

analysis. The economic analysis is 

summarized below. The full economic 

analysis may be viewed on the 

Regulations.gov Web site (see 

ADDRESSES at the beginning of this 

document for instructions for accessing 

Regulations.gov). You may request 

paper copies of the economic analysis 

by calling or writing to the person listed 

under FOR FURTHER INFORMATION

CONTACT. Please refer to Docket No. 

APHIS–2007–0038 when requesting 

copies. The economic analysis is also 

available for review in our reading room 

(information on the location and hours 

of the reading room is listed under the 

heading ADDRESSES at the beginning of 

this document). 


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Based upon available data and 

expected effects, we believe that the 

benefits of the interim rule, in terms of 

disease prevention, will justify the costs 

associated with restricting the 

movement of live fish. Costs associated 

with the interim rule will likely be 

difficult to distinguish from those 

already imposed by the amended 

Federal Order. Also, several of the 

States that will be regulated by the 

interim rule have regulations in place 

that compare closely with the interim 

rule. Net impacts of the interim rule 

therefore may be relatively small. 

We first consider potential costs of the 

rule for producers, allied industries, and 

State, Federal, and Tribal authorities. 

Possible benefits of the rule in terms of 

preventing the spread of VHS virus are 

then examined. Third, alternatives to 

the rule are presented. Lastly, we 

address expected impacts for small 

entities. 

Summary of Cost-Benefit Analysis 

The interim rule will place 

restrictions on the importation and 

interstate movement of live VHSregulated fish species from States within 

the Great Lakes Region where this 

disease has been confirmed. The 

potential impacts of the interim rule are 

not known, given the lack of 

information on aquaculture operations 

and commercial fisheries in the 

regulated areas. Additionally, little is 

known about the potential impacts on 

allied fishing industries and on 

hatcheries operating under Federal, 

State, or Tribal authority. 

Benefits of the rule will accrue from 

preventing the spread of an emerging 

strain of VHS virus to aquaculture 

facilities beyond the regulated States. 

Five of these States have comprehensive 

regulations in place to curb the spread 

of the virus. Impacts of the interim rule 

are likely to be largely already realized 

because of the amended Federal Order, 

and may be additionally diminished in 

the five States that have adopted 

movement restrictions consistent with 

the interim rule. 

Expected Costs of the Interim Rule 

One industry that may be impacted is 

the wild-caught segment of the baitfish 

industry, to the extent that the 

requirements of the interim rule are 

more restrictive than the amended 

Federal Order and the regulations of the 

various States. However, we foresee any 

incremental changes to be minimal. A 

testing and certification protocol by 

which movement will be allowed under 

the rule is unlikely to be feasible for this 

segment of the industry. In addition to 

aquaculture and commercial fisheries, 

allied fishing industries such as bait 

shops and marinas may also be affected 

by the interim rule. Bait shops that sell 

VHS-regulated species may face tighter 

supplies on top of the certification 

requirement for sales to unregulated 

States. 

State, Federal, and Tribal authorities 

may also be affected by the interim rule. 

Within the 8 regulated States, there are 

7 Federal, 69 State, and at least 13 

Tribal hatcheries. These hatcheries 

produce and stock fish in streams, 

rivers, and lakes throughout the eight 

States and possibly in surrounding 

States. The interim rule may limit 

production and stocking by the 

agencies, and therefore the availability 

of broodstock in the regulated States 

and possibly other States, depending on 

the species stocked. Affected States may 

also face a decline in the number of 

fishing licenses sold due to reduced 

stocking and a limited availability of 

bait. 

Overall, regulated aquaculture 

facilities and commercial fisheries will 

bear the costs of testing, cleaning, and 

disinfection of containers, and fees 

associated with inspections and the 

issuance of permits. However, given the 

regulatory response to VHS to date by 

five of the eight regulated States, the 

impact of the interim rule may be 

muted. Many of the regulations in place 

in Michigan, New York, Ohio, 

Pennsylvania, and Wisconsin are 

closely aligned with the requirements in 

the interim rule and in some cases may 

be even more restrictive. In some 

instances, effects of the interim rule are 

already realized because of rules 

implemented at the State level. 

Additionally, the rule will codify 

restrictions and procedures already in 

place under the amended Federal Order. 

Net impacts of the interim rule are 

expected to be small because of the 

existing State regulations and the 

Federal Order. 

Expected Benefits of the Interim Rule 

The interim rule is expected to benefit 

aquaculture facilities. The rule is 

intended to curtail the introduction of 

the VHS virus into areas outside of the 

Great Lakes Region. Mississippi 

dominates catfish farming in the United 

States. Alabama and Arkansas also have 

fairly large sales of cultured catfish. 

Additionally, Arkansas boasts the 

largest sales of cultured baitfish, 

accounting for 53 percent of baitfish 

aquaculture according to the 2005 

Census of Aquaculture. Preventing VHS 

from spreading to these areas will help 

preserve the catfish and baitfish 

industries, valued at almost $440 

million. 

Alternatives to the Interim Rule 

APHIS considered three alternatives 

for the interim rule. The first alternative 

considered by the Agency would entail 

regulations much broader in scope than 

the provisions of the May 4, 2007, 

amended Federal Order. This alternative 

would restrict interstate movement of 

VHS-regulated species for all States 

where any VHS virus strain is detected, 

and would restrict importation of VHSregulated species from all VHSregulated countries, including countries 

in Europe, and also would regulate 

additional commodities. APHIS 

determined the interim rule will be less 

costly and provide the same level of 

protection as this alternative, based on 

current knowledge of the status of the 

two strains of VHS virus, type IV(a) and 

type IV(b), in the United States and 

Canada. VHS virus strain type IV(a) is 

not known to exist anywhere other than 

in marine environments and, thus, is 

unlikely to be found in the Great Lakes 

Region. 

A second alternative considered by 

the Agency would be to regulate areas 

based on Hydrologic Unit Code (HUC) 

level 2, or regional, definitions. APHIS 

determined that regulating areas known 

to have VHS virus type IV(b) based on 

the HUC 2 definition could pose an 

undue burden on entities within these 

areas far removed from the specific 

location of the VHS virus type IV(b) 

confirmation. 

Finally, APHIS considered a ‘‘no 

action’’ alternative. In this instance, 

APHIS would not implement 

regulations covering the interstate 

movement of VHS-regulated fish from 

VHS-regulated areas or the importation 

of VHS-regulated fish from VHSregulated regions. Under this 

alternative, State agencies and Federal 

agencies other than APHIS would 

assume responsibility for preventing the 

spread of the VHS virus. Compliance 

with the various regulations could be 

burdensome for aquaculture producers 

and others who move fish interstate or 

internationally. 

Summary of the Initial Regulatory 

Flexibility Analysis 

In accordance with the Regulatory 

Flexibility Act, we examined the 

potential economic effects the interim 

rule will have on small entities. The 

interim rule may affect aquaculture 

facilities, commercial harvesters, 

marinas, and other allied fishing 

industries in Illinois, Indiana, Michigan, 

Minnesota, New York, Ohio, 

Pennsylvania, and Wisconsin. Although 

information concerning many of these 

industries is sparse, it is likely that most 


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of the entities within these industries 

are small as defined by the Small 

Business Administration (SBA) 

guidelines. 

While it is likely that the majority of 

firms affected by the interim rule will be 

small, the magnitude of the impacts is 

unclear given the lack of data. 

Aquaculture facilities in States not 

regulated for VHS will benefit from the 

interim rule because the likelihood that 

fish in these facilities will be exposed to 

this disease will be reduced. Facilities 

located in Illinois, Indiana, Michigan, 

Minnesota, New York, Ohio, 

Pennsylvania, and Wisconsin will face 

costs related to testing if they raise VHSregulated species for interstate 

movement. In States that have enacted 

their own regulations to prevent the 

potential spread of VHS, impacts on 

aquaculture facilities and commercial 

fishing operations as a result of this 

interim rule are likely to be dampened. 

The interim rule will impose some 

additional reporting, recordkeeping, and 

other compliance requirements. Live 

VHS-regulated species of fish may be 

imported and moved live from regulated 

Provinces and States. Movement 

requires testing and certification as 

described in the interim rule. Firms 

wishing to move live fish will be 

responsible for ensuring that the fish 

originate from a facility that has been 

tested and found to be free of VHS virus. 

Additionally, these firms will also be 

responsible for obtaining the permits 

needed to transport fish interstate, as 

well as paying the user fees associated 

with inspection of shipments. 

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 rule has been reviewed under 

Executive Order 12988, Civil Justice 

Reform. This rule: (1) Preempts all State 

and local laws and regulations that are 

in conflict with this rule; (2) has no 

retroactive effect; and (3) does not 

require administrative proceedings 

before parties may file suit in court 

challenging this rule. 

National Environmental Policy Act 

To provide the public with 

documentation of APHIS’ review and 

analysis of any potential environmental 

impacts associated with this interim 

rule, we have prepared an 

environmental assessment. The 

environmental assessment was prepared 

in accordance with: (1) The National 

Environmental Policy Act of 1969 

(NEPA), as amended (42 U.S.C. 4321 et 

seq.), (2) regulations of the Council on 

Environmental Quality for 

implementing the procedural provisions 

of NEPA (40 CFR parts 1500–1508), (3) 

USDA regulations implementing NEPA 

(7 CFR part 1b), and (4) APHIS’ NEPA 

Implementing Procedures (7 CFR part 

372). The environmental assessment 

provides a basis for our determination 

that implementation of this interim rule 

will not have a significant impact on the 

quality of the human environment. 

We will accept comments on the 

environmental assessment for 30 days. 

To comment, follow the instructions 

under ADDRESSES at the beginning of 

this document. The environmental 

assessment may be viewed on the 

Regulations.gov Web site or in our 

reading room. (Instructions for accessing 

Regulations.gov and information on the 

location and hours of the reading room 

are provided under the heading 

ADDRESSES at the beginning of this 

interim rule.) In addition, copies may be 

obtained by writing to the individual 

listed under FOR FURTHER INFORMATION

CONTACT. 

Paperwork Reduction Act 

In accordance with section 3507(j) of 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501 et seq.), the information 

collection and recordkeeping 

requirements included in this interim 

rule have been submitted for emergency 

approval to the Office of Management 

and Budget (OMB). OMB has assigned 

control number 0579–0340 to the 

information collection and 

recordkeeping requirements. 

We plan to request continuation of 

that approval for 3 years. Please send 

written comments on the 3-year 

approval request to the following 

addresses: (1) Office of Information and 

Regulatory Affairs, OMB, Attention: 

Desk Officer for APHIS, Washington, DC 

20503; and (2) Docket No. APHIS–2007–

0038, Regulatory Analysis and 

Development, PPD, APHIS, Station 3A–

03.8, 4700 River Road, Unit 118, 

Riverdale, MD 20737–1238. Please state 

that your comments refer to Docket No. 

APHIS–2007–0038 and send your 

comments within 60 days of publication 

of this rule. 

This interim rule establishes 

regulations to restrict the interstate 

movement and importation into the 

United States of live fish that are 

susceptible to VHS. In order to be 

moved interstate, live VHS-regulated 

fish must originate from a facility that 

has been found free of VHS virus 

through testing specified in the 

regulations and be accompanied by an 

ICI issued by an accredited veterinarian 

or a State, Tribal, or Federal competent 

authority for aquatic animal health. 

Live VHS-regulated fish to be 

imported into the United States may 

need to be accompanied by a permit and 

must be accompanied by a declaration 

and by a health certificate that states 

that the live fish originated in a region 

or facility that has demonstrated 

freedom from VHS through testing in 

accordance with the regulations. The 

fish must be shipped in new containers 

or containers that have been cleaned 

and disinfected to neutralize any VHS 

virus to which the shipping containers 

may have been exposed. The cleaning 

and disinfection protocols must be 

referenced in the health certificate or in 

a separate cleaning and disinfection 

certificate accompanying the shipment 

to the U.S. port of entry. Finally, live 

fish imported for slaughter or for 

research or diagnostic purposes must, 

among other things, be accompanied by 

a VS Form I–27, which will be issued 

by the port veterinarian. 

We are soliciting comments from the 

public (as well as affected agencies) 

concerning our information collection 

and recordkeeping requirements. These 

comments will help us: 

(1) Evaluate whether the information 

collection is necessary for the proper 

performance of our agency’s functions, 

including whether the information will 

have practical utility; 

(2) Evaluate the accuracy of our 

estimate of the burden of the 

information collection, including the 

validity of the methodology and 

assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

information collection on those who are 

to respond (such as through the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology; e.g., permitting 

electronic submission of responses). 

Estimate of burden: Public reporting 

burden for this collection of information 

is estimated to average 0.2681871 hours 

per response. 

Respondents: Accredited 

veterinarians, importers and exporters 

of VHS-regulated live fish, shippers 

moving VHS-regulated live fish 

interstate, and States. 

Estimated annual number of 

respondents: 515. 

Estimated annual number of 

responses per respondent: 16.601941. 


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Estimated annual number of 

responses: 8,550. 

Estimated total annual burden on 

respondents: 2,293. (Due to averaging, 

the total annual burden hours may not 

equal the product of the annual number 

of responses multiplied by the reporting 

burden per response.) 

Copies of this information collection 

can be obtained from Mrs. Celeste 

Sickles, APHIS’ Information Collection 

Coordinator, at (301) 851–2908. 

E-Government Act Compliance 

The Animal and Plant Health 

Inspection Service is committed to 

compliance with the E-Government Act 

to promote the use of the Internet and 

other information technologies, to 

provide increased opportunities for 

citizen access to Government 

information and services, and for other 

purposes. For information pertinent to 

E-Government Act compliance related 

to this interim rule, please contact Mrs. 

Celeste Sickles, APHIS’ Information 

Collection Coordinator, at (301) 851–

2908. 

List of Subjects 

9 CFR Part 71 

Animal diseases, Livestock, Poultry 

and poultry products, Quarantine, 

Reporting and recordkeeping 

requirements, Transportation. 

9 CFR Part 83 

Animal diseases, Livestock, 

Quarantine, Reporting and 

recordkeeping requirements, 

Transportation. 

9 CFR Part 93 

Animal diseases, Imports, Livestock, 

Poultry and poultry products, 

Quarantine, Reporting and 

recordkeeping requirements. 

■ Accordingly, we are amending 9 CFR 

chapter I as follows: 

PART 71—GENERAL PROVISIONS 

■ 1. The authority citation for part 71 

continues to read as follows: 

Authority: 7 U.S.C. 8301–8317; 7 CFR 2.22, 

2.80, and 371.4. 

■ 2. Section 71.3 is amended as follows: 

■ a. In paragraph (a), in the list of 

diseases which are endemic to the 

United States, by adding the words 

‘‘viral hemorrhagic septicemia,’’ after 

‘‘chlamydiosis,’’. 

■ b. By adding a new paragraph (c)(5) to 

read as set forth below. 

§ 71.3 Interstate movement of diseased 

animals and poultry generally prohibited. 

* * * * * 

(c)(5) Fish affected with viral 

hemorrhagic septicemia may be moved 

interstate in accordance with part 83 of 

this subchapter. 

* * * * * 

■ 3. A new part 83 is added to read as 

follows: 

PART 83—VIRAL HEMORRHAGIC 

SEPTICEMIA 

Sec. 

83.1 Definitions. 

83.2 General restrictions. 

83.3 Interstate movement of live VHSregulated fish species from VHSregulated areas. 

83.4 VHS-regulated fish and VHS-regulated 

areas. 

83.5 Interstate Certificate of Inspection 

(ICI). 

83.6 Testing requirements. 

83.7 Shipping containers; cleaning and 

disinfection. 

Authority: 7 U.S.C. 8301–8317; 7 CFR 2.22, 

2.80, and 371.4. 

§ 83.1 Definitions. 

Accredited veterinarian. A 

veterinarian who is approved by the 

Administrator, in accordance with part 

161 of this chapter, to perform official 

animal health work of the Animal and 

Plant Health Inspection Service 

specified in subchapters A, B, C, and D 

of this chapter; and to perform work 

required by cooperative State-Federal 

disease control and eradication 

programs. 

Administrator. The Administrator, 

Animal and Plant Health Inspection 

Service, or any person authorized to act 

for the Administrator. 

Anadromous fish. Fish that are born 

and spawn in freshwater, but which 

spend part of their lifecycle in saltwater. 

Animal and Plant Health Inspection 

Service (APHIS). The Animal and Plant 

Health Inspection Service of the United 

States Department of Agriculture. 

APHIS representative. A veterinarian 

or other individual employed by APHIS 

who is authorized to perform the 

services required by this part. 

Approved laboratory. A laboratory 

authorized by a State, Tribal, or Federal 

competent authority for aquatic animal 

health to perform assays for the 

detection of VHS virus. 

Catch-and-release fishing. Fishing for 

pleasure or for recreational purposes, 

including tournaments, organized 

fishing competitions, fishing derbies, or 

other types of contests where 

individuals catch, compare, and release 

live VHS-regulated fish. This term 

excludes VHS-regulated fish used, or 

intended to be used, as live bait. 

Competent authority. The State, 

Tribal, or Federal entity with the legal 

responsibility for ensuring or 

supervising the implementation of 

aquatic animal health measures. 

Cultured fish. Fish of the same species 

and age class, originating from the same 

broodstock and on the same water 

supply, whose care is partly or totally 

managed from the first life stage 

onwards. 

Department. The United States 

Department of Agriculture (USDA). 

Interstate. From one State into or 

through any other State. 

Interstate Certificate of Inspection 

(ICI). An official document issued by an 

accredited veterinarian or a State, 

Tribal, or Federal competent authority 

in the originating State that certifies that 

the fish being moved interstate 

originated from a facility that has been 

found free of VHS virus. 

Moved (movement). Shipped, 

transported, delivered, or otherwise 

aided, induced, or caused to be moved. 

Person. Any individual, corporation, 

company, association, firm, partnership, 

society, or joint stock company, or other 

legal entity. 

Secure water source. A biosecure 

water supply that does not contain 

pathogens or has not had the 

opportunity to be contaminated with 

pathogens. Biosecure water supplies 

include well, spring, or borehole water; 

surface water that does not contain fish 

populations; or water that has been 

treated to eliminate aquatic animal 

pathogens. 

State. Any of the 50 States, the 

Commonwealth of Puerto Rico, the 

Commonwealth of the Northern Mariana 

Islands, the District of Columbia, and 

any territories and possessions of the 

United States. 

State animal health official. The State 

official responsible for livestock, disease 

control, and eradication programs. 

VHS-regulated area. Any State or 

portion of a State listed in accordance 

with § 83.4. 

VHS-regulated fish. Any fish species 

listed in accordance with § 83.4. 

VHS virus. Any North American (type 

IV) strain of viral hemorrhagic 

septicemia (VHS) virus, a rhabdovirus of 

fish. 

Viral hemorrhagic septicemia (VHS). 

A disease caused by infection with VHS 

virus. 

§ 83.2 General restrictions. 

Live VHS-regulated fish may not be 

moved interstate from a VHS-regulated 

area except in compliance with this 

part. 


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§ 83.3 Interstate movement of live VHSregulated fish species from VHS-regulated 

areas. 

(a) Except as provided in paragraphs 

(b) through (e) of this section, live VHSregulated fish, including fish moved to 

live fish markets, may only be moved 

interstate from a VHS-regulated area if 

the fish originated from a facility that 

has been found free of the VHS virus in 

accordance with § 83.6 and the fish are 

accompanied by an Interstate Certificate 

of Inspection (ICI) issued by an 

accredited veterinarian or a State, 

Tribal, or Federal competent authority 

for aquatic animal health. 

(b) Live VHS-regulated fish may be 

moved interstate directly to a 

slaughtering establishment provided 

that: 

(1) The fish are accompanied by a VS 

Form 1–27; 

(2) The fish are transported in sealed 

conveyances; 

(3) The slaughtering establishment 

meets the following conditions: 

(i) The slaughtering establishment 

discharges its waste water to a 

municipal sewage system that includes 

waste water disinfection sufficient to 

neutralize any VHS virus or to either a 

non-discharging settling pond or a 

settling pond that disinfects, according 

to all applicable local, State, and 

Federal regulations, sufficiently to 

neutralize any VHS virus. 

(ii) Offal, including carcasses, from 

the slaughtering establishment is either 

rendered or composted. 

(4) Any water used to transport the 

fish is disposed of in a municipal 

sewage system that includes waste 

water disinfection sufficient to 

neutralize any VHS virus or to either a 

non-discharging settling pond or a 

settling pond that disinfects, according 

to all applicable local, State, and 

Federal regulations, sufficiently to 

neutralize any VHS virus. 

(c) Live VHS-regulated fish may be 

moved interstate for research or 

diagnostic purposes provided that: 

(1) The fish are accompanied by a VS 

Form 1–27; 

(2) The fish are transported in sealed 

conveyances; 

(3) The facility that receives the fish 

meets the following conditions: 

(i) The facility discharges its waste 

water to a municipal sewage system that 

includes waste water disinfection 

sufficient to neutralize any VHS virus or 

to either a non-discharging settling pond 

or a settling pond that disinfects, 

according to all applicable local, State, 

and Federal regulations, sufficiently to 

neutralize any VHS virus. 

(ii) Offal, including carcasses, from 

the facility is either rendered or 

composted. 

(4) Any water used to transport the 

fish is disposed to a municipal sewage 

system that includes waste water 

disinfection sufficient to neutralize any 

VHS virus or to either a non-discharging 

settling pond or a settling pond that 

disinfects, according to all applicable 

local, State, and Federal regulations, 

sufficiently to neutralize any VHS virus. 

(d) Live VHS-regulated fish may be 

moved interstate during catch-andrelease fishing. 

(e) The Administrator may, on a caseby-case basis, permit the interstate 

movement of fish not otherwise 

provided for in this part, under such 

conditions as the Administrator may 

prescribe in each case to prevent the 

introduction and dissemination of VHS. 

(Approved by the Office of Management and 

Budget under control number 0579–0340) 

§ 83.4 VHS-regulated fish and VHSregulated areas. 

(a)(1) APHIS will list as a VHSregulated fish any fish species found in 

freshwater to be susceptible to the North 

American (type IV) strain of VHS virus 

under natural (i.e., non-controlled) 

conditions of exposure and from which 

VHS virus has been isolated in cell 

culture or other assay determined by the 

Administrator to be adequate to detect 

VHS virus, with confirmation of strain 

identity through genetic sequencing. 

Anadromous fish that have migrated 

into freshwater and from which VHS 

strain type IV(a) has been isolated will 

not be considered VHS-regulated fish. 

(2) If APHIS determines that, in 

accordance with the criteria in 

paragraph (a)(1) of this section, a species 

should be added to the list of VHSregulated species, APHIS will publish a 

notice in the Federal Register 

announcing that determination. 

(b)(1) APHIS will list as a VHSregulated area each State or portion of 

a State from which VHS virus has been 

detected in any VHS-regulated fish 

species (with or without clinical signs of 

disease) in a water source that is not a 

secure water source, or which the 

Administrator determines should be 

regulated based on criteria such as 

inadequate surveillance or movement 

requirements, or other epidemiologic 

information. 

(2) If the Administrator determines 

that a State or portion of a State meets 

the criteria in paragraph (b)(1) of this 

section, APHIS will publish a notice of 

its decision in the Federal Register and 

take comments from the public. The 

designation as a VHS-regulated area will 

become effective upon publication of 

this notice. After reviewing the 

comments, APHIS will issue a second 

notice in the Federal Register 

announcing its decision on whether or 

not the designation as a VHS-regulated 

area will remain in effect. 

(c) APHIS maintains the lists of VHSregulated fish and VHS-regulated areas 

on the APHIS aquaculture Web site at 

http://www.aphis.usda.gov/animal

_health/animal_dis_spec/aquaculture. 

The lists may be obtained from the 

Animal and Plant Health Inspection 

Service, Veterinary Services, National 

Aquaculture Program, 4700 River Road 

Unit 46, Riverdale, MD 20737–1231. 

§ 83.5 Interstate Certificate of Inspection 

(ICI). 

(a) Live VHS-regulated fish moved 

interstate in accordance with § 83.3(a) 

must be accompanied by an ICI issued 

by an accredited veterinarian or a State, 

Tribal, or Federal competent authority 

for aquatic animal health. An ICI will be 

valid for 30 days from the date of 

issuance. 

(b) The ICI must state that: 

(1) The live fish were inspected by the 

accredited veterinarian or a State, 

Tribal, or Federal competent authority 

for aquatic animal health within 72 

hours prior to shipment, and were 

found to be free of any clinical signs of 

disease consistent with VHS. 

(2) The live fish covered by the ICI 

originated in an area or facility that has 

demonstrated freedom from VHS in 

accordance with § 83.6. 

(c) The ICI must include the following 

information: 

(1) The name, address, and phone 

number of the owner or owner’s agent. 

(2) The name, address, and phone 

number of the facility in which the fish 

originated. 

(3) The name, address, and phone 

number of the person or facility who 

will receive the fish; or the State or 

other regulatory authority responsible 

for oversight of the environment in 

which the fish will be introduced. 

(4) The name, address, and phone 

number of the shipping or 

transportation company. 

(5) The species and number of the 

fish. 

(6) The lot (or other) identification of 

the shipment. 

(7) The name, address, and phone 

number of the approved laboratory that 

performed the testing required by § 83.6. 

(i) The number of fish tested; 

(ii) The assay(s) used for testing; and 

(iii) The test results. 

(8) The date the certificate was issued. 

(9) The type of water source according 

to § 83.6(c). 

(Approved by the Office of Management and 

Budget under control number 0579–0340) 


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§ 83.6 Testing requirements. 

(a) A facility can demonstrate freedom 

from VHS through negative testing 

results provided by an approved 

laboratory. Testing must meet the 

following conditions: 

(1) Be conducted with a sample size 

that provides for a 95 percent 

confidence level of detecting a 2 percent 

prevalence of infection in the facility. 

(i) Facilities with cultured fish of 

VHS-regulated species which can 

document a 2-year history of negative 

testing for VHS virus, can conduct 

testing at a sampling level to provide a 

95 percent confidence level of detecting 

a 5 percent prevalence of infection in 

the facility. Such testing must be 

conducted twice a year, with at least 3 

months between tests. 

(ii) Facilities with cultured fish of 

VHS-regulated species which can 

document a 4-year history of negative 

testing for VHS virus can conduct 

testing at a sampling level to provide a 

95 percent confidence level of detecting 

a 10 percent prevalence of infection in 

the facility. Such testing must be 

conducted twice a year, with at least 3 

months between tests. 

(iii) Such facilities must be on a 

secure water source, and document that 

any VHS-regulated species in the 

facility that originated in VHS-regulated 

States or Canadian provinces originate 

from facilities of the same or higher 

health status. 

(2) Include virus isolation or other 

assays authorized by the Administrator, 

using appropriate cell lines to detect 

VHS virus, if present. All suspect VHS 

cytopathic effects must be positively 

identified as VHS through molecular 

assays and/or genetic sequencing. 

(3) Use proportional numbers of each 

VHS-regulated fish species which might 

be present in the facility. 

(4) Be conducted at water 

temperatures between 50 and 72 °F, or 

at other times or under environmental 

conditions when VHS is most likely to 

be detected, if present. 

(b) When APHIS adds a new species 

to the list of VHS-regulated species after 

a facility has been determined to be free 

of VHS in accordance with paragraph (a) 

of this section, the facility must conduct 

additional testing on fish of the newly 

listed species, if present in the facility, 

and the fish must be free of VHS virus 

for the facility to retain its free status. 

VHS testing must be conducted on each 

newly listed species with a sample size 

that provides for a 95 percent 

confidence level of detecting a 2 percent 

prevalence of infection in the facility. 

(c) For VHS-regulated fish maintained 

on a secure water source, test results 

will be valid for 6 months from the date 

of sample collection provided that no 

fish of a lesser or unknown health status 

are introduced into the facility. Test 

results for fish held on a water source 

that is not a secure water source will be 

valid for 30 days from the date of 

sample collection. 

§ 83.7 Shipping containers; cleaning and 

disinfection. 

(a) All live fish that are to be moved 

interstate in accordance with § 83.3(a) 

must be moved in new containers or in 

containers that have been cleaned and 

disinfected. 

(1) Cleaning and disinfection of 

shipping containers must be monitored 

by the accredited veterinarian or State, 

Tribal, or Federal competent authority 

for aquatic animal health who issues the 

ICI. 

(2) Cleaning and disinfection must be 

sufficient to neutralize any VHS virus to 

which shipping containers may have 

been exposed. 

(3) The cleaning and disinfection 

protocols used must be referenced in the 

ICI or in a separate cleaning and 

disinfection certificate accompanying 

the shipment. 

(b) [Reserved] 

(Approved by the Office of Management and 

Budget under control number 0579–0340) 

PART 93—IMPORTATION OF CERTAIN 

ANIMALS, BIRDS, FISH, AND 

POULTRY, AND CERTAIN ANIMAL, 

BIRD, AND POULTRY PRODUCTS; 

REQUIREMENTS FOR MEANS OF 

CONVEYANCE AND SHIPPING 

CONTAINERS 

■ 4. The authority citation for part 93 

continues to read as follows: 

Authority: 7 U.S.C. 1622 and 8301–8317; 

21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 

CFR 2.22, 2.80, and 371.4. 

■ 5. Section 93.900 is amended by 

adding the following definitions in 

alphabetical order to read as set forth 

below. 

§ 93.900 Definitions. 

* * * * * 

Anadromous fish. Fish that are born 

and spawn in freshwater, but which 

spend part of their lifecycle in saltwater. 

* * * * * 

Approved laboratory. A laboratory 

authorized by the competent authority 

of a country for aquatic animal health to 

perform assays for the detection of VHS 

virus. 

Catch-and-release fishing. Fishing for 

pleasure or for recreational purposes, 

including tournaments, organized 

fishing competitions, fishing derbies, or 

other types of contests where 

individuals catch, compare, and release 

live VHS-regulated fish. This term 

excludes VHS-regulated fish used, or 

intended to be used, as live bait. 

* * * * * 

Cultured fish. Fish of the same species 

and age class, originating from the same 

broodstock and on the same water 

supply, whose care is partly or totally 

managed from the first life stage 

onwards. 

* * * * * 

Secure water source. A biosecure 

water supply that does not contain 

pathogens or has not had the 

opportunity to be contaminated with 

pathogens. Biosecure water supplies 

include well, spring, or borehole water; 

surface water that does not contain fish 

populations; or water that has been 

treated to eliminate aquatic animal 

pathogens. 

* * * * * 

VHS-regulated fish. Any fish species 

listed in accordance with § 93.910. 

VHS-regulated region. Any region 

listed in accordance with § 93.910. 

VHS virus. Any North American (type 

IV) strain of VHS virus, a rhabdovirus of 

fish. 

Viral hemorrhagic septicemia (VHS). 

A disease caused by infection with VHS 

virus. 

§§ 93.901 through 93.906 [Undesignated 

heading added] 

■ 6. Subpart I is amended by adding an 

undesignated center heading, ‘‘General 

Provisions for SVC-Regulated Fish 

Species’’, preceding § 93.901. 

§§ 93.907 through 93.909 [Reserved] 

■ 7. Sections 93.907 through 93.909 are 

added and reserved. 

■ 8. An undesignated center heading 

and new §§ 93.910 through 93.916 are 

added to subpart I after the newly 

reserved §§ 93.907 through 93.909 to 

read as follows: 

General Provisions for VHS-Regulated 

Fish Species 

§ 93.910 General restrictions; exceptions. 

(a) No live VHS-regulated species of 

fish may be imported into the United 

States from VHS-regulated regions 

except in accordance with this subpart 

or the regulations of the U.S. Fish and 

Wildlife Service (FWS) in 50 CFR 

16.13(a)(3) and 16.13(b), nor may such 

live VHS-regulated fish be moved from 

the port of entry after arrival until 

released by an APHIS representative or 

FWS official; Provided, that the 

Administrator may, upon request in 

specific cases, allow the importation of 

live VHS-regulated fish into the United 

States under conditions other than those 

specifically set forth in this subpart 


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when the Administrator determines that 

such movement will not result in the 

further introduction of VHS into the 

United States. 

(b)(1) APHIS will list as a VHSregulated fish any fish species found in 

freshwater to be susceptible to the North 

American (type IV) strain of VHS virus 

under natural (i.e., non-controlled) 

conditions of exposure and from which 

VHS virus has been isolated in cell 

culture or other assay determined by the 

competent authority to be adequate to 

detect VHS virus, with confirmation of 

strain identity through genetic 

sequencing. Anadromous fish species 

that have migrated into freshwater and 

from which VHS strain type IV(a) has 

been isolated will not be considered 

VHS-regulated fish. 

(2) If APHIS determines that, in 

accordance with the criteria in 

paragraph (b)(1) of this section, a 

species should be added to the list of 

VHS-regulated species, APHIS will 

publish a notice in the Federal Register 

announcing that determination. 

(c)(1) APHIS will list as a VHSregulated region any region in which 

VHS virus has been officially reported 

to the World Health Organization for 

Animal Health by the country’s 

competent authority for aquatic animal 

health from any fish species in a water 

source that is not a secure water source, 

or which the Administrator determines 

to be at risk of having VHS based on 

criteria such as inadequate surveillance, 

less restrictive import requirements, or 

other epidemiologic information. 

(2) If the Administrator determines 

that a region meets the criteria in 

paragraph (c)(1) of this section, APHIS 

will publish a notice of its decision in 

the Federal Register and take comments 

from the public. The designation as a 

VHS-regulated region will become 

effective upon publication of this notice. 

After reviewing the comments, APHIS 

will issue a second notice in the Federal 

Register announcing its decision on 

whether or not the designation as a 

VHS-regulated region will remain in 

effect. 

(d) APHIS maintains the lists of VHSregulated fish and VHS-regulated 

regions on the APHIS aquaculture Web 

site at http://www.aphis.usda.gov/ 

animal_health/animal_dis_spec/ 

aquaculture. The lists may be obtained 

from the Animal and Plant Health 

Inspection Service, Veterinary Services, 

National Aquaculture Program, 4700 

River Road Unit 46, Riverdale, MD 

20737–1231. 

(e) Other provisions of this subpart 

relating to the importation of live VHSregulated fish shall not apply to 

shipments of such fish imported from 

VHS-regulated regions if they are 

imported in accordance with the FWS 

regulations in 50 CFR 16.13. 

(f) Other provisions of this subpart 

relating to the importation of live VHSregulated fish shall not apply to 

shipments of such fish in transit 

through the United States, if an import 

permit has been obtained under § 93.912 

and all conditions of the permit are 

observed, and if the live VHS-regulated 

fish species are handled as follows: 

(1) They are maintained under 

continuous confinement while in transit 

through the United States aboard an 

aircraft, ocean vessel, or other means of 

conveyance; or, if they are unloaded in 

the course of such transit, they are 

placed in a holding facility that is 

provided by the carrier or its agent and 

has been approved by the Administrator 

as adequate to prevent the spread within 

the United States of any finfish disease; 

they are maintained there under 

continuous confinement until loaded 

aboard a means of conveyance for 

transportation from the United States; 

and they are maintained under 

continuous confinement aboard such 

means of conveyance until it leaves the 

United States. 

(2) They are moved in accordance 

with any additional conditions 

prescribed in the permit that the 

Administrator has determined to be 

necessary to ensure that the fish do not 

introduce VHS into the United States. 

(3) For a holding facility to be 

approved by the Administrator, the 

following conditions must be met: 

(i) The holding facility must be 

sufficiently isolated to prevent direct or 

indirect contact of the live fish it 

contains with any other live VHSregulated fish species in the United 

States. 

(ii) The holding facility must be 

constructed to provide adequate 

protection against environmental 

conditions and so that it can be 

adequately cleaned, washed, and 

disinfected. 

(iii) Provision must be made for 

disposal of fish carcasses, shipping 

water, effluent, waste, and any 

associated shipping materials in a 

manner that will prevent dissemination 

of disease. 

(iv) Provision must be made for 

adequate sources of feed and water and 

for attendants for the care and feeding 

of fish in the facility. 

(v) The holding facility must comply 

with all applicable local, State, and 

Federal requirements for environmental 

quality. 

(vi) The holding facility must comply 

with any additional requirements that 

the Administrator may impose on a 

particular shipment in order to prevent 

the dissemination of disease. 

(g) Other provisions of this subpart 

relating to the importation of live VHSregulated fish shall not apply to fish 

moved into the United States from VHSregulated regions during catch-andrelease fishing. 

§ 93.911 Ports designated for the 

importation of live VHS-regulated fish 

species. 

(a) Live VHS-regulated fish from VHSregulated regions may be imported into 

the United States without an import 

permit through the following Canadian 

border ports: Eastport, ID; Houlton and 

Jackman, ME; Detroit, Port Huron, and 

Sault Ste. Marie, MI; Baudette, MN; 

Opheim, Raymond, and Sweetgrass, 

MT; Alexandria Bay, Buffalo, and 

Champlain, NY; Dunseith, Pembina, and 

Portal, ND; Derby Line and Highgate 

Springs, VT; and Oroville and Sumas, 

WA. 

(b) Live VHS-regulated fish may be 

imported into the United States with an 

import permit through the following 

ports: Anchorage, AK; Los Angeles and 

San Francisco, CA; Miami and Tampa, 

FL; Atlanta, GA; Honolulu, HI; Chicago, 

IL; Boston, MA; Newark, NJ; Jamaica 

and Newburgh, NY; Portland, OR; 

Memphis, TN; Dallas-Ft. Worth, TX; 

Seattle, WA; and San Juan, PR. 

(c) Designation of other ports. Other 

ports may be designated by the 

Administrator in specific cases with the 

concurrence of the Secretary of the 

Department of Homeland Security. 

§ 93.912 Import permits. 

(a) Live VHS-regulated fish imported 

from VHS-regulated regions through a 

limited port as described in § 93.911(b) 

must be accompanied by an import 

permit issued by APHIS and must be 

imported within 30 days of the 

proposed arrival date stated in the 

import permit. 

(b) An application for an import 

permit must be submitted for each 

shipment of live VHS-regulated fish to 

the Animal and Plant Health Inspection 

Service, Veterinary Services, National 

Center for Import and Export, 4700 

River Road Unit 38, Riverdale, MD 

20737–1231. Application forms for 

import permits may be obtained from 

this address. Applications may also be 

obtained from the following APHIS Web 

site: http://www.aphis.usda.gov/vs/ncie/ 

pdf/vs17-129.pdf. 

(c) A completed application must 

include the following information: 

(1) The name and address of the 

person intending to export live VHSregulated fish to the United States; 

(2) The proposed date of shipment to 

the United States; 


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(3) The name and address of the 

person intending to import live VHSregulated fish into the United States; 

(4) The species and number of live 

VHS-regulated fish to be imported into 

the United States; 

(5) The purpose of the importation; 

(6) The port of embarkation; 

(7) The mode of transportation; 

(8) The route of travel, including all 

carrier stops en route; 

(9) The port of entry in the United 

States; 

(10) The proposed date of arrival in 

the United States; and 

(11) The name and address of the 

person to whom the live VHS-regulated 

fish will be delivered in the United 

States. 

(d) If APHIS determines that the live 

VHS-regulated fish from VHS-regulated 

regions are eligible for importation, 

APHIS will issue an import permit 

indicating the applicable conditions for 

importation. An import permit does not 

guarantee that any live VHS-regulated 

fish will be allowed entry into the 

United States; the VHS-regulated fish 

will be allowed to enter the United 

States only if they meet all applicable 

requirements of the permit and 

regulations. 

(Approved by the Office of Management and 

Budget under control number 0579–0340) 

§ 93.913 Health certificate. 

(a) General. All live VHS-regulated 

fish that are imported from VHSregulated regions for other than 

immediate slaughter or research or 

laboratory use must be accompanied by 

a health certificate issued by a full-time 

salaried veterinarian of the national 

government of the exporting country, or 

issued by a certifying official and 

endorsed by the competent authority of 

that country. The health certificate must 

be written in English or contain an 

English translation. The health 

certificate will be valid for 30 days from 

the date of issuance. The health 

certificate for the live VHS-regulated 

fish must state that: 

(1) The live fish were inspected by the 

veterinarian or certifying official who 

issued the certificate within 72 hours 

prior to shipment, and were found to be 

free of any clinical signs of disease 

consistent with VHS; and 

(2) The live fish covered by the health 

certificate originated in a region or 

facility that has demonstrated freedom 

from VHS through testing in accordance 

with paragraphs (b) and (c) of this 

section. 

(b) Testing. A facility can demonstrate 

freedom from VHS through negative 

testing results by a pathogen detection 

laboratory approved for VHS viral 

assays by the competent authority of 

that country. Testing must meet the 

following conditions: 

(1) Testing must be conducted with a 

testing sample size that provides for a 

95 percent confidence level of detecting 

a 2 percent prevalence of infection in 

the facility. 

(i) Facilities with cultured fish of 

VHS-regulated species which can 

document a 2-year history of negative 

testing for VHS virus can conduct 

testing at a sampling level to provide a 

95 percent confidence level of detecting 

a 5 percent prevalence of infection in 

the facility. Such testing must be 

conducted twice a year, with at least 3 

months between tests. 

(ii) Facilities with cultured fish of 

VHS-regulated species which can 

document a 4-year history of negative 

testing for VHS virus can conduct 

testing at a sampling level to provide a 

95 percent confidence level of detecting 

a 10 percent prevalence of infection in 

the facility. Such testing must be 

conducted twice a year, with at least 3 

months between tests. 

(iii) Such facilities must be on a 

secure water source, and document that 

any VHS-regulated species in the 

facility that originated in VHS-regulated 

States or Canadian provinces originate 

from facilities of the same or higher 

health status. 

(2) Tests must include virus isolation 

or other assays authorized by the 

competent authority, using appropriate 

cell lines to detect VHS virus, if present. 

All suspect VHS cytopathic effects must 

be positively identified as VHS through 

molecular assays and/or genetic 

sequencing. 

(3) Proportional numbers of each 

VHS-regulated fish species which might 

be present in a shipment must be used 

for testing, if applicable. 

(4) Testing must be conducted at 

water temperatures between 50 and 72 

°F, or at other times or under 

environmental conditions when VHS 

virus is most likely to be detected, if 

present. 

(c) When APHIS adds a new species 

to the list of VHS-regulated species after 

a facility has been determined to be free 

of VHS in accordance with paragraph 

(b) of this section, the facility must 

conduct additional testing on fish of the 

newly listed species, if present in the 

facility, and the fish must be free of VHS 

virus for the facility to retain its free 

status. VHS testing must be conducted 

on each newly listed species with a 

sample size that provides for a 95 

percent confidence level of detecting a 

2 percent prevalence of infection in the 

fish facility. 

(d) Shipping containers. Except as 

provided in § 93.910(e)–(g), all live fish 

that are to be shipped to the United 

States must be shipped in new 

containers or in containers that have 

been cleaned and disinfected. 

(1) Cleaning and disinfection of 

shipping containers must be monitored 

by the veterinarian or certifying official 

who issues the health certificate. 

(2) Cleaning and disinfection must be 

sufficient to neutralize any VHS virus to 

which shipping containers may have 

been exposed. 

(3) The cleaning and disinfection 

protocols used must be referenced in the 

health certificate or in a separate 

cleaning and disinfection certificate 

accompanying the shipment to the U.S. 

port of entry. 

(Approved by the Office of Management and 

Budget under control number 0579–0340) 

§ 93.914 Declaration and other documents. 

(a) For live VHS-regulated fish offered 

for importation under this subpart, the 

importer or his or her agent must submit 

the following documents to the 

appropriate Customs and Border 

Protection officer for use by the port 

veterinarians: 

(1) All permits, certificates, or other 

documentation required under 

§§ 93.912 and 93.913; and 

(2) Two copies of a declaration that 

lists the port of entry; the name and 

address of the importer; the name and 

address of the broker; the origin of the 

live fish; the number, species, and the 

purpose of the importation; the name of 

the person to whom the fish will be 

delivered; and the location of the place 

to which such delivery will be made. 

(Approved by the Office of Management and 

Budget under control number 0579–0340) 

§ 93.915 Inspection at the port of entry. 

(a) Shipments of live VHS-regulated 

fish must be presented for inspection at 

a port of entry designated under 

§ 93.911. For live fish entering through 

a limited port listed in § 93.911(c), the 

APHIS port veterinarian must be 

notified at least 72 hours in advance of 

the arrival in the United States of the 

shipment. Any shipment that does not 

meet the requirements of this subpart 

will be refused entry. 

(b) Shipments refused entry must be 

exported within a time fixed in each 

case by the Administrator, and in 

accordance with other provisions he or 

she may require in each case for their 

handling, or the shipment will be 

disposed of as the Administrator may 

direct. 

(Approved by the Office of Management and 

Budget under control number 0579–0340) 


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§ 93.916 Special provisions. 

(a) Slaughter. Live VHS-regulated fish 

from VHS-regulated regions may be 

imported directly for slaughter under 

the following conditions: 

(1) An import permit has been 

obtained under § 93.912 and all 

conditions of the permit are observed. 

(2) An APHIS representative at the 

port seals the means of conveyance with 

official seals. 

(3) The shipment is moved directly 

from the port of entry to a slaughtering 

establishment that meets the following 

conditions: 

(i) The slaughtering establishment 

discharges its waste water to a 

municipal sewage system that includes 

waste water disinfection sufficient to 

neutralize any VHS virus or to either a 

non-discharging settling pond or a 

settling pond that disinfects, according 

to all applicable local, State, and 

Federal regulations, sufficiently to 

neutralize any VHS virus. 

(ii) Offal, including carcasses, from 

the slaughtering establishment is either 

rendered or composted. 

(4) An APHIS representative will 

unseal the vehicle upon arrival at the 

slaughtering establishment. 

(5) Any water used to transport the 

fish is disposed to a municipal sewage 

system that includes waste water 

disinfection sufficient to neutralize any 

VHS virus or to either a non-discharging 

settling pond or a settling pond that 

disinfects, according to all applicable 

local, State, and Federal regulations, 

sufficiently to neutralize any VHS virus. 

(b) Research or laboratory use. Live 

VHS-regulated fish may be imported 

from a VHS-regulated region for 

research or laboratory use under the 

following conditions: 

(1) An import permit has been 

obtained under § 93.912 and all 

conditions of the permit are observed. 

(2) The laboratory or research facility 

disposes of effluent to a municipal 

sewage system that includes waste 

water disinfection sufficient to 

neutralize any VHS virus or to either a 

non-discharging settling pond or a 

settling pond that disinfects, according 

to all applicable local, State, and 

Federal regulations, sufficiently to 

neutralize any VHS virus. 

(3) Carcasses must be rendered or 

composted. 

(4) Any water used to transport the 

fish is disposed to a municipal sewage 

system that includes waste water 

disinfection sufficient to neutralize any 

VHS virus or to either a non-discharging 

settling pond or a settling pond that 

disinfects, according to all applicable 

local, State, and Federal regulations, 

sufficiently to neutralize any VHS virus. 

Done in Washington, DC, this 4th day of 

September 2008. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. E8–20852 Filed 9–8–08; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

9 CFR Parts 317, 381, and 442 

[Docket No. FSIS–2008–0015] 

RIN # 0583–AD17 

Determining Net Weight Compliance 

for Meat and Poultry Products 

AGENCY: Food Safety and Inspection 

Service, USDA. 

ACTION: Final rule. 

SUMMARY: The Food Safety and 

Inspection Service (FSIS) is amending 

its regulations to reference the most 

recent version of the National Institute 

of Standards and Technology (NIST) 

Handbook 133 that contains standards 

for determining the reasonable 

variations allowed for the declared net 

weight on labels of immediate 

containers of meat and poultry 

products; the procedures to be used to 

determine the net weight and net weight 

compliance of meat and poultry 

products; and related definitions. The 

Agency is also consolidating the 

separate net weight regulations for meat 

and poultry products in a new CFR part, 

applicable to both meat and poultry 

products. 

This final rule does not incorporate by 

reference sections in Handbook 133 that 

concern the ‘‘wet tare’’ method for 

determining net weight. The ‘‘wet tare’’

method does not include free-flowing 

liquid as part of the product but as part 

of the tare weight. The Agency regards 

any solutions that are added to meat or 

poultry to be part of the product and 

considers free-flowing liquids to be an 

integral component of these products, 

and therefore uses the ‘‘dry tare’’, not 

the ‘‘wet tare’’ method. 

DATES: Effective Date: This regulation is 

effective October 9, 2008. The 

incorporation by reference of the NIST 

Handbook 133, Fourth Edition, is 

approved by the Director of the Federal 

Register as of October 9, 2008. 

FOR FURTHER INFORMATION CONTACT: 

Charles Gioglio, Director, Labeling and 

Program Delivery Division, Food Safety 

and Inspection Service, U.S. Department 

of Agriculture, Washington, DC 20250–

3700; (202) 205–0010. 

SUPPLEMENTARY INFORMATION: 

Background 

FSIS administers the Federal Meat 

Inspection Act (FMIA) (21 U.S.C. 601–

695), the Poultry Products Inspection 

Act (PPIA) (21 U.S.C. 451–470), and the 

regulations that implement these Acts. 

The FMIA and the PPIA require that 

packages of meat and poultry products 

bear an accurate statement of the 

quantity of their contents in terms of 

weight, measure, or numerical count (21 

U.S.C. 601(n)(5) and 453(b)(5)). The 

FMIA and PPIA also provide the 

Secretary of Agriculture with the 

authority to prescribe standards of fill of 

containers for such articles (21 U.S.C. 

607(c)(2), 457(b)(2)) that are not 

inconsistent with any such standards 

established under the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 301–

392). In implementing regulations, FSIS 

has elected to adopt the relevant NIST 

standards established for determining 

compliance with the net weight 

contents statement of packaged goods 

that are enumerated in NIST Handbook 

133. Consequently, FSIS has 

incorporated by reference certain NIST 

standards in the Federal meat and 

poultry inspection regulations. 

NIST was established by Congress in 

1988 to assist industry in the 

development of technology to improve 

product quality, to modernize 

manufacturing processes, to ensure 

product reliability, and to facilitate 

rapid commercialization of products 

based on new scientific discoveries. 

NIST’s basic functions include 

developing, maintaining, and retaining 

custody of the national standards of 

measurement and providing the means 

and methods for comparing standards 

used in science, engineering, 

manufacturing, commerce, industry, 

and education with the standards 

adopted or recognized by the Federal 

Government. 

NIST Handbook 133 is a procedural 

guide for compliance testing of net 

content statements on packaged goods. 

FSIS has elected to make mandatory the 

NIST standards in Handbook 133 

regarding the determination of the 

reasonable variations allowed from the 

declared net weight on labels of 

immediate containers of meat and 

poultry products, the procedures to be 

used to determine net weight and net 

weight compliance for meat and poultry 

products, and related definitions. 

Consequently, FSIS currently 

incorporates by reference the NIST 

standards from Handbook 133 in its 

meat and poultry regulations. The 

Agency first incorporated NIST 

Handbook 133 by reference in 


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