[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]


 ========================================================================
 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: [email protected]; 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: 
[email protected].

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

[[Page 50770]]

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