[Federal Register Volume 59, Number 169 (Thursday, September 1, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-21358]


[[Page Unknown]]

[Federal Register: September 1, 1994]


_______________________________________________________________________

Part V





Environmental Protection Agency





_______________________________________________________________________



40 CFR Part 172




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

40 CFR Part 172

[OPP-50668B; FRL-4752-7]
RIN 2070-AB77

 
Microbial Pesticides; Experimental Use Permits and Notifications

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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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