[Federal Register Volume 66, Number 138 (Wednesday, July 18, 2001)]
[Rules and Regulations]
[Pages 37397-37401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-17839]



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  Federal Register / Vol. 66, No. 138 / Wednesday, July 18, 2001 / 
Rules and Regulations  

[[Page 37397]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Parts 300 and 353

[Docket No. 99-030-2]


Accreditation Standards for Laboratory Seed Health Testing and 
Seed Crop Phytosanitary Inspection

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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

SUMMARY: We are amending the export certification regulations to 
provide specific standards under which non-government facilities may be 
accredited to perform laboratory seed testing and seed crop field 
inspection services to 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 non-government 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.

EFFECTIVE DATE: August 17, 2001. The incorporation by reference 
provided for by this rule is approved by the Director of the Federal 
Register as of August 17, 2001.

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.
    On June 20, 2000, we published in the Federal Register (65 FR 
38218-38223, Docket No. 99-030-1) a proposal describing standards to be 
used to evaluate facilities for accreditation to perform laboratory 
seed testing and seed crop field inspection in accordance with 7 CFR 
part 353.
    We solicited comments concerning our proposal for 60 days ending 
August 21, 2000. We received 28 comments by that date. They were from 
seed companies, seed industry associations, plant health associations, 
and individuals. All the commenters generally supported the proposed 
rule, although three commenters suggested certain specific changes to 
it. All issues raised by the commenters are discussed below.
    Two commenters suggested that we should replace references to seed 
crop field inspection in the rule with the term seed crop phytosanitary 
inspection or a similar term, and clarify that this activity includes 
inspection of greenhouses or growth chambers where plants are grown for 
seed production as well as visual inspection of seed crops. The same 
commenters suggested that we replace references to laboratory seed 
testing with the term laboratory seed health testing. They stated that 
in both cases, the terms in the proposal did not unambiguously identify 
the purpose of the inspection and testing.
    We agree, and have made the requested changes. We have also 
clarified in the discussion of the procedures for seed crop 
phytosanitary inspection in Sec. 353.9(b)(2)(i) that this activity 
includes inspection of greenhouses or growth chambers where plants are 
grown for seed production, as well as visual inspection of seed crops.
    One commenter suggested that the rule should specify that the 
activities performed by approved facilities include seed sampling for 
the purpose of laboratory seed health testing and visual inspection of 
seed just prior to export. We believe it is fairly clear in the rule 
that facilities that perform seed crop phytosanitary inspection and 
laboratory seed health testing may perform these activities as part of 
accomplishing the purpose of their inspection and testing. For example, 
the rule directs facilities to Reference Manual B for detailed 
procedures on seed sampling. However, we have added these two 
activities to Sec. 353.9(b)(2)(i) as examples of functions facilities 
may perform.
    Two commenters suggested, regarding the proposal's discussion of 
physical plant and equipment requirements for facilities, that a 
laboratory may need all the required equipment for full seed health 
testing but not for diagnostic activities in support of phytosanitary 
inspection, which often only requires a hand lens. They suggested that 
we change the rule to state that the accredited facility must ``have 
access'' to this equipment should it be necessary; i.e., make the 
equipment required test-dependent.
    The intent of the proposed rule was to require facilities to have 
specified equipment only if it is needed to perform the tests for which 
the facility is accredited. Proposed Sec. 353.9(b)(2) stated that a 
facility ``must use the equipment required to conduct the laboratory 
testing or seed crop phytosanitary inspections for which it is 
accredited.'' To clarify this point, we are

[[Page 37398]]

changing that sentence in this final rule to read that a facility 
``must have access to all equipment required to conduct the laboratory 
testing or seed crop phytosanitary inspections for which it is 
accredited.''
    One commenter noted, regarding the proposal's discussion of 
serological testing, that some laboratories may use ``field ready test 
kits'' that do not require all the equipment listed in 
Sec. 353.9(b)(2)(v).
    We agree. Proposed Sec. 353.9(b)(2)(v) stated regarding serological 
tests that ``These tests require grinding, extraction, and sample 
purification equipment; fluorescent microscopes; plate readers; 
spectrophotometers; and the appropriate assay materials.'' We are 
adding to the end of that sentence the phrase ``or appropriate 
equipment to use field ready test kits.''
    The same commenter also asked whether APHIS intended to prohibit 
field determinations, or to require field determinations to be 
confirmed by laboratory diagnostics. If laboratory confirmation is 
required, the commenter asked whether APHIS must accredit the 
laboratory providing the diagnostic confirmation.
    APHIS intends to allow field determinations that are conducted in 
accordance with the procedures authorized by Reference Manual B. In the 
normal practice of field inspection, samples are routinely sent to a 
laboratory for identification or confirmation of a visual 
identification. It is not APHIS' intention to accredit these 
laboratories. However, the procedures to provide this laboratory 
support, including the identity and qualifications of the laboratory, 
must be detailed in the accredited facility's quality manual. A 
facility's procedures for confirming field inspections may be reviewed 
during the initial approval and periodic audits of the accredited 
facility.
    Two comments addressed the proposed requirement in 
Sec. 353.9(b)(4)(i) that ``Evaluation of plant or tissue samples must 
be undertaken by a plant pathologist or by laboratory technicians under 
the supervision of a plant pathologist.'' These commenters noted that 
by using modern communications and computer technology, technicians may 
work ``under the supervision of a plant pathologist'' even if the 
pathologist is at a different location.
    We agree, and have added the following phrase at the end of the 
sentence in Sec. 353.9(b)(4)(i): ``who may provide such supervision 
either on-site, or from a remote location.''
    One commenter suggested that the Association of Official Seed 
Analysts should be added to the National Seed Health System (NSHS) 
Working Group identified in Reference Manual A.
    Membership in the NSHS Working Group is outside the scope of this 
rulemaking. This commenter should contact the current chair of the NSHS 
Seed Technical Working Group to address this issue.
    One commenter addressed a sentence in the economic analysis section 
of the proposed rule that read: ``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.'' This 
commenter noted that, in addition to laboratories, this is also true 
for non-laboratory accredited entities providing other phytosanitary 
inspection services.
    We agree, and have modified the language in this final rule's 
economic analysis accordingly.
    One commenter asked for APHIS to clarify whether only non-
government entities are eligible to apply for accreditation under the 
rule. In particular, this commenter asked about the eligibility of 
public universities that administer seed certification units.
    Even though most of the examples discussed in the proposed rule 
were private, non-government entities, the rule does not preclude 
accreditation of governmental agencies or other public institutions, 
including public universities. These agencies may apply for 
accreditation and, if eligible, will be accredited.
    One commenter asked how APHIS will accept and protect confidential 
business information submitted by applicants for accreditation.
    The regulations already in place at Sec. 353.8(b)(5) state that 
``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.'' APHIS will protect the 
confidentiality of such information. To make sure that such information 
is clearly identified by the applicant, we are adding the following 
sentence to paragraph Sec. 353.9(a) in the rule, which describes how to 
submit application material: ``If there are portions of the application 
deemed to contain trade secret or confidential business information 
(CBI), each page of the application containing such information should 
be marked `CBI Copy.' ''
    One commenter asked whether specific test methodologies and 
materials will be in Reference Manual B, or in a facility's quality 
manuals. As stated in the proposal, Reference Manual B will contain 
specific methodologies to conduct tests, field inspections, sampling, 
and related procedures. The facility's quality manual will document the 
quality system designed to ensure that the methodologies in Reference 
Manual B are followed, and will address matters such as purity of 
materials, and calibration of equipment, and so forth. Quality manuals 
may summarize or quote methodologies from Reference Manual B to the 
extent that facilities find it useful to do so.
    One commenter asked whether APHIS accepts liability for incorrect 
diagnostics or field inspections carried out by accredited entities.
    APHIS does not accept liability for inaccurate results. Once 
accredited, individual facilities retain the same liability for 
conducting tests that are inaccurate or fraudulent that they bore 
before becoming accredited. Facilities should be protected against 
liability if they follow the methodologies required by APHIS and report 
test and inspection results accordingly. If evidence accumulates that a 
particular methodology does not yield reliable results, APHIS may have 
to revise that methodology, but accredited facilities are only 
responsible for properly conducting and reporting the required 
procedures.
    One commenter asked for details regarding how often Reference 
Manuals A and B will be revised, and when they will be incorporated by 
reference. These manuals are currently posted on the APHIS website 
(http://www.aphis.usda.gov/ppq/pim/accreditation) in the form in which 
they have been incorporated by reference by this final rule. We expect 
that the manuals, especially Reference Manual B, will require updating 
as new tests are added or as improved test and inspection methodologies 
are validated. APHIS intends to update the copies of the Reference 
Manuals on the website, and the copies incorporated by reference with 
the Office of the Federal Register, as needed, perhaps about twice per 
year.
    One commenter noted that APHIS has stated that the Iowa State Seed 
Science Center will be used on the assessment team to evaluate and 
audit facilities applying for accreditation. This commenter stated that 
APHIS would need additional help to meet its evaluation workload in 
order to process all the applications from interested facilities, and 
stated that State governmental agencies could also be used to meet this 
need.

[[Page 37399]]

    We agree that APHIS will likely need additional assistance to meet 
the workload involved in evaluating and auditing facilities. Since 
APHIS does not have the capability or expertise to provide the 
necessary testing and auditing, we will utilize selected public 
facilities to conduct these activities. The Iowa State Seed Science 
Center will be used as the initial ``accreditation unit'' under this 
system; however, it is anticipated that APHIS may need to utilize other 
organizations, including State agencies, to properly evaluate all the 
private facilities that wish to be accredited.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, with the 
changes discussed in this document.

Executive Order 12866 and Regulatory Flexibility Act

    This 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 not been reviewed by the Office of 
Management and Budget.
    This rule will amend the export certification regulations to 
provide standards under which facilities may become accredited to 
perform laboratory seed health testing or inspection services that can 
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 7 CFR 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, when facilities are accredited under 
the accreditation criteria contained in this rule for seed laboratories 
and field inspection facilities, that action will 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 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 should 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 preaccreditation 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 and other accredited 
facilities 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 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 availability of 
accredited 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 preharvest inspections; 
accredited inspection facilities may be able to make such timely 
reports. In general, we expect that adding a number of non-government 
facilities providing testing and inspection services will allow the 
future demand for these services to be distributed among facilities in 
a manner that will readily adjust to fluctuations in the demand for 
these services, and will allow both government and non-government 
facilities to report results in a timely manner.
    Overall, the economic benefits that should result from the 
availability of accredited non-governmental seed laboratories and field 
inspection facilities greatly exceed the costs. By providing access to 
services by accredited non-government facilities to support the 
issuance of phytosanitary certificates that many trading partners 
require as a condition of entry for U.S. goods, this action should 
greatly enhance export opportunities for U.S. producers. While this 
rule does not directly create or open any new markets for U.S. seed 
exports, it makes it easier for exporters to obtain necessary 
certification in a timely manner. This should result in U.S. companies 
obtaining more contracts in which delivery time is of the essence. 
While we do not have data to exactly estimate the value of such 
potential contracts, comments from seed companies suggest that their 
value may be on the order of $10 million per year.
    We do not have detailed information on the number of small 
businesses engaged in exporting seeds or in testing seeds. Seed and 
bulb producers are combined in Standard Industrial Classification (SIC) 
0181 with several other types of businesses, and seed testing 
laboratories are combined with other types of testing laboratories 
under SIC 8734. From the data available, there appear to be several 
hundred seed producers that may be small businesses, but very few of 
these engage directly in export. Instead, they sell seed to wholesale 
seed brokers who sell to export markets. None of these wholesale seed 
brokers appear to be small businesses. Several very large seed 
production companies are known to sell their products directly to 
export markets. With regard to seed testing laboratories, we estimate 
that a dozen or so laboratories, some of which are small businesses, 
will become accredited in accordance with this rule and will increase 
their revenue from inspection and testing services.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action will 
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

[[Page 37400]]

intergovernmental consultation with State and local officials. (See 7 
CFR part 3015, subpart V.)

Executive Order 12988

    This rule has been reviewed under Executive Order 12988, Civil 
Justice Reform. This rule: (1) Preempts all State and local laws and 
regulations that are inconsistent with this rule; (2) has no 
retroactive effect; and (3) does not require administrative proceedings 
before parties may file suit in court challenging this rule.

Paperwork Reduction Act

    This 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, Incorporation by reference, Plant diseases and pests, 
Reporting and recordkeeping requirements.

    Accordingly, 7 CFR parts 300 and 353 are amended as follows:

PART 300--INCORPORATION BY REFERENCE

    1. The authority citation for part 300 continues to read as 
follows:

    Authority: 7 U.S.C. 7701-7772; 7 CFR 2.22, 2.80, and 371.3.


    2. In Sec. 300.1, new paragraphs (c) and (d) are added to read as 
follows:


Sec. 300.1  Materials incorporated by reference.

* * * * *
    (c) Reference Manual A. The Reference Manual for Administration, 
Procedures, and Policies of the National Seed Health System, which was 
published on February 25, 2000, 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 A:
    (1) Are available for inspection at the Office of the Federal 
Register Library, 800 North Capitol Street NW, Suite 700, Washington, 
DC, and the APHIS Library, U.S. Department of Agriculture, 4700 River 
Road, Riverdale, MD 20737; 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 Seed Health 
Testing and Phytosanitary Field Inspection Methods, which was published 
on February 27, 2001, 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, and the APHIS Library, U.S. Department of Agriculture, 4700 River 
Road, Riverdale, MD 20737; 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 A APHIS Web site at http://www.aphis.usda.gov/ppq/pim/accreditation.

PART 353--EXPORT CERTIFICATION

    3. The authority citation for part 353 continues to read as 
follows:

    Authority: 7 U.S.C. 7711, 7712, 7718, 7751, and 7754; 21 U.S.C. 
136 and 136a; 7 CFR 2.22, 2.80, and 371.3.

    4. In Sec. 353.1, definitions of Reference Manual A and Reference 
Manual B are added, in alphabetical order, to read as follows:


Sec. 353.1  Definitions.

* * * * *
    Reference Manual A. The Reference Manual for Administration, 
Procedures, and Policies of the National Seed Health System, 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 Seed Health Testing 
and Phytosanitary Field Inspection Methods, published by the National 
Seed Health System (NSHS). Reference Manual B contains the detailed 
seed health testing, seed sampling, and 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 is 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 is added to read as follows:


Sec. 353.9  Standards for accreditation of non-government facilities to 
perform laboratory seed health testing and seed crop phytosanitary 
inspection.

    (a) Application for accreditation, certification of accreditation, 
and monitoring of accredited facilities. A facility may apply to be 
accredited to perform laboratory seed health testing or seed crop 
phytosanitary inspection, or to renew such accreditation, by submitting 
an application in accordance with Sec. 353.8(b)(2) of this part. If 
there are portions of the application deemed to contain trade secret or 
confidential business information (CBI), each page of the application 
containing such information should be marked ``CBI Copy.'' 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) of this part 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) of this part. A facility may appeal 
denial of accreditation in accordance with Sec. 353.8(a)(2)(i) of this 
part, and may appeal withdrawal of

[[Page 37401]]

accreditation in accordance with Sec. 353.8(a)(2)(ii) of this part.
    (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) of this part, applies to be accredited to perform 
laboratory seed health testing or seed crop phytosanitary 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 have access to all equipment required to 
conduct the laboratory testing or seed crop phytosanitary 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 phytosanitary inspections. Seed crop phytosanitary 
inspection may also include related activities such as collection of 
seed samples for later laboratory testing, visual inspection of seed 
just prior to export, and inspection of greenhouses or growth chambers 
where plants are grown for seed production, as well as visual 
inspection of seed crops. In the field, inspectors must use accurate 
field maps, hand lenses, and secure containers for the collection, 
storage, and transportation of samples. 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; or 
the appropriate equipment to use field ready test kits.
    (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 health testing and seed crop phytosanitary 
inspection procedures in accordance with Reference Manual B. The 
facility must have a quality manual documenting its quality system for 
laboratory seed health testing and seed crop phytosanitary 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 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, who may provide such supervision either on-site, 
or from a remote location. 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 11th day of July 2001.
Craig A. Reed,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 01-17839 Filed 7-17-01; 8:45 am]
BILLING CODE 3410-34-U