[Federal Register Volume 63, Number 243 (Friday, December 18, 1998)]
[Rules and Regulations]
[Pages 70030-70035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33628]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300766; FRL-6049-4]
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 the insecticide tebufenozide, benzoic acid, 3,5-dimethyl-1-
(1,1-dimethylethyl)-2-(4-ethylbenzoyl) hydrazide in or on eggs; grass,
forage; grass, hay; hogs, fat; hogs, kidney; hogs, liver; hogs, meat;
hogs, mbyp; peanuts; peanut, hay; peanuts, meal; peanut, oil; poultry,
fat; poultry, meat; poultry, mbyp; rice, bran; rice, grain; rice,
hulls; rice, straw; and sweet potatoes. 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 pasture land, peanuts, rice, and sweet potatoes. This
regulation establishes maximum permissible levels for residues of
tebufenozide in these food commodities pursuant to section 408(l)(6) of
the Federal Food, Drug, and Cosmetic Act, as amended by the Food
Quality Protection Act of 1996. These tolerances will expire and are
revoked on December 31, 2000.
DATES: This regulation is effective December 18, 1998. Objections and
requests for hearings must be received by EPA on or before February 16,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300766], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the docket
control number, [OPP-300766], must also be submitted 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,
bring a copy of objections and hearing requests to Rm. 119, Crystal
Mall 2 (CM #2), 1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300766]. No Confidential Business Information (CBI) should
be submitted through e-mail. Electronic copies of objections and
hearing requests on this rule may be filed online at many Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Barbara Madden, Registration
Division 7505C, Office of Pesticide Programs, Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. Office location,
telephone number, and e-mail address: CM #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, (703) 305-6463, e-mail: Madden.barbara@epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
sections 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing tolerances for
residues of the insecticide, tebufenozide in or on eggs at 0.01 part
per million (ppm); grass, forage at 5 ppm; grass, hay at 18 ppm; hogs,
fat at 0.1 ppm; hogs, kidney at 0.02 ppm; hogs, liver at 1 ppm; hogs,
meat at 0.02 ppm; hogs, mbyp at 0.1 ppm; peanuts at 0.05 ppm; peanut,
hay at 5 ppm; peanut, meal at 0.15 ppm; peanut, oil at 0.15 ppm;
poultry, fat at 0.1 ppm; poultry, meat at 0.01 ppm; poultry, mbyp 0.05
ppm; rice, bran at 0.8 ppm; rice, grain at 0.1 ppm; rice, hulls at 0.5
ppm; rice, straw at 6 ppm; and sweet potatoes at 0.25. These
[[Page 70031]]
tolerances will expire and are revoked on December 31, 2000. EPA will
publish a document in the Federal Register to remove the revoked
tolerance from the Code of Federal Regulations.
I. Background and Statutory Findings
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. The FQPA amendments went into effect immediately. Among other
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures. These activities are described below and discussed in
greater detail in the final rule establishing the time-limited
tolerance associated with the emergency exemption for use of
propiconazole on sorghum (61 FR 58135, November 13, 1996)(FRL-5572-9).
New 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 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 FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
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.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemption for Tebufenozide on Certain Commodities and
FFDCA Tolerances
During the 1998 growing season several states (Arkansas, Louisiana,
Oklahoma, and Texas) availed themselves of the authority to declare a
crisis exemption to use tebufenozide for control of armyworms
(Spodoptera sp.) on pasture land, peanuts, rice, and sweet potatoes.
Due to the mild winter, severe drought and unusually hot summer in the
southern United States, many growers experienced heavy infestations of
armyworm. The use of tebufenozide to control armyworm is in accordance
with 40 CFR part 166, Subpart C.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of tebufenozide in or on
pasture land, peanuts, rice, and sweet potatoes. In doing so, EPA
considered the safety standard in FFDCA section 408(b)(2), and EPA
decided that the necessary tolerances under FFDCA section 408(l)(6)
would be consistent with the safety standard and with FIFRA section 18.
Consistent with the need to move quickly on the emergency exemption in
order to address an urgent non-routine situation and to ensure that the
resulting food is safe and lawful, EPA is issuing these tolerances
without notice and opportunity for public comment under section 408(e),
as provided in section 408(l)(6). Although thess tolerances will expire
and are revoked on December 31, 2000, under FFDCA section 408(l)(5),
residues of the pesticide not in excess of the amounts specified in the
tolerance remaining in or on 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 these tolerances earlier if any experience with, scientific data
on, or other relevant information on this pesticide indicate that the
residues are not safe.
Because these tolerances are being approved under emergency
conditions EPA has not made any decisions about whether tebufenozide
meets EPA's registration requirements for use on or whether a permanent
tolerance for this use would be appropriate. Under these circumstances,
EPA does not believe that these tolerances serve as a basis for
registration of tebufenozide by a State for special local needs under
FIFRA section 24(c). Nor does these tolerances serve as the basis for
any State other than to use this pesticide on these crops under section
18 of FIFRA without following all provisions of EPA's regulations
implementing section 18 as identified in 40 CFR part 166. For
additional information regarding the emergency exemption for
tebufenozide, contact the Agency's Registration Division at the address
provided above.
III. 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 time-limited tolerances for
residues of tebufenozide on eggs at 0.01 part per million (ppm); grass,
forage at 5 ppm; grass, hay at 18 ppm; hogs, fat at 0.1 ppm; hogs,
kidney at 0.02 ppm; hogs, liver at 1 ppm; hogs, meat at 0.02 ppm; hogs,
mbyp at 0.1 ppm; peanuts at 0.05 ppm; peanut, hay at 5 ppm; peanut,
meal at 0.15 ppm; peanut, oil at 0.15 ppm; poultry, fat at 0.1 ppm;
poultry, meat at 0.01 ppm; poultry, mbyp 0.05 ppm; rice, bran at 0.8
ppm; rice, grain at 0.1 ppm; rice, hulls at 0.5 ppm; rice, straw at 6
ppm; and sweet potatoes at 0.25 ppm. 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
[[Page 70032]]
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 below.
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 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.
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 (RfD)
for tebufenozide at 0.018 milligrams/kilogram/day (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
inter-species extrapolation and 10X for intra-species 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. This determination is based on the results of reproductive and
developmental toxicity studies. No evidence of additional sensitivity
to young rats or rabbits was observed following pre- 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 and walnuts.
Additionally, time-limited tolerances associated with emergency
exemptions have been established for cotton, leafy vegetables, pears,
pecans, peppers, sugar beet, sugarcane, turnip tops, milk, and
livestock commodities of cattle, goats, horses, and sheep. 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 one day or single exposure. Toxicity observed in oral toxicity
studies were not attributable to a single dose or one 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 RfD 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. Since the FQPA safety factor has been removed for all
population subgroups, the percent RfD 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 an ARC that is equivalent to percentages of the
RfD below 100% for all subgroups [i.e., U.S. population, 12% and non-
nursing infants (<1 year="" old),="" the="" most="" highly="" exposed="" subgroup,="" 25%].="" 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="" geneec="" and="" przm/exams="" for="" surface="" water,="" which="" are="" used="" to="" produce="" estimates="" of="" pesticide="" concentrations="" in="" a="" farm="" pond="" and="" sci-grow,="" which="" predicts="" pesticide="" concentrations="" in="" groundwater.="" 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.="" 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="" currently="" registered="" for="" use="" on="" residential="" non-food="" sites.="" 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="" 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="" [[page="" 70033]]="" 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.="" 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="" 12%="" of="" the="" rfd="" for="" the="" u.s.="" population.="" the="" major="" identifiable="" subgroup="" with="" the="" highest="" aggregate="" exposure,="" non-nursing="" infants=""><1 year="" old)="" (discussed="" below)="" will="" utilize="" 25%="" of="" the="" rfd.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" rfd="" because="" the="" rfd="" 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="" for="" surface="" and="" ground="" water,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" 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="" currently="" registered="" for="" use="" on="" residential="" non-food="" sites.="" 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.="" 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="" two-="" generation="" reproduction="" study="" in="" the="" rat.="" the="" developmental="" toxicity="" studies="" are="" designed="" to="" evaluate="" adverse="" effects="" on="" the="" developing="" organism="" resulting="" from="" maternal="" pesticide="" exposure="" during="" gestation.="" reproduction="" studies="" provide="" information="" relating="" to="" effects="" from="" exposure="" to="" the="" pesticide="" on="" the="" reproductive="" capability="" of="" mating="" animals="" and="" data="" on="" systemic="" toxicity.="" ffdca="" section="" 408="" provides="" that="" epa="" shall="" apply="" an="" additional="" tenfold="" margin="" of="" safety="" for="" infants="" and="" children="" in="" the="" case="" of="" threshold="" effects="" to="" account="" for="" pre-and="" post-natal="" toxicity="" and="" the="" completeness="" of="" the="" 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="" moe="" and="" uncertainty="" factor="" (usually="" 100="" for="" combined="" inter-="" and="" intra-species="" variability))="" and="" not="" the="" additional="" tenfold="" moe/uncertainty="" factor="" when="" epa="" has="" a="" complete="" data="" base="" under="" existing="" guidelines="" and="" when="" the="" severity="" of="" the="" effect="" in="" infants="" or="" children="" or="" the="" potency="" or="" unusual="" toxic="" properties="" of="" a="" compound="" do="" not="" raise="" concerns="" regarding="" the="" adequacy="" of="" the="" standard="" moe/safety="" factor.="" ii.="" developmental="" toxicity="" studies.="" in="" prenatal="" developmental="" toxicity="" studies="" in="" rats="" and="" rabbits,="" there="" was="" no="" evidence="" of="" maternal="" or="" developmental="" toxicity;="" the="" maternal="" and="" developmental="" noaels="" 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.="" conclusion.="" there="" is="" a="" complete="" toxicity="" database="" for="" tebufenozide="" and="" exposure="" data="" is="" complete="" or="" is="" 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="" 25%="" of="" the="" rfd="" for="" infants="" and="" 19%="" of="" the="" rfd="" for="" children.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" rfd="" because="" the="" rfd="" 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,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" 4.="" short-="" or="" intermediate-term="" risk.="" tebufenozide="" is="" not="" currently="" registered="" for="" use="" on="" residential="" non-food="" sites.="" 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.="" iv.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" residue="" of="" concern="" in="" plants="" is="" adequately="" understood="" and="" is="" tebufenozide="" per="" se.="" residues="" of="" concern="" in="" animals="" are="" not="" adequately="" understood.="" studies="" to="" address="" residues="" of="" concern="" for="" animals="" are="" currently="" under="" agency="" review.="" for="" the="" purpose="" of="" these="" section="" 18="" actions="" only,="" the="" agency="" has="" assumed="" the="" residue="" of="" concern="" is="" tebufenozide="" per="" se.="" b.="" analytical="" enforcement="" methodology="" adequate="" enforcement="" methodology="" (example="" -="" gas="" chromotography)="" is="" available="" to="" enforce="" the="" tolerance="" expression.="" the="" method="" may="" be="" requested="" from:="" calvin="" furlow,="" prrib,="" irsd="" (7502c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" 401="" m="" st.,="" sw.,="" washington,="" dc="" 20460.="" office="" location="" and="" telephone="" number:="" rm="" 101ff,="" cm="" #2,="" 1921="" jefferson="" davis="" hwy.,="" arlington,="" va="" 22202,="" (703)="" 305-5229.="" c.="" magnitude="" of="" residues="" residues="" of="" tebufenozide="" per="" se="" are="" not="" expected="" to="" exceed="" 0.01="" ppm="" on="" [[page="" 70034]]="" eggs;="" grass,="" forage="" at="" 5="" ppm;="" grass,="" hay="" at="" 18="" ppm;="" hogs,="" fat="" at="" 0.1="" ppm;="" hogs,="" kidney="" at="" 0.02="" ppm;="" hogs,="" liver="" at="" 1="" ppm;="" hogs,="" meat="" at="" 0.02="" ppm;="" hogs,="" mbyp="" at="" 0.1="" ppm;="" peanuts="" at="" 0.05="" ppm;="" peanut,="" hay="" at="" 5="" ppm;="" peanut,="" meal="" at="" 0.15="" ppm;="" peanut,="" oil="" at="" 0.15="" ppm;="" poultry,="" fat="" at="" 0.1="" ppm;="" poultry,="" meat="" at="" 0.01="" ppm;="" poultry,="" mbyp="" 0.05="" ppm;="" rice,="" bran="" at="" 0.8="" ppm;="" rice,="" grain="" at="" 0.1="" ppm;="" rice,="" hulls="" at="" 0.5="" ppm;="" rice,="" straw="" at="" 6="" ppm;="" and="" sweet="" potatoes="" at="" 0.25="" ppm="" as="" a="" result="" of="" these="" section="" 18="" uses.="" 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.="" e.="" rotational="" crop="" restrictions="" rotational="" crop="" data="" are="" currently="" under="" review="" by="" the="" agency.="" crops="" which="" the="" label="" allows="" to="" be="" treated="" directly="" can="" be="" planted="" at="" any="" time.="" based="" on="" preliminary="" data,="" a="" 30-day="" plantback="" interval="" is="" adequate="" for="" root,="" tuber,="" bulb,="" leafy,="" brassica,="" fruiting,="" and="" cucurbit="" vegetables.="" all="" other="" crops="" cannot="" be="" planted="" within="" 12="" months="" of="" the="" last="" tebufenozide="" application.="" v.="" conclusion="" therefore,="" tolerances="" are="" established="" for="" residues="" of="" tebufenozide="" in="" or="" on="" eggs="" at="" 0.01="" ppm;="" grass,="" forage="" at="" 5="" ppm;="" grass,="" hay="" at="" 18="" ppm;="" hogs,="" fat="" at="" 0.1="" ppm;="" hogs,="" kidney="" at="" 0.02="" ppm;="" hogs,="" liver="" at="" 1="" ppm;="" hogs,="" meat="" at="" 0.02="" ppm;="" hogs,="" mbyp="" at="" 0.1="" ppm;="" peanuts="" at="" 0.05="" ppm;="" peanut,="" hay="" at="" 5="" ppm;="" peanut,="" meal="" at="" 0.15="" ppm;="" peanut,="" oil="" at="" 0.15="" ppm;="" poultry,="" fat="" at="" 0.1="" ppm;="" poultry,="" meat="" at="" 0.01="" ppm;="" poultry,="" mbyp="" 0.05="" ppm;="" rice,="" bran="" at="" 0.8="" ppm;="" rice,="" grain="" at="" 0.1="" ppm;="" rice,="" hulls="" at="" 0.5="" ppm;="" rice,="" straw="" at="" 6="" ppm;="" and="" sweet="" potatoes="" at="" 0.25="" at="" ppm.="" vi.="" objections="" and="" hearing="" requests="" the="" new="" ffdca="" section="" 408(g)="" provides="" essentially="" the="" same="" process="" for="" persons="" to="" ``object''="" to="" a="" tolerance="" regulation="" issued="" by="" epa="" under="" new="" section="" 408(e)="" and="" (l)(6)="" as="" was="" provided="" in="" the="" old="" section="" 408="" and="" in="" section="" 409.="" however,="" the="" period="" for="" filing="" objections="" is="" 60="" days,="" rather="" than="" 30="" days.="" epa="" currently="" has="" procedural="" regulations="" which="" govern="" the="" submission="" of="" objections="" and="" hearing="" requests.="" these="" regulations="" will="" require="" some="" modification="" to="" reflect="" the="" new="" law.="" however,="" until="" those="" modifications="" can="" be="" made,="" epa="" will="" continue="" to="" use="" those="" procedural="" regulations="" with="" appropriate="" adjustments="" to="" reflect="" the="" new="" law.="" any="" person="" may,="" by="" february="" 16,="" 1999,="" file="" written="" objections="" to="" any="" aspect="" of="" this="" regulation="" and="" may="" also="" request="" a="" hearing="" on="" those="" objections.="" objections="" and="" hearing="" requests="" must="" be="" filed="" with="" the="" hearing="" clerk,="" at="" the="" address="" given="" above="" (40="" cfr="" 178.20).="" a="" copy="" of="" the="" objections="" and/or="" hearing="" requests="" filed="" with="" the="" hearing="" clerk="" should="" be="" submitted="" to="" the="" opp="" docket="" for="" this="" regulation.="" the="" objections="" submitted="" must="" specify="" the="" provisions="" of="" the="" regulation="" deemed="" objectionable="" and="" the="" grounds="" for="" the="" objections="" (40="" cfr="" 178.25).="" each="" objection="" must="" be="" accompanied="" by="" the="" fee="" prescribed="" by="" 40="" cfr="" 180.33(i).="" epa="" is="" authorized="" to="" waive="" any="" fee="" requirement="" ``when="" in="" the="" judgment="" of="" the="" administrator="" such="" a="" waiver="" or="" refund="" is="" equitable="" and="" not="" contrary="" to="" the="" purpose="" of="" this="" subsection.''="" for="" additional="" information="" regarding="" tolerance="" objection="" fee="" waivers,="" contact="" james="" tompkins,="" registration="" division="" (7505c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" 401="" m="" st.,="" sw.,="" washington,="" dc="" 20460.="" office="" location,="" telephone="" number,="" and="" e-mail="" address:="" rm.="" 239,="" cm="" #2,="" 1921="" jefferson="" davis="" hwy.,="" arlington,="" va,="" (703)="" 305-5697,="">tompkins.jim@epa.gov. Request for waiver of tolerance objection fees
should be sent to James Hollins, Information Resources and Services
Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460.
If a hearing is requested, the objections must include a statement
of the factual issues on which a hearing is requested, the requestor's
contentions on such issues, and a summary of any evidence relied upon
by the requestor (40 CFR 178.27). A request for a hearing will be
granted if the Administrator determines that the material submitted
shows the following: There is 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 in the
manner sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32). 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.
VII. Public Record and Electronic Submissions
EPA has established a record for this regulation under docket
control number [OPP-300766] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Rm. 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C)
Office of Pesticide Programs, Environmental Protection Agency, CM #2,
1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments may be sent directly to EPA at:
opp-docket@epamail.epa.gov.
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this regulation, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official record which will also
include all comments submitted directly in writing. The official record
is the paper record maintained at the Virginia address in ``ADDRESSES''
at the beginning of this document.
VIII. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes a tolerances under section 408 of the
FFDCA. The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993). This
final rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates
[[Page 70035]]
Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does it require any
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 in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997).
In addition, since tolerances and exemptions that are established
on the basis of a petition under FFDCA section 408(l)(6), 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. Nevertheless, the Agency has
previously assessed whether establishing tolerances, exemptions from
tolerances, raising tolerance levels or expanding exemptions might
adversely impact small entities and concluded, as a generic matter,
that there is no adverse economic impact. The factual basis for the
Agency's generic certification for tolerance actions published on May
4, 1981 (46 FR 24950), and was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local, or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide to OMB, in a separately
identified section of the preamble to the rule, a description of the
extent of EPA's prior consultation with representatives of affected
tribal governments, a summary of the nature of their concerns, and a
statement supporting the need to issue the regulation. In addition,
Executive Order 13084 requires EPA to develop an effective process
permitting elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
IX. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the 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: December 9, 1998.
Arnold E. Layne,
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. 346a and 371.
2. In Sec. 180.482, add the following commodities to the table in
paragraph (b) to read as follows:
Sec. 180.482 Tebufenozide; tolerances for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
* * * * * * *
Eggs............................ 0.01 12/31/00
* * * * * * *
Grass, forage................... 5 12/31/00
Grass, hay...................... 18 12/31/00
Hogs, fat....................... 0.1 12/31/00
Hogs, kidney.................... 0.02 12/31/00
Hogs, liver..................... 1 12/31/00
Hogs, meat...................... 0.02 12/31/00
Hogs, mbyp...................... 0.1 12/31/00
* * * * * * *
Peanuts......................... 0.05 12/31/00
Peanut, hay..................... 5 12/31/00
Peanut, meal.................... 0.15 12/31/00
Peanut, oil..................... 0.15 12/31/00
* * * * * * *
Poultry, fat.................... 0.1 12/31/00
Poultry, meat................... 0.01 12/31/00
Poultry, mbyp................... 0.05 12/31/00
Rice, bran...................... 0.8 12/31/00
Rice, grain..................... 0.1 12/31/00
Rice, hulls..................... 0.5 12/31/00
Rice, straw..................... 6 12/31/00
* * * * * * *
Sweet potatoes.................. 0.25 12/31/00
------------------------------------------------------------------------
* * * * *
[FR Doc. 98-33628 Filed 12-17-98; 8:45 am]
BILLING CODE 6560-50-F
