[Federal Register Volume 62, Number 127 (Wednesday, July 2, 1997)]
[Rules and Regulations]
[Pages 35683-35689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17370]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300500; FRL-5719-9]
RIN 2070-AB78
Tebufenozide; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
residues of the insecticide tebufenozide in or on the following raw
agricultural commodities: apples; apple pomace; cottonseed, undelinted;
cottonseed meal; cottonseed oil; cottonseed hulls, cotton gin
byproducts; milk; meat, meat fat, and meat by-products of cattle,
sheep, and goats; and horse meat in connection with EPA's granting of
emergency exemptions under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act authorizing use of tebufenozide on
apples in Pennsylvania, New Jersey, Virginia, West Virginia, Michigan
and New York. This regulation establishes maximum permissible levels
for residues of tebufenozide on the above raw agricultural 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 be revoked on June 30, 1998.
DATES: This regulation becomes effective July 2, 1997. Objections and
requests for hearings must be received by EPA on or before September 2,
1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300500], 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-300500], must be submitted to: Public Information
and Records Integrity Branch, Information Resources and Services
Division (7506C), 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. 1132, 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 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-300500]. 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: Pat Cimino, Registration
Division (7505W), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location, telephone number, and e-mail: Sixth Floor, Crystal Station
#1, 2800 Jefferson Davis Highway, Arlington, VA 22202. (703) 308-8328,
e-mail: cimino.pat@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
section 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 (benzoic acid, 3,5-dimethyl-1-
(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide) in or on apples at 1.0
part per million (ppm); apple pomace at 2.0 ppm; cottonseed, undelinted
at 0.2 ppm; cottonseed meal at 0.5 ppm; cottonseed oil at 1.3 ppm;
cottonseed hulls at 0.8 ppm; cotton gin byproducts at 4.0 ppm; milk at
0.05
[[Page 35684]]
ppm; meat of cattle, sheep, goats, and horses at 0.02 ppm; fat of
cattle, sheep, and goats at 0.10 ppm; meat by-products (except liver
kidney) of cattle, sheep, and goats at 0.10 ppm; liver of cattle,
sheep, and goats at 1.0 ppm; and kidney of cattle, sheep, and goats at
0.02 ppm. These tolerances will expire and be revoked by EPA on June
30, 1998. EPA will publish a document in the Federal Register to remove
the revoked tolerance from the Code of Federal Regulations.
I. Background and Statutory Authority
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the FFDCA, 21
U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. Among other things, FQPA
amends FFDCA to bring all EPA pesticide tolerance-setting activities
under 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 tolerance to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemptions for Tebufenozide on Apples and FFDCA
Tolerances
Between February 13 and April 24, 1997, the New Jersey Department
of Environmental Protection, Virginia Department of Agriculture and
Consumer Affairs, New York Department of Environmental Conservation,
and Pennsylvania, West Virginia, and Michigan Departments of
Agriculture requested a specific exemption under FIFRA section 18 for
the use of tebufenozide on apples to control tufted apple bud moth in
PA, NJ, VA and WV and oblique banded leafroller in NY and MI. These
pests are becoming increasingly resistant to registered pesticide
alternatives and growers are experiencing both quality and yield losses
from infestations. The registered alternative products do not provide
control of these pests and lack of a viable alternative is responsible
for growing levels of economic loss over the last several years.
Growers will experience significant economic loss if these pests are
not controlled. After having reviewed their submissions, EPA concurs
that emergency conditions exist.
Between March 18 and June 20, 1997, the Texas, South Carolina,
Louisiana, Florida, Mississippi, Arkansas, Alabama, Georgia and New
Mexico Departments of Agriculture requested a specific exemption under
FIFRA Section 18 for the use of tebufenozide on cotton to control beet
armyworm in cotton. This pest is resistant to control by currently
registered products and growers have experienced significant economic
losses from infestations of this pest. After having reviewed their
submissions, EPA concurs that emergency conditions exist.
As part of its assessment of these applications for emergency
exemption, EPA assessed the potential risks presented by residues of
tebufenozide on apples. In doing so, EPA considered the new safety
standard in FFDCA section 408(b)(2), and EPA decided to grant the
section 18 exemptions only after concluding that the necessary
tolerance under FFDCA section 408(l)(6) would clearly be consistent
with the new safety standard and with FIFRA section 18. These
tolerances for tebufenozide will permit the marketing of apples treated
in accordance with the provisions of the section 18 emergency
exemptions. Consistent with the need to move quickly on the emergency
exemptions 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 these tolerances will expire and be revoked by EPA on June 30,
1998, under FFDCA section 408(l)(5), residues of tebufenozide not in
excess of the amount specified in the tolerances remaining in or on
apples, milk, meat, meat fat and meat by-products after that date will
not be unlawful, provided the pesticide is applied during the term of,
and in accordance with all the conditions of, the emergency exemptions.
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.
EPA has not made any decisions about whether tebufenozide meets the
requirements for registration under FIFRA section 3 for use on apples
or whether permanent tolerances for tebufenozide for apples would be
appropriate. This action by EPA does not serve as a basis for
registration of tebufenozide by a State for special local needs under
FIFRA section 24(c). Nor does this action serve as the basis for any
States other than Pennsylvania, New Jersey, Virginia, West Virginia,
New York or Michigan to use this product on this crop under section 18
of FIFRA without following all provisions of section 18 as identified
in 40 CFR 180.166. For additional information regarding the emergency
exemptions for tebufenozide, contact the Agency's Registration Division
at the address provided above.
III. Risk Assessment and Statutory Findings
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many
[[Page 35685]]
adverse health effects, including (but not limited to) reproductive
effects, developmental toxicity, toxicity to the nervous system, and
carcinogenicity. For many of these studies, a dose-response
relationship can be determined, which provides a dose that causes
adverse effects (threshold effects) and doses causing no observed
effects (the ``no-observed effect level'' or ``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to 10 times more sensitive to pesticides than the
test animals, and that one person or subgroup of the population (such
as infants and children) could be up to 10 times more sensitive to a
pesticide than another. In addition, EPA assesses the potential risks
to infants and children based on the weight of the evidence of the
toxicology studies and determines whether an additional uncertainty
factor is warranted. Thus, an aggregate daily exposure to a pesticide
residue at or below the RfD (expressed as 100% or less of the RfD) is
generally considered acceptable by EPA. For shorter term risks, EPA
calculates a MOE by dividing the estimated human exposure into the NOEL
from the appropriate animal study. Commonly, EPA finds MOEs lower than
100 to be unacceptable. This 100-fold MOE is based on the same
rationale as the 100-fold uncertainty factor.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight-of-the-evidence review of all relevant toxicological data
including short-term and mutagenicity studies and structure-activity
relationships. Once a pesticide has been classified as a potential
human carcinogen, different types of risk assessments (e.g., linear
low-dose extrapolations or MOE calculation based on the appropriate
NOEL) will be carried out based on the nature of the carcinogenic
response and the Agency's knowledge of its mode of action.
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, residues in groundwater
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). Dietary exposure to
residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an
estimate of the level of residues consumed daily if each food item
contained pesticide residues equal to the tolerance. The TMRC is a
``worst case'' estimate since it is based on the assumptions that food
contains pesticide residues at the tolerance level and that 100% of the
crop is treated by pesticides that have established tolerances. If the
TMRC exceeds the RfD or poses a lifetime cancer risk that is greater
than approximately one in a million, EPA attempts to derive a more
accurate exposure estimate for the pesticide by evaluating additional
types of information (anticipated residue data and/or percent of crop
treated data) which show, generally, that pesticide residues in most
foods when they are eaten are well below established tolerances.
Percent of crop treated estimates are derived from reliable federal
and private market basket survey data. Typically, a range of estimates
are supplied and the upper end of this range is assumed for the
exposure assessment. By using the upper end estimate of percent of crop
treated, the Agency is reasonably certain that exposure is not
understated for any significant subpopulation group.
IV. Aggregate Risk Assessments 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.
A. Toxicological Profile
1. Acute toxicity. No acute toxicological effects of concern were
identified by the Agency.
2. Short- and intermediate-term toxicity. No short- or
intermediate-term toxicological effects of concern were identified by
the Agency.
3. Chronic toxicity. The RfD for tebufenozide is 0.018
milligrams(mg)/kilogram(kg)/day and is based on a 1-year feeding study
in dogs with a NOEL of 1.8 mg/kg/day and an uncertainty factor of 100.
Decreased red blood cells, hematocrit, and hemoglobin and increased
heinz bodies, reticulocytes, and platelets were observed at the lowest-
observed effect level (LOEL) of 8.7 mg/kg/day.
4. Cancer. Using its Guidelines for Carcinogen Risk Assessment
published September 24, 1986 (51 FR 33992), the Agency has classified
tebufenozide as a Group ``E'' chemical (no evidence of carcinogenicity)
based on the results of carcinogenicity studies in two species. There
was no evidence of carcinogenicity in a 2-year rat study and an 18-
month mouse study.
B. Aggregate Exposure
In examining aggregate exposure, FQPA directs EPA to consider
available information concerning exposures from the pesticide residue
in food and all other non-occupational exposures. The primary non-food
sources of exposure the Agency looks at include drinking water (whether
from groundwater or surface water), and exposure through pesticide use
in gardens, lawns, or buildings (residential and other indoor uses). In
evaluating food exposures, EPA takes into account varying consumption
patterns of major identifiable subgroups of consumers, including
infants and children.
A permanent tolerance of 0.1 ppm has been established for residues
of tebufenozide in or on walnuts and an apple import tolerance has been
established. Tebufenozide is not registered for indoor or outdoor
residential uses.
1. Acute exposure. 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. No acute toxicological effects of concern have been
identified for tebufenozide and an acute risk assessment is not
required.
2. Chronic exposure.--i. Dietary-food exposure. In conducting
exposure assessments for this section 18 request, EPA used tolerance
level residues and assumed that 100% of the crop would be treated with
the pesticide (TMRC worst-case analysis assumptions, as described
above).
ii. Drinking water exposure. Environmental fate data submitted to
the Agency suggest that tebufenozide is moderately persistent to
persistent and mobile and could potentially leach to groundwater and
runoff to surface water under certain environmental conditions.
No Maximum Concentration Level or Health Advisory Level has been
established for residues of tebufenozide in drinking water. There is no
entry for
[[Page 35686]]
tebufenozide in the ``Pesticides in Groundwater Database'' (EPA 34-12-
92-001, Sept. 1992).
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 (RfD's
or acute dietary NOEL's) 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
consumption of contaminated water, the ranges the Agency is continuing
to examine are all below the level that would cause tebufenozide to
exceed the RfD if the tolerance being considered in this document were
granted. The Agency has therefore concluded that the potential
exposures associated with tebufenozide in 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 tolerance is granted.
iii. Non-dietary, non-occupational exposure. Non-dietary, non-
occupational exposure is not expected because tebufenozide is not
registered for indoor or outdoor residential uses.
C. 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.'' The Agency believes that ``available
information'' in this context might include not only toxicity,
chemistry, and exposure data, but also scientific policies and
methodologies for understanding common mechanisms of toxicity and
conducting cumulative risk assessments. For most pesticides, although
the Agency has some information in its files that may turn out to be
helpful in eventually determining whether a pesticide shares a common
mechanism of toxicity with any other substances, EPA does not at this
time have the methodologies to resolve the complex scientific issues
concerning common mechanism of toxicity in a meaningful way. EPA has
begun a pilot process to study this issue further through the
examination of particular classes of pesticides. The Agency hopes that
the results of this pilot process will increase the Agency's scientific
understanding of this question such that EPA will be able to develop
and apply scientific principles for better determining which chemicals
have a common mechanism of toxicity and evaluating the cumulative
effects of such chemicals. The Agency anticipates, however, that even
as its understanding of the science of common mechanisms increases,
decisions on specific classes of chemicals will be heavily dependent on
chemical specific data, much of which may not be presently available.
Although at present the Agency does not know how to apply the
information in its files concerning common mechanism issues to most
risk assessments, there are pesticides as to which the common mechanism
issues can be resolved. These pesticides include pesticides that are
toxicologically dissimilar to existing chemical substances (in which
case the Agency can conclude that it is unlikely that a pesticide
shares a common mechanism of activity with other substances) and
pesticides that produce a common toxic metabolite (in which case common
mechanism of activity will be assumed).
EPA does not have, at this time, available data to determine
whether tebufenozide has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
tebufenozide does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that tebufenozide has a common mechanism of
toxicity with other substances.
D. Safety Determinations for U.S. Population
1. Acute risk. No acute toxicological effects of concern have been
identified for tebufenozide and an acute risk assessment is not
required.
2. Short- and intermediate-term risk. Because no toxicity concerns
have been identified by the Agency for short- or intermediate-term
exposure to tebufenozide and no indoor or outdoor residential uses are
registered, a short- or intermediate-term aggregate risk assessment is
not required.
3. Chronic risk. Using the conservative TMRC exposure assumptions
described above, EPA has concluded that chronic aggregate exposure to
tebufenozide from food will utilize 31% of the RfD for the U.S.
population. Aggregate exposure to tebufenozide from food utilizes <81% of="" the="" rfd="" for="" all="" major="" identifiable="" subgroups,="" including="" infants="" and="" 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,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" chronic="" aggregate="" exposure="" to="" tebufenozide="" residues.="" e.="" determination="" of="" safety="" for="" infants="" and="" children="" 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="" pesticide="" exposure="" during="" prenatal="" development="" to="" one="" or="" both="" parents.="" 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="" 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="" [[page="" 35687]]="" 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.="" based="" on="" current="" toxicological="" data="" requirements,="" the="" data="" base="" for="" developmental="" and="" reproductive="" studies="" for="" tebufenozide="" is="" complete.="" the="" data="" indicate="" that="" there="" are="" no="" special="" pre-="" or="" post-natal="" toxicity="" concerns="" for="" infants="" and="" children="" and="" that="" the="" standard="" uncertainty="" factor="" is="" adequate="" to="" protect="" the="" safety="" of="" infants="" and="" children.="" developmental="" toxicity="" was="" not="" observed="" in="" developmental="" studies="" using="" rats="" and="" rabbits.="" the="" noel="" for="" developmental="" effects="" in="" both="" rats="" and="" rabbits="" was="" 1,000="" mg/kg/day="" (hdt),="" which="" is="" the="" limit="" dose="" for="" testing="" in="" developmental="" studies.="" 1.="" developmental="" toxicity="" studies.--i.="" rat="" developmental="" toxicity.="" the="" maternal="" (systemic)="" noel="" was="" 250="" mg/kg/day="" and="" the="" loel="" was="" 1,000="" mg/kg/day="" based="" on="" decreased="" weight="" gain="" and="" food="" consumption.="" the="" developmental="" (pup)="" noel="" was="">1,000 mg/kg/day, the highest dose tested
(HDT).
ii. Rabbit developmental toxicity. The maternal (systemic) and
developmental (pup) NOELs were >1,000 mg/kg/day (HDT).
2. Reproductive toxicity studies.--Rat reproduction toxicity. In
the two-generation reproductive toxicity study in the rat, the parental
(systemic) NOEL was 0.85 mg/kg/day. Splenic pigmentation changes and
extramedullary hematopoiesis occurred in the parents at the LOEL of
12.1 mg/kg/day (in males and females and in both generations). In
addition to these effects, decreased body weight gain and food
consumption occurred at 171.1 mg/kg/day.
The reproductive (pup) NOEL was 12.1 mg/kg/day and the LOEL was
171.1 mg/kg/day based on a slight increase, in both generations, in the
number of pregnant females that did not deliver and a slight increase
in the number of second generation pregnant females that had difficulty
delivering and had to be sacrificed. Additionally, in second generation
dams at the LOEL, the length of gestation increased and implantation
sites decreased significantly. Finally, the number of pups per litter
decreased on Lactation Day (LD) 4 to 90% of the controls for the first
generation and on LD's 0 and 4 (80%) for the second generation. Because
these reproductive effects occurred in the presence of parental
(systemic) toxicity, these data do not suggest an increased post-natal
sensitivity to children and infants (that infants and children might be
more sensitive than adults) to tebufenozide exposure.
3. Pre- and post- natal sensitivity. The developmental (pup) NOELs
of >1,000 mg/kg/day (HDT) from the rat and rabbit developmental
toxicity studies demonstrate that there is no developmental (pre-natal)
toxicity present for tebufenozide. Additionally, these developmental
NOELs are greater than 500-fold higher than the NOEL of 1.8 mg/kg/day
from the 1-year feeding study in dogs which was the basis of the RfD.
In the reproductive toxicity study in rats, the reproductive NOEL
(12.1 mg/kg/day) is 14-fold higher than the parental NOEL (0.85 mg/kg/
day) and indicates that post-natal toxicity in the reproductive studies
occurs only in the presence of significant parental toxicity.
These developmental and reproductive studies indicate that
tebufenozide does not have additional sensitivity for infants and
children in comparison to other exposed groups.
4. Acute risk. No acute toxicological effects of concern have been
identified for tebufenozide and an acute risk assessment is not
required.
5. Short- and intermediate-term risk. Because no toxicity concerns
have been identified by the Agency for short- or intermediate-term
exposure to tebufenozide and no indoor or outdoor residential uses are
registered, a short- or intermediate-term aggregate risk assessment is
not required.
6. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that the percentage of RfD that will
be utilized by dietary (food only) exposure to residues of tebufenozide
ranges from 41% for nursing infants up to 80% for non-nursing infants
<1 year="" old.="" 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="" chronic="" exposure="" to="" tebufenozide="" in="" drinking="" water,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" chronic="" aggregate="" exposure="" to="" tebufenozide="" residues.="" v.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" metabolism="" in/on="" plants="" is="" adequately="" understood.="" the="" residue="" of="" concern="" is="" the="" parent="" compound,="" tebufenozide="" per="" se="" as="" specified="" in="" 40="" cfr="" 180.482.="" the="" metabolism="" in="" animals="" is="" not="" adequately="" understood;="" however,="" for="" purposes="" of="" these="" section="" 18="" exemptions="" only,="" the="" agency="" considers="" the="" residue="" of="" concern="" to="" be="" the="" parent="" compound,="" tebufenozide="" per="" se.="" estimates="" of="" secondary="" residues="" in="" ruminant="" tissues="" were="" extrapolated="" from="" data="" from="" a="" goat="" metabolism="" study="" submitted="" to="" support="" the="" import="" tolerance="" on="" apples.="" the="" recommended="" secondary="" ruminant="" tissue="" residues="" are="" based="" on="" high="" level="" dosing="" and="" maximum="" radioactive="" residues="" found="" in="" goat="" tissues="" and="" are="" likely="" conservative="" estimates="" of="" the="" actual="" residue="" levels="" that="" would="" occur="" in="" ruminants="" fed="" apple="" pomace="" containing="" tebufenozide="" residues.="" b.="" analytical="" enforcement="" methodology="" the="" hplc/uv="" method,="" tr="" 34-94-38="" is="" adequate="" to="" detect="" residue="" so="" the="" parent="" compound="" in="" apples.="" at="" this="" time,="" there="" are="" no="" analytical="" methods="" available="" to="" the="" agency="" to="" detect="" secondary="" residues="" in="" animal="" matrixes="" as="" a="" result="" of="" this="" use.="" c.="" magnitude="" of="" residues="" residues="" of="" tebufenozide="" are="" not="" expected="" to="" exceed="" the="" following="" levels="" as="" a="" result="" of="" this="" use:="" 1.0="" ppm="" in="" apples;="" 2.0="" ppm="" in="" apple="" pomace;="" 0.05="" ppm="" in="" milk;="" 0.02="" ppm="" in="" meat="" of="" cattle,="" sheep,="" goat,="" and="" horse;="" 0.1="" ppm="" in="" fat="" of="" cattle,="" sheep,="" and="" goats;="" 0.1="" ppm="" in="" meat="" by-="" products="" (except="" liver="" and="" kidney)="" of="" cattle,="" sheep,="" and="" goats;="" 1.0="" ppm="" in="" liver="" of="" cattle,="" sheep,="" and="" goat;="" and="" 0.02="" ppm="" in="" kidneys="" of="" cattle,="" sheep,="" and="" goats.="" d.="" international="" residue="" limits="" there="" are="" no="" codex,="" canadian,="" or="" mexican="" international="" residue="" limits="" established="" for="" use="" of="" tebufenozide="" on="" apples.="" vi.="" conclusion="" therefore,="" tolerances="" in="" connection="" with="" the="" fifra="" section="" 18="" emergency="" exemptions="" are="" established="" for="" residues="" of="" tebufenozide="" in/on="" the="" following:="" apples="" -="" 1.0="" ppm;="" apple="" pomace="" -="" 2.0="" ppm;="" cottonseed,="" undelinted="" -="" 0.2="" ppm;="" cottonseed="" meal="" -="" 0.5="" ppm;="" cottonseed="" oil="" -="" 1.3="" ppm;="" cottonseed="" hulls="" -="" 0.8="" ppm;="" cotton="" gin="" byproducts="" -="" 4.0="" ppm;="" milk="" -="" 0.05="" ppm;="" meat="" of="" cattle,="" sheep,="" goat,="" and="" horse="" -="" 0.02="" ppm;="" fat="" of="" cattle,="" sheep,="" and="" goats="" -="" 0.1="" ppm;="" meat="" by-products="" (except="" liver="" and="" kidney)="" of="" cattle,="" sheep,="" and="" goats="" -="" 0.1="" ppm;="" liver="" of="" cattle,="" sheep,="" and="" goat="" -="" 1.0="" ppm;="" and="" kidneys="" of="" cattle,="" sheep,="" and="" goats="" -="" 0.02="" ppm.="" [[page="" 35688]]="" vii.="" 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="" september="" 2,="" 1997,="" file="" written="" objections="" to="" any="" aspect="" of="" this="" regulation="" (including="" the="" revocation="" provision)="" 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="" rulemaking.="" 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).="" 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="" confidential="" business="" information="" (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.="" viii.="" public="" docket="" epa="" has="" established="" a="" record="" for="" this="" rulemaking="" under="" docket="" control="" number="" [opp-300500]="" (including="" any="" comments="" and="" data="" submitted="" electronically).="" a="" public="" version="" of="" this="" record,="" which="" does="" not="" include="" any="" information="" claimed="" as="" cbi,="" is="" available="" for="" inspection="" from="" 8="" a.m.="" to="" 4:30="" p.m.,="" monday="" through="" friday,="" excluding="" legal="" holidays.="" the="" public="" record="" is="" located="" in="" room="" 1132="" of="" the="" public="" information="" and="" records="" integrity="" branch,="" information="" resources="" and="" services="" division="" (7506c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" crystal="" mall="" #2,="" 1921="" jefferson="" davis="" highway,="" arlington,="" va.="" electronic="" comments="" may="" be="" sent="" diectly="" to="" epa:="">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 rulemaking, 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 rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
IX. Regulatory Assessment Requirements
This final rule establishes a tolerance under section 408 of the
FFDCA and is in response to a petition received by the Agency
requesting the establishment of such a tolerance. 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). In addition, 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) (Pub. L. 104-4). Nor does it require any prior consultation as
specified by Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or
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, because tolerances that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rwule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. Prior to the recent amendments to the FFDCA,
however, EPA had treated such actions as subject to the RFA. The
amendments to the FFDCA clarify that no proposed rule is required for
such regulatory actions, which makes the RFA inapplicable to these
actions. 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 (46 FR 24950, May 4, 1981). In accordance with Small Business
Administration (SBA) policy, this determination will be provided to the
Chief Counsel for Advocacy of the SBA upon request.
X. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted a
report containing this rule and other required information to the U.S.
Senate, the U.S. House ofRepresentatives, and the Comptroller General
of the General Accounting Office prior to publication of this rule in
today's Federal Register. This 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: June 13, 1997.
James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR Chapter I is amended as follows:
[[Page 35689]]
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. Section 180.482 is amended as follows:
a. In paragraph (a) by adding a heading.
b. In paragraph (b) by revising the introductory text and
alphabetically adding the entries to the table.
c. By adding the headings and reserving new paragraphs (c) and (d).
Sec. 180.482 Tebufenozide; tolerances for residues.
(a) General. * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the insecticide benzoic acid in connection
with use of the pesticide under section 18 emergency exemptions granted
by EPA. The tolerances will expire and are revoked on the dates
specified in the following table.
----------------------------------------------------------------------------------------------------------------
Expiration/Revocation
Commodity Parts per million Date
----------------------------------------------------------------------------------------------------------------
Apple pomace.................................................. 2.0 6/30/98
Apples........................................................ 1.0 6/30/98
Cattle, fat................................................... 0.10 6/30/98
Cattle, kidney................................................ 0.02 6/30/98
Cattle, liver................................................. 1.0 6/30/98
Cattle, mbyp.................................................. 0.10 6/30/98
Cattle, meat.................................................. 0.02 6/30/98
Cotton gin byproducts......................................... 4.0 6/30/98
Cottonseed hulls.............................................. 0.8 6/30/98
Cottonseed meal............................................... 0.5 6/30/98
Cottonseed oil................................................ 1.3 6/30/98
Cottonseed, undelinted........................................ 0.2 6/30/98
Goats, fat.................................................... 0.10 6/30/98
Goats, kidney................................................. 0.02 6/30/98
Goats, liver.................................................. 1.0 6/30/98
Goats, mbyp................................................... 0.10 6/30/98
Goats, meat................................................... 0.02 6/30/98
Horses, meat.................................................. 0.02 6/30/98
* * * * * *
*
Milk.......................................................... 0.05 6/30/98
* * * * * *
*
Sheep, fat.................................................... 0.10 6/30/98
Sheep, kidney................................................. 0.02 6/30/98
Sheep, liver.................................................. 1.0 6/30/98
Sheep, mbyp................................................... 0.10 6/30/98
Sheep, meat................................................... 0.02 6/30/98
* * * * * *
*
----------------------------------------------------------------------------------------------------------------
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 97-17370 Filed 7-1-97; 8:45 am]
BILLING CODE 6560-50-F
