[Federal Register Volume 65, Number 119 (Tuesday, June 20, 2000)]
[Proposed Rules]
[Pages 38218-38223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-15493]


========================================================================
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.

========================================================================


Federal Register / Vol. 65, No. 119 / Tuesday, June 20, 2000 / 
Proposed Rules

[[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.

-----------------------------------------------------------------------

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