[Federal Register Volume 64, Number 193 (Wednesday, October 6, 1999)]
[Rules and Regulations]
[Pages 54218-54224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25842]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300927; FRL-6382-3]
RIN 2070-AB78
Imazapic-Ammonium; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
combined residues of imazapic-ammonium, (+)-2-[4,5-dihydro-4-methyl-4-
(1-methylethyl)-5-oxo-1H-imidazol-2- yl]-5-methyl-3-pyridinecarboxylic
acid, applied as its ammonium salt and its metabolite (+)-2-[4,5-
dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-
hydromethyl-3- pyridinecarboxylic acid both free and conjugated in or
on grass forage at 30 ppm; grass hay at 15 ppm; milk, fat, meat, meat
byproducts (except kidney) of cattle, goats, hogs, horses, and sheep at
0.10 ppm; kidney of cattle, goats, hogs, horses, and sheep at 1 ppm.
This action is in response to EPA's granting of emergency exemptions
under section 18 of the Federal Insecticide, Fungicide, and Rodenticide
Act authorizing use of the pesticide on pasture/rangeland and land in
the Conservation Reserve Program. This regulation establishes a maximum
permissible level for residues of imazapic-ammonium and its metabolite
in these food commodities. The tolerances will expire and are revoked
on December 31, 2001.
DATES: This regulation is effective October 6, 1999. Objections and
requests for hearings, identified by docket control number OPP-300927,
must be received by EPA on or before December 6, 1999.
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 VII. of the ``SUPPLEMENTARY
INFORMATION'' section. To ensure proper receipt by EPA, your objections
and hearing requests must identify docket control number OPP-300927 in
the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Libby Pemberton, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone
number: 703 308-9364; and e-mail address: pemberton.libby@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does This Action Apply to Me?
You may be potentially 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
Categories NAICS Potentially
Affected Entities
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Industry........................ 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
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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
[[Page 54219]]
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-300927. 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
EPA, on its own initiative, in accordance with sections 408 (l)(6)
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is
establishing tolerances for combined residues of the [herbicide]
imazapic-ammonium and its metabolite both free and conjugated, in or on
grass forage at 30 part per million (ppm); grass hay at 15 ppm; milk,
fat, meat, meat byproducts (except kidney) of cattle, goats, hogs,
horses, and sheep at 0.10 ppm; kidney of cattle, goats, hogs, horses,
and sheep at 1 ppm. These tolerances will expire and are revoked on
December 31, 2001. EPA will publish a document in the Federal Register
to remove the revoked tolerances from the Code of Federal Regulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment.EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
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. . . .''
Section 18 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) authorizes EPA to exempt any Federal or State agency from
any provision of FIFRA, if EPA determines that ``emergency conditions
exist which require such exemption.'' This provision was not amended by
Food Quality Protection Act (FQPA). EPA has established regulations
governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemptions for Imazapic-Ammonium on Pasture/
Rangeland and Land in the Conservation Reserve Program and FFDCA
Tolerances
The Applicant has stated that picloram can not be used in areas
with sensitive desirable plants such as trees nor in areas with a
shallow depth to groundwater; and high rates of 2,4-D have proven
ineffective in controlling leafy spurge. Economic loss from the
infestation of leafy spurge is measured in loss of livestock carrying
capacity. It is estimated the potential economic loss will continue to
average $5.5 million per year in Nebraska without the use of imazapic.
EPA has authorized under FIFRA section 18 the use of imazapic-ammonium
on pasture/rangeland and land in the Conservation Reserve Program for
control of leafy spurge in Nebraska. After having reviewed the
submission, EPA concurs that emergency conditions exist for this state.
As part of its assessment of these emergency exemptions, EPA
assessed the potential risks presented by residues of (+)-2-[4,5-
dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H- imidazol-2-yl]-5-methyl-3-
pyridinecarboxylic acid applied as its ammonium salt and its metabolite
(+)-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-
5- hydromethyl-3-pyridinecarboxylic acid both free and conjugated in or
on grass forage; grass hay; milk, fat, meat, meat byproducts (except
kidney) of cattle, goats, hogs, horses, and sheep; and kidney of
cattle, goats, hogs, horses, and sheep. In doing so, EPA considered the
safety standard in FFDCA section 408(b)(2), and EPA decided that the
necessary tolerance under FFDCA section 408(l)(6) would be consistent
with the safety standard and with FIFRA section 18. Consistent with the
need to move quickly on the emergency exemption in order to address an
urgent non-routine situation and to ensure that the resulting food is
safe and lawful, EPA is issuing these tolerances without notice and
opportunity for public comment as provided in section 408(l)(6).
Although these tolerances will expire and are revoked on December 31,
2001, under FFDCA section 408(l)(5), residues of the pesticide not in
excess of the amounts specified in the tolerances remaining in or on
grass forage; grass hay; milk, fat, meat, meat byproducts (except
kidney) of cattle, goats, hogs, horses, and sheep; and kidney of
cattle, goats, hogs, horses, and sheep after that date will not be
unlawful, provided the pesticide is applied in a manner that was lawful
under FIFRA, and the residues do not exceed a level that was authorized
by these tolerances at the time of that application. EPA will take
action to revoke these tolerances earlier if any experience with,
scientific data on, or other relevant information on this pesticide
indicate that the residues are not safe.
Because these tolerances are being approved under emergency
conditions EPA has not made any decisions about whether imazapic-
ammonium meets EPA's registration requirements for use on pasture/
rangeland and land in the Conservation Reserve Program or whether
permanent tolerances for this use would be appropriate. Under these
circumstances, EPA does not believe that these tolerances serve as a
basis for registration of imazapic-ammonium by a State for special
local needs under FIFRA section 24(c). Nor do these tolerances serve as
the basis for any State other than Nebraska to use this pesticide on
these crops under section 18 of FIFRA without following all provisions
of EPA's regulations implementing section 18 as identified in 40 CFR
part 166. For additional information regarding the emergency exemptions
for imazapic-ammonium, contact the Agency's Registration
[[Page 54220]]
Division at the address provided under the ``ADDRESSES'' section.
IV. Aggregate Risk Assessment and Determination of Safety
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) .
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 imazapic-
ammonium and to make a determination on aggregate exposure, consistent
with section 408(b)(2), for time-limited tolerances for combined
residues of imazapic-ammonium and its metabolite both free and
conjugated on grass forage at 30 ppm; grass hay at 15 ppm; milk, fat,
meat, meat byproducts (except kidney) of cattle, goats, hogs, horses,
and sheep at 0.10 ppm; and kidney of cattle, goats, hogs, horses, and
sheep at 1 ppm. EPA's assessment of the dietary exposures and risks
associated with establishing the 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 imazapic-ammonium
are discussed in this unit.
B. Toxicological Endpoint
1. Acute toxicity. For acute dietary risk assessment, the no-
observed adverse effect level (NOAEL) of 175 milligrams/kilogram/day
(mg/kg/day), based on developmental effects increased incidence of
fetuses with rudimentary ribs at the lowest observed adverse effect
level (LOAEL) of 350 mg/kg/day, from the developmental study in rabbits
was used. Pregnant females 13+, is the population subgroup of concern.
The acute dietary population adjusted dose (aPAD) is defined as the
Reference Dose (RfD)/FQPA safety factor. The acute RfD of 1.75 mg/kg
day is based on the developmental NOAEL of 175 mg/kg/day and the usual
100x uncertainty factor for intra- and inter-species differences and
variations. The acute dietary aPAD is 0.175 mg/kg/day, based on the RfD
of 1.75 mg/kg/day, and an additional uncertainty factor of 10x to
account for potential pre- and post-natal toxicity and completeness of
the data with respect to exposure and toxicity to infants and children
(based on the determination of developmental effects below the level of
maternal toxicity in the rabbit developmental study). There is no acute
dietary aPAD for other population subgroups, including infants and
children.
2. Short- and intermediate-term toxicity. For short-term margin of
exposure (MOE) calculations, the developmental NOAEL of 175 mg/kg/day
from the developmental study in rabbits was used. At the LOAEL of 350
mg/kg/day, there were increased rudimentary ribs below a level of
maternal toxicity. The short term NOAEL can be used for both dermal and
inhalation. An MOE of 100 is required for both dermal and inhalation
exposure. For intermediate-term dermal exposures, the LOAEL of 137 mg/
kg/day lowest dose tested (LDT) from the one year feeding study in dogs
was used. At the LOAEL of 137 mg/kg/day, there was skeletal muscle
degeneration in both sexes. The intermediate term LOAEL can be used for
both dermal and inhalation exposures. An MOE of 300 is required for
both dermal and inhalation exposure and is based on the usual 100x
safety factor for intra- and inter-species differences and an addtional
3x safety factor for the absence of a NOAEL in the critical study.
3. Chronic toxicity. EPA has established the RfD for imazapic-
ammonium at 0.5 mg/kg/day. This RfD is based on a one year feeding
study in dogs with a LOAEL of 137 mg/kg/day (LDT) based on skeletal
muscle degeneration. A NOAEL was not established in the study. An
uncertainty factor of 3000x was recommended and was based on 10x for
interspecies differences, 10x for intraspecies variations, 10x for
infants and children, and 3x for absence of a NOAEL.
4. Carcinogenicity. Imazapic has been classified 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 180.490) for the combined residues of imazapic-ammonium and its
metabolite both free and conjugated, in or on peanut nutmeat at 0.1
ppm. Risk assessments were conducted by EPA to assess dietary exposures
and risks from imazapic-ammonium as follows:
i. Acute exposure and risk. Acute dietary risk assessments are
performed for a food-use pesticide if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a 1-day or single exposure. The acute dietary (food only) risk
assessment used the TMRC (theoretical maximum residue contribution). At
the 95th percentile of exposure for user- days and per-capita days, the
Tier 1 acute DEEM analysis predicts an exposure level of 0.000494 mg/
kg/day for the females (13+, pregnant, not nursing) population
subgroup, which is equivalent to 0.3% of the aPAD. This should be
viewed as a conservative risk estimate; refinement using anticipated
residue values and percent crop-treated data in conjunction with Monte
Carlo analysis would result in a lower acute dietary exposure estimate.
ii. Chronic exposure and risk. In conducting the chronic dietary
risk assessment, conservative assumptions -- 100% of all commodities
having imazapic tolerances will contain imazapic residues and those
residues would be at the level of the tolerance -- were used, which
results in an overestimation of human dietary exposure. The existing
imazapic tolerances (published and pending result in a Theoretical
Maximum Residue Contribution (TMRC) that is equivalent to the following
percentages of the RfD:
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Subgroup Percentage
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U.S. Population (48 States)............... 0.5
Nursing Infants (<1 year="" old).............="" 0.3="" non-nursing="" infants=""><1 year="" old).........="" 1.3="" children="" (1-6="" years="" old)..................="" 1.4="" children="" (7-12="" years="" old).................="" 0.9="" hispanics.................................="" 0.6="" males="" 13-19="" yrs...........................="" 0.6="" ------------------------------------------------------------------------="" the="" subgroups="" listed="" above="" are:="" (a)="" the="" u.s.="" population="" (48="" states);="" (b)="" those="" for="" infants="" and="" children;="" and,="" (c)="" the="" other="" subgroups="" for="" which="" the="" percentage="" of="" the="" rfd="" occupied="" is="" greater="" than="" that="" occupied="" by="" the="" subgroup="" u.s.="" population="" (48="" states).="" 2.="" from="" drinking="" water.="" acute="" and="" chronic="" (56-day)="" dwecs="" (drinking="" water="" estimated="" concentration)="" for="" surface="" water="" were="" calculated="" by="" geneec="" (generic="" expected="" environmental="" concentration)="" screening="" model="" to="" be="" 7.57="" and="" 4.16="" ppb,="" respectively.="" according="" to="" hed="" drinking="" water="" guidance="" (hed="" sop="" 98.4)="" the="" 56-day="" geneec="" value="" may="" be="" divided="" by="" 3="" to="" [[page="" 54221]]="" obtain="" a="" value="" for="" chronic="" risk="" assessment="" calculations.="" therefore,="" the="" tier="" 1="" chronic="" surface="" water="" value="" is="" 1.39="" ppb.="" a="" ground="" water="" estimate="" was="" made="" using="" the="" sci-grow="" (screening="" concentration="" in="" ground="" water)="" screening="" model="" based="" on="" actual="" ground="" water="" monitoring="" data="" collected="" from="" small-scale="" prospective="" ground="" water="" monitoring="" studies="" for="" the="" registration="" of="" a="" number="" of="" pesticides="" that="" serve="" as="" benchmarks="" for="" the="" model.="" the="" dwec="" for="" imazapic="" in="" ground="" water="" was="" calculated="" at="" 5.95="" ppb.="" this="" concentration="" may="" be="" used="" for="" both="" the="" acute="" and="" chronic="" scenarios.="" 3.="" from="" non-dietary="" exposure.="" imazapic-ammonium="" is="" not="" currently="" registered="" for="" sites="" that="" would="" result="" in="" non-dietary,="" non-occpational="" exposure.="" therefore,="" such="" exposures="" are="" not="" expected="" and="" have="" not="" been="" included="" in="" this="" risk="" assessment.="" 4.="" cumulative="" exposure="" to="" substances="" with="" common="" mechanism="" of="" toxicity.="" imazapic="" is="" a="" member="" of="" the="" imidazolinone="" class="" of="" pesticides.="" other="" members="" of="" this="" class="" include="" imazapyr,="" imazethapyr,="" imazaquin,="" and="" imazamethabenz-methyl.="" 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="" imazapic-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,="" imazapic-ammonium="" does="" not="" appear="" to="" produce="" a="" toxic="" metabolite="" produced="" by="" other="" substances.="" for="" the="" purposes="" of="" these="" tolerance="" actions,="" therefore,="" epa="" has="" not="" assumed="" that="" imazapic-ammonium="" has="" a="" common="" mechanism="" of="" toxicity="" with="" other="" substances.="" for="" more="" 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.="" for="" the="" population="" subgroup="" of="" concern,="" pregnant="" females="" 13+="" years,="" the="" acute="" aggregate="" exposure="" includes="" food="" and="" water.="" for="" pregnant="" females,="" 13+,="" 0.3%="" of="" the="" apad="" is="" occupied="" by="" dietary="" (food)="" exposure.="" the="" estimated="" maximum="" concentrations="" of="" imazapic-ammonium="" in="" surface="" and="" ground="" water="" are="" less="" than="" the="" dwloc="" for="" imazapic-ammonium="" in="" drinking="" water="" as="" a="" contribution="" to="" acute="" aggregate="" exposure.="" therefore,="" epa="" concludes="" with="" reasonable="" certainty="" that="" the="" acute="" aggregate="" risks="" resulting="" from="" residues="" of="" imazapic-="" ammonium="" in="" food="" and="" drinking="" water="" are="" below="" epa's="" level="" of="" concern.="" 2.="" chronic="" risk.="" for="" the="" u.s.="" population,="" 0.5%="" of="" the="" cpad="" is="" occupied="" by="" dietary="" (food)="" exposure.="" other="" highly="" exposed="" population="" subgroups="" include="" children="" 1-6="" years="" (1.4%="" cpad),="" hispanics="" (0.6%="" cpad),="" pregnant="" females="" 13+="" (0.4%="" cpad)="" and="" males="" 13-19="" years="" (0.6%="" cpad).="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100="" percent="" 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.="" the="" estimated="" average="" concentrations="" of="" imazapic-ammonium="" in="" surface="" and="" ground="" water="" are="" less="" than="" the="" dwloc="" for="" imazapic-="" ammonium="" in="" drinking="" water="" as="" a="" contribution="" to="" chronic="" aggregate="" exposure.="" therefore,="" epa="" concludes="" with="" reasonable="" certainty="" that="" the="" chronic="" aggregate="" risks="" resulting="" from="" residues="" of="" imazapic-="" ammonium="" in="" food="" and="" drinking="" water="" are="" below="" epa's="" level="" of="" concern.="" 3.="" short-="" and="" 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="" non-dietary,="" non-occupational="" exposure.="" since="" there="" are="" no="" registered="" uses="" for="" imazapic-ammonium="" that="" would="" result="" in="" such="" exposures,="" both="" short-="" and="" intermediate="" term="" aggregate="" risk="" assessments="" are="" not="" required.="" 4.="" aggregate="" cancer="" risk="" for="" u.s.="" population.="" a="" cancer="" risk="" assessment="" was="" not="" conducted,="" since="" imazapic="" has="" been="" classified="" as="" a="" group="" ``e''="" non-carcinogenicity="" for="" humans="" based="" on="" a="" negative="" tumorigenic="" potential="" in="" two="" acceptable="" animal="" studies.="" 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="" imazapic-="" 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="" imazapic-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="" 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="" moe="" and="" 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.="" in="" the="" developmental="" study="" in="" rats,="" the="" maternal="" (systemic)="" noael="" was="" 1,000="" mg/kg/day="" highest="" dose="" tested="" (hdt).="" the="" developmental="" (fetal)="" noael="" was="" 1,000="" mg/kg/day="" (hdt).="" in="" the="" developmental="" toxicity="" study="" in="" rabbits,="" the="" maternal="" (systemic)="" noael="" was="" 350="" mg/kg/day,="" based="" on="" decreased="" body="" weight="" and="" food="" consumption="" at="" the="" loael="" of="" 500="" mg/kg/day.="" the="" developmental="" (fetal)="" noael="" was="" 175="" mg/kg/day,="" based="" on="" increased="" incidence="" of="" rudimentary="" ribs="" at="" the="" loael="" of="" 350="" mg/kg/day.="" iii.="" reproductive="" toxicity="" study.="" in="" the="" 2-generation="" reproductive="" toxicity="" study="" in="" rats,="" the="" maternal="" (systemic)="" noael="" was="" 1,484="" mg/kg/="" day="" (hdt).="" the="" developmental="" (pup)="" noael="" was="" 1,484="" mg/kg/day="" (hdt).="" the="" reproductive="" noael="" was="" 1,484="" mg/kg/day="" (hdt).="" iv.="" pre-="" and="" post-natal="" sensitivity.="" the="" toxicological="" data="" base="" for="" evaluating="" pre-="" and="" post-natal="" toxicity="" for="" imazapic-ammonium="" is="" complete="" with="" respect="" to="" current="" data="" requirements.="" there="" appears="" to="" be="" extra-sensitivity="" [[page="" 54222]]="" based="" on="" the="" pre-natal="" results="" in="" the="" rabbit="" developmental="" study.="" the="" developmental="" noael="" was="" 175="" mg/kg/day="" based="" on="" the="" increased="" incidence="" of="" rudimentary="" ribs="" at="" the="" loael="" of="" 350="" mg/kg/day.="" in="" contrast,="" the="" maternal="" noael="" was="" 350="" mg/kg/day="" based="" on="" decreased="" body="" weight="" and="" food="" consumption="" at="" the="" loael="" of="" 500="" mg/kg/day.="" therefore,="" pre-natal="" developmental="" toxicity="" occurred="" at="" a="" dose="" level="" 350="" mg/kg/day,="" which="" did="" not="" demonstrate="" any="" maternal="" toxicity.="" based="" on="" the="" above,="" epa="" concludes="" that="" reliable="" data="" support="" use="" of="" a="" 1,000-fold="" moe/="" uncertainty="" factor="" to="" protect="" infants="" and="" children.="" based="" on="" the="" conclusions="" of="" the="" rabbit="" developmental="" study,="" epa="" used="" the="" fqpa="" tier="" i="" approach="" which="" retains="" the="" 10x="" safety="" factor.="" v.="" conclusion.="" there="" is="" a="" complete="" toxicity="" database="" for="" imazapic-="" ammonium="" and="" exposure="" data="" is="" complete="" or="" is="" estimated="" based="" on="" data="" that="" reasonably="" accounts="" for="" potential="" exposures.="" 2.="" acute="" risk.="" the="" apad="" only="" applies="" to="" pregnant="" females,="" 13+="" and="" is="" not="" required="" for="" infants=""><1 year),="" non-nursing="" infants,="" and="" children="" (1-6="" years).="" for="" pregnant="" females,="" 13+,="" dietary="" exposure="" utilized="" 0.4%="" of="" the="" apad.="" the="" estimated="" average="" concentrations="" of="" imazapic-="" ammonium="" in="" surface="" and="" ground="" water="" are="" less="" than="" epa's="" level="" of="" concern="" for="" imazapic-="" ammonium="" in="" drinking="" water="" as="" a="" contribution="" to="" acute="" aggregate="" exposure.="" 3.="" chronic="" risk.="" the="" %cpad="" utilized="" for="" chronic="" dietary="" exposure="" were="" 1.3%="" for="" non-="" nursing="" infants,="" 1.4%="" for="" children="" 1-6="" years,="" and="" 1.0%="" for="" all="" infants=""><1 year).="" the="" estimated="" average="" concentrations="" of="" imazapic-ammonium="" in="" surface="" and="" ground="" water="" are="" less="" than="" epa's="" level="" of="" concern="" for="" imazapic-ammonium="" in="" drinking="" water="" as="" a="" contribution="" to="" chronic="" aggregate="" exposure.="" 4.="" short-="" or="" intermediate-term="" risk.="" since="" there="" are="" no="" registered="" uses="" for="" imazapic-ammonium="" which="" would="" result="" in="" non-dietary,="" non-="" occupational="" exposure,="" contributions="" to="" the="" aggregate="" risk="" from="" both="" short-="" and="" intermediate="" non-dietary="" exposures="" are="" not="" expected.="" 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="" imazapic-ammonium="" residues.="" v.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" nature="" of="" the="" residue="" in="" plants="" and="" livestock="" has="" been="" adequately="" defined="" for="" this="" time-limited="" tolerance.="" the="" residues="" of="" concern="" in="" grass="" are="" imazapic-ammonium="" and="" its="" hydroxymethyl="" metabolite,="" both="" free="" and="" conjugated.="" based="" on="" the="" results="" of="" a="" goat="" metabolism="" study,="" the="" residues="" of="" concern="" in="" ruminants="" were="" identified="" as="" imazapic-ammonium="" and="" its="" hydroxymethyl="" metabolite.="" for="" the="" purposes="" of="" this="" time-limited="" tolerance="" only,="" the="" residues="" of="" concern="" in="" animals="" are="" imazapic="" and="" its="" hydroxymethyl="" metabolite.="" b.="" analytical="" enforcement="" methodology="" an="" adequate="" analytical="" enforcement="" method="" is="" available="" to="" enforce="" the="" grass="" forage="" and="" hay="" tolerances="" for="" imazapic-ammonium="" and="" its="" hydroxymethyl="" metabolite.="" american="" cyanamid="" company="" submitted="" an="" independent="" laboratory="" validation="" (ilv)="" of="" a="" capillary="" electrophoresis="" determinative="" method="" (method="" m3114)="" for="" determination="" of="" residues="" in="" grass.="" adequate="" analytical="" enforcement="" methods="" are="" available="" to="" enforce="" the="" animal="" commodity="" tolerances="" for="" imazapic-ammonium="" and="" its="" hydroxymethyl="" metabolite.="" american="" cyanamide="" company="" submitted="" independent="" laboratory="" validations="" (ilvs)="" of="" capillary="" electrophoresis="" determinative="" and="" lc/ms="" confirmatory="" methods="" (methods="" m3118;="" m3222;="" and="" m3233)="" for="" determination="" of="" residues="" in="" milk;="" cattle="" muscle,="" kidney,="" and="" liver="" tissue;="" and="" bovine="" milk="" fat="" and="" tissue="" fat,="" respectively.="" the="" methods="" 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
Residues of imazapic-ammonium and its hydroxymethyl metabolite,
free and conjugated, are not expected to exceed 30 and 15 ppm in/on
grass forage and hay, respectively, as a result of this emergency use.
Secondary residues in animal commodities are not expected to exceed
0.10 ppm in milk, meat, fat, or meat byproducts (except kidney); or 1.0
ppm in kidney as a result of this emergency use. There are no processed
food/feed items resulting from this emergency use.
D. International Residue Limits
There are no CODEX, Canadian, or Mexican maximum residue limits for
imazapic on pastures/rangeland.
VI. Conclusion
Therefore, the tolerances are established for [combined residues]
of imazapic- ammonium, (+)-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-
oxo-1H-imidazol-2-yl]-5- methyl-3-pyridinecarboxylic acid, applied as
its ammonium salt and its metabolite (+)-2- [4,5-dihydro-4-methyl-4-(1-
methylethyl)-5-oxo-1H-imidazol-2-yl]-5-hydromethyl-3-
pyridinecarboxylic acid both free and conjugated in grass forage at 30
ppm; grass hay at 15 ppm; milk, fat, meat, meat byproducts (except
kidney) of cattle, goats, hogs, horses, and sheep at 0.10 ppm; and
kidney of cattle, goats, hogs, horses, and sheep at 1 ppm.
VII. 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-300927 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 December
6, 1999.
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
[[Page 54223]]
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 VII.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 the docket
number OPP-300927, 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).
VIII. Regulatory Assessment Requirements
This final rule establishes a tolerance under section 408 of the
FFDCA. 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, 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, 1997). 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,
1987). 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
Cosmetic Act, 21 U.S.C. section 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 under FFDCA
section 408(l)(6), such as the tolerance 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.
IX. 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).
[[Page 54224]]
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 23, 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), 346(a), and 371.
2. Section 180.490 is revised to read as follows:
Sec. 180.490 Imazapic-ammonium; tolerances for residues.
(a) General. Tolerance is established for residues of the
herbicide; (+)-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-
imidazol-2-yl]-5-methyl-3-pyridinecarboxylic acid applied as its
ammonium salt and its metabolite (+)-2-[4,5-dihydro-4-methyl-4-(1-
methylethyl)-5-oxo-1H-imidazol-2-yl]-5-hydromethyl-3-pyridinecarboxylic
acid both free and conjugated; in or on the following food commodity:
------------------------------------------------------------------------
Commodities Parts per million
------------------------------------------------------------------------
Peanut nutmeat............................ 0.1
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for combined residues of the herbicide imazapic-ammonium,
(+)-2-[4,5-dihydro-4-methyl-4-(1- methylethyl)-5-oxo-1H-imidazol-2-yl]-
5-methyl-3-pyridinecarboxylic acid, applied as its ammonium salt and
its metabolite (+)-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-
imidazol-2-yl]-5-hydromethyl-3-pyridinecarboxylic acid both free and
conjugated in connection with use of the pesticide under section 18
emergency exemptions granted by EPA. The tolerances are specified in
the table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
Cattle, fat..................... 0.10 12/31/01
Cattle, kidney.................. 1.0 12/31/01
Cattle, mbyp (except kidney).... 0.1 12/31/01
Cattle, meat.................... 0.1 12/31/01
Goats, fat...................... 0.1 12/31/01
Goats, kidney................... 1.0 12/31/01
Goats, mbyp (except kidney)..... 0.1 12/31/01
Goats, meat..................... 0.1 12/31/01
Grass, forage................... 30 12/31/01
Grass, hay...................... 15 12/31/01
Hogs, fat....................... 0.1 12/31/01
Hogs, kidney.................... 1.0 12/31/01
Hogs, mbyp (except kidney)...... 0.1 12/31/01
Hogs, meat...................... 0.1 12/31/01
Horses, fat..................... 0.1 12/31/01
Horses, kidney.................. 1.0 12/31/01
Horses, mbyp (except kidney).... 0.1 12/31/01
Horses, meat.................... 0.1 12/31/01
Sheep, fat...................... 0.1 12/31/01
Sheep, kidney................... 1.0 12/31/01
Sheep, mbyp (except kidney)..... 0.1 12/31/01
Sheep, meat..................... 0.1 12/31/01
------------------------------------------------------------------------
(c) Tolerances with reginal registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 99-25842 Filed 10-5-99; 8:45 am]
BILLING CODE 6560-50-F
