[Federal Register Volume 64, Number 5 (Friday, January 8, 1999)]
[Rules and Regulations]
[Pages 1098-1106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-396]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 353
[Docket No. 95-071-2]
RIN 0579-AA75
Export Certification; Accreditation of Non-Government Facilities
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are amending the export certification regulations to
provide for the establishment of a program under which non-government
facilities may become accredited to perform specific laboratory testing
or phytosanitary inspection services that may serve as the basis for
the issuance of a Federal phytosanitary certificate, export certificate
for processed plant products, or phytosanitary certificate for
reexport. Prior to this rule, only tests conducted by public
laboratories or inspections carried out by Federal, State, or county
inspectors or by agents could be used as the basis for the issuance of
Federal certificates. The accreditation criteria for particular
laboratory testing and phytosanitary inspection services will be
developed by the Animal and Plant Health Inspection Service in
cooperation with other interested government, industry, academic, or
research entities. The accreditation program will 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.
EFFECTIVE DATE: February 8, 1999.
FOR FURTHER INFORMATION CONTACT: Mr. Narcy G. Klag, Accreditation
Program Manager, Phytosanitary Issues Management, PPQ, APHIS, 4700
River Road Unit 140, Riverdale, MD 20737-1236; (301) 734-8469.
SUPPLEMENTARY INFORMATION:
Background
The export certification regulations in 7 CFR part 353 (referred to
below as the regulations) set forth the procedures for obtaining
certification for plants and plant products offered for export or
reexport. Under the regulations, 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. 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. The regulations also
provide for an industry-based certification, under certain conditions,
of certain low-risk plant products such as kiln-dried lumber offered
for export.
On November 25, 1997, we published in the Federal Register (62 FR
62699-62707, Docket No. 95-071-1) a proposal to amend the 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.
We solicited comments concerning our proposed rule for 60 days
ending January 26, 1998. We received 34 comments by that date. The
comments were from processors and distributors of agricultural
commodities, State and county agricultural agencies, a seed trade
association, seed companies, crop improvement associations, a
university laboratory, private testing and certification services, an
association of State agricultural officials, laboratory accreditation
organizations, a foreign plant health agency, and an association of
seed certifying officials. Although all of the commenters supported the
concept of an accreditation program, all but six of them had specific
concerns, questions, or suggestions regarding the proposed
accreditation program. The comments are addressed below.
[[Page 1099]]
Role of Accredited Facilities
Several commenters referred to accredited facilities as ``private
certifiers'' or as having responsibility for the issuance of
phytosanitary certificates. We wish to make it clear that accredited
facilities will not be ``certifiers,'' nor will accredited facilities
issue phytosanitary certificates. Rather, an accredited facility would
perform specific tests or inspections that would serve as the basis for
phytosanitary certification; phytosanitary certificates will continue
to be issued by Federal, State, or county-level inspectors, as provided
by the regulations.
Handling of Samples
Two commenters raised the issue of the handling of samples
submitted for testing or inspection. The commenters were concerned that
the proposed rule did not address issues such as who would collect and
prepare samples for testing or inspection and how the integrity of
samples would be maintained during movement and while at the accredited
facility. One of the commenters stated that APHIS should specify how
all samples are to be collected and handled, while the second commenter
suggested that a sample handling accreditation program be made part of
the regulations.
We agree with the commenters that the proper handling of samples is
important to any laboratory testing or inspection program. Because the
procedures and requirements for the collection and handling of samples
will likely vary to some extent from plant to plant or product to
product, we believe that sample collection and handling should be
addressed in each set of specific accreditation standards as they are
prepared, rather than in a general way in the regulations. Further,
because the sample handling requirements will be part of each set of
specific accreditation standards, we do not believe that it is
necessary to establish a separate sample handling accreditation
program.
Conflict of Interest
Two commenters suggested that APHIS or State agencies should act as
an intermediary between accredited laboratories and their customers,
serving as the conduit for contracting and payment for services and the
submission of samples for testing. Two other commenters stated that
APHIS must ensure that laboratory analyses are not performed by anyone
having an interest in the product to avoid conflicts of interest. These
four commenters sought to separate the entity performing an inspection
or test from the entity for whom the work is performed in order to
prevent any influence or bias. One of them noted that the current
regulations in Sec. 353.6(a)(3) prohibit agents from performing
inspections of any plants or plant products in which they or a family
member are directly or indirectly financially interested, and stated
that the same conflict of interest rules should apply to accredited
facilities. Two different commenters foresaw the possibility that an
accredited facility might be a division or affiliate of a company that
would use its testing or inspection services and asked how APHIS would
deal with the potential conflicts of interest inherent in a facility
testing or inspecting its own plants or plant products.
The issue in all of the comments summarized in the previous
paragraph appears to be whether or not an accredited facility that is
connected in some way to a commercial entity for which it is performing
a service will be able to conduct unbiased tests or inspections and
accurately report the results of those tests or inspections. The
commenters appear to be worried that an accredited facility might
tailor test protocols or alter results in order to get the ``right''
answer that will please the commercial entity with which the facility
is associated.
We acknowledge that it is possible that an accredited facility
could attempt to provide inaccurate information to an inspector in
order to secure a phytosanitary certificate. However, given the
investment of time, money, and other resources that becoming accredited
would require, we do not believe that an accredited facility would risk
having its accreditation withdrawn by falsely certifying that a
specific test or inspection had been conducted and its results
faithfully reported.
Falsified test or inspection results can be detected by inspectors
conducting post-accreditation reviews or audits of facilities or
through random checks by certifying officials of plants or plant
products for which a phytosanitary certificate is sought. Under
Sec. 353.8(b)(4), facilities must agree to be periodically assessed and
evaluated by means of proficiency testing or check samples in order to
retain accreditation. Further, the tests or inspections that accredited
facilities will perform are for pests or diseases that are likely to
manifest themselves at some point. Presumably, an importing country is
asking for a phytosanitary certificate because a certain pest or
disease that may be present in the United States does not exist or is
not widely prevalent in that importing country; if the pest or disease
is detected in the importing country following the receipt of a
shipment certified on the basis of falsified test results, it is likely
that the pest or disease will be traced to that shipment. If it can be
confirmed that the exporting company, through its accredited facility,
used false test results to obtain a phytosanitary certificate, several
consequences are possible: The facility's accreditation could be
withdrawn, the facility or its parent company could be subject to civil
or even criminal penalties in the United States or the importing
country, and the parent company would likely lose the trust--and the
business--of its customers. We believe that the likelihood of detection
and the consequences associated with falsifying results will serve as a
deterrent in those cases where such deterrence is necessary.
Composition of Assessment Teams
One commenter asked if competitors of a facility seeking
accreditation would be involved in a facility's pre-accreditation
assessment. The commenter stated that such participation would be
inappropriate because the assessment team members must be completely
impartial and assess the facility on the standards established by the
rule without any appearance of bias. Another commenter asked if State
plant regulatory agencies would be involved in the pre-accreditation
assessment process and post-accreditation activities.
We do not anticipate that we will seek the participation of
operators or employees of commercial laboratories or inspection
services in the pre-accreditation assessment process. We do expect that
there will be instances when we will seek the formal assistance of our
cooperators in State plant regulatory agencies in the pre-accreditation
assessment process or in post-accreditation facility visits and
reviews. In addition, we would welcome the participation of our State
cooperators in any accreditation activities being conducted in their
respective States.
Post-Accreditation Supervision
One commenter stated that his organization could support the
concept of accreditation only if APHIS maintained continuous, day-to-
day oversight of the program through the appointment of an
accreditation manager who would administer the application procedures
and audits, arrange for proficiency testing, develop and provide
training for seed health tests and field inspection procedures, issue
accreditation credentials, maintain accreditation records, and
establish
[[Page 1100]]
standard tests for laboratory and field inspection procedures.
The need for program management such as that described by the
commenter was recognized by APHIS at the time the proposed rule was
being prepared, so there are already plans to appoint an accreditation
manager within APHIS' Plant Protection and Quarantine program to
perform the tasks identified by the commenter.
Another commenter questioned whether APHIS had sufficient staff to
implement and adequately monitor the accreditation program. The
commenter stated that there are universities and State departments of
agriculture that could serve as accreditors to more efficiently perform
the actual accreditation work for APHIS; APHIS' role could be purely
administrative, with the bulk of operational work being accomplished by
the State-level accreditors.
As noted above, an accreditation manager will be appointed in APHIS
to oversee the program's operation. We anticipate that the
accreditation manager will work closely with the export certification
program's traditional cooperators at the State and county level,
relying on them for advice and assistance with regard to accreditation
activities in their geographic area or within their realm of expertise.
As with other aspects of the program, the extent to which State
cooperators will become involved in accreditation-related activities
will depend largely on demand for accreditation and the number of
facilities that become accredited.
One commenter had several questions regarding post-accreditation
supervision of facilities: What will be the frequency of post-
accreditation audits or inspections? Will State plant regulatory
agencies be able to request an audit or inspection if an irregularity
is noted or a complaint is received? Will State plant regulatory
agencies be notified of the results of those audits or inspections?
The frequency of post-accreditation audits and inspections will be
determined, at least in part, by the type of service a facility becomes
accredited to perform. The performance of field inspections and even
some types of laboratory testing will be subject to seasonal changes
and other variables, so it would be difficult to prescribe a universal
audit schedule as part of this final rule. Thus, the frequency of post-
accreditation audits and inspections for a particular area of
accreditation will be determined at the same time the specific
standards for accreditation in that area are developed.
We would encourage State plant regulatory agencies, as well as
other entities that have dealings with an accredited facility, to
report any observed deficiencies or irregularities in an accredited
facility to the APHIS accreditation manager or to an inspector. APHIS
will review all reports received and, as appropriate, will perform an
inspection or audit in order to resolve any issues that arise regarding
accredited facilities. As cooperators in APHIS' phytosanitary export
certification program, State plant regulatory agencies will be kept
informed of developments in the program, including those related to
accredited facilities.
One other commenter was concerned that the quality of inspection
could suffer under an accreditation plan. Although he offered no
specific examples, the commenter stated that in some situations where
self-inspection has been performed, quality problems such as
overlooking specific infestations or diseases have manifested
themselves. If the quality of inspection is reduced or is unacceptable
to an importing country, the commenter concluded, the U.S.
phytosanitary inspection system as a whole may come under scrutiny.
We agree with the commenter's assertion that the quality of
inspection must be maintained to ensure the continued confidence of our
trading partners. We believe that the accreditation program provided
for by this final rule, with its focus on standards and required levels
of performance, will preserve--and even enhance--the quality and
credibility of the U.S. phytosanitary certification program.
Issuance of Certificates
One commenter asked if accredited facilities would apply to APHIS
or to State cooperators for export certificates and, if application for
a certificate was made to a State cooperator, whether the State
cooperator would be required to issue a certificate.
The regulations in Sec. 353.7 state that phytosanitary certificates
are signed and issued by inspectors; an inspector, as defined in
Sec. 353.1, could be either an APHIS employee or a State or county
plant regulatory official designated by the Secretary of Agriculture to
inspect and certify to shippers and other interested parties as to the
phytosanitary condition of plant products. Any shipment offered for
certification that meets the requirements of the importing country and
is in compliance with the regulations is expected to be certified; to
do otherwise would be a disservice to--and likely challenged by--those
individuals seeking a certificate.
On a similar note, a commenter from a county agricultural agency
stated that she was concerned about the possibility of placing the
county in a position of greater liability if she had to issue a
phytosanitary certificate based on laboratory analysis or field
inspections completed by a private company rather than a public agency.
No liability should attach to a certifying official as long as the
certification is made in accordance with the regulations. The
certifying statement on the phytosanitary certificate states that
``This is to certify that the plants or plant products described below
have been inspected according to appropriate procedures and are
considered free from quarantine pests * * *'' Using test or inspection
results provided by an accredited facility is an appropriate and
defensible procedure.
Costs of Accreditation
Several commenters were opposed to the provisions of the proposed
rule that would require the operator of a facility seeking
accreditation to enter into a trust fund agreement with APHIS prior to
accreditation. Several commenters stated that private entities need to
know in advance what the costs associated with the accreditation
process will be in order to be able to accurately calculate all costs
and benefits of the system. The commenters further stated that the
failure to accurately calculate all costs of accreditation, at all
levels of administration, could lead to an accreditation system that is
not viable, cost effective, or competitive in delivering phytosanitary
certification services. The commenters suggested that the trust fund
requirement apply only to entities that have not completed the
necessary cost analyses for implementing an accreditation scheme for
their constituents, or for entities that have not established a cash
reserve to cover the startup and long-term administration costs of
accreditation.
Given the tenor of those comments, it appears that the purpose and
scope of the trust fund agreement may not have been fully explained in
the proposed rule. We do not intend for the trust fund to be a single
pool of money funded by a particular industry segment from which APHIS
will draw to fund its activities in a certain area of accreditation.
Associations representing certain industry sectors may certainly play a
role in helping to develop accreditation standards that will be applied
to facilities within their industry, but when it comes to the actual
accreditation of facilities, those
[[Page 1101]]
facilities will individually enter into trust fund agreements with
APHIS to cover the costs of their accreditation.
Under a trust fund agreement, APHIS will, in advance, provide the
facility's operator with an estimate of the costs it expects to incur
through its involvement in the pre-accreditation assessment process. As
particular standards are developed, we will be better able to forecast
that cost and the costs of the maintenance of the facility's
accreditation. The operator of the facility would then deposit a
certified or cashier's check with APHIS for the amount of the estimated
costs, and the pre-accreditation assessment process would begin. If the
deposit is not sufficient to meet all costs incurred by APHIS, the
facility operator, under the terms of the trust fund agreement, would
deposit another certified or cashier's check with APHIS for the amount
of the remaining costs 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.
Because this is a new program, we cannot say with certainty what
all the costs will be and whether this trust fund agreement process
will be the best way of handling the recovery of the costs of our
participation in the accreditation process. Trust fund agreements have
been used successfully in other APHIS programs, and we believe that
they will be useful in this accreditation program. However, if the
agreement process proves unwieldy or unworkable, we will propose to
amend the regulations to modify the way in which APHIS recovers its
costs.
Costs of Services
One commenter was concerned that APHIS' intention to recover all
costs associated with its administration of the accreditation program
would result in fees that would be so high that they would render the
program infeasible.
As explained in the proposed rule, the administrative expenses that
we expect to incur and recover will be for items such as laboratory
fees for evaluating check test results and all salaries, travel
expenses, and other incidental expenses incurred by APHIS in performing
the pre-accreditation assessment. As long as we could determine that it
would be feasible and practical to establish an accreditation program
in a particular area to begin with, we do not expect that costs related
to those activities would be prohibitive. To make that consideration
clear, we have amended Sec. 353.8(b)(1) in this final rule to provide
that APHIS will make a determination regarding the practicality of
establishing an accreditation program in a particular area before
beginning the process of developing the standards that would be
applicable to accreditation in that area. Further, participation in the
accreditation program will be voluntary, and an estimate of costs will
be provided to each applicant before APHIS begins any accreditation-
related activities, so there will be ample opportunity for the
applicant to consider whether accreditation will be desirable from a
cost perspective.
One commenter stated that the services of accredited facilities
could become very expensive for industry if private entities providing
services charged enough to cover their expenses. The commenter
concluded that because some State agencies charge less than what is
actually necessary to cover their expenses, the fees charged by private
facilities will likely exceed the fees charged by government
facilities. Although it is possible that an accredited entity could
charge a higher fee than a public agency, a customer may still choose
to use the accredited entity's services if the customer receives an
added benefit such as faster reporting of results. However, if an
accredited entity charges fees that are perceived to be too high by
prospective customers, it is likely that those customers would take
their business elsewhere, i.e., to a government facility or other
accredited facility. Private entities providing inspection or testing
services will be subject to the same market forces as any other entity
providing services and will have to maintain a competitive fee schedule
to remain in business.
Standards for Field Inspection
One commenter agreed that the four major accreditation assessment
areas (physical plant, equipment, methods of testing or inspection, and
personnel) were appropriate, but stated that quality control is more
problematic regarding the accreditation of field inspectors. The
commenter noted that an accreditor cannot place a diseased or infested
plant in a field as part of a pre-accreditation assessment to see if it
is detected and reported. The commenter concluded by stating that
special attention must be given to the need for credible assessment
mechanisms when standards are set for accrediting private entities to
perform field inspections.
We acknowledge that assessing proficiency in the area of field
inspection may prove to be more of a challenge than assessing
proficiency in the somewhat more easily quantifiable area of laboratory
testing. The development of specific standards for accreditation to
conduct field inspections (as well as all other specific standards)
will be a collaborative process, as APHIS will seek the input,
cooperation, and comments of industry, academic, government, or other
personnel with expertise or interest in the areas that will be
assessed. We are confident that this collaborative process will result
in field inspection accreditation standards that will provide an
accurate assessment of an individual or entity seeking accreditation in
that area.
Withdrawal or Denial of Accreditation
One commenter was concerned that the 10 days that would be provided
for the operator of a facility to appeal a denial or withdrawal of
accreditation would not allow enough time to develop an adequate
appeal. The commenter stated that 30 days should be provided to file an
appeal, and that the Administrator's decision regarding an appeal
should also be made within 30 days, rather than the proposed ``as
promptly as circumstances permit.''
We do not believe that it is necessary to extend the time for a
person to submit an appeal. To appeal a denial, the operator must
provide the reasons why he or she believes that accreditation was
wrongfully denied; to appeal a withdrawal, the operator must provide
all of the facts and reasons upon which he or she relies to show that
the reasons for the proposed withdrawal are incorrect or do not support
the withdrawal. Because APHIS will inform the operator of all of the
reasons on which it based its denial or withdrawal of accreditation,
and the appeal is, in essence, the operator's specific response to each
of those stated reasons, we believe that 10 days is a sufficient amount
of time for an operator to prepare an appeal. Although the
Administrator will, in most cases, be able to respond to an appeal in
less than the 30-day limit suggested by the commenter, we have retained
``as promptly as circumstances permit'' as the time frame for the
Administrator's decision so as not to limit our ability to investigate
or review the circumstances surrounding a withdrawal or denial in light
of the information provided in the appeal.
Two other commenters were concerned about the length of time that
could potentially pass before the withdrawal of a facility's
accreditation became effective due to the proposed provisions for the
operator to appeal the withdrawal. Both commenters stated
[[Page 1102]]
that allowing an accredited entity to continue to perform phytosanitary
work while an appeal was filed and heard could result in the issuance
of additional invalid phytosanitary certificates. One of those
commenters further stated that the proposed provision for immediate
withdrawal to protect ``public health, interest, or safety''
constituted a high legal standard that might be easily and often
challenged.
As noted by one of the commenters, the regulations will provide for
the withdrawal of a facility's accreditation to become effective
immediately when the Administrator determines that an immediate
withdrawal action is necessary to protect the public health, interest,
or safety. The withdrawal will be effective upon oral or written
notification, whichever is earlier, to the operator of the facility and
will continue in effect pending the completion of the proceeding, and
any judicial review of the proceeding, unless otherwise ordered by the
Administrator. Because a credible phytosanitary export certification
program, which greatly facilitates U.S. export trade in plants and
plant products, is clearly in the public interest, we believe that we
can justify the immediate withdrawal of a facility's accreditation when
circumstances warrant.
Accreditation of Government Facilities
Several commenters discussed the apparent disparity between the
requirements for government and non-government facilities, each making
an argument for a different degree of uniformity between the public and
private facilities. One commenter stated that APHIS should provide
government facilities with copies of the standards and procedures and
minimum recordkeeping guidelines, and should provide training in the
standards at no charge to the government facility as part of the
cooperative agreement between APHIS and the States. A second commenter
stated that APHIS should require all entities, both government and non-
government, to conduct their diagnostic tests or field inspections in
accordance with the standards and procedures. A third commenter
suggested that government facilities should be able to become
accredited if they choose to do so, while a fourth commenter stated
that accreditation should be required for both government and non-
government facilities. Another commenter stated that the draft North
American Plant Protection Organization (NAPPO) accreditation standards
mentioned in the proposed rule clearly state that all personnel
carrying out the same phytosanitary certification inspection functions,
be they government or non-government personnel, must meet the same
standards, so government facilities should be required to be
accredited. All of these commenters cited the need for standard testing
and inspection protocols and warned that failure to provide for
coordination in that area could result in discrepancies in the U.S.
phytosanitary certification system and a subsequent erosion in the
confidence of importing countries with regard to that system.
The accreditation provided for by the final rule is, in essence,
the means by which APHIS can approve a non-government facility to
perform, in an official capacity, the same tests or inspections that
Federal and State laboratories and personnel currently perform in
support of the phytosanitary export certification program. As such,
there is no reason to require facilities operated by a State or other
governmental entity to become accredited. That being said, we do agree
with those commenters who have pointed out the need for standardization
and uniformity in phytosanitary testing and inspection. When developing
specific standards for a particular area of accreditation, we will
solicit and encourage the participation of all interested parties in
the public and private sectors and academia, and we expect the
resulting standards will reflect the best available science, processes,
and methods. Once completed, those standards will be used not only to
evaluate facilities seeking accreditation, but will be distributed to
Federal and State facilities performing phytosanitary certification
work to ensure that they are using the best available science,
processes, and methods.
Promulgation of Standards
Several commenters were concerned that the specific standards for
accreditation would be subject to notice and comment rulemaking after
they had been developed and before they could be applied to the
accreditation of non-government facilities. These commenters stated
that having to publish standards in the Federal Register would result
in delays that would have a negative effect on the entire accreditation
program. Most of these commenters stated that APHIS must make a clear
distinction between those standards that would require publication in
the Federal Register and those that would not, suggesting that basic,
generally applicable standards might be promulgated through rulemaking,
while items with more limited applicability, such as the protocols for
a specific test, could be made available as part of the guidelines that
apply to a specific area of accreditation.
We recognize the commenters' concerns and agree that the
development and promulgation of specific standards must be accomplished
in a manner that will allow the program to grow and adapt to new
technologies without undue process-driven delays. At the same time,
however, we must balance that desire for responsiveness and flexibility
with the need for program standards that are enforceable and that have
been developed with the necessary level of public participation.
Because this final rule only makes specific accreditation programs
possible and does not itself contain any specific standards, it is
difficult to conclusively define what will and will not be included
when standards are published. As an example, an accreditation standard
might call for a particular test to be performed; while the type and
purpose of the test will be published with the criteria for
interpreting test results and other aspects of the standard, the
detailed instructions and protocols for conducting the actual test
itself would not necessarily have to be published. Our goal is to
develop and promulgate standards in a manner that will allow the
process to be responsive and flexible while ensuring that the standards
themselves are fair and enforceable.
Use of Subcontractors
Four of the commenters were concerned about the provisions of the
proposed rule that would allow the use of subcontractors by accredited
facilities. One comment, from a foreign agricultural agency, stated
that his agency viewed the use of subcontractors as a further
delegation by APHIS of its phytosanitary certification duties. The
commenter closed by saying that APHIS must negotiate such delegations
with its foreign counterparts before proceeding with allowing the use
of contractors. The second commenter noted that although the proposed
rule would provide for a review of a subcontractor's qualifications,
there are no limits placed on the services the subcontractor could
provide. The commenter was concerned that an accredited facility might
use a subcontractor to, for example, entirely conduct a test that the
facility had been accredited to conduct. The commenter also pointed out
that the proposed rule did not prohibit a subcontractor to itself use a
subcontractor. The third commenter was concerned that an
[[Page 1103]]
accredited facility that was facing the withdrawal of its accreditation
might attempt to shift the blame for their shortcomings to a
subcontractor and simply fire one subcontractor and hire another in an
effort to retain accreditation. The fourth commenter stated that
allowing the use of subcontractors by accredited facilities would make
it very difficult to maintain program credibility and would allow for
too much extended liability.
We believe that all four of the commenters have made valid points
that bring into question the advisability of allowing accredited
facilities to use subcontractors. Therefore, in this final rule, we
have eliminated the reference to the use of subcontractors that had
been in Sec. 353.8(b)(3)(iv) of the proposed rule.
Use of International Standards
Two of the commenters recommended that APHIS utilize private sector
accreditation services for government and non-government laboratories.
These commenters stated that accrediting laboratories in accordance
with the International Standards Organization's (ISO's) internationally
recognized ISO Guide 25 would be a more reasonable and less burdensome
approach to accreditation and would be more easily recognized
internationally. One commenter noted that other Federal agencies accept
third-party laboratory accreditation in areas such as environmental
lead and asbestos or electromagnetic compatibility testing.
Additionally, that commenter stated, Public Law 104-113 mandates the
utilization of private sector laboratory accreditation services.
As explained above in the response to a previous comment, the
accreditation program provided by this final rule is a way for APHIS to
approve a non-government facility to perform tests or inspections in
support of the phytosanitary export certification program. The program
is not intended as, nor has it been presented as, a full-blown
laboratory evaluation and accreditation program such as those provided
under the auspices of the ISO. The underlying principles of ISO
certification, such as quality documentation and accountability,
certainly will be applied when specific standards are developed, but we
do not believe that it is necessary for a non-government facility to
receive ISO 25 certification before it can perform testing or
inspection services under the phytosanitary export certification
program.
Qualifications
One commenter asked what the minimum qualifications for the
accreditation of these private phytosanitary services would be, and how
and when the standards would be established. Two other commenters
stated that the minimum qualifications for accredited inspectors must
be established and should be at least equal to the minimum
qualifications required of county, State, or Federal inspectors.
Specific qualifications for personnel involved in any particular
area of accreditation are not within the scope of this final rule. As
discussed in the proposed rule, personnel standards are one of the
areas in which non-government facilities will be assessed and will,
therefore, be one of the areas for which specific standards will be
developed. Generally speaking, the qualifications of employees of non-
government facilities will be similar to those of government laboratory
personnel and inspectors. The draft NAPPO standard for accreditation
mentioned in the proposed rule states that accredited personnel should
not be held to standards that are higher than those for government
personnel, a concept with which we agree.
Availability of Information
Two of the commenters wanted to know if the information generated
by accredited facilities in the course of their inspection or testing
activities would be available for review by APHIS or its State
cooperators. One of the commenters stated such data must be available
for review to ensure the validity of the testing process. The other
commenter stated that because State plant regulatory agencies are
cooperators with APHIS in both pest detection and export commodity
certification, it is essential that States have access to such
information in order to maintain the credibility of their own
activities in those areas.
As standards are developed for specific areas of accreditation, we
will ensure that recordkeeping is addressed in a manner appropriate to
each area of accreditation. In general, we expect to require that
records related to a facility's area of accreditation be made available
to APHIS during the pre-accreditation assessment and during subsequent
post-accreditation reviews or audits. Similarly, the specific standards
will include, as appropriate, provisions for each accredited facility
to report pests and diseases to APHIS or the State plant health agency
for further action.
Notification of Changes
Two commenters noted that the proposed regulations call for a
facility to notify APHIS ``as soon as circumstances permit'' when there
is a change in key management personnel or facility staff, or when
there is a change involving the location, ownership, physical plant,
equipment, or relevant conditions at the plant. Both commenters stated
that ``as soon as circumstances permit'' was too vague a time frame
given the potential importance of such changes. One of those commenters
suggested that a facility should be required to notify APHIS within 48
hours of such changes, while the other recommended that notice be given
to APHIS within 10 days. We agree with the commenters that a more
concrete time frame for notification is desirable given the potential
impact of such changes, so we have amended paragraphs (b)(4)(v) and
(b)(4)(vi) of Sec. 353.8 to require the operator of a facility to
notify APHIS as soon as possible, but no more than 10 days following
its occurrence, of any change in the elements set forth in those
paragraphs.
Therefore, based on the rationale set forth in the proposed rule
and in this document, we are adopting the provisions of the proposal as
a final rule with the changes discussed in this document.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. The rule
has been determined to be significant for the purposes of Executive
Order 12866 and, therefore, has been reviewed by the Office of
Management and Budget.
This rule amends the export certification regulations to provide
for the establishment of a program under which non-government
facilities may 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 export certificates for processed plant
products. The accreditation criteria for particular laboratory testing
and phytosanitary inspection services will be developed by APHIS in
cooperation with other interested individuals or government, industry,
academic, or research entities. As specific accreditation criteria are
developed, the accreditation program will 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
[[Page 1104]]
issuance of certificates for certain plants or plant products.
The regulations in this rule are intended only to provide a
framework upon which accreditation programs for specific functions may
be established, so they will not, in and of themselves, entail any
costs to APHIS or any non-government facility. However, any specific
accreditation program that is established under these regulations will
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 will 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 will, 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 will be
reimbursed will 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 will vary depending on the range of
activities for which a facility seeks accreditation, the number of
assessors needed to adequately conduct a 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.
The regulations stipulate that APHIS will provide an estimate of
its anticipated fees to the operator of the facility prior to
undertaking any activities that will result in fees being charged to a
facility. Participation in any accreditation program developed under
these regulations will be voluntary. At this time, we estimate that 15
individual non-government facilities are 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
will 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 may result from the establishment of specific
accreditation programs.
The seed industry is expected to 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; benefits can be realized in terms of more timely
certifications, which in turn can lead to reduced costs as well as
increased U.S. exports.
The value of seed exported from the United States to other
countries continues to grow rapidly, from $665 million in 1994-95 (July
to June), to $705 million in 1995-96, to more than $800 million
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
are much less likely to occur if there is more timely reporting of pre-
harvest inspections; accredited non-government inspection facilities
may be able to make such timely reports. In general, non-government
testing and inspection services are 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, can be
gained through the standardization of testing and inspection protocols
that will result from the establishment of accreditation standards,
particularly when internationally recognized standards are used. Major
seed trading partners of the United States, such as 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 will underlie the accreditation of non-
government facilities in the United States can help reduce the
differences among international phytosanitary regulations, thereby
expediting U.S. seed exports.
Accreditation of non-government facilities, by promoting more
streamlined exports based on internationally recognized standards, can
also be expected to benefit exports outside of the seed industry. As a
self-supporting system, private firms that expect benefits in excess of
costs of accreditation are likely to participate. In addition to the
net benefits received by these firms directly, society as a whole will
benefit from enhanced trade.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action will
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12372
This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 7 CFR part 3015, subpart V.)
Executive Order 12988
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform. This rule: (1) Preempts all State and local laws and
regulations that are inconsistent with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq.), the information collection or recordkeeping requirements
included in this rule have been approved by the Office of Management
and Budget (OMB) under OMB control number 0579-0130.
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.
[[Page 1105]]
Accordingly, we are amending 7 CFR part 353 as follows:
PART 353--EXPORT CERTIFICATION
1. The authority citation for part 353 continues 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 is 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) are each
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 a laboratory test or an inspection
performed by a non-government facility accredited in accordance with
Sec. 353.8.
* * * * *
4. A new Sec. 353.8 is 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 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
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
[[Page 1106]]
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
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 maintenance of the facility's accreditation.
Done in Washington, DC, this 5th day of January 1999.
Craig A. Reed,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 99-396 Filed 1-7-99; 8:45 am]
BILLING CODE 3410-34-P
