[Code of Federal Regulations]
[Title 7, Volume 5, Parts 200 to 399]
[Revised as of January 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 7CFR353.8]

[Page 410-413]
 
                          TITLE 7--AGRICULTURE
 
 CHAPTER III--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 353--EXPORT CERTIFICATION--Table of Contents
 
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 Phytosanitary Issues Management, PPQ, APHIS, 4700 River 
Road, Unit 140, 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 confirmation will 
be given as promptly as circumstances allow. This withdrawal will 
continue in effect pending the completion of the

[[Page 411]]

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, and the Administrator determines 
that accreditation in that area is practical, APHIS 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

[[Page 412]]

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 
followed 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.
    (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 possible, but no more than 10 days 
following its occurrence, of any change 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 possible, but no more than 10 days 
following its occurrence, any change 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 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

[[Page 413]]

maintenance of the facility's accreditation.

[64 FR 1105, Jan. 8, 1999]