Microbial Pesticides; Experimental Use Permits and Notifications; Final Rule ENVIRONMENTAL PROTECTION AGENCY

SUMMARY: This notice promulgates an amendment to the experimental use

permit (EUP) regulations for pesticides that was proposed on January

22, 1993. These regulations clarify the circumstances under which an

EUP is presumed not to be required and implement a screening procedure

that requires notification to EPA before initiation of small-scale

testing of certain microbial pesticides. This notification scheme

implements provisions of the EPA policy statement published in the

Federal Register of June 26, 1986, with modifications.

DATES: This final rule is effective October 31, 1994.

FOR FURTHER INFORMATION CONTACT: By mail: Evert K. Byington, Chief,

Science Analysis and Coordination Staff, Environmental Fate and Effects

Division (7507C), Environmental Protection Agency, 401 M St., SW.,

Washington, DC 20460. Office location and telephone number: Rm. 1016A,

Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, (703-305-

6307).

SUPPLEMENTARY INFORMATION: Section 5 of the Federal Insecticide,

Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136c, and 40 CFR part

172 provide for issuance by the Agency of experimental use permits

(EUPs) for the testing of new pesticides or new uses of existing

pesticides. Such permits are generally issued for large-scale testing

of pesticides.

Large-scale tests under 40 CFR part 172 include any terrestrial

application on a cumulative total of more than 10 acres of land or any

aquatic application on more than 1 surface acre of water. EPA has

generally presumed that testing on up to 10 acres of land or 1 surface

acre of water (``small-scale test'') would not require EUPs. However,

the Agency believes that small-scale tests in the environment with some

microbial pesticides may pose sufficiently different risk

considerations from conventional chemical pesticides that a closer

evaluation at the small-scale testing stage may be warranted.

Therefore, the Agency is amending 40 CFR part 172 to require

notification before initiation of small-scale testing in the

environment of certain microbial pesticides so that EPA may determine

whether these tests should be conducted under an EUP. This rule

codifies the notification provisions of the Agency's policy statement

of June 26, 1986 (51 FR 23302), with modifications.

I. Authority and Background

A. Statutory and Regulatory Authority

These regulations are promulgated under sections 3(a), 5, 8, and 25

of FIFRA. Section 5 governs the issuance of EUPs; section 3(a), 7

U.S.C. 136a(a), allows the Agency to regulate unregistered pesticides

that are not subject to an EUP in order to prevent unreasonable adverse

effects on the environment; section 8, 7 U.S.C. 136f, gives the Agency

authority to require recordkeeping; and section 25, 7 U.S.C. 136w,

gives EPA the authority to issue regulations and to exempt pesticides

from regulation under FIFRA.

Section 5 of FIFRA provides that any person wishing to test a

pesticide may apply for an EUP. As stated in the preamble proposing the

issuance of the original regulations under section 5 (39 FR 11306,

March 27, 1974), ``The purpose behind section 5 is to facilitate the

generation of data necessary to support an application for registration

under section 3 and yet provide sufficient regulatory control to

prevent adverse environmental effects.'' An EUP issued pursuant to

section 5 authorizes limited use of a pesticide on a limited number of

acres, under specific and controlled conditions, to develop the

necessary data.

EPA will issue an EUP only if issuance of such a permit will not

cause unreasonable adverse effects on the environment. Similarly, EPA

may revoke an existing EUP if it determines that the terms and

conditions of the permit are inadequate to avoid unreasonable adverse

effects, 7 U.S.C. 136c; 40 CFR 172.10. Section 2(bb) of FIFRA, 7 U.S.C.

136(bb), defines ``unreasonable adverse effects on the environment'' as

``any unreasonable risk to man or the environment, taking into account

the economic, social, and environmental costs and benefits of use of

[the] pesticide.''

When the EUP regulations, 40 CFR part 172, were originally

promulgated (40 FR 18782, April 30, 1975), the Agency recognized that

the development of an effective pesticide, culminating in registration,

is a multi-stage process that warrants a scaling in the level of

oversight by EPA. EPA therefore set forth procedures that would ``. .

.place experimental programs under reasonable constraints without

imposing burdens unrelated to needed protection of human health and the

environment'' (39 FR 11307, March 27, 1974). The final regulations

included a presumption that EUPs would not be required for most small-

scale tests (40 CFR 172.3). However, the regulations also explicitly

recognized that a wide variety of testing situations may arise and that

a flexible regulatory approach is needed to deal with these situations.

B. Historical Development

The Agency recognizes that there has been a long history of safe

use of microbial pesticides. With respect to small-scale testing of

most microbial pesticides, the Agency believes that the likelihood that

such tests will result in significant adverse impacts on human health

or the environment is sufficiently low that Agency oversight is

unnecessary. Thus, the Agency believes that, in most instances, small-

scale tests with microbial pesticides should continue to be excluded

from the requirement for an EUP.

However, since the issuance of the original EUP regulations, new

and different microbial pesticides have been developed that warrant a

closer review before being excluded from the EUP requirements at the

small-scale testing stage. In amending the EUP regulations, the

Agency's goal is to set forth a system that focuses on the

characteristics and risks of the product, protects human health and the

environment, establishes a screening mechanism that does not unduly

impede potentially beneficial research, and is designed to accommodate

rapid advances in biotechnology.

In 1984, EPA issued an interim policy statement entitled

``Microbial Pesticides: Interim Policy on Small-Scale Field Testing''

(49 FR 40659, October 17, 1984). This statement announced that the

presumption in the 1975 EUP regulations (40 CFR 172.3) would not

automatically apply to tests using genetically altered and

nonindigenous microbial pesticide products and that the Agency should

be notified before initiation of any such testing. Since 1984, the

Agency has used this notification scheme to evaluate small-scale tests

involving genetically altered and/or nonindigenous microbial pesticides

for possible risk to human health or the environment and to determine

whether EUPs would be required before the tests could be initiated.

Subsequent to publication of the Interim Policy, this same basic

position was published for comment in EPA's section of the Office of

Science and Technology Policy (OSTP) ``Proposal for a Coordinated

Framework for Regulation of Biotechnology'' (49 FR 50856, December 31,

1984). The final OSTP statement of policy was published on June 26,

1986 (51 FR 23302, June 26, 1986). In the 1986 Policy Statement, the

Agency stated its intention to codify the major elements of the

notification procedure in the EUP regulations (40 CFR part 172).

EPA published a proposal to amend its EUP regulations on January

22, 1993 (58 FR 5878). The proposal reflected changes in the 1986

Policy position made in response to public comments, the

recommendations of the FIFRA Scientific Advisory Panel (SAP) and the

EPA Biotechnology Science Advisory Committee (BSAC), and Federal

biotechnology policy statements.

Specifically influencing the Agency's proposal were the

``Principles for Federal Oversight of Biotechnology: Planned

Introduction into the Environment of Organisms with Modified Hereditary

Traits'' (55 FR 31118), and the policy announcement (57 FR 6753)

entitled ``Exercise of Federal Oversight Within Scope of Statutory

Authority: Planned Introductions of Biotechnology Products Into the

Environment.''

The Agency received 19 comments in response to the notice of

proposed rulemaking published on January 22, 1993 (58 FR 5878). These

comments were received from trade associations, business firms, public

interest groups, scientific researchers, State and Federal agencies,

and others. Unit IV of this preamble summarizes and responds to the

significant issues raised in these comments.

II. Summary of Proposed Rule

The proposed rule set out a scheme for codifying the Agency

procedure, under which EPA has been operating from 1984, of screening

planned small-scale tests to evaluate the potential for adverse effects

on human health or the environment and allowing EPA to determine

whether an EUP would be required for the test. The proposed rule added

a Subpart C, ``Notification for Certain Genetically Modified Microbial

Pesticides,'' to the existing EUP regulations (40 CFR part 172). The

Agency proposed that its review of a notification would be completed

within 90 days. At the conclusion of the review, the Agency could make

one of the following determinations: Approve the test without requiring

an EUP; approve the test without requiring an EUP as long as certain

modifications in the proposed test plan are incorporated; require

additional information; require an EUP for the test; or disapprove the

test because of the potential for unreasonable adverse effects.

The proposed rule requested comment on two options (Options 1 and

3) for defining which microbial pesticides would be subject to the

notification requirement. A third option was also discussed (Option 2),

but only for illustrative and comparative purposes. The Agency's goal

in setting forth these options was to discuss alternative approaches to

identifying those microbial pesticides having the greatest potential to

pose risks, or those where sufficient information and knowledge are

lacking about the potential risk when the microbial pesticide is

introduced into the environment. In the proposal, EPA indicated its

preference for Option 1.

Under Option 1, the Agency proposed that the Agency be notified

before initiation of small-scale testing with microbial pesticides

``whose pesticidal properties have been enhanced or imparted by the

introduction of genetic material that has been deliberately modified.''

Key terms in Option 1 were defined as follows:

1. ``Deliberately modified'' means the directed addition,

rearrangement, or removal of a nucleotide sequence(s) to or from

genetic material.

2. ``Introduction of genetic material'' means the movement of a

nucleotide sequence(s) into a microorganism, regardless of the

technique used.

3. ``Pesticidal property'' means a characteristic exhibited by a

microorganism that contributes to the intentional use of the

microorganism to prevent, destroy, repel, or mitigate a pest or to act

as a plant regulator, defoliant, or desiccant.

In Option 3, EPA proposed notification for ``Indigenous microbial

pesticides for which specific pesticidal activities have been created

or increased by deliberate processes or techniques.''

Under Option 3, notification would not be required for microbial

pesticides whose pesticidal activities have been increased, but which

are unlikely to pose a greater risk in the test site environment, in

terms of increased host range, competitiveness, survivability, or

genetic mobility, compared to the microorganism(s) from which they were

derived, and notification would not be required for microorganisms

whose phenotype has been changed only by the microorganism's

introduction into a new environment, but which are unlikely to pose a

greater risk in the test site environment resulting from an increase in

host range, competitiveness, survivability, or genetic mobility.

Key terms used in Option 3 were defined as follows:

1. ``Pesticidal activities,'' for the purpose of this option, means

hazard characteristics expressed by the microorganism, which is the

active ingredient, that prevent, repel, destroy, or mitigate a pest or

act as a plant growth regulator, defoliant, or desiccant through toxin

production, infectivity, pathogenicity, or virulence. Pesticidal

activities do not include non-cytotoxic modes of action such as those

brought about by niche exclusion, substrate competition, or nutrient

sequestration.

2. ``Created'' means the microorganism has been given a pesticidal

activity that is not part of the normal genetic complement of the

species in nature.

3. ``Increased pesticidal activity'' means an augmentation of a

pesticidal activity that can be shown to be part of the normal genetic

complement of the species in nature.

4. ``Deliberate processes or techniques'' means the intentional

movement of the microorganism to a new environment or a change in the

genetic information of the microorganism resulting from natural

breeding, selection for spontaneous mutations, chemical or physical

mutagenesis, transduction, transformation, conjugation, cell fusion,

recombinant DNA or other genetic manipulations.

5. ``Test site environment'' means the immediate test site and the

area surrounding the test site to which the microorganism or its

genetic material may reasonably be expected to be dispersed.

6. ``Genetic mobility'' means the horizontal movement [i.e., from

the genome of one species to the genome of another] of genetic

material.

The Agency also requested comment on specific administrative

aspects of implementation of the scope of coverage.

Under any option, the Agency proposed to no longer require

notifications for any naturally occurring nonindigenous microbial

pesticides. EPA based its decision on its experience since 1984 with

the assessment of these types of microbial pesticide products at the

small-scale testing stage and its belief that continued imposition of

the notification requirement for these microbial pesticides would

constitute unnecessary duplicative oversight of research and

development with that of the U.S. Department of Agriculture Animal and

Plant Health Inspection Service (USDA/APHIS).

The proposed rule also provided, at Sec. 172.45, that testing

conducted in a facility with adequate containment and inactivation

controls would not be subject to the notification requirement.

Responsibility for selection and use of adequate containment and

inactivation controls would lie with the researcher or institution

conducting the test.

The proposed rule contained a discussion of the kinds of data and

information to be submitted in a notification at Sec. 172.48.

Procedures for claiming data and information provided to the Agency in

a notification as confidential business information (CBI) were proposed

in Sec. 172.46(d).

A mechanism for designating, in the future, generic exemptions from

the requirement for notification prior to testing at the small-scale

stage was proposed at Sec. 172.52. Using this mechanism, certain

subgroups of microbial pesticides, otherwise subject to notification

would, on the basis of scientific knowledge and experience, be added to

a list of exemptions from the notification requirement.

The Agency also proposed to revise Sec. 172.3 to clarify its

rationale for presuming that an EUP is not required prior to small-

scale testing with most pesticides. The Agency would modify the

language of the rule to clarify that the determination of whether an

EUP is required is based on risk considerations, rather than on a

definitional presumption about whether the substance is a pesticide.

Whether a substance is a pesticide, and therefore under the

jurisdiction of FIFRA, is governed by the definition in section 2(u) of

FIFRA; whether a pesticide should be regulated under FIFRA is governed

by risk/benefit considerations.

EPA proposed, at Secs. 172.57 and 172.59, means to address

situations where small-scale tests covered in Subpart C result in

unanticipated and untoward effects. Section 172.57 was proposed to

address situations where a person using a microbial pesticide in small-

scale testing obtains information concerning the potential for

unreasonable adverse effects. This section would require a person to

submit such information to EPA within 30 days so that the Agency could

evaluate the information and take any necessary action to minimize the

potential for adverse effects. In situations where threat of harm to

human health or the environment is immediate and serious,

Sec. 172.59(a) sets out the manner in which EPA would act immediately

to prevent adverse impacts.

The provisions set forth in proposed Subpart C Secs. 172.43 through

172.59 for the review of small-scale tests of certain microbial

pesticides would not affect the already established Agency procedures

for the review of pesticides for EUPs or for registration purposes.

III. Summary of Final Rule

The Agency has determined that Option 1 of the proposed rule

provides a scope of coverage which best addresses potential risks

presented by certain categories of small-scale testing with microbial

pesticides. It does so by focusing the notification requirement on

tests involving microbial pesticides with the potential for presenting

new and different hazards or exposures to humans or the environment on

the basis of simple and directly addressable criteria that form the

scope definition. This final rule significantly reduces the number of

notifications that will be sent to EPA relative to existing EPA policy.

Thus, Option 1 as it appears in the proposed rule will become part of

Subpart C to be added to the existing EUP regulations in 40 CFR part

172.

In the proposed rule, EPA provided a rationale for, and requested

comment on, the scientific merit of adding a categorical exemption to

proposed Option 1 for microorganisms modified solely by rearrangement

or deletion of nucleotide sequences within a single genome. Public

comment supported this approach. Thus, at Sec. 172.45(d) of the

regulatory text, EPA specifically exempts a category of microbial

pesticides otherwise captured by the scope of the requirements, by

adding the following language.

``Microbial pesticides resulting from deletions or rearrangements

within a single genome that are brought about by the introduction of

genetic material.''

Key terms are defined as follows:

1. ``Single genome'' means the sum total of chromosomal and

extrachromosomal genetic material of an isolate and any descendants

derived under axenic culture conditions from that isolate.

2. ``Microbial pesticides resulting from rearrangements'' means

microbial pesticides resulting from translocations or inversions.

With regard to nonindigenous microbial pesticides, the Agency,

through discussions with USDA/APHIS and its own investigations, has not

been able to identify any category of nonindigenous microorganisms

potentially used as a pesticide that are not covered by APHIS

authorities. However, in response to public comment, Subpart C

contains, in Sec. 172.45(c), a provision that EPA require

notifications, at the small-scale testing stage, for nonindigenous

microbial pesticides that have not been acted upon by USDA (i.e.,

either by issuing or denying a permit or determining that a permit is

unnecessary; or a permit is not pending with USDA).

In the final rule, testing conducted in a facility with adequate

containment and inactivation controls will not be subject to the

notification requirements. Responsibility for selection and use of

adequate containment and inactivation controls lies with the researcher

or institution conducting the research and can be based on available

guidance. In the proposed rule, the Agency asked for public comment on

whether minimal recordkeeping to document the selection and use of

containment and inactivation controls should be required. Public

comment favored this proposal and at 40 CFR 172.45(e) contains language

to this effect.

Section 172.46 describes the format of a notification and when and

where to submit the notification. A provision for claiming data and

information provided in a notification as CBI is included in

Sec. 172.46(d). Section 172.48 identifies the data and information to

be included in a notification. Section 172.50 indicates the time (90

days) the Agency allows itself to review and respond to a notification.

Section 172.52 describes a process petitioners may use to request

exemption of specific microbial pesticides or categories of microbial

pesticides from the notification requirement.

Sections 172.57 and 172.59 are included to enable the Agency to

address situations where small-scale tests covered by Subpart C result

in unanticipated and untoward effects.

The Agency has revised 40 CFR 172.3 to clarify its rationale for

presuming that an EUP is not required prior to small-scale testing with

most pesticides. In response to public comment on the proposed rule,

EPA has revised the proposed text of Sec. 172.3 to clarify that the

applicability of EUP requirements will be based upon risk/benefit

considerations, and to include testing of new uses of registered

pesticides.

IV. Response to Comments

EPA received a total of 19 comments on its proposal to amend its

EUP regulations for microbial pesticides (58 FR 5878, January 22,

1993). A detailed analysis of the public comments was prepared by EPA

and is available in the public record (``Analysis of Comments, 40 CFR

part 172 Microbial Pesticides; Experimental Use Permits and

Notification; Proposed Rule. 58 FR 5878.'' Docket Control Number OPP-

50668A).

The following organizations or individuals provided comments on the

proposed rule: S. Abramson; American Council on Science and Health

(ACSH); American Farm Bureau Federation (AFBF); The American

Phytopathological Society (APS); Council for Responsible Genetics

(CRG); DuPont Agricultural Products (DuPont); Ecogen, Inc.;

Environmental Defense Fund (EDF); M. Goettel; Industrial Biotechnology

Association (IBA); D. Keppel; Massachusetts Audubon Society (MAS);

Mycogen, Inc.; National Audubon Society (NAS); National Wildlife

Federation (NWF); Novo Nordisk Bioindustrials (NNB); U.S. Department of

Agriculture National Agriculture Pesticide Impact Assessment Program

(USDA/NAPIAP); Wisconsin Department of Agriculture, Trade, and Consumer

Protection (WDATCP); A. Wood.

A. Scope of Coverage

In its proposal, EPA requested comment on two approaches to scope

of coverage. EPA's preferred option, Option 1, represents a

``centralized'' approach to regulation. That is, EPA defined in Option

1 the specific microbial pesticides subject to the notification

requirement. To arrive at Option 1, EPA performed an initial assessment

of the potential risk presented by certain categories of small-scale

testing with microbial pesticides to determine which microbial

pesticides need not be subject to the notification requirement. The

Option 1 language was then drafted to describe those microbial

pesticides which could not generically be exempted from the

notification requirement. EPA would perform the review of the risks and

benefits of the subject microbial pesticides on a case-specific basis.

The language used to describe the microbial pesticides subject to

notification consisted of three fairly straightforward and specific

criteria that could be answered by either a ``yes'' or ``no.''

Option 3, on the other hand, is an option based on a

``decentralized'' approach. That is, based on general criteria supplied

by EPA, the researcher conducts a comprehensive evaluation of the

microbial pesticide and the proposed test and makes a determination of

whether a test would be subject to EPA notification review. Those

microbial pesticides the researcher determines would be subject to

notification would be reviewed by EPA on a case-specific basis. The

criteria used to determine whether the test would be subject to

notification are greater in number and would not usually be answered by

either a simple ``yes'' or ``no.'' Rather, researchers would use their

judgement to determine whether EPA should be notified.

A total of 16 comments were received on the question of the

relative merits of the two options. Fifteen commenters supported Option

1. One commenter (ACSH) supported Option 3 unequivocally. Of the 15

commenters supporting Option 1, seven (NWF, M. Goettel, NAS, Ecogen,

IBA, NNB, and AFBF) supported the option unequivocally; eight (EDF,

MAS, CRG, A. Wood, WDATCP, Mycogen, APS, and USDA/NAPIAP) supported the

option but suggested modifications to the scope of coverage. Seven

(Ecogen, NWF, CRG, EDF, WDATCP, MAS, and NAS) of the 15 commenters

supporting Option 1 specifically voiced opposition to Option 3. All

seven were opposed to a decentralized approach per se; two (MAS and

CRG) of these seven identified major concerns with the language of the

scope of coverage of Option 3. Among the 15 who supported Option 1, two

(AFBF and APS) saw some advantages to a decentralized approach; and 1

of these 2 (APS) requested that EPA reconsider a decentralized approach

in 3 years.

Commenters who supported Option 1 but suggested modifications to

the language of the scope of coverage can be grouped into three

categories based on the extensiveness of the suggested modifications.

In the first group, five commenters (EDF, MAS, CRG, A. Wood, and

WDATCP) suggested that the definition of ``deliberately modified'' be

changed to include all genetic material that is introduced and not, as

currently set forth in Option 1, only that genetic material that has

experienced ``directed addition, rearrangement, or removal of a

nucleotide sequence(s) to or from genetic material.'' In the second

group, one of the seven commenters (Mycogen) requested a broad scope of

coverage. Specifically, this commenter suggested that the Agency adopt

the centralized approach with the following scope language,

``Indigenous microbial pesticides for which specific pesticidal

activities have been created or increased by deliberate processes or

techniques.'' In the third group, two commenters suggested a somewhat

different direction. USDA/NAPIAP suggested that ``biological control

agents'' be differentiated from ``microbial pesticides'' and that

microbial biological control agents be exempted from the notification

requirement. The EPA proposal did not make such a differentiation. The

other commenter (APS) offered a suggestion that ``[a] modification to

Option 1 might be considered for potential exemption or to allow

initiation of experiments simultaneously with notification in the case

of rearrangements or deletions within a single genome that result in

phenotypes comparable to those observed in natural populations.''

EPA Response: EPA agrees with the comments supporting Option 1 and

has adopted Option 1 in the final rule. EPA believes that a centralized

approach is the more efficient and protective approach to small-scale

testing of microbial pesticides at this time.

EPA believes the scope of coverage of Option 1 creates a structure

wherein the assessment of whether a test is subject to notification to

EPA is made on the basis of simple and directly addressable criteria

that form the scope definitions. Under this approach, all interested

parties (e.g., industry, researchers, public interest groups, and EPA)

would, in most instances, conclude from a reading of the definitions

alone whether a test involving a specific microbial pesticide is

subject to the notification requirement. In addition, this final rule

significantly reduces the number of notifications that will be sent to

EPA relative to existing EPA policy.

EPA believes Option 1 appropriately focuses attention on microbial

pesticides with (1) new or different hazard traits; and, (2) the

potential to present new or different exposures, e.g., organisms which

heretofore might not have been exposed to a particular substance might

now be exposed to that substance through the microbial pesticide. EPA

judges pesticides in these categories to present relatively greater

potential for risk than those microbial pesticides EPA would no longer

subject to the notification requirement.

EPA has examined the eight comments suggesting modification of the

Option 1 language; however, EPA does not believe any of the suggested

modifications are warranted. EPA believes the word ``directed'' in the

definition of ``deliberately modified'' as proposed in Option 1

addresses what appears to be the primary concerns of the majority of

commenters. From their letters, three commenters (EDF, CRG, and WDATCP)

appear to believe that some types of microbial pesticides EPA intends

to be captured for notification under Option 1, would not be captured.

EDF, for example, noted that an ``unmodified scorpion gene would not

require notification'' under Option 1. WDATCP made a similar point

using a wasp toxin gene as an example.

EPA believes that the Option 1 language in its proposal of January

22, 1993, would capture such microbial pesticides, because some type of

``directed'' modification would have to be made in the development of

these microbial pesticides. In the examples mentioned by EDF and

WDATCP, appropriate regulatory sequences would have to be added

directly to the nucleotide sequences encoding the structural gene for

the toxin, and this complete genetic construct introduced into the

recipient microorganism, in order to be expressed in the recipient

microorganism. Inserted structural genes lacking appropriate regulatory

sequences have an extremely low probability of being expressed. Without

appropriate regulatory sequences, the only possibility for an

introduced gene to be expressed is if it accidentally inserts in a

position on the microorganism's chromosome adjacent to appropriate

regulatory genes. However, an introduced gene is unlikely to insert by

chance at a position adjacent to sequences necessary for expression by

the recipient microorganism. EPA is not aware of any reports in the

scientific literature documenting that this can occur, and no examples

of such genetic modifications were provided in public comments on the

proposed rule.

An additional technical problem would arise as a result of the

extreme difficulty of identifying and isolating, without the use of

marker genes, microorganisms appropriately expressing the desired

introduced pesticidal traits. The use of marker genes entails

``directed'' modification. Without marker genes, the time required for

researchers to test thousands, if not millions, of individual microbial

isolates to identify the microorganism that has undergone the rare

event of insertion of a pesticidal trait is not practical.

To summarize, it is technically extremely difficult to introduce an

``unmodified'' scorpion or wasp gene into a microorganism to create a

novel microbial pesticide. Directed addition of nucleotide sequences

would be necessary for either selection of the modified microorganism

or proper expression of the gene encoding the pesticide.

EPA has not modified the rule to incorporate the suggestion

(Mycogen) to broaden the scope to all genetically altered microbial

pesticides by utilizing a scope of coverage for all ``indigenous

microbial pesticides for which specific pesticidal activities have been

created or increased by deliberate processes or techniques.'' EPA's

experience, in the past 10 years, in reviewing notifications for small-

scale testing with genetically altered microbial pesticides has allowed

the Agency to conclude that certain of these microbial pesticides need

not be subject to the notification process. EPA believes the scope of

coverage in the final rule addresses the appropriate category of

microbial pesticides, while excluding from notification microbial

pesticides similar to those likely to occur in microbial populations in

nature. Laboratory-generated microbial pesticides similar to those

likely to occur in nature are not likely to present new hazard or

exposure issues when tested at small-scale, with the possible exception

of certain nonindigenous microbial pesticides as discussed below.

EPA has determined not to take the suggestion that ``biological

control agents'' be differentiated from ``microbial pesticides.'' Since

EPA did not propose such a distinction in the proposed rule, the

distinction cannot be incorporated into this final rule. Moreover, such

a modification would require substantive changes in regulations and

guidance that are not related to this rulemaking; changes that EPA does

not believe are warranted. FIFRA applies to all pesticides, whether

they be microbial pesticides or other types of biological control

agents. EPA does not know of any risk-based reason to create two

separate categories that should be treated differently. The commenter

has not provided sufficient support for the suggestion that

microorganisms that act by means of competitive displacement pose low

risk. Little data either supporting or disproving this contention exist

in the literature. Competitive displacement interactions among

microorganisms can be mediated by microbial toxins, and such toxins can

raise concerns for effects on nontarget organisms.

With regard to the comment suggesting that deletions or

rearrangements within a single genome be handled either as exemptions

or as post-card notifications, the Agency believes this suggestion

could be handled under the exemption provision of Sec. 172.52, and the

Agency's determination is discussed under unit E, ``Exemption

Process,'' of this final rule.

B. Administrative Aspects of Implementation of Scope of Coverage

EPA requested comment on four administrative aspects of

implementation of scope of coverage. These four administrative

procedures could apply to both Options 1 and 3, but are more relevant

to Option 3. The four procedures are: (1) Guidance from EPA on the

considerations used in making a determination of whether a

microorganism is covered by the scope; (2) documentation of the

determination; (3) review of the determination by a third party; and,

(4) retention of the records of the determination.

Six respondents commented on this issue. Three comments (AFBF,

WDATCP, and MAS) were received supporting the need for Agency guidance

on considerations relevant to determining whether a microbial pesticide

is subject to the notification requirement.

Three commenters (EDF, NAS, and NWF) stated that, if Option 3 were

adopted, a third-party review procedure would not adequately protect

human health and the environment. One comment (AFBF) was received

suggesting that third-party review would strengthen a process where

researchers make a determination of whether a microorganism is covered

by the scope in terms of consistency, ensuring the correct

determination, and addressing the concerns of the public. One comment

(AFBF) was received supporting the retention of records.

Two commenters (MAS and AFBF) stated that if Option 3 were chosen

by EPA, documentation of the considerations used in making a

determination of whether a microorganism is covered by the scope should

be required.

EPA Response: EPA will implement in the final rule the scope of

coverage described in its proposed Option 1. EPA believes that

researchers' laboratory notebooks routinely include the types of

information considered in making a determination of whether a

microorganism is covered by the notification requirement set forth in

Option 1. Although researchers are not required to develop and maintain

records specifically supporting a determination of whether a

microorganism is covered by this notification requirement, researchers'

laboratory notebooks or other documentation would be treated by EPA as

records.

Because of the sufficiently straightforward nature of the language

of Option 1, third-party review would add little to the determination,

and this is not judged by EPA to be necessary for Option 1. In terms of

guidance to submitters, the Agency believes that the selection of

Option 1 obviates the need for extensive guidance. The criteria

contained in Option 1 are fairly straightforward and the selection

criteria set forth in the scope definition, as well as the rationale

discussion in Unit III of the proposed rule, provide sufficient

guidance. Developers of microbial pesticides may also consult with the

Agency for guidance on notification requirements, including whether a

particular microbial pesticide is subject to the notification

requirement.

C. Nonindigenous Microbial Pesticides

Since 1984, EPA has had in place policies that require notification

to EPA for small-scale testing of all genetically altered and

nonindigenous microbial pesticides. ``Nonindigenous microorganism'' was

defined in the 1986 ``Coordinated Framework for Regulation of

Biotechnology'' (51 FR 23302, June 26, 1986), which stated that a

microorganism would be considered to be nonindigenous to ``any one of

the geographic areas listed below if it is isolated from outside that

area: (1) The continental United States, including Alaska, and the

immediately adjoining countries (i.e., Canada and Mexico); (2) The

Hawaiian Islands; (3) The Caribbean Islands including Puerto Rico and

the U.S. Virgin Islands.'' EPA stated in the proposed rule that

``nonindigenous'' microbial pesticides should no longer be subject to

the notification requirement because they are adequately regulated by

another Federal agency. In the proposed rule, EPA requested comment on

whether a category could be identified consisting of nonindigenous

microbial pesticides that pose a potential for significant risk to

human health or the environment, when used in testing at small-scale,

that are not otherwise reviewed by another Federal agency. Three

commenters (IBA, NNB, and Ecogen) supported EPA's proposal to exclude

nonindigenous microbial pesticides from the scope of coverage. Four

other commenters (MAS, EDF, A. Wood, and ACSH) opposed omitting

nonindigenous microbial pesticides from the scope of coverage of this

rule. Two among this second group of commenters (MAS and EDF) stated

that the Agency should consider covering those nonindigenous microbial

pesticides not regulated by other Federal agencies. These commenters

asked the Agency to provide a more detailed analysis of how other

Federal agencies' authorities would apply to nonindigenous

microorganisms, and ensure safe use. The other two commenters opposed

to omitting nonindigenous microbial pesticides from the scope of

coverage (A. Wood and ACSH) believed that all microbial pesticides

should be reviewed before initial field testing.

EPA Response: The Agency believes that the vast majority, if not

all, of nonindigenous microorganisms (some of which are microbial

pesticides) are addressed by the regulatory authorities of USDA/APHIS.

Nonindigenous microorganisms that may have direct or indirect plant

pest or adverse animal health effects are regulated by USDA/APHIS.

Under its authorities (Federal Plant Pest Act, U.S.C. 150aa et. seq.;

Plant Quarantine Act, 7 U.S.C. 151 et. seq.; Federal Noxious Weed Act,

7 U.S.C. 2801 et. seq.; and several animal quarantine statutes, 21

U.S.C. 111, 114, 134), and pursuant to its responsibilities under the

National Environmental Policy Act (NEPA) 42 U.S.C. 4321 et seq., USDA/

APHIS considers the human health and environmental impacts associated

with nonindigenous microorganisms that have plant pest potential or are

animal pests. USDA/APHIS has issued regulations at 7 CFR part 330 which

regulate the importation and interstate movement of plant pests

including provisions on the port of entry, inspection, emergency

measures, and the information needed in applications for permits to

move plant pests.

EPA believes that small-scale tests involving naturally occurring

nonindigenous microbial pesticides, that have been acted upon by USDA

(i.e., either by issuing or denying a permit or determining that a

permit is unnecessary; or a permit is not pending with USDA), are

adequately regulated and thus are unlikely to cause any significant

impact on the environment. Another measure of oversight is provided by

the U.S. Public Health Service, which regulates the importation and

subsequent distribution of microorganisms that are of human health

concern.

EPA's preferred option in the proposed rule was to exclude, based

on its analysis of USDA/APHIS regulatory authorities, nonindigenous

microbial pesticides from the notification requirement. However, EPA

also stated that it would consider reviewing nonindigenous microbial

pesticides that pose a potential for significant risk to human health

or the environment when used in testing at small-scale and that are not

otherwise reviewed by another Federal agency, provided that a category

of such microorganisms can be identified. However, the Agency explained

that it was not aware of the existence of such a category of

nonindigenous microbial pesticides.

In this final rule EPA will require notification, at small-scale

field testing, for nonindigenous microbial pesticides that have not

been acted upon by USDA (i.e., either by issuing or denying a permit or

determining that a permit is unnecessary; or a permit is not pending

with USDA), even though at this time no microbial pesticides may be

described by this category. EPA believes this approach will ensure that

all nonindigenous microbial pesticides, testedat small-scale, will be

reviewed by a Federal agency. EPA believes this cautious approach

addresses the concerns raised in public comments and the comments of

the SAP (see proposed rule at 58 FR 5878), both of which suggested a

similar approach.

The Agency will, under its EUP and registration authority, continue

to regulate nonindigenous microbial pesticides prior to any use at more

than 10 acres of land or 1 surface acre of water.

D. Testing in Contained Facilities

In the proposed rule, EPA proposed that testing within a contained

facility, such as a laboratory or greenhouse, where appropriate

containment controls and procedures are employed, would not require

notification. The individual or institution conducting the contained

research would be given the discretion to select and use procedures and

controls appropriate to achieve the ``performance standard'' of

adequate containment. EPA requested comment on whether minimal

recordkeeping to document the selection and use of containment and

inactivation controls should be required.

Six respondents commented on this issue. None of the six commenters

(IBA, NNB, APS, Ecogen, AFBF, and EDF) supported the concept that

notification to EPA for contained research is necessary. Two commenters

(IBA and NNB) thought the National Institutes of Health (NIH)

Guidelines for Research Involving Recombinant DNA Molecules provided

suitable guidance and standards for selecting and using procedures and

equipment to obtain appropriate containment. One commenter (AFBF)

suggested guidance should be based on USDA, NIH, or American Society

for Microbiology guidelines.

Two commenters (AFBF and APS) stated that no additional and

specific recordkeeping is necessary beyond what occurs in standard

laboratory practice; e.g., laboratory notebooks. One commenter (EDF)

strongly supported requiring minimal recordkeeping to document the

selection and use of the containment and inactivation controls. In

addition, this commenter believed that EPA's proposed performance

standard for containment is vague and not protective.

EPA Response: EPA continues to believe that notification for

contained research with microbial pesticides is not necessary. EPA

agrees that adequate guidance on selecting appropriate microbiological

procedures for achieving adequate containment is available from sources

such as the Public Health Service, Centers for Disease Control guidance

on the use of etiologic agents and the NIH Guidelines for Research

Involving Recombinant DNA Molecules. Selection and use of specific

containment and inactivation controls can be based on this available

guidance, and EPA does not plan to issue additional guidance at this

time. Researchers are reminded that they must keep records documenting

selection and use of appropriate containment and inactivation controls.

These may be kept in laboratory notebooks. If the NIH Guidelines are

used as guidance, the researcher's notebook should indicate the level

of containment suggested by the Guidelines and that this guidance was

selected and used. In order to clarify that such records should be

available for either inspection by EPA or submission to EPA upon the

Agency's request, Sec. 172.45(e)(4) of the regulatory text reads as

follows: ``Records shall be developed and maintained describing the

selection and use of the containment and inactivation controls,

including contingency plans for emergency clean-up and test

termination, that will be used during the test. These records shall be

available for inspection at the test facility. In addition, these

records shall be submitted to EPA at EPA's request and within the

timeframe specified in EPA's request.'' EPA believes that persons

following the NIH Guidelines would keep adequate records as part of

normal procedures for informing their Institutional Biosafety Committee

of the contained research.

In the proposed rule, the Agency asked for comment on whether

selection of containment and inactivation controls should be approved

in writing by an authorized official of the organization. EPA received

no specific comments on this provision either in support or opposition.

EPA believes that most research organizations follow such a provision

on approval by an authorized official as a matter of course. For

example, those institutions complying with the NIH Guidelines would

meet this provision through the Institutional Biosafety Committee

provisions of the Guidelines. EPA therefore has included the provision

on approval by an authorized official at Sec. 172.45(e)(3) of the

regulatory text.

In comments on the proposed rule, EDF stated that EPA's performance

standard is too vague and not protective because EPA fails to define

what is meant by ``adequate'' containment and inactivation controls.

EPA believes that it is appropriate to give the individual or

institution conducting the testing the discretion to select and use

procedures that would achieve adequate containment, based on available

guidance, such as the guidance on containment procedures for

microorganisms used in research laboratories found in the NIH

Guidelines for Research Involving Recombinant DNA Molecules. EPA's

approach accepts that the judgement of the individual or institution

conducting the research must take into account the many different kinds

of microorganisms used in research and the fact that appropriate

containment conditions vary depending on the microorganism. EPA

believes that experience with contained research with microbial

pesticides demonstrates that this approach is adequate in protecting

against unreasonable adverse effects to human health and the

environment. Thus, EPA has determined that the recordkeeping

requirements at Secs. 172.45(e)(3) and 172.45(e)(4) of the regulatory

text, along with the procedures for reporting unreasonable adverse

effects at Secs. 172.57 and 172.59, are appropriate for the level of

risk presented by contained research with microbial pesticides.

E. Exemption Process

The Agency proposed in Sec. 172.52 a process for exempting from the

notification requirement certain subgroups of microbial pesticides

otherwise captured by the scope of coverage laid out by Option 1. All

five comments (AFBF, IBA, NNB, APS, and MAS) received on this issue

supported the concept of a mechanism for exemption of microbial

pesticides, otherwise captured by the scope of the rule, from the

notification requirements. Two commenters (IBA and NNB) suggested as

candidates for exemption Bacillus thuringiensis which have been

genetically modified through the introduction of genetic material from

other strains of Bacillus thuringiensis and/or genetic material for

selectable marker genes. One commenter (MAS) suggested changes in the

exemption process: a longer public comment period and ``less vague''

qualification criteria. One commenter (APS) suggested in their comments

on scope of coverage a somewhat different exemption mechanism than

discussed by the Agency in its proposal. The commenter proposed that

``[a] modification to Option 1 might be considered for potential

exemption or to allow initiation of experiments simultaneously with

notification in the case of rearrangements or deletions within a single

genome that result in phenotypes comparable to those observed in

natural populations.''

EPA Response: The Agency has included at Sec. 172.52 a mechanism

for exempting, as information warranting such action becomes available,

certain subgroups of microbial pesticides from the notification

requirement. EPA agrees with the comment (MAS) received concerning the

time allowed for public comment on proposed exemptions. EPA will

utilize a comment period of 45 days, instead of the proposed 30 days,

in order to allow more time for public participation. EPA will still

review these petitions within the 180-day timeframe stated in the

regulatory text.

With regard to the comment on the criteria for exemption (MAS), EPA

believes that, at this time, it is not possible to generically describe

the criteria that will be used for specific exemptions from

notification under Sec. 172.52 of the final regulation. EPA believes

that petitions for exemption have to be addressed on a case-specific

basis. In instances where EPA believes that an exemption is

appropriate, EPA will issue a notice of proposed rulemaking in the

Federal Register, which will explain the basis for the Agency's

proposed decision.

MAS also asked how the exemptions from notification under

Sec. 172.52 would differ from EPA's policy, stated in the proposed

rule, of informing submitters on an individual basis when no further

notification to EPA was required for specific microbial pesticides. EPA

will encourage submitters to use the exemption from notification

process to address such situations in the future. Use of the exemption

from notification process under Sec. 172.52 will allow the public the

opportunity to comment on any exemption petition submitted to EPA.

In the proposed rule, EPA requested comment on the scientific merit

of adding an exemption under Sec. 172.45(d)(1) of the regulatory text

for ``. . . microorganisms modified solely by rearrangement (i.e.,

translocation or inversion) or deletion of nucleotide sequences within

a single genome, including its extrachromosomal elements.'' This

concept was supported by APS when they suggested a modification of the

scope of coverage to exempt small-scale testing of microbial pesticides

``. . . in the case of rearrangements or deletions within a single

genome that result in phenotypes comparable to those observed in

natural populations.'' An exemption describing this category of

microbial pesticides is included at Sec. 172.45(d)(1) of the regulatory

text. EPA has gained experience in the review of notifications of such

organisms and is persuaded that such microbial pesticides are similar

to those that would be likely to occur in microbial populations in

nature, since it is known that deletions and rearrangements of genetic

material within a single genome occur in microorganisms in nature. The

microbial pesticides described by the exemption at Sec. 172.45(d)(1)(i)

would, thus, likely be subject to the same constraints as other

naturally occurring microbial populations in the environment.

EPA agrees with the commenters (IBA and NNB) who proposed an

exemption for microbial pesticides based on the organism Bacillus

thuringiensis that such an exemption may be merited under Sec. 172.52

of the regulatory text. After publication of this final rule in the

Federal Register, EPA will begin work on developing an exemption for

certain genetically modified Bacillus thuringiensis strains as proposed

in public comments. EPA requests that individuals supporting this

exemption provide to the Agency any information or data on why the

specific microbial pesticide or class of microbial pesticides meet the

criteria of Sec. 172.3 for small-scale tests of pesticides that do not

require an EUP.

F. Notification Process

Proposed Sec. 172.48, included a discussion of the kinds of data

and information to be submitted in a notification; e.g., the identity

of the microbial pesticide, a characterization of its relevant biology

and ecology, a description, if applicable, of how the microbial

pesticide has been modified, and a description of the objectives,

experimental design, and other relevant parameters of the proposed

test. EPA proposed in Sec. 172.46 that Agency review of a notification

would be completed within 90 days. Proposed Sec. 172.46 also contained

information on where and how to submit a notification.

Six comments were received on the proposed notification process.

Four of the six comments dealt with data requirements. Two of these

four commenters (IBA and NNB) agreed with EPA's proposed regulatory

text. The third (MAS) requested that EPA require the use of marker and

suicide genes in microbial pesticides and also require information be

submitted on the management of resistance to pesticides in populations

of target organisms. The fourth commenter (WDATCP) offered suggestions

on data requirements addressing survival and potential effects on non-

target organisms. Two of the six comments (IBA and NNB) requested that

EPA review notifications in 60 days rather than the 90 days proposed by

the Agency. Two commenters (MAS and WDATCP) addressed issues of

coordination with State authorities responsible for oversight of

microbial pesticides. One commenter (A. Wood) suggested that EPA

develop a data base of human health and environmental data generated

from field tests of microbial pesticides, including those under

notification, in order to improve the data based for future regulatory

decisions. One commenter (APS) suggested that EPA change the term

``notification'' to ``screening procedure'' or ``microbial pesticides

pre-test review procedure'' because notification is a misnomer.

EPA Response: In this final rule EPA will implement its proposal of

allowing 90 days as the outer limit for review of notifications. Ninety

days is required to achieve coordination with State and local

authorities and with USDA/APHIS where jurisdictional overlap occurs

between EPA and USDA. Ninety days also permits the Agency sufficient

time to fully evaluate whether any risk issues are associated with the

test and to examine them in detail, including providing the opportunity

for public participation in the review of notifications. EPA's goal is

to complete reviews of notifications in a timely fashion and, whenever

possible, notify submitters of the Agency's decision in less than 90

days.

In terms of the use of marker genes, EPA included, upon the request

of the SAP in 1988, a statement in proposed Sec. 172.48 encouraging the

use of such genes. EPA is retaining this statement in the final rule.

EPA believes use of such genes should be encouraged to facilitate the

identification or monitoring of microbial pesticides in the

environment. However, EPA will not make use of such genes a mandatory

general requirement for all small-scale field tests. EPA has the

flexibility to make a determination, on a case-specific basis, of

whether the use of marker genes should be required for particular

tests; for example, when the use of marker genes for monitoring of a

microorganism is judged by EPA to be an appropriate means of risk

management for a particular field test. Technical and efficacy

considerations can be taken into account on a case-specific basis in

determining the relative cost/benefit ratio of using marker genes. EPA

believes the requirement that microbial pesticides contain suicide

genes is premature because the efficacy of suicide genes in controlling

microbial populations in the environment has not been demonstrated to

date in the scientific literature.

The suggestion that EPA include a requirement for a pesticide

resistance management plan is beyond the scope of this rule, which

addresses only notification for small-scale tests of certain microbial

pesticides. The Agency is aware of this issue for all pesticides and is

evaluating its approach to resistance management.

Comments on data requirements included the suggestion that survival

of the microbial pesticide in the environment and evaluation of a broad

range of potential non-target organisms for adverse effects is

important (WDATCP). EPA agrees that information on the survival of a

microbial pesticide should be evaluated in a notification and has

retained this data requirement in the final rule at Sec. 172.48. EPA

will not, however, routinely require in a notification that a broad

range of potential non-target organisms be addressed by the submitter.

EPA can require testing of effects on potential non-target organisms in

a specific notification if the characteristics of a particular

microbial pesticide indicate that this is justified. Data requirements

for EUPs and registration in Sec. 158.740 describe tests to address

non-target effects of microbial pesticides. These requirements utilize

single-species testing, which the Agency has found to be the most

effective way to address potential for non-target effects.

The suggestion (A. Wood) that EPA develop a data base of human

health and environmental data generated from field tests of microbial

pesticides is beyond the scope of this rule which addresses only

notification for small-scale testing of certain microbial pesticides.

However, applicants submit human health and environmental data as part

of the notification, EUP, and registration processes, and the Agency's

experience base grows through this process.

While, as suggested by APS, the term ``screening procedure'' or

``microbial pesticides pre-test review procedure'' may provide a more

accurate description of the reporting process described in the proposed

rule, the term ``notification'' has been used by EPA since the

publication of the 1984 policy statement and is both accepted and

understood by interested parties. To change the term now could lead to

confusion. EPA, thus, will continue to use the term ``notification'' to

describe this process. The notification process described in

Sec. 172.46(b) indicates how submissions should be marked to ensure

that notifications are properly processed.

G. Substantiation of Claims for Confidential Information

The Agency requested comment on the proposed requirement

(Sec. 172.46(d)) that any claim of confidentiality must be

substantiated at the time the claim is made (i.e., ``up-front

substantiation''). Specifically, the Agency sought comment on how to

achieve the best balance between the burden on industry to provide

substantiation before public disclosure becomes an active issue (e.g.,

in preparation for SAP meetings) and the regulated community's desire

to receive timely responses on notifications. This balance must take

into consideration the needs of pesticide developers to protect

information they believe to be critical to maintaining their

competitiveness and the public's need for access to information related

to potential environmental or human health effects early enough in the

notification review process to provide informed comment before the

Agency makes a decision.

Five respondents (Ecogen, IBA, NNB, EDF, and CRG) commented on

EPA's proposed approach on substantiation of CBI claims. All five

commenters supported EPA's proposal to require up-front substantiation;

three of these commenters (Ecogen, IBA, and NNB) recommended that EPA

implement an initial screening process to identify and address

expeditiously any CBI issues.

EPA Response: EPA continues to believe that up-front substantiation

of CBI is appropriate and necessary for expeditious decisions on

notifications. EPA believes that, given the Agency's procedural

requirements for making final CBI determinations, without up-front

substantiation, the 90-day response time associated with the

notification procedure at Sec. 172.50 would be difficult or impossible

to meet if it becomes necessary to resolve a CBI issue before a

decision on the notification can be made. Up-front substantiation

allows the Agency to make available to the public expurgated copies of

each submission and a rationale for any exclusions, and, in necessary

cases, to make final determinations of the validity of CBI claims. The

Agency does not believe that a formal initial screening process needs

to be implemented because a submitter always has the option of

consulting with the Agency on these and other issues.

Two commenters (IBA and NNB) felt that EPA should issue guidance on

the types of information that constitute a valid claim of CBI for

microbial pesticides. EPA will consider developing such guidance in the

future. It may be more useful for the Agency to develop such guidance

after gaining more experience in the review of microbial pesticides

subject to this final rule.

H. Voluntary Submissions

Although not specifically proposed in the rule, the Agency

requested comment on whether, in addition to the notification

requirement, EPA should offer the opportunity to obtain review on a

voluntary basis, of any microbial pesticide that a company or

researchers believes could benefit by such a review, regardless of the

scope of coverage for notification in the final rule. The two

commenters (IBA and NNB) who offered comment on this issue supported a

provision for voluntary submissions, although one commenter (NNB)

expressed concern over the burden on Agency resources as a result of

the increased number of submissions.

EPA Response: EPA agrees with the comment that the Agency's

resources may be overly burdened by voluntary submissions if developers

of microbial pesticides decide to submit notifications for microbial

pesticides outside the scope of coverage. Such voluntary reviews could

be equivalent to a notification in terms of Agency resources required

to conduct a review. After consideration of the public comments on this

issue, the Agency believes that it should focus its limited resources

on review of notifications of microbial pesticides subject to this

rule. However, submitters who are not clear about the reporting status

of a microbial pesticide, in terms of the scope of coverage, are

encouraged to contact the Agency for guidance on whether a notification

is required.

I. Scope of Requirement

Two commenters (Abramson and DuPont) questioned how the proposed

changes in Sec. 172.3 affect the relationship between FIFRA sections 5

and 12(b)(5) and the definition of pesticide in section 2(u) and how it

would affect testing of registered pesticides in a non-registered use.

One commenter (DuPont) suggested modifications of the language of

proposed Sec. 172.3(c)(1)(i) and Secs. 172.3(c)(1)(iii),

172.3(c)(2)(iv), and 172.3(c)(3). The commenter believed such modified

language would more clearly state EPA's intent. This commenter also

suggested the word ``not'' had inadvertently been omitted from proposed

Sec. 172.3(d). In addition, the commenter asserted that proposed

Sec. 172.3(e) was impractical, unnecessary, and unwarranted, and would

give the Agency new powers.

EPA Response: As described in the proposed rule, EPA is modifying

Sec. 172.3, to clarify that the basis for the presumption concerning

the need for an EUP for small-scale testing is based on risk/benefit

considerations, rather than on a definitional determination of whether

a substance is a pesticide.

DuPont was concerned that, in revising Sec. 172.3, EPA was

modifying the status under FIFRA of a substance being tested, and

questioned whether EPA intended to classify all test substances as

pesticides.

As EPA stated in the preamble to the proposal, the determination of

whether a substance or mixture of substances is a pesticide is governed

by the intent test of FIFRA section 2(u). Once a substance is

determined to be a pesticide, the applicability of FIFRA section 5 EUP

requirements must still be set out. In other words, EPA must explain

under what circumstances an EUP will be required for testing conducted

on a pesticide. This determination is separate and distinct from

whether the substance is or is not a pesticide. The current language of

Sec. 172.3(a) mingles the two determinations, and implies that a

pesticidal determination can be made on the same basis as the

determination of EUP applicability. In fact, a pesticide determination

must be based upon intent under the definition of pesticide in FIFRA,

whereas EUP applicability will be based upon risk/benefit

considerations only after pesticide status has been attained. The

revised Sec. 172.3 only addresses the latter of these two

determinations.

EPA emphasizes, however, that it does not intend to change the

status of any testing with respect to EUP applicability. Small-scale

testing previously conducted on a ``substance'' not subject to the

requirement of an EUP, in most instances, will continue to be permitted

on a ``pesticide'' without the requirement for an EUP. As under the

existing Sec. 172.3, this final rule will contain a presumption that an

EUP is not required for small-scale testing of pesticidal substances. A

substance that does not meet the intent test of FIFRA section 2(u) and

is therefore not a pesticide would not be covered by FIFRA section 5

under any circumstances. In addition, in this final rule, EPA does not

intend to change the status of the exemption under section 12(b)(5) of

FIFRA which allows the shipping of a pesticidal substance, under the

conditions of that section, without being subject to penalty for

failure to have a registration or an EUP. Both Abramson and DuPont

commented that EPA had omitted reference in its proposal to the status

of testing of new uses of registered pesticides that is currently

explicitly stated in Sec. 172.3(c). EPA did not intend to preclude such

testing. Such testing will continue to be eligible for the presumption

that an EUP is not required for certain small-scale testing under the

final rule. In response to both these comments, EPA has revised the

text of Sec. 172.3(a) to clarify the applicability of EUP requirements

as being a risk/benefit determination, and to include testing of new

uses of registered pesticides.

Proposed Sec. 172.3(e) reserved to the Agency the right to require

an EUP on a case-by-case basis, notwithstanding the presumptions in

earlier paragraphs that EUPs would not be required. DuPont contended

that proposed Sec. 172.3(e) would be impractical, unnecessary,

unenforceable, and unduly expand the Agency's authority. DuPont's

principal concern was that EPA had not set out criteria for making this

determination, and that the regulated community could therefore not

discern when it was subject to the requirement of an EUP.

EPA disagrees that the Agency is extending its authority. Rather,

it is expressly articulating the authority it has always had to rebut

the presumptions, either for specific tests or categories of tests.

Section 5 of FIFRA authorizes EPA to require EUPs for all tests,

regardless of acreage. EPA has determined, however, that based on risk

considerations, EUPs generally are not necessary for small-scale tests

conducted using most pesticides. Since the applicability of EUP

requirements depends on risk/benefit considerations, EPA believes it is

entirely appropriate that the Agency retain this flexibility and be

able to make case-by-case determinations of EUP applicability. If EPA

has reason to believe that certain small-scale testing should be

regulated under an EUP for risk/benefit reasons, it should ensure that

appropriate controls are in place before the testing takes place.

However, in response to DuPont's concern that the regulated

community could not determine when an EUP would be required, EPA has

revised Sec. 172.3(e) in the final rule to specify that, if EPA

determines that an EUP is required, it will notify the affected parties

of the need for an EUP. Prior to such notice from the Agency, parties

may assume that the presumption that no EUP is required is applicable

to their small-scale tests. EPA notes that the provisions of Subpart C

are an example of the type of circumstances where EPA has determined

that it is appropriate to rebut the presumption that no EUP is

required. Where, as in this rulemaking, EPA is rebutting the

presumption generically for a category of pesticides or tests, it will

use the rulemaking process as the means of notification. In other

cases, EPA could choose to notify a producer individually of the need

for an EUP. DuPont commented that the language of proposed

Sec. 172.3(c), which pertains to testing covering more than one target

pest occurring at different times and places, was confusing, and

suggested revised text to clarify the intent. EPA recognizes that the

proposed language may be confusing and has clarified Secs. 172.3(c)(1)

and (c)(2) of the regulatory text. For example, in Sec. 172.3(c)(1), it

is generally EPA's intent that testing of a pesticide for one target

pest would qualify for the presumption when conducted on no more than

10 acres cumulative, including all test locations. When testing for

more than one target pest, the presumption again applies to testing on

no more than 10 acres per pest, where the testing occurs either in

different locations or at different times. Thus, testing for two target

pests on the same site, one of which occurs in the spring and the other

in the fall, can be conducted without an EUP as long as neither test

exceeds 10 acres. Similarly, testing for two pests at the same time,

one of which is a pest only in the Southeast United States, and the

other in the Southwest, can be conducted without an EUP as long as

neither test exceeds 10 acres. However, testing is limited to 10 acres

total if more than one target pest is being tested at the same time and

same locality.

EPA has also addressed the comment from DuPont that the use of the

term ``crop'' in proposed Sec. 172.3(c)(1)(iii) is confusing when

referring to pesticide residues in or on the crop. The confusion could

arise because the term ``crop'' does not properly apply to fish and

animals, even though these may be the subject of tests involving

pesticides. EPA has clarified this language in Sec. 172.3(c)(1)(ii) in

the regulatory text by not specifically referring to crops.

With regard to the comment from DuPont on Sec. 172.3(d), EPA

acknowledges that the word ``not'' was inadvertently omitted from

proposed Sec. 172.3(d), and the final regulatory text has been

corrected.

J. Submission of Information Regarding Potential Unreasonable Adverse

Effects

One comment (WDATCP) was received on the proposal at Sec. 172.57 to

require reporting of unreasonable adverse effects. This commenter

believed that: (1) Researchers tend to under assess potential impacts;

(2) microorganisms may continue to disperse and increase in numbers;

and (3) the phrase ``potential unreasonable adverse effects'' should be

defined.

EPA Response: In this final rule, EPA has included Sec. 172.57 as

proposed. Section 172.57 applies to all microbial pesticides identified

in Sec. 172.45(c), including those subject to the notification

requirements and those that are exempt from the notification

requirements under Sec. 172.45(d). While EPA has done generic

assessment of potential risk in the development of this rule, and

concluded that some, but not all, categories of microbial pesticides

warrant notification, the Agency cannot foresee all adverse effects to

human health or the environment which may arise in specific individual

small-scale tests. Section 172.57 is meant to address unforeseeable

adverse effects resulting from use of such pesticides. EPA believes

that such effects are likely to be extremely rare; however, Sec. 172.57

is a means of ensuring that potential risk is addressed and that the

Agency's data base is as complete as possible for future tests.

Unreasonable adverse effects must be reported if they are directly

observed by the submitter or if the submitter has learned through

another source that a microbial pesticide has the potential to result

in an unreasonable adverse effect.

K. Related Issues Not Specifically Posed for Comment

Two other topics, not specifically posed for comment by EPA in its

January 22, 1993 proposal were also raised by commenters. One commenter

(D. Keppel) requested that a moratorium be placed on all releases of

genetically modified organisms. Two other commenters (IBA and NNB)

requested that EPA reorganize the Office of Pesticide Programs (OPP) so

as to form a specific branch dealing with biological pesticides.

EPA Response: EPA believes that its approach to microbial

pesticides (i.e., its proposed notification program for small-scale

testing, its EUP program for large-scale testing and its registration

program) provide adequate protection from unreasonable adverse effects

to human health and the environment. The Agency believes there is no

evidence from experience with many years of small-scale testing of

genetically modified microbial pesticides that would support a request

for a moratorium on such tests. EPA, thus, does not believe a

moratorium on testing is warranted.

The issue of OPP internal organization is not an issue which is

appropriately addressed through rulemaking and is not considered in

this final regulation. OPP is, however, examining mechanisms to

introduce efficiencies into its program for biological pesticides.

V. Statutory Requirements

In accordance with FIFRA section 25(a), a draft of this final rule

was submitted to the FIFRA SAP, the Secretary of Agriculture (USDA),

and the House Committee on Agriculture and Senate Committee on

Agriculture, Nutrition, and Forestry for comment.

A. FIFRA Scientific Advisory Panel

A Subpanel of the SAP provided written comments on the draft final

rule. No major issues were identified in comments received from the

SAP. One comment was received from a Subpanel member noting that the

SAP, at its meeting on September 26, 1990 (see 58 FR 5878), raised the

issue that certain deletions or rearrangements of genetic material

within a single genome could impart or enhance characteristics of

potential concern. This commenter questioned EPA's scientific

justification for including such an exemption in the final rule, while

noting that there is no major problem with such an exemption.

EPA Response: EPA has included in the regulatory text, at

Sec. 172.45(d)(i), an exemption for small-scale testing of microbial

pesticides resulting from deletions or rearrangements within a single

genome. As stated in Unit IV of this preamble, EPA has gained

experience in the review of notifications of such organisms and is

persuaded that such microbial pesticides are similar to those that

would be likely to occur in microbial populations in nature since

deletions and rearrangements of genetic material within a single genome

are known to occur in microorganisms in nature. EPA has also taken into

consideration a point raised in the SAP report from the meeting on

September 26, 1990, which noted that the long-term survival and/or

competitiveness of these kinds of microorganisms may be compromised by

genetic modifications involving deletions or rearrangements within a

single genome. In making a decision on this exemption, EPA considered

both the concerns and mitigating factors raised by the SAP, along with

public comment. EPA believes that, on balance, these microbial

pesticides, when tested at small-scale, would be subject to natural

constraints on their populations in the environment.

Under Sec. 172.57 of the regulatory text, unreasonable adverse

effects resulting from microbial pesticides must be reported to EPA.

These reporting requirements also apply to the microbial pesticides

exempted at Sec. 172.45(d)(i), if any adverse effects should occur.

B. U.S. Congress and U.S. Department of Agriculture

In accordance with FIFRA section 25, a draft of this final rule was

submitted in February 1994 to the U.S. Congress and USDA. USDA

commented that the final rule simplifies the regulation of small-scale

testing of microbial pesticides, focuses on microbial pesticides posing

the greatest risk, and reduces the number of notifications to EPA when

compared to current policy.

USDA requested two changes in their comments, both of which EPA

agreed to incorporate in the final rule. The first modification

pertained to the text in the parentheses in Sec. 172.45(c)(2), which

read as follows: ``Nonindigenous microbial pesticides that have not

been favorably acted upon by the USDA (i.e., by the granting of a

permit or the determination that a permit is necessary).'' The USDA

suggested that the phrase ``not favorably acted upon'' may imply that

if USDA were to deny a permit because of a plant pest risk, EPA could

authorize testing under 40 CFR part 172. To avoid confusion, USDA

suggested the language read: ``Nonindigenous microbial pesticides that

have not been acted upon by USDA (i.e., either by issuing or denying a

permit or determining that a permit is unnecessary; or a permit is not

pending with USDA).'' EPA accepted this comment and the regulatory text

suggested by USDA appears in the final rule at Sec. 172.45(c)(2).

Second, USDA pointed out that both the USDA and EPA should consider

the effect of the current regulations on the testing and introduction

of biological control agents, given the commitment at USDA to the

development of more environmentally friendly biological control

approaches in agriculture. EPA agrees that it is important to work with

USDA on this issue given EPA's authority to regulate pesticides. EPA

and USDA will continue discussions on biological control agents and

microbial pesticides to ensure that there is appropriate regulation of

these applications, while minimizing potentially duplicative reviews

and accelerating availability of safer pest management technologies.

No comments were received from the U.S. Congress during the 60-day

comment period.

VI. Public Record

EPA has established a public record for this rulemaking (docket

control number OPP-50668A). The record includes all information

considered by EPA in developing this final rule. The record includes

the following items:

1. All prior Federal Register Notices, and supporting public

dockets, relating to the regulation of microbial pesticides under

FIFRA. These include:

a. The 1984 Statement of Interim Policy on Small-Scale Testing of

Nonindigenous and Genetically Altered Microbial Pesticides (49 FR

40659, October 17, 1984).

b. The December 1984 EPA Federal Register Notice on Biotechnology

(49 FR 50856, December 31, 1984).

c. The 1986 Policy Statement (51 FR 23302, June 26, 1986).

d. ``Biotechnology; Request for Comment on Regulatory Approach,''

(54 FR 7027, February 15, 1989).

e. The 1993 Proposed Rule for Microbial Pesticides; Experimental

Use Permits and Notifications (58 FR 5878, January 22, 1993).

2. Public comments submitted in response to each of the above

Notices and the EPA ``Analysis of Comments, Proposed Rule, FIFRA Part

172: Microbial Pesticides; Experimental Use Permits and

Notifications.''

3. ``Principles for Federal Oversight of Biotechnology: Planned

Introduction into the Environment of Organisms With Modified Hereditary

Traits,'' Office of Science and Technology Policy (55 FR 31118, July

31, 1990).

4. ``Exercise of Federal Oversight Within Scope of Statutory

Authority; Planned Introductions of Biotechnology Products into the

Environment,'' Office of Science and Technology Policy (57 FR 6753,

February 27, 1992).

5. Reports of all SAP and BSAC meetings pertaining to this rule.

6. The Regulatory Impact Analysis for this rule.

7. Support documents and reports, including:

a. National Research Council. 1989. ``Field Testing Genetically

Modified Organisms: Framework for Decisions.'' National Academy Press,

Washington, D.C.

b. Tiedje, J.M., R.K. Colwell, Y.L. Grossman, R.E. Hodson, R.E.

Lenski, R.N. Mack, and P.J. Regal. 1989. ``The Planned Introduction of

Genetically Engineered Organisms: Ecological Considerations and

Recommendations.'' Ecology 70:298-315.

c. The President's Council on Competitiveness. 1991. Report on

National Biotechnology Policy, February 1991.

8. Records of all communications between EPA personnel and persons

outside EPA pertaining to the development of this rule. (This does not

include any inter- or intra-agency memoranda, unless specifically noted

in the Index of this docket.)

VII. Regulatory Assessment Requirements

A. Executive Order 12866

Under Executive Order (E.O.) 12866, the Agency must determine

whether the regulatory action is ``significant'' and therefore subject

to all the requirements of the Executive Order (i.e., Regulatory Impact

Analysis, review by the Office of Management and Budget (OMB)). Under

section 3(f), the order defines ``significant'' as those actions likely

to lead to a rule (1) Having an annual effect on the economy of $100

million or more, or adversely and materially affecting a section of the

economy, productivity, competition, jobs, the environment, public

health or safety, or State, local or tribal governments or communities

(``economically significant''); (2) creating serious inconsistency or

otherwise interfering with an action taken or planned by another

agency; (3) materially altering the budgetary impacts of entitlement,

grants, user fees, or loan programs; or (4) raising novel legal or

policy issues arising out of legal mandates, the President's

priorities, or the principles set forth in this Executive Order.

Pursuant to the terms of this Executive Order, EPA has determined that

this rule is ``significant'' because it raises novel policy issues

arising out of legal mandates. As such, this action was submitted to

OMB for review, and any comments or changes made in response to OMB

suggestions or recommendations have been documented in the public

record.

B. Regulatory Flexibility Act

Under the Regulatory Flexibility Act (5 U.S.C. 605 (b)), EPA

certifies that this rule will not have a significant economic impact on

a substantial number of small businesses. This conclusion is based on

the fact that this rule is only the codification, with modification, of

relevant operative provisions of the June 26, 1986 Policy Statement. As

such, this rule will not create any additional impacts on affected

small businesses or other small entities beyond those currently in

effect. In fact, this rule will reduce the number and scope of

microbial pesticides requiring EPA oversight from those covered under

the current policy.

C. Paperwork Reduction Act

The information collection requirements in this final amendment

have been submitted for approval to the Office of Management and Budget

(OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. An

Information Collection Request (ICR) document has been prepared by EPA

(ICR No. 0276.07; OMB control No. 2070-0040) and a copy may be obtained

from Sandy Farmer, Information Policy Branch (MC-2136); U.S.

Environmental Protection Agency; 401 M St., SW.; Washington, DC 20460

or by calling (202) 260-2740.

List of Subjects in 40 CFR Part 172

Environmental protection, Intergovernmental relations, Labeling,

Pesticides and pests, Recordkeeping and reporting requirements,

Research.

Dated: August 19, 1994.

Carol M. Browner,

Administrator.

Therefore, 40 CFR part 172 is amended as follows:

PART 172--[AMENDED]

1. The authority citation for part 172 is revised to read as

follows:

Authority: 7 U.S.C. 136a, 136c, 136f, 136v, and 136w.

2. By revising Sec. 172.3 to read as follows:

Sec. 172.3 Scope of requirement.

(a) An experimental use permit (EUP) is generally required for

testing of any unregistered pesticide or any registered pesticide being

tested for an unregistered use. However, as described in paragraph (b)

of this section, certain of such tests are presumed not to involve

unreasonable adverse effects and, therefore, do not require an EUP.

(b) Except as provided in subpart C of this part or as specifically

determined by the Environmental Protection Agency (EPA), it may be

presumed that EUPs are not required when:

(1) The experimental use of the pesticide is limited to:

(i) Laboratory or greenhouse tests,

(ii) Limited replicated field trials as described in paragraph (c)

of this section to confirm such tests, or

(iii) Other tests as described in paragraph (c) of this section

whose purpose is only to assess the pesticide's potential efficacy,

toxicity, or other properties.

(2) The producer, applicator, or any other person conducting the

test does not expect to receive any benefit in pest control from the

pesticide's use.

(c) For purposes of paragraphs (b)(1)(ii) and (b)(1)(iii) of this

section, the following types of experimental tests are presumed not to

need an EUP:

(1) A small-scale test involving use of a particular pesticide that

is conducted on a cumulative total of no more than 10 acres of land per

pest, except that:

(i) When testing for more than one target pest occurs at the same

time and in the same locality, the 10 acre limitation shall encompass

all of the target pests.

(ii) Any food or feed crops involved in, or affected by, such tests

(including, but not limited to, crops subsequently grown on such land

which may reasonably be expected to contain residues of the tested

pesticides) shall be destroyed or consumed only by experimental animals

unless an appropriate tolerance or exemption from a tolerance has been

established under the Federal Food, Drug, and Cosmetic Act (FFDCA) for

residues of the pesticide.

(2) A small-scale test involving the use of a particular pesticide

that is conducted on a cumulative total of no more than 1 surface acre

of water per pest, except that:

(i) When the testing for more than one target pest occurs at the

same time and in the same locality, the 1 acre limitation shall

encompass all of the target pests.

(ii) Waters which are involved in or affected by such tests are not

used for irrigation purposes, drinking water supplies, or body contact

recreational activities.

(iii) Testing shall not be conducted in any waters which contain or

affect fish, shellfish, plants, or animals taken for recreational or

commercial purposes and used for food or feed, unless an appropriate

tolerance or exemption from a tolerance has been established under the

FFDCA for residues of the pesticide.

(3) Animal treatment tests involving the use of a particular

pesticide that are conducted only on experimental animals which will

not be used for food or feed, unless an appropriate tolerance or an

exemption from a tolerance has been established for animal products and

byproducts under the FFDCA for residues of the pesticide.

(d) The examples in paragraphs (c)(1), (c)(2), and (c)(3) of this

section are not all-inclusive and do not preclude testing in larger

areas or larger numbers of units if the intended use meets the criteria

of paragraph (a) of this section. However, tests which do not come

within the examples in paragraphs (c)(1), (c)(2), and (c)(3) of this

section, absent a specific determination by EPA to the contrary,

require an EUP. Subdivision I of the Pesticide Assessment Guidelines

provides guidance on the procedures, data requirements, and general

aspects pertaining to the issuance and use of EUPs. Persons intending

to conduct tests who are uncertain whether the testing may be conducted

without a permit may submit a request for determination to the

Registration Division (7505C), Office of Pesticide Programs,

Environmental Protection Agency, 401 M St., SW., Washington, DC 20460,

Telephone: (703-305-5447). Such a request shall include the information

listed in Sec. 172.4(b)(1)(ii) and (b)(1)(iii) and in the case of an

unregistered product, the information in Sec. 172.4(b)(3)(i).

(e) Notwithstanding paragraphs (b) through (d) of this section, EPA

may, on a case-by-case basis, require that certain testing of a

particular pesticide or class of pesticides be carried out under an

EUP, if it is determined that such EPA oversight is warranted. If EPA

determines that an EUP is required, it will notify the developer of the

pesticide of the need for an EUP and provide opportunity for comment or

objections before imposing the requirement.

(f) No EUP is required for a substance or mixture of substances

being put through tests for the sole purpose of gathering data required

for approval of such substance or mixture under the FFDCA (21 U.S.C.

301 et seq.) as:

(1) A ``new drug'' (21 U.S.C. sec. 321(p) and sec. 355).

(2) A ``new animal drug'' (21 U.S.C. sec. 321(w) and sec. 360(b)),

or

(3) An ``animal feed'' (21 U.S.C. sec. 321 (x)) containing a ``new

animal drug'' (21 U.S.C. sec. 360(b)).

(g) Paragraph (f) of this section shall not apply when a purpose of

such test is to accumulate information necessary to register a

pesticide under section 3 of the Act.

3. By adding a new subpart C to read as follows:

Subpart C--Notification for Certain Genetically Modified Microbial

Pesticides

Sec.

172.43 Definitions.

172.45 Requirement for a Notification.

172.46 Submission of a Notification.

172.48 Data requirements for a Notification.

172.50 Response to a Notification.

172.52 Notification exemption process.

172.57 Submission of information regarding potential

unreasonable adverse effects.

172.59 Enforcement.

Subpart C--Notification for Certain Genetically Modified Microbial

Pesticides

Sec. 172.43 Definitions.

Terms used in this subpart shall, with the exception of those

defined below, have the meaning set forth in the Act and in Sec. 172.1.

``Containment and inactivation controls'' means any combination of

mechanical, procedural, or biological controls designed and operated to

restrict environmental release of viable microorganisms from a

facility.

``Deliberately modified'' means the directed addition,

rearrangement, or removal of nucleotide sequences to or from genetic

material.

``Introduction of genetic material'' means the movement of

nucleotide sequences into a microorganism, regardless of the technique

used.

``Inversions of genetic material'' means the replacement of an

internal section of a chromosome in the reverse orientation.

``Microbial pesticide'' means any pesticide whose active ingredient

is a microorganism intended for preventing, destroying, repelling, or

mitigating any pest, or intended for use as a plant regulator,

defoliant, or desiccant.

``Microbial pesticides resulting from rearrangements'' means a

microbial pesticide resulting from translocations or inversions of

genetic material.

``Microorganism'' means a bacterium, fungus, alga, virus, or

protozoan.

``Nonindigenous microbial pesticide'' means a microbial pesticide

brought into one of the following geographic areas from outside that

area:

(1) The continental United States, including Alaska, and the

immediately adjoining countries (i.e., Canada and Mexico).

(2) The Hawaiian Islands.

(3) The Caribbean Islands including Puerto Rico and the U.S. Virgin

Islands.

``Pesticidal property'' means a characteristic exhibited by a

microorganism that contributes to the intentional use of the

microorganism to prevent, destroy, repel, or mitigate a pest or to act

as a plant regulator, defoliant, or desiccant.

``Single genome'' means the sum total of chromosomal and

extrachromosomal genetic material of an isolate and any descendants

derived under axenic culture conditions from that isolate.

``Small-scale test'' means the experimental use of a microbial

pesticide in a facility such as a laboratory or greenhouse, or use in

limited replicated field trials or other tests as described in

Sec. 172.3(c).

``Test'' or ``testing'' means any use of a microbial pesticide

consistent with section 5 of the Act, including limited replicated

field trials and associated activities.

``Translocations of genetic material'' means a chromosomal

configuration in which part of a chromosome becomes attached to a

different chromosome, or inserts in a different location on the same

chromosome.

Sec. 172.45 Requirement for a Notification.

(a) Who must submit a Notification. Notwithstanding Sec. 172.3, any

person who plans to conduct small-scale testing of a type of microbial

pesticide identified in paragraph (c) of this section must submit a

Notification to EPA and obtain prior approval for either of the

following tests:

(1) Small-scale tests that involve an intentional environmental

introduction of that microbial pesticide.

(2) Small-scale tests performed in a facility without adequate

containment and inactivation controls as provided in paragraph (e) of

this section.

(b) Alternative to Notification. In lieu of a Notification, any

person required to submit a Notification under paragraph (a) of this

section may submit an application for an experimental use permit (EUP)

to EPA for approval.

(c) Small-scale testing that requires a Notification. As provided

in paragraph (a) of this section, and notwithstanding any other

approval by any governmental entity, EPA review and approval are

required prior to the initiation of any small-scale test involving

either of the following microbial pesticides:

(1) Microbial pesticides whose pesticidal properties have been

imparted or enhanced by the introduction of genetic material that has

been deliberately modified.

(2) Nonindigenous microbial pesticides that have not been acted

upon by the U.S. Department of Agriculture (i.e., either by issuing or

denying a permit or determining that a permit is unnecessary; or a

permit is not pending with the USDA).

(d) Small-scale testing that does not require a Notification. (1)

Testing conducted with microbial pesticides identified in paragraph (c)

of this section, but made exempt pursuant to Sec. 172.52, does not

require a Notification. The following microbial pesticides (or classes

of pesticides) are exempt from the notification requirement in

paragraph (a) of this section:

(i) Microbial pesticides resulting from deletions or rearrangements

within a single genome that are brought about by the introduction of

genetic material that has been deliberately modified.

(ii) [Reserved]

(2) Testing conducted in a facility with adequate containment and

inactivation controls, as provided in paragraph (e) of this section,

does not require a Notification.

(e) Selection and use of containment and inactivation controls. (1)

Selection and use of containment and inactivation controls for a

particular microbial pesticide shall take into account the following:

(i) Factors relevant to the microbial pesticide's ability to

survive in the environment.

(ii) Potential routes of release in air, solids, and liquids; in or

on waste materials and equipment; in or on people (including

maintenance and custodial personnel); and in or on other organisms such

as insects and rodents.

(iii) Procedures for transfer of materials between facilities.

(iv) Plans for routine or emergency clean-up and test termination.

(2) For purposes of paragraph (e)(1) of this section, EPA will

presume that compliance with the containment provisions of the National

Institutes of Health (NIH) ``Guidelines for Research Involving

Recombinant DNA Molecules'' (51 FR 16958, May 7, 1986) constitutes

selection and use of adequate containment and inactivation controls.

(3) The selection of containment and inactivation controls shall be

approved by an authorized official of the organization that is

conducting the test prior to commencement of the test.

(4) Records shall be developed and maintained describing the

selection and use of the containment and inactivation controls,

including contingency plans for emergency clean-up and test

termination, that will be used during the test. These records shall be

available for inspection at the test facility. In addition, these

records shall be submitted to EPA at EPA's request and within the time

frame specified in EPA's request.

(5) Subsequent to any EPA review of the containment/inactivation

controls selected under paragraph (e)(1) of this section, changes to

the controls necessary to prevent unreasonable adverse effects must be

made upon EPA request. Failure to comply with EPA's request shall

result in automatic revocation of the exemption from the requirement to

submit a Notification.

Sec. 172.46 Submission of a Notification.

(a) When to submit a Notification. A Notification shall be

submitted for approval at least 90 days prior to the initiation of the

proposed test.

(b) Where to submit a Notification. A Notification shall be

submitted to the Registration Division (7505C), Office of Pesticide

Programs, Environmental Protection Agency, 401 M St.,SW., Washington,

DC 20460, and clearly marked ``ATTN: Biotechnology Notification

Review.''

(c) How to format a Notification. A Notification submitted under

this section must comply with the following procedures, but is not

required to comply with the format and other provisions governing

submission of data in Secs. 158.32 and 158.33 of this chapter. However,

because data submitted with the Notification may subsequently be used

to support other regulatory actions (e.g., used in EUP or registration

applications), it is recommended that such data comply with EPA

requirements in Secs. 158.32 and 158.33 of this chapter.

(1) Each Notification must be accompanied by a transmittal document

that clearly identifies the EPA action supported as a Biotechnology

Notification Review.

(2) Five copies of each Notification must be submitted to EPA.

(3) Any claims of confidentiality for information submitted in the

Notification must be made as described in paragraph (d) of this

section.

(d) How to make confidential business information (CBI) claims in a

Notification. Although it is strongly recommended that the submitter

minimize the amount of data and other information claimed as CBI, a

submitter may assert a claim of confidentiality for all or part of the

information submitted to EPA in a Notification (See part 2, Subpart B

of this chapter). To assert such a claim, the submitter must comply

with the following procedures:

(1) Any claim of confidentiality must accompany the information at

the time the information is submitted to EPA. Failure to assert a claim

at that time will be considered a waiver of confidentiality for the

information submitted, and the information may be made available to the

public, subject to section 10(g) of the Act, with no further notice to

the submitter.

(2) Of the five copies of the Notification required by paragraph

(c) of this section, four copies must be complete with the information

that is claimed confidential clearly marked in the manner described in

Sec. 2.203(b) of this chapter. All information claimed as confidential

must be deleted from the fifth copy, but it must be otherwise complete.

The first page of the fifth copy must be marked ``Contains no

information claimed as confidential.'' EPA may include the fifth copy

in a public file without further notice. EPA will consider incomplete a

Notification containing information claimed as CBI that is not

submitted in accordance with this paragraph and will suspend the review

period on the Notification until such procedures are followed.

(3) Any claim of confidentiality must be accompanied, at the time

the claim is made, by comments substantiating the claim and explaining

why the submitter believes that the information should not be

disclosed. The submitter should refer to Sec. 2.204(e)(4) of this

chapter for points to address in the substantiation. If such comments

are themselves claimed confidential and are marked confidential when

submitted to EPA, they will be treated as such in accordance with

Sec. 2.205(c) of this chapter. EPA will consider incomplete all

Notifications containing information claimed as CBI that are not

accompanied by substantiation, and will suspend the review period on

such Notifications until the required substantiation is provided.

(4) EPA will disclose information that is subject to a claim of

confidentiality asserted under this section only to the extent and by

means of the procedures set forth in section 10 of the Act, in this

subpart, and in part 2 of this chapter.

Sec. 172.48 Data requirements for a Notification.

This section identifies the data and information to be included in

each Notification. When specific information is not submitted, an

explanation of why it is not practical or necessary to provide the

information is to be provided.

(a) The identity of the microorganism which constitutes the

microbial pesticide including:

(1) Summary of data supporting the taxonomic designation and its

interpretation.

(2) Means and limit of detection using sensitive and specific

methods (e.g., note the use of any markers that are used to distinguish

the introduced population from native microorganisms). Introduction

into the microbial pesticide of a unique genetic marker is encouraged.

(b) Description of the natural habitat of the parental strain of

the microbial pesticide including information on:

(1) Physical and chemical features important to growth and survival

of the parental strain.

(2) Biological features of the parental strain that would have an

impact on the microbial pesticide (e.g., presence of phages that infect

the microorganism).

(3) Competitors.

(c) Information on the host range of the microbial pesticide, if

any, with an assessment of infectivity and pathogenicity to nontarget

organisms.

(d) Information on survival and the ability of the microbial

pesticide to increase in numbers (biomass) in the environment (e.g., in

the environment into which the microbial pesticide will be introduced,

and in substantially different environments that may be in the

immediate vicinity). These data may be derived from the scientific

literature or from tests conducted in a laboratory or other containment

facility.

(e) The identity of possible transmission vectors (e.g., insects).

(f) Data on relative environmental competitiveness compared to the

parental strain of the microbial pesticide.

(g) Description of the methods used to genetically modify the

microbial pesticide.

(h) The identity and location of the gene segments that have been

rearranged or inserted/deleted (host source, nature, and, for example,

base sequence data, or restriction enzyme map of the genes).

(i) Information on the control region of the genes, and a

description of the new traits or characteristics that are expressed.

(j) Data on potential for genetic transfer and exchange with other

organisms and on genetic stability of any inserted sequences in the

microbial pesticide.

(k) A description of the proposed testing program including:

(1) The purpose or objectives of the proposed testing.

(2) Designation of the pest organisms involved (common and

scientific names).

(3) The States in which the proposed program will be conducted.

(4) The exact location of the test sites (including proximity to

residences and human activities, surface water, etc.).

(5) The crops, fauna, flora, geographical description of sites,

modes, dosage rates, frequency, and situation of application on or in

which the pesticide is to be used.

(6) The total amount of pesticide product proposed for use in the

testing.

(7) The method of application.

(8) A comparison of the natural habitat of the microbial pesticide

with the proposed test site.

(9) The number of acres, structural sites, or animals/plants by

State, to be treated or included in the area of experimental use.

(10) Procedures to be used to protect the test area from intrusion

by unauthorized individuals.

(11) The proposed dates or periods during which the testing program

is to be conducted, and the manner in which supervision of the program

will be accomplished.

(12) Description of procedures for monitoring the microbial

pesticide within and adjacent to the test site during the test.

(13) The method of sanitation or disposal of plants, animals,

soils, farm tools, machinery etc., that will be exposed to the

microbial pesticide during or after the test.

(14) Means of evaluating potential adverse effects and methods of

controlling the microbial pesticide if detected beyond the test area.

(l) A statement of composition for the formulation to be tested,

giving:

(1) The name and percentage by weight (or other suitable units) of

each ingredient, active and inert.

(2) Production methods.

(3) Extraneous microorganisms present as contaminants.

(4) Amount and potency of any toxin present.

(5) Where applicable, the number of viable microorganisms per unit

weight or volume of the product or other appropriate system for

designating the quantity of active ingredient.

(m) Any additional factual information regarding the potential for

unreasonable adverse effects on the environment.

Sec. 172.50 Response to a Notification.

(a) EPA will review and evaluate each Notification as expeditiously

as possible and will make a determination no later than 90 days after

receipt of the complete Notification; however, under no circumstances

shall the proposed test proceed until the submitter has received notice

from EPA of its approval of such test.

(b) For each Notification, EPA may make the following

determinations:

(1) Require additional information from the submitter to assess the

proposed test adequately.

(2) Approve the proposed test.

(3) Approve the proposed test provided that the submitter makes

certain modifications to the test proposal.

(4) Require an EUP for the test.

(5) Disapprove the proposed test because of the potential for

unreasonable adverse effects. Such disapproval by EPA shall be

considered the equivalent of denial of an EUP and the remedies for such

denial provided by Sec. 172.10 are available to the submitter.

(c) If the proposed test is approved by EPA, then the submitter

shall perform the test in the same manner described in the

Notification, subject to any requirements imposed under paragraph

(b)(3) of this section.

Sec. 172.52 Notification exemption process.

(a) Initiation of the exemption process. Pesticides may be added to

the list of exemptions in Sec. 172.45(d) by rule at EPA's initiative or

in response to a petition submitted in accordance with paragraph (b) of

this section.

(b) Petitions for exemption from the requirement for a Notification

--(1) Who may submit a petition. Any person may submit a petition

requesting an exemption from the notification requirements of this

subpart for a specific microbial pesticide or class of microbial

pesticides.

(2) Where to submit a petition. All petitions shall be submitted to

the following location: Registration Division (7507C), Office of

Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,

Washington, DC 20460.

(3) Content of petition. Each petition shall contain the following:

(i) Name and address of petitioner and name, address, and telephone

number of a person who may be contacted for further information.

(ii) Description of the exemption requested, including the specific

microbial pesticide or class of microbial pesticides to be tested under

the petition for exemption.

(iii) Basis for the petitioner's contention that the specific

microbial pesticide or class of microbial pesticides meet the criteria

of Sec. 172.3 for small-scale tests of pesticides that do not require

an EUP.

(iv) Discussion of the extent to which the microbial pesticide or

class of microbial pesticides covered by the petition differ from

microbial pesticides that are already registered or subject to an EUP

under the Act.

(4) Administrative action on a petition. EPA will review and

evaluate petitions as expeditiously as possible and may request further

information from the petitioner to assess the proposed exemption

adequately. No later than 180 days after the submission of a petition,

or 90 days after the last submission of additional information by the

petitioner, whichever is later, EPA will take one of the following

actions with respect to the petition:

(i) Grant the petition and publish a notice of proposed rulemaking

in the Federal Register for a 45-day comment period proposing the

exemption requested by the petitioner.

(ii) Grant the petition and publish a notice of proposed rulemaking

in the Federal Register for a 45-day comment period proposing an

exemption under such terms and conditions as EPA deems appropriate.

(iii) Deny the petition and provide the petitioner with a written

explanation of EPA's decision.

(5) Confidential business information (CBI) claims. To assert a

claim of confidentiality, the petitioner must comply with the

applicable procedures in Sec. 172.46(d).

(6) Supplements, amendments, and withdrawals. The petitioner may

supplement, amend, or withdraw his or her petition in writing without

EPA approval at any time prior to the granting or denial of the

petition under paragraph (b)(4) of this section. The withdrawal of a

petition shall be without prejudice to the resubmission of the petition

at a later date.

Sec. 172.57 Submission of information regarding potential

unreasonable adverse effects.

Any person using a microbial pesticide in small-scale testing

covered by this subpart who obtains information regarding potential

unreasonable adverse effects on health or the environment must within

30 days of receipt of such information submit the information to EPA,

unless the person has actual knowledge that EPA has been adequately

informed of such information. The requirement to submit information

applies both to those microbial pesticides subject to the notification

requirements under Sec. 172.45(c) and those that are exempt under

Sec. 172.45(d).

Sec. 172.59 Enforcement.

(a) Imminent threat of substantial harm to health or the

environment. The use of a microbial pesticide in small-scale testing

covered by this subpart (whether subject to the notification

requirements of Sec. 172.45(c) or exempt under Sec. 172.45(d)) in a

manner that creates an imminent threat of substantial harm to health or

the environment is prohibited, and is considered a violation of section

12(a)(2)(S) of the Act.

(b) EPA response to violations. Under section 14 of the Act, EPA

may seek civil or criminal penalties for violations of the Act. Failure

to comply with the regulations in this part could result in civil or

criminal penalties. Moreover, under sections 14 and 16(c) of the Act,

EPA may at any time take appropriate action against violators to

prevent or otherwise restrain use of a microbial pesticide in small-

scale testing if it is determined that:

(1) Such use would create an imminent threat of substantial harm to

health or the environment that is prohibited under paragraph (a) of

this section; or

(2) The terms or conditions on which approval of the testing was

granted under this Subpart C are violated.

[FR Doc. 94-21358 Filed 8-31-94; 8:45 am]

BILLING CODE 6560-50-F