Plant Pest Regulations; Review of Current Provisions

Proposed Rules

Federal Register

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Proposed Rules

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.

ernative 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

OR 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

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

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

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

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

es 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

e 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

ant 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.

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

od 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

rs 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

ermits 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

nt 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

ould 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

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

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

nat

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

ver 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]

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