[Federal Register Volume 61, Number 41 (Thursday, February 29, 1996)]
[Rules and Regulations]
[Pages 7732-7734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4399]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 4F4405/R2206; FRL-5350-8]
RIN 2070-AB78
Nicosulfuron; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This document establishes tolerances for residues of the
herbicide nicosulfuron [3-pyridinecarboxamide, 2-((((4,6-
dimethoxypyrimidin-2-yl)aminocarbonyl)aminosulfonyl)-N,N-dimethyl] in
or on the raw agricultural commodities (RACs) corn, sweet (kernals plus
cobs with husks removed) at 0.1 part per million (ppm); corn, sweet,
forage at 0.1 ppm and corn, sweet, fodder (stover) at 0.1 ppm. E.I. du
Pont de Nemours and Company, Inc., requested these tolerances in a
petition submitted to EPA pursuant to the Federal Food, Drug, and
Cosmetic Act (FFDCA).
EFFECTIVE DATE: This regulation becomes effective February 29, 1996.
ADDRESSES: Written objections and hearing requests, identified by the
document control number [PP4405/R2206], may be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. 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. A copy of any objections and hearing request
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 copy of objections and hearing requests to:
Rm 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: [email protected]. 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
[PP4F4405/R2206]. 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, Robert J. Taylor, Product
Manager (PM-25), Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location, telephone number, and e-mail address: Rm.
241, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-6027;
e-mail: [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of February 8, 1995
(60 FR 7540), EPA issued a notice announcing that Du Pont, Agricultural
Products, Barley Mill, P.O. Box 80038, Wilmington, DE 19880-0038, had
submitted a pesticide petition (PP4F4405) proposing to amend 40 CFR
part 180 by establishing a regulation under section 408(d) of the
Federal Food, Drug and Cosmetic Act (21 U.S.C. 346a(d) to permit
residues of the herbicide nicosulfuron (3-pyridinecarboxamide, 2-
((((4,6-dimethoxypyrimidin-2-y1) aminocarbonyl)aminosulfonyl)-N,N-
dimethyl), in or on corn, sweet (kernals plus cobs with husks removed)
at 0.1 part per million (ppm) and corn, sweet, forage at 0.1 ppm. There
were no comments or requests for referral to an advisory committee
received in response to the notice of filing.
The petitioner subsequently amended the petition by submitting a
revised Section F proposing to establish tolerances for nicosulfuron in
or on the RACs corn, sweet (Kernels plus cobs with Husks Removed) at
0.1 ppm; corn; sweet, forage at 0.1 ppm, and corn, sweet, fodder
(stover) at 0.1 ppm. In the Federal Register of September 13, 1995 (60
FR 47578), EPA issued an amended filing notice proposing these
tolerances. The Agency received one comment opposing these tolerances.
The commenter's opposition to the tolerance was based upon
toxicological concerns including the concept of ``NOEL'' (No observed
effect level); the use of animal testing to represent human reaction to
potentially toxic substances (pesticides); the indications of a link
between pesticide exposure and Parkinson's Disease (PD).
The Agency has reviewed the comment and decided to proceed with
these tolerances. The Agency, made the decision that a wide variety of
toxicological studies would serve as the basis for determining if a
pesticide could be registered and used without unreasonable risk. It is
true that animal models do not and cannot predict every possible human
reaction to pesticides, but the general consensus is that they offer
the best information as to what a pesticide might do to humans.
Usually, the Agency requires and reviews long-term studies in rodents
and non-rodents to determine a dose which causes no apparent adverse
effects. The NOEL is divided by an uncertainty factor - often at least
100 - to arrive at doses or exposures that should not cause harmful
effects on humans. In the Agency's regulation of pesticides, the Agency
does not approve uses which will cause unreasonable adverse effects to
humans or the environment.
The Agency understands that the testing of one pesticide at a time
does not predict all the possible adverse interactions with other
pesticides - or for that matter other drugs or environmental
pollutants. The Agency is exploring ways of testing for the
[[Page 7733]]
interactions of pesticides having similar toxicity endpoint, but
progress in that area is slow.
With reference to the indications of a link between pesticide
exposure and Parkinson's Disease, the Agency is aware that many
researchers are investigating the potential reaction of pesticide
exposures to chronic neurological diseases including Parkinson's
Disease, and additional research is needed to study this important
area. Available studies in humans or animals have not yet established
any relationship between pesticide exposures and Parkinson's Disease.
The data submitted in the petition and other relevant material have
been evaluated. The toxicology data listed below were considered in
support of this tolerance.
1. Several acute toxicology studies placing the technical-grade
herbicide in Toxicity Category III.
2. A 1-year feeding study with dogs fed dosages of 0, 6.25, 125,
and 500 mg/kg/day resulted in a systemic NOEL of 125 mg/kg/day in males
based upon a decrease in body weight gains and a concomitant increase
in relative liver and kidney weights in males. The NOEL for females was
500 mg/kg/day, the highest dose tested (HDT).
3. A 2-year chronic toxicity/carcinogenicity study with rats fed
dosages of 0, 1.9/2.6, 58.1/77.1, 289/382, and 786/1,098 mg/kg/day
(males/females demonstrated that no carcinogenic effects were observed
under the conditions of the study at dose levels up to and including
786/1,098 (males/females) mg/kg/day (HDT) and a systemic NOEL equal to
or greater than 786 mg/kg/day (males) and 1,098 mg/kg/day (females),
(HDT).
4. An 18-month carcinogenicity study with mice fed dosages of 0,
3.3/4.4, 32.7/44.8, 327/438, and 993/1,312 mg/kg/day (males/females)
demonstrated that no carcinogenic effects were observed under the
conditions of the study up to and including 993/1,312 (males/females)
mg/kg/day (HDT) and a systemic NOEL of 993/1,312 (males/females) mg/kg/
day (HDT).
5. A developmental toxicity study in rats fed dosages of 0, 200,
1,000, 2,500, and 6,000 mg/kg/day had a developmental and maternal NOEL
equal to or greater than 6,000 mg/kg/day, (HDT).
6. A developmental toxicity study in rabbits fed dosages of 0, 100,
500, 1,000, and 2,000 mg/kg/day had a maternal NOEL of 100 mg/kg/day
based upon maternal toxicity occurring at 500 mg/kg/day. Maternal
toxicity was demonstrated by an increase in clinical signs, gross
pathological observations, abortions, postimplantation loss and
decrease in body weight gain during the dosing period. The
developmental NOEL was 500 mg/kg/day based upon developmental toxicity
evidenced at 1,000 mg/kg/day in the form of reduced mean fetal body
weights and the apparent increase in postimplantation loss at 500 mg/
kg/day and above.
7. A multi-generation reproduction study in the rat administered
dosages of 0, 12.5, 287, and 1,269 mg/kg/day had a systemic NOEL of 287
mg/kg/day based upon F1 (first mating) females with a lower body weight
gain during the final week of gestation and a similar pattern in the F0
females during the same period of gestation at 1,269 mg/kg/day (HDT).
The reproductive NOEL was 287 mg/kg/day based on a minimal reduction of
litter size at birth and in pup weights at postpartum days 14 through
21 in the F2a high-dose group at 1,269 mg/kg/day (HDT).
8. A mutagenic test with Salmonella typhimurium did not show
mutagenicity in four test strains (TA97A, TA98, TA100, and TA1535) with
or without metabolic activation; in vitro chromosomal aberration test
in cultured human lymphocytes indicated negative response at the
concentrations of 40 to 470 ug/mL; an unscheduled DNA damage assay at
the concentrations of 0.04 to 470 ug/mL was negative; in vitro gene
mutation assay in Chinese hamster ovary cells was nonmutagenic at the
concentrations of 4 to 465 ug/mL with or without metabolic activation;
and a micronucleus assay in mouse bone marrow had negative responses at
the dose levels of 500 to 5,000 mg/kg.
The reference dose (RFD), based on a 1 year dog feeding study (NOEL
of 125 mg/kg bwt/day) and using a hundred fold safety factor, is
calculated to be 1.25 mg/kg bwt/day. The theoretical maximum residue
contribution (TMRC) for the existing tolerances is 0.000034 mg/kg/day
and utilizes 0.003% of the RFD. The current action will increase the
TMRC by 0.000024 mg/kg/day. These tolerances and previously established
tolerances will utilize a total of 0.005% of the RFD for the overall
U.S. population. For U.S. subgroup populations nonnursing infants and
children 1 to 6, the current action and previously established
tolerances utilize 0.011% of the RFD, assuming that residue levels are
at the established tolerances and 100% of the crop is treated.
No desirable data are lacking. The pesticide is useful for the
purpose for which the tolerance is sought. Adequate analytical
methodology (liquid chromatography with ultraviolet detection) is
available for enforcement purposes. The method is not yet published in
the Pesticide Analytical Manual (PAM), but can be obtained as follows:
by mail: Calvin Furlow, Public Information Branch, Field Operations
Division (H7506C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460, Office
location and telephone number: Crystal Mall #2, Rm 1130A, 1921
Jefferson Davis Hwy., Arlington, VA, (703-305-5937).
There are currently no actions pending against the registration of
this chemical. No secondary residues are expected to occur in poultry,
meat, meat byproducts, or eggs based on the proposed use on sweet corn,
since sweet corn is not fed to poultry. No secondary residues are
expected to occur in milk and the meat, and meat byproducts of cattle,
goats, hogs, horses and sheep.
Based on the information cited above, the Agency has determined
that the establishment of the tolerances by amending 40 CFR part 180
will protect the public health; therefore, the tolerances 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 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 in 40 CFR 180.33
(i). If a hearing is requested, the objections must include a statement
of 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).
A record has been established for this rulemaking under docket
number [PP 4F4405/R2206] (including objections and hearing requests
submitted
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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 docket
control number [PP 4F4405/R2206] 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-
[email protected] 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, October 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 obligation 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, 21 U.S.C. 601-612), the
Administrator has determined that regulations establishing new
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).
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 20, 1996.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR 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. In section 180.454 by amending the table therein by adding and
alphabetically inserting new entries for corn, sweet (kernals plus cobs
with husks removed); corn, sweet, fodder (stover); and corn, sweet,
forage; to read as follows:
Sec. 180.454 Nicosulfuron, [3-pyridinecarboxamide, 2-((((4,6-
dimethoxypyrimidin-2-yl)aminocarbonyl)aminosulfonyl)-N,N-dimethyl];
tolerances for residues.
* * * * *
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Commodity Parts per million
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* * * * *
corn, sweet (kernals plus cobs with husks
removed)...................................... 0.1
corn sweet, fodder (stover).................... 0.1
corn, sweet, forage............................ 0.1
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[FR Doc. 96-4399 Filed 2-28-96; 8:45 am]
BILLING CODE 6560-50-F