[Federal Register Volume 64, Number 195 (Friday, October 8, 1999)]
[Notices]
[Pages 54859-54860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-26360]
[[Page 54859]]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 99-079-1]
Commodity Pest Risk Analysis Process
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice of public meeting and request for comments.
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SUMMARY: We are seeking comments on several issues related to commodity
pest risk analysis process used by the Agency's Plant Protection and
Quarantine's program, including several recommendations made in a
report on Plant Protection and Quarantine safeguarding system. We will
use the information gathered through this notice as we consider options
to improve public involvement in the process and public access to
information about new and pending pest risk analyses.
DATES: We invite you to comment on this docket. We will consider all
comments that we receive by December 7, 1999. We will also consider
comments made at a public meeting that will be held in Washington, DC,
on November 10, 1999.
ADDRESSES: Please send your comment and three copies to: Docket No. 99-
079-1, Regulatory Analysis and Development, PPD, APHIS, Suite 3C03,
4700 River Road Unit 118, Riverdale, MD 20737-1238.
Please state that your comment refers to Docket No. 99-079-1.
You may read any comments that we receive on this docket in our
reading room. The reading room is located in room 1141 of the USDA
South Building, 14th Street and Independence Avenue, SW., Washington,
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 690-2817 before coming.
APHIS documents published in the Federal Register, and related
information, including the names of organizations and individuals who
have commented on APHIS rules, are available on the Internet at http://
www.aphis.usda.gov/ppd/rad/webrepor.html.
The public meeting will be held at the Washington Court Hotel,
Sagamore Hill Room, 525 New Jersey Avenue, NW., Washington, DC.
FOR FURTHER INFORMATION CONTACT: Mr. Michael A. Lidsky, Assistant
Director, Regulatory Coordination, PPQ, APHIS, 4700 River Road Unit
147, Riverdale, MD 20737-1236; (301) 734-5371.
SUPPLEMENTARY INFORMATION:
Safeguarding System Review
In October 1998, the Plant Protection and Quarantine (PPQ) program
of the Animal and Plant Health Inspection Service (APHIS) asked the
National Plant Board to review its efforts to safeguard American
agriculture and plant resources. The National Plant Board assembled a
group of 43 stakeholders from States, industry, academia, and
environmental groups. The Safeguarding Review Group, through extensive
research, interviews, site visits, and other interactions with APHIS
and its stakeholders, prepared a thorough analysis of the challenges
facing the safeguarding system in four major areas: Pest exclusion,
international information, pest permits, and pest detection and
response. The Safeguarding Review Group identified a number of
opportunities to enhance the safeguarding system, which are outlined in
the group's final report, ``Safeguarding American Plant Resources: A
Stakeholder Review of the APHIS-PPQ Safeguarding System,'' which was
submitted to PPQ on July 1, 1999. (The report may be viewed in its
entirety on APHIS' Internet website, located at www.aphis.usda.gov.)
PPQ is now working with its employees and stakeholders to address the
report's more than 300 recommendations on how the current safeguarding
system can be improved.
One subject that was examined in the safeguarding review was the
use of risk analysis, which is composed of risk assessment, risk
mitigation, and risk communication, within PPQ programs. While the
final report did discuss the role of risk analysis in managing
resources--e.g., as a basis for adjusting staffing levels at a
particular port of entry--considerably more attention was paid to PPQ's
pest risk analysis activities relating to international trade and our
obligations under international agreements, with a particular focus on
the role of pest risk analysis in supporting decisions and justifying
quarantine actions regarding the importation of plants and plant parts
for propagation or consumption. While the role of pest risk analysis in
PPQ's biotechnology and organism permitting program areas was noted in
the report, there was no detailed discussion of those aspects of PPQ's
risk analysis activities. The higher visibility accorded to PPQ's
commodity pest risk analysis process can be attributed to the important
role that pest risk analyses play in supporting the regulatory changes
that are necessary before a new commodity from a particular foreign
region may be imported into the United States. Indeed, many of the
issues raised in the safeguarding report are similar to issues raised
in comments submitted pursuant to specific proposed regulatory changes
and in other correspondence directed to PPQ.
Response to Report
PPQ has already taken steps to begin to address the risk-analysis-
related concerns raised in the report by asking the APHIS Business
Practices Team to commence a PPQ-wide review of the program's risk
analysis processes. This has resulted in the formation of three working
groups that are responsible for addressing the following areas:
Benchmarking (i.e., how do the risk analysis processes in
PPQ compare to one another and to those of other APHIS program areas,
as well as to those of other government agencies and nongovernmental
entities?);
Obtaining customer and stakeholder feedback on ways to
improve PPQ's risk analysis processes (e.g., risk assessment
methodologies, risk communication strategies, etc.); and
Documenting PPQ's risk analysis processes in order to
identify any redundant or unnecessary activities and to provide a
starting point for the design and implementation of subsequent process
improvements.
In addition to this business practices review initiative, we are
also forming a group to evaluate all of the safeguarding report's
specific recommendations that relate to pest risk analysis. This group
will work closely with the Business Practices Team.
With regard to the benchmarking aspect of our review activities, we
are considering convening a symposium to review and discuss the
existing international standards for pest risk analysis and the current
``state of the art'' relative to conducting pest risk analyses. We
envision that this symposium would also include a report by APHIS on
the comments received in response to this notice and an update on any
improvements being made to our risk analysis processes resulting from
the review by the Business Practices Team. We are currently planning to
convene the pest risk analysis symposium during the first quarter of
calendar year 2000. Once more specific information becomes available,
we will publish a notice in the Federal Register concerning the dates
and location, as well as a draft agenda, for the symposium.
[[Page 54860]]
Improving Transparency and Participation
In considering PPQ's commodity pest risk analysis process as it
relates to rulemaking, the safeguarding review team concluded that the
process is hampered by inadequate risk communication on the part of
APHIS, which leads to conflicting interpretations about the nature and
significance of risks. The final report recommended that PPQ
incorporate stakeholder collaboration and scientific consultation into
its pest risk analysis process. By increasing the transparency of the
process and providing an opportunity for interested parties to
participate prior to rulemaking, this collaboration and consultation
would likely increase the amount and quality of information available
to the risk assessors.
As a first step in our initiative to obtain customer and
stakeholder feedback on ways to improve PPQ's commodity pest risk
analysis process, we are soliciting public comment on these subjects.
With regard to the preparation of commodity pest risk assessments, we
are particularly interested in comments in the following areas:
Qualitative versus quantitative risk assessments. The
qualitative and quantitative pest risk assessments prepared by PPQ are
similar in most respects. Both types of assessment identify quarantine
pests and utilize qualitative ratings in their assessments of the
consequences of introduction. Where they differ is in assessing the
likelihood of introduction: Qualitative assessments utilize qualitative
ratings for the likelihood of introduction, while quantitative
assessments estimate the likelihood of introduction using scenario
analysis and Monte Carlo simulation to arrive at a numerically
expressed distribution of estimates (e.g., mean, mode, median, 95th
percentile) for the likelihood of pest introduction. The safeguarding
report notes that PPQ currently uses the less complex qualitative pest
risk assessments for routine commodity import decisions and
quantitative pest risk assessments for more complex commodity import
decisions. However, in the absence of specific criteria for
differentiating between routine and complex commodity import decisions,
PPQ managers must rely on their judgment in determining what type of
pest risk assessment should be used. With that in mind, what specific
criteria could be used for determining which type of risk assessment is
appropriate in a given situation?
Preparation of assessments. The safeguarding report
recommended allowing exporters or exporting countries to conduct pest
risk assessments under APHIS guidance as a means of expediting the
handling of requests for commodities to be allowed entry into the
United States. Would this be acceptable, or would the perception that
there is an inherent conflict of interest be too great? Would strict
adherence by the preparer to the risk assessment guidelines of the
United Nations Food and Agriculture Organization and subsequent APHIS
review and approval be enough to overcome that perception?
With regard to the issue of transparency and public participation,
we are particularly interested in comments in the following areas:
Notification of the initiation of a pest risk analysis. It
has been suggested that APHIS publish a notice in the Federal Register
to notify the public whenever PPQ initiates a pest risk analysis
pursuant to a request for a commodity to be allowed entry into the
United States. Would such a notification mechanism be useful? Should
notice be given of all requests received, i.e., those involving both
routine and nonroutine decisions, or should such Federal Register
notices be reserved for the more complex nonroutine decisions? Could
this notification be satisfactorily provided through means other than
the Federal Register?
Web-based tracking system. PPQ's plant pest and
biotechnology permitting staffs currently administer Internet-
accessible tracking systems that allow the public to check on the
status of permit applications submitted to those staffs. (The tracking
systems of the plant pest and biotechnology permitting staffs may be
found on APHIS' Internet home page at www.aphis.usda.gov/ppq/bats/
permits/query-permits.html and www.aphis.usda.gov/bbep/bp/status.html,
respectively.) We believe that a similar web-based tracking system
could be used to enhance the transparency of, and facilitate
participation in, the commodity pest risk analysis development process.
Such a system would provide the public with timely information about
the receipt of import petitions, the status of those petitions, and the
status of their associated pest risk analyses, and could provide a
mechanism for the public to offer information and feedback regarding
those petitions and pest risk analyses. Would such a tracking system be
useful? Would the existence of a web-based tracking system preclude the
need for APHIS to publish notices in the Federal Register as discussed
in the previous item?
You may submit your written comments to the address provided at the
beginning of this notice under the heading ADDRESSES. In addition, we
will be hosting a public meeting to provide interested persons a full
opportunity to orally present any data, views, suggestions, and
questions. The public meeting will be held on November 10, 1999, at the
Washington Court Hotel, Sagamore Hill Room, 525 New Jersey Avenue, NW.,
Washington, DC.
A representative of APHIS will preside at the public meeting. Any
interested person may appear and be heard in person, by attorney, or by
other representative. Written statements may be submitted and will be
made part of the meeting record. Persons who wish to speak at the
meeting will be asked to provide their name and organization. We ask
that anyone who reads a statement or submits a written statement
provide two copies to the presiding officer at the meeting.
Registration for the public meeting will take place from 9:30 to
10:00 a.m. at the meeting room. The public meeting will begin at 10
a.m. and is scheduled to end at 5 p.m., local time. However, the
meeting may be terminated at any time after it begins if all persons
desiring to speak have been heard. If the number of speakers at the
meeting warrants it, the presiding officer may limit the time for
presentations so that everyone wishing to speak has the opportunity.
We welcome all comments on the issues discussed above and encourage
the submission of ideas on any associated topics or other suggestions
for the evaluation of risk and the improvement of our risk analysis
processes. We will consider all comments and recommendations we receive
in response to this notice as part of our Business Practices Team
review initiative and the related safeguarding report implementation
efforts.
Done in Washington, DC, this 4th day of October, 1999.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 99-26360 Filed 10-7-99; 8:45 am]
BILLING CODE 3410-34-P