65FR38218 Accreditation Standards for Laboratory Seed Health Testing and Seed Crop Field Inspection
robop...@us.govnews.org
Posting-number: Volume 65, Issue 119, Page 38218
[Federal Register: June 20, 2000 (Volume 65, Number 119)]
[Proposed Rules]
[Page 38218-38223]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20jn00-18]
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Proposed Rules
Federal Register
________________________________________________________________________
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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[[Page 38218]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Parts 300 and 353
[Docket No. 99-030-1]
Accreditation Standards for Laboratory Seed Health Testing and
Seed Crop Field Inspection
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 specific standards under which nongovernment facilities
could become accredited to perform laboratory seed testing and seed
crop field 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 standards for these laboratory testing and field
inspection services were developed to provide the basis for
nongovernment facilities to become accredited to perform the testing or
inspection services that may be used as supporting documentation for
the issuance of certificates for certain plants or plant products.
DATES: We invite you to comment on this docket. We will consider all
comments that we receive by August 21, 2000.
ADDRESSES: Please send your comment and three copies to: Docket No. 99-
030-1, Regulatory Analysis and Development, PPD, APHIS, Suite 3C03,
4700 River Road, Unit 118, Riverdale, MD 20737-1238. Please state that
your comment refers to Docket No. 99-030-1.
You may read any comments that we receive on this docket in our
reading room. The reading room is located in room 1141 of the USDA
South Building, 14th Street and Independence Avenue, SW., Washington,
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 690-2817 before coming.
APHIS documents published in the Federal Register, and related
information, including the names of organizations and individuals who
have commented on APHIS dockets, are available on the Internet at
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Mr. Narcy G. Klag, Program Manager,
Phytosanitary Issues Management, Operational Support, PPQ, APHIS, 4700
River Road, Unit 140, Riverdale, MD 20737-1236; (301) 734-8262.
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 reexport. 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 and county 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 benefit to exporters of plants and
plant products in terms of both time and convenience.
In a final rule published in the Federal Register on January 8,
1999 (64 FR 1098-1106, Docket No. 95-071-2), we amended the regulations
to provide for the establishment of a program under which nongovernment
facilities (referred to below as facilities) could become accredited to
perform specific laboratory seed testing or seed crop field 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. That final rule
broadened the options for persons who needed to obtain inspection and
export certification services.
The final rule stated that in order to accredit facilities,
standards would have to be developed to evaluate the capability of
facilities to perform various laboratory seed testing and seed crop
field inspection services. In Sec. 353.8(b), the regulations state,
``APHIS will develop appropriate standards applicable to accreditation
in the area for which the nongovernment 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.''
There are two reasons for this approach. First, it would be
difficult, if not impossible, for APHIS to develop a single, one-size-
fits-all set of accreditation standards for the numerous disciplines
that play a role in phytosanitary certification. Secondly, this
approach allows APHIS to develop standards with the participation of
those best able to recommend valid scientific criteria; i.e., the
government, academic, industry, research, and private-sector
individuals who have the experience and expertise in the particular
area for which standards are being developed.
This proposed rule publishes for comment standards to be used to
evaluate facilities for accreditation to perform laboratory seed
testing and seed crop field inspection.
Laboratory seed testing and seed crop field inspection comprise a
wide variety of technical tests and procedures, including both
laboratory tests and visual inspection of plants growing in fields. The
laboratory tests include procedures such as various forms of
microscopic examination, culturing microorganisms in various media and
[[Page 38219]]
subsequently identifying them, and conducting serological and DNA probe
tests of organisms. Test protocols are contained in the Reference
Manual for Laboratory Test and Phytosanitary Inspection Methodologies,
a publication of the National Seed Health System (referred to below as
Reference Manual B). A copy of Reference Manual B is available on the
APHIS Web site at http://www.aphis.usda.gov/ppq/pim/accreditation, and
Reference Manual B will be incorporated by reference into the
regulations when final action is taken on this proposal.
In Sec. 353.8(b)(3), the regulations state that when evaluating the
fitness of a facility to be accredited, APHIS will form an assessment
team that will focus on four major areas: Physical plant, equipment,
methods of testing or inspection, and personnel. The assessment team
will compare the facility's performance in these four areas against the
accreditation standards that have been identified for the particular
laboratory seed testing or seed crop field inspection services for
which the facility is seeking accreditation. The standards we propose
to establish for facilities to perform laboratory seed testing and seed
crop field inspection are discussed below.
Physical Plant
The facility's physical plant (e.g., laboratory space, office
space, greenhouses, vehicles, etc.) would have to conform to all State
and local zoning and other ordinances, to ensure consistency with State
and local laws and to prevent disruption of services that might occur
for exporters of plants and plant products if the local government
found the facility's physical plant to be in violation of local
ordinances. The facility's physical plant would have to consist of a
work area that is dedicated to laboratory functions and that has
sufficient space to conduct the required tests. Storage space for test
materials and samples would have to be large enough to accommodate the
samples within a laboratory at any given time and secure from
contamination by other samples within the laboratory and other sources.
The laboratory area would have to be enclosed by walls and have locking
doors to prevent unauthorized access.
Equipment
Equipment is the second major area evaluated when considering a
facility for accreditation under the regulations. We propose that the
facility's personnel must possess or have unrestricted access to the
equipment identified as necessary to properly conduct the laboratory
seed testing or seed crop field inspection services in accordance with
the procedures contained in Reference Manual B. Specific test
methodologies, materials, and the calibration and monitoring of the
equipment would have to conform to Reference Manual B. The general
procedures proposed are listed below.
1. Equipment for Seed Crop Field Inspections: We propose to require
that facilities accredited for seed crop field inspection services have
direct access to laboratories that are fully equipped to carry out any
required field sample diagnostics. Field inspectors would have to have
accurate field maps and transportation to the inspection site. Field
inspectors would also have to have hand lenses and secure containers
for the collection, storage, and transportation of samples.
2. Equipment for Direct Visual Examination: We propose to require
that facilities accredited to conduct visual examination of seed be
equipped with stereo microscopes. Facilities conducting visual
examination of tissues would also have to be equipped with compound
light microscopes, and those conducting visual examination of loosely
attached or accompanying material would have to be equipped with a
centrifuge and shaker.
3. Equipment for Incubation: We propose to require that facilities
accredited to conduct incubations be equipped with incubation chambers,
laminar flow hoods, media preparation equipment, scales, pH meters,
distilled and sterile water, gas burners, an autoclave, and the
appropriate media for the specified tests.
4. Equipment for Grow Out Tests: We propose to require that
facilities accredited to conduct grow out tests have greenhouse or
growth chambers or an outdoor quarantine location, plus access to a
laboratory that is fully equipped to carry out any required diagnostic
tests.
5. Equipment for Serological Tests: We propose to require that
facilities accredited to conduct serological tests be equipped with
grinding, extraction, and sample purification equipment; fluorescent
microscopes; plate readers; spectrophotometers; and the appropriate
assay materials.
6. Equipment for DNA Probes: We propose to require that facilities
accredited to conduct DNA probe tests be equipped with polymerase chain
reaction (PCR) equipment, including thermal cyclers, electrophoresis
and gel blotting equipment, and the reagents and DNA polymerases
necessary to conduct PCR.
Reference Manual B will contain the complete testing protocols and
will be updated with new and improved test protocols from time to time
in order to keep abreast of the latest technologies, new diagnostic
methods, and equipment.
Methods of Testing or Inspection
The third major area to be evaluated when considering a facility
for accreditation under the regulations would be methods of testing or
inspection. For testing and inspection to be reliable, they must be
conducted in accordance with a quality system. The generally accepted
definition of a quality system is that it is the organizational
structure, procedures, processes and resources needed to ensure quality
in the operation and products of a business. The regulations already
require that a facility establish a quality system and follow
procedures recorded in a quality manual developed by the facility, or
equivalent documentation, to ensure that the facility employs
scientifically valid and up-to-date methodology to conduct its
laboratory seed testing or seed crop field inspection activities. We
propose that, when evaluating a facility for accreditation, the
assessment team would review the facility's quality manual or other
equivalent documentation that describes the system in place at the
facility for the conduct of the laboratory seed testing or seed crop
field inspection services for which the facility seeks accreditation.
The assessors would verify that the quality manual was available to,
and in use by, the facility personnel who perform the tests or
services.
We propose that the quality system and other controls on test and
inspection methods at the facility would have to meet the following
requirements.
The quality system would have to follow the general guidelines
described in ANSI/ASQC Q9001-1994, ``American National Standard:
Quality Systems-Model for Quality Assurance in Design, Development,
Production, Installation and Servicing.'' This is an internationally
accepted guideline for effective quality systems and is available from
the American Society for Quality Control (ASQC), 611 East Wisconsin
Avenue, Milwaukee, WI 53202. Acceptable models for quality systems for
accredited facilities are also described in detail in the ``Reference
Manual for Procedures and Policies'' (also known as Reference Manual
A), published by the National Seed Health System. Reference Manual A
describes quality systems that meet the
[[Page 38220]]
requirements of ANSI/ASQC Q9001-1994, but with particular emphasis on
how quality systems would be designed for seed laboratories. Reference
Manual A will be incorporated by reference when final action is taken
on this proposal and is available on the APHIS Web site at http://
www.aphis.usda.gov/ppq/pim/accreditation. Reference Manual A describes
the industry-accepted structure, administration, procedures, policies,
and working practices of facilities engaged in seed testing and field
inspection.
We also propose that the facility would have to document its
procedures and maintain records that will show it is following its
quality system. These records will help APHIS representatives when they
visit the facility for audit purposes. The facility would have to
maintain documented procedures for identification, collection,
indexing, access, filing, storage, maintenance, and disposition of
quality system records. The purpose of these records would be to
demonstrate conformance to the quality manual and the effective
operation of the quality system.
Personnel
Personnel would be the fourth major area evaluated when considering
a facility for accreditation under the regulations. We propose to
require that facilities have a selection procedure and a training
system to ensure technical competence of all staff members. The
education, technical knowledge, and experience required to perform
assigned test and inspection functions would have to be documented and
clearly defined. In particular:
1. Evaluation of plant or tissue samples would have to be
undertaken by a plant pathologist or by laboratory technicians under
the supervision of a plant pathologist. Where personnel are required to
be trained at a facility to evaluate the particular types of plants or
tissue samples handled by the facility, the training program would have
to be evaluated by APHIS and determined to be effective.
2. All staff would have to have access to and be familiar with the
reference materials, guides, and manuals required for the routine
performance of the tests and inspections they conduct.
Application Procedures, Certification of Accreditation, Monitoring, and
Costs
A facility would have to apply to be accredited to perform
laboratory seed testing or seed crop field inspection, or to renew such
accreditation, by submitting an application in accordance with the
procedures already established in Sec. 353.8(b)(2). In addition to the
information required in that section, the application would have to be
accompanied by a copy of the facility's quality manual and a
nonrefundable application fee of $1,000. We would set this application
fee at $1,000 based on our experience that processing an application
would take 3 days time by employees or contractors with base hourly
salary rates of at least $56, a base rate we have used in the past to
calculate user fees for activities by employees of Plant Protection and
Quarantine, APHIS. We also believe that an initial fee of $1,000, which
would go toward the cost of APHIS services for accrediting the
facility, would be high enough to prevent frivolous applications or
applications from facilities that are not yet ready to qualify for
accreditation. We believe the total cost of APHIS services (site
visits, evaluation of facility equipment and quality and recordkeeping
systems, etc.) required to accredit a facility would always be
substantially more than $1,000. Therefore, the applicant would have to
make additional deposits into a trust fund, upon request by the
Administrator, to cover the costs of gaining and maintaining
accreditation. If the cost of approving the initial application comes
to less than $1,000, any remainder would be deposited into this trust
fund and would be applied toward future costs of maintaining
accreditation. However, it is most unlikely that the cost of the
initial approval would be less than $1,000. APHIS will adjust the
amount of this application fee in future rulemaking if experience in
processing the applications for this program indicates that the
application fee should be increased or decreased to more closely match
actual costs. The procedures for APHIS to recover the costs of its
services, and for deposits into a trust fund, are already established
in Sec. 353.8(c).
Upon determining that a facility is eligible for accreditation, the
Administrator would issue the facility a certificate of accreditation.
Accreditation would be for a period of 3 years from the date of
issuance of the certificate of accreditation and could be renewed upon
request and the submission of a new application and application fee. We
believe that requiring reaccreditation every 3 years would be a
valuable tool, along with the monitoring audits discussed below, to
ensure that accredited facilities continue to meet the requirements for
accreditation.
The existing regulations state that the Administrator could deny or
withdraw accreditation in accordance with the procedures in
Sec. 353.8(a)(2). A facility could appeal denial or withdrawal of
accreditation in accordance with Sec. 353.8(a)(2)(i) and (ii).
We propose to require that a facility that has been denied
accreditation or had accreditation withdrawn must wait at least 60 days
from the date the facility was notified in writing that accreditation
was denied or withdrawn before applying again. We believe this delay is
justified because accreditation would not be denied or withdrawn unless
there were flaws in the facility or its procedures that required time
to correct.
We propose to require facilities that are accredited to allow APHIS
access to the facility and all of its equipment and records for the
purpose of audits to determine the facility's continuing eligibility
for accreditation. Such audits would occur as necessary, based on
quality system criteria contained in Reference Manual A. These
monitoring audits would ensure that facilities continue to meet the
requirements for accreditation throughout their period of
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 not 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 standards under which facilities could become accredited to
perform laboratory seed testing or seed crop field inspection services
that could serve as the basis for the issuance of Federal phytosanitary
certificates for export, phytosanitary certificates for reexport, or
export certificates for processed plant products. Accrediting such
facilities is currently allowed under 7CFR 353.8. The existing
regulations provide a framework upon which accreditation programs could
be established, but they do not, in and of themselves, entail any costs
to APHIS or any facility. However, if facilities are accredited under
the accreditation criteria proposed here for seed laboratories and
field inspection facilities, that action would entail costs to both the
entities being accredited and the accrediting body; i.e., APHIS. Those
costs, and the benefits expected from the accreditation program, are
summarized below and were fully evaluated in the economic analysis
section of the previous final rule that established a program for
accrediting facilities, published in the Federal
[[Page 38221]]
Register on January 8, 1999 (64 FR 1098-1106, Docket No. 95-071-2).
The accreditation program is expected to be self-supporting, and
any costs to APHIS would be recouped through accreditation fees. Costs
for establishing each accredited facility will vary depending on the
range of activities for which a facility seeks accreditation, the
initial cost of the APHIS pre-accreditation assessment, the type and
number of any proficiency tests that will have to be conducted, and the
frequency with which post-accreditation evaluation activities such as
check tests and site visits will have to be conducted. It is expected
that, like any business, seed testing laboratories will recoup these
expenses by appropriate structuring of the fees they set for their
services.
The seed industry is expected to benefit from this action 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; benefits can be realized in
terms of more timely certifications, which in turn can 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 in
1996-97. There has been a concomitant rise in demand for laboratory
testing and seed crop field 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 facilities would have prevented the loss of export
sales.
For example, some seed export opportunities have been forfeited
because the results of preharvest field inspections are usually not
known until after harvest, due to the limited number and heavy workload
of government laboratories available to perform seed testing. It is
common for seed from several fields to be blended after harvest and
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 are much less likely to
occur if there is more timely reporting of pre-harvest inspections;
accredited inspection facilities may be able to make such timely
reports. In general, nongovernment testing and inspection services are
expected to be completed with minimal delay, leading to greater
marketing flexibility and lower risk of lost sales.
Overall, the economic benefits that would result from the
availability of accredited nongovernmental seed laboratories and field
inspection facilities would greatly exceed the costs. By providing
access to the accreditation needed to issue the phytosanitary
certificates that many trading partners require as a condition of entry
for U.S. goods, this action would greatly enhance export opportunities
for U.S. producers.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action would
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12372
This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 7 CFR part 3015, subpart V.)
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. If this proposed rule is adopted: (1) All State
and local laws and regulations that are inconsistent with this rule
will be preempted; (2) no retroactive effect will be given to this
rule; and (3) administrative proceedings will not be required before
parties may file suit in court challenging this rule.
Paperwork Reduction Act
This proposed rule contains no new information collection or
recordkeeping requirements under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
List of Subjects
7 CFR Part 300
Incorporation by reference, Plant diseases and pests, Quarantine.
7 CFR Part 353
Exports, Plant diseases and pests, Reporting and recordkeeping
requirements.
Accordingly, we propose to amend 7 CFR parts 300 and 353 as
follows:
PART 300--INCORPORATION BY REFERENCE
1. The authority citation for part 300 would continue to read as
follows:
Authority: 7 U.S.C. 150ee, 154, 161, 162 and 167; 7 CFR 2.22,
2.80, and 371.2(c).
2. In Sec. 300.1, new paragraphs (c) and (d) would be added to read
as follows:
Sec. 300.1 Materials incorporated by reference.
* * * * *
(c) Reference Manual A. The Reference Manual for Procedures and
Policies, published by the National Seed Health System (NSHS), has been
approved for incorporation by reference in 7 CFR chapter III by the
Director of the Office of the Federal Register in accordance with
5U.S.C. 552(a) and 1 CFR part 51. Copies of Reference Manual A:
(1) Are available for inspection at the Office of the Federal
Register Library, 800 North Capitol Street NW, Suite 700, Washington,
DC; or,
(2) May be obtained by writing to Phytosanitary Issues Management,
Operational Support, PPQ, APHIS, 4700 River Road, Unit 140, Riverdale,
MD 20737-1236, and on the APHIS Web site at http://www.aphis.usda.gov/
ppq/pim/accreditation.
(d) Reference Manual B. The Reference Manual for Laboratory Test
and Phytosanitary Inspection Methodologies, published by the National
Seed Health System (NSHS), has been approved for incorporation by
reference in 7 CFR chapter III by the Director of the Office of the
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
Copies of Reference Manual B:
(1) Are available for inspection at the Office of the Federal
Register Library, 800 North Capitol Street NW, Suite 700, Washington,
DC; or,
(2) May be obtained by writing to Phytosanitary Issues Management,
Operational Support, PPQ, APHIS, 4700 River Road, Unit 140, Riverdale,
MD 20737-1236, and on the APHIS Web site at http://www.aphis.usda.gov/
ppq/pim/accreditation.
PART 353--EXPORT CERTIFICATION
3. 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; 7 CFR 2.22,
2.80, and 371.2(c).
4. In Sec. 353.1, definitions of Reference Manual A and Reference
Manual B would be added, in alphabetical order, to read as follows:
[[Page 38222]]
Sec. 353.1 Definitions.
* * * * *
Reference Manual A. The Reference Manual for Procedures and
Policies, published by the National Seed Health System (NSHS).
Reference Manual A describes the structure, administration, procedures,
policies, and working practices of the NSHS and also contains relevant
documentation, forms, and references for the NSHS. Reference Manual A
is incorporated by reference at Sec. 300.1 of this chapter, and is
available by writing to Phytosanitary Issues Management, Operational
Support, PPQ, APHIS, 4700 River Road, Unit 140, Riverdale, MD 20737-
1236, and on the APHIS Web site at http://www.aphis.usda.gov/ppq/pim/
accreditation.
Reference Manual B. The Reference Manual for Laboratory Test and
Phytosanitary Inspection Methodologies, published by the National Seed
Health System (NSHS). Reference Manual B contains the detailed seed
health testing, seed sampling, and seed crop field inspection
procedures for the NSHS. Reference Manual B is incorporated by
reference at Sec. 300.1 of this chapter, and is available by writing to
Phytosanitary Issues Management, Operational Support, PPQ, APHIS, 4700
River Road, Unit 140, Riverdale, MD 20737-1236, and on the APHIS Web
site at http://www.aphis.usda.gov/ppq/pim/accreditation.
Sec. 353.8 [Amended]
5. Section 353.8 would be amended by adding a new sentence at the
end of the section to read as follows: ``(Approved by the Office of
Management and Budget under control number 0579-0130.)''.
6. A new Sec. 353.9 would be added to read as follows:
Sec. 353.9 Standards for accreditation of nongovernment facilities to
perform laboratory seed testing and seed crop field inspection.
(a) Application for accreditation, certification of accreditation,
and monitoring of accredited facilities. A facility may apply to be
accredited to perform laboratory seed testing or seed crop field
inspection, or to renew such accreditation, by submitting an
application in accordance with Sec. 353.8(b)(2). The application must
be accompanied by a copy of the facility's quality manual and a
nonrefundable application fee of $1,000. The applicant must make
additional deposits to cover the costs of gaining and maintaining
accreditation into a trust fund established in accordance with
Sec. 353.8(c) upon request by the Administrator.
(1) Upon determining that a facility is eligible for accreditation,
the Administrator will issue the facility a certificate of
accreditation. Accreditation will be for a period of 3 years from the
date of issuance of the certificate of accreditation and may be renewed
by submitting a new application and application fee in accordance with
this paragraph.
(2) The Administrator may deny or withdraw accreditation in
accordance with Sec. 353.8(a)(2). A facility may appeal denial of
accreditation in accordance with Sec. 353.8(a)(2)(i), and may appeal
withdrawal of accreditation in accordance with Sec. 353.8(a)(2)(ii).
(3) A facility that has been denied accreditation or had its
accreditation withdrawn may not reapply within 60 days of the date the
facility was notified in writing that accreditation was denied or
withdrawn.
(4) After a facility is accredited, the facility must allow APHIS
access to the facility and all of its equipment and records for the
purpose of conducting unannounced audits to determine the facility's
continuing eligibility for accreditation. Such audits will occur at
least once a year and may be performed more frequently at the
discretion of the Administrator.
(b) Standards for accreditation. A facility that, in accordance
with Sec. 353.8(b)(2), applies to be accredited to perform laboratory
seed testing or seed crop field inspection will be evaluated for
accreditation against these standards:
(1) Physical plant. The facility's physical plant (e.g., laboratory
space, office space, greenhouses, vehicles, etc.) must:
(i) Have laboratory and office spaces enclosed by walls and locking
doors to prevent unauthorized access;
(ii) Conform to all State and local zoning and other ordinances;
and
(iii) Provide a work area that is dedicated to laboratory functions
and has sufficient space to conduct the required tests and store the
materials and samples required for the tests in a manner that prevents
contamination by other samples in the laboratory and from other
sources.
(2) The facility must use the equipment required to conduct the
laboratory testing or seed crop field inspections for which it is
accredited. Specific test methodologies, materials, and the calibration
and monitoring of the equipment must conform to Reference Manual B,
which is incorporated by reference at Sec. 300.1 of this chapter. The
general requirements for each test category are as follows:
(i) Seed crop field inspections. Field inspectors must use accurate
field maps, hand lenses, and secure containers for the collection,
storage, and transportation of samples. Field inspectors must have
direct access to a laboratory that is fully equipped to carry out any
necessary diagnostic tests needed for field samples.
(ii) Direct visual examination. Visual examination of seed requires
a stereo microscope. Visual examination of tissue requires a compound
light microscope. Visual examination of loosely attached or
accompanying material requires a centrifuge and shaker.
(iii) Incubation. Required equipment includes incubation chambers,
laminar flow hoods, media preparation equipment, scales, pH meters,
distilled and sterile water, gas burners, an autoclave, and the
appropriate media for the specified tests.
(iv) Grow-out tests. Grow-out tests require a greenhouse, growth
chamber, or an outdoor quarantine location, and access to a laboratory
that is fully equipped to carry out any required diagnostic tests.
(v) Serological tests. These tests require grinding, extraction,
and sample purification equipment; fluorescent microscopes; plate
readers; spectrophotometers; and the appropriate assay materials.
(vi) DNA probes. To conduct these tests, a laboratory must be
equipped with polymerase chain reaction (PCR) equipment, including
thermal cyclers, electrophoresis and gel blotting equipment, and the
reagents and DNA polymerases necessary to conduct the PCR.
(3) Methods of testing and inspection. The facility must conduct
its laboratory seed testing and seed crop field inspection procedures
in accordance with Reference Manual B. The facility must have a quality
manual documenting its quality system for laboratory seed testing and
seed crop field inspection procedures. The quality system must follow
the general guidelines described in ANSI/ASQC Q9001-1994, American
National Standard: Quality Systems-Model for Quality Assurance in
Design, Development, Production, Installation and Servicing. Acceptable
models for quality systems for accredited facilities are also described
in detail in Reference Manual A, which is incorporated by reference at
Sec. 300.1 of this chapter. The personnel who perform the testing and
inspection services must comply with the quality manual, and management
[[Page 38223]]
must enforce this compliance. The facility must maintain documented
procedures for identification, collection, indexing, access, filing,
storage, maintenance, and disposition of quality system records. The
facility must maintain quality system records to demonstrate
conformance to the quality manual and the effective operation of the
quality system.
(4) Personnel. There must be a selection procedure and a training
system to ensure technical competence of all staff members. The
education, technical knowledge, and experience required to perform
assigned test and inspection functions must be documented and clearly
defined. In addition:
(i) Evaluation of plant or tissue samples must be undertaken by a
plant pathologist or by laboratory technicians under the supervision of
a plant pathologist. Where personnel are required to be trained at a
facility to evaluate the particular types of plants or tissue samples
handled by the facility, the training program must be evaluated by
APHIS and determined to be effective.
(ii) All staff must have access to and be familiar with the
reference materials, guides, and manuals required for the routine
performance of the tests and inspections they conduct.
(Approved by the Office of Management and Budget under control number
0579-0130.)
Done in Washington, DC, this 14th day of June 2000.
Richard L. Dunkle,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 00-15493 Filed 6-19-00; 8:45 am]
BILLING CODE 3410-34-U