[Federal Register Volume 60, Number 130 (Friday, July 7, 1995)]
[Proposed Rules]
[Pages 35365-35367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-16753]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 4E4404/P618; FRL-4962-1]
RIN 2070-AC18
Glyphosate; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish pesticide tolerances for residues of
glyphosate in or on the raw agricultural commodities peppermint and
spearmint. The Interregional Research Project No. 4 (IR-4) requested in
a petition submitted to EPA pursuant to the Federal Food, Drug and
Cosmetic Act (FFDCA) this proposed regulation to establish maximum
permissible levels for residues of the pesticide in or on the
commodities.
DATES: Comments, identified by the document control number [PP 4E4404/
P618], must be received on or before August 7, 1995.
ADDRESSES: By mail, submit written comments 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 comments to: Rm. 1132, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA 22202. Information submitted
as a comment concerning this document may be claimed confidential by
marking any part or all of that information as ``Confidential Business
Information.'' CBI should not be submitted through e-mail. Information
marked as CBI will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2. A copy of the comment that does
not contain CBI must be submitted for inclusion in the public record.
Information not marked confidential may be disclosed publicly by EPA
without prior notice. All written comments will be available for public
inspection in Rm. 1132 at the address given above, from 8 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays.
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: [email protected]. Electronic
comments must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Comments and data will also be
accepted on disks in WordPerfect 5.1 file format or ASCII file format.
All comments and data in electronic form must be identified by the
docket number [PP 4E4404/P618]. Electronic comments on this proposed
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: Hoyt L. Jamerson,
Registration Division (7505W), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington,
[[Page 35366]]
DC 20460. Office location and telephone number: Sixth Floor, Crystal
Station #1, 2800 Jefferson Davis Highway, Arlington, VA 22202, (703)-
308-8783; e-mail: [email protected].
SUPPLEMENTARY INFORMATION: The Interregional Research Project No. 4
(IR-4), New Jersey Agricultural Experiment Station, P.O. Box 231,
Rutgers University, New Brunswick, NJ 08903, has submitted pesticide
petition (PP) 4E4404 to EPA on behalf of the Agricultural Experiment
Station of Washington. This petition requests that the Administrator,
pursuant to section 408(e) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e), amend 40 CFR 180.364(d) by establishing
tolerances for residues of glyphosate (N-(phosphonomethyl)glycine)
resulting from the application of the isopropylamine salt of
glyphosate, in or on the raw agricultural commodities peppermint and
spearmint at 200 parts per million (ppm).
The scientific data submitted in the petition and other relevant
material have been evaluated. The toxicological data considered in
support of the proposed tolerances include:
1. Several acute toxicology studies placing technical-grade
glyphosate in Toxicity Category III (acute oral and dermal).
2. A 1-year chronic feeding study in dogs fed glyphosate in gelatin
capsules containing 0, 20, 100, or 500 milligrams (mg)/kilogram (kg)/
day with a no-observed-effect level (NOEL) established at 500 mg/kg/
day. There were no toxic effects observed under the conditions of the
study.
3. A 26-month chronic feeding carcinogenicity study in rats fed
diets containing 0, 30, 100, or 300 ppm glyphosate (equivalent to 0/0,
3/3, 10/11, 31/34 mg/kg/day for males/females) with a NOEL for systemic
toxicity established at 300 ppm. There were no treatment related
systemic effects observed under the conditions of the study. The
following findings were observed, however, in the high-dose groups when
compared to the concurrent controls: (1) increased incidence of thyroid
C-cell carcinomas in females; and (2) increased incidence of
interstitial cell (Leydig cell) testicular tumors in males. EPA
concluded that these neoplasms were not treatment related, and
glyphosate was not considered to be carcinogenic in this study because
the incidence of thyroid carcinomas was not statistically significant
and the incidence of testicular tumors was within the historical
incidence. This study is not considered an acceptable carcinogenic
study since the feeding levels were not high enough to assess the
carcinogenicity of glyphosate.
4. A 2-year chronic feeding/carcinogenicity study in rats fed diets
containing 0, 2,000, 8,000, or 20,000 ppm (equivalent to 0/0, 89/113,
362/457, or 940/1,183 mg/kg/day for males/females) with a NOEL
established at 8,000 ppm. Treatment-related systemic effects, which
were only observed in the high-dose group, included decreased body
weight gains in females, increased incidence of cataracts and lens
abnormalities, decreased urinary pH, increased absolute liver weight,
and increased liver/brain weight ratio in males. The study also showed
slightly increased incidence of (1) pancreatic islet cell adenomas in
the low-dose and high-dose males; (2) hepatocellular (liver) adenomas
in the low-dose and high-dose males; and (3) thyroid C-cells adenomas
in the mid-dose and high-dose male and females. EPA concluded that
these adenomas were not treatment related, and glyphosate was not
considered to be carcinogenic in this study.
5. A carcinogenicity study in mice fed diets containing 0, 150,
750, or 4,500 mg/kg/day for 18 months with a systemic NOEL established
at 750 mg/kg/day. The following findings were observed in the high-dose
group: (1) decreased body weight gain in males and females; (2)
increased incidence of hepatocellular hypertrophy, hepatocellular
necrosis and interstitial nephritis in males; (3) increased incidence
of proximal tubule epithelial basophilia and hypertrophy in females;
and (4) slightly increased incidence of renal tubular adenomas in
males. EPA concluded that the occurrence of the renal tubular adenomas
in male mice was spontaneous rather than compound induced because the
incidence of these in males was not statistically significant when
compared with the concurrent controls. Glyphosate was not considered to
be carcinogenic in this study.
6. A developmental toxicity study in rats given gavage doses of 0,
300, 1,000, or 3,500 mg/kg/day of glyphosate during days 6 through 19
of gestation with a NOEL for developmental toxicity established at
1,000 mg/kg/day. There was an increase in the number of litters and
fetuses with unossified sternebrae and a decrease in the fetal body
weight at the 3,500-mg/kg/day dose.
7. A developmental toxicity study in rabbits given gavage doses of
0, 75, 175, or 350 mg/kg/day of glyphosate during days 6 through 27 of
gestation. Developmental toxicity was not observed at any dose tested.
The NOEL for developmental toxicity was established at 175 mg/kg/day.
Due to high maternal mortality (10 of 16 females rabbits died) at the
350-mg/kg/day dose level, too few liters were available to adequately
assess developmental toxicity at the high dose.
8. A three-generation reproductive study in rats fed diets
containing 0, 3, 10, or 30 mg/kg/day with a systemic and reproductive
NOEL of 30 mg/kg/day and a developmental NOEL of 10 mg/kg/day. The only
effect observed was an increased incidence of focal tubular dilation of
the kidney (both unilateral and bilateral combined) in the high-dose
male F3b pups.
9. A two-generation reproductive study in rats fed diets containing
0, 100, 500, or 1,500 mg/kg/day of glyphosate with systemic and
developmental NOEL's of 500 mg/kg/day and a reproductive NOEL of 1,500
mg/kg/day. Treatment-related effects, which were observed only in the
high-dose group, include soft stools in the F0 and F1 males and
females, decreased food consumption and body weight gain of the F0 and
F1 males and females; and decreased body weight gain of the F1a, F2a,
and F2b male and female pups during the second and third week of
lactation.
10. A battery of mutagenicity studies including: gene mutation
assay (Ames Test and assay in mammalian cells), negative; structural
chromosomal aberration assay (cytogenic in vivo), negative; and other
genotoxicity assays (rec-assay using Bacillus subtilis and reverse
mutation assay using Escherichia coli), negative.
11. Metabolism studies in rats show that glyphosate is excreted in
the urine and feces as the parent compound. Aminomethylphosphonic acid
was the only metabolite excreted. Less than 1.0 percent of the absorbed
dose remained in the tissues and organs, primarily in the bone tissue.
The dietary risk assessment for glyphosate indicates that there is
minimal risk from established tolerances and the proposed tolerances
for peppermint and spearmint. A cancer risk assessment is not
appropriate for glyphosate since the pesticide is assigned to ``Group
E'' (no evidence of carcinogenicity) of EPA's cancer classification
system. Dietary risk assessments for the pesticide were conducted using
the Reference Dose (RfD) to assess chronic exposure.
The RfD is calculated at 2 mg/kg/ of body weight/day based on a
NOEL of 175 mg/kg/day from the rabbit developmental toxicity study and
an uncertainty factor of 100. The theoretical maximum residue
[[Page 35367]]
contribution (TMRC) from existing tolerances and the proposed
tolerances utilizes l percent of the RfD for the general population, or
3 percent of the RfD for non-nursing infants less than 1 year old (the
subgroup population most highly exposed).
The nature of the residue is adequately understood in plants and
animals. An adequate analytical method utilizing highpressure liquid
chromatography, is available for enforcement purposes. An analytical
method for enforcing this tolerance has been published in the Pesticide
Analytical Manual (PAM), Vol. II. No secondary residues in meat, milk,
poultry, or eggs are expected since peppermint and spearmint are not
considered livestock feed commodities.
There are currently no actions pending against the continued
registration of this chemical. EPA concludes that all uses of currently
registered products containing the isopropylamine and sodium salts of
glyphosate, when used in accordance with the labeling specified in the
Reregistration Eligibility Document (RED), issued September 1993, will
not pose unreasonable risks of adverse effects to humans or the
environment and are eligible for reregistration.
Based on the information and data considered, the Agency has
determined that the tolerances established by amending 40 CFR 180.364
would protect the public health. Therefore, it is proposed that the
tolerances be established as set forth below.
Any person who has registered or submitted an application for
registration of a pesticide, under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) as amended, which contains any of the
ingredients listed herein, may request within 30 days after publication
of this notice in the Federal Register that this rulemaking proposal be
referred to an Advisory Committee in accordance with section 408(e) of
the FFDCA.
A record has been established for this rulemaking under docket
number [PP 4E4404/P618] (including comments and data 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 Rm. 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.
Electronic comments can be sent directly to EPA at:
opp-D[email protected]
Electronic comments 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 all comments 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, Oct. 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).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 23, 1995.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be 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 Sec. 180.364, paragraph (d) is amended by adding and
alphabetically inserting the entries for peppermint and spearmint, to
read as follows:
Sec. 180.364 Glyphosate; tolerances for residues.
* * * * *
(d) * * *
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Parts per
Commodity million
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* * * * *
Peppermint................................................. 200
Spearmint.................................................. 200
* * * * *
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[FR Doc. 95-16753 Filed 7-6-95; 8:45 am]
BILLING CODE 6560-50-F