[Federal Register Volume 64, Number 188 (Wednesday, September 29, 1999)]
[Rules and Regulations]
[Pages 52457-52463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25314]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300923; FRL-6383-6]
RIN 2070-AB78
Tebufenozide; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
Tebufenozide benzoic acid, 3,5-dimethyl-,1-(1,1-dimethylethyl)-2-(4-
ethylbenzoyl) hydrazide in or on turnips and canola. The Interregional
Research Project Number 4 (IR-4) requested this tolerance under the
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality
Protection Act of 1996.
DATES: This regulation is effective September 29, 1999. Objections and
requests for hearings, identified by docket control number OPP-300923,
must be received by EPA on or before November 29, 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 VI. of the ``SUPPLEMENTARY
INFORMATION'' section. To ensure proper receipt by EPA, your objections
and hearing requests must identify docket control number OPP-300923 in
the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460;
telephone number: (703) 308-3194; and e-mail address: brothers.shaja
@epamail.epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Examples of Potentially
Categories NAICS Affected Entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed in the ``FOR FURTHER INFORMATION
CONTACT'' section.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically.You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations'' and then look up the entry for this document under the
``Federal Register--Environmental Documents.'' You can also go directly
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
2. In person. The Agency has established an official record for
this action under docket control number OPP-300923. 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
[[Page 52458]]
that are referenced in those documents. The public version of the
official record does not include any information claimed as CBI. The
public version of the official record, which includes printed, paper
versions of any electronic comments submitted during an applicable
comment period is available for inspection in the Public Information
and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The PIRIB telephone number is
(703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of February 9, 1999 (64 FR 6351) (FRL-
6058-3), EPA issued a notice pursuant to section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the
Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170)
announcing the filing of pesticide petitions (PP) for tolerance by IR-
4. This notice included a summary of the petitions prepared by the Rohm
and Haas Company, the registrant. There were no comments received in
response to the notice of filing.
The petitions requested that 40 CFR 180.482 be amended by
establishing tolerances for residues of the insecticide tebufenozide,
in or on turnip tops, turnip roots, canola seed, and refined canola oil
at 9.0, 0.25, 1.75, and 3.75 part per million (ppm), respectively. The
petitions were subsequently amended by IR-4 to propose tolerances for
turnip tops at 9.0 ppm, turnip roots at 0.3 ppm, canola seed at 2.0
ppm, and canola oil, refined at 4.0 ppm.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of
tebufenozide and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for tolerances for residues of
tebufenozide on turnip tops, turnip roots, canola seed, and refined
canola oil at 9.0, 0.3, 2.0, and 4.0 ppm, respectively. EPA's
assessment of the dietary exposures and risks associated with
establishing these tolerances follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by tebufenozide are
discussed in unit II.A. of the Final rule on Tebufenozide Pesticide
Tolerances published in the Federal Register on April 7, 1999 (64 FR
16850) (FRL-6072-6).
B. Toxicological Endpoints
The toxicology endpoints for tebufenozide are discussed in Unit
II.B. of the Final rule on Tebufenozide Pesticide Tolerances published
in the Federal Register of April 7, 1999.
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. Canola meal and turnip tops are ruminant
feed item. Permanent tolerances for livestock commodities (excluding
poultry) were published in the Federal Register (64 FR 39060, July 21,
1999). Risk assessments were conducted by EPA to assess dietary
exposures from tebufenozide as follows:
Section 408(b)(2)(F) states that the Agency may use data on the
actual percent of crop treated (PCT) for assessing chronic dietary risk
only if the Agency can make the following findings: That the data used
are reliable and provide a valid basis to show what percentage of the
food derived from such crop is likely to contain such pesticide
residue; that the exposure estimate does not underestimate exposure for
any significant 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.
The Agency used PCT information as follows:
Estimates of PCT were used for the following crops. In all cases
the maximum estimate was used. Almonds: average < 1%="" maximum="">< 1%,="" apples:="" average="" 1%="" maximum="" 2%,="" beans/peas,="" dry:="" average="" 0%="" maximum="" 1%,="" cotton:="" average="" 1%="" maximum="" 4%,="" sugarcane:="" average="" 3%="" maximum="" 5%,="" and="" walnuts:="" average="" 10%="" maximum="" 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="" [[page="" 52459]]="" have="" available="" information="" on="" the="" regional="" consumption="" of="" food="" to="" which="" may="" be="" applied="" in="" a="" particular="" area.="" 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="" (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="" mg/kg.="" 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.="" this="" risk="" assessment="" is="" not="" required.="" the="" agency="" considers="" acute="" exposure/risk="" to="" be="" negligible.="" ii.="" chronic="" exposure="" and="" risk.="" the="" residue="" of="" concern="" for="" tebufenozide="" in="" plant="" and="" animal="" commodities="" is="" the="" parent="" compound="" per="" se.="" the="" chronic="" population="" adjusted="" dose="" (cpad)="" used="" for="" the="" chronic="" dietary="" analysis="" is="" 0.018="" mg/kg/day.="" in="" performing="" chronic="" dietary="" exposure="" and="" risk="" analysis,="" the="" agency="" used="" the="" dietary="" exposure="" evaluation="" model="" (deem),="" which="" incorporates="" data="" from="" the="" continuing="" survey="" of="" food="" intake="" by="" individuals="" (csfii)="" for="" the="" period,="" 1989="" to="" 1992.="" some="" refinement="" to="" the="" dietary="" exposure="" estimates="" was="" made="" through="" the="" use="" of="" percent-of-crop-treated="" data.="" the="" resulting="" anticipated="" residue="" contributions="" (arc)="" for="" the="" u.s.="" population="" and="" various="" deem="" population="" subgroups="" can="" be="" determined.="" of="" these="" subgroups,="" the="" highest="" exposure="" is="" projected="" for="" children="" ages="" 1-6="" years,="" whose="" chronic="" intake="" is="" estimated="" as="" 73%="" of="" the="" cpad.="" percent="" cpad="" values="" for="" other="" subgroups="" include:="" u.s.="" population="" for="" the="" 48="" states="" (36%),="" all="" infants="" less="" than="" 1="" yr.="" (52%),="" and="" children="" 7="" to="" 12="" yrs.="" (46%).="" generally,="" in="" the="" absence="" of="" additional="" safety="" factors,="" the="" agency="" is="" not="" concerned="" with="" exposures="" less="" than="" 100%="" of="" the="" cpad.="" thus,="" for="" all="" populations,="" the="" chronic="" human="" health="" risk="" from="" exposure="" to="" tebufenozide="" in="" foods="" is="" below="" the="" agency's="" level="" of="" concern.="" 2.="" from="" drinking="" water.="" available="" data="" suggest="" that="" tebufenozide="" ranges="" from="" moderately="" persistent="" to="" persistent="" and="" is="" mobile;="" thus,="" tebufenozide="" could="" potentially="" leach="" to="" ground="" water="" and="" runoff="" to="" surface="" water="" under="" certain="" environmental="" conditions.="" there="" is="" no="" maximum="" contaminant="" level="" (mcl)="" for="" residues="" of="" tebufenozide="" in="" drinking="" water.="" no="" drinking="" water="" health="" advisories="" have="" been="" issued="" for="" tebufenozide.="" there="" is="" no="" entry="" for="" tebufenozide="" in="" the="" ``pesticides="" in="" groundwater="" database="" (epa="" 734-12-92-001,="" september="" 1992).="" i.="" acute="" exposure="" and="" risk.="" because="" no="" acute="" dietary="" endpoint="" was="" determined,="" the="" agency="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" of="" no="" harm="" from="" acute="" exposure="" from="" drinking="" water.="" ii.="" chronic="" exposure="" and="" risk.="" submitted="" environmental="" fate="" studies="" suggest="" that="" tebufenozide="" ranges="" from="" moderately="" persistent="" to="" persistent="" and="" is="" mobile;="" thus,="" tebufenozide="" could="" potentially="" leach="" to="" ground="" water="" and="" runoff="" to="" surface="" water="" under="" certain="" environmental="" conditions.="" there="" is="" no="" established="" mcl="" for="" residues="" of="" tebufenozide="" in="" drinking="" water.="" no="" drinking="" water="" health="" advisories="" have="" been="" issued="" for="" tebufenozide.="" there="" is="" no="" entry="" for="" tebufenozide="" in="" the="" ``pesticides="" in="" groundwater="" database.''="" monitoring="" data="" are="" not="" available="" to="" assess="" the="" human="" exposure="" to="" tebufenozide="" via="" drinking="" water.="" in="" lieu="" of="" these,="" epa="" has="" calculated="" the="" tier="" i="" estimated="" environmental="" concentrations="" in="" drinking="" water="" (eecs)="" for="" tebufenozide="" using="" generic="" expected="" environmental="" concentration="" (geneec)="" (surface="" water)="" and="" screening="" concentration="" in="" ground="" water="" (sci-grow)="" (ground="" water)="" for="" use="" in="" the="" human="" health="" risk="" assessment.="" the="" maximum="" application="" rate="" for="" tebufenozide="" is="" 0.25="" pound="" (lb)="" active="" ingredient="" (a.i.)="" with="" 5="" applications="" per="" year="" on="" pecans.="" this="" application="" scenario="" was="" used="" to="" calculate="" the="" eecs="" for="" the="" human="" health="" risk="" assessment.="" due="" to="" the="" wide="" range="" of="" aerobic="" soil="" half-life="" values,="" geneec="" and="" scigrow="" were="" run="" based="" on="" aerobic="" half-lives="" of="" 66="" (california="" loam)="" and="" 729="" (worst-case="" soil="" with="" low="" microbial="" activity)="" days.="" for="" surface="" water,="" the="" chronic="" (56-day)="" values="" are="" 13.3="" parts="" per="" billion="" (ppb)="" and="" 16.5="" ppb="" for="" the="" half-lives="" of="" 66="" and="" 729="" days,="" respectively.="" the="" ground="" water="" screening="" concentrations="" are="" 0.16="" ppb="" and="" 1.04="" ppb="" for="" the="" half-lives="" of="" 66="" and="" 729="" days,="" respectively.="" these="" values="" represent="" upper-bound="" estimates="" of="" the="" concentrations="" that="" might="" be="" found="" in="" surface="" and="" ground="" water="" due="" to="" the="" use="" of="" tebufenozide="" on="" pecans.="" in="" performing="" this="" risk="" assessment,="" epa="" has="" calculated="" drinking="" water="" levels="" of="" comparison="" (dwlocs)="" for="" each="" of="" the="" deem="" population="" subgroups.="" within="" each="" subgroup,="" the="" population="" with="" the="" highest="" estimated="" exposure="" was="" used="" to="" determine="" the="" maximum="" concentration="" of="" tebufenozide="" that="" can="" occur="" in="" drinking="" water="" without="" causing="" an="" unacceptable="" human="" health="" risk.="" as="" a="" comparison="" value,="" epa="" has="" used="" the="" 16.5="" ppb="" value="" in="" this="" risk="" assessment,="" as="" this="" represents="" a="" worst-case="" scenario.="" the="" dwlocs="" for="" tebufenozide="" are="" above="" the="" drinking="" water="" estimated="" concentrations="" (dwec)="" of="" 16.5="" ppb="" for="" all="" population="" subgroups.="" therefore,="" the="" human="" health="" risk="" from="" exposure="" to="" tebufenozide="" through="" drinking="" water="" in="" not="" likely="" to="" exceed="" epa's="" level="" of="" concern.="" because="" the="" agency="" lacks="" sufficient="" water-related="" exposure="" data="" to="" complete="" a="" comprehensive="" drinking="" water="" risk="" assessment="" for="" many="" pesticides,="" epa="" has="" commenced="" and="" nearly="" completed="" a="" process="" to="" identify="" a="" reasonable="" yet="" conservative="" bounding="" figure="" for="" the="" potential="" contribution="" of="" water-related="" exposure="" to="" the="" aggregate="" risk="" posed="" by="" a="" pesticide.="" in="" developing="" the="" bounding="" figure,="" epa="" estimated="" residue="" levels="" in="" water="" for="" a="" number="" of="" specific="" pesticides="" using="" various="" data="" sources.="" the="" agency="" then="" applied="" the="" estimated="" residue="" levels,="" in="" conjunction="" with="" appropriate="" toxicological="" endpoints="" cpads="" or="" acute="" dietary="" no="" observed="" adverse="" effect="" levels="" (noaels)="" and="" assumptions="" about="" body="" weight="" and="" consumption,="" to="" calculate,="" for="" each="" pesticide,="" the="" increment="" of="" aggregate="" risk="" contributed="" by="" consumption="" of="" contaminated="" water.="" while="" epa="" has="" not="" yet="" pinpointed="" the="" appropriate="" bounding="" figure="" for="" exposure="" from="" contaminated="" water,="" the="" ranges="" the="" agency="" is="" continuing="" to="" examine="" are="" all="" below="" the="" level="" that="" would="" cause="" to="" exceed="" the="" cpad="" if="" the="" tolerances="" being="" considered="" in="" this="" document="" were="" granted.="" the="" agency="" has="" therefore="" concluded="" that="" the="" potential="" exposures="" associated="" with="" water,="" even="" at="" the="" higher="" levels="" the="" agency="" is="" considering="" as="" a="" conservative="" upper="" bound,="" would="" not="" prevent="" the="" agency="" from="" determining="" that="" there="" is="" a="" reasonable="" certainty="" of="" no="" harm="" if="" the="" tolerances="" are="" granted.="" 3.="" from="" non-dietary="" exposure.="" tebufenozide="" is="" not="" currently="" registered="" for="" use="" on="" residential="" non-food="" sites.="" the="" agency="" concludes="" that="" there="" are="" no="" acute,="" chronic,="" short-="" or="" intermediate-term="" non-="" dietary="" exposure="" scenarios.="" 4.="" cumulative="" exposure="" to="" substances="" with="" common="" mechanism="" of="" toxicity.="" section="" 408(b)(2)(d)(v)="" requires="" that,="" when="" considering="" whether="" to="" establish,="" modify,="" or="" revoke="" a="" tolerance,="" the="" agency="" consider="" ``available="" information``="" concerning="" the="" cumulative="" effects="" of="" a="" particular="" pesticide's="" residues="" and="" ``other="" substances="" that="" have="" a="" common="" mechanism="" of="" toxicity.''="" epa="" does="" not="" have,="" at="" this="" time,="" available="" data="" to="" determine="" whether="" tebufenozide="" has="" a="" common="" mechanism="" [[page="" 52460]]="" 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="" 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.="" since="" no="" acute="" toxicity="" endpoints="" were="" identified="" for="" tebufenozide,="" the="" agency="" concludes="" that="" acute="" aggregate="" risk="" from="" the="" use="" of="" the="" pesticide="" will="" not="" pose="" an="" unacceptable="" risk="" to="" human="" health.="" 2.="" chronic="" risk.="" using="" the="" arc="" exposure="" assumptions="" described="" in="" this="" unit,="" epa="" has="" concluded="" that="" aggregate="" exposure="" from="" food="" will="" utilize="" 10%="" of="" the="" cpad="" for="" the="" u.s.="" population.="" the="" major="" identifiable="" subgroup="" with="" the="" highest="" aggregate="" exposure="" is="" children="" (1-6="" years="" old)="" at="" 21%="" of="" the="" cpad="" discussed="" below.="" submitted="" environmental="" fate="" studies="" suggest="" that="" tebufenozide="" is="" moderately="" persistent="" to="" persistent="" and="" mobile;="" thus,="" tebufenozide="" could="" potentially="" leach="" to="" ground="" water="" and="" runoff="" to="" surface="" water="" under="" certain="" environmental="" conditions.="" the="" modeling="" data="" for="" tebufenozide="" indicate="" levels="" less="" than="" epa's="" dwloc.="" 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.="" since="" there="" is="" no="" potential="" for="" exposure="" to="" tebufenozide="" from="" residential="" uses,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" cpad.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" tebufenozide="" residues.="" 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.="" due="" to="" lack="" of="" endpoints="" and/or="" residential="" use="" registrations,="" the="" agency="" concludes="" that="" short-="" and="" intermediate-term="" risk="" via="" non-dietary="" routes="" (e.g.,="" dermal,="" inhalation,="" non-dietary="" oral)="" will="" not="" pose="" an="" unacceptable="" risk="" to="" human="" health.="" 4.="" aggregate="" cancer="" risk="" for="" u.s.="" population.="" tebufenozide="" has="" been="" classified="" as="" a="" group="" e="" chemical="" (no="" evidence="" of="" carcinogenicity="" for="" humans).="" the="" agency="" concludes="" that="" the="" aggregate="" cancer="" risk="" for="" the="" u.s.="" population="" is="" not="" impacted="" by="" the="" establishment="" of="" these="" tolerances.="" 5.="" determination="" of="" safety.="" based="" on="" the="" risk="" assessments="" discussed="" above,="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" tebufenozide="" 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="" 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="" 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="" database="" unless="" epa="" determines="" that="" a="" different="" margin="" of="" safety="" will="" be="" safe="" for="" infants="" and="" children.="" margins="" of="" safety="" are="" incorporated="" into="" epa="" risk="" assessments="" either="" directly="" through="" use="" of="" a="" margin="" of="" exposure="" (moe)="" analysis="" or="" through="" using="" uncertainty="" (safety)="" factors="" in="" calculating="" a="" dose="" level="" that="" poses="" no="" appreciable="" risk="" to="" humans.="" epa="" believes="" that="" reliable="" data="" support="" using="" the="" standard="" uncertainty="" factor="" (usually="" 100="" for="" combined="" inter-="" and="" intra-species="" variability)="" and="" not="" the="" additional="" tenfold="" moe/="" uncertainty="" factor="" when="" epa="" has="" a="" complete="" data="" base="" under="" existing="" guidelines="" and="" when="" the="" severity="" of="" the="" effect="" in="" infants="" or="" children="" or="" the="" potency="" or="" unusual="" toxic="" properties="" of="" a="" compound="" do="" not="" raise="" concerns="" regarding="" the="" adequacy="" of="" the="" standard="" moe/safety="" factor.="" ii.="" developmental="" toxicity="" studies.="" developmental="" toxicity="" studies="" showed="" no="" increased="" sensitivity="" in="" fetuses="" as="" compared="" to="" maternal="" animals="" following="" in="" utero="" exposures="" in="" rats="" and="" rabbits.="" see="" discussion="" under="" unit="" ii.a="" of="" the="" final="" rule="" for="" tebufenozide="" tolerances="" published="" in="" the="" federal="" register="" on="" april="" 7,="" 1999.="" iii.="" reproductive="" toxicity="" study.="" multi-generation="" reproduction="" toxicity="" studies="" in="" rats="" showed="" no="" increased="" sensitivity="" in="" pups="" as="" compared="" to="" adults="" and="" offsprings.="" see="" discussion="" under="" unit="" ii.a="" of="" the="" final="" rule="" for="" tebufenozide="" tolerances="" published="" in="" the="" federal="" register="" on="" april="" 7,="" 1999.="" iv.="" pre-="" and="" post-natal="" sensitivity.="" the="" agency="" determined="" that="" available="" data="" provide="" no="" indication="" of="" increased="" sensitivity="" of="" rats="" or="" rabbits="" to="" in="" utero="" and/or="" postnatal="" exposure="" to="" tebufenozide.="" v.="" conclusion.="" the="" agency="" believes="" that="" reliable="" data="" support="" using="" the="" standard="" 100-fold="" safety="" factor="" for="" assessing="" sensitivity="" to="" residues="" of="" tebufenozide="" and="" that="" an="" additional="" 10-fold="" margin="" of="" safety="" for="" infants="" and="" children="" is="" not="" warranted.="" there="" is="" a="" complete="" toxicity="" database="" for="" tebufenozide="" and="" exposure="" data="" are="" complete="" or="" estimated="" based="" on="" data="" that="" reasonably="" account="" for="" potential="" exposures.="" 2.="" acute="" risk.="" no="" acute="" toxicity="" endpoints="" for="" tebufenozide="" have="" been="" identified="" and="" this="" risk="" assessment="" is="" not="" required.="" no="" acute="" aggregate="" risk="" exist.="" 3.="" chronic="" risk.="" using="" the="" exposure="" assumptions="" described="" in="" this="" unit,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" tebufenozide="" from="" food="" will="" utilize="" 21%="" of="" the="" cpad="" for="" children="" (1-6)="" the="" most="" highly="" exposed="" population="" subgroup.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" cpad="" because="" the="" cpad="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" from="" tebufenozide="" in="" food,="" drinking="" water,="" and="" from="" non-dietary="" exposure="" to="" exceed="" the="" agency's="" level="" of="" concern.="" 4.="" short-="" or="" intermediate-term="" risk.="" since="" no="" short-="" or="" intermediate-term="" toxicological="" endpoints="" were="" identified="" by="" the="" agency="" for="" tebufenozide="" and="" there="" are="" no="" registered="" uses="" that="" would="" result="" in="" residential="" exposure,="" the="" agency="" concludes="" that="" this="" risk="" criterion="" is="" negligible="" and="" the="" subject="" tolerances="" adequately="" protect="" the="" safety="" of="" infants="" and="" children.="" 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.="" [[page="" 52461]]="" iv.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" qualitative="" nature="" of="" the="" residue="" in="" plants="" is="" adequately="" understood="" based="" upon="" acceptable="" apple,="" sugar="" beet,="" and="" rice="" metabolism="" studies.="" epa="" has="" concluded="" that="" the="" residue="" of="" regulatory="" concern="" 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="" turnips.="" ir-4="" used="" rohm="" and="" haas="" high="" performance="" liquid="" chromatographic="" (hplc)/ultra="" violet="" (uv)="" analytical="" method="" tr-34-94-41="" to="" collect="" residue="" data="" from="" the="" field="" trials="" on="" turnips.="" ir-4="" slightly="" modified="" the="" hplc="" system="" used="" to="" quantify="" tebufenozide="" residues,="" but="" made="" no="" substantive="" changes.="" adequate="" recovery="" data="" and="" representative="" chromatograms="" for="" turnip="" roots="" and="" tops="" were="" provided.="" the="" limit="" of="" quantitation="" (loq)="" in="" turnip="" roots="" and="" tops="" is="" 0.01="" ppm.="" this="" method="" has="" been="" conditionally="" approved="" by="" the="" agency="" as="" an="" analytical="" enforcement="" method,="" pending="" incorporation="" of="" the="" corrections="" noted="" during="" the="" analytical="" chemistry="" branch/bead's="" petition="" method="" validation="" (pmv)="" trial.="" this="" method="" is="" considered="" adequate="" for="" the="" enforcement="" of="" tebufenozide="" residues="" in/on="" turnip="" roots="" and="" tops.="" a="" copy="" of="" the="" corrected="" version="" of="" tr-34-94-41="" will="" be="" submitted="" for="" publication="" in="" the="" pesticide="" analytical="" manual,="" volume="" ii="" (pam="" ii).="" canola.="" ir-4="" used="" rohm="" and="" haas="" hplc/uv="" analytical="" method="" tr-34-96-="" 135="" to="" collect="" residue="" data="" from="" the="" field="" trials="" on="" canola.="" adequate="" validation="" data="" and="" representative="" chromatograms="" for="" canola="" commodities="" (seed,="" meal,="" oil,="" soapstock)="" were="" provided.="" the="" loq="" is="" 0.01="" ppm="" for="" the="" seed="" and="" meal="" and="" 0.03="" ppm="" for="" the="" oil="" and="" soapstock.="" a="" pmv="" is="" not="" required,="" as="" this="" method="" is="" similar="" to="" those="" for="" walnuts="" and="" apples="" which="" have="" been="" successfully="" validated.="" a="" copy="" of="" tr-34-96-135="" incorporating="" the="" corrections="" specified="" in="" the="" independent="" laboratory="" validation="" (ilv)="" study="" will="" be="" submitted="" for="" publication="" in="" pam="" ii.="" adequate="" enforcement="" methodology="" (example="" -="" gas="" chromotography)="" is="" available="" to="" enforce="" the="" tolerance="" expression="" for="" canola="" seed="" and="" refined="" oil="" and="" turnip="" roots="" and="" tops.="" these="" 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
Turnips. The submitted turnip top and root residue data are
adequate to support the proposed use. The six studies on turnips
adequately address the number and geographic representation of studies
suggested in the OPPTS Test Guidelines. Residues of tebufenozide ranged
from 0.02 to 0.23 ppm for turnip roots and from 0.31 to 8.31 ppm for
turnip tops. The proposed tolerances of 9.0 ppm and 0.3 ppm are
appropriate on turnip tops and turnip roots respectively.
Canola. The submitted canola residue data are adequate to support
the proposed use. Residues of tebufenozide ranged from 0.29 to 1.64 ppm
for canola seed. The proposed tolerance 2.0 ppm on canola seed is
appropriate. Processed commodities from canola (meal, oil, and
soapstock) were generated using procedures that mimic commercial
practice. Residues of tebufenozide did not concentrate in canola meal
(average concentration factor = 0.16X) or soapstock (1.1X), but did
concentrate in refined oil (an average of 2.3X). Based on the highest
average field trial value for canola seed (1.58 ppm), a tolerance of
4.0 ppm is appropriate for refined canola oil.
D. International Residue Limits
No CODEX, Canadian or Mexican limits for tebufenozide were
established on the subject crops at the time of this review.
V. Conclusion
Therefore, the tolerance is established for residues of
tebufenozide; benzoic acid, 3,5-dimethyl-, 1-(1,1-dimethylethyl)-2-(4-
ethylbenzoyl) hydrazide in turnip tops, turnip roots, canola seed, and
refined canola oil at 9.0, 0.3, 2.0, and 4.0 ppm, respectively.
VI. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-300923 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 November
29, 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 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,
[[Page 52462]]
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.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A. of
this preamble, you should also send a copy of your request to the PIRB
for its inclusion in the official record that is described in Unit
I.B.2. of this preamble. Mail your copies, identified by docket number
OPP-300923, to: Public Information and Records Integrity Branch,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. In person or by courier, bring a copy to the
location of the PRIB described in Unit I.B.2. of this preamble. You may
also send an electronic copy of your request via e-mail to: docket@epa.gov. Please use an ASCII file format and avoid the use of
special characters and any form of encryption. Copies of electronic
objections and hearing requests will also be accepted on disks in
WordPerfect 5.1/6.1 file format or ASCII file format. Do not include
any CBI in your electronic copy. You may also submit an electronic copy
of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Regulatory Assessment Requirements
This final rule establishes tolerances under section 408(d) of the
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, 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, and Cosmetic Act,
21 U.S.C. 346a(b)(4). This action does not involve any technical
standards that would require Agency consideration of voluntary
consensus standards pursuant to section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law
104-113, section 12(d) (15 U.S.C. 272 note). In addition, since
tolerances and exemptions that are established on the basis of a
petition under FFDCA section 408(d), such as the tolerances in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by
the Small Business Regulatory Enforcement Fairness Act of 1996,
generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. EPA will submit a report containing this
rule and other required information to the U.S. Senate, the U.S. House
of Representatives, and the Comptroller General of the United States
prior to publication of this rule in the Federal Register. This rule
is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 20, 1999.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), (346a), and 371.
[[Page 52463]]
2. In Sec. 180.482, the table to paragraph (a)(1) is amended by
adding entries for canola, seed; canola, refined oil; turnip, tops; and
turnip, roots, to read as follows:
Sec. 180.482 Tebufenozide; tolerances for residues..
(a) * * *
------------------------------------------------------------------------
Parts
Commodity per
million
------------------------------------------------------------------------
* * * * *
Canola, refined oil............................................ 4.0
Canola, seed................................................... 2.0
* * * * *
Turnip, roots.................................................. 0.3
Turnip, tops................................................... 9.0
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-25314 Filed 9-28-99; 8:45 am
BILLING CODE 6560-50-F
