[Federal Register Volume 64, Number 213 (Thursday, November 4, 1999)]
[Rules and Regulations]
[Pages 60112-60121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-28887]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300945; FRL-6391-5]
RIN 2070-AB78
Glufosinate Ammonium; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for combined residues
of glufosinate ammonium (butanoic acid, 2-amino-4-
(hydroxymethylphosphinyl)-mono ammonium salt) and metabolite(s) (3-
methylphosphinico-propionic acid and 2-acetamido-4-methylphosphinico-
butanoic acid), expressed as 2-amino-4-(hydroxymethylphosphinyl)
butanoic acid equivalents in or on almond hulls; apples; bananas;
cattle fat, meat and meat-byproducts; eggs; goat fat, meat, and meat-
by-products; grapes, hog fat, meat, and meat-by-products; horse fat,
meat, and meat-by-products; milk; potatoes, potato chips and granules/
flakes; poultry fat, meat, and meat-by-products; sheep fat, meat, and
meat-by-products; transgenic aspirated grain fractions, transgenic
corn, field, forage; transgenic corn, field, grain; transgenic corn,
field, stover; transgenic soybean hulls, transgenic soybeans, and tree
nuts group. AgrEvo USA Company requested these tolerances under the
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality
Protection Act of 1996. This regulation also corrects the existing
regulation for time-limited tolerances for transgenic canola and sweet
corn commodities.
DATES: This regulation is effective November 4, 1999. Objections and
requests for hearings, identified by docket control number OPP-300945,
must be received by EPA on or before January 3, 2000.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the ``SUPPLEMENTARY
INFORMATION'' section. To ensure proper receipt by EPA, your objections
and hearing requests must identify docket control number OPP-300945 in
the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460;
telephone number: (703) 305-6224 and e-mail address:
miller.joanne@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
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Examples of Potentially
Categories NAICS Affected Entities
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Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed in the ``FOR FURTHER INFORMATION
CONTACT'' section.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically.You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations'' and then look up the entry for this document under the
``Federal Register--Environmental Documents.'' You can also go directly
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
2. In person. The Agency has established an official record for
this action under docket control number OPP-300945. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of October 8, l997, (62 FR 52544) (FRL-
5746-9) and July 14, l999 (64 FR 37973) (FRL-6085-5), EPA issued
notices pursuant to section 408 of the Federal Food, Drug, and Cosmetic
Act (FFDCA), 21 U.S.C. 346a(d) as amended by the Food Quality
Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the
filing of a pesticide petition (PP) for tolerance by AgrEvo USA
Company, Little Falls
[[Page 60113]]
Centre One, 2711 Centerville Road, Wilmington, DE 19808. These notices
included a summary of the petition prepared by AgrEvo USA Company, the
registrant. There were no comments received in response to the notices
of filing.
These petitions requested that 40 CFR 180.473 be amended by
establishing permanent tolerances for combined residues of the
herbicide glufosinate ammonium and its metabolite(s) expressed as 2-
amino-4-(hydroxymethylphosphinyl) butanoic acid in or on almond hulls
at 0.50 part per million (ppm), apples at 0.05 ppm, bananas at 0.3 ppm
(not more than 0.2 ppm shall be present in the pulp after peel is
removed), cattle, fat and meat at 0.05 ppm; cattle, meat-by-products at
0.10 ppm; eggs at 0.05 ppm, goats, fat and meat at 0.05 ppm; goats,
meat-by-products at 0.10 ppm; grapes at 0.05 ppm; hogs, fat and meat at
0.05 ppm; hogs, meat-by-product at 0.10 ppm; horses, fat and meat at
0.05 ppm; horses, meat-by-products at 0.10 ppm; milk at 0.02 ppm,
potatoes at 0.8 ppm, potato chips at 1.6 ppm, potato granules/flakes at
2.0 ppm, poultry, fat and meat at 0.05 ppm; poultry, meat-by-products
at 0.10 ppm; sheep, fat and meat at 0.05 ppm; sheep, meat-by-products
at 0.10 ppm; transgenic aspirated grain fractions at 25.0 ppm,
transgenic corn, field, forage at 4.0 ppm; trangenic corn, field, grain
at 0.2 ppm; transgenic corn, field stover at 6.0 ppm; transgenic
soybeans hulls at 5.0 ppm, transgenic soybeans at 2.0 ppm and tree nut
group at 0.1 ppm.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for permanent tolerances for combined residues of
glufosinate ammonium and its metabolite(s) in or on almond hulls at
0.50 ppm, apples at 0.05 ppm, bananas at 0.3 ppm (not more that 0.2 ppm
shall be present in the pulp after peel is removed), cattle, fat and
meat at 0.05 ppm; cattle, meat-by-products at 0.10 ppm, eggs at 0.05
ppm, goats, fat and meat at 0.05 ppm; goats, meat-by-products at 0.10
ppm; grapes at 0.05 ppm, hogs, fat and meat at 0.05 ppm; hogs, meat-by-
product at 0.10 ppm; horses, fat and meat at 0.05 ppm; horses, meat-by-
products at 0.10 ppm; milk at 0.02 ppm; potatoes at 0.8 ppm; potato
chips at 1.6 ppm; potato granule/flakes at 2.0 ppm; poultry, fat and
meat at 0.05 ppm; poultry, meat-by-products at 0.10 ppm; sheep, fat and
meat at 0.05 ppm; sheep, meat-by-products at 0.10 ppm; transgenic
aspirated grain fractions at 25.0 ppm, transgenic corn, field, forage
at 4.0 ppm; transgenic corn, field, grain at 0.2 ppm; transgenic corn,
field, stover at 6.0 ppm; transgenic soybeans, hulls at 5.0 ppm;
transgenic soybeans at 2.0 ppm and tree nuts group at 0.1 ppm. The
addition (a corrective action on the Administrator's own initiative
under section 408(e)(A)(C) of a second metabolite (2-acetamido-4-
methylphosphinico-butamoic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl) butanoic acid equivalents) to the residues of
glufosinate ammonium found in transgenic canola and sweet corn
commodities is consistent with section 408(b)(2)(D) and is appropriate
because the second metabolite consistently occurs in commodities
derived from transgenic plants. The risk assessment included the second
metabolite found in canola and sweet corn commodities. EPA's assessment
of the dietary exposures and risks associated with establishing these
tolerances follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by are discussed in
this unit.
1. Glufosinate ammonium (also referred to as DL-glufosinate
ammonium or HOE 039866 ) is toxicity category III for acute oral,
dermal, and eye irritation toxicities. It is toxicity category III for
inhalation toxicity. It is not a dermal irritant (toxicity category IV)
nor is it a dermal sensitizer.
2. In a sub-chronic oral toxicity study, glufosinate-ammonium
(95.3% active ingredient (a.i.)) was administered to 10 NMRI mice/sex/
dose in the diet at levels of 0, 80, 320 or 1,280 ppm (equivalent to 0,
12, 48 or 192 millgrams/kilogram/day (mg/kg/day)) for 13 weeks.
Significant (p< 0.05)="" increases="" were="" observed="" in="" serum="" aspartate="" aminotransferase="" and="" in="" alkaline="" phosphatase="" in="" high-dose="" (192="" mg/kg/="" day)="" males.="" also="" observed="" were="" increases="" in="" absolute="" and="" relative="" liver="" weights="" in="" mid-(48="" mg/kg/day)="" and="" high-dose="" males.="" the="" no="" observed="" adverse="" effect="" level="" (noael)="" is="" 12="" mg/kg/day,="" the="" lowest="" observed="" adverse="" effect="" level="" (loael)="" is="" 48="" mg/kg/day="" based="" on="" the="" changes="" in="" clinical="" biochemistry="" and="" liver="" weights.="" 3.="" in="" a="" 21-day="" repeated="" dose="" dermal="" toxicity="" study,="" groups="" of="" 6="" male="" and="" 6="" female="" wistar="" rats="" were="" treated="" with="" hoe="" 039866="" (95.3%)="" in="" deionized="" water="" by="" dermal="" occlusion="" at="" doses="" of="" 0,="" 100,="" 300="" or="" 1,000="" mg/kg/day,="" 6="" hours/day,="" 5="" days/week="" for="" 21="" applications="" in="" 30="" days.="" an="" additional="" five="" males="" and="" five="" females/dose="" group="" were="" dose="" and="" observed="" for="" 44="" days="" in="" a="" ``recovery="" study''.="" two="" of="" 6="" ldt="" males="" at="" 300="" mg/kg/day,="" and="" 4="" of="" 11="" males="" and="" two="" of="" 11="" females="" at="" 1,000="" mg/kg/day="" displayed="" aggressive="" behavior,="" piloerection="" and="" a="" high="" startle="" response.="" there="" were="" no="" effects="" of="" toxicological="" importance="" on="" body="" weights,="" food="" consumption,="" hematology,="" clinical="" chemistry,="" urinalysis,="" organ="" weights,="" or="" gross="" or="" microscopic="" pathology.="" based="" on="" clinical="" observations,="" the="" loael="" is="" 300="" mg/kg/day="" and="" the="" noael="" is="" 100="" mg/kg/="" day.="" 4.="" in="" an="" oncogenicity="" study,="" hoe="" 039866="" (glufosinate="" ammonium)="" was="" administered="" to="" 50="" nmri="" mice/sex/dose="" in="" the="" diet="" at="" dose="" levels="" of="" 0,="" 80,="" 160="" (males="" only)="" or="" 320="" (females="" only)="" ppm="" for="" 104="" weeks.="" dose="" levels="" corresponded="" to="" 0,="" 2.83,="" 10.82,="" 22.60="" mg/kg/day="" in="" males="" and="" 0,="" 4.23,="" 16.19,="" 66.96="" mg/kg/="" [[page="" 60114]]="" day="" in="" females.="" the="" noael="" for="" systemic="" toxicity="" is="" 80="" ppm="" (10.82/16.19="" mg/kg/day="" in="" males/females="" (m/f)),="" and="" the="" loael="" is="" 160/320="" ppm="" (22.60/="" 63.96="" mg/kg/day="" in="" m/f),="" based="" on="" increased="" mortality="" in="" males,="" increased="" glucose="" levels="" in="" males="" and="" females,="" and="" consistent="" changes="" in="" glutathione="" levels="" in="" males.="" no="" increase="" in="" tumor="" incidence="" was="" found="" in="" any="" treatment="" group.="" 5.="" in="" a="" chronic="" feeding="" study,="" hoe="" 039866="" technical="" was="" fed="" to="" male="" and="" female="" beagle="" dogs="" for="" 12="" months="" in="" the="" diet="" at="" levels="" of="" 2.0,="" 5.0="" or="" 8.5="" mg/kg/day.="" there="" were="" no="" overt="" signs="" of="" toxicity="" or="" dose-="" related="" effects="" on="" body="" weight,="" food="" consumption,="" ophthalmology,="" hematology,="" clinical="" chemistry,="" urinalyses="" or="" organ="" weights.="" two="" dogs="" receiving="" 8.5="" mg/kg/day="" died="" during="" the="" study="" as="" a="" result="" of="" heart="" and="" circulatory="" system="" failure="" from="" rapid="" diet="" consumption="" and="" necrotizing="" aspiration="" pneumonia.="" electrocardiogram="" results="" of="" dosed="" males="" and="" females="" indicated="" a="" dose-related="" decrease="" in="" heart="" rate="" at="" 6="" months;="" heart="" rates="" of="" dosed="" animals="" at="" 12="" months="" were="" considered="" to="" be="" normal.="" the="" noael="" is="" 5.0="" mg/kg/day,="" the="" loael="" is="" 8.5="" mg/kg/day="" based="" on="" mortality.="" 6.="" in="" a="" rat="" oncogenicity="" study,="" glufosinate-ammonium="" (95.2-96.0%="" a.i.)="" was="" administered="" to="" wistar="" rats="" (60/sex/group)="" for="" up="" to="" 24="" months="" at="" 0,="" 1,000,="" 5,000,="" or="" 10,000="" ppm="" (equivalent="" to="" 0,="" 45.4,="" 228.9,="" or="" 466.3="" mg/kg/day="" in="" males="" and="" 0,="" 57.1,="" 281.5,="" or="" 579.3="" mg/kg/day="" in="" females).="" the="" loael="" for="" chronic="" toxicity="" is="" 5,000="" ppm="" (equivalent="" to="" 228.9="" mg/kg/day="" for="" male="" rats="" and="" 281.5="" mg/kg/day="" for="" females),="" based="" on="" increased="" incidences="" of="" retinal="" atrophy.="" the="" chronic="" noael="" is="" 1,000="" ppm.="" under="" the="" conditions="" of="" this="" study,="" there="" was="" no="" evidence="" of="" carcinogenic="" potential.="" dosing="" was="" considered="" adequate="" based="" on="" increased="" incidences="" of="" retinal="" atrophy.="" 7.="" in="" a="" combined="" chronic="" toxicity/oncogenicity="" study,="" glufosinate="" ammonium="" was="" administered="" to="" 50="" wistar="" rats/sex/dose="" in="" the="" diet="" for="" 24="" months="" at="" dose="" levels="" of="" 0,="" 40,="" 140,="" or="" 500="" ppm="" (mean="" compound="" intake="" in="" males="" was="" 0,="" 1.9,="" 6.8,="" and="" 24.4="" mg/kg/day="" and="" for="" females="" was="" 0,="" 2.4,="" 8.2="" and="" 28.7="" mg/kg/day,="" respectively).="" the="" loael="" is="" 2.4="" mg/kg/day="" (ldt)="" based="" on="" the="" increase="" in="" kidney="" glutamine="" synthetase="" activity="" and="" increased="" kidney="" weights="" in="" females.="" a="" noael="" was="" not="" established.="" there="" was="" no="" clear="" demonstration="" of="" increased="" tumor="" incidence="" following="" exposure="" to="" glufosinate="" ammonium.="" dosing="" was="" considered="" adequate="" based="" on="" the="" increase="" in="" kidney="" glutamine="" synthetase="" activity="" and="" increased="" kidney="" weights="" in="" females.="" 8.="" in="" a="" developmental="" toxicity="" study,="" groups="" of="" 20="" pregnant="" female="" wistar="" rats="" were="" administered="" by="" gavage="" hoe="" 039866="" (glufosinate="" ammonium,="" 96.9="" a.i.)="" at="" doses="" of="" 0,="" 0.5,="" 2.24="" 10,="" 50="" and="" 250="" mg/kg/day="" from="" days="" 7="" to="" 16="" of="" pregnancy.="" the="" noael="" for="" maternal="" toxicity="" is="" 10="" mg/kg/day;="" the="" loael="" is="" 50="" mg/kg/day="" based="" on="" vaginal="" bleeding="" and="" hyperactivity="" in="" dams.="" in="" the="" fetus,="" the="" noael="" is="" 50="" mg/kg/day,="" based="" on="" dilated="" renal="" pelvis="" at="" the="" loael="" of="" 250="" mg/kg/day.="" 9.="" in="" a="" developmental="" toxicity="" study,="" groups="" of="" 15="" pregnant="" female="" himalayan="" rabbits="" were="" administered="" by="" gavage="" hoe="" 039866="" at="" doses="" of="" 0,="" 2.0,="" 6.3="" or="" 20.0="" mg/kg/day="" from="" days="" 7="" to="" 19="" of="" pregnancy.="" the="" noael="" for="" both="" maternal="" toxicity="" and="" developmental="" toxicity="" was="" 2.0="" mg/kg/="" day.="" the="" loael="" is="" 6.3="" mg/kg/day="" based="" on="" reduced="" food="" consumption,="" body="" weight="" and="" weight="" gains="" and="" increased="" kidney="" weights="" in="" dams,="" and="" incomplete="" ossification="" in="" fetuses="" with="" fetal="" death="" at="" 20="" mg/kg/day.="" 10.="" in="" a="" multigeneration="" reproduction="" study,="" glufosinate="" ammonium="" was="" administered="" to="" groups="" of="" 30="" male="" and="" 30="" female="" wistar/han="" rats="" in="" the="" diet="" at="" concentrations="" of="" 0,="" 40,="" 120="" or="" 360="" ppm="" (approximately="" 2.0,="" 6.0,="" 18.0="" mg/kg).="" the="" loael="" for="" systemic="" toxicity="" is="" 120="" ppm="" (6="" mg/kg/="" day)="" based="" on="" increased="" kidney="" weights="" in="" both="" sexes="" and="" generations.="" the="" systemic="" toxicity="" noael="" is="" 40="" ppm="" (2="" mg/kg/day).="" the="" loael="" for="" reproductive/developmental="" toxicity="" is="" 360="" ppm="" (18="" mg/kg/day)="" based="" on="" decreased="" number="" of="" viable="" pups="" in="" all="" generations.="" the="" noael="" is="" 120="" ppm.="" 11.="" there="" is="" no="" concern="" for="" mutagenic="" activity="" in="" several="" studies,="" including:="" salmonella="" spp.,="" e.="" coli,="" in="" vitro="" mammalian="" cell="" gene="" mutation="" assays,="" mammalian="" cell="" chromosome="" aberration="" assays,="" in="" vivo="" mouse="" bone="" marrow="" micronucleus="" assays,="" and="" unscheduled="" dna="" synthesis="" assays.="" 12.="" a="" rat="" metabolism="" study="" with="" dermal="" application="" showed="" that="" about="" 50%="" of="" the="" given="" radioactivity="" is="" absorbed="" 48="" hours="" after="" a="" single="" dose="" application.="" in="" other="" metabolism="" studies,="" it="" was="" shown="" that="" over="" 80%="" of="" administered="" radioactivity="" is="" excreted="" within="" 24="" to="" 48="" hours="" as="" the="" parent="" compound="" in="" the="" feces="" and="" kidneys.="" highest="" tissue="" levels="" were="" found="" in="" liver,="" kidney="" and="" gonads.="" a="" consistent="" pattern="" of="" neurotoxicity="" was="" seen="" in="" several="" studies,="" including="" the="" subchronic,="" developmental="" and="" chronic="" studies="" in="" rats,="" mice="" and="" dogs.="" in="" addition="" to="" the="" clinical="" signs="" such="" as="" hyperactivity,="" aggressive="" behavior,="" piloerection,="" high="" startle="" response,="" retinal="" atrophy="" was="" observed.="" changes="" in="" glutamine="" synthetase="" levels="" were="" observed="" in="" liver,="" kidney="" and="" brain="" in="" rats.="" these="" occurrences="" raise="" concern="" for="" the="" mechanism="" of="" neurotoxicity="" in="" these="" studies,="" an="" area="" where="" there="" are="" data="" gaps.="" it="" is="" expected="" that="" the="" requested="" neurotoxicity="" studies="" will="" provide="" the="" information="" needed="" for="" further="" characterization="" of="" these="" effects.="" additional="" testing="" was="" conducted="" with="" the="" major="" metabolites,="" hoe="" 061517="" and="" hoe="" 099730,="" as="" well="" as="" the="" l-isomer,="" identified="" as="" hoe="" 058192.="" these="" compounds,="" tested="" in="" subchronic="" rat,="" mouse="" and="" dog="" studies,="" and="" in="" developmental="" toxicity="" studies="" in="" rat="" and="" rabbit="" showed="" a="" similar="" profile="" of="" toxicity="" as="" the="" parent="" compound="" (hoe="" 039866).="" b.="" toxicological="" endpoints="" 1.="" acute="" toxicity.="" an="" acute="" reference="" dose="" (rfd)="" was="" not="" established="" for="" the="" general="" population.="" no="" appropriate="" toxicological="" endpoint="" attributable="" to="" a="" single="" exposure="" was="" identified="" in="" the="" available="" toxicity="" studies.="" however,="" an="" acute="" rfd="" of="" 0.063="" mg/kg/day="" was="" established="" for="" the="" females="" 13+="" subgroup,="" based="" on="" a="" developmental="" noael="" of="" 6.3="" mg/kg/day="" in="" the="" rabbit="" and="" a="" 100x="" uncertainty="" factor="" (10x="" inter-="" 10x="" intra-species="" extrapolation).="" the="" developmental="" loael="" (20="" mg/kg/day)="" was="" based="" on="" reduced="" fetal="" body="" weight="" and="" increased="" fetal="" death.="" the="" fqpa="" safety="" factor="" of="" 10x="" was="" reduced="" to="" 3x="" because="" there="" was="" no="" qualitative="" or="" quantitative="" indication="" of="" increased="" susceptibility="" in="" the="" prenatal="" developmental="" toxicities="" in="" rats="" and="" rabbits="" or="" in="" the="" 2-generation="" reproductive="" study="" in="" rats="" with="" parent="" compound,="" the="" isomer="" or="" metabolites="" of="" concern.="" toxicological="" studies="" showed="" neurological="" effects="" in="" short="" term="" studies="" described="" as="" aggressive="" behavior,="" piloerection="" and="" a="" high="" startle="" response="" at="" dosages="" of="" 300="" mg/kg/day.="" based="" on="" these="" effects,="" epa="" determined="" that="" a="" 3x="" fqpa="" safety="" factor="" was="" appropriate="" for="" the="" risk="" assessment="" for="" the="" food="" and="" feed="" used="" of="" glufosinate="" ammonium.="" using="" the="" 3x="" fqpa="" safety="" factor,="" the="" acute="" population="" adjusted="" dose="" (apad)="" for="" glufosinate="" ammonium="" is="" 0.021="" mg/kg/day.="" 2.="" short-,="" intermediate-,="" and="" long-term="" toxicity.--i.="" dermal.="" short-="" and="" intermediate-term="" dermal="" toxicity="" risk="" assessments="" were="" recommended="" based="" on="" neurological="" clinical="" signs="" (hyperactivity,="" aggressive="" behavior,="" pilo="" erection)="" observed="" in="" the="" 21-day="" dermal="" study="" at="" 300="" mg/kg/day="" (loael).="" the="" noael="" was="" 100="" mg/kg/day.="" a="" long-="" [[page="" 60115]]="" term="" dermal="" risk="" assessment="" was="" recommended="" based="" on="" the="" noael="" of="" 2.1="" mg/kg/day="" established="" in="" the="" 2-year="" chronic="" study="" in="" rats="" (see="" chronic="" dietary;="" 50%="" dermal="" absorption).="" ii.="" inhalation.="" with="" the="" exception="" of="" an="" acute="" inhalation="" study,="" no="" other="" inhalation="" studies="" were="" available.="" therefore,="" oral="" noaels="" were="" selected="" for="" inhalation="" risk="" assessments.="" because="" an="" oral="" dose="" was="" used,="" the="" exposure="" assessments="" was="" conducted="" by="" converting="" the="" application="" rate="" to="" oral="" equivalents="" and="" assuming="" 100%="" absorption.="" short-term="" inhalation="" risk="" assessments="" were="" recommended="" based="" on="" the="" developmental="" noael="" of="" 6.3="" mg/kg/day="" in="" the="" rabbit="" (see="" acute="" dietary="" endpoint).="" intermediate-term="" inhalation="" risk="" assessments="" were="" recommended="" based="" on="" the="" noael="" of="" 2.1="" mg/kg/day="" from="" the="" 2-year="" chronic="" rat="" study="" (see="" chronic="" dietary="" endpoint="" below).="" 3.="" chronic="" toxicity.="" epa="" has="" established="" the="" rfd="" for="" glufosinate="" ammonium="" at="" 0.021="" mg/kg/day="" based="" on="" the="" noael="" of="" 2.1="" mg/kg/day="" in="" the="" 2-year="" chronic="" study="" in="" rats="" and="" a="" 100x="" uncertainty="" factor="" (10x="" inter-="" 10x="" intra-species="" extrapolation).="" the="" loael="" in="" the="" study="" was="" based="" on="" increased="" kidney="" weight="" and="" kidney/brain="" weight="" in="" males="" at="" 52="" weeks="" (6.8="" mg/kg/day)="" and="" decreased="" survival="" in="" females="" at="" 130="" weeks="" (8.2="" mg/="" kg/day).="" using="" the="" 3x="" fqpa="" safety="" factor,="" the="" chronic="" population="" adjusted="" dose="" (cpad)="" for="" glufosinate="" ammonium="" is="" 0.007="" mg/kg/day.="" 4.="" carcinogenicity.="" based="" on="" a="" lack="" of="" mutagenic="" potential="" as="" assessed="" in="" a="" battery="" of="" mutagenicity="" assays="" and="" the="" absence="" of="" treatment-related="" tumors="" in="" rats="" and="" mice="" at="" dose="" levels="" adequate="" for="" assessment,="" the="" epa="" has="" determined="" that="" glufosinate="" ammonium="" is="" not="" likely="" a="" carcinogen;="" and="" has="" classified="" it="" as="" a="" ``group="" e="" --="" evidence="" of="" non-carcinogenicity="" for="" humans''="" chemical.="" c.="" exposures="" and="" risks="" 1.="" from="" food="" and="" feed="" uses.="" tolerances="" have="" been="" established="" (40="" cfr="" 180.473="" for="" the="" combined="" residues="" of="" glufosinate="" ammonium="" and="" its="" metabolites,="" in="" or="" on="" a="" variety="" of="" raw="" agricultural="" commodities.="" all="" tolerances="" listed="" under="" unit="" iii="" of="" this="" rule="" except="" those="" for="" potatoes="" at="" 0.8="" ppm,="" potato="" chips="" at="" 1.6="" ppm,="" potato="" granules/flakes="" at="" 2.0="" ppm,="" were="" previously="" established="" as="" time-limited="" tolerances="" with="" expiration="" dates.="" this="" rule="" addresses="" a="" pending="" petition="" for="" these="" tolerances="" and="" the="" establishment="" of="" the="" time-limited="" tolerances="" as="" permanent="" tolerances="" for="" this="" pesticide.="" risk="" assessments="" were="" conducted="" by="" epa="" to="" assess="" dietary="" exposures="" from="" tolerance="" levels="" of="" residue="" as="" follows:="" section="" 408(b)(2)(f)="" states="" that="" the="" agency="" may="" use="" data="" on="" the="" actual="" percent="" of="" crop="" treated="" (pct)="" for="" assessing="" chronic="" dietary="" risk="" only="" if="" the="" agency="" can="" make="" the="" following="" findings:="" that="" the="" data="" used="" are="" reliable="" and="" provide="" a="" valid="" basis="" to="" show="" what="" percentage="" of="" the="" food="" derived="" from="" such="" crop="" is="" likely="" to="" contain="" such="" pesticide="" residue;="" that="" the="" exposure="" estimate="" does="" not="" underestimate="" exposure="" for="" any="" significant="" sub-population="" group;="" and="" that="" if="" data="" are="" available="" on="" pesticide="" use="" and="" food="" consumption="" in="" a="" particular="" area,="" the="" exposure="" estimate="" does="" not="" understate="" exposure="" for="" the="" population="" in="" such="" area.="" in="" addition,="" the="" agency="" must="" provide="" for="" periodic="" evaluation="" of="" any="" estimates="" used.="" to="" provide="" for="" the="" periodic="" evaluation="" of="" the="" estimate="" of="" pct="" as="" required="" by="" section="" 408(b)(2)(f),="" epa="" may="" require="" registrants="" to="" submit="" data="" on="" pct.="" the="" agency="" used="" pct="" information="" as="" follows:="" the="" chronic="" dietary="" exposure="" analysis="" assumed="" tolerance="" level="" residues="" for="" all="" registered="" and="" proposed="" commodities.="" the="" weighted="" average="" percent="" crop="" treated="" was="" incorporated="" for="" all="" registered="" commodities.="" sweet="" corn="" and="" proposed="" commodities="" were="" maintained="" at="" 100%="" crop="" treated.="" the="" agency="" believes="" that="" the="" three="" conditions="" listed="" above="" have="" been="" met.="" the="" percent="" of="" crop="" treated="" estimates="" are="" derived="" from="" federal="" and="" private="" market="" survey="" data,="" which="" are="" reliable="" and="" have="" a="" valid="" basis.="" epa="" uses="" a="" weighted="" average="" percent="" crop="" treated="" for="" chronic="" dietary="" exposure="" estimates.="" this="" weighted="" average="" percent="" crop="" treated="" figure="" is="" derived="" by="" averaging="" state-level="" data="" for="" a="" period="" of="" up="" to="" 10="" years,="" and="" weighting="" for="" the="" more="" robust="" and="" recent="" data.="" a="" weighted="" average="" of="" the="" percent="" crop="" treated="" reasonably="" represents="" a="" person's="" dietary="" exposure="" over="" a="" lifetime,="" and="" is="" unlikely="" to="" underestimate="" exposure="" to="" an="" individual="" because="" of="" the="" fact="" that="" pesticide="" use="" patterns="" (both="" regionally="" and="" nationally)="" tend="" to="" change="" continuously="" over="" time,="" such="" that="" an="" individual="" is="" unlikely="" to="" be="" exposed="" to="" more="" than="" the="" average="" percent="" crop="" treated="" over="" a="" lifetime.="" for="" acute="" dietary="" exposure="" estimates,="" epa="" uses="" an="" estimated="" maximum="" percent="" crop="" treated.="" the="" exposure="" estimates="" resulting="" from="" this="" approach="" reasonably="" represent="" the="" highest="" levels="" to="" which="" an="" individual="" could="" be="" exposed,and="" are="" unlikely="" to="" underestimate="" an="" individual's="" acute="" dietary="" exposure.="" the="" agency="" is="" reasonably="" certain="" that="" the="" percentage="" of="" the="" food="" treated="" is="" not="" likely="" to="" be="" an="" underestimation.="" the="" regional="" consumption="" information="" and="" consumption="" information="" for="" significant="" subpopulations="" is="" taken="" into="" account="" through="" epa's="" computer-based="" model="" for="" evaluating="" the="" exposure="" of="" significant="" subpopulations="" including="" several="" regional="" groups.="" use="" of="" this="" consumption="" information="" in="" epa's="" risk="" assessment="" process="" ensures="" that="" epa's="" exposure="" estimate="" does="" not="" understate="" exposure="" for="" any="" significant="" subpopulation="" group="" and="" allows="" the="" agency="" to="" be="" reasonably="" certain="" that="" no="" regional="" population="" is="" exposed="" to="" residue="" levels="" higher="" than="" those="" estimated="" by="" the="" agency.="" other="" than="" the="" data="" available="" through="" national="" food="" consumption="" surveys,="" epa="" does="" not="" have="" available="" information="" on="" the="" regional="" consumption="" of="" food="" to="" which="" pesticide="" glufosinate="" ammonium="" may="" be="" applied="" in="" a="" particular="" area.="" i.="" acute="" exposure="" and="" risk.="" the="" acute="" dietary="" exposure="" analysis="" for="" females="" 13+="" (no="" acute="" dietary="" endpoint="" was="" identified="" for="" the="" general="" u.s.="" population="" including="" infants="" and="" children)="" assumed="" tolerance="" level="" residues="" and="" 100%="" crop="" treated="" for="" all="" registered="" and="" proposed="" commodities="" (tier="" 1="" analysis).="" the="" most="" highly="" exposed="" population="" was="" females="" 13+/nursing="" at="" 58%="" of="" the="" apad="" (95th="" percentile).="" acute="" dietary="" food="" exposure="" to="" glufosinate="" ammonium="" is="" below="" epa's="" level="" of="" concern.="" ii.="" chronic="" exposure="" and="" risk.="" the="" chronic="" dietary="" exposure="" analysis="" assumed="" tolerance="" level="" residues="" for="" all="" registered="" and="" proposed="" commodities.="" the="" weighted="" average="" percent="" crop="" treated="" was="" incorporated="" for="" all="" registered="" commodities.="" sweet="" corn="" and="" proposed="" commodities="" were="" maintained="" at="" 100%="" crop="" treated.="" the="" most="" highly="" exposed="" population="" was="" children="" 1-6="" years="" old="" at="" 71%="" of="" the="" cpad="" (0.004974="" mg/kg/day).="" chronic="" dietary="" food="" exposure="" to="" glufosinate="" ammonium="" is="" below="" epa's="" level="" of="" concern.="" 2.="" from="" drinking="" water.="" aggregate="" exposures="" are="" generally="" calculated="" by="" summing="" dietary="" (food="" and="" water)="" and="" residential="" exposures.="" if="" the="" aggregate="" exposure="" is="" less="" than="" the="" specified="" pad,="" the="" exposure="" is="" not="" expected="" to="" be="" a="" concern.="" because="" epa="" does="" not="" have="" ground="" and="" surface="" water="" monitoring="" data="" to="" calculate="" a="" quantitative="" aggregate="" exposure,="" a="" drinking="" water="" level="" of="" concentration="" (dwloc)="" was="" calculated.="" the="" dwloc="" is="" the="" upper="" limit="" of="" a="" chemical's="" concentration="" in="" drinking="" water="" that="" will="" result="" in="" an="" acceptable="" aggregate="" exposure.="" the="" dwloc="" is="" used="" as="" a="" point="" of="" comparison="" against="" model="" estimates="" of="" a="" pesticide's="" concentration="" [[page="" 60116]]="" in="" water.="" dwloc="" values="" are="" not="" regulatory="" standards="" for="" drinking="" water.="" they="" do="" have="" indirect="" regulatory="" impact="" through="" aggregate="" exposure="" and="" risk="" assessments.="" to="" calculate="" the="" acceptable="" acute="" and="" chronic="" exposure="" to="" glufosinate="" ammonium="" in="" drinking="" water,="" the="" dietary="" food="" exposure="" estimate="" was="" subtracted="" from="" the="" appropriate="" pad="" (only="" short-term="" residential="" exposure).="" a="" dwloc="" was="" then="" calculated="" by="" using="" default="" body="" weights="" and="" drinking="" water="" consumption="" figures="" (70kg/2l="" (adult="" male),="" 60kg/2l="" (adult="" female)="" and="" 10kg/1l="" (infant/child)).="" the="" estimated="" maximum="" and="" average="" concentration="" of="" glufosinate="" ammonium="" in="" ground="" and="" surface="" water="" are="" less="" than="" epa's="" dwloc="" for="" glufosinate="" ammonium="" as="" a="" contribution="" to="" acute="" and="" chronic="" aggregate="" exposure="" (for="" all="" population="" subgroups).="" i.="" acute="" exposure="" and="" risk.="" the="" agency's="" analysis="" based="" on="" the="" information="" available="" is="" presented="" in="" the="" following="" table="" 1:="" table="" 1.--="" acute="" dwlocs="" ----------------------------------------------------------------------------------------------------------------="" food="" maximum="" apad="" exposure="" water="" dwloc\3\="" sci-="" przm-="" population="" subgroup\1\="" mg/kg/="" mg/kg/="" exposure\2\="" ppb="" grow="" exams="" day="" day="" mg/kg/day="" ppb="" ppb="" ----------------------------------------------------------------------------------------------------------------="" females="" (13+,="" nursing)..................................="" 0.021="" 0.012131="" 0.008869="" 270="" 1.16="" 34.1="" ----------------------------------------------------------------------------------------------------------------="" \1\="" highest="" exposed="" subgroup="" among="" females="" 13+="" \2\="" maximum="" water="" exposure="" (mg/kg/day)="0.021" mg/kg/day="" -="" acute="" food="" exposure="" (mg/kg/day)="" \3\="" dwloc="[(maximum" water="" exposure="" mg/kg/day)(body="" weight="" kg)/(water="" consumption="" liters)]="" *="" 1,000.="" ii.="" chronic="" exposure="" and="" risk.="" the="" agency's="" analysis="" based="" on="" the="" information="" available="" is="" presented="" in="" the="" following="" table.="" table="" 2.--="" chronic="" (non-cancer)="" dwloc="" ----------------------------------------------------------------------------------------------------------------="" food="" maximum="" cpad="" exposure="" water="" dwloc\3\="" sci-="" przm-="" population="" subgroup\1\="" mg/kg/="" mg/kg/="" exposure\2\="" ppb="" grow="" exams="" day="" day="" mg/kg/day="" ppb="" ppb="" ----------------------------------------------------------------------------------------------------------------="" u.s.="" population...........................................="" 0.007="" 0.002120="" 0.004880="" 170="" 1.16="" 0.79="" non-hispanic="" blacks.......................................="" 0.007="" 0.002246="" 0.004754="" 170="" 1.16="" 0.79="" non-hispanic/non-.white/non-black.........................="" 0.007="" 0.002256="" 0.004744="" 170="" 1.16="" 0.79="" non-hispanic="" whites.......................................="" 0.007="" 0.002132="" 0.004868="" 170="" 1.16="" 0.79="" children="" 1-6="" yrs..........................................="" 0.007="" 0.004974="" 0.002026="" 20="" 1.16="" 0.79="" females="" 13+="" nursing.......................................="" 0.007="" 0.002035="" 0.004965="" 150="" 1.16="" 0.79="" males="" 13-19="" yrs...........................................="" 0.007="" 0.002449="" 0.004551="" 160="" 1.16="" 0.79="" ----------------------------------------------------------------------------------------------------------------="" \1\="" the="" subgroups="" listed="" above="" are="" the="" following:="" (1)="" u.s.="" population,="" (2)="" the="" other="" general="" subgroups="" for="" which="" the="" %cpad="" is="" greater="" than="" that="" of="" the="" u.s.="" population="" and="" (3)="" the="" most="" highly="" exposed="" population="" among="" infants="" and="" children,="" females,="" and="" males.="" \2\="" maximum="" water="" exposure="" (mg/kg/day)="(0.007" mg/kg/day="" -="" acute="" food="" exposure,="" (mg/kg/day));="" no="" residential="" exposure.="" \3\="" dwloc="[(maximum" water="" exposure="" mg/kg/day)(body="" weight="" kg)/(water="" consumption="" liters)]*="" 1,000.="" 3.="" from="" non-dietary="" exposure.="" glufosinate="" ammonium="" is="" currently="" registered="" for="" use="" on="" the="" following="" non-food="" sites:="" areas="" around="" ornamentals,="" shade="" trees,="" christmas="" trees,="" shrubs,="" walks,="" driveways,="" flower="" beds,="" farmstead="" buildings,="" in="" shelter="" belts,="" and="" along="" fences.="" it="" is="" also="" registered="" for="" use="" as="" a="" post-emergent="" herbicide="" on="" farmsteads,="" areas="" associated="" with="" airports,="" commercial="" plants,="" storage="" and="" lumber="" yards,="" highways,="" educational="" facilities,="" fence="" lines,="" ditch="" banks,="" dry="" ditches,="" schools,="" parking="" lots,="" tank="" farms,="" pumping="" stations,="" parks,="" utility="" rights-of="" -way,="" roadsides,="" railroads,="" and="" other="" public="" areas="" and="" similar="" industrial="" and="" non-food="" crop="" areas.="" it="" is="" also="" registered="" for="" lawn="" renovation="" uses.="" in="" a="" pharmacokinetics="" study="" with="" dermal="" application="" in="" rats="" radioactive="" glufosinate="" ammonium="" at="" levels="" of="" 0.1,="" 1.0,="" or="" 10.0="" mg/rat="" on="" 6="" cm="" square="" of="" shaved="" skin="" and="" exposed="" for="" 0.5,="" 1,="" 2,="" 4,="" 10,="" 24,="" or="" 168="" hrs.="" at="" the="" low="" dose="" (0.1="" mg)="" 42.5="" to="" 50.8%="" of="" the="" applied="" radioactivity="" was="" absorbed="" whereas="" at="" the="" high="" dose="" (10.0="" mg)="" 26%="" was="" absorbed.="" after="" removal="" and="" washing="" of="" the="" treated="" skin="" a="" substantial="" amount="" of="" the="" radioactivity="" still="" remained="" in="" the="" skin.="" and="" it="" was="" gradually="" absorbed="" and="" eliminated.="" radioactivity="" was="" found="" in="" both="" fecies="" and="" urine="" samples,="" but="" the="" majority="" of="" glufosinate="" ammonium="" was="" eliminated="" in="" the="" urine.="" in="" all="" organs/tissues="" examined,="" radioactivity="" was="" found="" to="" reach="" a="" maximum="" level="" either="" at="" 4="" or="" 10="" hours="" after="" exposure.="" subsequently,="" the="" radioactivity="" dropped="" rapidly.="" the="" amount="" of="" radioactivity="" found="" in="" the="" brain="" was="" minimal="" relative="" to="" that="" of="" kidneys="" and="" liver.="" based="" on="" this="" study,="" a="" 50%="" dermal="" absorption="" factor="" was="" determined="" based="" on="" the="" range="" of="" 42.5%="" to="" 50.8%="" of="" radioactivity="" absorbed="" at="" 0.10="" mg/kg.="" i.="" acute="" exposure="" and="" risk.="" there="" are="" no="" acute="" non-dietary="" exposure="" scenarios.="" ii.="" chronic="" exposure="" and="" risk.="" there="" are="" no="" chronic="" non-dietary="" exposure="" scenarios.="" iii.="" short-="" and="" intermediate-term="" exposure="" and="" risk.="" it="" is="" not="" appropriate="" to="" aggregate="" short-="" and="" intermediate-term="" non-dietary="" exposure="" with="" dietary="" exposures="" in="" this="" risk="" assessment="" because="" the="" end-points="" are="" different.="" iv.="" cumulative="" exposure="" to="" substances="" with="" common="" mechanism="" of="" toxicity.="" section="" 408(b)(2)(d)(v)="" requires="" that,="" when="" considering="" whether="" to="" establish,="" modify,="" or="" revoke="" a="" tolerance,="" the="" agency="" consider="" ``available="" information''="" concerning="" the="" cumulative="" effects="" of="" a="" particular="" pesticide's="" residues="" and="" ``other="" substances="" that="" have="" a="" common="" mechanism="" of="" toxicity.''="" epa="" does="" not="" have,="" at="" this="" time,="" available="" data="" to="" determine="" whether="" [[page="" 60117]]="" glufosinate="" ammonium="" has="" a="" common="" mechanism="" of="" toxicity="" with="" other="" substances="" or="" how="" to="" include="" this="" pesticide="" in="" a="" cumulative="" risk="" assessment.="" unlike="" other="" pesticides="" for="" which="" epa="" has="" followed="" a="" cumulative="" risk="" approach="" based="" on="" a="" common="" mechanism="" of="" toxicity,="" glufosinate="" ammonium="" does="" not="" appear="" to="" produce="" a="" toxic="" metabolite="" produced="" by="" other="" substances.="" for="" the="" purposes="" of="" this="" tolerance="" action,="" therefore,="" epa="" has="" not="" assumed="" that="" glufosinate="" ammonium="" has="" a="" common="" mechanism="" of="" toxicity="" with="" other="" substances.="" for="" information="" regarding="" epa's="" efforts="" to="" determine="" which="" chemicals="" have="" a="" common="" mechanism="" of="" toxicity="" and="" to="" evaluate="" the="" cumulative="" effects="" of="" such="" chemicals,="" see="" the="" final="" rule="" for="" bifenthrin="" pesticide="" tolerances="" (62="" fr="" 62961,="" november="" 26,="" 1997).="" d.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" u.s.="" population="" 1.="" acute="" risk.="" the="" acute="" dietary="" exposure="" analysis="" assumed="" tolerance="" level="" residues="" and="" 100%="" crop="" treated="" for="" all="" commodities="" derived="" from="" glufosinate="" ammonium="" treated="" crops.="" for="" the="" most="" highly="" exposed="" subgroup="" among="" females="" 13+="" (nursing="" females),="" 58%="" of="" the="" apad="" is="" occupied="" by="" dietary="" (food)="" exposure,="" an="" acute="" rfd="" was="" not="" established="" for="" the="" general="" population="" including="" infants="" and="" children.="" the="" estimated="" glufosinate="" ammonium="" concentration="" in="" surface="" and="" ground="" water="" are="" less="" than="" epa's="" dwloc="" (for="" all="" population="" subgroups).="" acute="" aggregate="" exposure="" to="" glufosinate="" ammonium="" and="" related="" metabolites,="" as="" a="" result="" of="" all="" registered="" and="" proposed="" uses,="" is="" below="" epa's="" level="" of="" concern.="" 2.="" chronic="" risk.="" there="" are="" no="" chronic="" non-dietary="" exposure="" scenarios.="" therefore,="" only="" food="" and="" water="" are="" included="" in="" the="" chronic="" aggregate="" risk.="" the="" chronic="" dietary="" exposure="" analysis="" assumed="" tolerance="" level="" residues="" for="" all="" commodities="" derived="" from="" the="" crop="" use="" of="" glufosinate="" ammonium="" and="" incorporated="" the="" weighted="" average="" percent="" crop="" treated="" for="" all="" commodities="" derived="" from="" glufosinate="" ammonium="" treated="" crops,="" except="" for="" sweet="" corn,="" registered="" under="" section="" 18="" of="" the="" federal="" insecticide,="" fungicide="" and="" rodenticide="" act="" (fifra),="" as="" amended.="" for="" the="" most="" highly="" exposed="" subgroup="" (children,="" 1-6="" years),="" 71%="" of="" the="" cpad="" is="" occupied="" by="" dietary="" (food)="" exposure.="" the="" estimated="" glufosinate="" ammonium="" concentrations="" in="" surface="" and="" ground="" water="" are="" less="" than="" epa's="" dwloc="" for="" all="" population="" subgroups.="" chronic="" aggregate="" exposure="" to="" glufosinate="" ammonium="" as="" a="" result="" of="" all="" registered="" and="" proposed="" uses="" is="" below="" epa's="" level="" of="" concern.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" cpad="" because="" the="" cpad="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" life="" time="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" despite="" the="" potential="" for="" chronic="" exposure="" to="" glufosinate="" ammonium="" in="" drinking="" water,="" after="" calculating="" a="" dwloc="" (236="" parts="" per="" billion="" (ppb))="" for="" the="" u.s.="" population="" and="" comparing="" it="" to="" conservative="" model="" estimates="" of="" concentrations="" of="" glufosinate="" ammonium="" surface="" and="" ground="" water="" (59.43="" ppb="" and="" 1.16="" ppb,="" respectively),="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" cpad.="" 3.="" short-="" and="" intermediate-term="" risk.="" short-="" and="" intermediate-term="" aggregate="" exposure="" takes="" into="" account="" chronic="" dietary="" food="" and="" water="" (consider="" to="" be="" a="" background="" exposure="" level)="" plus="" indoor="" and="" outdoor="" residential="" exposure.="" there="" are="" registered="" residential="" uses="" for="" glufosinate="" ammonium.="" the="" potential="" dermal="" exposures="" were="" not="" aggregated="" because="" the="" toxic="" effects="" for="" short-="" and="" intermediate-term="" exposure="" (neurological="" clinical="" signs)="" and="" chronic="" exposure="" (increases="" in="" absolute="" and="" relative="" kidney="" weights)="" are="" different.="" 4.="" aggregate="" cancer="" risk="" for="" u.s.="" population.="" there="" is="" no="" cancer="" concern="" based="" on="" negative="" results="" observed="" in="" three="" guideline="" studies="" available="" for="" the="" carcinogenicity="" screen:="" a="" chronic="" feeding="" study="" in="" rats,="" a="" carcinogenicity="" study="" in="" rats="" and="" a="" carcinogenicity="" study="" in="" mice,="" each="" described="" under="" the="" ``toxicology="" profile''="" of="" this="" rule.="" glufosinate="" ammonium="" has="" been="" classified="" as="" a="" ``not="" likely''="" carcinogen="" according="" to="" the="" epa="" proposed="" guidelines="" for="" carcinogn="" risk="" assessment.="" therefore,="" a="" cancer="" risk="" assessment="" was="" not="" necessary.="" 5.="" determination="" of="" safety.="" based="" on="" these="" risk="" assessments,="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" glufosinate="" ammonium="" residues.="" e.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" infants="" and="" children="" 1.="" safety="" factor="" for="" infants="" and="" children--="" i.="" in="" general.="" in="" assessing="" the="" potential="" for="" additional="" sensitivity="" of="" infants="" and="" children="" to="" residues="" of="" glufosinate="" ammonium,="" epa="" considered="" data="" from="" developmental="" toxicity="" studies="" in="" the="" rat="" and="" rabbit="" and="" a="" 2-generation="" reproduction="" study="" in="" the="" rat.="" the="" developmental="" toxicity="" studies="" are="" designed="" to="" evaluate="" adverse="" effects="" on="" the="" developing="" organism="" resulting="" from="" maternal="" pesticide="" exposure="" during="" gestation.="" reproduction="" studies="" provide="" information="" relating="" to="" effects="" from="" exposure="" to="" the="" pesticide="" on="" the="" reproductive="" capability="" of="" mating="" animals,="" and="" data="" on="" systemic="" toxicity.="" ffdca="" section="" 408="" provides="" that="" epa="" shall="" apply="" an="" additional="" tenfold="" margin="" of="" safety="" for="" infants="" and="" children="" in="" the="" case="" of="" threshold="" effects="" to="" account="" for="" pre-and="" post-natal="" toxicity="" and="" the="" completeness="" of="" the="" data="" base="" unless="" epa="" determines="" that="" a="" different="" margin="" of="" safety="" will="" be="" safe="" for="" infants="" and="" children.="" margins="" of="" safety="" are="" incorporated="" into="" epa="" risk="" assessments="" either="" directly="" through="" use="" of="" a="" margin="" of="" exposure="" (moe)="" analysis="" or="" through="" using="" uncertainty="" (safety)="" factors="" in="" calculating="" a="" dose="" level="" that="" poses="" no="" appreciable="" risk="" to="" humans.="" epa="" believes="" that="" reliable="" data="" support="" using="" the="" standard="" uncertainty="" factor="" (usually="" 100="" for="" combined="" inter-="" and="" intra-species="" variability)="" and="" not="" the="" additional="" tenfold="" moe/="" uncertainty="" factor="" when="" epa="" has="" a="" complete="" data="" base="" under="" existing="" guidelines="" and="" when="" the="" severity="" of="" the="" effect="" in="" infants="" or="" children="" or="" the="" potency="" or="" unusual="" toxic="" properties="" of="" a="" compound="" do="" not="" raise="" concerns="" regarding="" the="" adequacy="" of="" the="" standard="" moe/safety="" factor.="" ii.="" developmental="" toxicity="" studies.="" two="" studies="" were="" described="" in="" the="" toxicology="" profile="" section="" (see="" unit="" iii.a.8.="" and="" 9.="" of="" this="" rule.).="" iii.="" reproductive="" toxicity="" study.="" a="" reproductive="" toxicity="" study="" was="" described="" in="" the="" toxicology="" profile="" (see="" unit="" iii.a.10.="" of="" this="" rule.).="" iv.="" pre-="" and="" post-natal="" sensitivity.="" the="" toxicological="" data="" base="" for="" evaluating="" prenatal="" and="" postnatal="" toxicity="" for="" glufosinate="" ammonium="" is="" complete="" with="" respect="" to="" current="" data="" requirements.="" there="" are="" no="" prenatal="" or="" postnatal="" susceptibility="" concerns="" for="" infants="" and="" children,="" based="" on="" the="" results="" of="" the="" rat="" and="" rabbit="" developmental="" toxicity="" studies="" and="" the="" 2-generation="" reproduction="" study.="" v.="" other="" studies.="" based="" on="" clinical="" signs="" of="" neurological="" toxicity="" in="" short="" and="" intermediate="" dermal="" toxicity="" studies="" with="" rats,="" epa="" has="" determined="" that="" an="" added="" fqpa="" safety="" factor="" of="" 3x="" is="" appropriate="" for="" the="" risk="" assessment="" for="" the="" tolerances="" in="" the="" commodities="" listed="" in="" this="" final="" rule.="" the="" fqpa="" safety="" factor="" of="" 10x="" was="" reduced="" to="" 3x="" because="" there="" were="" no="" qualitative="" or="" quantitative="" indications="" of="" increased="" susceptibility="" in="" the="" prenatal="" developmental="" toxicities="" in="" rats="" and="" rabbits,="" or="" in="" the="" 2-generation="" reproductive="" studies="" in="" rats="" with="" the="" parent="" compound,="" the="" isomer="" or="" metabolites="" of="" concern.="" vi.="" conclusion.="" there="" is="" a="" complete="" toxicity="" database="" for="" glufosinate="" [[page="" 60118]]="" ammonium,="" and="" exposure="" data="" is="" complete="" or="" is="" estimated="" based="" on="" data="" that="" reasonably="" accounts="" for="" potential="" exposures.="" 2.="" acute="" risk.="" the="" acute="" dietary="" exposure="" analysis="" assumed="" tolerance="" level="" residues="" and="" 100%="" crop="" treated="" for="" all="" registered="" and="" proposed="" commodities.="" for="" the="" most="" highly="" exposed="" subgroup="" among="" females="" 13="" -="" 50="" (nursing="" females),="" 58%="" of="" the="" apad="" is="" occupied="" by="" dietary="" (food)="" exposure="" (no="" acute="" rfd="" was="" established="" for="" the="" general="" population="" including="" infants="" and="" children).="" the="" estimated="" glufosinate="" ammonium="" concentration="" in="" surface="" and="" ground="" water="" are="" less="" than="" epa's="" dwloc="" (for="" all="" population="" subgroups).="" acute="" aggregate="" exposure="" to="" glufosinate="" ammonium="" and="" related="" metabolites,="" as="" a="" result="" of="" all="" registered="" and="" proposed="" uses,="" is="" below="" epa's="" level="" of="" concern.="" 3.="" chronic="" risk.="" based="" on="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" glufosinate="" ammonium="" from="" food="" will="" utilize="" 71%="" of="" the="" cpad="" for="" children="" 1-6="" years="" of="" age,="" the="" most="" highly="" exposed="" subgroup.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" cpad="" because="" the="" cpad="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" despite="" the="" potential="" for="" chronic="" exposure="" to="" glufosinate="" ammonium="" in="" drinking="" water,="" after="" calculating="" a="" dwloc="" (64="" ppb)="" for="" non-nursing="" infants="" and="" comparing="" it="" to="" conservative="" model="" estimates="" of="" concentrations="" of="" glufosinate="" ammonium="" in="" surface="" and="" ground="" water="" (59.43="" ppb="" and="" 11.16="" ppb,="" respectively),="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" cpad.="" 4.="" short-="" or="" intermediate-term="" risk.="" short-="" and="" intermediate-term="" aggregate="" exposure="" takes="" into="" account="" chronic="" dietary="" food="" and="" water="" (considered="" to="" be="" a="" background="" exposure="" level)="" plus="" indoor="" and="" outdoor="" residential="" uses.="" there="" are="" registered="" residential="" uses="" for="" glufosinate="" ammonium,="" however,="" the="" potential="" dermal="" exposures="" were="" not="" aggregated="" because="" the="" toxic="" effects="" for="" short-="" and="" intermediate-term="" exposure="" (neurological="" clinical="" signs)="" and="" chronic="" exposure="" (increases="" in="" absolute="" and="" relative="" kidney="" weights)="" are="" different.="" 5.="" determination="" of="" safety.="" based="" on="" these="" risk="" assessments,="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" residues="" of="" glufosinate="" ammonium="" residues.="" iv.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" 1.="" plants.="" the="" nature="" of="" the="" residues="" of="" glufosinate="" ammonium="" is="" considered="" to="" be="" understood.="" the="" agency="" has="" concluded="" that="" the="" residues="" of="" concern="" are="" glufosinate="" ammonium="" and="" its="" metabolites="" 2-acetamido-4-="" methylphosphinico-butanoic="" acid="" and="" 3-methylphosphinico-propionic="" acid="" expressed="" as="" glufosinate="" ammonium="" free="" acid="" equivalents.="" 2.="" animals="" a="" rat="" metabolism="" study="" with="" dermal="" application="" indicated="" that="" about="" 50%="" of="" the="" given="" radioactivity="" was="" absorbed="" 48="" hours="" after="" a="" single="" dose="" application.="" in="" other="" metabolism="" studies,="" it="" was="" shown="" that="" over="" 80%="" of="" administered="" radioactivity="" is="" excreted="" within="" 24="" to="" 48="" hours="" as="" the="" parent="" compound="" in="" the="" feces="" and="" kidneys.="" highest="" tissue="" levels="" were="" found="" in="" liver,="" kidney="" and="" gonads.="" the="" nature="" of="" glufosinate="" ammonium="" residues="" in="" lactating="" goats="" and="" hens="" is="" considered="" to="" be="" understood.="" glufosinate="" ammonium="" and="" its="" metabolite="" (3-="" methylphosphinico="" propionic="" acid)="" are="" largely="" excreted="" and="" do="" not="" accumulate="" too="" any="" great="" degree="" in="" animal="" tissues.="" the="" only="" identifiable="" compounds="" in="" feces,="" urine,="" milk,="" eggs="" and="" tissues="" were="" the="" parent="" and="" 3-methylphosphinico="" propionic="" acid.="" epa="" has="" concluded="" that="" the="" residues="" of="" concern="" in="" commodities="" derived="" from="" ruminants="" and="" poultry="" are="" glufosinate="" ammonium="" and="" its="" metabolite="" 3-methylphospinico="" propionic="" acid,="" expressed="" as="" glufosinate="" ammonium="" free="" acid="" equivalents.="" b.="" analytical="" enforcement="" methodology="" in="" pesticide="" analytical="" manual="" ii="" (pam="" ii),="" method="" hrav-5a="" describes="" an="" adequate="" analytical="" method="" for="" determining="" residues="" of="" glufosinate="" ammonium="" and="" its="" metabolite="" 3-methylphosphinico="" propionic="" acid="" in="" or="" on="" apples,="" bananas,="" grape,="" potatoes="" and="" tree="" nuts.="" in="" pam="" ii,="" method="" hrav-12,="" is="" an="" adequate="" method="" for="" determining="" residues="" of="" glufosinate="" ammonium="" and="" its="" metabolite="" 3-methylphosphinico-propionic="" acid="" in="" or="" on="" milk,="" eggs="" and="" tissues="" of="" ruminants="" and="" poultry.="" method="" xam-24a,="" which="" is="" a="" modification="" of="" method="" hrav-5a="" is="" an="" adequate="" method="" for="" determining="" residues="" of="" glufosinate="" ammonium="" and="" its="" metabolites="" in="" or="" on="" transgenic="" field="" corn,="" and="" transgenic="" soybeans.="" the="" method="" describes="" an="" additional="" post-extraction="" cation="" exchange="" procedure="" to="" allow="" for="" separate="" detection="" and="" measurement="" of="" each="" residue="" component.="" final="" determination="" is="" made="" by="" gas="" chromatography="" with="" flame="" photometric="" detection="" operating="" in="" the="" phosphorus="" selective="" mode="" (p-mode).="" residues="" are="" expressed="" as="" glufosinate="" ammonium="" free="" acid="" equivalents.="" adequate="" enforcement="" methodology="" (gas="" chromatography="" with="" mass="" spectrophotometry)="" is="" available="" to="" enforce="" the="" tolerances="" for="" commodities="" derived="" from="" potatoes.="" the="" method="" may="" be="" requested="" from:="" calvin="" furlow,="" prrib,="" irsd="" (7502c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" 401="" m="" st.,="" sw.,="" washington,="" dc="" 20460;="" telephone="" number:="" (703)="" 305-5229;="" e-mail="" address:="">furlow.calvin@epa.gov.
C. Magnitude of Residues
The residues established by this regulation are qualified and
quantified in Unit V of this Rule.
D. International Residue Limits
The Codex Alimentarius Commission has established maximum residue
limits (CODEX MRLs) for the combined residues of glufosinate ammonium
and 3-methylphosphinico propionic acid, expressed as glufosinate free
acid equivalents, in or on potatoes at 0.5 ppm. Because the appropriate
U.S. tolerance for potatoes (0.8 ppm) is greater than the CODEX MRL of
0.5 ppm and CODEX MRLs for residues in or on potato chips and potato
granules and flakes do not exist, harmonization is not possible. The
Codex Alimentarius Commission did not establish MRLs for glufosinate
ammonium in processed potato commodities because earlier processing
studies in cooked potatoes did not show any concentration of residues
after cooking in water. The difference in residues represented by the
CODEX MRL of 0.5 ppm and the 0.8 ppm tolerance for residues in or on
potatoes established by this Rule was apparently due to differences in
the methods used by the two Agencies in determining the level of
residues that would be appropriate. The EPA sets tolerances based on
the residue level from the highest average field trial where as the
CODEX and European authorities use statistical calculations derived
from all residue data covering one worst case label for the calculation
of MRL proposals.
E. Rotational Crop Restrictions
A 120 day plant-back interval is required for all crops with the
exceptions of buckwheat, barley, millet oats, rye, sorghum, triticale
and wheat that requires a 70-day plant-back interval. Field corn and
soybeans may be planted back any time.
[[Page 60119]]
V. Conclusion
Therefore, permanent tolerances are established for combined
residues of glufosinate ammonium and its metabolite(s) in or on almond
hulls at 0.50 ppm, apples at 0.05 ppm, bananas at 0.3 (not more than
0.2 ppm shall be present in the pulp after peel is removed), cattle,
fat and meat at 0.05 ppm; cattle, meat by-products at 0.10 ppm; eggs at
0.05 ppm; goats, fat and meat at 0.05 ppm; goats, meat-by-products at
0.10 ppm; grapes at 0.05 ppm; hogs, fat and meat at 0.05 ppm; hogs,
meat-by-products at 0.10 ppm; horses, fat and meat at 0.05 ppm; horses,
meat-by-products at 0.10 ppm; milk at 0.02 ppm; potatoes at 0.8 ppm;
potato chips at 1.6 ppm; potato granule/flakes at 2.0 ppm; poultry, fat
and meat at 0.05 ppm; poultry, meat-by-products at 0.10 ppm; sheep, fat
and meat at 0.05 ppm; sheep, meat-by-products at 0.10 pm; transgenic
aspirated grain fractions at 25.0 ppm; transgenic corn, field, forage
at 4.0 ppm; transgenic corn, field, grain at 0.2 ppm; transgenic corn,
field, stover at 6.0 ppm; transgenic soybeans, hulls at 5.0 ppm;
transgenic soybeans at 2.0 ppm and tree nuts group at 0.1 ppm.
The time-limited tolerances for residues in transgenic canola and
transgenic sweet corn commodities under Section 18 emergency exemptions
(64 FR 44829-44836, August 18, l999)) are not replaced, These time-
limited tolerances will expire December 1, l999.
VI. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-300945 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before January
3, 2000.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(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).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information 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.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
You may also deliver your request to the Office of the Hearing Clerk in
Room M3708, Waterside Mall, 401 M St., SW., Washington, DC 20460. The
Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission be labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ''when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' (cite). For
additional information regarding the waiver of these fees, you may
contact James Tompkins by phone at (703) 305-5697, by e-mail at
tompkins.jim@epa.gov, or by mailing a request for information to Mr.
Tompkins at Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A. of
this preamble, you should also send a copy of your request to the PIRB
for its inclusion in the official record that is described in Unit
I.B.2. of this preamble. Mail your copies, identified by docket number
OPP-300945, to: Public Information and Records Integrity Branch,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. In person or by courier, bring a copy to the
location of the PRIB described in Unit I.B.2. of this preamble. You may
also send an electronic copy of your request via e-mail to: docket@epa.gov. Please use an ASCII file format and avoid the use of
special characters and any form of encryption. Copies of electronic
objections and hearing requests will also be accepted on disks in
WordPerfect 5.1/6.1 file format or ASCII file format. Do not include
any CBI in your electronic copy. You may also submit an electronic copy
of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
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 issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Regulatory Assessment Requirements
This final rule establishes tolerances under section 408(d) of the
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735,
[[Page 60120]]
October 4, 1993). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require prior consultation with State, local, and tribal
government officials as specified by Executive Order 12875, entitled
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28,
1993) and Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19,1998), or special
consideration of environmental justice related issues under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994) or require OMB review in accordance with Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, l997). The Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 12612,
entitled Federalism (52 FR 41685, October 30, l987). This action
directly regulates growers, food processors, food handlers and food
retailers, not States. This action does not alter the relationships or
distribution of power and responsibilities established by Congress in
the preemption provisions of the Federal Food, Drug, and Cosmetic Act,
21 U.S.C. 346a(b)(4). This action does not involve any technical
standards that would require Agency consideration of voluntary
consensus standards pursuant to section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law
104-113, section 12(d) (15 U.S.C. 272 note). In addition, since
tolerances and exemptions that are established on the basis of a
petition under FFDCA section 408(d), such as the tolerances in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by
the Small Business Regulatory Enforcement Fairness Act of 1996,
generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. EPA will submit a report containing this
rule and other required information to the U.S. Senate, the U.S. House
of Representatives, and the Comptroller General of the United States
prior to publication of this rule in the Federal Register. This rule
is not a ``major rule'' as defined by 5 U.S.C. 804(2).
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 26, 1999.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), (346a), and 371.
2. By revising Sec. 180.473 to read as follows:
Sec. 180. 473 Glufosinate ammonium; tolerances for residues.
(a) General. (1) Tolerances are established for residues of the
herbicide glufosinate ammonium (butonoic acid, 2-amino-4-
(hydroxymethylphosphinyl)-, monoammonium salt) and its metabolite, 3-
methylphosphinico-propionic acid, expressed as 2-amino-4-
(hydroxmethylphosphinyl) butanoic acid equivalents, in or on the
following food commodities:
------------------------------------------------------------------------
Parts
Commodity per
million
------------------------------------------------------------------------
Almond hulls................................................... 0.50
Apples......................................................... 0.05
Bananas........................................................ 0.30
Bananas, pulp.................................................. 0.20
Cattle, fat.................................................... 0.05
Cattle, meat................................................... 0.05
Cattle, mbyp................................................... 0.10
Eggs........................................................... 0.05
Goats, fat..................................................... 0.05
Goats, meat.................................................... 0.05
Goats, mbyp.................................................... 0.10
Grapes......................................................... 0.05
Hogs, fat...................................................... 0.05
Hogs, meat..................................................... 0.05
Hogs, mbyp..................................................... 0.10
Horses, fat.................................................... 0.05
Horses, meat................................................... 0.05
Horses, mbyp................................................... 0.10
Milk........................................................... 0.02
Potatoes....................................................... 0.80
Potato chips................................................... 1.60
Potato granules and flakes..................................... 2.00
Poultry, fat................................................... 0.05
Poultry, meat.................................................. 0.05
Poultry, mbyp.................................................. 0.10
Sheep, fat..................................................... 0.05
Sheep, meat.................................................... 0.05
Sheep, mbyp.................................................... 0.10
Tree nuts group................................................ 0.10
------------------------------------------------------------------------
(2) Tolerances are established for the combined residues of
glufosinate ammonium (butanoic acid, 2-ammino-4-
(hydroxymethylphosphinyl)- monoammonium salt) and its metabolites, 2-
acetamido-4-methylphosphinico-butanoic acid and 3-methylphosphinico-
propionic acid, expressed as 2-amino-4-(hydroxymethylphosphinyl)
butanoic acid equivalents, in or on the following raw agricultural
commodities derived from transgenic field corn and transgenic soybeans
and that are tolerant to the herbicide glufosinate ammonium as follows:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Aspirated Grain Fractions.................................. 25.0
Corn, field, forage........................................ 4.0
Corn, field, grain......................................... 0.2
Corn, field, stover........................................ 6.0
Soybean hulls.............................................. 5.0
Soybeans................................................... 2.0
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for combined residues of the herbicide (butanoic acid, 2-
amino-4-(hydroxymethylphosphinyl) -monoamonium salt and its metabolites
, 2-acetamido-4-methylphosphinico-butamoic acid and 3-
methylphosphinico-propionic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl) butanoic acid equivalents in or on the
following raw agricultural commodities derived from transgenic canola
and transgenic sweet corn in connection with use of section 18
emergency exemptions granted by EPA. The tolerances will expire and are
revoked on the date specified in the following table:
[[Page 60121]]
------------------------------------------------------------------------
Parts Expiration/
Commodity per Revocation
million Date
------------------------------------------------------------------------
Canola meal.................................... 1.1 12/1/99
Canola Seed.................................... 0.4 12/1/99
Corn, sweet, forage............................ 4.0 12/1/99
Corn, sweet, kernels and cobs with husks 4.0 12/1/99
removed.......................................
Corn, sweet, stover............................ 6.0 12/1/99
------------------------------------------------------------------------
(c) Tolerances with regional restrictions. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 99-28887 Filed 11-3-99; 8:45 am]
BILLING CODE 6560-50-F
