[Federal Register Volume 63, Number 42 (Wednesday, March 4, 1998)]
[Rules and Regulations]
[Pages 10537-10543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-5417]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300606; FRL-5767-1]
RIN 2070-AB78
Hydramethylnon; 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 hydramethylnon in or on pineapple. 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 pineapple. This regulation establishes a
maximum permissible level for residues of hydramethylnon in this food
commodity pursuant to section 408(l)(6) of the Federal Food, Drug, and
Cosmetic Act, as amended by the Food Quality Protection Act of 1996.
The tolerance will expire and is revoked on January 31, 1999.
DATES: This regulation is effective March 4, 1998. Objections and
requests for hearings must be received by EPA on or before May 4, 1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300606], 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-300606], 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, 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: [email protected]. 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-300606]. 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: Virginia Dietrich,
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: Crystal Mall #2,
1921 Jefferson Davis Hwy., Arlington, VA, (703) 308-9359, e-mail:
[email protected].
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 a tolerance for
residues of the insecticide hydramethylnon, in or on pineapple at 0.05
part per million (ppm). This tolerance will expire and is revoked on
January 31, 1999. 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 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 tolerance to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
[[Page 10538]]
II. Emergency Exemption for hydramethylnon on pineapple and FFDCA
Tolerances
On May 21, 1997 the state of Hawaii applied for an emergency
exemption for the use of hydramethylnon to control big-headed and
Argentine ants in pineapples. These ants are involved in the spread of
mealy bugs in pineapple fields and the subsequent development of
mealybug wilt, a devastating disease responsible for the near demise of
the pineapple industry in the 1920's. Alternate control strategies are
not effective. Currently registered materials for in-field ant control
are not effective due to the mobility of the ants. After reviewing the
submission the EPA authorized under FIFRA section 18 the use of
hydramethylnon on pineapple for control of big headed and Argentine
ants in Hawaii.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of hydramethylnon in or on
pineapple. In doing so, EPA considered the new safety standard in FFDCA
section 408(b)(2), and EPA decided that the necessary tolerance under
FFDCA section 408(l)(6) would be consistent with the new safety
standard and with FIFRA section 18. Consistent with the need to move
quickly on the emergency exemption in order to address an urgent non-
routine situation and to ensure that the resulting food is safe and
lawful, EPA is issuing this tolerance without notice and opportunity
for public comment under section 408(e), as provided in section
408(l)(6). Although this tolerance will expire and is revoked on
January 31, 1999, under FFDCA section 408(l)(5), residues of the
pesticide not in excess of the amounts specified in the tolerance
remaining in or on pineapple after that date will not be unlawful,
provided the pesticide is applied in a manner that was lawful under
FIFRA. EPA will take action to revoke this tolerance earlier if any
experience with, scientific data on, or other relevant information on
this pesticide indicate that the residues are not safe.
Because this tolerance is being approved under emergency conditions
EPA has not made any decisions about whether hydramethylnon meets EPA's
registration requirements for use on pineapple or whether a permanent
tolerance for this use would be appropriate. Under these circumstances,
EPA does not believe that this tolerance serves as a basis for
registration of hydramethylnon by a State for special local needs under
FIFRA section 24(c). Nor does this tolerance serve as the basis for any
State other than Hawaii to use this pesticide on this crop under
section 18 of FIFRA without following all provisions of section 18 as
identified in 40 CFR part 166. For additional information regarding the
emergency exemption for hydramethylnon, 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 adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. Second,
EPA examines exposure to the pesticide through the diet (e.g., food and
drinking water) and through exposures that occur as a result of
pesticide use in residential settings.
A. Toxicity
1. Threshold and non-threshold effects. For many animal 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. EPA generally uses the RfD to
evaluate the chronic risks posed by pesticide exposure. For shorter
term risks, EPA calculates a margin of exposure (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
relationship. 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.
2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity data base, and based on
the effects seen for different durations and routes of exposure,
determines which risk assessments should be done to assure that the
public is adequately protected from any pesticide exposure scenario.
Both short and long durations of exposure are always considered.
Typically, risk assessments include ``acute,'' ``short-term,''
``intermediate term,'' and ``chronic'' risks. These assessments are
defined by the Agency as follows.
Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
High end exposure to food and water residues are typically assumed.
Short-term risk results from exposure to the pesticide for a period
of 1-7 days, and therefore overlaps with the acute risk assessment.
Historically, this risk assessment was intended to address primarily
dermal and inhalation exposure which could result, for example, from
residential pesticide applications. However, since enaction of FQPA,
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from
food, water, and residential uses when reliable data are available. In
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated.
[[Page 10539]]
High-end exposures from all 3 sources are not typically added because
of the very low probability of this occurring in most cases, and
because the other conservative assumptions built into the assessment
assure adequate protection of public health. However, for cases in
which high-end exposure can reasonably be expected from multiple
sources (e.g. frequent and widespread homeowner use in a specific
geographical area), multiple high-end risks will be aggregated and
presented as part of the comprehensive risk assessment/
characterization. Since the toxicological endpoint considered in this
assessment reflects exposure over a period of at least 7 days, an
additional degree of conservatism is built into the assessment; i.e.,
the risk assessment nominally covers 1-7 days exposure, and the
toxicological endpoint/NOEL is selected to be adequate for at least 7
days of exposure. (Toxicity results at lower levels when the dosing
duration is increased.)
Intermediate-term risk results from exposure for 7 days to several
months. This assessment is handled in a manner similar to the short-
term risk assessment.
Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated considering average exposure from all sources for
representative population subgroups including infants and children.
B. Aggregate Exposure
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. In evaluating food
exposures, EPA takes into account varying consumption patterns of major
identifiable subgroups of consumers, including infants and children.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 federal and
private market survey data. Typically, a range of estimates are
supplied and the upper end of this range is assumed for the exposure
assessment. By using this upper end estimate of percent of crop
treated, the Agency is reasonably certain that exposure is not
understated for any significant subpopulation group. Further, regional
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations
including several regional groups, to pesticide residues. For this
pesticide, the most highly exposed population subgroup (non-nursing
infants less than one year old) was not regionally based.
IV. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action, EPA has sufficient data to assess the hazards of
hydramethylnon and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerance for
residues of hydramethylnon, also known as tetrahydro-5,5-dimethyl-2-
(1H)-pyrimidinoine(3-(4-trifluoromethyl)phenyl)-1- [2-
[4(trifluoromethly)phenyl]ethenyl)-2-propenylidene) hydrazone on
pineapple at 0.05 ppm. EPA's assessment of the dietary exposures and
risks associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by hydramethylnon are
discussed below.
1. Acute toxicity. An acute endpoint has not been identified. This
risk assessment is not required.
2. Short - and intermediate - term toxicity. For short-term MOE
calculations, the Agency's Hazard Identification Committee recommended
use of the Systemic No Observed Adverse Effect Level (NOAEL)
(freestanding) of 250 milligrams/kilogram/day (mg/kg/day) from the 21-
day dermal toxicity study in New Zealand white rabbits. Nonadverse
signs at the NOAEL included decreased food consumption in males and
females, and thrombocytopenia in females. For intermediate-term MOE
calculations, the Agency's Hazard Identification Committee recommended
use of the systemic NOAEL (freestanding) of 250 mg/kg/day from the 21-
day dermal toxicity study in New Zealand white rabbits. Nonadverse
signs at the NOAEL included decreased food consumption in males and
females, and thrombocytopenia in females.
3. Chronic toxicity. EPA has established the RfD for hydramethylnon
at 0.001 mg/kg/day. This RfD is based on a 6-month feeding study in
dogs with a NOAEL of 1.0 mg/kg/day based on an increased incidence of
soft stools, mucoid stools, and diarrhea at the Lowest Observed Adverse
Effect Level (LOAEL) of 3.0 mg/kg/day. Since a NOEL was not defined in
this study, an uncertainty factor of 1,000 was used during calculation
of the RfD instead of the usual 100-fold factor.
4. Carcinogenicity. Hydramethylnon has been classified as a Group C
chemical (possible human carcinogen) by the Agency's Cancer Peer Review
Committee. The Committee recommended using the RfD approach for risk
assessment.
B. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.395) for the residues of hydramethylnon, in or on a variety of
raw agricultural commodities. Risk assessments were conducted by EPA to
assess dietary exposures and risks from hydramethylnon as follows:
a. 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. The acute dietary (food only) risk
assessment is not required as the Agency's Hazard Identification
Committee did not
[[Page 10540]]
identify any acute dietary risk endpoints.
b. Chronic exposure and risk. In conducting this chronic dietary
risk assessment, HED has made very conservative assumptions -- 100% of
pineapple commodities will contain hydramethylnon residues and those
residues will be at the level of the required tolerance -- which
results in an overestimate of human dietary exposure. Thus, in making a
safety determination for this tolerance, HED is taking into account
this conservative exposure assessment. The hydramethylnon Section 18
tolerance results in a TMRC that is equivalent to the following
percentages of the RfD:
------------------------------------------------------------------------
Population Subgroup % RfD
------------------------------------------------------------------------
U.S. Population........................... <1%
Nursing Infants........................... <1%
Non-Nursing Infants (<1 year old)......... 2%
Children (1-6 years old).................. 1%
Children (7-12 years old)................. <1%
------------------------------------------------------------------------
The subgroups listed above are: (1) the U.S. population (48
states); (2) those for infants and children; and, (3) the other
subgroups for which the percentage of the RfD occupied is greater than
that occupied by the subgroup U.S. population (48 states).
2. From drinking water. Based on information that Agency has in
files, hydramethylnon and its degradates are not expected to leach to
groundwater. Information on its persistence is inconclusive. There are
no established Maximum Contaminant Levels (MCLs) for residues of
hydramethylnon in drinking water and no health advisory levels for this
active ingredient in drinking water have been issued.
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 exposure
from contaminated water, the ranges the Agency is continuing to examine
are all below the level that would cause hydramethylnon 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 hydramethylnon 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.
3. From non-dietary exposure. Hydramethylnon is currently
registered for use on the following residential non-food sites:
recreational areas, ornamental plants, lawns, turf, and household or
domestic dwellings. However, the Agency currently lacks sufficient
residential-related exposure data to complete a comprehensive
residential risk assessment for many pesticides, including
hydramethylnon.
4. Cumulative exposure to substances with common mechanism of
toxicity. Hydramethylnon is a member of the amidinohydrazones class of
pesticides. There are no other members of this class of pesticides.
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 hydramethylnon 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,
hydramethylnon 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 hydramethylnon has a common
mechanism of toxicity with other substances.
C. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. An acute endpoint has not been identified. The
Agency's Hazard Identification Committee determined that this risk
assessment is not required.
2. Chronic risk. Using the TMRC exposure assumptions described
above, EPA has concluded that aggregate exposure to hydramethylnon from
food will utilize <1% of the RfD for the U.S. population. 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 hydramethylnon in drinking water
and from non-dietary, non-occupational exposure, 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
[[Page 10541]]
result from aggregate exposure to hydramethylnon residues. According to
Agency policy, the residential uses of hydramethylnon do not fall under
a chronic exposure scenario. The Agency concludes that there is a
reasonable certainty that no harm will result from chronic aggregate
exposure to hydramethylnon residues.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential exposure. Although hydramethylnon has residential uses, the
Agency currently lacks sufficient residential-related exposure data to
complete a comprehensive residential risk assessment for many
pesticides, including hydramethylnon.
D. Aggregate Cancer Risk for U.S. Population
Hydramethylnon has been classified as a Group C chemical (possible
human carcinogen) by the Cancer Peer Review Committee . The Committee
recommended using the RfD approach for risk assessment. Thus, the
cancer risk estimate is the same as our estimate of chronic aggregate
risk, which is discussed above. Based upon the discussion of the
chronic aggregate risk estimate, we conclude the cancer risk estimate
does not exceed HED's level of concern.
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 hydramethylnon, 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 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 --a. Rats. In the developmental
study in rats, the maternal (systemic) NOEL was 3 mg/kg/day. The
maternal (systemic) NOAEL was 10 mg/kg/day, based on an 8% decrease in
body weight and yellowish discoloration of the fat. The maternal
(systemic) LOAEL was 30 mg/kg/day based on a 16% decrease in body
weight; increased incidence of nasal mucus, alopecia, soft stool, and
staining of the ano-genital fur; and yellowish discoloration of the fat
and small thymus. The developmental (fetal) NOEL was 10 mg/kg/day,
based on decreased mean fetal weights and the increased incidence of
rudimentary structures and incompletely ossified supraoccipitals at the
LOAEL of 30 mg/kg/day.
b. Rabbits. In the developmental toxicity study in rabbits, the
maternal (systemic) NOEL could not be defined. The maternal (systemic)
NOAEL was 5 mg/kg/day, based on decreased body weight gain
(6%), soft stool, and reduced amount of stool. The maternal
LOAEL was 10 mg/kg/day based on soft stool, reduced amount of stool,
and anogenital matting and discharge. The developmental (fetal) NOEL
could not be defined. The developmental (fetal) NOAEL was 5 mg/kg/day
based on decreased fetal weight (8%). The developmental (fetal) LOAEL
was 10 mg/kg/day based on decreased fetal weight (16%).
iii. Reproductive toxicity study. In the 2-generation reproductive
toxicity study in rats, the maternal (systemic) NOEL was 25 ppm (1.66 /
2.01 mg/kg/day, (male/female)), based on degeneration of the germinal
epithelium and aspermia at the LOAEL of 50 ppm (3.32 / 4.13 mg/kg/day,
(male/female)). No adverse effects were observed in the pups.
iv. Pre- and post-natal sensitivity. The toxicology data base for
hydramethylnon is complete with respect to current toxicological data
requirements. There are no pre- or post-natal toxicity concerns for
infants and children, based on the results of the rat and rabbit
developmental toxicity studies and the 2-generation reproductive
toxicity study in rats.
v. Conclusion. Based on the above, HED concludes that reliable data
support use of the standard 100-fold uncertainty factor and that an
additional factor is not needed to protect infants and children.
However, because a NOEL was not established in the chronic toxicity
study, an additional uncertainty factor of 10 was added.
2. Acute risk. There is no reliable endpoint that can be attributed
to an acute exposure. Therefore, this risk assessment is not
appropriate.
3. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that aggregate exposure to
hydramethylnon from food ranges from <1% for several population
subgroups to 2% for non-nursing infants (<1 year old) of the RfD for
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 hydramethylnon in drinking water and from non-dietary, non-
occupational exposure, 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
aggregate exposure to hydramethylnon residues.
F. Endocrine Disruptor Effects
EPA is required to develop a screening program to determine whether
certain substances (including all pesticides and inerts) ``may have an
effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or such other endocrine effect...'' The Agency is
currently working with interested stakeholders, including other
government agencies, public interest groups, industry and research
scientists in developing a screening and testing program and a priority
setting scheme to implement this program. Congress has allowed 3 years
from the passage of FQPA (August 3, 1999) to implement this program. At
that time, EPA may require further testing of this active ingredient
and end use products for endocrine disruptor effects.
[[Page 10542]]
V. Other Considerations
A. Metabolism In Plants and Animals
The nature of the residue in plants is adequately understood for
this section 18 use. The Agency's Metabolism Committee determined that
the residue of concern in grass is hydramethylnon per se. The Agency
believes that this conclusion can be translated to pineapple.
B. Analytical Enforcement Methodology
Adequate enforcement methodology is available in PAM II (Method I)
to enforce the tolerance expression. A confirmatory method has recently
been submitted to the FDA for inclusion in PAM II.
C. Magnitude of Residues
Residues of hydramethylnon are not expected to exceed 0.05 ppm in/
on pineapple. Residues are not expected to concentrate in pineapple
processed products. The Agency is establishing a time-limited tolerance
at this level. Secondary residues of hydramethylnon are not expected in
animal commodities as a result of this section 18 use. Tolerances for
secondary residues of hydramethylnon in livestock commodities are not
currently established.
D. International Residue Limits
There are no Codex, Canadian or Mexican residue limits established
for hydramethylnon in/on pineapple. Thus, harmonization is not an issue
for this section 18.
E. Rotational Crop Restrictions
Pineapple is not typically rotated. Thus, rotational crop
restrictions are not required.
VI. Conclusion
Therefore, the tolerance is established for residues of
hydramethlynon in pineapple at 0.05 ppm.
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 May 4, 1998, 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 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 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 Record and Electronic Submissions
EPA has established a record for this rulemaking under docket
control number [OPP-300606] (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, Crystal
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments may be sent directly to EPA at:
[email protected].
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 FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (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, since these tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408 (d),
such as the tolerance in this final rule, do not require the issuance
of a proposed rule, the requirements of the
[[Page 10543]]
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 acations published on May 4, 1981 (46 FR 24950), and was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.
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 of Representatives, 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: February 20, 1998.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR Chapter I is amended as follows:
PART 180 -- [AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority : 21 U.S.C. 346a and 371.
2. Section 180.395 is amended as follows:
a. By revising the section heading.
b. By designating the existing text as paragraph (a) and adding a
paragraph heading.
c. By adding paragraph (b).
d. By adding and reserving paragraphs (c) and (d).
Sec. 180.395 Hydramethylnon; tolerances for residues.
(a) General. * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the insecticide hydramethylnon; tetrahydro-
5,5-dimethyl-2-(1H)-pyrimidinoine(3-(4-trifluoromethyl)phenyl)-1-[2-
[4(trifluoromethly)phenyl]ethenyl)-2-propenylidene) hydrazone in
connection with the use of the pesticides under section 18 emergency
exemptions granted by EPA. The tolerance will expire and is revoked on
the date specified in the following table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Pineapple....................... 0.05 1/31/99
------------------------------------------------------------------------
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 98-5417 Filed 3-3-98; 8:45 am]
BILLING CODE 6560-50-F