[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
