[Federal Register Volume 60, Number 13 (Friday, January 20, 1995)]
[Rules and Regulations]
[Pages 4095-4097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1499]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 1F3986, PP 1F3987, and PP 1F3988/R2098; FRL-4928-6]
RIN 2070-AB78
Sodium 5-Nitroguaiacolate, Sodium O-Nitrophenolate, and Sodium P-
Nitrophenolate; Exemptions from the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes exemptions from the requirement of a
tolerance for residues of the biochemical plant regulators sodium 5-
nitroguaiacolate, sodium o-nitrophenolate, and sodium p-nitrophenolate
in or on the raw agricultural commodities cottonseed, cotton gin
byproducts, rice, rice straw, soybeans, and soybean forage and hay when
products containing 0.1%, 0.2%, and 0.3% by weight of these active
ingredients, respectively, are applied at rates of 20 grams of each
active ingredient per acre or less per application in accordance with
good agricultural practices. These exemptions were requested by Asahi
Chemical Manufacturing Co., Ltd.
EFFECTIVE DATE: Effective on January 9, 1995.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 1F3986, PP 1F3987, and PP 1F3988/R2098],
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 document control 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 a copy of the
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.
FOR FURTHER INFORMATION CONTACT: By mail: Leonard S. Cole, Jr., Acting
Product Manager (PM) 21, Registration Division (7505C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location and telephone number: Rm. 227, CM
#2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703) 305-6900.
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register of December 13, 1991 (56 FR 65080), which announced
that Asahi Chemical Manufacturing Co., Ltd., 500 Takayasu, IkarugaCho,
Ikoma-Gun, Nara Prefecture, Japan, had submitted pesticide petitions
(PP) 1F3986, 1F3987, and 1F3988 proposing to amend 40 CFR part 180 by
establishing a regulation pursuant to the Federal Food, Drug, and
Cosmetic Act, 21 U.S.C. 346a and 371, to exempt from the requirement of
a tolerance the residues of the biochemical plant regulators sodium 5-
nitroguaiacolate, sodium o-nitrophenolate, and sodium p-nitrophenolate
when applied at rates of 20 grams of active ingredient or less per acre
per application in or on the raw agricultural commodities from
application to cotton, rice, and soybeans.
No comments were received in response to the Federal Register
notice.
The data submitted in the petitions and all other relevant material
have been evaluated. The toxicological data considered in support of
the exemptions from the requirement of a tolerance include acute
toxicity tests, subchronic oral toxicity tests, developmental toxicity
studies, and mutagenicity studies. Acute toxicity tests place the end-
use product in Toxicity Category IV. The acute toxicity tests for the
individual technical chemicals indicate that sodium 5-nitroguaiacolate
is in Toxicity Category I based on primary eye irritation, sodium p-
nitrophenolate is in Toxicity Category II based on acute oral toxicity
and primary eye irritation, and sodium o-nitrophenolate is in Toxicity
Category II based on primary [[Page 4096]] eye irritation. Atonic is a
mild dermal sensitizer.
Atonik, the end-use product, containing 0.3% sodium p-
nitrophenolate, 0.2% sodium o-nitrophenolate, and 0.1% sodium 5-
nitroguaiacolate by weight, was fed to rats in the subchronic oral
toxicity test at dietary levels of 0, 5,000, 15,000 and 50,000 parts
per million (ppm), which was equivalent to 515, 1,589, and 5,056 mg/kg/
day for males and 531, 1,723, and 6,553 mg/kg/day for females. Based on
decreased weight gains, changes in hematology parameters, relative
organ weights of liver and kidney, and pigment accumulation in kidney
and spleen, the lowest-observed-effect level (LOEL) is approximately
1,600 mg/kg/day (1,589 and 1,723 mg/kg/day in males and females,
respectively). The no-observed-effect level (NOEL) is approximately 525
mg/kg/day (515 and 531 mg/kg/day in males and females, respectively).
In a developmental toxicity study, Atonik was administered to rats
by gastric gavage at dose levels of 0, 100, 300, and 600 mg/kg/day.
Maternal toxicity was observed at the 600 mg/kg/day level, manifested
as significantly decreased body weight gain and food consumption. One
death at this dose level was considered to be treatment related. Based
on these results, the maternal toxicity NOEL and LOEL were 300 and 600
mg/kg/day, respectively. Developmental toxicity was not observed in
this study. The NOEL for developmental toxicity was 600 mg/kg/day, and
the LOEL was not determined.
In mutagenicity studies, the individual active ingredients were
negative for mutagenicity when tested using the Ames Test, the Mouse
Micronucleus Assay, and the Mouse Lymphoma Assay.
All of the toxicity studies submitted are considered acceptable.
The toxicity data provided are sufficient to show that there are no
foreseeable human or domestic animal health hazards likely to arise
from the use of these active ingredients as plant regulators in the
concentrations present in the end-use product and applied at rates of
20 grams of each active ingredient or less per acre.
Acceptable daily intake (ADI) and maximum permissible intake (MPI)
considerations are not relevant to these petitions. Chronic exposure
data upon which ADI and MPI values are based are not required for
pesticides which are classified as biochemicals and applied at rates of
20 grams or less of each active ingredient per acre. Although the
individual active ingredients are acutely toxic in certain tests, the
end-use product containing the combined active ingredients at the
concentrations specified above was in the lowest toxicity category. At
application rates of 20 grams per acre or less, the level of active
ingredient which may be present in any of the food or feed items would
be far below levels which demonstrated any effects in the subchronic
oral toxicity test, developmental toxicity studies, and mutagenicity
studies. For example, in order to reach a dosage rate comparable to the
LOEL (1,600 mg/kg/day) obtained in the subchronic oral toxicity study,
it is calculated that a person weighing 50 kg would need to consume all
of the produce from 4 acres of crop every day.
Because the tolerance exemption does not define a permitted residue
level in food, 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 the active
ingredients, sodium 5-nitroguaiacolate, sodium o-nitrophenolate, and
sodium p-nitrophenolate. By way of public reminder, this notice also
reiterates the registrant's responsibility under section 6(a)(2) of
FIFRA, to submit additional factual information regarding adverse
effects on the environment and to human health by these pesticides.
These active ingredients are considered useful for the purpose for
which the exemptions from the requirement of a tolerance are sought.
Based on the information considered, the Agency concludes that
establishment of the exemptions will protect the public health.
Therefore, the regulation 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 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
in 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 to the
contrary; and resolution of factual issue(s) in the manner sought by
the requestor would be adequate to justify the action requested. 40 CFR
178.32.
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 an 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
Environmental protection, Administrative practice and procedures,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: January 9, 1995.
Stephen L. Johnson,
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is amended as follows:
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. In subpart D, by adding new Secs. 180.1139, 180.1140, and
180.1141, to read as follows: [[Page 4097]]
Sec. 180.1139 Sodium 5-nitroguaiacolate; exemption from the
requirement of a tolerance.
The biochemical sodium 5-nitroguaiacolate is exempted from the
requirement of a tolerance when used as a plant regulator in end-use
products at a concentration of 0.1% by weight and applied at an
application rate of 20 grams of active ingredient per acre (20 g ai/A)
or less per application, in or on the raw agricultural commodities
cottonseed, cotton gin byproducts, rice, rice straw, soybeans, and
soybean forage and hay.
Sec. 180.1140 Sodium o-nitrophenolate; exemption from the requirement
of a tolerance.
The biochemical sodium o-nitrophenolate is exempted from the
requirement of a tolerance when used as a plant regulator in end-use
products at a concentration of 0.2% by weight and applied at an
application rate of 20 grams of active ingredient per acre (20 g ai/A)
or less per application, in or on the raw agricultural commodities
cottonseed, cotton gin byproducts, rice, rice straw, soybeans, and
soybean forage and hay.
Sec. 180.1141 Sodium p-nitrophenolate; exemption from the requirement
of a tolerance.
The biochemical sodium p-nitrophenolate is exempted from the
requirement of a tolerance when used as a plant regulator in enduse
products at a concentration of 0.3% by weight and applied at an
application rate of 20 grams of active ingredient per acre (20 g ai/A)
or less per application, in or on the raw agricultural commodities
cottonseed, cotton gin by-products, rice, rice straw, soybeans and
soybean forage and hay.
[FR Doc. 95-1499 Filed 1-19-95; 8:45 am]
BILLING CODE 6560-50-F
