[Federal Register Volume 61, Number 189 (Friday, September 27, 1996)]
[Proposed Rules]
[Pages 50767-50770]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24847]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 61, No. 189 / Friday, September 27, 1996 /
Proposed Rules
[[Page 50767]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 330
[Docket No. 95-095-1]
RIN 0579-AA80
Plant Pest Regulations; Review of Current Provisions
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Advance notice of proposed rulemaking and notice of public
meeting.
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SUMMARY: We are soliciting public comment on several issues pertaining
to our current regulations regarding the importation and interstate
movement of plant pests. Specifically, we are seeking public comment on
the criteria used to determine whether an organism is a plant pest;
what types of direct and indirect injury or damage to plants and plant
products should be regulated; how to facilitate the interstate movement
and use of biological control organisms; and how to best evaluate the
safety of proposed releases into the environment of organisms with
plant pest characteristics. The information gathered through this
advance notice of proposed rulemaking will be used by the Animal and
Plant Health Inspection Service as we consider the need for regulatory
changes and weigh alternative methods of addressing plant pest risk as
it pertains to the importation, interstate movement, and release into
the environment of plant pest or potential plant pest organisms.
DATES: Consideration will be given only to comments received on or
before December 26, 1996. We will also consider comments made at a
public hearing to be held on November 7, 1996, from 10 a.m. until 5:00
p.m.
ADDRESSES: Please send an original and three copies of your comments to
Docket No. 95-095-1, Regulatory Analysis and Development, PPD, APHIS,
Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please
state that your comments refer to Docket No. 95-095-1. Comments
received may be inspected at USDA, room 1141, South Building, 14th
Street and Independence Avenue SW., Washington, DC, between 8 a.m. and
4:30 p.m., Monday through Friday, except holidays. Persons wishing to
inspect comments are requested to call ahead on (202) 690-2817 to
facilitate entry into the comment reading room. The public hearing will
be held on November 7, 1996, at the USDA Center at Riverside, 4700
River Road, Riverdale, MD.
FOR FURTHER INFORMATION CONTACT: Dr. Sally McCammon, Science Advisor,
OA, APHIS, P.O. Box 96464, Washington, DC 20090-6464, (202) 720-8014,
E-mail: smccammon@aphis.usda.gov; or Dr. Robert Flanders, Entomologist,
Biological Assessment and Taxonomic Support, PPQ, APHIS, 4700 River
Road Unit 133, Riverdale, MD 20737-1236, (301) 734-8896, E-mail:
bflanders@aphis.usda.gov.
SUPPLEMENTARY INFORMATION:
Background
The Federal Plant Pest Act (FPPA), as amended (7 U.S.C. 150aa
through 150jj), grants the Secretary of Agriculture broad authority to
carry out operations or measures to detect, eradicate, suppress,
control, or to prevent or retard the spread of plant pests; that
authority gives the United States Department of Agriculture (USDA) the
flexibility to respond appropriately to a wide range of needs and
circumstances to protect American agriculture against foreign plant
pests. The FPPA defines a plant pest as ``any living stage of any
insects, mites, nematodes, slugs, snails, protozoa, or other
invertebrate animals, bacteria, fungi, other parasitic plants or
reproductive parts thereof, viruses, or any organisms similar to or
allied with any of the foregoing, or any infectious substances, which
can directly or indirectly injure or cause disease or damage in any
plants or parts thereof, or any processed, manufactured, or other
products of plants.''
The Secretary's authority under the FPPA and the Plant Quarantine
Act, as amended (7 U.S.C. 151 through 164a, 167) has been delegated to
the Administrator of the USDA's Animal and Plant Health Inspection
Service (APHIS), which administers regulations and conducts activities
for the purpose of controlling and eradicating plant pests. APHIS'
Plant Protection and Quarantine program area bears primary
responsibility within the agency for those plant pest control and
eradication activities.
Many of APHIS regulations in title 7, chapter III, of the Code of
Federal Regulations focus on the importation or interstate movement of
plants or plant products--e.g., nursery stock, seeds, fruits and
vegetables, logs and lumber--as a means of preventing the introduction
and dissemination of plant pests that are new to or not widely
distributed within and throughout the United States. Those regulations
are based on the premise that certain plants or plant products may be a
vector of, or be infected or infested with, a plant pest. Similarly, 7
CFR chapter III also contains regulations that restrict or prohibit the
movement of articles such as soil, stone, and quarry products, garbage,
packing materials, and soil-moving equipment due to the risks that
those articles may introduce or disseminate plant pests. Still other
regulations in 7 CFR chapter III focus on organisms that may be a
vector of, or be infected or infested with, plant pests. Examples of
such organisms are live bees other than honeybees of the genus Apis
regulated under 7 CFR 319.76; live honeybees of the genus Apis
regulated under 7 CFR part 322; and organisms genetically engineered
through recombinant DNA techniques regulated under 7 CFR part 340.
Finally, there are regulations that focus on assessing and mitigating
the plant pest risks associated with the movement of plant pests
themselves.
APHIS' plant pest regulations in 7 CFR 330.200 (referred to below
as the plant pest regulations) are for the stated purpose of preventing
the dissemination of plant pests into the United States, or interstate,
by regulating the movement of plant pests into or through the United
States and interstate. When these regulations were first promulgated in
1959, they adequately addressed the needs of the regulated community,
which at the time consisted mostly of government and academic
researchers. In the years since 1959, however, the range of research
and applications involving organisms that present plant pest risk has
broadened enormously. In
[[Page 50768]]
addition to applications to move the ``traditional'' plant pests, APHIS
now regularly receives requests to import or move interstate organisms
such as parasites and predators for the biological control of arthropod
pests; centipedes, walking sticks, praying mantises, butterflies, giant
cockroaches, etc. for insect zoos; and microbes for soil treatment.
Although the range of organisms for which plant pest permits are
requested has changed dramatically since 1959, APHIS' plant pest
regulations have not been substantively amended to keep pace with those
changes.
Nonindigenous Species Report
APHIS did propose to supplement its plant pest regulations
following the September 1993 release of a report by the U.S. Congress'
Office of Technology Assessment (OTA) entitled ``Harmful Non-Indigenous
Species in the United States'' (OTA-F-565, Washington, DC; U.S.
Government Printing Office, September 1993, referred to below as the
OTA report). The OTA report examined pathways through which harmful
nonindigenous organisms enter the United States, the harmful effects
and economic consequences of many introduced organisms, and the State/
Federal regulatory framework in place to prevent their introduction.
One conclusion of the OTA report was that Federal agencies, including
APHIS, should reevaluate, within their respective areas of
responsibility, their approaches to dealing with introductions into the
United States of nonindigenous organisms. The OTA report also
highlighted the benefits that could accrue as a result of the increased
use of biological control in pest management.
In response to the OTA report, APHIS published a proposed rule in
the Federal Register on January 26, 1995 (60 FR 5288-5307, Docket No.
93-026-1) to establish new regulations to provide a means of screening
certain nonindigenous organisms prior to their introduction to
determine the potential plant pest risks associated with their
introduction. We received over 250 comments on that proposed rule, none
of which supported the proposed rule as written. After considering all
the comments, we determined that the revisions needed to reconcile the
proposed regulations with the very diverse views expressed in the
comments would be so significant that any final rule would be
substantially different from the proposed rule on which the public had
the opportunity to comment. Therefore, on June 16, 1995, we withdrew
the proposed rule (60 FR 31647, Docket No. 93-026-4).
Regulatory Reform
In addition to any issues that may remain unresolved with regard to
the recommendations of the OTA report, we have also made a commitment
to reassess our plant pest regulations in response to 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. To further both of
those objectives, we have prepared this advance notice of proposed
rulemaking to identify and seek input on several issues that we believe
must be addressed in order for us to improve the service we provide to
our stakeholders and move forward with a long overdue revision of the
plant pest regulations. These issues are:
The criteria used to determine whether an organism is a
plant pest;
What types of direct and indirect injury or damage to
plants and plant products should be regulated;
APHIS' role in facilitating the interstate movement and
use of biological control organisms; and
How to best evaluate the safety of proposed releases into
the environment of organisms with plant pest characteristics.
These issues, and our questions regarding them, are discussed in
detail below.
Determination of Plant Pest Status
The provisions of the plant pest regulations are most often
implemented when a person requests a permit for the importation or
interstate movement of an organism that is, or may be, a plant pest or
that presents a risk of introducing or disseminating a plant pest. When
a person seeks to import such an organism into the United States for
the first time, APHIS will generally allow it to enter the country
provided the organism is consigned directly to a containment facility
inspected by APHIS, particularly if the organism is unidentified or
field-collected. Such facilities are designed and operated to minimize
the risk that the organisms contained in them could escape. Once in
containment, an imported organism is separated from any contaminants
(e.g., other organisms or plant materials) and evaluated in terms of
the potential it has to directly or indirectly injure or cause damage
or disease in plants or plant products. The same evaluation is applied
to organisms already present in the United States, i.e. those organisms
for which a plant pest permit for interstate movement has been
requested.
To determine whether or not an organism is a plant pest or poses a
risk of introducing or disseminating a plant pest, APHIS conducts what
we refer to as a first-tier pest risk assessment. First, because the
identity of an organism is the key to subsequent research, we seek to
establish whether the organism has been identified by a recognized
authority or, if the species is undescribed or if it belongs to a group
poorly understood by taxonomists, whether voucher materials have been
deposited in a major U.S. repository, such as the collection at a major
university. Once that consideration has been addressed, we then look at
the organism in light of five questions; an affirmative answer to any
one of these questions would give us reason to believe that the subject
organism is a plant pest. Those questions are:
Does the organism feed on, infect, or parasitize living
plant tissues?
Does the organism feed on, infect, or contaminate plant
products such as stored grain, stored fruit, or lumber?
Does the organism transmit plant pathogens?
Does the organism develop as a secondary parasite,
pathogen, or predator of a primary natural enemy of a herbivore or
plant pathogen?
Does the organism adversely affect commercially important
pollinators or important herbivores or plant pathogens that control
weeds?
In that those five questions dictate, in large measure, the
questions that we would ask on an application for a plant pest permit
or in some sort of pre-application guidance document, we would like
your comments on those questions. Do they constitute an adequate
measure of plant pest risk, or should additional criteria be included?
Indirect Injury or Damage
Many of the commenters who responded to our January 1995 proposed
rule were critical of our lack of specificity when it came to what we
might consider ``indirect'' injury or damage to plants or plant
products. The tone of the proposed rule implied that we considered
potential injury very broadly to include all negative impacts of all
organisms within food chains where plants are the primary producers.
Under such a scheme, herbivores and plant pathogens cause direct plant
injury, while parasites and predators at higher trophic levels may
cause indirect injury; any proposed insertion of an organism into a
food web would require an evaluation of all potential disturbances
within that food web.
[[Page 50769]]
While some groups may support an approach that requires an evaluation
of all potential significant environmental impacts of introducing new
organisms into an established food web, other groups strongly oppose
that approach because it means that many parasites, predators, and
pathogens that have traditionally been released to control herbivores
and plant pathogens (i.e., biological control organisms) would be
defined as plant pests because their effects on their intended targets
could be construed as causing indirect injury or damage to plants or
plant products.
In order that we may more clearly delineate the types of effects
that could be considered ``indirect'' injury or damage to a plant or
plant product and thus bring a greater degree of clarity or
predictability to the plant pest permitting process, we are offering
the following interpretation of ``indirect'' injury or damage for your
consideration:
Direct and indirect injury or damage refers only to impacts within
a food chain that negatively affect plants or plant products. Thus, for
example, parasites or predators that inflict population-level damage on
herbivorous invertebrates would not themselves be considered plant
pests because their actions cause a reduction in direct injury or
damage to plants or plant products. However, organisms at the next
higher trophic level (e.g., hyperparasites) would be seen as causing
indirect injury or damage to plants or plant products if they suppress
the actions of the parasites, predators, or pathogens that would
otherwise reduce the degree of direct injury or damage to plants or
plant products. Similarly, because organisms such as honey bees,
bumblebees, etc. are critical pollinators, any parasites, predators, or
pathogens that adversely impact those pollinators would be seen as
causing indirect injury or damage to plants or plant products due to
the potential negative impact of reduced pollination.
Considering all the ramifications, is this interpretation of
indirect injury or damage too narrow, or would a broader interpretation
of indirect injury or damage unnecessarily hinder or delay the
resolution of plant pest problems?
Voluntary Standards
When, as a result of our review, we determine that an organism is
not a plant pest, we will inform the applicant that a plant pest permit
is not required for the importation or interstate movement of the
organism. In many cases, an applicant will request that APHIS issue a
courtesy permit for the movement of such an organism. The plant pest
regulations provide for the issuance of courtesy permits for the
movement of organisms that are not subject to regulation under the FPPA
or any other act, as a courtesy to facilitate movement when the
movement might otherwise be impeded because of the similarity of the
organisms with others regulated under the FPPA. Such permits are most
frequently requested for the interstate movement of parasites,
predators, and pathogens that are intended for use in the biological
control of plant pests.
APHIS deals regularly with State plant health officials who wish to
see some Federal regulatory oversight for the interstate movement of
such organisms. That is one of the reasons that courtesy permits are so
often issued to facilitate the interstate movement of parasites,
predators, and pathogens that are intended for use in the biological
control of plant pests. Indeed, it may be desirable for there to be
some degree of regulatory oversight on the part of APHIS to address the
plant pest risks related to the movement of field-collected biological
control organisms and host material.
One idea that has been raised that might fill any potential
regulatory void while promoting the use of biological control is the
formation of a cooperative program involving Federal and State
agencies, biological control producers and distributors, and the
biological control research community. The goal of the cooperative
program would be to establish and promote compliance with a set of
voluntary or consensus standards for the interstate movement and
release into the environment of organisms used in the biological
control of plant pests.
Under the FPPA, the Secretary of Agriculture is authorized to carry
out measures to prevent or retard the spread of plant pests, either
independently or in cooperation with States, farmers' associations and
similar organizations, or individuals. In that the voluntary program
would be a cooperative effort to facilitate research into and the
movement of organisms used to prevent or retard the spread of plant
pests, we believe that it could be established under our existing
statutory authority.
A benefit of the plan would be that it could serve as a ``seal of
approval'' for biological control researchers, producers, and
distributors in the sense that its guidelines would be considered
optimal for the research community and the industry. The voluntary plan
could be operated under standards produced through consensus by its
participants, i.e., government, industry, and the research community; a
document drafted and widely distributed by the National Biological
Control Institute, a non-regulatory unit within APHIS, entitled
``Options for Changes in Biological Control Regulations and Guidelines
in the United States: A Strawman for Comment'' is one example of the
form that the voluntary plan's guidelines could take. Because
participation in the plan would be voluntary, individuals would be
likely to participate in the program as long as the benefits they
derive from the program outweigh any added costs they might incur
through their participation.
Would the level of support and participation from industry and the
research community be great enough to justify the formation of such a
program?
We are interested in receiving any ideas at all about the
membership, leadership, responsibilities, funding, authority, etc. of a
voluntary, cooperative program for organisms intended for the
biological control of plant pests.
Releasing Plant Pests
When we have reason to believe that an organism is a plant pest or
poses the risk of introducing or disseminating plant pests, that
organism will be held in containment or refused permission to be moved
interstate. However, there are organisms that possess plant pest
characteristics but that have potential applications outside the
laboratory or containment that would recommend their eventual release
into the environment. Specifically, such organisms may have use in the
biological control of weeds.
APHIS would only consider allowing such an organism to be released
into the environment after it has been determined that the organism
causes population-level injury, damage, or disease in a demonstrably
narrow range of closely related plant species. The targeted plant
species must also be overwhelmingly considered undesirable weeds before
APHIS would consider allowing the release of an organism displaying
plant pest characteristics.
We believe that a case can be made for the considered release into
the environment of certain organisms that manifest plant pest
characteristics; indeed, APHIS has, on a case-by-case basis, considered
and granted approval for such releases. However, our current plant pest
regulations make no provisions for such releases.
The demonstrated benefits accruing from the public and private use
of integrated pest management principles make it likely that the use of
organisms for the biological control of weeds will only increase.
Therefore, we believe that it is necessary to develop standards that
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would allow us to determine whether an organism could be safely
employed for the biological control of weeds. Through our previous
experience with determining the safety of potential biological control
organisms of weeds, we have developed several questions that speak to
the primary factor that must be considered in assessing such releases,
i.e., host specificity. Those questions are:
Does the organism feed upon, infect, or suppress only the
target plant species or a few closely related species?
If an arthropod, does the organism deposit eggs on plant
species besides the target? If so, how closely are these plant species
related to the target? Similarly, if the organism is a plant pathogen,
can its spores or other propagules germinate and penetrate the tissues
of plants other than the target?
If the organism deposits eggs on plant species other than
the target, do those eggs hatch and can the resulting immature stages
significantly feed on them and complete their development? For plant
pathogens, does penetration of the plant tissues lead to disease
symptoms or signs in the plant?
If the organism is an arthropod, are its immature stages
capable of completing development on plants other than the target, and
are the resulting adults fertile? Similarly, if the organism is a plant
pathogen, does infection of nontarget plants result in the subsequent
production of viable spores or other infective units?
Does the probable ecological range (especially those
related to tolerances for physical environmental parameters, especially
temperature and humidity) of the organism overlap the distribution of
native plant species that are related to the target in the United
States and that are attacked in laboratory tests?
Is the organism closely related to other species or
strains that exhibit narrow or broad host specificities?
Can the organism feed upon, attack, infect, or otherwise
adversely impact endangered or threatened plant or animal species in
the United States?
We are seeking your input on the appropriateness of these questions
for assessing the risks of releasing organisms with plant pest
characteristics for the biological control of weeds. What other
considerations might be appropriate for such an assessment? Should any
special requirements be imposed on organisms proposed for release on
islands such as Puerto Rico or the State of Hawaii? Should APHIS
require applicants to submit post-release monitoring data regarding
possible attacks on nontarget plant species?
Public Hearing
APHIS will host a public hearing to provide interested persons a
full opportunity to present oral presentations of data, views,
arguments, and questions regarding this advance notice of proposed
rulemaking. The hearing will be held on November 7, 1996, at the USDA
Center at Riverside, 4700 River Road, Riverdale, MD.
A representative of APHIS will preside at the public hearing. Any
interested person may appear and be heard in person, by attorney, or by
other representative. Persons who wish to speak at the public hearing
will be asked to sign in, listing their names and organizations.
The public hearing will begin at 10 a.m. local time and is
scheduled to end at 5 p.m. local time. However, the hearing may be
terminated at any time after it begins if all persons desiring to speak
have been heard. We ask that anyone who reads a statement provide two
copies to the presiding officer at the hearing. If the number of
speakers at the hearing warrants it, the presiding officer may limit
the time for each presentation so that everyone wishing to speak has
the opportunity.
We welcome all comments on the scope, approach, criteria, and
issues outlined above and encourage the submission of ideas on any
associated topics or other suggestions for the evaluation of plant pest
risk and the improvement of the evaluation and permitting process.
APHIS will consider all comments and recommendations in developing any
revisions to the current FPPA regulations and will initiate rulemaking
for any changes deemed appropriate.
Authority: 7 U.S.C. 149, 150bb, 150dd, 150ee, 150ff, 154, 159,
160, 162, and 2260; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR
2.22, 2.80, and 371.2(c).
Done in Washington, DC, this 24th day of September 1996.
Terry L. Medley,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-24847 Filed 9-26-96; 8:45 am]
BILLING CODE 3410-34-P
