[Federal Register Volume 60, Number 158 (Wednesday, August 16, 1995)]
[Rules and Regulations]
[Pages 42458-42460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20305]
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40 CFR Parts 180 and 185
40 CFR Parts 180 and 185
[OPP-300389A; FRL-4967-9]
RIN 2070-AB78
Sodium Propionate, Methoprene, and Heliothis zea NPV; Tolerance
Actions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: For each of the pesticides subject to the actions listed in
this rule, EPA has completed the reregistration process and issued a
Reregistration Eligibility Document (RED). In the reregistration
process, all information to support a pesticide's continued
registration is reviewed for adequacy and, when needed, supplemented
with new scientific studies. Based on the RED tolerance assessments for
the pesticide chemicals subject to this rule, EPA is taking the
following tolerance actions: amending the exemptions from the
requirement of a tolerance for methoprene; revoking exemptions for
sodium propionate; and making wording changes to the exemption from the
requirement of a tolerance for Heliothis zea NPV. With this rule to
amend the exemptions from the requirement of tolerances for methoprene,
the Agency is correcting its position in the RED, which stated that the
exemptions should be revoked. The Agency believes that exemptions from
the requirement of tolerances for these uses are appropriate.
EFFECTIVE DATE: This regulation becomes effective on August 16, 1995.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [OPP-300389A], may 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),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk should be identified by
the document control number and submitted to: Public
[[Page 42459]]
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.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect in 5.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket number
[OPP-300389A]. No Confidential Business Information (CBI) should be
submitted through e-mail. Electronic copies of 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: Philip Poli, Special Review
and Reregistration Division (7505W), Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. Office location and telephone
number: Crystal Station #1, 3rd Floor, 2800 Crystal Drive, Arlington,
VA 22202, (703)-308-8038; e-mail: poli.philip@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of June 28, 1995 (60
FR 33383), EPA issued a proposed rule (FRL-4960-5) affecting 40 CFR
180.2, 180.1015, 180.1027, 180.1033, and 185.4150 regarding various
chemicals and tolerance actions the Agency proposed to take.
Specifically, EPA proposed actions regarding the following chemicals:
Methoprene, the revision of the methoprene regulation in 40 CFR
180.1033 to reflect changed uses and the revocation of the methoprene
regulation in 40 CFR 185.4150; sodium propionate, the revocation of
exemptions under 40 CFR 180.2(a) and 180.1015; and Heliothis zea NPV,
the amendment of 40 CFR 180.1027 to better reflect the current viral
identification and testing technology.
There were no comments or requests for referral to an advisory
committee received in response to the proposed rule.
The data submitted with the proposal and other relevant material
have been evaluated and discussed in the proposed rule. Based on the
data and information considered, the Agency concludes that the
regulations issued in this document will protect the public health.
Therefore, the regulations are 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 and/or request a hearing 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 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).
A record has been established for this rulemaking under docket
number [OPP-300389A] (including any objections and hearing requests
submitted electronically as described below). A public version of this
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.
Written objections and hearing requests, identified by the document
control number [OPP-300389A], may be submitted to the Hearing Clerk
(1900), Environmental Protection Agency, Rm. 3708, 401 M St., SW.,
Washington, DC 20460.
A copy of electronic objections and hearing requests filed with the
Hearing Clerk can be sent directly to EPA at:
opp-Docket@epamail.epa.gov
A copy of electronic objections and hearing requests filed with the
Hearing Clerk 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 will be kept in paper form. Accordingly,
EPA will transfer any 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 objections and hearing requests 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, Oct. 4, 1993), the Agency
must determine whether the regulatory action is ``significant'' and
therefore subject to review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the order defines a ``significant regulatory action'' as an action that
is likely to result in 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 referred to 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 the rights and obligations of recipients
thereof; 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 the 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
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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 Parts 180 and 185
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Food additives, Pesticides and pests,
Reporting and recordkeeping requirements.
Dated: August 8, 1995.
Lois Rossi,
Director, Special Review and Reregistration Division, 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 180.2 is revised to read as follows:
Sec. 180.2 Pesticide chemicals considered safe.
(a) As a general rule, pesticide chemicals other than benzaldehyde
(when used as a bee repellant in the harvesting of honey), ferrous
sulfate, lime, lime-sulfur, potassium carbonate, potassium polysulfide,
potassium sorbate, sodium carbonate, sodium chloride, sodium
hypochlorite, sodium polysulfide, sodium sesquicarbonate, sorbic acid,
sulfur, and when used as plant desiccants, sodium metasilicate (not to
exceed 4 percent by weight in aqueous solution) and when used as
postharvest fungicide, citric acid, fumaric acid, oil of lemon, oil of
orange, and sodium benzoate are not for the purposes of section 408(a)
of the Act generally recognized as safe.
(b) Upon written request, the Registration Division will advise
interested persons whether a pesticide chemical should be considered as
poisonous or deleterious, or one not generally recognized by qualified
experts, as safe.
(c) The training and experience necessary to qualify experts to
evaluate the safety of pesticide chemicals for the purposes of section
408(a) of the Act are essentially the same as training and experience
necessary to qualify experts to serve on advisory committees prescribed
by section 408(g) of the Act. (See Sec. 180.11.)
Sec. 180.1015 [Removed]
c. Section 180.1015 is removed.
d. Section 180.1027 is revised to read as follows:
Sec. 180.1027 Nuclear polyhedrosis virus of Heliothis zea; exemption
from the requirement of a tolerance.
(a) For the purposes of this section, the viral insecticide must be
produced with an unaltered and unadulterated inoculum of the single-
embedded Heliothis zea nuclear polyhedrosis virus (HzSNPV). The
identity of the seed virus must be assured by periodic checks.
(b) Each lot of active ingredient of the viral insecticide shall
have the following specifications:
(1) The level of extraneous bacterial contamination of the final
unformulated viral insecticide should not exceed 107 colonies per
gram as determined by an aerobic plate on trypticase soy agar.
(2) Human pathogens, e.g., Salmonella, Shigella, or Vibrio, must be
absent.
(3) Safety to mice as determined by an intraperitoneal injection
study must be demonstrated.
(4) Identity of the viral product, as determined by the most
sensitive and standardized analytical technique, e.g., restriction
endonuclease and/or SDS-PAGE analysis, must be demonstrated.
(c) Exemptions from the requirement of a tolerance are established
for the residues of the microbial insecticide Heliothis zea NPV, as
specified in paragraphs (a) and (b) of this section, in or on all
agricultural commmodities including: corn, cottonseed, beans, lettuce,
okra, peppers, sorghum, soybeans, and tomatoes.
e. Section 180.1033 is revised to read as follows:
Sec. 180.1033 Methoprene; exemption from the requirement of a
tolerance.
Methoprene is exempt from the requirement of a tolerance in or on
all raw agricultural commodities when used to control mosquito larvae
including pastures, rice fields, vineyards, date palm orchards, nut
orchards, berry orchards, and fruit orchards.
PART 185--[AMENDED]
2. In part 185:
a. The authority citation for part 185 continues to read as
follows:
Authority: 21 U.S.C. 348.
b. Section 185.4150 is revised to read as follows:
Sec. 185.4150 Methoprene.
A tolerance of 10 parts per million is established for residues of
isopropyl (E,E)-11-methoxy-3,7,11-trimethyl-2,4-dodecadienoate) in or
on the food additive commodity cereal grain milled fractions (except
flour and rice hulls).
[FR Doc. 95-20305 Filed 8-15-95; 8:45 am]
BILLING CODE 6560-50-F
