[Federal Register Volume 67, Number 70 (Thursday, April 11, 2002)]
[Rules and Regulations]
[Pages 17605-17611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-8779]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 53

[Docket No. 01-126-1]


Infectious Salmon Anemia; Payment of Indemnity

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Interim rule and request for comments.

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SUMMARY: We are amending the regulations regarding the control and 
eradication of certain communicable diseases of livestock or poultry to 
provide for the payment of indemnity to producers in the State of Maine 
for fish destroyed due to infectious salmon anemia. Because 
depopulation is required to control infectious salmon anemia, a 
successful control program will require indemnification for depopulated 
fish to gain producer support. This action will, therefore, increase 
the effectiveness of our efforts to control infectious salmon anemia in 
Maine and prevent further outbreaks of the disease.

DATES: This interim rule was effective April 5, 2002. We will consider 
all comments we receive that are postmarked, delivered, or e-mailed by 
June 10, 2002 .

ADDRESSES: You may submit comments by postal mail/commercial delivery 
or by e-mail. If you use postal mail/commercial delivery, please send 
four copies of your comment (an original and three copies) to: Docket 
No. 01-126-1, Regulatory Analysis and Development, PPD, APHIS, Station 
3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state 
that your comment refers to Docket No. 01-126-1. If you use e-mail, 
address your comment to [email protected]. Your comment must 
be contained in the body of your message; do not send attached files. 
Please include your name and address in your message and ``Docket No. 
01-126-1'' on the subject line.
    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.
    APHIS documents published in the Federal Register, and related 
information, including the names of organizations and individuals who 
have commented on APHIS dockets, are available on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: Dr. Otis Miller, Jr., National 
Aquaculture Coordinator, Planning, Certification, and Monitoring, VS, 
APHIS, 4700 River Road Unit 36, Riverdale, MD 20737-1231; (301) 734-
8715.

SUPPLEMENTARY INFORMATION:

[[Page 17606]]

Background

    The regulations at 9 CFR part 53 (referred to below as the 
regulations) provide for the control and eradication of diseases 
including foot-and-mouth disease, rinderpest, contagious 
pleuropneumonia, exotic Newcastle disease, highly pathogenic avian 
influenza, or other communicable diseases of livestock or poultry that, 
in the opinion of the Secretary of Agriculture, constitute an emergency 
and threaten the livestock or poultry of the United States. The 
regulations authorize payments for the fair market value of the animals 
destroyed, as well as payments for their destruction and disposal. The 
regulations also authorize payments for materials that must be cleaned 
and disinfected or destroyed because of being contaminated by or 
exposed to disease.
    In a document effective December 13, 2001, and published in the 
Federal Register on December 20, 2001 (66 FR 65679-65680, Docket No. 
01-082-1), the Secretary declared an emergency because of infectious 
salmon anemia (ISA), a foreign animal disease of Atlantic salmon, 
caused by an orthomyxovirus. The disease affects both wild and farmed 
Atlantic salmon. The first case of ISA in the United States was 
confirmed in Maine on February 15, 2001. As of June 25, 2001, ISA has 
been confirmed in eight sites in Maine.
    ISA is the clinical disease resulting from infection with the ISA 
virus. Signs include hemorrhaging and anemia, which may result in very 
pale gills. Other external signs may include exophthalmia (bulging 
eyes), lethargy, and darkening or petechia (pinpoint hemorrhage) on the 
skin. Internally, kidneys, livers or intestines may show signs of 
petechia or hemorrhage. Mortality due to ISA varies; cumulative 
mortality due to the disease varies greatly from a very low percentage 
(near zero) to more than 50 percent of the fish population. ISA virus 
does not infect humans or other mammals, since the virus is inactivated 
at temperatures over 25  deg.C, far lower than typical mammalian 
internal temperatures of 37 to 40  deg.C.
    ISA poses a substantial threat to the economic viability and 
sustainability of salmon aquaculture in the United States and abroad. 
Salmon production in Maine exceeds 36.2 million pounds annually, with a 
value of $101 million. Because of outbreaks of ISA in Maine, the 
State's salmonid industry had already depopulated approximately 900,000 
salmon worth nearly $11 million by the time of the Secretary's 
declaration of emergency. This loss is even greater when capital 
expenditures such as labor costs and equipment are considered.
    Additionally, the existence of ISA in Maine has affected other 
States due to its ramifications for international trade. For example, 
when ISA emerged in Maine, Chile and the European Union prohibited the 
importation of trout and salmon eggs from Washington, Maine, and Idaho. 
The resulting trade loss is estimated at $2 million for 2001.
    On April 24, 2001, the Maine Department of Marine Resources, the 
Maine Aquaculture Association, and the Maine State Veterinarian 
requested that the U.S. Department of Agriculture (USDA or the 
Department) provide the State with assistance in the areas of 
indemnification, epidemiology, and surveillance for ISA. The 
Department's Animal and Plant Health Inspection Service (APHIS) has 
entered into a cooperative ISA control program with the State of Maine 
to help safeguard the salmon industry from future incursions of this 
exotic disease and monitor and manage the ISA status of salmonid 
aquaculture sites in that State.
    Because depopulation is required to control ISA, a successful 
control program will require indemnification for depopulated fish to 
gain producer support. Therefore, this interim rule amends the 
regulations in part 53 to provide for the payment of indemnity for fish 
destroyed because of ISA on or after the December 13, 2001, date of the 
Secretary's declaration of emergency. The specific amendments are 
discussed below.

Definitions

    We have amended the definition of disease in Sec. 53.1 to include 
ISA among the diseases specifically listed. In addition, we have added 
a definition of accredited veterinarian. This definition, which is the 
same as the definition used for the term elsewhere in our regulations 
in title 9, is necessary because, as explained below, the cooperative 
ISA control program administered by APHIS and the State of Maine 
requires participants to engage the services of an accredited 
veterinarian.
    We have also provided a definition for ISA Program Veterinarian. 
The ISA Program Veterinarian is the APHIS veterinarian assigned to 
manage the infectious salmon anemia program for APHIS in the State of 
Maine and who reports to the Area Veterinarian in Charge. As explained 
below, participants in the ISA program will be required to submit 
certain documents to the ISA Program Veterinarian; the ISA Program 
Veterinarian will also determine the schedule for the periodic on-site 
disease surveillance, testing, and reporting activities required under 
the ISA program.

Payment of Indemnity

    Section 53.2 of the regulations provides for the Administrator to 
enter into an agreement with proper State authorities in order to 
control and eradicate disease. Paragraph (b) of this section provides 
for the payment of indemnity to cover 50 percent of expenses of 
purchase, destruction, and disposition of animals and materials 
required to be destroyed because of being contaminated by or exposed to 
such disease. In the case of exotic Newcastle disease and highly 
pathogenic avian influenza, up to 100 percent of these expenses may be 
covered.
    Based on the Secretary's December 13, 2001, declaration of 
emergency, approximately $8.29 million was transferred from the 
Commodity Credit Corporation for the Department's ISA control and 
indemnification efforts for fiscal year 2002. Of this $8.29 million, 
$7.2 million was estimated to be for indemnification costs. The 
apportionment for those funds specifies that the Department may pay up 
to 60 percent of indemnity costs. Therefore, we are adding a provision 
to Sec. 53.2(b) to provide that, subject to the availability of 
funding, APHIS may pay up to 60 percent of the expenses of purchase, 
destruction, and disposition of animals and materials required to be 
destroyed during fiscal year 2002 because of being contaminated by or 
exposed to ISA. Section 53.2 contains provisions for the appraisal of 
animals and materials; reports of the required appraisals will be used 
in determining the amount of indemnity to be paid in specific cases. 
The appraisal will consider the number and age of the fish depopulated. 
The amount of indemnity paid per fish will be the fair market value of 
the fish, which we will calculate based on industry production costs; 
as noted previously, APHIS will pay up to 60 percent of the value of 
the fish destroyed subject to the availability of funding. The 
Administration is examining how the costs of program activities, 
including the payment of indemnity, are shared among the Federal 
government and cooperators such as State and local governments, 
industry, and producers. Hence, in the future, the indemnity rate 
provided under this rule may change.

Salvage Value

    Paragraph (a) of Sec. 53.4 directs operators to destroy animals 
affected by or exposed to disease promptly after

[[Page 17607]]

appraisal and dispose of them by burial or burning, unless otherwise 
specifically provided by the Administrator. Because fish infected with 
or exposed to ISA may retain salvage value if they are sold for 
processing or rendering, we are adding a provision to this section to 
allow for those options. Operators who collect salvage value for fish 
destroyed because of ISA will have that value subtracted from the 
amount of indemnity they are eligible to receive from APHIS under 
Sec. 53.2(b).

Program Participation

    Section 53.10 of the regulations lists reasons why the 
Administrator will disallow indemnity claims. We are adding a provision 
to this section to require that, in order to receive indemnity for fish 
destroyed because of ISA, claimants must participate fully in the 
cooperative ISA control program administered by APHIS and the State of 
Maine.
    We are requiring that claimants participate in this program because 
ongoing surveillance and early detection of disease are essential to 
effective prevention, management, and control of ISA. Under this 
program, participants must, at a minimum:
     Establish and maintain a veterinary client-patient 
relationship with an APHIS accredited veterinarian and inform the ISA 
Program Veterinarian in writing of the name of their accredited 
veterinarian at the time the participant enrolls in the ISA program and 
within 15 days of any change in accredited veterinarians.
    The farmed salmon industry uses highly qualified personnel 
experienced in all aspects of fish culture, husbandry, and health 
management. While most industry members have established in-house 
procedures for increased disease surveillance and a working 
relationship with aquaculture veterinarians and diagnostic laboratories 
to provide further technical expertise, this requirement will ensure 
that all participants have ready access to an APHIS accredited 
veterinarian, who will conduct the surveillance, testing, and reporting 
activities discussed in the next paragraph and will assist participants 
in carrying out the other aspects of the program discussed below.
     Cooperate with and assist in periodic on-site disease 
surveillance, testing, and reporting activities for ISA, which will be 
conducted by their APHIS accredited veterinarian or a State or Federal 
official as directed by the ISA Program Veterinarian.
    Surveillance ensures that resources and producers' attention will 
be directed at routine and regularly scheduled inspections and health 
assessments of fish so that ISA will be quickly diagnosed. Testing with 
the best and most scientifically sound assays at an approved laboratory 
will insure prompt and accurate diagnosis. Reporting procedures ensure 
that once infected or diseased fish are identified control measures and 
depopulation can proceed rapidly.
     Develop and implement biosecurity protocols for use at all 
participant-leased finfish sites and participant-operated vessels 
engaged in aquaculture operations throughout Maine. A copy of these 
protocols shall be submitted to the ISA Program Veterinarian at the 
time the participant enrolls in the ISA program and within 15 days of 
any change in the protocols.
    The implementation of effective biosecurity protocols will reduce 
the risk of the introduction and spread of ISA due to human activities 
into and between marine sites and cages by movement of farmed fish, 
equipment, and people.
     Develop, with the involvement of the participant's 
accredited veterinarian and the fish site health manager, a site-
specific ISA action plan for the control and management of ISA. A copy 
of the action plan shall be submitted to APHIS for review at the time 
the participant enrolls in the ISA program and within 15 days of any 
change in the action plan.
    The action plan is a document developed for each site that defines 
the response contingencies for ISA--e.g., activities to be undertaken 
upon disease detection, notification procedures, etc.--should the 
disease emerge at the site.
     Participate in the State of Maine's integrated pest 
management (IPM) program for the control of sea lice on salmonids. A 
copy of the management plan developed by the participant for the State 
IPM program shall be submitted to APHIS for review at the time the 
participant enrolls in the ISA program and within 15 days of any change 
in the management plan.
    Sea lice are copepod arthropods belonging to the genera 
Lepeophtheirus and Caligus. Species of both genera infest Atlantic 
salmon and live in the mucus layer, where they attach and suck blood or 
cause sores. The larger Lepeophtheirus species are generally regarded 
as capable of transmitting ISA. Sea lice of both genera can cause 
stress on fish, which adversely affects the immune response. The Maine 
IPM program for sea lice provides for monitoring, treatment, and 
management practices designed to minimize the presence of sea lice in 
pen sites and reduce the need for the use of chemicals and medications. 
We consider control of sea lice to be a vital component of the ISA 
control program in Maine; therefore, we will, in cooperation with the 
State of Maine, review and verify the adequacy of each participant's 
sea lice management plan.
     Submit to the ISA Program Veterinarian at the time the 
participant enrolls in the ISA program a complete and current fish 
inventory information for each participant-leased finfish site with 
site and cage identifiers. Fish inventory information must include the 
numbers, age, date of saltwater transfer, vaccination status, and 
previous therapeutant history for all fish in each participant-leased 
finfish site.
    This information will provide APHIS with the data necessary to 
establish disease control actions, complete epidemiological 
assessments, and increase our ability to effectively monitor fish 
populations.
     Maintain, and make available to the ISA Program 
Veterinarian upon request, mortality data for each participant-leased 
finfish site and pen in production.
    This can be accomplished utilizing existing industry records 
systems and log sheets. The mortality data will be used by APHIS in 
conjunction with the fish inventory information discussed previously to 
establish disease control actions, complete epidemiological 
assessments, and increase our ability to effectively monitor fish 
populations.
     Cooperate with and assist APHIS in the completion of 
biosecurity audits at all participant-leased finfish sites and 
participant-operated vessels involved in salmonid aquaculture.
    These audits will be performed to assess the efficacy of the 
biosecurity protocols established by the participants to reduce the 
risk of the introduction and spread of ISA due to human activities into 
and between marine sites and cages by movement of farmed fish, 
equipment, and people.

Miscellaneous Changes

    In Sec. 53.2, we have removed two outdated references to the 
``Director of Division'' (i.e., the Animal Health Division, a precursor 
to APHIS' Veterinary Services) and replaced them with references to the 
Administrator. Also in Sec. 53.2, a reference to the definition of 
disease cited the location of that definition as Sec. 53.1(f). As the 
definitions in Sec. 53.1 no longer carry paragraph designations, we 
have removed the reference to paragraph (f).

[[Page 17608]]

Emergency Action

    This rulemaking is necessary on an emergency basis to ensure that 
the ISA indemnity program is implemented as soon as possible to prevent 
the spread of ISA. Under these circumstances, the Administrator has 
determined that prior notice and opportunity for public comment are 
contrary to the public interest and that there is good cause under 5 
U.S.C. 553 for making this rule effective less than 30 days after 
publication in the Federal Register.
    We will consider comments we receive during the comment period for 
this interim rule (see DATES above). After the comment period closes, 
we will publish another document in the Federal Register. The document 
will include a discussion of any comments we receive and any amendments 
we are making to the rule as a result of the comments.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been reviewed under Executive Order 12866. The rule 
has been determined to be significant for the purposes of Executive 
Order 12866 and, therefore, has been reviewed by the Office of 
Management and Budget.
    We are amending the regulations to provide for the payment of 
indemnity to producers in the State of Maine for fish destroyed due to 
ISA. Because depopulation is required to control ISA, a successful 
control program will require indemnification for depopulated fish to 
gain producer support. This action will, therefore, increase the 
effectiveness of our efforts to control ISA in Maine and prevent 
further outbreaks of the disease.
    Below is an economic analysis for the ISA indemnity program 
described in this document. This economic analysis also provides a 
cost-benefit analysis as required by Executive Order 12866 and an 
analysis of the potential economic effects on small entities as 
required by the Regulatory Flexibility Act.
    We do not have enough data for a comprehensive analysis of the 
economic effects of this interim rule on small entities. Therefore, in 
accordance with 5 U.S.C. 603, we have performed an initial regulatory 
flexibility analysis for this interim rule. We are inviting comments 
about this interim rule as it relates to small entities. In particular, 
we are interested in determining the number and kind of small entities 
who may incur benefits or costs from implementation of this rule and 
the economic impact of those benefits or costs.
    In accordance with 21 U.S.C. 111-113, 114a, 115, 117, 120, 123, and 
134a, the Secretary of Agriculture has the authority to promulgate 
regulations and take measures to prevent the introduction into the 
United States and the interstate dissemination within the United States 
of communicable diseases of livestock and poultry, and to pay claims 
growing out of the destruction of animals. Animal health regulations 
promulgated by the Department under this authority include those 
specifically addressing control programs and indemnity payments for 
tuberculosis (part 50), brucellosis (part 51), pseudorabies (part 52), 
and scrapie (part 54), and regulations in part 53 regarding payment of 
claims for other diseases.

Program Description and Benefits

    ISA is recognized to cause considerable and growing economic 
losses. In 2002, the Secretary of Agriculture authorized the transfer 
from the Commodity Credit Corporation of $8.29 million as one part of a 
2-year ISA indemnity and control program. Most of this money will be 
used for indemnity costs, and the remainder will be used for disposal, 
cleanup, epidemiology, and surveillance. Under this rule, subject to 
the availability of funding, APHIS may pay up to 60 percent of the fair 
market value of the fish destroyed, and the amount paid per fish will 
likely fluctuate during the course of the ISA indemnity program. 
Participation may be limited if funds are exhausted due to increases in 
the fair market value above our current estimates.
    This interim rule provides Federal indemnification of up to 60 
percent of the fair market value, as determined by APHIS based on 
industry production costs, for fish infected with or exposed to ISA. 
Previously, there was no such indemnification program.
    The farmed Atlantic salmon industry in Maine is estimated to be 
currently producing over 15,000 tons (or 30 million lbs.) of fish per 
year. Production and value of production is increasing rapidly. In 
2000, production value is estimated to have surpassed $100 million in 
Maine. Maine's farmed Atlantic salmon industry directly employs 
approximately 1,000 people, primarily in Washington and Hancock 
Counties, and it is estimated that an additional 2,500 people have jobs 
that directly depend on the Maine's farmed Atlantic salmon industry. 
There are approximately 28 to 33 employees per every million pounds of 
product output. The amount of fish stock per farm varies; currently 
there are 26 active pen sites and 45 permitted pen sites, and, on 
average, the number of fish per site is 350,000.

Value Determination for Non-Marketable Animals

    Under this rule, an appraiser determines the fair market value of 
fish to be destroyed. Value is based on age; as salmon mature, their 
value increases significantly. Initially, salmon smolts are raised in 
freshwater pens for approximately 14 or 15 months. On average, these 
smolts weigh about 0.25 lbs. and carry no market value. On or about May 
1 of each year, operators move salmon into saltwater pens, where they 
grow at a rapid pace. Therefore, salmon that are 16 months old have 
actually only been in a saltwater pen for approximately 1 month. Salmon 
grow approximately 0.5 to 1 lb. each month, except for the coldest 
winter months. During that first winter (December to March), when 
salmon are between 21 to 24 months, their weight stagnates at 
approximately 3 lbs. This weight stagnation process occurs each year, 
and in the spring, salmon resume growing at their previous pace. 
Typically, a producer strives to harvest fish when they are the ideal 
market age of 38 to 42 months old (about 24 to 28 months in a saltwater 
pen, or about the time they reach 10 to 14 lbs.).
    We are still working, in cooperation with the State of Maine and 
the Maine salmonid industry, to finalize an indemnity schedule that 
accurately reflects per-fish production costs. Based on information 
submitted from producers, it appears that average production costs per 
fish may range from approximately $2.59 for a 15- to 16-month-old fish 
(1 month in a saltwater pen) to about $13.38 for a 38- to 42-month-old 
fish (approximately 28 months in a saltwater pen). Paid at the 60 
percent rate provided for by this rule, indemnity payments based on 
those production costs would range from $1.55 (1 month in pen) to $8.03 
(28 months in pen) per fish before considering salvage value. These 
figures are, however, preliminary and are intended to serve as an 
example; we anticipate that the indemnity schedule will be finalized in 
the near future. At that point, we will make the schedule available 
through the person listed under FOR FURTHER INFORMATION CONTACT.
    Between December 2001 and February 2002, APHIS, with the 
cooperation with the State of Maine and affected producers, depopulated 
just over 1.42 million exposed or infected salmon in Maine. 
Specifically, there were 718,212 salmon removed from 3 sites that had 
been in saltwater pens for 10 months, and 706,187 salmon removed from 4 
sites that had been in saltwater pens for

[[Page 17609]]

9 months. As all these fish had been in pens for only 9 or 10 months, 
they were too small to be marketable for rendering or processing (i.e., 
there will not be any salvage value for these fish). Average production 
costs are estimated at $5.40 per fish for the 10-month-old fish and 
$5.05 per fish for the 9-month-old fish. At the 60 percent rate 
provided for by this rule, we estimate indemnity payments of $2,327,007 
for the 10-month-old fish and $2,139,747 for the 9-month-old fish, for 
a total indemnity of $4,466,754. Again, it is important to note that 
these figures are preliminary.

Salvage Value--Value Determination for Marketable Animals

    Under this rule, salmon producers have the option of selling stock 
for rendering or other processing. The prices offered for salmon sold 
for rendering or processing are based on a number of criteria, but 
primarily consider the weight of the salvageable portion of the fish. 
These prices are offered by the processors; the prices for fish sold 
for salvage will be reported to APHIS. We will subtract any salvage 
value gained at slaughter from the indemnity payment.

Cost Benefit Analysis

    As noted previously, none of the estimated 1.42 million fish 
depopulated since December 2001 weighed enough to be salvageable. 
(Because young, small fish are not marketable for processing and/or 
rendering, any possibility of salvage value is dependent on the salmon 
reaching 29 months of age, i.e. when they have been in a saltwater pen 
approximately 15 months and weigh approximately 5.5 to 6 lbs.) If few 
or no fish can be sold for salvage, then indemnity costs rise 
accordingly. Since we can not speculate when, during the salmon growth/
aging process it may become necessary to depopulate a particular pen, 
it is impossible for us to determine how indemnity costs may fluctuate 
over the 2 years of the program.
    There is one vital benefit to this action: The entire farmed 
Atlantic salmon industry in Maine is at risk if ISA is not controlled. 
The benefits of keeping this $100 million dollar per year industry 
viable outweighs the cost of this program. Additionally, this action 
will provide salmon owners with a financial incentive to identify and 
destroy their ISA infected and/or exposed fish, thus arresting the 
spread of the disease and accelerating eradication efforts. Those 
producers who have not been participating in the ISA control program 
will now have an incentive to do so. Several benefits flow from this 
action. First, it will reduce costs to the Maine salmon industry from 
animal mortality, costs from possible State regulatory actions, and 
trade restrictions on U.S. salmon product exports. Second, an 
aggressive program now, while the number of known affected pens is 
reasonably small, may obviate the need for higher future Federal costs 
to contain a more widespread outbreak.
    This action may also reduce the impact of trade restrictions due to 
ISA. When ISA emerged in Maine, Chile and the European Union prohibited 
the importation of trout and salmonid eggs from Washington, Maine, and 
Idaho; the resulting trade loss is estimated at $2 million for 2001. 
The establishment of an effective ISA control program may result in the 
removal or relaxation of the restrictions imposed by those regions.
    This rule will also produce third-party trade benefits by 
demonstrating to trading partners the intent and ability of the United 
States to protect its animal industries, thus enhancing our ability to 
negotiate access to foreign markets.
    This action can also be expected to reduce potential future 
eradication program costs. Canada has been battling ISA for several 
years; from 1998 to 2000, fish farmers in that country lost 
approximately $70 million (in U.S. dollars). Canada's Provincial and 
Federal Governments have contributed over $29.5 million (in U.S. 
dollars) to compensate salmon farmers. As a result of early 
intervention, based on a compensation program with enough financial 
incentive to encourage active participation among salmon farmers, 
Canada has reduced the incidence of ISA from 18 infected sites in 1998 
to 4 infected sites in 2001.

Options Considered

    In assessing the need for this interim rule, we identified three 
alternatives. The first was to maintain the status quo, where State 
efforts are supported by Federal technical assistance but not by 
Federal compensation programs or interstate movement restrictions. We 
rejected this option because it does not fully address the risks 
associated with a more widespread ISA epidemic. While Maine has the 
authority to quarantine a pen site once it is known to be infected with 
ISA, the State lacks the resources to conduct the comprehensive testing 
and traceback activities that are necessary to identify newly infected 
sites. States also lack authority to directly regulate interstate 
commerce in salmon. Finally, while State quarantines are an important 
tool, quarantining a pen site does not eliminate the risk, since people 
may accidentally or deliberately violate the quarantine. Making Federal 
indemnity funds available serves as a powerful incentive for producers 
to participate in the ISA control program and for owners of infected 
sites to depopulate, which are factors that greatly reduce the risk of 
further spread of ISA.
    The second option would have been to provide financial and 
technical assistance to Maine's farmed salmon industry for continuation 
and expansion of a variety of pen site management practices to reduce 
or eliminate ISA. Although this option may be less costly than the 
option we chose, option 3 below, we did not select it because it does 
not allow us to advance the ISA control program as quickly or 
effectively as the chosen option. However, APHIS will continue to work 
with industry and the State of Maine to further develop ISA management 
practices to preserve and increase the reduction in ISA levels that the 
indemnity program is expected to achieve.
    The third option, to provide indemnity payments to depopulate ISA 
infected and/or exposed fish, was the one we chose. Depopulation of 
infected animals, which clears the way for a disinfection program, is 
currently the single most effective way to eliminate ISA. Under this 
alternative, producers will gain partial compensation for ISA infected 
and or/exposed fish.

Potential Impact on Small Entities

    This interim rule establishes a voluntary program that allows 
salmon producers in Maine to be paid indemnity for ISA infected and 
exposed animals. Many producers, as well as a number of processors who 
render salmon into food and non-food byproducts may be small 
businesses. To the extent that the interim rule contributes to the 
elimination of ISA in Maine, all salmon producers should benefit over 
the long term. In the short term, the economic impact on producers will 
vary.
    The U.S. Small Business Administration (SBA) defines a small fin 
fish and/or fish hatchery operation as one that has per-farm gross 
receipts of less that $750,000. There are 12 Atlantic salmon farms in 
the State of Maine. Collectively, they employ approximately 1,200 
workers in 25 separate pen site locations; also, another 2,500 jobs, 
primarily in processing, rendering, or transport directly depend on 
these operations. The gross receipts of the affected salmon producers 
is unknown. However, it is reasonable to assume that most exceed the 
SBA small entity threshold because, collectively,

[[Page 17610]]

these 12 firms produced gross receipts in excess of $100 million in 
2000.
    This interim rule contains various recordkeeping and reporting 
requirements. These requirements are described in this document under 
the heading ``Paperwork Reduction Act.''

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.

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 0579-0192 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. 01-126-1, Regulatory Analysis and Development, PPD, APHIS, 
station 3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. 
Please state that your comments refer to Docket No. 01-126-1 and send 
your comments within 60 days of publication of this rule.
    This interim rule amends the regulations regarding the control and 
eradication of certain communicable diseases of livestock or poultry to 
provide for the payment of indemnity to producers in the State of Maine 
for fish destroyed due to ISA. In order to take part in the indemnity 
program, producers must enroll in the cooperative ISA control program 
administered by APHIS and the State of Maine. Program participants must 
inform the ISA Program Veterinarian in writing of the name of their 
accredited veterinarian; develop biosecurity protocols and a site-
specific ISA action plan; submit fish inventory and mortality 
information; assist APHIS or State officials with on-site disease 
surveillance, testing, and biosecurity audits; and complete an 
appraisal and indemnity claim form.
    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 4.209469153 hours per response.
    Respondents: Program participants and their employees, APHIS 
accredited veterinarians, State animal health officials, and State 
personnel who may perform appraisals.
    Estimated annual number of respondents: 110.
    Estimated annual number of responses per respondent: 6.33636.
    Estimated annual number of responses: 697.
    Estimated total annual burden on respondents: 2,934 hours. (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) 
734-7477.

List of Subjects in 9 CFR Part 53

    Animal diseases, Indemnity payments, Livestock, Poultry and poultry 
products.

    Accordingly, we are amending 9 CFR part 53 as follows:

PART 53--FOOT-AND-MOUTH DISEASE, PLEUROPNEUMONIA, RINDERPEST, AND 
CERTAIN OTHER COMMUNICABLE DISEASES OF LIVESTOCK OR POULTRY

    1. The authority citation for part 53 continues to read as follows:

    Authority: 21 U.S.C. 111, 114, and 114a; 7 CFR 2.22, 2.80, and 
371.4.


    2. In Sec. 53.1, the definition of Disease is amended by adding the 
words ``infectious salmon anemia,'' after the word ``influenza,'' and 
by adding, in alphabetical order, definitions of accredited 
veterinarian and ISA Program Veterinarian to read as follows:


Sec. 53.1  Definitions.

    Accredited veterinarian. A veterinarian approved by the 
Administrator in accordance with part 161 of this chapter to perform 
functions specified in parts 1, 2, 3, and 11 of subchapter A of this 
chapter and subchapters B, C, and D of this chapter, and to perform 
functions required by cooperative State-Federal disease control and 
eradication programs.
* * * * *
    ISA Program Veterinarian. The APHIS veterinarian assigned to manage 
the infectious salmon anemia program for APHIS in the State of Maine 
and who reports to the Area Veterinarian in Charge.
* * * * *


Sec. 53.2  [Amended]

    3. Section 53.2 is amended as follows:
    a. In paragraph (a), by removing the words ``Director of Division'' 
and adding the word ``Administrator'' in their place, and by removing 
the citation ``Sec. 53.1(f)'' and adding the citation ``Sec. 53.1'' in 
its place.
    b. In paragraph (b), by removing the words ``Director of Division'' 
and adding the word ``Administrator'' in their place, and by removing 
the word ``percent)'' and adding the words ``percent, and in the case 
of infectious salmon anemia, up to 60 percent)'' in its place.

    4. In Sec. 53.4, paragraph (a) is revised to read as follows:


Sec. 53.4  Destruction of animals.

    (a) Animals affected by or exposed to disease shall be killed 
promptly after appraisal and disposed of by burial or burning, unless 
otherwise specifically provided by the Administrator, at his or her 
discretion. In the case of animals depopulated due to infectious salmon 
anemia, salvageable fish may be sold for rendering, processing, or any 
other purpose approved by the Administrator.

[[Page 17611]]

If fish retain salvage value, the proceeds gained from the sale of the 
fish will be subtracted from any indemnity payment from APHIS for which 
the producer is eligible under Sec. 53.2(b).
* * * * *

    5. Section 53.10 is amended by adding a new paragraph (e) to read 
as follows:


Sec. 53.10  Claims not allowed.

* * * * *
    (e) The Department will not allow claims arising out of the 
destruction of fish due to infectious salmon anemia (ISA) unless the 
claimants have agreed in writing to participate fully in the 
cooperative ISA control program administered by APHIS and the State of 
Maine. Participants in the ISA control program must:
    (1) Establish and maintain a veterinary client-patient relationship 
with an APHIS accredited veterinarian and inform the ISA Program 
Veterinarian in writing of the name of their accredited veterinarian at 
the time the participant enrolls in the ISA program and within 15 days 
of any change in accredited veterinarians.
    (2) Cooperate with and assist in periodic on-site disease 
surveillance, testing, and reporting activities for ISA, which will be 
conducted by their APHIS accredited veterinarian or a State or Federal 
official as directed by the ISA Program Veterinarian.
    (3) Develop and implement biosecurity protocols for use at all 
participant-leased finfish sites and participant-operated vessels 
engaged in aquaculture operations throughout Maine. A copy of these 
protocols shall be submitted to the ISA Program Veterinarian at the 
time the participant enrolls in the ISA program and within 15 days of 
any change in the protocols.
    (4) Develop, with the involvement of the participant's accredited 
veterinarian and the fish site health manager, a site-specific ISA 
action plan for the control and management of ISA. A copy of the action 
plan shall be submitted to APHIS for review at the time the participant 
enrolls in the ISA program and within 15 days of any change in the 
action plan.
    (5) Participate in the State of Maine's integrated pest management 
(IPM) program for the control of sea lice on salmonids. A copy of the 
management plan developed by the participant for the State IPM program 
shall be submitted to APHIS for review at the time the participant 
enrolls in the ISA program and within 15 days of any change in the 
management plan.
    (6) Submit to the ISA Program Veterinarian at the time the 
participant enrolls in the ISA program a complete and current fish 
inventory information for each participant-leased finfish site with 
site and cage identifiers. Fish inventory information must include the 
numbers, age, date of saltwater transfer, vaccination status, and 
previous therapeutant history for all fish in each participant-leased 
finfish site.
    (7) Maintain, and make available to the ISA Program Veterinarian 
upon request, mortality data for each participant-leased finfish site 
and pen in production.
    (8) Cooperate with and assist APHIS in the completion of 
biosecurity audits at all participant-leased finfish sites and 
participant-operated vessels involved in salmonid aquaculture. 
(Approved by the Office of Management and Budget under control number 
0579-0192).

    Done in Washington, DC, this 5th day of April 2002.
Bill Hawks,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 02-8779 Filed 4-10-02; 8:45 am]
BILLING CODE 3410-34-P