[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  

[[Page 62699]]


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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

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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