[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]
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