[Federal Register Volume 59, Number 218 (Monday, November 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-27842]


[[Page Unknown]]

[Federal Register: November 14, 1994]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[PP 2E4057/P594; FRL-4918-2]
RIN 2070-AC18

 

Pesticide Tolerance for Glufosinate-Ammonium

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: EPA proposes to establish a time-limited tolerance for 
combined residues of the herbicide glufosinate-ammonium, monoammonium 
2-amino-4-(hydroxymethylphosphinyl)butanoate, and its metabolite, 3-
methylphosphinicopropionic acid expressed as 2-amino-4-
(hydroxymethylphosphinyl)butanoic acid equivalents, in or on the 
imported raw agricultural commodity bananas at 0.3 part per million. 
(Not more than 0.2 ppm shall be present in the pulp after peel is 
removed). Hoechst Celanese Corp. (now AgrEVO Corp.) petitioned for this 
proposed regulation to establish a maximum permissible level for 
combined residues of the herbicide.

DATES: Comments, identified by the document control number, [PP 2E4057/
P594], must be received on or before December 14, 1994.

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). 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 address given above, from 8 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller, Product 
Manager (PM) 23, Registration Division (7505C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. Office location and telephone number: Rm. 237, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-7830.

SUPPLEMENTARY INFORMATION: AgrEVO Corp., Little Falls Center One, 2711 
Centerville Rd., Wilmington, DE 19808, has submitted pesticide petition 
(PP) 2E4057 to EPA. This petition requested that the Administrator, 
pursuant to section 408(e) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a(e), establish a tolerance for combined residues 
of the herbicide glufosinate-ammonium (monoammonium 2-amino-4-
(hydroxymethylphosphinyl) butanoate) and its metabolite, 3-
methylphosphinicopropionic acid, in or on the imported raw agricultural 
commodity bananas at 0.2 ppm. The petition was subsequently amended to 
raise the tolerance level to 0.3 ppm.
    The data submitted in support of the petition and other relevant 
materials have been evaluated. The pesticide is considered useful for 
the purpose for which the tolerance is sought. The toxicological data 
considered in support of the tolerances include the following:
    1. A 90-day feeding study in rats at dietary intakes of 0, 0.52, 
4.1, 32, or 263 mg/kg/day with a no-observed-effect level (NOEL) of 4.1 
mg/kg/day. The lowest-observed-effect level (LOEL) was established at 
32 mg/kg/day based on increased absolute and relative kidney weights.
    2. A 90-day feeding study in mice at dietary intakes of 0, 16.6, 
67.1, or 278 mg/kg/day for males and 19.4, 86.6, or 288.2 mg/kg/day for 
females with a NOEL of 16.6 mg/kg/day and a LOEL of 67.1 mg/kg/day 
based on increased absolute and relative liver weights (both sexes) and 
an increase in serum potassium levels (males).
    3. Three teratology studies in rats at doses from 0.5 to 250 mg/kg/
day with no teratogenic effects occurring up to and including 250 mg/
kg/day. A NOEL for developmental toxicity was 2.24 mg/kg/day, based 
upon an increase in the incidence of dilated renal pelvis with 
hydroureter in the fetuses at 10 mg/kg/day. The maternal NOEL was also 
2.24 mg/kg/day.
    4. A teratology study in rabbits at doses of 0, 2, 6.3, or 20 mg/
kg/day with no teratogenic effects occurring up to and including 20 mg/
kg/day, and a maternal NOEL of 6.3 mg/kg/day and a developmental NOEL 
of 20 mg/kg/day, the highest dose tested.
    5. A two-generation reproduction study in rats at dietary 
concentrations of 0, 40, 120, or 360 ppm with a NOEL for reproductive 
effects at 120 ppm (equivalent to 12 mg/kg/day) based upon reduced 
number of pups in the high- dose group. The NOEL for parental toxicity 
was also 120 ppm based upon increased kidney weights in the high-dose 
group.
    6. A 12-month feeding study in dogs at doses of 0, 2, 5, or 8.5 mg/
kg/day. The NOEL was 5.0 mg/kg/day based upon the death of one male and 
one female dog at 8.5 mg/kg/day with no other treatment-related 
toxicity.
    7. A mouse carcinogenicity study at doses of 0, 2.8, 10.8, or 22.7 
mg/kg/day in males and 0, 4.2, 16.2, or 64.0 mg/kg/day in females for 
104 weeks with no carcinogenic effects observed under the conditions of 
the study up to and including 64 mg/kg/day and a systemic NOEL of 10.8 
and 16.2 for males and females, respectively, based on the dose-related 
increase in mortality.
    8. A chronic feeding/carcinogenicity study in rats at dietary doses 
of 0, 2.5, 8.8, or 31.5 mg/kg/day (males) and 0, 2.4, 8.2, or 28.7 mg/
kg/day (females) with a NOEL of 2.1 mg/kg/day for systemic effects 
based on an increase in mortality rate in females at the two higher 
doses. There were no treatment-related carcinogenic effects at any dose 
level.
    9. Acceptable studies on gene mutation (Salmonella, E. coli and 
mouse lymphoma assays), structural chromosomal aberration (in vivo 
micronucleus assay in mice), and other genotoxic effects (unscheduled 
DNA synthesis assay with rat hepatocytes) yielded negative results.
    10. Pharmacokinetic and metabolism studies which indicated that 
approximately 80 to 90 percent of the orally administered dose of 
glufosinate-ammonium remained unabsorbed and was eliminated in the 
feces. Approximately 10 to 15 percent was eliminated in the urine. The 
major metabolic pathway is oxidative deamination yielding the 
metabolite, 3-methylphospinicopropionic acid.
    The chronic analysis used a Reference Dose (RfD) of 0.02 mg/kg body 
weight/day, based on a no-observed-effect level (NOEL) of 2.1 mg/kg/day 
and an uncertainty factor of 100. The NOEL is based on a 2-year rat 
feeding study that demonstrated increased absolute and relative kidney 
weight in males as an endpoint effect.
    Using tolerance-level residues and assumptions that 100 percent of 
every crop for which glufosinate-ammonium has a proposed or published 
use is treated, the total Theoretical Maximum Residue Contribution 
(TMRC) for the general population is 1%, for nonnursing infants it is 4 
%. EPA believes exposure below 100% of the RFD for chronic effect 
presents no appreciable risk.
    A data gap currently exists for a rat carcinogenicity study. The 
tolerances will be time-limited because of this gap. The time 
limitation allows for development and review of the data.
    There are presently no actions pending against the continued 
registration of this chemical. The metabolism of glufosinateammonium in 
plants is adequately understood. There is no reasonable expectation 
that secondary residues will occur in meat, fat, and meat byproducts of 
cattle, goats, hogs, horses, sheep, or poultry, and there is no 
reasonable expectation that secondary residues will occur in eggs or 
milk.
    An adequate analytical method, gas chromatography with flame 
photometric detection (P-mode), is available for enforcement purposes. 
Because of the long lead time from establishing this tolerance to 
publication of the enforcement methodology in the Pesticide Analytical 
Manual, Vol. II, the analytical methodology is being made available in 
the interim to anyone interested in pesticide enforcement when 
requested from: Calvin Furlow, Public Response and Program Branch, 
Field Operations Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
The office location and telephone number are: Rm. 242, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA 22202, (703-305-4432).
    Based on the information and data considered, the Agency has 
determined that the tolerance established by amending 40 CFR part 180 
would protect the public health. Therefore, it is proposed that the 
tolerance 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.
    Interested persons are invited to submit written comments on the 
proposed regulation. Comments must bear a notation indicating the 
document control number, [PP 2E4057/P594]. 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 p.m., Monday through Friday, except legal holidays.
    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: October 25, 1994.

Stephen L. Johnson,
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. 180.473, by redesignating existing paragraph (b) as new 
paragraph (c) and adding new paragraph (b), to read as follows:


Sec. 180.473   Glufosinate ammonium; tolerances for residues.

* * * * *
    (b)(1) A tolerance, to expire on (date 5 years after the date of 
publication of the final rule in the Federal Register), is established 
as follows for combined residues of glufosinate ammonium (monoammonium 
2-amino-4-(hydroxymethylphosphinyl) butanoate) and its metabolite 3-
methylphosphinicopropionic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl)butanoic acid equivalents.

------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
                                                                        
Bananas....................................................     0.3 (Not
                                                               more than
                                                                 0.2 ppm
                                                                shall be
                                                              present in
                                                                the pulp
                                                              after peel
                                                                      is
                                                               removed).
                                                                        
------------------------------------------------------------------------

    (2) There are no U.S. registrations as of August 24, 1994, for 
bananas.
* * * * *

[FR Doc. 94-27842 Filed 11-10-94; 8:45 am]
BILLING CODE 6560-50-F