[Federal Register Volume 63, Number 132 (Friday, July 10, 1998)]
[Rules and Regulations]
[Pages 37286-37289]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18277]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300665; FRL-5794-3]
RIN 2070-AB78


Gliocladium Catenulatum Strain J1446; Exemption from the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule establishes an exemption from the requirement of a 
tolerance for residues of the biological pesticide Gliocladium 
catenulatum strain J1446 in or on all agricultural commodities. Kemira 
Agro Oy submitted a petition to EPA under the Federal Food, Drug and 
Cosmetic Act as amended by the Food Quality Protection Act of 1996 
requesting the tolerance exemption. This regulation eliminates the need 
to establish a maximum permissible level for residues of Gliocladium 
catenulatum strain J1446.
DATES: This regulation is effective July 10, 1998. Objections and 
requests for hearings must be received by EPA on or before September 8, 
1998.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number [OPP-300665], 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 Petition 
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-300665], 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-300665]. 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: Susanne Cerrelli, c/o Product 
Manager (PM) 90, Biopesticides and Pollution Prevention Division 
(7511C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460, Office location and telephone 
number, and e-mail address: CM #2 Rm. 902 W48, 1921 Jefferson Davis 
Hwy., Arlington, VA, (703) 308-8077, e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of June 25, 1997 (62 
FR 34271)(FRL-5721-7), EPA issued a notice pursuant to section 408(d), 
of the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), 
announcing the filing of a pesticide tolerance petition by Kemira Agro 
Oy (PP 7F4137). The notice contained 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 Food 
Quality Protection Act (FQPA) of 1996. The petition requested that 40 
CFR part 180 be amended by establishing an exemption from the 
requirement of a tolerance for residues of the biological pest control 
agent Gliocladium catenulatum strain J1446. There were no comments 
received in response to the notice of filing.
    The data submitted in the petition and other material have been 
evaluated. The toxicology data requirements in support of this 
exemption from the requirement of a tolerance were satisfied via 
submitted data.

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 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...'' Additionally, 
section 408(b)(2)(D)(v) requires that the Agency consider ``available 
information'' concerning the cumulative effects of a particular 
pesticide's residues and ``other substances that have a common 
mechanism of toxicity.''
    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 use in residential settings.

II. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the

[[Page 37287]]

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 Gliocladium catenulatum 
strain J1446 is of low toxicity. Acute oral toxicity/pathogenicity, 
dermal irritation and eye irritation were classified toxicity category 
IV. Acute oral toxicity/pathogenicity limit test and acute pulmonary 
toxicity/pathogenicity tests were classified category III. Gliocladium 
catenulatum strain J1446 did not survive, replicate, infect, or produce 
disease in test animals injected with a single high dose of this 
microbial agent. No mechanism of toxicity was identified for 
Gliocladium catenulatum, therefore a common mechanism of human toxicity 
with other agents is not indicated, so no cumulative effects are 
considered.

III. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 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).
    1. Dietary exposure. (a) Food. The use of Gliocladium catenulatum 
strain J1446 is not expected to result in any new dietary exposure to 
this organism. Fungi such as Gliocladium catenulatum strain J1446 are 
ubiquitous in the agricultural environment. It is anticipated that the 
concentrations of Gliocladium catenulatum on treated plants may be 
elevated immediately after application but will rapidly decline to 
environmental background levels. The risks anticipated for dietary 
exposure are considered minimal because no signs of toxicity were 
observed in the acute oral toxicity/pathogenicity studies (Toxicity 
Category IV).
    (b) Drinking water. Gliocladium catenulatum strain J1446 is a 
naturally-occurring fungus and is widespread in the environment 
throughout the world. Gliocladium catenulatum is not known as an 
aquatic fungus, and therefore is not expected to proliferate in aquatic 
habitats. Moreover, Gliocladium catenulatum is not considered to be a 
risk to drinking water. Drinking water is accordingly not being 
screened for Gliocladium catenulatum as a potential indicator of 
microbial contamination or as a direct pathogenic contaminant. Both 
percolation through soil and municipal treatment of drinking water 
would reduce the possibility of exposure to Gliocladium catenulatum 
through drinking water. Therefore, the potential of significant 
transfer to drinking water is minimal to non-existent.
    2. Other non-occupational exposure. Other non-occupational exposure 
of Gliocladium catenulatum strain J1446 via residential and indoor uses 
of it as a pesticide, e.g., uses around homes, parks, recreation areas, 
will be minimal to non-existent. The risk from non-occupational 
exposure is considered minimal as there is no evidence of adverse 
effects from oral, dermal or inhalation exposure to this microbial 
agent.
    (a) Dermal exposure. The risks anticipated for this route of 
exposure are considered minimal because no signs of dermal toxicity or 
irritation were observed in the acute dermal toxicity and irritation 
studies (Toxicity Category IV).
    (b) Inhalation exposure. The risks anticipated for this route of 
exposure are considered minimal because this microbial agent did not 
exhibit toxicity and pathogenicity in the acute pulmonary toxicity/
pathogenicity studies. (Toxicity Category III) The anticipated risks 
from aggregate exposure via dermal and inhalation are a compilation of 
two low risk exposure scenarios and are considered negligible.

IV. Other Considerations

    1. Endocrine disrupters. The Agency has no information to suggest 
that Gliocladium catenulatum has an effect on the immune and endocrine 
systems. No specific tests have been conducted with Gliocladium 
catenulatum strain J1446 to determine such effects. However, as is 
expected from a non-pathogenic microorganism, the submitted toxicity/
pathogenicity studies in rodents indicated that following several 
routes of exposure, the immune system is still intact and able to 
process and clear the active ingredient. There are no reports 
indicating that Gliocladium catenulatum strain J1446 produces any 
toxins or antibiotics. Therefore, it is unlikely that this organism 
would have estrogenic or endocrine effects because it has demonstrated 
low mammalian toxicity. 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.
    2. Analytical method. The Agency proposes to establish an 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 Gliocladium catenulatum.
    3. Codex Maximum Residue Level. There are no CODEX tolerances nor 
international tolerance exemptions established for Gliocladium 
catenulatum strain J1446 at this time.

V. Determination of Safety for U.S. Population, Infants and 
Children

    Based on all available information, the Agency concludes that 
Gliocladium catenulatum strain J1446 has no significant toxicity. 
Further, there is no evidence which suggests that aggregate exposure of 
either adults or infants and children to Gliocladium catenulatum leads 
to any harm. Accordingly, EPA concludes that there is a reasonable 
certainty that no harm will result to the U.S. population or any 
significant subpopulation, including infants and children, from 
aggregate exposure under this exemption.
    FFDCA section 408 provides that EPA shall apply an additional ten-
fold margin of exposure (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 margin of exposure will be safe for infants and children. 
Margins of exposure are often referred to as uncertainty (safety) 
factors. In this instance, the Agency believes there is reliable data 
to support the conclusion that this microbial agent is practically non-
toxic to mammals, including infants and children, and, thus, there are 
no threshold effects; therefore, EPA has not used a margin of exposure 
approach to assess the safety of Gliocladium catenulatum strain J1446. 
As a result, the provision requiring an additional margin of exposure 
does not apply.

VI. Objections and Hearing Requests

    The new FFDCA section 408(g) 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) 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 govern the submission of 
objections and hearing requests. These

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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 8, 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.

VII. Public Docket and Electronic Submissions

    A record has been established for this rulemaking under docket 
control number [OPP-300665]. 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 Highway, 
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.

VIII. Regulatory Assessment Requirements

    This final rule establishes an exemption from the tolerance 
requirement under FFDCA section 408(d) 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.

IX. 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 Congress and 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 rule 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: June 24, 1998.

Stephen L. Johnson,

Acting Director, Office of Pesticide Programs.
    Therefore, 40 CFR part 180 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 180.1198 is added to read as follows:


Sec. 180.1198  Gliocladium catenulatum strain J1446; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the microbial pesticide, Gliocladium

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catenulatum strain J1446 when used in or on all food commodities.

[FR Doc. 98-18277 Filed 7-9-98; 8:45 am]
BILLING CODE 6560-50-F