[Federal Register Volume 64, Number 235 (Wednesday, December 8, 1999)]
[Rules and Regulations]
[Pages 68631-68637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-31547]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300947; FRL-6390-9]
RIN 2070-AB78
Tebufenozide; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
residues of tebufenozide in or on soybeans. This action is in response
to EPA's granting of an emergency exemption under section 18 of the
Federal Insecticide, Fungicide, and Rodenticide Act authorizing use of
the pesticide on soybeans. This regulation establishes a maximum
permissible level for residues of benzoic acid, 3,5-dimethyl-1-(1,1-
dimethylethyl)-2-(4-ethylbenzoyl)hydrazide in this food commodity. The
tolerance will expire and is revoked on December 31, 2001.
DATES: This regulation is effective December 8, 1999. Objections and
requests for hearings, identified by docket control number OPP-300947,
must be received by EPA on or before February 7, 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 VII. of the ``SUPPLEMENTARY
INFORMATION.'' To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-300947 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Andrew Ertman, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone
number: (703) 308-9367; and e-mail address: ertman.andrew@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
[[Page 68632]]
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS codes potentially
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 under ``FOR FURTHER INFORMATION
CONTACT.''
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-300947. 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 a tolerance for residues of the insecticide tebufenozide,
in or on soybeans at 2.0 part per million (ppm). This tolerance will
expire and is revoked on December 31, 2001. EPA will publish a document
in the Federal Register to remove the revoked tolerance 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
the Food Quality Protection Act (FQPA). EPA has established regulations
governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Tebufenozide on Soybeans and FFDCA
Tolerances
The state of Louisiana declared a crisis for the use of
tebufenozide on soybeans to control fall armyworms due to lack of
efficacy of currently labeled products. EPA has authorized under FIFRA
section 18 the use of tebufenozide on soybeans for control of fall
armyworms in Louisiana.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of tebufenozide in or on
soybeans. 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 this tolerance without notice and opportunity for public
comment as provided in section 408(l)(6). Although this tolerance will
expire and is revoked on December 31, 2001, under FFDCA section
408(l)(5), residues of the pesticide not in excess of the amounts
specified in the tolerance remaining in or on soybeans 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 this tolerance at the time of that application.
EPA will take action to revoke this tolerance earlier if any experience
with, scientific data on, or other relevant information on this
pesticide indicate that the residues are not safe.
Because this tolerance is being approved under emergency
conditions, EPA has not made any decisions about whether tebufenozide
meets EPA's registration requirements for use on soybeans or whether a
permanent tolerance for this use would be appropriate. Under these
circumstances, EPA does not believe that this tolerance serves as a
basis for registration of tebufenozide by a State for special local
needs under FIFRA section 24(c). Nor does this tolerance serve as the
basis for any State other than Louisiana to use this pesticide on this
crop 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
[[Page 68633]]
information regarding the emergency exemption for tebufenozide, contact
the Agency's Registration Division at the address provided under ``FOR
FURTHER INFORMATION CONTACT.''
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
tebufenozide and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerance for
residues of tebufenozide on soybeans at 2.0 ppm. EPA's assessment of
the dietary exposures and risks associated with establishing the
tolerance 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 tebufenozide are
discussed in this unit.
B. Toxicological Endpoint
1. Acute toxicity. No toxicological endpoint has been identified
for acute toxicity. Toxicity observed in oral toxicity studies were not
attributable to a single dose (exposure). No neurological or systemic
toxicity was observed in rats given a single oral administration of
tebufenozide at 0, 500, 1,000 or 2,000 milligrams/kilograms/day (mg/kg/
day). No maternal or developmental toxicity was observed following oral
administration of tebufenozide at 1,000 mg/kg/day (limit-dose) during
gestation to pregnant rats or rabbits.
2. Short- and intermediate-term toxicity. No toxicological
endpoints have been identified for short- and intermediate-term
toxicity. No dermal or systemic toxicity was seen in rats administered
15 dermal applications at 1,000 mg/kg/day (limit dose) over 21 days
with either technical tebufenozide or 23% active ingredient
formulation. Despite hematological effects seen in the dog study,
similar effects were not seen in these rats receiving the compound via
the dermal route indicating poor dermal absorption. Also, no
developmental endpoints of concern were evident due to the lack of
developmental toxicity in either rat or rabbit studies.
3. Chronic toxicity. EPA has established the reference dose, or
RfD, for tebufenozide at 0.018 mg/kg/day. This RfD is based on the no
observable adverse effect level (NOAEL) of 1.8 mg/kg/day based on
growth retardation, alterations in hematology parameters, changes in
organ weights, and histopathological lesions in the bone, spleen and
liver at the lowest observable adverse effect level (LOAEL) of 8.7 mg/
kg/day. An uncertainty factor of 100 (10X for interspecies
extrapolation and 10X for intraspecies variability) was applied to the
NOAEL of 1.8 mg/kg/day to calculate the RfD of 0.018 mg/kg/day.
EPA has determined that the 10X factor to account for enhanced
susceptibility of infants and children (as required by FQPA) can be
removed, and therefore, the chronic Population Adjusted Dose (cPAD), is
0.018 mg/kg/day, which is the same as the RfD. For purposes of this
risk assessment, the term cPAD will be used instead of RfD. The
determination that the 10X factor be removed is based on the results of
reproductive and developmental toxicity studies. No evidence of
additional sensitivity to young rats or rabbits was observed following
prenatal or postnatal exposure to tebufenozide.
4. Carcinogenicity. Tebufenozide is classified as Group E (no
evidence of carcinogenicity in humans).
C. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.482) for the residues of tebufenozide, in or on a variety of
raw agricultural commodities. Tolerances, in support of registrations,
currently exist for residues of tebufenozide on apples, berries,
canola, cotton, cranberries, fruiting vegetables, leafy vegetables,
milk, mint, pears, pecans, pome fruit, sugarcane, turnips, walnuts and
livestock commodities of cattle, goats, hogs, horses, and sheep.
Additionally, time-limited tolerances associated with emergency
exemptions have been established for poultry, eggs, peanuts, rice, and
sweet potatoes. Risk assessments were conducted by EPA to assess
dietary exposures and risks from tebufenozide 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. Toxicity observed in oral toxicity
studies were not attributable to a single dose or 1 day exposure.
Therefore, no toxicological endpoint was identified for acute toxicity
and no acute dietary risk assessment is needed.
ii. Chronic exposure and risk. The Agency conducted a chronic
dietary exposure analysis and risk assessment. The chronic analysis for
tebufenozide used a cPAD of 0.018 mg/kg/day. The analysis evaluated
individual food consumption as reported by respondents in the USDA
1989-92 Continuing Surveys of Food Intake by Individuals and
accumulates exposure to the chemical for each commodity. Tolerance
level residues and some percent crop treated (PCT) assumptions were
made for the proposed commodities to estimate the Anticipated Residue
Concentration (ARC) for the general population and subgroups of
interest. The percent of the cPAD that would exceed the Agency level of
concern would be 100%. The existing tebufenozide tolerances (published,
pending, and including the necessary section 18 tolerance(s)) result in
a ARC that is equivalent to percentages of the cPAD below 100% for all
subgroups U.S. population, 14% and non-nursing infants (<1 year="" old),="" the="" most="" highly="" exposed="" subgroup,="" 44%.="" section="" 408(b)(2)(f)="" states="" that="" the="" agency="" may="" use="" data="" on="" the="" actual="" 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="" subpopulation="" group;="" and="" 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.="" estimates="" of="" pct="" were="" used="" for="" the="" following="" crops.="" in="" all="" cases="" the="" maximum="" estimate="" was="" used:="" [[page="" 68634]]="" ------------------------------------------------------------------------="" crops="" average="" maximum="" ------------------------------------------------------------------------="" almonds.......................................=""><1%><1% apples........................................="" 1%="" 2%="" beans/peas,="" dry...............................="" 0%="" 1%="" cabbage,="" fresh................................="" 2%="" 3%="" cole="" crops....................................="" 1%="" 2%="" cotton........................................="" 1%="" 4%="" pears.........................................=""><5% spinach,="" fresh................................="" 2%="" 3%="" spinach,="" processed............................="" 20%="" 29%="" sugarcane.....................................="" 3%="" 5%="" walnuts.......................................="" 10%="" 16%="" ------------------------------------------------------------------------="" the="" agency="" believes="" that="" the="" three="" conditions,="" discussed="" in="" section="" 408(b)(2)(f)="" in="" this="" unit="" concerning="" the="" agency's="" responsibilities="" in="" assessing="" chronic="" dietary="" risk="" findings,="" have="" been="" met.="" the="" pct="" estimates="" are="" derived="" from="" federal="" and="" private="" market="" survey="" data,="" which="" are="" reliable="" and="" have="" a="" valid="" basis.="" typically,="" a="" range="" of="" estimates="" are="" supplied="" and="" the="" upper="" end="" of="" this="" range="" is="" assumed="" for="" the="" exposure="" assessment.="" by="" using="" this="" upper="" end="" estimate="" of="" the="" pct,="" the="" agency="" is="" reasonably="" certain="" that="" the="" percentage="" of="" the="" food="" treated="" is="" not="" likely="" to="" be="" underestimated.="" 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="" tebufenozide="" may="" be="" applied="" in="" a="" particular="" area.="" 2.="" from="" drinking="" water.="" the="" agency="" lacks="" sufficient="" water-related="" exposure="" data="" to="" complete="" a="" comprehensive="" drinking="" water="" exposure="" analysis="" and="" risk="" assessment="" for="" tebufenozide.="" because="" the="" agency="" does="" not="" have="" comprehensive="" and="" reliable="" monitoring="" data,="" drinking="" water="" concentration="" estimates="" must="" be="" made="" by="" reliance="" on="" some="" sort="" of="" simulation="" or="" modeling.="" to="" date,="" there="" are="" no="" validated="" modeling="" approaches="" for="" reliably="" predicting="" pesticide="" levels="" in="" drinking="" water.="" the="" agency="" is="" currently="" relying="" on="" generic="" expected="" environmental="" concentration="" (geneec)="" and="" epa's="" pesticide="" root="" zone="" model="" (przm/exams)="" for="" surface="" water,="" which="" are="" used="" to="" produce="" estimates="" of="" pesticide="" concentrations="" in="" a="" farm="" pond="" and="" screening="" concentrations="" in="" ground="" water="" (sci-grow),="" which="" predicts="" pesticide="" concentrations="" in="" ground="" water.="" none="" of="" these="" models="" include="" consideration="" of="" the="" impact="" processing="" of="" raw="" water="" for="" distribution="" as="" drinking="" water="" would="" likely="" have="" on="" the="" removal="" of="" pesticides="" from="" the="" source="" water.="" the="" primary="" use="" of="" these="" models="" by="" the="" agency="" at="" this="" stage="" is="" to="" provide="" a="" coarse="" screen="" for="" sorting="" out="" pesticides="" for="" which="" it="" is="" highly="" unlikely="" that="" drinking="" water="" concentrations="" would="" ever="" exceed="" human="" health="" levels="" of="" concern.="" for="" the="" proposed="" uses,="" based="" on="" the="" geneec="" and="" sci-grow="" models,="" the="" chronic="" drinking="" water="" concentration="" value="" are="" estimated="" to="" be="" 29="" ppb="" for="" surface="" water="" and="" 1="" pbb="" for="" ground="" water.="" in="" the="" absence="" of="" monitoring="" data="" for="" pesticides,="" drinking="" water="" levels="" of="" comparison="" (dwlocs)="" are="" calculated="" and="" used="" as="" a="" point="" of="" comparison="" against="" the="" model="" estimates="" of="" a="" pesticide's="" concentration="" in="" water.="" dwlocs="" are="" theoretical="" upper="" limits="" on="" a="" pesticide's="" concentration="" in="" drinking="" water="" in="" light="" of="" total="" aggregate="" exposure="" to="" a="" pesticide="" in="" food,="" drinking="" water,="" and="" residential="" uses.="" a="" dwloc="" will="" vary="" depending="" on="" the="" toxic="" endpoint,="" with="" drinking="" water="" consumption,="" and="" body="" weights.="" different="" populations="" will="" have="" different="" dwlocs.="" dwlocs="" are="" used="" in="" the="" risk="" assessment="" process="" as="" a="" surrogate="" measure="" of="" potential="" exposure="" associated="" with="" pesticide="" exposure="" through="" drinking="" water.="" dwloc="" values="" are="" not="" regulatory="" standards="" for="" drinking="" water.="" since="" dwlocs="" address="" total="" aggregate="" exposure="" to="" tebufenozide="" they="" are="" further="" discussed="" in="" the="" aggregate="" risk="" sections="" below.="" 3.="" from="" non-dietary="" exposure.="" tebufenozide="" is="" not="" registered="" on="" any="" use="" sites="" which="" would="" result="" in="" non-dietary,="" non-occupational="" exposure.="" therefore,="" epa="" expects="" only="" dietary="" and="" occupational="" exposure="" from="" the="" use="" of="" tebufenozide.="" 4.="" cumulative="" exposure="" to="" substances="" with="" a="" 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="" tebufenozide="" 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,="" tebufenozide="" 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="" tebufenozide="" 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.="" as="" discussed="" above,="" no="" toxicological="" endpoint="" was="" identified="" for="" acute="" toxicity.="" therefore,="" no="" acute="" aggregate="" risk="" assessment="" is="" needed.="" 2.="" chronic="" risk.="" using="" the="" arc="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" tebufenozide="" from="" food="" will="" utilize="" 14%="" of="" the="" cpad="" for="" the="" u.s.="" population.="" the="" major="" identifiable="" subgroup="" with="" the="" highest="" aggregate="" exposure,="" non-nursing="" infants=""><1 year="" old)="" will="" utilize="" 44%="" of="" the="" cpad.="" 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="" exposure="" to="" tebufenozide="" in="" drinking="" water,="" after="" calculating="" dwlocs="" and="" comparing="" them="" to="" conservative="" model="" estimates="" of="" concentrations="" of="" tebufenozide="" in="" surface="" and="" ground="" water="" (29="" ppb="" and="" 1="" 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="" (considered="" to="" be="" a="" background="" exposure="" level)="" plus="" indoor="" and="" outdoor="" residential="" exposure.="" tebufenozide="" is="" not="" registered="" on="" any="" use="" sites="" which="" would="" result="" in="" non-dietary,="" non-occupational="" exposure.="" therefore="" no="" short-="" and="" intermediate-term="" aggregate="" risk="" assessments="" are="" needed.="" 4.="" aggregate="" cancer="" risk="" for="" u.s.="" population.="" tebufenozide="" is="" classified="" as="" group="" e="" (no="" evidence="" of="" carcinogenicity="" in="" humans).="" 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="" tebufenozide="" residues.="" [[page="" 68635]]="" 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="" tebufenozide,="" 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="" prenatal="" and="" postnatal="" 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="" moe="" and="" uncertainty="" factor="" (usually="" 100="" for="" combined="" interspecies="" and="" intraspecies="" 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="" prenatal="" developmental="" toxicity="" studies="" in="" rats="" and="" rabbits,="" there="" was="" no="" evidence="" of="" maternal="" or="" developmental="" toxicity;="" the="" maternal="" and="" developmental="" noels="" were="" 1,000="" mg/kg/day="" (highest="" dose="" tested).="" iii.="" reproductive="" toxicity="" study.="" in="" 2-generation="" reproduction="" studies="" in="" rats,="" toxicity="" to="" the="" fetuses/offspring,="" when="" observed,="" occurred="" at="" equivalent="" or="" higher="" doses="" than="" in="" the="" maternal/parental="" animals.="" iv.="" prenatal="" and="" postnatal="" sensitivity.="" the="" data="" provided="" no="" indication="" of="" increased="" sensitivity="" of="" rats="" or="" rabbits="" to="" in="" utero="" and/="" or="" postnatal="" exposure="" to="" tebufenozide.="" no="" maternal="" or="" developmental="" findings="" were="" observed="" in="" the="" prenatal="" developmental="" toxicity="" studies="" at="" doses="" up="" to="" 1,000="" mg/kg/day="" in="" rats="" and="" rabbits.="" in="" the="" 2-generation="" reproduction="" studies="" in="" rats,="" effects="" occurred="" at="" the="" same="" or="" lower="" treatment="" levels="" in="" the="" adults="" as="" in="" the="" offspring.="" v.="" conclusion.="" there="" is="" a="" complete="" toxicity="" data="" base="" for="" tebufenozide="" and="" exposure="" data="" are="" complete="" or="" are="" estimated="" based="" on="" data="" that="" reasonably="" accounts="" for="" potential="" exposures.="" data="" provided="" no="" indication="" of="" increased="" sensitivity="" of="" rats="" or="" rabbits="" to="" in="" utero="" and/="" or="" postnatal="" exposure="" to="" tebufenozide.="" based="" on="" this,="" epa="" concludes="" that="" reliable="" data="" support="" the="" use="" of="" the="" standard="" 100-fold="" uncertainty="" factor,="" and="" that="" an="" additional="" uncertainty="" factor="" is="" not="" needed="" to="" protect="" the="" safety="" of="" infants="" and="" children.="" 2.="" acute="" risk.="" no="" toxicological="" endpoint="" was="" identified="" for="" acute="" toxicity.="" therefore,="" no="" acute="" aggregate="" risk="" assessment="" is="" needed.="" 3.="" chronic="" risk.="" using="" the="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" tebufenozide="" from="" food="" will="" utilize="" 44%="" of="" the="" cpad="" for="" infants="" and="" 29%="" of="" the="" cpad="" for="" children.="" 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="" exposure="" to="" tebufenozide="" in="" drinking="" water,="" after="" calculating="" dwlocs="" and="" comparing="" them="" to="" conservative="" model="" estimates="" of="" concentrations="" of="" tebufenozide="" in="" surface="" and="" ground="" water="" (29="" ppb="" and="" 1="" ppb,="" respectively),="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" cpad.="" 4.="" short-="" or="" intermediate-term="" risk.="" tebufenozide="" is="" not="" registered="" on="" any="" use="" sites="" which="" would="" result="" in="" non-dietary,="" non-occupational="" exposure.="" therefore="" no="" short-="" and="" intermediate-term="" aggregate="" risk="" assessments="" are="" needed.="" 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="" tebufenozide="" residues.="" v.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" residue="" of="" concern="" in="" plants="" is="" adequately="" understood="" and="" is="" tebufenozide="" per="" se.="" the="" qualitative="" nature="" of="" the="" residues="" in="" animals="" is="" also="" adequately="" understood="" based="" on="" acceptable="" poultry="" and="" ruminant="" metabolism="" studies.="" for="" animals,="" epa="" has="" concluded="" that="" the="" residues="" of="" regulatory="" concern="" are="" tebufenozide="" and="" its="" metabolites="" benzoic="" acid,="" 3,5-dimethyl-1-(1,1-dimethylethyl)-2-((4-="" carboxymethyl)benzoyl)hydrazide),="" benzoic="" acid,="" 3-hydroxymethyl,5-="" methyl-1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide,="" the="" stearic="" acid="" conjugate="" of="" benzoic="" acid,="" 3-hydroxymethyl,="" 5-methyl-1-(1,1-="" dimethylethyl)-2-(4-ethylbenzoyl)hydrazide="" and="" benzoic="" acid,="" 3-="" hydroxymethyl-5-methyl-1-(1,1-dimethylethyl)-2-(4-(1-="" hydroxyethyl)benzoyl)hydrazide.="" b.="" analytical="" enforcement="" methodology="" adequate="" enforcement="" methodology="" (for="" example,="" gas="" chromotography)="" is="" available="" to="" enforce="" the="" tolerance="" expression.="" the="" method="" may="" be="" requested="" from:="" calvin="" furlow,="" pirib,="" 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 tebufenozide per se are not expected to exceed 2.0 ppm
on soybeans as a result of this section 18 use.
D. International Residue Limits
There are currently no Canadian, or Mexican listings for
tebufenozide residues. Codex maximum residue levels (MRLs) have been
set for tebufenozide at 0.1 ppm for rice (husked), 0.05 ppm for
walnuts, and 1 ppm for pome fruits.
VI. Conclusion
Therefore, the tolerance is established for residues of
tebufenozide in soybeans at 2.0 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
[[Page 68636]]
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-300947 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 February
7, 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
Rm. 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 by 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.'' 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., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by the docket control number OPP-300947, 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 PIRIB described in Unit
I.B.2. You may also send an electronic copy of your request via e-mail
to: opp-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 6.1/8.0 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 time-limited tolerance under FFDCA
section 408. 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 any prior consultation
as specified by Executive Order 13084, entitled Consultation and
Coordination with Indian Tribal Governments (63 FR 27655, May 19,
1998); special considerations as required by 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 or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). 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). Since
tolerances and exemptions that are established on the basis of a FIFRA
section 18 petition under FFDCA section 408, 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. In addition, 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 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to
[[Page 68637]]
include regulations that have ``substantial direct effects on the
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.'' This final rule 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 FFDCA section 408(n)(4).
IX. Submission to Congress and the General Accounting Office
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 final rule in the Federal Register. This final
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: November 17, 1999.
Peter Caulkins,
Acting 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. In Sec. 180.482, by adding alphabetically to the table in
paragraph (b), the following commodity to read as follows:
Sec. 180.482 Tebufenozide; tolerances for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Parts Expiration/
Commodity per revocation
million date
------------------------------------------------------------------------
* * * * *
Soybeans......................................... 2.0 12/31/01
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-31547 Filed 12-7-99; 8:45 am]
BILLING CODE 6560-50-F
