[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