Document ID: EPA-HQ-OPP-2004-0415-0048
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-10-26T04:00Z

Final Rule for 40 CFR Part 158, Subparts U&V:  Data Requirements for
Biochemical and Microbial Pesticides

Response to Comments Summary

The Agency did receive comments that applied to both biochemical and
microbial pesticide data requirements. 

The issues are discussed as follows:

1. Endangered species assessments

Summary of comments

Incidental to its proposed data requirements for conventional
pesticides, EPA discussed the possibility of future data and information
needs to develop and/or refine risk assessments for endangered species.
EPA did not propose any data requirements specific to endangered species
but described its current level of information and data usage. EPA
requested comment on the value and utility of location and usage
information, and on additional types of research that might yield
greater refinement in risk assessments for endangered species. One
commenter questioned whether the Agency’s endangered species
discussion in the preamble applies only to biochemical and microbial
pesticides or for conventional pesticides as well. Two commenters
indicated the Agency should require toxicity data for surrogate species,
and in particular reptile and amphibian data.

Response to comments

EPA appreciates the responses it received from the commenter on this
topic. As endangered species data requirements were not proposed, EPA
has not responded to the comment as part of this final rule but will
consider them in the context of its ongoing risk assessments. If EPA
finds that it needs to amend part 158 to normalize endangered species
data requirements, the Agency will consider these comments in the
development of a future proposed rule. The Agency has in the past and
will continue to rely on the avian, fish, and invertebrate testing to
indicate the potential toxicity for other non-target species.

2. Product performance

Summary of comments

Without proposing changes to existing product performance data
requirements (§ 158.640), the Agency augmented language for both
biochemical and microbial pesticide data requirements for product
performance with the regulatory text. One commenter indicated that the
Agency requires data for uses other than for public health pests.
Another comment was that EPA’s language in the proposed preamble
required clarification, indicating some products are not as efficacious
as conventional pesticides. Another commenter indicated that the label
should be supported by the efficacy data provided to the Agency.

Response to comments

The Agency agrees that product performance data are required for all
uses, but are only required to be submitted for review at the time of
registration to support public health claims. These provisions, i.e. new
§§ 158.2070 and 158.2160 for biochemical and microbial pesticides,
respectively, are not replacing the data requirement tables in §
158.640, but only adding additional text for clarifying when submission
of product performance data are typically necessary for biochemical and
microbial pesticides. EPA is finalizing the language as proposed. 

EPA agrees with the commenters that the data must be submitted to
support the label claims for registration of these public health
pesticides. EPA did not propose to change the existing data requirements
and neither the existing data table nor the proposed regulating text
would require the applicant to submit data comparing product efficacy.
The Agency agrees with the commenter that there should not have been a
distinction between biochemical and conventional pesticides in their
efficacy, but that the efficacy varies between all pesticides and their
products, and with respect to public health claims, the label should
reflect the efficacy of the product.

3. Addition of passerine species and appropriate nomenclature of test
species within non-target ecological effects data requirements

Summary of comments

The Agency proposed to add another possible test species for the avian
acute oral toxicity study, the red-winged blackbird, a passerine
species. EPA also proposed to continue to include the identification of
other possible avian test species (bobwhite quail and mallards), and for
fish species (rainbow trout and bluegill sunfish). One commenter
requested that EPA revise the word ‘‘songbird’’ to read
‘‘passerine.’’ Another commenter indicated that the Agency
should require historical control data on the red-winged blackbird for
the past 5 years to develop a baseline for future testing on the
species.

Response to comments

The Agency recommends that if the registrant and the Agency deem it
appropriate to test a passerine species, the registrant meet with the
Agency before initiating the study to determine if the passerine species
is appropriate based on the current scientific methodology and use
pattern of the proposed registration. This test species may be required
if the use pattern would result in higher exposure to this order of
avian species. In addition, after reviewing the comments submitted, the
Agency decided to discontinue specific species designation for all
non-target organisms. The test notes in the final rule only indicate
upland game, waterfowl, or passerine species for avian concerns and
coldwater and warmwater fish for fish concerns.

In summary, passerine species data are still conditionally required in
the final rule for both biochemical and microbial pesticides. The
individual test notes indicate when these data would be appropriate.
With respect to developing test data over 5 years, EPA will consider
such protocol concerns when it revises its test guidelines. The Agency
is finalizing the proposed addition of the passerine species.

4. Reptile/amphibian testing

Summary of comments

The Agency did not propose to require separate reptile testing. One
commenter indicated that amphibian testing needed to be included in the
data requirements for evaluating effects to non-target ecological
species.

Response to comments

The Agency has in the past and will continue to rely on avian, fish, and
invertebrate testing to indicate the potential toxicity for other
non-target species. Additional information will be required as needed.

5. New studies providing little or no practical value

Summary of comments

EPA proposed to require a few newly codified studies, i.e.,
applicator/user exposure data to refine data requirements, i.e.,
mutagenicity data requirements. One commenter believed the Agency was
using a ‘‘check box’’ approach to requiring data rather than
regulatory need.

Response to comments

The Agency reviewed the data typically submitted or determined to be
necessary to support registration requests received over 7 years.
EPA’s proposed rule was based on that review. In some cases, EPA
proposed new data requirements to codify existing practices and in other
cases EPA proposed to amend test notes, for example, to clarify existing
data requirements. EPA’s analysis and proposed rule were based on
decisions that the data and the modifications to the tables were
necessary. Without more specific comment, EPA can not further respond to
this comment.

6. Providing adequate guidance when data are required/use pattern

Clarification

Summary of comments

When EPA revised the proposed rule, there was a concerted effort to
provide informative test notes, which would clarify when data are
required. However, a commenter did not provide specific data requirement
issues but indicated the Agency was not clear on the expanded use
patterns. This commenter also indicated that the waiver policy was
unclear.

Response to comments

As indicated in the preamble for the final rule, the Agency provided a
section on ‘‘Consultation with Applicants’’ in the proposal
which the commenter indicated was missing. It is a description of the
pre-submission and post-submission process within the Agency encouraging
the registrant to meet with the Agency as early as possible in the
process in order to minimize delays and avoid unnecessary test costs. In
most cases the numbers of use patterns were actually combined for
transparency, i.e., food use and non-food use. The test notes provided
for biochemical and microbial pesticides are more detailed than in the
current regulation.

7. There are no accepted protocols or guidelines for many data
requirements

Summary of comments

One commenter indicated that the Agency published data requirements
without supporting published guidelines. This commenter cited the
environmental fate guidelines.

Response to comments

The Agency proposed newly codified data requirements guidelines for
applicator/user exposure data; particle size, fiber length, and diameter
distribution; product use information; and companion animal safety.
There were also some new guideline numbers identified for environmental
fate data requirements. All of these data requirements have guidelines
available. At the time of the publication of the proposed rule, the
environmental fate guidelines were not finalized. The Agency did provide
the existing guideline numbers that denoted the test methods at that
time. The environmental fate guidelines (835 series) are anticipated to
be published this year. In the interim, we have provided the current
guideline numbers and the proposed guideline numbers in the data table.
Once the final guidelines are published, the Agency will amend the
guideline references in the data tables, as appropriate. As indicated
previously, the guideline references are provided in part 158 as
information/guidance to applicants. As with existing guidelines, an
applicant is not compelled to use the cited draft guidelines, but may
choose to use an alternative methodology that will provide the
information needed to complete the risk assessment.

8. Codifying existing practice

Summary of comments

EPA made revisions, which included codified, newly codified, or new data
requirements. One commenter stated that the Agency was mistaken in its
distinction between ‘‘new requirements’’ and ‘‘newly
codified requirements.’’ The commenter provided the example that the
immunotoxicity study (guideline 885.3550), is a new requirement, as no
such data requirement previously existed, regardless of whether the
guideline was available.

Response to comments

In developing this rule, the Agency received the data typically
submitted or determined to be necessary to support registration requests
received over the last 7 years. If the data had never been submitted to
support registration, then the data requirement would be considered new.
However, if the data had been submitted or required to support recent
registrations, and were not listed in the 1984 promulgated rule, then
the Agency would classify that data requirement as newly codified. 

As for the specific example of immunotoxicity, these data are currently
required and are being submitted to support existing registrations and
is currently required in 40 CFR 158.690. EPA has been requiring or
applicants have been submitting immunotoxicity data based on specific
conditions, consistent with the 880.3550 guideline in more recent years,
so the Agency classified this as a newly codified data requirement as a
Tier II and Tier III data requirement.

9. Animal welfare concerns

Summary of comments

The Agency received comment on individual studies suggesting alternative
approaches to substitute for them. This comment was designed to
recommend reducing the number of animals used in studies.

Response to comments

All new studies required under today’s rule for biochemical and
microbial pesticides were all standard guideline studies that are also
part of the data requirements for conventional pesticides. The EPA’s
Biopesticides and Pollution

Prevention Division (BPPD) uses, where possible, the same studies that
are used for conventional pesticides to allow for similar risk
assessment procedures; to support the validated, time-tried, methods; to
reduce the complexity of studies that testing laboratories must provide;
to avoid excessive expenses for the typically small businesses that
market these biopesticides; and to avoid instituting novel,
non-validated procedures for a relatively small group of pesticides. 
The Agency is committed to avoiding unnecessary animal testing, while
taking into consideration principles of sound science and the
requirements of FIFRA to protect humans and the environment. The
complete response to these comments also applies to microbial and
biochemical pesticide data requirements. BPPD will consider test methods
that do not use animals and is working with the rest of the Agency to
move towards these goals. In addition, BPPD will continue to be
available for pre-submission and post-submission meetings to allow an
applicant to submit only those data needed to support that particular
product.