Source: https://www.federalregister.gov/documents/2000/06/20/00-15493/accreditation-standards-for-laboratory-seed-health-testing-and-seed-crop-field-inspection
Timestamp: 2017-09-20 01:18:09
Document Index: 262370367

Matched Legal Cases: ['§\u2009353', '§\u2009353', '§\u2009353', '§\u2009353', '§\u2009353', '§\u2009353', 'arts 300', '§\u2009300', 'art 51', 'art 51', 'art 353', '§\u2009353', '§\u2009300', '§\u2009300', '§\u2009353', '§\u2009353', '§\u2009353', '§\u2009353', '§\u2009353', '§\u2009353', '§\u2009353', '§\u2009300', '§\u2009300']

Federal Register :: Accreditation Standards for Laboratory Seed Health Testing and Seed Crop Field Inspection
Accreditation Standards for Laboratory Seed Health Testing and Seed Crop Field Inspection
A Proposed Rule by the Animal and Plant Health Inspection Service on 06/20/2000
38218-38223 (6 pages)
Docket No. 99-030-1
Methods of Testing or Inspection
Application Procedures, Certification of Accreditation, Monitoring, and Costs
https://www.federalregister.gov/d/00-15493 https://www.federalregister.gov/d/00-15493
Start Preamble Start Printed Page 38218
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.
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.
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.
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 § 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 Start Printed Page 38219subsequently 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 § 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.
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 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.
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 Start Printed Page 38220requirements 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 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.
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 § 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 § 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 § 353.8(a)(2). A facility could appeal denial or withdrawal of accreditation in accordance with § 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.
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 Start Printed Page 38221Register 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 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.
Accordingly, we propose to amend 7 CFR parts 300 and 353 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 § 300.1, new paragraphs (c) and (d) would be added to read as follows:
(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:
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 § 353.1, definitions of Reference Manual A and Reference Manual B would be added, in alphabetical order, to read as follows:
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 § 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 § 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.
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 § 353.9 would be added to read as follows:
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 § 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 § 353.8(c) upon request by the Administrator.
(2) The Administrator may deny or withdraw accreditation in accordance with § 353.8(a)(2). A facility may appeal denial of accreditation in accordance with § 353.8(a)(2)(i), and may appeal withdrawal of accreditation in accordance with § 353.8(a)(2)(ii).
(b) Standards for accreditation. A facility that, in accordance with § 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:
(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 § 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.
(v) Serological tests. These tests require grinding, extraction, and sample purification equipment; fluorescent microscopes; plate readers; spectrophotometers; and the appropriate assay materials.
(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 § 300.1 of this chapter. The personnel who perform the testing and inspection services must comply with the quality manual, and management Start Printed Page 38223must 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.
(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.
[FR Doc. 00-15493 Filed 6-19-00; 8:45 am]