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Glyphosate - Pesticide Tolerance 2/96

[Federal Register: February 29, 1996 (Volume 61, Number 41)]
[Proposed Rules]
[Page 7764-7765]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 5F4493/R2205; FRL-5351-5]
RIN 2070-AB78
Pesticide Tolerance for Glyphosate
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes a tolerance for residues of the
herbicide glyphosate [N-(phosphonomethyl)glycine] in or on the raw
agricultural commodity (RAC) cotton gin byproducts at 100 parts per
million (ppm). Monsanto Company requested this tolerance in a petition
submitted to EPA pursuant to the Federal Food, Drug, and Cosmetic Act
(FFDCA).

EFFECTIVE DATE: These regulations become effective February 29, 1996.

ADDRESSES: Written objection and hearing requests, identified by the

docket number, [PP 5F4493/R2205], 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 docket 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 objections and hearing requests to: Rm. 1132, CM #2, 1921 Jefferson
Davis Hwy., Arlington, VA 22202. A copy of objections and hearing requests
filed with the Hearing Clerk may also be submitted electronically by sending
electronic mail (e-mail) to: oppdocket@epamail.epa.gov.

    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 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 [PP 5F4493/R2205]. 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 submission can be found below in this document.

FOR FURTHER INFORMATION CONTACT: By mail, Robert J. Taylor, Product
Manager, Registration Division (H7505C), 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: EPA issued a notice in the Federal Register
of August 17, 1995 (60 FR 42884), which announced that Monsanto
Company, 700 14th Street, NW., Suite #1100, Washington, DC 20005 had
submitted a petition (5F4493) proposing to amend 40 CFR part 180
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) cotton gin byproducts at 100 parts per million (ppm).
    There were no comments or requests for referral to an advisory
committee received in response to this notice of filing.
    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 0, 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 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 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).
    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/bwt/day. The theoretical maximum
residue contribution (TMRC) for published tolerances and food and feed
additive regulations is 0.02059 mg/kg/bwt/day or 1.0 percent of the RfD
for the overall U.S. population. The current action on cotton gin
byproducts will not increase the TMRC or percent of the RfD.
Established tolerances utilize a total of 1.0 percent of the RfD for
the overall U.S. population.
    For U.S. subgroup populations, nonnursing infants and children 1 to
6 years of age, the current action and previously established
tolerances and the food additive regulation utilize, respectively, a
total of 2.4 and 2.3 percent of the RfD, assuming that residue levels
are at the established tolerance levels and that 100 percent of the
crop is treated.
    There are no desirable data lacking for this pesticide. 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,
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. Any secondary residues
occurring in the kidney and liver of cattle, goats, horses, hogs, and
sheep and liver and kidney of poultry will be covered by existing
tolerances. The pesticide is considered useful for the purpose for
which the regulation is sought and is capable of achieving the intended
physical or technical effect.
    Based on the information cited above, the Agency has determined
that the establishment of this tolerance by amending 40 CFR part 180
will protect the public health. Therefore, EPA is establishing this
tolerance 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 by
40 CFR 180.33(i). If a hearing is requested, the objections must
include a statement of the factual issue(s) on which the 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 possibly that
available evidence identified by the requestor would, if established,
resolve one or more 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 5F4493/R2205] (including objections and hearing requests
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 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
number [5F4493/R2205] 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-Docket@epamail.epa.gov
    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 rulemaking record which will also include
all objections and hearing requests 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 orpolicy 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
ORB 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 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, chapter I, part 180 of title 40 of the Code of Federal
Regulations is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as
follows:
    Authority: 21 U.S.C. a and 371.

    2. In Sec. 180.364, by amending the table in paragraph (d) by
alphabetically adding the raw agricultural commodity "cotton gin
byproducts" to read as follows:

Sec. 180.364  Glyphosate; tolerances for residues.

*    *    *    *    *
    (d) *  *  *

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                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
                  *        *        *        *        *
Cotton gin byproducts........................................    100.0
                  *        *        *        *        *
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