[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: [email protected]. 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: 
[email protected].

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:
    [email protected]


    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