Spodoptera exigua - Tolerance Exemption—Final Rule 4/93
40 CFR Part 180
[PP 2F4040/R1178; FRL-4185-2]
Spod-X Bioinsecticide; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This document establishes an exemption from the requirement
of a tolerance for residues of the microbial pest control agent
Spodoptera exigua nuclear polyhedrosis virus in or on all raw
agricultural commodities. The product Spod-X is an insecticidal
virus product containing the polyhedral inclusion bodies of
Spodoptera exigua nuclear polyhedrosis virus (Family: Baculoviridae).
This exemption was requested by Crop Genetics International.
This rule eliminates the need to establish a maximum permissible
level for residues of Spodoptera exigua nuclear polyhedrosis
EFFECTIVE DATE: Effective on April 28, 1993.
ADDRESSES: Written objections, identified by the document control
number [PP 2F4040/R1178], may be submitted to the Hearing Clerk
(A-110), Environmental Protection Agency, Rm. 3708M, 401 M St.,
SW., Washington, DC 20460.
FOR FURTHER INFORMATION CONTACT: Philip O. Hutton, Product Manager
(PM) 18, Registration Division (H7505C), Office of Pesticide
Programs, Environmental Protection Agency, Rm. 213, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-7690.
SUPPLEMENTARY INFORMATION: In the Federal Register of March
11, 1992 (57 FR 8658), EPA issued a notice that announced Espro,
Inc., (subsequently acquired by Crop Genetics International,
7170 Standard Drive, Hanover, MD 21076), had submitted pesticide
petition (PP) 2F4040 to EPA under section 408(d) of the Federal
Food, Drug, and Cosmetic Act, 21 U.S.C. 346a(d), proposing that
40 CFR part 180 be amended by establishing an exemption from
the requirement of a tolerance for residues of the insecticide
Spod-X containing the polyhedral inclusion bodies of S. exigua
nuclear polyhedrosis virus in or on all raw agricultural commodities
when used to control the beet armyworm.
There were no comments or requests for referral to an advisory
committee received in response to the notice of filing.
Residue Chemistry Data and Toxicology Data
Although Spod-X bioinsecticide will be applied on a variety
of vegetable and floriculture crops at rates varying from 2
to 50 grams per acre, residue chemistry data were not required.
Such data were determined to be necessary only if the submitted
toxicology studies indicated that additional Tier II or III
toxicology data would be required as specified in 40 CFR 158.165(e).
The submitted toxicology data for this use indicated that the
product is of low mammalian toxicity; therefore, Tier II or
III data were not required.
The toxicological data considered in support of this exemption
from the requirements of a tolerance included an acute oral
toxicity/pathogenicity study in the rat, an acute pulmonary
toxicity/pathogenicity study in the rat, an acute intraperitoneal
toxicity/pathogenicity study in the rat, and a primary eye irritation
study in the rabbit. A dermal toxicty study was submitted and
considered supplemental data. The results of the toxicity/pathogenicity
studies showed no toxic, pathogenic, or adverse effects.
Reference Dose (RfD) and maximum permissible intake (MPI)
considerations are not relevant to this petition because of
the low toxicity and lack of pathogenicity or infectivity observed
in the submitted studies.
Based on the information cited above, the Agency has determined
that the potential acute toxicity/pathogenicity of Spodoptera
exigua nuclear polyhedrosis virus is sufficiently low to support
the proposed exemption from the requirements of a tolerance
on all raw agricultural commodities. Thus, a tolerance for the
active ingredient Spodoptera exigua nuclear polyhedrosis virus
is not necessary to protect the public health. Therefore, 40
CFR part 180 is amended as set forth below.
Any person adversely affected by this regulation may, within
30 days after the date of publication of this document in the
Federal Register, file written objections and/or a request for
a hearing with the Hearing Clerk at the address given above.
40 CFR 178.20. 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 each such issue, 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 issue(s) in the manner sought
by the requestor would be adequate to justify the action requested.
40 CFR 178.32.
The Office of Management and Budget has exempted this rule
from the requirements of section 3 of Executive Order 12291.
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 food additive regulations or raising tolerance levels or
food additive regulations 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).
List of Subjects in 40 CFR Part 180
Administrative practice and procedure, Agricultural commodities,
Pesticides and pests, Recording and recordkeeping requirements.
Dated: April 8, 1993.
Douglas D. Campt,
Director, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is amended as follows:
1. In part 180:
a. The authority citation for part 180 continues to read
Authority: 21 U.S.C. 346a and 371.
b. In subpart D, by adding new .180.1118, to read as follows:
.180.1118 Spodoptera exigua nuclear polyhedrosis virus; exemption
from the requirement of a tolerance.
An exemption from the requirement of a tolerance is established
for the microbial pest control agent Spodoptera exigua nuclear
polyhedrosis virus when used as a pesticide control agent on
all raw agricultural commodities.
[FR Doc. 93-9810 Filed 4-27-93; 8:45 am]
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