[Federal Register Volume 62, Number 227 (Tuesday, November 25, 1997)]
[Proposed Rules]
[Pages 62699-62707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30944]
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Proposed Rules
Federal Register
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This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 62, No. 227 / Tuesday, November 25, 1997 /
Proposed Rules
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 353
[Docket No. 95-071-1]
RIN 0579-AA75
Export Certification; Accreditation of Non-Government Facilities
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: We are proposing to amend the export certification regulations
to provide for the establishment of a program under which non-
government facilities could become accredited to perform specific
laboratory testing or phytosanitary inspection services that could
serve as the basis for the issuance of a Federal phytosanitary
certificate, export certificate for processed plant products, or
phytosanitary certificate for reexport. The accreditation criteria for
particular laboratory testing and phytosanitary inspection services
would be developed by the Animal and Plant Health Inspection Service in
cooperation with other interested government, industry, academic, or
research entities. Currently, only tests conducted by public
laboratories or inspections carried out by Federal, State, or county
inspectors or by agents may be used as the basis for the issuance of
Federal certificates. The proposed accreditation program would provide
a mechanism for qualified non-government facilities to become
accredited to perform testing or inspection services that may be used
as supporting documentation for the issuance of certificates for
certain plants or plant products.
DATES: Consideration will be given only to comments received on or
before January 26, 1998.
ADDRESSES: Please send an original and three copies of your comments to
Docket No. 95-071-1, Regulatory Analysis and Development, PPD, APHIS,
Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please
state that your comments refer to Docket No. 95-071-1. Comments
received may be inspected at USDA, room 1141, South Building, 14th
Street and Independence Avenue SW., Washington, DC, between 8 a.m. and
4:30 p.m., Monday through Friday, except holidays. Persons wishing to
inspect comments are requested to call ahead on (202) 690-2817 to
facilitate entry into the comment reading room.
FOR FURTHER INFORMATION CONTACT: Mr. Narcy G. Klag, Operations Officer,
Port Operations, PPQ, APHIS, 4700 River Road Unit 139, Riverdale, MD
20737-1236; (301) 734-8537.
SUPPLEMENTARY INFORMATION:
Background
The export certification regulations contained in 7 CFR part 353
(referred to below as the regulations) set forth the procedures for
obtaining certification for plants and plant products offered for
export or re-export. Export certification is not required by the
regulations; rather, it is provided by the Animal and Plant Health
Inspection Service (APHIS) as a service to exporters who are shipping
plants or plant products to countries that require phytosanitary
certification as a condition of entry. After assessing the condition of
the plants or plant products intended for export, relative to the
receiving country's regulations, an inspector will issue an
internationally recognized phytosanitary certificate (PPQ Form 577), a
phytosanitary certificate for reexport (PPQ Form 579), or an export
certificate for processed plant products (PPQ Form 578), if warranted.
Since 1975, APHIS has participated with State governments in the
Cooperative Phytosanitary Export Certification Program, which allows
certain State officials, as well as APHIS officials, to issue
phytosanitary certificates, phytosanitary certificates for reexport, or
export certificates for processed plant products. Because the number of
Federal inspectors is limited, the use of State and county inspectors
is a considerable service to exporters of plants and plant products in
terms of both time and convenience.
In a final rule published in the Federal Register on April 8, 1996
(61 FR 15365-15371, Docket No. 90-117-3), we amended the export
certification regulations to, among other things: (1) Revise the
requirements for a person to qualify as an inspector; (2) allow county-
level plant regulatory officials, in addition to State and APHIS
officials, to qualify as inspectors; (3) allow persons other than
inspectors--those persons being referred to as ``agents''--to perform
phytosanitary field inspections; and (4) provide for an industry-based
certification, under certain conditions, of certain low-risk plant
products such as kiln-dried lumber offered for export. Those amendments
were intended, in part, to provide additional qualified personnel and
export certification options in order to relieve some of the demands
placed upon the existing pool of inspectors by increasingly stringent
foreign import requirements and dwindling Federal and State budgets.
In this document, we are proposing to further broaden the options
for inspection and export certification by establishing regulations
under which non-government facilities such as commercial laboratories
and private inspection services could become accredited by APHIS to
perform specific laboratory testing or phytosanitary inspection
services that could serve as the basis for the issuance of a Federal
phytosanitary certificate, phytosanitary certificate for reexport, or
export certificate for processed plant products. This proposed approach
is consistent with current international trends toward industry self-
certification and is based upon the recent efforts of a working group
within the North Atlantic Plant Protection Organization (NAPPO) to
draft standards for the accreditation of laboratories performing
phytosanitary and other export certification activities to ensure
compliance with import requirements for products moving into or within
the regional territories of the NAPPO member countries (Canada, Mexico,
and the United States).
The regulations proposed in this document would establish a means
by which non-government facilities could be accredited by APHIS to
perform certain functions related to phytosanitary export
certification. It is important to note, however, that these proposed
regulations would only establish a template upon which accreditation
programs for specific functions could be developed--these proposed
regulations would not establish specific accreditation
[[Page 62700]]
standards for, by way of example, a private laboratory seeking to be
accredited to perform virus testing on plant material intended for
export. Rather, specific accreditation standards would be developed as
demand dictates. If, for example, a private laboratory wishes to
perform virus testing on plant material intended for export, APHIS
would work with that laboratory, and any other similarly situated
laboratory, as well as with any other appropriate and interested
government, industry, academic, or research entity, to identify and
develop the appropriate specific standards against which the private
laboratory's ability and competence to perform that virus testing could
be judged. Once completed, those standards would be reviewed by APHIS
and its cooperators and published in the Federal Register for comment.
Once approved and published as a final rule, they would become the
standard for the accreditation of non-government facilities to perform
virus testing of plant material intended for export. Such standards
would be published in 7 CFR part 353.
We believe that this proposed approach is beneficial in two ways:
First, it would be difficult, if not impossible, for APHIS to develop a
single, one-size-fits-all set of standards for the numerous disciplines
that play a role in phytosanitary export certification. Secondly, the
proposed approach would allow APHIS to develop specific standards with
the participation of those best able to recommend valid scientific
criteria, i.e., the government, academic, and private-sector
individuals who have the experience and expertise in the particular
area for which specific standards are being developed.
Proposed Regulations
To establish this proposed accreditation program, we would first
amend Sec. 353.1 to add a definition of non-government facility, which
we would define as ``laboratory, research facility, inspection service,
or other entity that is maintained, at least in part, for the purpose
of providing laboratory testing or phytosanitary inspection services
and that is not operated by the Federal Government or by the government
of a State or a subdivision of a State.'' We believe that laboratories,
research facilities, or inspection services are the types of entities
most likely to seek accreditation under the proposed regulations. By
excluding facilities operated by Federal, State, county, or local
governments, the intent is that the accreditation program is to apply
only to private entities. The involvement of government-run facilities
in phytosanitary export certification is already covered under the
current regulations in part 353; it is not our intent to require
facilities operated by any level of Federal or State government to
become accredited.
The regulations in Sec. 353.7 currently state, with regard to the
issuance of certificates, that the Administrator of APHIS may authorize
inspectors to issue phytosanitary certificates, phytosanitary
certificates for reexport, or export certificates for processed plant
products on the basis of inspections made by cooperating Federal,
State, and county agencies. Therefore, to accommodate the proposed
accreditation program, we are proposing to amend paragraphs (a), (b),
and (c) of Sec. 353.7 to further provide that the Administrator may
also authorize inspectors to issue those certificates on the basis of a
laboratory test or an inspection conducted by a non-government facility
that has been accredited in accordance with Sec. 353.8, which is a new
section that we would add to the regulations to spell out the specific
provisions of the proposed accreditation program.
The proposed new Sec. 353.8 would be divided into three main
paragraphs: Paragraph (a) would serve to describe the accreditation
program, paragraph (b) would set out the criteria for accreditation,
and paragraph (c) would discuss the fees related to the accreditation
program. These three paragraphs are discussed in greater detail below.
Paragraph (a) of proposed Sec. 353.8 would begin by stating that
the Administrator may accredit a non-government facility to perform
specific laboratory testing or phytosanitary inspection services if the
Administrator determines that the facility meets the criteria for
accreditation found in paragraph (b). (Note: The term ``Administrator''
is used in this document, as it is used throughout APHIS' regulations,
to mean the Administrator of APHIS or any person authorized to act for
the Administrator.) A list of accredited non-government facilities
could be obtained by writing to APHIS.
To determine whether or not a facility meets the criteria for
accreditation, APHIS would conduct an assessment of the facility and
its fitness to conduct the testing or inspection services for which it
is seeking accreditation. A description of the assessment process is
found below in the discussion of the criteria for accreditation.
Paragraph (a)(2) of proposed Sec. 353.8 describes the conditions
under which the Administrator could deny accreditation to a non-
government facility or withdraw the accreditation that had been
previously granted to a facility. Clearly, a facility would have to be
able to meet and comply with the standards identified as being
necessary for the accurate and reliable execution of the testing or
inspection services for which it has been, or is seeking to be,
accredited. Therefore, the proposed regulations would provide that the
Administrator could deny accreditation to a facility that APHIS
determines, through its pre-accreditation assessment, does not meet the
criteria for accreditation and has failed to take the remedial action
recommended to correct identified deficiencies. Similarly, the
Administrator could withdraw the accreditation of an accredited
facility if APHIS determined that the facility was not adhering to the
criteria for the maintenance of accreditation and had failed to take
the remedial action recommended to correct the identified deficiencies.
If APHIS denied a facility's application for accreditation, the
operator of the facility would be informed of the reasons for the
denial and would be afforded the opportunity to appeal the decision to
the Administrator. To ensure that there would be an informed and timely
review of the appeal, the operator's appeal would have to be in writing
and submitted within 10 days after receiving notification of the denial
and would have to include all of the facts and reasons upon which the
operator was relying to show that the facility had been wrongfully
denied accreditation. The Administrator would then grant or deny the
operator's appeal in writing as promptly as circumstances permitted,
with the response stating the reasons for his or her decision. If there
was a conflict as to any material fact regarding the denial or the
reasons for the denial, a hearing would be held to resolve the conflict
under rules of practice adopted by the Administrator.
The withdrawal of a facility's accreditation would be handled in
much the same way. The operator of the facility would be informed of
the reasons for the proposed withdrawal before any action was taken and
given the opportunity to appeal the proposed withdrawal. The appeal
would have to be in writing and submitted to the Administrator within
10 days after the operator was informed of the reasons for the proposed
withdrawal. The appeal would have to include all of the facts and
reasons upon which the operator of the facility was relying to show
that the reasons for the proposed withdrawal
[[Page 62701]]
were incorrect or did not support the withdrawal of the facility's
accreditation. The Administrator would grant or deny the appeal in
writing as promptly as circumstances permitted and would state the
reason for his or her decision. If there was a conflict as to any
material fact regarding the proposed withdrawal or the reasons for the
proposed withdrawal, a hearing would be held to resolve the conflict
under rules of practice adopted by the Administrator. However, the
proposed regulations would provide that the withdrawal of a facility's
accreditation could become effective before a final determination was
made regarding an appeal if the Administrator determined that an
immediate withdrawal was necessary to protect the public health,
interest, or safety. In such a case, the withdrawal would be effective
at the time APHIS notifies the operator of the facility either orally
or in writing. In the event of an oral notification, a written
confirmation would be given to the operator as promptly as
circumstances allowed. The withdrawal would continue in effect pending
the completion of the withdrawal and appeal proceedings, and any
subsequent judicial review of those proceedings, unless the
Administrator ordered otherwise.
The proposed regulations also would provide that the Administrator
would withdraw a facility's accreditation if the operator of the
facility informed APHIS in writing that the facility wished to
terminate its accredited status.
We would allow a non-government facility that has had its
application for accreditation denied or its accreditation withdrawn to
reapply for accreditation using the same application procedures
provided for first-time applicants. However, if the facility's
accreditation had been denied or withdrawn because it failed to meet or
comply with the standards for accreditation, we would require the
facility operator to include written documentation with the application
that specified what actions had been taken to correct the conditions
that led to the denial or withdrawal of the facility's accreditation.
It is likely that a pre-accreditation assessment of a reapplying
facility would place added emphasis on those areas in which the
facility had been deficient, so the documentation describing the
actions taken to correct those deficiencies would be useful when
determining the scope and design of the assessment.
Because a facility may need to disclose confidential business
information to APHIS during the course of its pre-accreditation
assessment or during the term of its accreditation, paragraph (a) of
proposed Sec. 353.8 would conclude by stating that all information
gathered by APHIS during its accreditation-related activities would be
treated with the appropriate level of confidentiality. As set forth in
the U.S. Department of Agriculture's (USDA's) administrative
regulations in 7 CFR 1.11, the USDA is responsible for making the final
determination with regard to the disclosure or nondisclosure of
information submitted by a business, but the policy of the USDA is to
obtain and consider the views of the submitter of any privileged or
confidential business information and to provide the submitter the
opportunity to object to the disclosure of such information.
Pre-Accreditation Assessment
Paragraph (b) of proposed Sec. 353.8 would set out the criteria for
the achievement and retention of accreditation. The paragraph would
begin by stating that specific standards for accreditation in a
particular area of laboratory testing or phytosanitary inspection could
be obtained by writing to APHIS. However, as discussed previously in
this document, specific standards have not yet been developed for any
area of accreditation. Rather, it is our intention that specific
standards would be developed in the future on an ``as needed'' basis
when a non-government facility informs APHIS that it would like to
become accredited in a particular area of laboratory testing or
phytosanitary inspection. Once standards in a particular area have been
developed and adopted by APHIS, those standards would be available to
non-government facilities that may wish to become similarly accredited.
Because accreditation standards under the proposed regulations
would, at least initially, have to be drafted and adopted before the
assessment process could begin, the proposed regulations would provide
for APHIS' development of standards. Therefore, paragraph (b)(1) would
state that if specific standards for accreditation in a particular area
of laboratory testing or phytosanitary inspection had not been
identified by APHIS, the Administrator would develop the appropriate
specific standards applicable to accreditation in that particular area.
The regulations would further provide that APHIS would place a notice
in the Federal Register to inform the public of the opportunity to
participate in the development of those standards by submitting
suggested criteria or recommending particular considerations that may
need to be addressed in the standards. This proposed approach would
ensure that APHIS' resources are focused on those areas in which
facilities are interested in obtaining accreditation and allow for
standards to be prepared through a collaborative, cooperative process
that provides for the participation of all interested parties,
including the operator of the non-government facility seeking
accreditation and any other interested governmental, industry,
academic, or research entity.
Once accreditation standards are promulgated, the operator of a
non-government facility seeking accreditation would begin the
accreditation process by submitting an application to APHIS. The first
items on the application would be the legal name and full address of
the facility and the name, address, telephone number, and fax number of
the operator of the facility or his or her authorized representative.
These items would enable APHIS to identify the facility for its records
and contact the facility's operator or an authorized representative as
the pre-accreditation assessment process begins and during the term of
the facility's accreditation.
The application would then have to contain a description of the
facility itself. This information would enable APHIS to understand the
nature of the facility, i.e., whether the facility is a stand-alone
building or is located within a larger office or laboratory building,
what the facility's primary function is and the scope of operations
within the facility, and, if applicable, the relationship the facility
has to a larger corporate entity. This type of information would give
APHIS a frame of reference as it considers the suitability of the
facility for the type of work it is seeking to perform under the
accreditation program and would provide a starting point for the design
of a pre-accreditation assessment. The application would conclude with
a description of the specific laboratory testing or phytosanitary
inspection services for which the facility is seeking accreditation.
The completed application would then have to be signed by the operator
of the facility or his or her authorized representative.
After it had received the completed application, APHIS would review
the application to identify the scope of the assessment that would be
necessary to adequately review the facility's fitness to conduct the
laboratory testing or phytosanitary inspection services for which it is
seeking accreditation. Through that review, APHIS would determine the
number of assessors needed for an assessment team, the fields of
expertise that should be
[[Page 62702]]
represented on the team, and the means by which the facility's
competence to conduct the applicable laboratory tests or phytosanitary
inspections could be evaluated.
Once the scope of the assessment has been defined, APHIS could
identify the individuals who would comprise the assessment team,
determine the materials that would be needed for the assessment, and
project the length of the assessment process, which would allow APHIS
to develop an estimate of the expenses that would be incurred by the
government in the course of the pre-accreditation assessment process.
Those expenses would have to be reimbursed by the facility seeking
accreditation, so APHIS would provide the estimate to the operator of
the facility before embarking upon any activities that would result in
costs being incurred.
Before the assessment of a facility could begin, the operator of
the facility would have to agree, in writing, to allow the assessment
team access to its facilities, supply the team with the information it
needs to evaluate the facility, and to enter into a trust fund
agreement with APHIS to pay the assessment fee regardless of the
assessment's outcome (i.e., even if the assessment team recommends that
the facility not be accredited), and, if accreditation is granted, to
pay the charges related to the subsequent maintenance of the facility's
accreditation, such as laboratory fees for the corroboration of check
tests. (The specific provisions of the trust fund agreement are
explained below under ``Fees and Trust Fund Agreement.'') Once the
operator of the facility had agreed, in writing, to these terms, APHIS
would assemble the assessment team and commence the assessment as soon
as circumstances permitted.
The assessment itself would focus on four major areas: Physical
plant, equipment, methods of testing or inspection, and personnel. The
assessment team would compare the facility's performance in those areas
against the specific accreditation standards that had been identified
for the particular laboratory testing or phytosanitary inspection
services for which the facility was seeking accreditation. The four
areas are explained in greater detail below.
Physical Plant
The facility's physical plant would have to meet the criteria
identified in the accreditation standards as necessary to properly
conduct the laboratory testing or phytosanitary inspection services for
which it seeks accreditation. For example, a facility that wished to be
accredited to perform laboratory testing would have to have adequate
laboratory space in which to perform the testing, storage space for
holding samples and supplies, and office space for preparing reports
and other documentation.
Equipment
The assessment team would determine whether the facility's
personnel had unrestricted access to the equipment identified in the
accreditation standards as necessary to properly conduct the laboratory
testing or phytosanitary inspection services for which it seeks
accreditation. To continue with the example in the previous paragraph,
a facility seeking accreditation for laboratory testing would have to
have the microscopes, computers, scales, analyzers, etc. that would be
necessary for the facility to properly conduct that laboratory testing.
The assessment team would also verify, where appropriate, that
calibration and monitoring of the required equipment is documented and
conforms to prescribed standards.
Methods of Testing or Inspection
To ensure that the facility was employing scientifically valid and
up-to-date methodology to conduct its laboratory testing or
phytosanitary inspection activities, the assessment team would review
the facility's quality manual or other equivalent documentation that
described the system in place at the facility for the conduct of the
laboratory testing or phytosanitary inspection services for which the
facility seeks accreditation. The assessors would verify that the
manual was available to, and in use by, the facility personnel who
perform the services and that the methods and procedures described in
the manual were equal to those identified in the accreditation
standards.
Personnel
The assessment team would also review the qualifications of the
facility's personnel, both management and staff, who were responsible
for the testing or inspection services for which the facility was
seeking accreditation. Those personnel, who would have to be identified
to the assessment team, would have to possess the training, education,
or experience identified in the accreditation standards as necessary to
properly conduct the testing or inspection services for which the
facility was seeking accreditation, and that training, education, or
experience would have to be documented. If the particular accreditation
standards under which the facility was being reviewed allowed for the
use of subcontractors, the assessment team would also review the
qualifications of any subcontractors used by the facility in connection
with its laboratory testing or phytosanitary inspection activities.
Retaining Accreditation
Once accredited, the non-government facility would have to observe
several conditions to maintain its accreditation. First, the facility
would have to continue to observe the specific standards applicable to
its area of accreditation, i.e., the standards by which it was judged
in its initial, pre-accreditation assessment. To give APHIS the ability
to monitor the facility's compliance with those standards, the facility
would have to agree to be assessed and evaluated on a periodic basis
through proficiency tests or check samples and be able to demonstrate
on request that it is able to perform the tests or inspection services
for which it was accredited. If, in the course of an assessment or
evaluation, APHIS identifies any deficiencies in the facility or in its
conduct of testing or inspection activities, the operator of the
facility would have to ensure that those deficiencies are resolved.
Because the facility's accreditation would have been based largely
on APHIS' review and acceptance of specific elements in place at the
facility at the time of the assessment, we would require that the
facility notify APHIS when those elements changed. Specifically, we
would require that the operator of the facility notify APHIS when there
are any changes in key management personnel or facility staff
accountable for the testing or inspection services for which the
facility has been accredited. We would also require the operator of the
facility to report any changes involving the location, ownership,
physical plant, equipment, or other conditions that existed at the
facility at the time accreditation was granted.
Fees and Trust Fund Agreement
To cover the costs of APHIS' involvement in the assessment process,
the operator of the facility seeking accreditation would have to enter
into a trust fund agreement with APHIS. Under the agreement, the
operator of the facility would pay in advance all estimated costs that
APHIS expected to incur through its involvement in the pre-
accreditation assessment process and the maintenance of the facility's
accreditation. Those costs would include administrative expenses
incurred in those activities, such as laboratory fees for evaluating
check test
[[Page 62703]]
results, and all salaries (including overtime and the Federal share of
employee benefits), travel expenses (including per diem expenses), and
other incidental expenses incurred by the APHIS in performing those
activities. The agreement would require the operator of the facility to
deposit a certified or cashier's check with APHIS for the amount of the
costs, as estimated by APHIS. If the deposit was not sufficient to meet
all costs incurred by APHIS, the agreement would further require the
operator of the facility to deposit another certified or cashier's
check with APHIS for the amount of the remaining costs, as determined
by APHIS, before APHIS' services would be completed. After a final
audit at the conclusion of the pre-accreditation assessment, any
overpayment of funds would be returned to the operator of the facility
or held on account until needed for future activities related to the
maintenance of the facility's accreditation.
Executive Order 12866 and Regulatory Flexibility Act
This proposed 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.
This proposed rule would amend the export certification regulations
to provide for the establishment of a program under which non-
government facilities could become accredited to perform specific
laboratory testing or phytosanitary inspection services that could
serve as the basis for the issuance of Federal phytosanitary
certificates, phytosanitary certificates for reexport, or an export
certificates for processed plant products. The accreditation criteria
for particular laboratory testing and phytosanitary inspection services
would be developed by APHIS with the participation of other interested
governmental, industry, academic, or research entities. Currently, only
tests conducted by public laboratories or inspections carried out by
Federal, State, or county inspectors or by agents may be used as the
basis for the issuance of a Federal certificate. The proposed
accreditation program would provide a mechanism for qualified non-
government facilities to become accredited to perform the testing or
inspection services that may be used as supporting documentation for
the issuance of Federal certificates for the export or reexport of
certain plants or plant products.
The regulations proposed in this document are intended only to
provide a framework upon which accreditation programs for specific
functions could be established, so they would not, in and of
themselves, entail any costs to APHIS or any non-government facility.
However, any specific accreditation program that would be established
under these proposed regulations would entail costs to both the
entities being accredited and the accrediting body, i.e., APHIS.
Because the accreditation program is expected to be self-supporting,
the costs to APHIS would be recouped through accreditation fees. The
fees charged by APHIS in connection with the initial accreditation of a
non-government facility and the maintenance of that accreditation
would, therefore, have to be adequate to recover the costs incurred by
the government in the course of APHIS' accreditation activities. We
expect that the costs that would have to be reimbursed would be largely
attributable to the cost of transportation for the assessors to travel
to the site of the facility, lodging for the assessors, their salary
and per diem, any laboratory fees charged for evaluating check test
results, and administrative expenses. Costs for specific accreditation
programs would vary depending on the range of activities for which a
facility was seeking accreditation, the number of assessors needed to
adequately conduct a pre-accreditation assessment, the type and number
of any proficiency tests that would have to be conducted, and the
frequency with which post-accreditation evaluation activities such as
check tests and site visits would have to be conducted.
The proposed regulations would stipulate that APHIS would provide
an estimate of its anticipated fees to the operator of the facility
prior to undertaking any activities that would result in fees being
charged to a facility. Participation in any accreditation program
developed under these proposed regulations would be voluntary. At this
time, we estimate that 15 individual non-government facilities would be
likely to seek and maintain accreditation annually on about 82
accredited procedures, as long as the costs of participating in an
accreditation program are lower than the benefits they receive from the
program. As a result, this program would have to meet the test of the
marketplace.
The domestic seed industry, through the American Seed Trade
Association, has indicated its interest in establishing an
accreditation program for seed health testing and field inspection of
seed, so we have used the domestic seed industry to illustrate the
potential benefits that could result from the establishment of specific
accreditation programs.
The seed industry would likely benefit from the establishment of an
accreditation program because domestic seed exporters routinely require
the services of inspectors and agents in order to obtain the
phytosanitary certification required by most, if not all, importing
countries; the benefits would be realized in terms of more timely
certifications, which in turn could lead to reduced costs as well as
increased U.S. exports.
The value of seed exported from the United States to other
countries continues to grow rapidly, from $665 million in 1994-95 (July
to June), to $705 million in 1995-96, to more than $800 million
projected for 1996-97. There has been a concomitant rise in demand for
laboratory testing and phytosanitary inspection services to meet other
countries' import requirements. The ability of Federal, State, and
county testing and inspection services to meet this growing demand will
be increasingly strained. Already there are instances in which the
accreditation of non-government facilities would have prevented the
loss of export sales.
For example, some seed export opportunities have been forfeited
because the results of pre-harvest field inspections are usually not
known until after harvest. It is common for seed from several fields to
be blended before shipment. If the sample from one field is
subsequently reported to contain an actionable pest, then none of the
blended seed--which may have been harvested from as many as eight or
nine fields--could be exported. In one case in which this occurred, the
affected seed company lost foreign sales worth $250,000. Such losses
would be much less likely to occur if there were more timely reporting
of pre-harvest inspections; accredited non-government inspection
facilities could make timely reporting a reality. In general, non-
government testing and inspection services could be expected to be
completed with minimal delay, leading to greater marketing flexibility
and lower risk of lost sales.
Additional benefits, of even greater potential significance, would
be gained through the standardization of testing and inspection
protocols that would result from the establishment of accreditation
standards, particularly when internationally recognized standards are
used. Major seed trading partners of the United States, such as
[[Page 62704]]
Canada, France, and The Netherlands, have national seed health
organizations that address seed health issues in part by employing
laboratory accreditation protocols. The standards that would underlie
accreditation of non-government facilities in the United States could
help lead to the removal of discrepancies among foreign phytosanitary
regulations, thereby expediting U.S. seed exports.
Accreditation of non-government facilities, by promoting more
streamlined exports based on internationally recognized standards,
could be expected to benefit other export sales besides those of the
seed industry. As a self-supporting system, private firms that expect
benefits in excess of costs of accreditation would participate. In
addition to the net benefits received by these firms directly, society
as a whole would benefit from enhanced trade.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action would
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12372
This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 7 CFR part 3015, subpart V.)
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. If this proposed rule is adopted: (1) All State
and local laws and regulations that are inconsistent with this rule
will be preempted; (2) no retroactive effect will be given to this
rule; and (3) administrative proceedings will not be required before
parties may file suit in court challenging this rule.
Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection or
recordkeeping requirements included in this proposed rule have been
submitted for approval to the Office of Management and Budget (OMB).
Please send written comments to the Office of Information and
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington,
DC 20503. Please state that your comments refer to Docket No. 95-071-1.
Please send a copy of your comments to: (1) Docket No. 95-071-1,
Regulatory Analysis and Development, PPD, APHIS, suite 3C03, 4700 River
Road Unit 118, Riverdale, MD 20737-1238, and (2) Clearance Officer,
OIRM, USDA, room 404-W, 14th Street and Independence Avenue SW.,
Washington, DC 20250. A comment to OMB is best assured of having its
full effect if OMB receives it within 30 days of publication of this
proposed rule.
This proposed rule would provide for the establishment of a program
under which non-government facilities could become accredited to
perform specific laboratory testing or phytosanitary inspection
services that could serve as the basis for the issuance of a Federal
phytosanitary certificate, export certificate for processed plant
products, or phytosanitary certificate for reexport. This proposed
accreditation program would provide a mechanism for qualified non-
government facilities to become accredited to perform testing or
inspection services that may be used as supporting documentation for
the issuance of certificates for certain plants or plant products.
Launching this accreditation program would necessitate that APHIS
use a number of information collection activities to ensure that non-
government facilities participating or seeking to participate in the
program possess the necessary qualifications. Therefore, we are seeking
OMB approval to employ the following information collection activities
in connection with the APHIS export certification program:
Application for accreditation: The operator of a non-government
facility who wishes to be accredited in a particular area of laboratory
testing or phytosanitary inspection must submit an application to
APHIS. The application must contain the legal name and full address of
the facility; the name, address, telephone, and fax number of the
facility's operator; a description of the facility; and a description
of the specific laboratory testing or phytosanitary inspection services
for which the facility is seeking accreditation.
Agreement to fulfill accreditation procedure: Before APHIS will
assess a non-government facility to determine whether it meets the
standards for accreditation, the operator of the facility must sign an
agreement with APHIS. Specifically, the operator must agree to supply
any information needed for the evaluation of the facility, pay the fees
charged for the assessment, and accept the charges related to the
subsequent maintenance of the facility's accreditation.
Documentation of equipment: The equipment used in the non-
government facility (microscopes, computers, etc.) must be calibrated
and monitored to ensure that it conforms to the standards for
accreditation. This calibration and monitoring must be documented by
facility personnel.
Quality manual or equivalent documentation: The operator of a non-
government facility is responsible for maintaining a quality manual or
similar documentation at the facility that describes the system in
place for conducting the laboratory testing or phytosanitary inspection
services for which the faculty is accredited. The manual must be
available to and used by facility personnel performing the work.
Identity of personnel and subcontractor's qualifications: The
personnel employed at the non-government facility must be identified
and possess the training, education, or experience necessary to perform
the laboratory testing or phytosanitary inspection services for which
the facility is accredited. The operator of the facility is responsible
for acquiring and maintaining documentation concerning the training,
education, and experience of facility personnel. If the non-government
facility uses a subcontractor to perform some of its testing or
inspection services, the qualifications of the subcontractor must be
documented and made available to APHIS. The facility operator is
responsible for acquiring and maintaining this documentation.
Notification of changes in personnel: The facility operator must
notify APHIS whenever the facility undergoes any change in personnel.
This notification may be written, communicated via telephone, or by any
other means of communication convenient to the facility's operator.
Report changes in location or ownership: The facility operator must
notify APHIS if the facility moves its operations to a new location,
undergoes an ownership change, replaces equipment, or experiences any
other changes in the conditions that existed at the time the facility
received its accreditation. This notification may be written,
communicated via telephone, or by any other means of communication
convenient to the facility's operator.
We are soliciting comments from the public (as well as affected
agencies) concerning our proposed information collection and
recordkeeping requirements. We need this outside input to help us:
(1) Evaluate whether the proposed information collection is
necessary for the proper performance of our agency's
[[Page 62705]]
functions, including whether the information will have practical
utility;
(2) Evaluate the accuracy of our estimate of the burden of the
proposed 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 3.609 hours per response.
Respondents: Operators of non-government facilities who wish to be
accredited to perform laboratory testing or phytosanitary inspection
services in connection with APHIS' export certification program and
certain employees of such non-government facilities.
Estimated number of respondents: 15.
Estimated number of responses per respondent: 5.466.
Estimated annual number of responses: 82.
Estimated total annual burden on respondents: 296 hours.
Copies of this information collection can be obtained from
Clearance Officer, OIRM, USDA, room 404-W, 14th Street and Independence
Avenue SW., Washington, DC 20250.
All responses to this notice will be summarized and included in the
request for OMB approval. All comments will also become a matter of
public record.
Regulatory Reform
This action is part of the President's Regulatory Reform
Initiative, which, among other things, directs agencies to remove
obsolete and unnecessary regulations and to find less burdensome ways
to achieve regulatory goals.
List of Subjects in 7 CFR Part 353
Exports, Plant diseases and pests, Reporting and recordkeeping
requirements.
Accordingly, 7 CFR part 353 would be amended as follows:
PART 353--EXPORT CERTIFICATION
1. The authority citation for part 353 would continue to read as
follows:
Authority: 7 U.S.C. 147a; 21 U.S.C. 136 and 136a; 44 U.S.C. 35;
7 CFR 2.22, 2.80, and 371.2(c).
2. In Sec. 353.1, a definition of non-government facility would be
added, in alphabetical order, to read as follows:
Sec. 353.1 Definitions.
* * * * *
Non-government facility. A laboratory, research facility,
inspection service, or other entity that is maintained, at least in
part, for the purpose of providing laboratory testing or phytosanitary
inspection services and that is not operated by the Federal Government
or by the government of a State or a subdivision of a State.
* * * * *
3. In Sec. 353.7, paragraphs (a)(4), (b)(4), and (c)(4) would each
be amended by adding a new sentence at the end of each paragraph to
read as follows:
Sec. 353.7 Certificates.
(a) * * *
(4) * * * The Administrator may also authorize inspectors to issue
a certificate on the basis of a laboratory test or an inspection
performed by a non-government facility accredited in accordance with
Sec. 353.8.
* * * * *
(b) * * *
(4) * * * The Administrator may also authorize inspectors to issue
a certificate on the basis of a laboratory test or an inspection
performed by a non-government facility accredited in accordance with
Sec. 353.8.
* * * * *
(c) * * *
(4) * * * The Administrator may also authorize inspectors to issue
a certificate on the basis of laboratory test or an inspection
performed by a non-government facility accredited in accordance with
Sec. 353.8.
* * * * *
4. A new Sec. 353.8 would be added to read as follows:
Sec. 353.8 Accreditation of non-government facilities.
(a) The Administrator may accredit a non-government facility to
perform specific laboratory testing or phytosanitary inspection
services if the Administrator determines that the non-government
facility meets the criteria of paragraph (b) of this
section.1
---------------------------------------------------------------------------
\1\ A list of accredited non-government facilities may be
obtained by writing to Port Operations, PPQ, APHIS, 4700 River Road
Unit 139, Riverdale, MD 20737-1236.
---------------------------------------------------------------------------
(1) A non-government facility's compliance with the criteria of
paragraph (b) of this section shall be determined through an assessment
of the facility and its fitness to conduct the laboratory testing or
phytosanitary inspection services for which it seeks to be accredited.
If, after evaluating the results of the assessment, the Administrator
determines that the facility meets the accreditation criteria, the
facility's application for accreditation will be approved.
(2) The Administrator may deny accreditation to, or withdraw the
accreditation of, any non-government facility to conduct laboratory
testing or phytosanitary inspection services upon a determination that
the facility does not meet the criteria for accreditation or
maintenance of accreditation under paragraph (b) of this section and
has failed to take the remedial action recommended to correct
identified deficiencies.
(i) In the case of a denial, the operator of the facility will be
informed of the reasons for the denial and may appeal the decision in
writing to the Administrator within 10 days after receiving
notification of the denial. The appeal must include all of the facts
and reasons upon which the person relies to show that the facility was
wrongfully denied accreditation. The Administrator will grant or deny
the appeal in writing as promptly as circumstances permit, stating the
reason for his or her decision. If there is a conflict as to any
material fact, a hearing will be held to resolve the conflict. Rules of
practice concerning the hearing will be adopted by the Administrator.
(ii) In the case of withdrawal, before such action is taken, the
operator of the facility will be informed of the reasons for the
proposed withdrawal. The operator of the facility may appeal the
proposed withdrawal in writing to the Administrator within 10 days
after being informed of the reasons for the proposed withdrawal. The
appeal must include all of the facts and reasons upon which the person
relies to show that the reasons for the proposed withdrawal are
incorrect or do not support the withdrawal of the accreditation of the
facility. The Administrator will grant or deny the appeal in writing as
promptly as circumstances permit, stating the reason for his or her
decision. If there is a conflict as to any material fact, a hearing
will be held to resolve the conflict. Rules of practice concerning the
hearing will be adopted by the Administrator. However, withdrawal shall
become effective pending final determination in the proceeding when the
Administrator determines that such action is necessary to protect the
public health, interest, or safety. Such withdrawal will be effective
upon oral or written notification, whichever is earlier, to the
operator of the facility. In the event of oral notification, written
[[Page 62706]]
confirmation will be given as promptly as circumstances allow. This
withdrawal will continue in effect pending the completion of the
proceeding, and any judicial review thereof, unless otherwise ordered
by the Administrator.
(3) The Administrator will withdraw the accreditation of a non-
government facility if the operator of the facility informs APHIS in
writing that the facility wishes to terminate its accredited status.
(4) A non-government facility whose accreditation has been denied
or withdrawn may reapply for accreditation using the application
procedures in paragraph (b) of this section. If the facility's
accreditation was denied or withdrawn under the provisions of paragraph
(a)(2) of this section, the facility operator must include with the
application written documentation specifying what actions have been
taken to correct the conditions that led to the denial or withdrawal of
accreditation.
(5) All information gathered during the course of a non-government
facility's assessment and during the term of its accreditation will be
treated by APHIS with the appropriate level of confidentiality, as set
forth in the U.S. Department of Agriculture's administrative
regulations in Sec. 1.11 of this title.
(b) Criteria for accreditation of non-government facilities. (1)
Specific standards for accreditation in a particular area of laboratory
testing or phytosanitary inspection are set forth in this part and may
be obtained by writing to APHIS. If specific standards for
accreditation in a particular area of laboratory testing or
phytosanitary inspection have not been promulgated by APHIS, the
Administrator will develop appropriate standards applicable to
accreditation in the area for which the non-government facility is
seeking accreditation and publish a notice of proposed rulemaking in
the Federal Register to inform the public and other interested persons
of the opportunity to comment on and participate in the development of
those standards.
(2) The operator of a non-government facility seeking accreditation
to conduct laboratory testing or phytosanitary inspection shall submit
an application to the Administrator. The application must be completed
and signed by the operator of the facility or his or her authorized
representative and must contain the following:
(i) Legal name and full address of the facility;
(ii) Name, address, and telephone and fax number of the operator of
the facility or his or her authorized representative;
(iii) A description of the facility, including its physical plant,
primary function, scope of operation, and, if applicable, its
relationship to a larger corporate entity; and
(iv) A description of the specific laboratory testing or
phytosanitary inspection services for which the facility is seeking
accreditation.
(3) Upon receipt of the application, APHIS will review the
application to identify the scope of the assessment that will be
required to adequately review the facility's fitness to conduct the
laboratory testing or phytosanitary inspection services for which it is
seeking accreditation. Before the assessment of the facility begins,
the applicant's representative must agree, in writing, to fulfill the
accreditation procedure, especially to receive the assessment team, to
supply any information needed for the evaluation of the facility, and
to enter into a trust fund agreement as provided by paragraph (c) of
this section to pay the fees charged to the applicant facility
regardless of the result of the assessment and to pay the charges of
subsequent maintenance of the accreditation of the facility. Once the
agreement has been signed, APHIS will assemble an assessment team and
commence the assessment as soon as circumstances permit. The assessment
team will measure the facility's fitness to conduct the laboratory
testing or phytosanitary inspection services for which it is seeking
accreditation against the specific standards identified by the
Administrator for those services by reviewing the facility in the
following areas:
(i) Physical plant. The facility's physical plant (e.g., laboratory
space, office space, greenhouses, vehicles, etc.) must meet the
criteria identified in the accreditation standards as necessary to
properly conduct the laboratory testing or phytosanitary inspection
services for which it seeks accreditation.
(ii) Equipment. The facility's personnel must possess or have
unrestricted access to the equipment (e.g., microscopes, computers,
scales, triers, etc.) identified in the accreditation standards as
necessary to properly conduct the laboratory testing or phytosanitary
inspection services for which it seeks accreditation. The calibration
and monitoring of that equipment must be documented and conform to
prescribed standards.
(iii) Methods of testing or inspection. The facility must have a
quality manual or equivalent documentation that describes the system in
place at the facility for the conduct of the laboratory testing or
phytosanitary inspection services for which the facility seeks
accreditation. The manual must be available to, and in use by, the
facility personnel who perform the services. The methods and procedures
used by the facility to conduct the laboratory testing or phytosanitary
inspection services for which it seeks accreditation must be
commensurate with those identified in the accreditation standards and
must be consistent with or equivalent to recognized international
standards for such testing or inspection.
(iv) Personnel. The management and facility personnel accountable
for the laboratory testing or phytosanitary inspection services for
which the facility is seeking accreditation must be identified and must
possess the training, education, or experience identified in the
accreditation standards as necessary to properly conduct the testing or
inspection services for which the facility seeks accreditation, and
that training, education, or experience must be documented. Any
subcontractor utilized by the facility in connection with the testing
or inspection services for which accreditation is sought must be
identified to APHIS; the subcontractor's qualifications will be
reviewed by APHIS as part of the facility's assessment.
(4) To retain accreditation, the facility must agree to:
(i) Observe the specific standards applicable to its area of
accreditation;
(ii) Be assessed and evaluated on a periodic basis by means of
proficiency testing or check samples;
(iii) Demonstrate on request that it is able to perform the tests
or inspection services representative of those for which it is
accredited;
(iv) Resolve all identified deficiencies;
(v) Notify APHIS as soon as circumstances permit of any changes in
key management personnel or facility staff accountable for the
laboratory testing or phytosanitary inspection services for which the
facility is accredited; and
(vi) Report to APHIS as soon as circumstances permit any changes
involving the location, ownership, physical plant, equipment, or other
conditions that existed at the facility at the time accreditation was
granted.
(c) Fees and trust fund agreement. The fees charged by APHIS in
connection with the initial accreditation of a non-government facility
and the maintenance of that accreditation shall be adequate to recover
the costs incurred by the government in the course of APHIS'
accreditation
[[Page 62707]]
activities. To cover those costs, the operator of the facility seeking
accreditation must enter into a trust fund agreement with APHIS under
which the operator of the facility will pay in advance all estimated
costs that APHIS expects to incur through its involvement in the pre-
accreditation assessment process and the maintenance of the facility's
accreditation. Those costs shall include administrative expenses
incurred in those activities, such as laboratory fees for evaluating
check test results, and all salaries (including overtime and the
Federal share of employee benefits), travel expenses (including per
diem expenses), and other incidental expenses incurred by the APHIS in
performing those activities. The operator of the facility must deposit
a certified or cashier's check with APHIS for the amount of the costs,
as estimated by APHIS. If the deposit is not sufficient to meet all
costs incurred by APHIS, the operator of the facility must deposit
another certified or cashier's check with APHIS for the amount of the
remaining costs, as determined by APHIS, before APHIS' services will be
completed. After a final audit at the conclusion of the pre-
accreditation assessment, any overpayment of funds will be returned to
the operator of the facility or held on account until needed for future
activities related to the maintenance of the facility's accreditation.
Done in Washington, DC, this 19th day of November 1997.
Terry L. Medley,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 97-30944 Filed 11-24-97; 8:45 am]
BILLING CODE 3410-34-P