[Federal Register Volume 63, Number 137 (Friday, July 17, 1998)]
[Rules and Regulations]
[Pages 38495-38498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18986]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300681; FRL-6016-7]
RIN 2070-AB78
Pseudomonas Fluorescens Strain PRA-25; Temporary Exemption From
the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes a temporary exemption from the
requirement of a tolerance for residues of the microbial pest control
agent pseudomonas fluorescens strain PRA-25 on peas, snap beans, sweet
corn, supersweet corn when applied/used on vegetable seeds in the
planter box immediately before planting to reduce seed rot and damping-
off disease cause by Pythium spp. and root rot caused by Aphanomyces
euteiches. Good Bugs, Inc. submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA) as amended by the Food
Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170) requesting the
temporary/time-limited tolerance. This regulation eliminates the need
to establish a maximum permissible level for residues of pseudomonas
fluorescens strain PRA-25. The tolerance will expire on July 31, 2001.
DATES: This regulation is effective July 17, 1998. Objections and
requests for hearings must be received by EPA on or before September
15, 1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300681], must be submitted to: Hearing Clerk
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW.,
Washington, DC 20460. Fees accompanying objections and hearing requests
shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA
Headquarters Accounting Operations Branch, OPP (Tolerance Fees) and
forwarded to: EPA Headquarters Accounting Operations Branch, OPP
(Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any
objections and hearing requests filed with the Hearing Clerk identified
by the docket control number, [OPP-300681], must also be submitted to:
Public Information and Records Integrity Branch, Information Resources
and Services Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
In person, bring a copy of objections and hearing requests to Rm. 119,
CM #2, 1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: opp-docket@epamail.epa.gov. Copies of electronic objections
and hearing requests must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Copies of
electronic objections and hearing requests will also be accepted on
disks in WordPerfect 5.1/6.1 file format or ASCII file format. All
copies of electronic objections and hearing requests must be identified
by the docket number [OPP-300681]. No Confidential Business Information
(CBI) should be submitted through e-mail. Copies of electronic
objections and hearing requests on this rule may be filed online at
many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Linda A. Hollis, c/o Product
Manager (PM) 90, Biopesticides and Pollution Prevention Division
(7511C), Environmental Protection Agency, 401
[[Page 38496]]
M St., SW, Washington, DC 20460. Office location, telephone number, and
e-mail address: Rm. , 9th fl., CM #2 1921 Jefferson Davis Hwy.,
Arlington, VA 22202, (703) 308-8733, e-mail:
hollis.linda@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of February 26, 1997
(62 FR 8735) (FRL-5589-1), EPA issued a notice pursuant to section 408
of the FFDCA, 21 U.S.C. 346a(e) announcing the filing of a pesticide
tolerance petition (PP 7G4803) Good Bugs, Inc. P.O. Box 939, New
Glarus, WI 53574. This notice included a summary of the petition
prepared by the petitioner and this summary contained conclusions and
arguments to support its conclusion that the petition complied with the
FQPA of 1996. The petition requested that 40 CFR part 180 be amended by
establishing a temporary/time-limited tolerance for residues of
pseudomonas fluorescens strain PRA-25.
There were no comments received in response to the notice of filing
The data submitted in the petition and all other relevant material have
been evaluated.
I. Risk Assessment and Statutory Findings
New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) defines ``safe'' to
mean that ``there is a reasonable certainty that no harm will result
from aggregate exposure to the pesticide chemical residue, including
all anticipated dietary exposures and all other exposures for which
there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) requires EPA to give
special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue...'' EPA performs a number of analyses to determine the risks
from aggregate exposure to pesticide residues. First, EPA determines
the toxicity of pesticides. Second, EPA examines exposure to the
pesticide through food, drinking water, and through other exposures
that occur as a result of pesticide us in residential settings.
II. Toxicological Profile
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action and considered its validity, completeness and
reliability and the relationship of this information to human risk. EPA
has also considered available information concerning the variability of
the sensitivities of major identifiable subgroups of consumers,
including infants and children.
All available information indicates that there is a reasonable
certainty that no harm will result from residues of pseudomonas
fluorescens strain PRA-25 on the treated vegetables because of the
ubiquitous nature of this bacterium commonly associated with roots,
stems, leaves and bolossoms of a tremendous variety of plants, soil,
freshwater, raw and refrigerated milk, meat, fish and cheese and
readily isolated from foodstuff and its low toxicity to humans. The
toxicological data submitted with this petition demonstrate a lack of
human health issues and fully support a temporary exemption from the
requirement of a tolererance for psuedomonas fluorescens strain PRA-25.
1. Acute Mammalian Toxicity/Pathogenicity/Infectivity Testing- no
acute toxicity/pathogenicity effects were observed when rats were given
a maximum dose of >1.75 x 108 cfu.
2. Nontarget Organism Testing of Microbial Pest Control Agent -
waivers were submitted for all data requirements for nontarget avian,
freshwater fish and aquatic inveterbrate, insects and honeybees. No
additional nontarget Tier I studies required for intended MPCA use as a
pre-plant seed treatment.
3. Acute Oral Limit Toxicity- no acute toxicity was observed when
rats were administered an acute oral dose of 1.75 x 108 cfu.
III. Aggregate Exposures
In examining aggregate exposure, section 408 of the FFDCA directs
EPA to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from groundwater or surface water and exposure
through pesticide use in gardens, lawns, or buildings (residential and
other indoor uses).
A. Dietary Exposure
Food. Pseudomonas fluorescens strain PRA-25 is a ubiquitous
bacterium that is commonly associated with soil, water, plant roots and
leaves, meat, fish, and dairy products. Therefore, no aditional
exposure to food or drinking water is anticipated by using psuedomonas
fluorescens strain PRA-25.
B. Other Non-Occupational Exposure
Non-dietary exposure such as lawn care, topical insect repellents,
etc. is not anticipated since this microbial pesticide does not have
these uses. Occupational exposure will be mitigated sthrough the use of
proper personal protective equipment
IV. Cumulative Exposure to Substances with Common Mechanisms of
Toxicity
Pseudomonas fluorescens strain PRA-25 does not exhibit a particular
mechanixm of toxicity in common with other agents, therefore,
cumulative effects with any other substance are not considered.
V. Determination of Safety for U.S. Population, Infants and
Children
For the U.S. population, including infants and children,
pseudomonas fluorescens strain PRA-25, EPA concludes that there is
reasonable certainty that no harm will result from aggregate exposure
to the U.S. population, including infants and children, to residues of
psuedomonas fluorescens starin PRA-25. This includes all anticipated
dietary exposures and all other exposures for which there is reliable
information. The Agency has arrive at this conclusion because as
discussed above, no toxicity to mammals has been observed for
pseudomonas fluorescens strain PRA-25 and under reasonable foreseeable
cirucumstances it does not pose a risk. Thus, a temporary tolerance for
pseudomonas fluorescens strain PRA-25 is not necessary to ensure the
saftey of consumers. Therefore, 40 CFR part 180 is amended as set forth
below.
FFDCA section 408 provides that EPA shall apply an additional ten-
fold margin of exposure (MOE)(safety) for infants and children in the
case of threshold effects to account for pre-and post natal toxicity
and the completeness of the database, unless EPA determines that a
different MOE will be safe for infants and children. MOEs are often
referred to as uncertainty (safety) factors. In this microbial agency
is practically non-toxic to mammals, including infancts and children,
and, thus, there are no threshold effects; therefore, EPA has not used
a MOE approach to assess the safety of pseudomonas fluorescens strain
PRA-25. As a result, EPA concludes that this temporary exemption will
be safe without use of an additional margin of safety.
[[Page 38497]]
VI. Other Considerations
A. Endocrine Disruptors
The Agency has no information to suggest the pseudomonas
fluorescens strain PRA-25 will have an effect on the immune and
endocrine systems. The Agency is not requiring information on the
endocrine effects of this biological pesticide at this time; Congress
has allowed 3 years after August 3, 1996, for the Agency to implement a
screening program with respect to endocrine effects.
B. Analytical Method(s)
The Agency proposes to establish a temporary exemption from the
requirement of a tolerance without any numerical limitation; therefore,
the Agency has concluded that an analytical method is not required for
enforcement purposes for pseudomonas fluorescens strain PRA-25.
VII. Objections and Hearing Requests
The new section 408(g) of the FFDCA provides essentially the same
process for persons to ``object'' to a regulation for an exemption from
the requirement of a tolerance issued by EPA under new section
408(d)and as was provided in the old section 408 and in section 409.
However, the period for filing objections is 60 days, rather than 30
days. EPA currently has procedural regulations which governs the
submission of objections and hearing requests. These regulations will
require some modification to reflect the new law. However, until those
modifications can be made, EPA will continue to use those procedural
regulations with appropriate adjustments to reflect the new law.
Any person may, by September 15, 1998, file written objections to
any aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
hearing clerk, at the address given under the ADDRESSES section (40 CFR
178.20). A copy of the objections and/or hearing requests filed with
the hearing clerk should be submitted to the OPP docket for this
rulemaking. The objections submitted must specify the provisions of the
regulation deemed objectionable and the grounds for the objections (40
CFR 178.25). Each objection must be accompanied by the fee prescribed
by 40 CFR 180.33(i). If a hearing is requested, the objections must
include a statement of the factual issues(s) on which a hearing is
requested, the requestor's contentions on such issues, and a summary of
any evidence relied upon by the objector (40 CFR 178.27). A request for
a hearing will be granted if the Administrator determines that the
material submitted shows the following: There is a genuine and
substantial issue of fact; there is a reasonable possibility that
available evidence identified by the requestor would, if established
resolve one or more of such issues in favor of the requestor, taking
into account uncontested claims or facts to the contrary; and
resolution of the factual issues(s) in the manner sought by the
requestor would be adequate to justify the action requested (40 CFR
178.32). Information submitted in connection with an objection or
hearing request may be claimed confidential by marking any part or all
of that information as CBI. Information so marked will not be disclosed
except in accordance with procedures set forth in 40 CFR part 2. A copy
of the information that does not contain CBI must be submitted for
inclusion in the public record. Information not marked confidential may
be disclosed publicly by EPA without prior notice.
VIII. Public Record and Electronic Submissions
A record has been established for this rulemaking under docket
control number [OPP-300681]. A public version of this record, which
does not include any information claimed as CBI, is available for
inspection from 8:30 a.m. to 4 p.m., Monday through Friday, excluding
legal holidays. The public record is located in Room 119 of the Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA 22202.
Electronic comments can be sent directly to EPA at:
opp-docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above, is kept in paper form. Accordingly, in the
event there are objections and hearing request, EPA will transfer any
copies of objections and hearing requests received electronically into
printed, paper form as they are received and will place the paper
copies in the official rulemaking record. The official rulemaking
record is the paper record maintained at the Virginia address in
ADDRESSES at the beginning of this document.
IX. Regulatory Assessment Requirements
This final rule establishes an exemption from the tolerance
requirement under section 408(d) of the FFDCA in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., or impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub.L. 104-4). Nor does it require and prior
consultation as specified by Executive Order 12875, entitled Enhancing
the Intergovernmental Partnership (58 FR 58093, October 28, 1993), or
special considerations as required by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629), February 16,
1994), or require OMB review in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). In additions, since
tolerance exemptions that are established on the basis of a petition
under FFDCA section 408(d), such as the exemption in this final rule,
do not require the issuance of a proposed rule, the requirements of the
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.
Nevertheless, the Agency previously assessed whether establishing
tolerances, exemptions from tolerances, raising tolerance levels or
expanding exemptions might adversely impact small entities and
concluded, as a generic matter, that there is no adverse economic
impact. The factual basis for the Agency's generic certification for
tolerance actions published on May 4, 1981 (46 FR 24950), and was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.
X. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the
[[Page 38498]]
Congress and to the Comptroller General of the United States. EPA will
submit a report containing this rule and other required information to
the U.S. Senate, the U.S. House of Representatives and the Comptroller
General of the United States prior to publication of the rule in the
Federal Register. This is not a ``major rule'' as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 8,1998.
Stephen L. Johnson,
Deputy Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180-- [AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. Section 180.1200 is added to subpart D to read as follows:
Sec. 180.1200 Pseudomonas fluorescens strain PRA-25; temporary
exemption from the requirement of a tolerance.
A temporary exemption from the requirement of a tolerance is
established for residues of the microbial pesticide, pseudomonas
fluorescens strain PRA-25 when used on peas, snap beans and sweet corn
and will expire July 31, 2001.
[FR Doc. 98-18986 Filed 7-16-98; 8:45 am]
BILLING CODE 6560-50-F
