[Federal Register Volume 61, Number 55 (Wednesday, March 20, 1996)]
[Rules and Regulations]
[Pages 11313-11315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-6730]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP 4F4398/R2209; FRL-5352-2]
RIN 2070-AB78


Dried Fermentation Solids and Solubles of Myrothecium Verrucaria; 
Exemption From the Requirement of a Tolerance on All Food Crops and 
Ornamentals

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule establishes an exemption from the requirement for a 
tolerance for residues of killedMyrothecium verrucaria in or on all 
food crop and ornamental commodities when applied pre-planting, pre-
seeding or post-planting in accordance with good agricultural 
practices. This exemption was requested by Abbott Laboratories. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of this nematicide on food crops and ornamentals.


[[Page 11314]]


EFFECTIVE DATE: This regulation becomes effective March 20, 1996.

ADDRESSES: Written objections and hearing requests, identified by the 
docket number, [PP 4F4398/R2209], may be submitted to: Hearing Clerk 
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., 
Washington, DC 20460. A copy of any objections and hearing requests 
filed with the Hearing Clerk should be identified by the docket number 
and submitted to: Public Response and Program Resources Branch, Field 
Operations Division (7506C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington , DC 20460. 
In person, bring copy of objections and hearing requests to Rm. 1132, 
CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. Fees 
accompanying objections shall be labeled ``Tolerance Petition Fees'' 
and forwarded to: EPA Headquarters Accounting Operations Branch, OPP 
(Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251. An electronic 
copy of objections and hearing requests filed with the Hearing Clerk 
may be submitted to OPP by sending electronic mail (e-mail) to:opp-
[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 file format 
or ASCII file format. All copies of electronic objections and hearing 
requests must be identified by the docket number [PP 4F4398/R2209] . 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. Additional 
information on electronic submissions can be found below in this 
document.

FOR FURTHER INFORMATION CONTACT: By mail: Cindy Schaffer, Product 
Manager (PM) Biopesticides and Pollution Prevention Division (7501W), 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
(703) 308-8272; e-mail: [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of February 8, 1995 
(60 FR 7539), EPA issued a notice (PF-617; FRL-4926-4) that Abbott 
Laboratories, Chemical and Agricultural Products Division, 1401 
Sheridan Road, North Chicago, IL 60064, had submitted pesticide 
petition (PP) 4F4398 to EPA proposing to amend 40 CFR part 180 by 
establishing a regulation pursuant to section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to exempt from the 
requirement of a tolerance the residues of the nematicide dried 
fermentation solids and solubles ofMyrothecium verrucaria in or on food 
crops and ornamental commodities when applied in accordance with good 
agricultural practices.
    There were no adverse comments, or requests for referral to an 
advisory committee received in response to the notice of filing of PP 
4F4398.

Myrothecium Verrucaria Natural Occurance

    Myrothecium verrucaria is a soil hyphomycete fungus originally 
isolated from a nematode cadaver. This organism has been found on plant 
material, cellulosic matter, running and still water, and in various 
cultivated and non-cultivated soils.

Toxicology Assessment

    The data submitted in the petition and all other relevant material 
have been evaluated. The toxicological data considered in support of 
the exemption from the requirement of a tolerance include: an acute 
oral toxicity study, an acute dermal toxicity study, an acute 
intratracheal toxicity study, and a primary dermal irritation study.
    The results of these studies indicated that the organism was not 
toxic to test animals when administered via oral, dermal, 
intratracheal, or inhalation routes.
    Mild ocular irritation observed in the eye irritation study 
dissipated within 3 days; very slight skin irritation noted immediately 
following exposure to the compound dissipated within 3 days. There have 
been no reports of hypersensitivity related to the active ingredient. 
All of the toxicity studies submitted are considered acceptable.
    The toxicology data provided are sufficient to demonstrate that 
there are no foreseeable human health hazards likely to arise from the 
use of killedMyrothecium verrucaria on all food crops and ornamental 
commodities in accordance with good agricultural practices.
    Residue data requirements shall apply to microbial pesticides when 
Tier II or III toxicology data are required, as specified in 40 CFR 
158.740 and are therefore not relevant to this petition. The data 
submitted demonstrate that this biological control agent is not toxic 
to humans at a Tier I level by dietary exposure. No enforcement actions 
are expected. Therefore, the requirement for an analytical method for 
enforcement purposes is not applicable to this exemption request. This 
is the first exemption from the requirement of a tolerance for this 
killed biological control agent.
    Submitted Data-Acute Toxicology for driedMyrothecium verrucaria 
solids and solubles:
     Acute Oral LD50 > 5,000 mg/kg
    Acute Dermal LD50 > 2,000 mg/kg
     Acute Inhalation LD50 > 5.99 mg/L
    Acute Intratracheal LD50 > 50 mg/kg
    Primary Dermal Irritation - Mild Irritant
    Primary Eye Irritation - Slight Irritant

Conclusion

    Based on the low toxicity of driedMyrothecium verrucaria solids and 
solubles, the Agency concludes that establishment of a tolerance is not 
necessary to protect the public health. Therefore, the exemption from 
tolerance is established as set forth below.
    Any person adversely affected by this regulation may, within 30 
days after publication of this document in the Federal Register, file 
written objections to the 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 above (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 issue(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 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 issue(s) in the manner sought by the requestor would be 
adequate to justify the action requested (40 CFR 178.32).
    A record has been established for this rulemaking under the docket 
number [PP 4F4398/R2209] (including any comments and data submitted 
electronically). A public version of this

[[Page 11315]]

record, including printed, paper versions of electronic comments, which 
does not include any information claimed as CBI, is available for 
inspection from 8 a.m. to 4:30 p.m., Monday through Friday, excluding 
legal holidays. The public record is located in Room 1132 of the Public 
Response and Program Resources Branch, Field Operations Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
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 which 
will also include all comments submitted directly in writing. The 
official rulemaking record is the paper record maintained at the 
address in ``ADDRESSES'' at the beginning of this document.
    Under Executive Order 12866 (58 FR 51735, October 4, 1993), 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 sector of the economy, productivity, 
competition, jobs, the environment, public health or safety, or State, 
local or tribal governments or communities (also known as 
``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 not ``significant'' and is therefore not subject to 
OMB review.
    Pursuant to the requirements of the Regulatory Flexibility Act 
(Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator 
has determined that regulations establishing new tolerances or raising 
tolerance levels or establishing exemptions from tolerance requirements 
do not have a significant economic impact on a substantial number of 
small entities. A certification statement to this effect was published 
in the Federal Register of May 4, 1981 (46 FR 24950).
     Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 
Pub.L. 104-4, establishes requirements for Federal agencies to assess 
the effects of their regulatory actions on State, local, and tribal 
governments and the private sector. Under section 202 including a cost-
benefit analysis, for proposed and final rules with ``Federal 
mandates'' that may result in expenditures to State, local, and tribal 
governments, in the aggregate, or to the private sector, of $100 
million or more in any one year. Before promulgating an EPA rule for 
which a written statement is needed, consider a reasonable number of 
regulatory alternatives and adopt the least costly, most cost-effective 
or least burdensome alternative that achieves the objectives of the 
rule. The provisions of section 205 do not apply when they are 
inconsistent with applicable law. Moreover, section 205 allows EPA to 
adopt an alternative other than the least costly, most cost-effective 
or least burdensome alternative if the Administrator publishes with the 
final rule an explanation why that alternative was not adopted. Before 
EPA establishes any regulatory requirements that may significantly or 
uniquely affect small governments, enabling timely input in the 
development of EPA regulatory proposals with significant Federal 
intergovernmental mandates, and informing, educating, and advising 
small governments on compliance with the regulatory requirements.
    Today's rule contains no Federal mandates (under the regulatory 
provisions of Title II of the UMRA) for State, local or tribal 
governments or the private sector. The rule imposes no enforceable duty 
on any State, local or tribal governments or the private sector. Thus, 
today's rule is not subject to the requirements of sections 202 and 205 
of the UMRA.
    In addition, EPA has determined that this rule contains no 
regulatory requirements that might significantly or uniquely affect 
small governments because the rule imposes no regulatory requirements 
on any party.

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: February 29, 1996.

Daniel M. Barolo,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I, 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 180.1163 is added to subpart D to read as follows:


Sec. 180.1163  Killed Myrothecium verrucaria; exemption from the 
requirement of a tolerance.

    KilledMyrothecium verrucaria is exempted from the requirement of a 
tolerance in or on all raw agricultural commodities when applied as a 
pre-seed or pre- or post-planting soil treatment alone or mixed with 
water and the mixed suspension be applied through drip or border 
irrigation systems at a rate not to exceed 20 to 40 lbs/acre and the 
indicator mycotoxin levels do not exceed 15 ppm.

[FR Doc. 96-6730 Filed 3-19-96; 8:45 am]
BILLING CODE 6560-50-F