[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