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glufosinate-ammonium (Rely, Finale) Pesticide Tolerances 12/95

[Federal Register: December 13, 1995 (Volume 60, Number 239)]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 8F3607/R2184; FRL-4985-3]
RIN 2070-AB78
Glufosinate Ammonium; Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This document establishes time-limited tolerances for residues 
of the herbicide glufosinate ammonium (butanoic acid, 2-amino-4-
(hydroxymethylphosphinyl)-, monoammonium salt) and its metabolite, 3-
methylphosphinico-propionic acid, in or on various raw agricultural 
commodities (RAC's). AgrEvo USA Co. submitted a petition to EPA under 
the Federal Food, Drug and Cosmetic Act (FFDCA) requesting the 
tolerances. The document also conforms the chemical expression for the 
herbicide to Chemical Abstract nomenclature.
EFFECTIVE DATE: This regulation becomes effective December 13, 1995. 
The tolerances will expire on July 13, 1999.
ADDRESSES: Written objections and hearing requests, identified by the 
document control number, [PP 8F3607/R2184], may be submitted to: 
Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M 
St., SW., Washington, DC 20460. Fees accompanying objections and 
hearing requests 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 requests filed with the Hearing Clerk should be 
identified by the document control 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 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: opp-docket@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 in 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 
8F3607/R2184]. 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 submissions can be 
found below in this document.
FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller, Product 
Manager (PM) 23, Registration Division (7505C), 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)-305-6224; e-mail: 
miller.joanne@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of July 26, 1995 (60 
FR 38334), EPA issued a notice announcing that AgrEvo USA Co., Little 
Falls One, 2711 Centerville Rd., Wilmington, DE 19808, had submitted an 
amendment to PP 8F3607 (published at 53 FR 18897, May 25, 1988) 
proposing to amend 40 CFR 180.473 by adding tolerances for residues of 
glufosinate ammonium and its metabolite, 3-methylphosphinico-propionic 
acid, in or on the following raw agricultural commodities: Tree nuts 
group at 0.10 ppm, almond hulls at 0.50 ppm, cattle fat at 0.05 ppm, 
cattle meat at 0.05 ppm, cattle meat byproducts (mbyp) at 0.10 ppm, 
eggs at 0.05 ppm, goat fat at 0.05 ppm, goat meat at 0.05 ppm, goat 
mbyp at 0.10 ppm, hog fat at 0.05 ppm, hog meat at 0.05 ppm, hog mbyp at 
0.10 ppm, horse fat at 0.05 ppm, horse meat at 0.05 ppm, horse mbyp at 0.10
ppm, milk at 0.02 ppm, poultry fat at 0.05 ppm, poultry meat at 0.05 ppm,
poultry mbyp at 0.10 ppm, sheep fat at 0.05 ppm, sheep meat at 0.05 ppm, and
sheep mbyp at 0.10 ppm. Almonds are not considered a poultry feed 
commodity under present EPA Guidelines, and AgrEvo USA Co. has 
requested that the proposed tolerances for secondary residues in eggs, 
poultry fat, meat, and meat byproducts be deleted from the tolerances 
requested. This document also amends 40 CFR 180.473 to change the 
chemical expression for the herbicide to that given above in conformity 
with Chemical Abstract nomenclature.
    The chemical expression for glufosinate ammonium has been changed 
to follow that given by the Chemical Abstracts Index Name for this 
chemical. This action is taken in concert with the final rule for 
Premanufacture Notification; Revisions of Premanufacture Notification 
Regulations, published in the Federal Register of March 29, 1995 (60 FR 
16298-16310). The proposed analytical method for determining residues 
is high-pressure liquid chromatography.
    There were no comments or requests for referral to an advisory 
committee received in response to the notice of filing.
    The data submitted in the petition and other relevant material have 
been evaluated. The toxicology data listed below were considered in 
support of these tolerances.
    1. A battery of acute toxicity studies placing technical 
glufosinate-ammonium in Toxicity Categories II and III.
    2. 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.
    3. A 90-day feeding study in mice at dietary intakes of 0, 16.6, 
67.1, or 278 mg/kg/day with a NOEL of 16.6 mg/kg/day and an 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).
    4. 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.
    5. 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.
    6. A two-generation reproduction study in rats at dietary 
concentrations of 0, 40, 120, or 360 ppm with an 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.
    7. 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.
    8. 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.
    9. 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 an 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.
    10. 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.
    11. Pharmacokinetic and metabolism studies in rats 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-methyl-phospinico propionic acid.
    The chronic analysis used a Reference Dose (RfD) of 0.02 mg/kg/ 
body weight day, based on an 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 use is 
treated, the total Theoretical Maximum Residue Contribution (TMRC) for 
the general population and the highest exposed subgroup in DRES are as 
follows (as percents of RFD): General population, 0.627 percent; 
nonnursing infants less than 1-year-old, 3.7 percent.
    A data gap currently exists for a rat carcinogenicity study. All 
tolerances are time-limited because of this gap. The time limitation 
allows for development and review of the data.
    The analysis for glufosinate-ammonium using tolerance level 
residues suggests that the proposed uses on apples, grapes, and tree 
nut group will not cause exposure to exceed the levels at which the 
Agency believes there is an appreciable risk. All DRES subgroups are 
below 100 of the RfD for chronic effects.
    The pesticide is useful for the purposes for which these tolerances 
are sought. The nature of the residues is adequately understood for the 
purpose of establishing these tolerances. Adequate analytical 
methodology (gas chromatography with flame photometric detection of 
phosphorus) is available for enforcement purposes. Because of the long 
lead time from establishing these tolerances to publication, the 
enforcement methodology is being made available in the interim to 
anyone interested in pesticide enforcement when requested by mail from: 
Calvin Furlow, Public Response Branch, Field Operations Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. Office location and telephone 
number: Rm. 1130A, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 
22202, (703)-305-5937.
    Based on the information cited above, the Agency has determined 
that the establishment of the time-limited tolerances by amending 40 
CFR 180.473 will protect the public health; therefore, the time-limited 
tolerances are established 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 and/or request a hearing 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 a hearing is 
requested, the requestor's contentions on such issues, 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 possibility that 
available evidence identified by the requestor would, if established, 
resolve one or more of such 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 8F3607/R2184] (including any 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 document 
control number [PP 8F3607/R2184], 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 official rulemaking record which will 
also include all objections and hearing requests 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 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 obligations 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 the 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: November 30, 1995.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR part 180 is 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 revising paragraph (a), to read as follows:
Sec. 180.473   Glufosinate ammonium; tolerances for residues.
    (a)(1) Time-limited tolerances are established for residues of the 
herbicide glufosinate ammonium (butanoic acid, 2-amino-4-(hydroxymethyl
phosphinyl)-, monoammonium salt) and its metabolite, 3-methylphosphinico-
propionic acid, in or on the following raw agricultural commodities:
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                                                 Parts per    Expiration
                   Commodity                      million        date   
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Almond hulls..................................     0.50     July 13, 1999
Apples........................................     0.05          Do.
Cattle, fat...................................     0.05          Do.
Cattle, meat..................................     0.05          Do.
Cattle, mbyp..................................     0.10          Do.
Goats, fat....................................     0.05          Do.
Goats, meat...................................     0.05          Do.
Goats, mbyp...................................     0.10          Do.
Grapes........................................     0.05          Do.
Hogs, fat.....................................     0.05          Do.
Hogs, meat....................................     0.05          Do.
Hogs, mbyp....................................     0.10          Do.
Horses, fat...................................     0.05          Do.
Horses, meat..................................     0.05          Do.
Horses, mbyp..................................     0.10          Do.
Milk..........................................     0.02          Do.
Sheep, fat....................................     0.05          Do.
Sheep, meat...................................     0.05          Do.
Sheep, mbyp...................................     0.10          Do.
Tree nuts group...............................     0.1           Do.
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    (2) Residues in these commodities not in excess of the established 
tolerances resulting from the uses described in paragraph (a)(1) of 
this section remaining after expiration of the time-limited tolerance 
will not be considered to be actionable if the herbicide is applied 
during the term of and in accordance with the provisions of paragraph 
(a)(1) of this section.
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