[Federal Register Volume 61, Number 135 (Friday, July 12, 1996)]
[Proposed Rules]
[Pages 36688-36691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17660]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 6E4645/P672; FRL-5384-1]
Glyphosate; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes to establish a time-limited tolerance
for residues of the herbicide glyphosate [N-(phosphonomethyl)glycine]
in or on the raw agricultural commodity (RAC) oats at 20 parts per
million (ppm). Because additional time is needed for the petitioner to
submit additional details on the processing study and the composition
of the foreign product, the Agency is proposing to grant this tolerance
with a 3-year expiration date. This tolerance is being established to
allow for the legal import of oats treated with glyphosate. Monsanto
Company requested this tolerance in a petition submitted to EPA
pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: Comments, identified by the docket control number [PP 6E4645/
P672], must be received on or before August 12, 1996.
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. Comments and data may
also be submitted to OPP electronically by sending electronic mail (e-
mail) to: opp-docket@epamail.epa.gov. 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 in 5.1 file format or ASCII file format. All
comments and data in electronic form must be identified by the docket
number [PP 6E4645/P672]. Electronic comments on this proposed rule may
be filed online at many Federal Depository Libraries. Additional
information on electronic submission can be found in the
``SUPPLEMENTARY INFORMATION'' section of this document.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all that information as
``Confidential Business Information'' (CBI). Information so marked 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 Virginia address given above, from 8 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail, Robert J. Taylor, Product
Manager, Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location and telephone number: Rm. 241, CM #2, 1921 Jefferson
Davis Hwy., Arlington, VA, (703)-305-6027; e-mail:
taylor.robert@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: Monsanto Company, 700 14th St., NW., Suite
1100, Washington, DC 20005, has submitted a pesticide petition (PP)
6E4645 proposing to amend 40 CFR 180.364, pursuant to section 408(d) of
the Federal Food, Drug, and Cosmetic Act (FFDCA) 21 U.S.C. 346(a), by
establishing a regulation to permit residues of the herbicide
glyphosate [N-(phosphonomethyl)glycine] resulting from the application
of the isopropylamine salt and/or the monoammonium salt of glyphosate
in or on the raw agricultural commodity (RAC) oats at 20.0 parts per
million (ppm). The data submitted in the petitions and other relevant
material have been evaluated. The glyphosate toxicological data listed
below were considered in support of these tolerances.
1. Several acute toxicology studies placing technical-grade
glyphosate in Toxicity Category III and Toxicity Category IV.
2. A 1-year feeding study with dogs fed dosage levels of 0, 20,
100, and 500 milligrams/kilogram/day (mg/kg/day) with a no-observable-
effect level (NOEL) of 500 mg/kg/day.
3. A 2-year carcinogenicity study in mice fed dosage levels of 0,
150, 750, and 4,500 mg/kg/day with no carcinogenic effect at the
highest dose tested (HDT) of 4,500 mg/kg/day.
4. A chronic feeding/carcinogenicity study in male and female rats
fed dosage levels of 0, 3, 10, and 31 mg/kg/day (males) and 0, 3, 11,
or 34 mg/kg/day (females) with no carcinogenic effects observed under
the conditions of the study at dose levels up to and including 31 mg/
kg/day (HDT) (males) and 34 mg/kg/day (HDT) (females) and a systemic
NOEL of 31 mg/kg/day (HDT) (males) and 34 mg/kg/day (HDT) (females).
Because a maximum tolerated dose (MTD) was not reached, this study was
classified as supplemental for carcinogenicity.
5. A chronic feeding/carcinogenicity study in male and female rats
fed dosage levels of 0, 89, 362, and 940 mg/kg/day (males) and 1, 113,
457, and 1,183 mg/kg/day (females) with no carcinogenic effects noted
under the conditions of the study at dose levels up to and including
940/1,183 mg/kg/day (males/females) (HDT) and a systemic NOEL of 362
mg/kg/day (males) based on an increased incidence of cataracts and lens
abnormalities, decreased urinary pH, increased liver weight and
increased liver weight/brain ratio (relative liver weight) at 940 mg/
kg/day (males) (HDT) and 457 mg/kg/day (females) based on decreased
body weight gain at 1,183 mg/kg/day (females) (HDT).
6. A developmental toxicity study in rats given doses of 0, 300,
1,000, and 3,500 mg/kg/day with a developmental NOEL of 1,000 mg/kg/day
based on an increase in number of litters and fetuses with unossified
sternebrae, and decrease in fetal body weight at 3,500 mg/kg/day, and a
maternal NOEL of 1,000 mg/kg/day based on decrease in body weight gain,
diarrhea, soft stools, breathing rattles, inactivity, red matter in the
region of nose, mouth, forelimbs, or dorsal head, and deaths at 3,500
mg/kg/day (HDT).
7. A developmental toxicity study in rabbits given doses of 0, 75,
175, and 350 mg/kg/day with a developmental NOEL of 350 mg/kg/day
(HDT); a maternal NOEL of 175 mg/kg/day based on increased incidence of
soft stool, diarrhea, nasal discharge, and deaths at 350 mg/kg/day
(HDT).
8. A multigeneration reproduction study with rats fed dosage levels
of 0, 3, 10, and 30 mg/kg/day with a developmental NOEL of 10 mg/kg/day
based on an apparent increased incidence of focal tubular dilation of
the kidney (both unilateral and bilateral combined) of male F3b pups.
9. A two generation reproduction study with rats fed dosage levels
of 0, 100, 500, and 1,500 mg/kg/day with a developmental NOEL of 500
mg/kg/day based on decreased pup body weight and body weight gain on
lactation days 14 and 21 at 1,500 mg/kg/day (HDT), a systemic NOEL of
500 mg/kg/day based on soft stools in Fo and F1 males and females at
1,500 mg/kg/day (HDT) and a reproductive NOEL of 1,500 mg/kg/day (HDT).
Additionally, since there was no increase in focal tubular dilation
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of the kidney of the pups at any dose level, the findings at 30 mg/kg/
day in the earlier study was considered sparious.
10. Mutagenicity data included chromosomal aberration in vitro (no
aberrations in Chinese hamster ovary cells were caused with and without
S9 activation); DNA repair in rat hepatocyte; in vivo bone marrow
cytogenic test in rats; rec-assay with B. subtilis; reverse mutation
test with S. typhimurium; Ames test with S. typhimurium; and dominant-
lethal mutagenicity test in mice (all negative).
The reference dose (RfD) based on a developmental study with
rabbits (NOEL of 175 mg/kg/ bwt/day) and using a hundred-fold safety
factor is calculated to be 2.0 mg/kg body weight/day. The theoretical
maximum residue contribution (TMRC) for published tolerances is
0.021460 mg/kg bwt/day or 1.0% of the RfD for the overall U.S.
population. This current action on oats will contribute 0.001644 mg/kg/
day to the TMRC. This tolerance will utilize a total of 0.082% of the
RfD for the overall U.S. population. For U.S. subgroup population,
nonnursing infants, the current action and previously established
tolerances utilize, a total of 3.2% of the RFD, assuming that residue
levels are at the established tolerance levels and that 100% of the
crop is treated.
Data desirable for this petition include additional details for the
processing study and composition of the foreign product. The Agency is
granting the tolerance for oats with a 3-year expiration date to allow
the petitoner, Monsanto Company, to provide the required data.
There are currently no actions pending against the continued
registration of this pesticide. No detectable residues of N-
nitrosoglyphosate, a contaminant of glyphosate, are expected to be
present in the commodities for which tolerances are established. The
carcinogenic potential of glyphosate was first considered by a panel,
then called the Toxicology Branch AD Hoc Committee, in 1985. The
Committee, in a consensus review dated March 4, 1985, classified
glyphosate as a Group C carcinogen based on an increased incidence of
renal tumors in male mice. The Committee also concluded that dose
levels tested in the 26-month rat study were not adequate for
assessment of glyphosate's carcinogenic potential in this species.
These findings, along with additional information, including a
reexamination of the kidney slides from the long-term mouse study, were
referred to the FIFRA Scientific Advisory Panel (SAP). In its report
dated February 24, 1986, SAP classified glyphosate as a Group D
Carcinogen (inadequate animal evidence of carcinogenic potential). SAP
concluded that, after adjusting for the greater survival in the high-
dose mice compared to concurrent controls, that no statistically
significant pairwise differences existed, although the trend was
significant.
The SAP determined that the carcinogenic potential of glyphosate
could not be determined from existing data and proposed that the rat
and/or mouse studies be repeated in order to classify these equivocal
findings. On reexamination of all information, the Agency classified
glyphosate as a Group D carcinogen and requested that the rat study be
repeated and that a decision on the need for a repeat mouse study would
be made upon completion of review of the rat study.
Upon receipt and review of the second rat chronic feeding/
carcinogenicity study, all toxicological findings for glyphosate were
referred to the Health Effects Division Carcinogenicity Peer Review
Committee on June 26, 1991, for discussion and evaluation of the weight
of evidence on glyphosate with particular emphasis on its carcinogenic
potential. The Peer Review Committee classified glyphosate as a Group E
(evidence of noncarcinogenicity for humans), based upon lack of
convincing carcinogenicity evidence in adequate studies in two animal
species. This classification is based on the following findings: (1)
None of the types of tumors observed in the studies (pancreatic islet
cell adenomas in male rat, thyroid c-cell adenomas and/or carcinomas in
male and female rats, hepatocellular adenomas and carcinomas in male
rats, and renal tubular neoplasms in male mice) were determined to be
compound related; (2) glyphosate was tested up to the limit dose on the
rat and up to levels higher than the limit dose in mice; and (3) there
is no evidence of genotoxicity for glyphosate. Accordingly, EPA
concludes that glyphosate has not been ``found to induce cancer when
ingested by man or animal.'' 21 U.S.C. 348(c)(3).
The nature of the residue in plants is adequately understood. The
residue to be regulated is the parent glyphosate. Adequate methodology
(HPLC) with flurometric detection is available for enforcement
purposes, and the methodology has been published in the Pesticide
Analytical Manual (PAM), Vol. II. The submitted residue data adequately
support the proposed tolerance of 20 ppm. Any secondary residues
occurring in milk, eggs, meat, fat, liver, and kidney of cattle, goats,
horses, hogs, and sheep be covered by existing tolerances.
Based on the information cited above, the Agency has determined
that when used in accordance with good agricultural practice, this
ingredient is useful and the tolerance established by amending 40 CFR
part 180 will protect the public health. It is proposed, therefore,
that the tolerance be established as set forth below.
Any person who has registered or submitted and 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 document in the Federal Register that this proposal be referred
to an Advisory Committee in accordance with Section 408 of the Federal
Food, Drug, and Cosmetic Act.
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
document control number, [6E4645/P672]. All written comments filed in
response to this petition will be available in the Public Response and
Program Resources Branch, at the address given above from 8 a.m. to
4:30 p.m., Monday through Friday, except legal holidays.
A record has been established for this rulemaking under docket
number [PP 6E4645/P672] (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-docket@epamail.epa.gov
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 any comments electronically into printed, paper form
as they are received and will place the paper copies in the rulemaking
record which will
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also include all comments submitted directly in writing. The official
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 this Executive Order,
EPA has determined that this proposed rule is not ``significant'' and
is therefore not subject to OMB review.
This action does not impose any enforceable duty, or contain any
``unfunded mandates'' as described in Title II of the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as
specified by Executive Order 12875 (58 FR 58093, October 28, 1993),
entitled ``Enhancing the Intergovernmental Partnership,'' or special
consideration as required by Executive Order 12898 (59 FR 7629,
February 29, 1994).
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 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.
Dated: June 28, 1996.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 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. Section 180.364 is amended by revising the entry for grain crops
(except wheat) under paragraph (a) in the table therein and adding a
new paragraph (e) to read as follows:
Sec. 180.364 Glyphosate: tolerances for residues.
(a) * * *
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Commodity Parts per million
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* * * * *
grain crops (except wheat and oats)....... 0.13
* * * * *
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* * * * *
(e) A tolerance to expire (Insert date 3-years after date of
publication of the final rule in the Federal Register) is established
for residues of the herbicide glyphosate (N-(phosphonomethyl)glycine)
resulting from the application of the isopropylamine salt of glyphosate
and/or the monoammonium salt of glyphosate in or on the raw
agricultural commodity oat at 20 parts per million.
[FR Doc. 96-17660 Filed 7-11-96; 8:45 am]
BILLING CODE 6560-50-F
