Export Certification; Accreditation of Non-Government Facilities

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 353

[Docket No. 95-071-1]

RIN 0579-AA75

Export Certification; Accreditation of Non-Government Facilities

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend the export certification regulations

to provide for the establishment of a program under which non-

government facilities could become accredited to perform specific

laboratory testing or phytosanitary inspection services that could

serve as the basis for the issuance of a Federal phytosanitary

certificate, export certificate for processed plant products, or

phytosanitary certificate for reexport. The accreditation criteria for

particular laboratory testing and phytosanitary inspection services

would be developed by the Animal and Plant Health Inspection Service in

cooperation with other interested government, industry, academic, or

research entities. Currently, only tests conducted by public

laboratories or inspections carried out by Federal, State, or county

inspectors or by agents may be used as the basis for the issuance of

Federal certificates. The proposed accreditation program would provide

a mechanism for qualified non-government facilities to become

accredited to perform testing or inspection services that may be used

as supporting documentation for the issuance of certificates for

certain plants or plant products.

DATES: Consideration will be given only to comments received on or

before January 26, 1998.

ADDRESSES: Please send an original and three copies of your comments to

Docket No. 95-071-1, Regulatory Analysis and Development, PPD, APHIS,

Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please

state that your comments refer to Docket No. 95-071-1. Comments

received may be inspected at USDA, room 1141, South Building, 14th

Street and Independence Avenue SW., Washington, DC, between 8 a.m. and

4:30 p.m., Monday through Friday, except holidays. Persons wishing to

inspect comments are requested to call ahead on (202) 690-2817 to

facilitate entry into the comment reading room.

FOR FURTHER INFORMATION CONTACT: Mr. Narcy G. Klag, Operations Officer,

Port Operations, PPQ, APHIS, 4700 River Road Unit 139, Riverdale, MD

20737-1236; (301) 734-8537.

SUPPLEMENTARY INFORMATION:

Background

The export certification regulations contained in 7 CFR part 353

(referred to below as the regulations) set forth the procedures for

obtaining certification for plants and plant products offered for

export or re-export. Export certification is not required by the

regulations; rather, it is provided by the Animal and Plant Health

Inspection Service (APHIS) as a service to exporters who are shipping

plants or plant products to countries that require phytosanitary

certification as a condition of entry. After assessing the condition of

the plants or plant products intended for export, relative to the

receiving country's regulations, an inspector will issue an

internationally recognized phytosanitary certificate (PPQ Form 577), a

phytosanitary certificate for reexport (PPQ Form 579), or an export

certificate for processed plant products (PPQ Form 578), if warranted.

Since 1975, APHIS has participated with State governments in the

Cooperative Phytosanitary Export Certification Program, which allows

certain State officials, as well as APHIS officials, to issue

phytosanitary certificates, phytosanitary certificates for reexport, or

export certificates for processed plant products. Because the number of

Federal inspectors is limited, the use of State and county inspectors

is a considerable service to exporters of plants and plant products in

terms of both time and convenience.

In a final rule published in the Federal Register on April 8, 1996

(61 FR 15365-15371, Docket No. 90-117-3), we amended the export

certification regulations to, among other things: (1) Revise the

requirements for a person to qualify as an inspector; (2) allow county-

level plant regulatory officials, in addition to State and APHIS

officials, to qualify as inspectors; (3) allow persons other than

inspectors--those persons being referred to as ``agents''--to perform

phytosanitary field inspections; and (4) provide for an industry-based

certification, under certain conditions, of certain low-risk plant

products such as kiln-dried lumber offered for export. Those amendments

were intended, in part, to provide additional qualified personnel and

export certification options in order to relieve some of the demands

placed upon the existing pool of inspectors by increasingly stringent

foreign import requirements and dwindling Federal and State budgets.

In this document, we are proposing to further broaden the options

for inspection and export certification by establishing regulations

under which non-government facilities such as commercial laboratories

and private inspection services could become accredited by APHIS to

perform specific laboratory testing or phytosanitary inspection

services that could serve as the basis for the issuance of a Federal

phytosanitary certificate, phytosanitary certificate for reexport, or

export certificate for processed plant products. This proposed approach

is consistent with current international trends toward industry self-

certification and is based upon the recent efforts of a working group

within the North Atlantic Plant Protection Organization (NAPPO) to

draft standards for the accreditation of laboratories performing

phytosanitary and other export certification activities to ensure

compliance with import requirements for products moving into or within

the regional territories of the NAPPO member countries (Canada, Mexico,

and the United States).

The regulations proposed in this document would establish a means

by which non-government facilities could be accredited by APHIS to

perform certain functions related to phytosanitary export

certification. It is important to note, however, that these proposed

regulations would only establish a template upon which accreditation

programs for specific functions could be developed--these proposed

regulations would not establish specific accreditation

[[Page 62700]]

standards for, by way of example, a private laboratory seeking to be

accredited to perform virus testing on plant material intended for

export. Rather, specific accreditation standards would be developed as

demand dictates. If, for example, a private laboratory wishes to

perform virus testing on plant material intended for export, APHIS

would work with that laboratory, and any other similarly situated

laboratory, as well as with any other appropriate and interested

government, industry, academic, or research entity, to identify and

develop the appropriate specific standards against which the private

laboratory's ability and competence to perform that virus testing could

be judged. Once completed, those standards would be reviewed by APHIS

and its cooperators and published in the Federal Register for comment.

Once approved and published as a final rule, they would become the

standard for the accreditation of non-government facilities to perform

virus testing of plant material intended for export. Such standards

would be published in 7 CFR part 353.

We believe that this proposed approach is beneficial in two ways:

First, it would be difficult, if not impossible, for APHIS to develop a

single, one-size-fits-all set of standards for the numerous disciplines

that play a role in phytosanitary export certification. Secondly, the

proposed approach would allow APHIS to develop specific standards with

the participation of those best able to recommend valid scientific

criteria, i.e., the government, academic, and private-sector

individuals who have the experience and expertise in the particular

area for which specific standards are being developed.

Proposed Regulations

To establish this proposed accreditation program, we would first

amend Sec. 353.1 to add a definition of non-government facility, which

we would define as ``laboratory, research facility, inspection service,

or other entity that is maintained, at least in part, for the purpose

of providing laboratory testing or phytosanitary inspection services

and that is not operated by the Federal Government or by the government

of a State or a subdivision of a State.'' We believe that laboratories,

research facilities, or inspection services are the types of entities

most likely to seek accreditation under the proposed regulations. By

excluding facilities operated by Federal, State, county, or local

governments, the intent is that the accreditation program is to apply

only to private entities. The involvement of government-run facilities

in phytosanitary export certification is already covered under the

current regulations in part 353; it is not our intent to require

facilities operated by any level of Federal or State government to

become accredited.

The regulations in Sec. 353.7 currently state, with regard to the

issuance of certificates, that the Administrator of APHIS may authorize

inspectors to issue phytosanitary certificates, phytosanitary

certificates for reexport, or export certificates for processed plant

products on the basis of inspections made by cooperating Federal,

State, and county agencies. Therefore, to accommodate the proposed

accreditation program, we are proposing to amend paragraphs (a), (b),

and (c) of Sec. 353.7 to further provide that the Administrator may

also authorize inspectors to issue those certificates on the basis of a

laboratory test or an inspection conducted by a non-government facility

that has been accredited in accordance with Sec. 353.8, which is a new

section that we would add to the regulations to spell out the specific

provisions of the proposed accreditation program.

The proposed new Sec. 353.8 would be divided into three main

paragraphs: Paragraph (a) would serve to describe the accreditation

program, paragraph (b) would set out the criteria for accreditation,

and paragraph (c) would discuss the fees related to the accreditation

program. These three paragraphs are discussed in greater detail below.

Paragraph (a) of proposed Sec. 353.8 would begin by stating that

the Administrator may accredit a non-government facility to perform

specific laboratory testing or phytosanitary inspection services if the

Administrator determines that the facility meets the criteria for

accreditation found in paragraph (b). (Note: The term ``Administrator''

is used in this document, as it is used throughout APHIS' regulations,

to mean the Administrator of APHIS or any person authorized to act for

the Administrator.) A list of accredited non-government facilities

could be obtained by writing to APHIS.

To determine whether or not a facility meets the criteria for

accreditation, APHIS would conduct an assessment of the facility and

its fitness to conduct the testing or inspection services for which it

is seeking accreditation. A description of the assessment process is

found below in the discussion of the criteria for accreditation.

Paragraph (a)(2) of proposed Sec. 353.8 describes the conditions

under which the Administrator could deny accreditation to a non-

government facility or withdraw the accreditation that had been

previously granted to a facility. Clearly, a facility would have to be

able to meet and comply with the standards identified as being

necessary for the accurate and reliable execution of the testing or

inspection services for which it has been, or is seeking to be,

accredited. Therefore, the proposed regulations would provide that the

Administrator could deny accreditation to a facility that APHIS

determines, through its pre-accreditation assessment, does not meet the

criteria for accreditation and has failed to take the remedial action

recommended to correct identified deficiencies. Similarly, the

Administrator could withdraw the accreditation of an accredited

facility if APHIS determined that the facility was not adhering to the

criteria for the maintenance of accreditation and had failed to take

the remedial action recommended to correct the identified deficiencies.

If APHIS denied a facility's application for accreditation, the

operator of the facility would be informed of the reasons for the

denial and would be afforded the opportunity to appeal the decision to

the Administrator. To ensure that there would be an informed and timely

review of the appeal, the operator's appeal would have to be in writing

and submitted within 10 days after receiving notification of the denial

and would have to include all of the facts and reasons upon which the

operator was relying to show that the facility had been wrongfully

denied accreditation. The Administrator would then grant or deny the

operator's appeal in writing as promptly as circumstances permitted,

with the response stating the reasons for his or her decision. If there

was a conflict as to any material fact regarding the denial or the

reasons for the denial, a hearing would be held to resolve the conflict

under rules of practice adopted by the Administrator.

The withdrawal of a facility's accreditation would be handled in

much the same way. The operator of the facility would be informed of

the reasons for the proposed withdrawal before any action was taken and

given the opportunity to appeal the proposed withdrawal. The appeal

would have to be in writing and submitted to the Administrator within

10 days after the operator was informed of the reasons for the proposed

withdrawal. The appeal would have to include all of the facts and

reasons upon which the operator of the facility was relying to show

that the reasons for the proposed withdrawal

[[Page 62701]]

were incorrect or did not support the withdrawal of the facility's

accreditation. The Administrator would grant or deny the appeal in

writing as promptly as circumstances permitted and would state the

reason for his or her decision. If there was a conflict as to any

material fact regarding the proposed withdrawal or the reasons for the

proposed withdrawal, a hearing would be held to resolve the conflict

under rules of practice adopted by the Administrator. However, the

proposed regulations would provide that the withdrawal of a facility's

accreditation could become effective before a final determination was

made regarding an appeal if the Administrator determined that an

immediate withdrawal was necessary to protect the public health,

interest, or safety. In such a case, the withdrawal would be effective

at the time APHIS notifies the operator of the facility either orally

or in writing. In the event of an oral notification, a written

confirmation would be given to the operator as promptly as

circumstances allowed. The withdrawal would continue in effect pending

the completion of the withdrawal and appeal proceedings, and any

subsequent judicial review of those proceedings, unless the

Administrator ordered otherwise.

The proposed regulations also would provide that the Administrator

would withdraw a facility's accreditation if the operator of the

facility informed APHIS in writing that the facility wished to

terminate its accredited status.

We would allow a non-government facility that has had its

application for accreditation denied or its accreditation withdrawn to

reapply for accreditation using the same application procedures

provided for first-time applicants. However, if the facility's

accreditation had been denied or withdrawn because it failed to meet or

comply with the standards for accreditation, we would require the

facility operator to include written documentation with the application

that specified what actions had been taken to correct the conditions

that led to the denial or withdrawal of the facility's accreditation.

It is likely that a pre-accreditation assessment of a reapplying

facility would place added emphasis on those areas in which the

facility had been deficient, so the documentation describing the

actions taken to correct those deficiencies would be useful when

determining the scope and design of the assessment.

Because a facility may need to disclose confidential business

information to APHIS during the course of its pre-accreditation

assessment or during the term of its accreditation, paragraph (a) of

proposed Sec. 353.8 would conclude by stating that all information

gathered by APHIS during its accreditation-related activities would be

treated with the appropriate level of confidentiality. As set forth in

the U.S. Department of Agriculture's (USDA's) administrative

regulations in 7 CFR 1.11, the USDA is responsible for making the final

determination with regard to the disclosure or nondisclosure of

information submitted by a business, but the policy of the USDA is to

obtain and consider the views of the submitter of any privileged or

confidential business information and to provide the submitter the

opportunity to object to the disclosure of such information.

Pre-Accreditation Assessment

Paragraph (b) of proposed Sec. 353.8 would set out the criteria for

the achievement and retention of accreditation. The paragraph would

begin by stating that specific standards for accreditation in a

particular area of laboratory testing or phytosanitary inspection could

be obtained by writing to APHIS. However, as discussed previously in

this document, specific standards have not yet been developed for any

area of accreditation. Rather, it is our intention that specific

standards would be developed in the future on an ``as needed'' basis

when a non-government facility informs APHIS that it would like to

become accredited in a particular area of laboratory testing or

phytosanitary inspection. Once standards in a particular area have been

developed and adopted by APHIS, those standards would be available to

non-government facilities that may wish to become similarly accredited.

Because accreditation standards under the proposed regulations

would, at least initially, have to be drafted and adopted before the

assessment process could begin, the proposed regulations would provide

for APHIS' development of standards. Therefore, paragraph (b)(1) would

state that if specific standards for accreditation in a particular area

of laboratory testing or phytosanitary inspection had not been

identified by APHIS, the Administrator would develop the appropriate

specific standards applicable to accreditation in that particular area.

The regulations would further provide that APHIS would place a notice

in the Federal Register to inform the public of the opportunity to

participate in the development of those standards by submitting

suggested criteria or recommending particular considerations that may

need to be addressed in the standards. This proposed approach would

ensure that APHIS' resources are focused on those areas in which

facilities are interested in obtaining accreditation and allow for

standards to be prepared through a collaborative, cooperative process

that provides for the participation of all interested parties,

including the operator of the non-government facility seeking

accreditation and any other interested governmental, industry,

academic, or research entity.

Once accreditation standards are promulgated, the operator of a

non-government facility seeking accreditation would begin the

accreditation process by submitting an application to APHIS. The first

items on the application would be the legal name and full address of

the facility and the name, address, telephone number, and fax number of

the operator of the facility or his or her authorized representative.

These items would enable APHIS to identify the facility for its records

and contact the facility's operator or an authorized representative as

the pre-accreditation assessment process begins and during the term of

the facility's accreditation.

The application would then have to contain a description of the

facility itself. This information would enable APHIS to understand the

nature of the facility, i.e., whether the facility is a stand-alone

building or is located within a larger office or laboratory building,

what the facility's primary function is and the scope of operations

within the facility, and, if applicable, the relationship the facility

has to a larger corporate entity. This type of information would give

APHIS a frame of reference as it considers the suitability of the

facility for the type of work it is seeking to perform under the

accreditation program and would provide a starting point for the design

of a pre-accreditation assessment. The application would conclude with

a description of the specific laboratory testing or phytosanitary

inspection services for which the facility is seeking accreditation.

The completed application would then have to be signed by the operator

of the facility or his or her authorized representative.

After it had received the completed application, APHIS would review

the application to identify the scope of the assessment that would be

necessary to adequately review the facility's fitness to conduct the

laboratory testing or phytosanitary inspection services for which it is

seeking accreditation. Through that review, APHIS would determine the

number of assessors needed for an assessment team, the fields of

expertise that should be

[[Page 62702]]

represented on the team, and the means by which the facility's

competence to conduct the applicable laboratory tests or phytosanitary

inspections could be evaluated.

Once the scope of the assessment has been defined, APHIS could

identify the individuals who would comprise the assessment team,

determine the materials that would be needed for the assessment, and

project the length of the assessment process, which would allow APHIS

to develop an estimate of the expenses that would be incurred by the

government in the course of the pre-accreditation assessment process.

Those expenses would have to be reimbursed by the facility seeking

accreditation, so APHIS would provide the estimate to the operator of

the facility before embarking upon any activities that would result in

costs being incurred.

Before the assessment of a facility could begin, the operator of

the facility would have to agree, in writing, to allow the assessment

team access to its facilities, supply the team with the information it

needs to evaluate the facility, and to enter into a trust fund

agreement with APHIS to pay the assessment fee regardless of the

assessment's outcome (i.e., even if the assessment team recommends that

the facility not be accredited), and, if accreditation is granted, to

pay the charges related to the subsequent maintenance of the facility's

accreditation, such as laboratory fees for the corroboration of check

tests. (The specific provisions of the trust fund agreement are

explained below under ``Fees and Trust Fund Agreement.'') Once the

operator of the facility had agreed, in writing, to these terms, APHIS

would assemble the assessment team and commence the assessment as soon

as circumstances permitted.

The assessment itself would focus on four major areas: Physical

plant, equipment, methods of testing or inspection, and personnel. The

assessment team would compare the facility's performance in those areas

against the specific accreditation standards that had been identified

for the particular laboratory testing or phytosanitary inspection

services for which the facility was seeking accreditation. The four

areas are explained in greater detail below.

Physical Plant

The facility's physical plant would have to meet the criteria

identified in the accreditation standards as necessary to properly

conduct the laboratory testing or phytosanitary inspection services for

which it seeks accreditation. For example, a facility that wished to be

accredited to perform laboratory testing would have to have adequate

laboratory space in which to perform the testing, storage space for

holding samples and supplies, and office space for preparing reports

and other documentation.

Equipment

The assessment team would determine whether the facility's

personnel had unrestricted access to the equipment identified in the

accreditation standards as necessary to properly conduct the laboratory

testing or phytosanitary inspection services for which it seeks

accreditation. To continue with the example in the previous paragraph,

a facility seeking accreditation for laboratory testing would have to

have the microscopes, computers, scales, analyzers, etc. that would be

necessary for the facility to properly conduct that laboratory testing.

The assessment team would also verify, where appropriate, that

calibration and monitoring of the required equipment is documented and

conforms to prescribed standards.

Methods of Testing or Inspection

To ensure that the facility was employing scientifically valid and

up-to-date methodology to conduct its laboratory testing or

phytosanitary inspection activities, the assessment team would review

the facility's quality manual or other equivalent documentation that

described the system in place at the facility for the conduct of the

laboratory testing or phytosanitary inspection services for which the

facility seeks accreditation. The assessors would verify that the

manual was available to, and in use by, the facility personnel who

perform the services and that the methods and procedures described in

the manual were equal to those identified in the accreditation

standards.

Personnel

The assessment team would also review the qualifications of the

facility's personnel, both management and staff, who were responsible

for the testing or inspection services for which the facility was

seeking accreditation. Those personnel, who would have to be identified

to the assessment team, would have to possess the training, education,

or experience identified in the accreditation standards as necessary to

properly conduct the testing or inspection services for which the

facility was seeking accreditation, and that training, education, or

experience would have to be documented. If the particular accreditation

standards under which the facility was being reviewed allowed for the

use of subcontractors, the assessment team would also review the

qualifications of any subcontractors used by the facility in connection

with its laboratory testing or phytosanitary inspection activities.

Retaining Accreditation

Once accredited, the non-government facility would have to observe

several conditions to maintain its accreditation. First, the facility

would have to continue to observe the specific standards applicable to

its area of accreditation, i.e., the standards by which it was judged

in its initial, pre-accreditation assessment. To give APHIS the ability

to monitor the facility's compliance with those standards, the facility

would have to agree to be assessed and evaluated on a periodic basis

through proficiency tests or check samples and be able to demonstrate

on request that it is able to perform the tests or inspection services

for which it was accredited. If, in the course of an assessment or

evaluation, APHIS identifies any deficiencies in the facility or in its

conduct of testing or inspection activities, the operator of the

facility would have to ensure that those deficiencies are resolved.

Because the facility's accreditation would have been based largely

on APHIS' review and acceptance of specific elements in place at the

facility at the time of the assessment, we would require that the

facility notify APHIS when those elements changed. Specifically, we

would require that the operator of the facility notify APHIS when there

are any changes in key management personnel or facility staff

accountable for the testing or inspection services for which the

facility has been accredited. We would also require the operator of the

facility to report any changes involving the location, ownership,

physical plant, equipment, or other conditions that existed at the

facility at the time accreditation was granted.

Fees and Trust Fund Agreement

To cover the costs of APHIS' involvement in the assessment process,

the operator of the facility seeking accreditation would have to enter

into a trust fund agreement with APHIS. Under the agreement, the

operator of the facility would pay in advance all estimated costs that

APHIS expected to incur through its involvement in the pre-

accreditation assessment process and the maintenance of the facility's

accreditation. Those costs would include administrative expenses

incurred in those activities, such as laboratory fees for evaluating

check test

[[Page 62703]]

results, and all salaries (including overtime and the Federal share of

employee benefits), travel expenses (including per diem expenses), and

other incidental expenses incurred by the APHIS in performing those

activities. The agreement would require the operator of the facility to

deposit a certified or cashier's check with APHIS for the amount of the

costs, as estimated by APHIS. If the deposit was not sufficient to meet

all costs incurred by APHIS, the agreement would further require the

operator of the facility to deposit another certified or cashier's

check with APHIS for the amount of the remaining costs, as determined

by APHIS, before APHIS' services would be completed. After a final

audit at the conclusion of the pre-accreditation assessment, any

overpayment of funds would be returned to the operator of the facility

or held on account until needed for future activities related to the

maintenance of the facility's accreditation.

Executive Order 12866 and Regulatory Flexibility Act

This proposed rule has been reviewed under Executive Order 12866.

The rule has been determined to be significant for the purposes of

Executive Order 12866 and, therefore, has been reviewed by the Office

of Management and Budget.

This proposed rule would amend the export certification regulations

to provide for the establishment of a program under which non-

government facilities could become accredited to perform specific

laboratory testing or phytosanitary inspection services that could

serve as the basis for the issuance of Federal phytosanitary

certificates, phytosanitary certificates for reexport, or an export

certificates for processed plant products. The accreditation criteria

for particular laboratory testing and phytosanitary inspection services

would be developed by APHIS with the participation of other interested

governmental, industry, academic, or research entities. Currently, only

tests conducted by public laboratories or inspections carried out by

Federal, State, or county inspectors or by agents may be used as the

basis for the issuance of a Federal certificate. The proposed

accreditation program would provide a mechanism for qualified non-

government facilities to become accredited to perform the testing or

inspection services that may be used as supporting documentation for

the issuance of Federal certificates for the export or reexport of

certain plants or plant products.

The regulations proposed in this document are intended only to

provide a framework upon which accreditation programs for specific

functions could be established, so they would not, in and of

themselves, entail any costs to APHIS or any non-government facility.

However, any specific accreditation program that would be established

under these proposed regulations would entail costs to both the

entities being accredited and the accrediting body, i.e., APHIS.

Because the accreditation program is expected to be self-supporting,

the costs to APHIS would be recouped through accreditation fees. The

fees charged by APHIS in connection with the initial accreditation of a

non-government facility and the maintenance of that accreditation

would, therefore, have to be adequate to recover the costs incurred by

the government in the course of APHIS' accreditation activities. We

expect that the costs that would have to be reimbursed would be largely

attributable to the cost of transportation for the assessors to travel

to the site of the facility, lodging for the assessors, their salary

and per diem, any laboratory fees charged for evaluating check test

results, and administrative expenses. Costs for specific accreditation

programs would vary depending on the range of activities for which a

facility was seeking accreditation, the number of assessors needed to

adequately conduct a pre-accreditation assessment, the type and number

of any proficiency tests that would have to be conducted, and the

frequency with which post-accreditation evaluation activities such as

check tests and site visits would have to be conducted.

The proposed regulations would stipulate that APHIS would provide

an estimate of its anticipated fees to the operator of the facility

prior to undertaking any activities that would result in fees being

charged to a facility. Participation in any accreditation program

developed under these proposed regulations would be voluntary. At this

time, we estimate that 15 individual non-government facilities would be

likely to seek and maintain accreditation annually on about 82

accredited procedures, as long as the costs of participating in an

accreditation program are lower than the benefits they receive from the

program. As a result, this program would have to meet the test of the

marketplace.

The domestic seed industry, through the American Seed Trade

Association, has indicated its interest in establishing an

accreditation program for seed health testing and field inspection of

seed, so we have used the domestic seed industry to illustrate the

potential benefits that could result from the establishment of specific

accreditation programs.

The seed industry would likely benefit from the establishment of an

accreditation program because domestic seed exporters routinely require

the services of inspectors and agents in order to obtain the

phytosanitary certification required by most, if not all, importing

countries; the benefits would be realized in terms of more timely

certifications, which in turn could lead to reduced costs as well as

increased U.S. exports.

The value of seed exported from the United States to other

countries continues to grow rapidly, from $665 million in 1994-95 (July

to June), to $705 million in 1995-96, to more than $800 million

projected for 1996-97. There has been a concomitant rise in demand for

laboratory testing and phytosanitary inspection services to meet other

countries' import requirements. The ability of Federal, State, and

county testing and inspection services to meet this growing demand will

be increasingly strained. Already there are instances in which the

accreditation of non-government facilities would have prevented the

loss of export sales.

For example, some seed export opportunities have been forfeited

because the results of pre-harvest field inspections are usually not

known until after harvest. It is common for seed from several fields to

be blended before shipment. If the sample from one field is

subsequently reported to contain an actionable pest, then none of the

blended seed--which may have been harvested from as many as eight or

nine fields--could be exported. In one case in which this occurred, the

affected seed company lost foreign sales worth $250,000. Such losses

would be much less likely to occur if there were more timely reporting

of pre-harvest inspections; accredited non-government inspection

facilities could make timely reporting a reality. In general, non-

government testing and inspection services could be expected to be

completed with minimal delay, leading to greater marketing flexibility

and lower risk of lost sales.

Additional benefits, of even greater potential significance, would

be gained through the standardization of testing and inspection

protocols that would result from the establishment of accreditation

standards, particularly when internationally recognized standards are

used. Major seed trading partners of the United States, such as

[[Page 62704]]

Canada, France, and The Netherlands, have national seed health

organizations that address seed health issues in part by employing

laboratory accreditation protocols. The standards that would underlie

accreditation of non-government facilities in the United States could

help lead to the removal of discrepancies among foreign phytosanitary

regulations, thereby expediting U.S. seed exports.

Accreditation of non-government facilities, by promoting more

streamlined exports based on internationally recognized standards,

could be expected to benefit other export sales besides those of the

seed industry. As a self-supporting system, private firms that expect

benefits in excess of costs of accreditation would participate. In

addition to the net benefits received by these firms directly, society

as a whole would benefit from enhanced trade.

Under these circumstances, the Administrator of the Animal and

Plant Health Inspection Service has determined that this action would

not have a significant economic impact on a substantial number of small

entities.

Executive Order 12372

This program/activity is listed in the Catalog of Federal Domestic

Assistance under No. 10.025 and is subject to Executive Order 12372,

which requires intergovernmental consultation with State and local

officials. (See 7 CFR part 3015, subpart V.)

Executive Order 12988

This proposed rule has been reviewed under Executive Order 12988,

Civil Justice Reform. If this proposed rule is adopted: (1) All State

and local laws and regulations that are inconsistent with this rule

will be preempted; (2) no retroactive effect will be given to this

rule; and (3) administrative proceedings will not be required before

parties may file suit in court challenging this rule.

Paperwork Reduction Act

In accordance with section 3507(d) of the Paperwork Reduction Act

of 1995 (44 U.S.C. 3501 et seq.), the information collection or

recordkeeping requirements included in this proposed rule have been

submitted for approval to the Office of Management and Budget (OMB).

Please send written comments to the Office of Information and

Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington,

DC 20503. Please state that your comments refer to Docket No. 95-071-1.

Please send a copy of your comments to: (1) Docket No. 95-071-1,

Regulatory Analysis and Development, PPD, APHIS, suite 3C03, 4700 River

Road Unit 118, Riverdale, MD 20737-1238, and (2) Clearance Officer,

OIRM, USDA, room 404-W, 14th Street and Independence Avenue SW.,

Washington, DC 20250. A comment to OMB is best assured of having its

full effect if OMB receives it within 30 days of publication of this

proposed rule.

This proposed rule would provide for the establishment of a program

under which non-government facilities could become accredited to

perform specific laboratory testing or phytosanitary inspection

services that could serve as the basis for the issuance of a Federal

phytosanitary certificate, export certificate for processed plant

products, or phytosanitary certificate for reexport. This proposed

accreditation program would provide a mechanism for qualified non-

government facilities to become accredited to perform testing or

inspection services that may be used as supporting documentation for

the issuance of certificates for certain plants or plant products.

Launching this accreditation program would necessitate that APHIS

use a number of information collection activities to ensure that non-

government facilities participating or seeking to participate in the

program possess the necessary qualifications. Therefore, we are seeking

OMB approval to employ the following information collection activities

in connection with the APHIS export certification program:

Application for accreditation: The operator of a non-government

facility who wishes to be accredited in a particular area of laboratory

testing or phytosanitary inspection must submit an application to

APHIS. The application must contain the legal name and full address of

the facility; the name, address, telephone, and fax number of the

facility's operator; a description of the facility; and a description

of the specific laboratory testing or phytosanitary inspection services

for which the facility is seeking accreditation.

Agreement to fulfill accreditation procedure: Before APHIS will

assess a non-government facility to determine whether it meets the

standards for accreditation, the operator of the facility must sign an

agreement with APHIS. Specifically, the operator must agree to supply

any information needed for the evaluation of the facility, pay the fees

charged for the assessment, and accept the charges related to the

subsequent maintenance of the facility's accreditation.

Documentation of equipment: The equipment used in the non-

government facility (microscopes, computers, etc.) must be calibrated

and monitored to ensure that it conforms to the standards for

accreditation. This calibration and monitoring must be documented by

facility personnel.

Quality manual or equivalent documentation: The operator of a non-

government facility is responsible for maintaining a quality manual or

similar documentation at the facility that describes the system in

place for conducting the laboratory testing or phytosanitary inspection

services for which the faculty is accredited. The manual must be

available to and used by facility personnel performing the work.

Identity of personnel and subcontractor's qualifications: The

personnel employed at the non-government facility must be identified

and possess the training, education, or experience necessary to perform

the laboratory testing or phytosanitary inspection services for which

the facility is accredited. The operator of the facility is responsible

for acquiring and maintaining documentation concerning the training,

education, and experience of facility personnel. If the non-government

facility uses a subcontractor to perform some of its testing or

inspection services, the qualifications of the subcontractor must be

documented and made available to APHIS. The facility operator is

responsible for acquiring and maintaining this documentation.

Notification of changes in personnel: The facility operator must

notify APHIS whenever the facility undergoes any change in personnel.

This notification may be written, communicated via telephone, or by any

other means of communication convenient to the facility's operator.

Report changes in location or ownership: The facility operator must

notify APHIS if the facility moves its operations to a new location,

undergoes an ownership change, replaces equipment, or experiences any

other changes in the conditions that existed at the time the facility

received its accreditation. This notification may be written,

communicated via telephone, or by any other means of communication

convenient to the facility's operator.

We are soliciting comments from the public (as well as affected

agencies) concerning our proposed information collection and

recordkeeping requirements. We need this outside input to help us:

(1) Evaluate whether the proposed information collection is

necessary for the proper performance of our agency's

[[Page 62705]]

functions, including whether the information will have practical

utility;

(2) Evaluate the accuracy of our estimate of the burden of the

proposed information collection, including the validity of the

methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to

be collected; and

(4) Minimize the burden of the information collection on those who

are to respond (such as through the use of appropriate automated,

electronic, mechanical, or other technological collection techniques or

other forms of information technology, e.g., permitting electronic

submission of responses).

Estimate of burden: Public reporting burden for this collection of

information is estimated to average 3.609 hours per response.

Respondents: Operators of non-government facilities who wish to be

accredited to perform laboratory testing or phytosanitary inspection

services in connection with APHIS' export certification program and

certain employees of such non-government facilities.

Estimated number of respondents: 15.

Estimated number of responses per respondent: 5.466.

Estimated annual number of responses: 82.

Estimated total annual burden on respondents: 296 hours.

Copies of this information collection can be obtained from

Clearance Officer, OIRM, USDA, room 404-W, 14th Street and Independence

Avenue SW., Washington, DC 20250.

All responses to this notice will be summarized and included in the

request for OMB approval. All comments will also become a matter of

public record.

Regulatory Reform

This action is part of the President's Regulatory Reform

Initiative, which, among other things, directs agencies to remove

obsolete and unnecessary regulations and to find less burdensome ways

to achieve regulatory goals.

List of Subjects in 7 CFR Part 353

Exports, Plant diseases and pests, Reporting and recordkeeping

requirements.

Accordingly, 7 CFR part 353 would be amended as follows:

PART 353--EXPORT CERTIFICATION

1. The authority citation for part 353 would continue to read as

follows:

Authority: 7 U.S.C. 147a; 21 U.S.C. 136 and 136a; 44 U.S.C. 35;

7 CFR 2.22, 2.80, and 371.2(c).

2. In Sec. 353.1, a definition of non-government facility would be

added, in alphabetical order, to read as follows:

Sec. 353.1 Definitions.

* * * * *

Non-government facility. A laboratory, research facility,

inspection service, or other entity that is maintained, at least in

part, for the purpose of providing laboratory testing or phytosanitary

inspection services and that is not operated by the Federal Government

or by the government of a State or a subdivision of a State.

* * * * *

3. In Sec. 353.7, paragraphs (a)(4), (b)(4), and (c)(4) would each

be amended by adding a new sentence at the end of each paragraph to

read as follows:

Sec. 353.7 Certificates.

(a) * * *

(4) * * * The Administrator may also authorize inspectors to issue

a certificate on the basis of a laboratory test or an inspection

performed by a non-government facility accredited in accordance with

Sec. 353.8.

* * * * *

(b) * * *

(4) * * * The Administrator may also authorize inspectors to issue

a certificate on the basis of a laboratory test or an inspection

performed by a non-government facility accredited in accordance with

Sec. 353.8.

* * * * *

(c) * * *

(4) * * * The Administrator may also authorize inspectors to issue

a certificate on the basis of laboratory test or an inspection

performed by a non-government facility accredited in accordance with

Sec. 353.8.

* * * * *

4. A new Sec. 353.8 would be added to read as follows:

Sec. 353.8 Accreditation of non-government facilities.

(a) The Administrator may accredit a non-government facility to

perform specific laboratory testing or phytosanitary inspection

services if the Administrator determines that the non-government

facility meets the criteria of paragraph (b) of this

section.1

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

\1\ A list of accredited non-government facilities may be

obtained by writing to Port Operations, PPQ, APHIS, 4700 River Road

Unit 139, Riverdale, MD 20737-1236.

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

(1) A non-government facility's compliance with the criteria of

paragraph (b) of this section shall be determined through an assessment

of the facility and its fitness to conduct the laboratory testing or

phytosanitary inspection services for which it seeks to be accredited.

If, after evaluating the results of the assessment, the Administrator

determines that the facility meets the accreditation criteria, the

facility's application for accreditation will be approved.

(2) The Administrator may deny accreditation to, or withdraw the

accreditation of, any non-government facility to conduct laboratory

testing or phytosanitary inspection services upon a determination that

the facility does not meet the criteria for accreditation or

maintenance of accreditation under paragraph (b) of this section and

has failed to take the remedial action recommended to correct

identified deficiencies.

(i) In the case of a denial, the operator of the facility will be

informed of the reasons for the denial and may appeal the decision in

writing to the Administrator within 10 days after receiving

notification of the denial. The appeal must include all of the facts

and reasons upon which the person relies to show that the facility was

wrongfully denied accreditation. The Administrator will grant or deny

the appeal in writing as promptly as circumstances permit, stating the

reason for his or her decision. If there is a conflict as to any

material fact, a hearing will be held to resolve the conflict. Rules of

practice concerning the hearing will be adopted by the Administrator.

(ii) In the case of withdrawal, before such action is taken, the

operator of the facility will be informed of the reasons for the

proposed withdrawal. The operator of the facility may appeal the

proposed withdrawal in writing to the Administrator within 10 days

after being informed of the reasons for the proposed withdrawal. The

appeal must include all of the facts and reasons upon which the person

relies to show that the reasons for the proposed withdrawal are

incorrect or do not support the withdrawal of the accreditation of the

facility. The Administrator will grant or deny the appeal in writing as

promptly as circumstances permit, stating the reason for his or her

decision. If there is a conflict as to any material fact, a hearing

will be held to resolve the conflict. Rules of practice concerning the

hearing will be adopted by the Administrator. However, withdrawal shall

become effective pending final determination in the proceeding when the

Administrator determines that such action is necessary to protect the

public health, interest, or safety. Such withdrawal will be effective

upon oral or written notification, whichever is earlier, to the

operator of the facility. In the event of oral notification, written

[[Page 62706]]

confirmation will be given as promptly as circumstances allow. This

withdrawal will continue in effect pending the completion of the

proceeding, and any judicial review thereof, unless otherwise ordered

by the Administrator.

(3) The Administrator will withdraw the accreditation of a non-

government facility if the operator of the facility informs APHIS in

writing that the facility wishes to terminate its accredited status.

(4) A non-government facility whose accreditation has been denied

or withdrawn may reapply for accreditation using the application

procedures in paragraph (b) of this section. If the facility's

accreditation was denied or withdrawn under the provisions of paragraph

(a)(2) of this section, the facility operator must include with the

application written documentation specifying what actions have been

taken to correct the conditions that led to the denial or withdrawal of

accreditation.

(5) All information gathered during the course of a non-government

facility's assessment and during the term of its accreditation will be

treated by APHIS with the appropriate level of confidentiality, as set

forth in the U.S. Department of Agriculture's administrative

regulations in Sec. 1.11 of this title.

(b) Criteria for accreditation of non-government facilities. (1)

Specific standards for accreditation in a particular area of laboratory

testing or phytosanitary inspection are set forth in this part and may

be obtained by writing to APHIS. If specific standards for

accreditation in a particular area of laboratory testing or

phytosanitary inspection have not been promulgated by APHIS, the

Administrator will develop appropriate standards applicable to

accreditation in the area for which the non-government facility is

seeking accreditation and publish a notice of proposed rulemaking in

the Federal Register to inform the public and other interested persons

of the opportunity to comment on and participate in the development of

those standards.

(2) The operator of a non-government facility seeking accreditation

to conduct laboratory testing or phytosanitary inspection shall submit

an application to the Administrator. The application must be completed

and signed by the operator of the facility or his or her authorized

representative and must contain the following:

(i) Legal name and full address of the facility;

(ii) Name, address, and telephone and fax number of the operator of

the facility or his or her authorized representative;

(iii) A description of the facility, including its physical plant,

primary function, scope of operation, and, if applicable, its

relationship to a larger corporate entity; and

(iv) A description of the specific laboratory testing or

phytosanitary inspection services for which the facility is seeking

accreditation.

(3) Upon receipt of the application, APHIS will review the

application to identify the scope of the assessment that will be

required to adequately review the facility's fitness to conduct the

laboratory testing or phytosanitary inspection services for which it is

seeking accreditation. Before the assessment of the facility begins,

the applicant's representative must agree, in writing, to fulfill the

accreditation procedure, especially to receive the assessment team, to

supply any information needed for the evaluation of the facility, and

to enter into a trust fund agreement as provided by paragraph (c) of

this section to pay the fees charged to the applicant facility

regardless of the result of the assessment and to pay the charges of

subsequent maintenance of the accreditation of the facility. Once the

agreement has been signed, APHIS will assemble an assessment team and

commence the assessment as soon as circumstances permit. The assessment

team will measure the facility's fitness to conduct the laboratory

testing or phytosanitary inspection services for which it is seeking

accreditation against the specific standards identified by the

Administrator for those services by reviewing the facility in the

following areas:

(i) Physical plant. The facility's physical plant (e.g., laboratory

space, office space, greenhouses, vehicles, etc.) must meet the

criteria identified in the accreditation standards as necessary to

properly conduct the laboratory testing or phytosanitary inspection

services for which it seeks accreditation.

(ii) Equipment. The facility's personnel must possess or have

unrestricted access to the equipment (e.g., microscopes, computers,

scales, triers, etc.) identified in the accreditation standards as

necessary to properly conduct the laboratory testing or phytosanitary

inspection services for which it seeks accreditation. The calibration

and monitoring of that equipment must be documented and conform to

prescribed standards.

(iii) Methods of testing or inspection. The facility must have a

quality manual or equivalent documentation that describes the system in

place at the facility for the conduct of the laboratory testing or

phytosanitary inspection services for which the facility seeks

accreditation. The manual must be available to, and in use by, the

facility personnel who perform the services. The methods and procedures

used by the facility to conduct the laboratory testing or phytosanitary

inspection services for which it seeks accreditation must be

commensurate with those identified in the accreditation standards and

must be consistent with or equivalent to recognized international

standards for such testing or inspection.

(iv) Personnel. The management and facility personnel accountable

for the laboratory testing or phytosanitary inspection services for

which the facility is seeking accreditation must be identified and must

possess the training, education, or experience identified in the

accreditation standards as necessary to properly conduct the testing or

inspection services for which the facility seeks accreditation, and

that training, education, or experience must be documented. Any

subcontractor utilized by the facility in connection with the testing

or inspection services for which accreditation is sought must be

identified to APHIS; the subcontractor's qualifications will be

reviewed by APHIS as part of the facility's assessment.

(4) To retain accreditation, the facility must agree to:

(i) Observe the specific standards applicable to its area of

accreditation;

(ii) Be assessed and evaluated on a periodic basis by means of

proficiency testing or check samples;

(iii) Demonstrate on request that it is able to perform the tests

or inspection services representative of those for which it is

accredited;

(iv) Resolve all identified deficiencies;

(v) Notify APHIS as soon as circumstances permit of any changes in

key management personnel or facility staff accountable for the

laboratory testing or phytosanitary inspection services for which the

facility is accredited; and

(vi) Report to APHIS as soon as circumstances permit any changes

involving the location, ownership, physical plant, equipment, or other

conditions that existed at the facility at the time accreditation was

granted.

(c) Fees and trust fund agreement. The fees charged by APHIS in

connection with the initial accreditation of a non-government facility

and the maintenance of that accreditation shall be adequate to recover

the costs incurred by the government in the course of APHIS'

accreditation

[[Page 62707]]

activities. To cover those costs, the operator of the facility seeking

accreditation must enter into a trust fund agreement with APHIS under

which the operator of the facility will pay in advance all estimated

costs that APHIS expects to incur through its involvement in the pre-

accreditation assessment process and the maintenance of the facility's

accreditation. Those costs shall include administrative expenses

incurred in those activities, such as laboratory fees for evaluating

check test results, and all salaries (including overtime and the

Federal share of employee benefits), travel expenses (including per

diem expenses), and other incidental expenses incurred by the APHIS in

performing those activities. The operator of the facility must deposit

a certified or cashier's check with APHIS for the amount of the costs,

as estimated by APHIS. If the deposit is not sufficient to meet all

costs incurred by APHIS, the operator of the facility must deposit

another certified or cashier's check with APHIS for the amount of the

remaining costs, as determined by APHIS, before APHIS' services will be

completed. After a final audit at the conclusion of the pre-

accreditation assessment, any overpayment of funds will be returned to

the operator of the facility or held on account until needed for future

activities related to the maintenance of the facility's accreditation.

Done in Washington, DC, this 19th day of November 1997.

Terry L. Medley,

Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 97-30944 Filed 11-24-97; 8:45 am]

BILLING CODE 3410-34-P