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Ethalfluralin. December 17, 1997, Pesticide Tolerances for Canola Seed. Emergency Exemption. Final Rule. Federal Register.
[Federal Register: December 17, 1997 (Volume 62, Number 242)]
[Rules and Regulations]
[Page 66008-66014]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17de97-10]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300585; FRL 5756-4]
RIN 2070-AB78
Ethalfluralin; 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 ethalfluralin in or on canola seed. This action is in
response to EPA allowing issuance of crisis emergency exemptions under
section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act
authorizing use of the pesticide on canola in Montana and North Dakota.
This regulation establishes a maximum permissible level for residues of
ethalfluralin 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 October 31, 1998.
DATES: This regulation is effective December 17, 1997. Objections and
requests for hearings must be received by EPA on or before February 17,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300585], 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-300585], 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. 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 5.1/6.1
or ASCII file format. All copies of objections and hearing requests in
electronic form must be identified by the docket control number [OPP-
300585]. 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: Andrea Beard, 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) 308-9356; e-mail:
beard.andrea@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 a tolerance for
residues of the herbicide ethalfluralin, in or on canola seed at 0.05
part per million (ppm). This tolerance will expire and is revoked on
October 31, 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 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
[[Page 66009]]
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 Exemption for Ethalfluralin on Canola and FFDCA
Tolerances
The Applicants state that as canola acreage has grown, wild
buckwheat has become an increasingly significant weed pest, and that
the only available herbicide, trifluralin, does not provided adequate
control of this weed. Thus, the Applicants found it necessary to issue
crisis exemptions for this use of ethalfluralin, to avoid significant
economic loss. EPA has authorized under FIFRA section 18 (the crisis
provisions) the use of ethalfluralin on canola for control of wild
buckwheat in Montana and North Dakota.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of ethalfluralin in or on
canola seed. 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
October 31, 1998, under FFDCA section 408(l)(5), residues of the
pesticide not in excess of the amounts specified in the tolerance
remaining in or on canola seed 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 ethalfluralin meets EPA's
registration requirements for use on canola 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 ethalfluralin 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 Montana or North Dakota 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 ethalfluralin, 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
[[Page 66010]]
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. 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, < 1 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
ethalfluralin and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerance for
residues of ethalfluralin on canola seed 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 ethalfluralin are
discussed below.
1. Acute toxicity. For acute dietary risk assessment, EPA
scientists have determined that the developmental NOEL of 75 mg/kg/day,
from the rabbit developmental study should be used. The LOEL of 150 mg/
kg/day is based on increased number of resorptions and increased
sternal and cranial variations. Since the effect of concern is
reproductive in nature, the acute risk assessment will evaluate acute
dietary risk to the population subgroup of concern, females 13 + years
old.
2. Short - and intermediate - term toxicity. No short- or
intermediate-term toxicity endpoints have been identified for
ethalfluralin, and OPP scientists determined that this assessment is
not necessary.
3. Chronic toxicity. EPA has established the RfD for ethalfluralin
at 0.04 milligrams/kilogram/day (mg/kg/day). This RfD is based on a 1-
year feeding study in dogs with a NOEL of 4.0 mg/kg/day, and an
uncertainty factor of 100. The LOEL of 20 mg/kg/day was based upon
altered red cell morphology and urinary bilirubin.
4. Carcinogenicity. Based on mammary gland fibroadenomas and
combined mammary gland adenomas and/or fibroadenomas in female rats,
ethalfluralin has been classified in Group C possible human carcinogen,
according to EPA's Cancer Assessment Guidelines. The OPP Cancer Peer
Review Committee recommended using the Q* approach for risk assessment,
and the Q* of 8.9 x 10-2 has been calculated.
B. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.416) for the residues of ethalfluralin, in or on the following
raw agricultural commodities: dry beans and peas, cucurbit vegetables,
peanuts, soybeans, and sunflower seeds; and in animal commodities fat,
meat, and meat byproducts of cattle, goats, hogs, horses, poultry, and
sheep; and milk and eggs. According to the Ethalfluralin Reregistration
Eligibility Document (RED), published March 1995, EPA is requiring
revocation of all animal commodity tolerances, as they are not needed
there is no expectation of finite residues. In the following risk
assessments, the animal commodity tolerances are included, and then
subsequently excluded from the refined cancer risk assessment. Risk
assessments were conducted by EPA to
[[Page 66011]]
assess dietary exposures and risks from ethalfluralin as follows:
i. Acute exposure and risk. Acute dietary risk assessments are
performed for a food-use pesticide if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a one day or single exposure. The acute risk assessment used
tolerance-level residues for all commodities having ethalfluralin
tolerances. For the population subgroup of concern, females 13 + years
old, the Margin of Exposure (MOE) for the high-end consumer was
calculated to be 25,000 (an MOE of 100 represents a
negligible risk. Canola seed is processed into canola oil, a commodity
which is not listed in OPP's dietary risk exposure system (DRES), so a
standard DRES risk analysis including it cannot be conducted. However,
canola oil is a very low consumption human food item 0.01% of the RfD,
see below, and would be expected to contribute only a minor incremental
increase to the acute dietary exposure. Additionally, the estimate
given above should be considered extremely conservative, and if it were
refined, using a Monte Carlo technique and incorporating anticipated
residues and percent of crop treated figures, the MOEs would likely be
much higher.
ii. Chronic exposure and risk. The chronic dietary (food only) risk
assessment for ethalfluralin was conducted using anticipated residue
values and percent of crop treated information for some of the crops.
Based on this, EPA has concluded that dietary exposure to ethalfluralin
will utilize 2% of the RfD for the Overall US Population 0.01% of this
attributed to canola oil. The major identifiable subgroup with the
highest exposure is non-nursing infants < 1 year old, at 9% of the RfD.
This is further discussed below in the section on infants and children.
EPA generally has no concern for exposure 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 ethalfluralin in drinking
water. EPA does not expect the aggregate exposure to exceed 100% of the
RfD.
2. From drinking water. According to available data, ethalfluralin
is moderately persistent and relatively immobile in soil, and is not
expected to be a groundwater contaminant. Ethalfluralin does appear to
have some potential to reach surface waters on eroded soil particles,
but in surface waters, ethalfluralin would be expected to photodegrade
rapidly. According to EPA's Pesticides in Ground Water Database, a
total of 188 wells in Texas were monitored for ethalfluralin residues
in 1987-88, and no detectable residues were reported. There are no
Maximum Contaminant Levels or Health Advisory Levels established for
ethalfluralin in drinking water.
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 (RfDs
or acute dietary NOELs) 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 ethalfluralin 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 ethalfluralin 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. Ethalfluralin is not currently
registered for use on any residential non-food sites, and thus, it is
not expected that non-occupational, non-dietary exposures will occur.
4. Cumulative exposure to substances with common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.'' 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.
Although ethalfluralin is a member of the nitroaniline class of
herbicides, EPA does not have, at this time, available data to
determine whether ethalfluralin 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,
ethalfluralin 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 ethalfluralin has a common mechanism of
toxicity with other substances.
C. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. For the population subgroup of concern, females 13 +
years old, the calculated MOE value for dietary exposure from food only
is
[[Page 66012]]
25,000. Although there is potential for exposure to ethalfluralin in
drinking water, EPA does not expect that this would result in an
aggregate MOE food plus water that would exceed the level of concern
MOE < 100 for acute dietary exposure. Therefore, EPA concludes that
there is reasonable certainty that no harm will result from aggregate
acute exposure to ethalfluralin.
2. Chronic risk. Using the ARC exposure assumptions described
above, EPA has concluded that aggregate exposure to ethalfluralin from
food will utilize 2% of the RfD for the U.S. population. The major
identifiable subgroup with the highest aggregate exposure is non-
nursing infants < 1 year old, at 9% of the RfD, discussed below. 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 ethalfluralin 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 from
aggregate chronic exposure to ethalfluralin residues.
D. Aggregate Cancer Risk for U.S. Population
Based on the Q* of 0.089 (mg/kg/day)-1, and the
anticipated residue contribution, the upper bound cancer risk estimate
for the U.S. population is 6.2 x 10-5, contributed through
all the published tolerances for ethalfluralin. However, as stated
above, EPA is requiring revocation of the ethalfluralin tolerances for
meat, milk, poultry, and eggs, due to the presumption that there are
undetectable residues in these food items. When the cancer risk is
calculated excluding these animal commodity tolerances, the resulting
upper bound risk is 5.7 x 10-7, which is considered a
negligible risk. This cancer risk analysis does not include canola oil,
which is not covered by the DRES analysis. However, the consumption of
canola oil has been calculated to comprise only 0.01% of the RfD, and
thus, in the best scientific judgment of EPA, would not contribute
appreciably to the dietary cancer risk from food uses of ethalfluralin.
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 ethalfluralin, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 3-generation
reproduction study in the rat, and a 7-month multigeneration study in
rats. The developmental toxicity studies are designed to evaluate
adverse effects on the developing organism resulting from maternal
pesticide exposure during gestation. Reproduction studies provide
information relating to effects from exposure to the pesticide on the
reproductive capability of mating animals and data on systemic
toxicity.
FFDCA section 408 provides that EPA shall apply an additional 10-
fold 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 100-fold safely factor
usually 100 for combined inter- and intra-species variability and not
the additional 10-fold safety 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
safety factor.
ii. Developmental toxicity studies. In the developmental toxicity
study in rats, the maternal systemic NOEL was 50 mg/kg/day, based on
decreased body weight gain and dark urine at the LOEL of 250 mg/kg/day.
The fetal developmental NOEL was 1000 mg/kg/day, at the highest dose
tested (no effects observed to the fetuses).
In the developmental toxicity study in rabbits, the maternal
systemic NOEL was 75 mg/kg/day, based on abortions and decreased food
consumption at the LOEL of 150 mg/kg/day. The fetal developmental NOEL
was also 75 mg/kg/day, based on a slightly increased number of
resorptions, abnormal cranial development, and increased sternal
variants, at the LOEL of 150 mg/kg/day.
iii. Reproductive toxicity study. In a 3-generation reproductive
toxicity study in rats, the parental systemic NOEL was 12.5 mg/kg/day,
based on decreased mean body weight gains in males in all generations,
at the LOEL of 37.5 mg/kg/day. The pup reproductive NOEL was 37.5 mg/
kg/day, the highest dose tested no effects seen on the pups.
In a 7-month multigeneration study in rats, the parental NOEL of 20
mg/kg/day was based on increased liver weights at the LOEL of 61 mg/kg/
day. The pup reproductive NOEL was 61 mg/kg/day, the
highest dose tested no effects seen on the pups.
iv. Pre- and post-natal sensitivity. The toxicological data base
for evaluating pre- and post-natal effects is complete for
ethalfluralin. Based on the results of the developmental and
reproduction studies outlined above, there are no pre- or post-natal
toxicity concerns for infants and children, from exposure to
ethalfluralin.
v. Conclusion. Since no pre-or post-natal concerns have been
identified for ethalfluralin, EPA scientists conclude that reliable
data support use of the standard 100-fold uncertainty factor, and an
additional uncertainty factor is not needed to protect infants and
children.
2. Acute risk. For the population subgroup of concern, females 13 +
years old, the MOE for ethalfluralin dietary (food only) exposure is
25,000; this accounts for both maternal and fetal exposure. Although
there is potential for exposure to ethalfluralin in drinking water, EPA
does not expect that this would result in an aggregate MOE (food plus
water) that would exceed the level of concern MOE < 100 for acute
dietary exposure. Therefore, EPA concludes that there is reasonable
certainty that no harm will result, for both Females 13+ Years Old, and
for the pre-natal development of infants, from aggregate acute exposure
to ethalfluralin.
3. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that aggregate exposure to
ethalfluralin from food will utilize 9% of the RfD for the highest
exposed subgroup of infants and children, 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 exposure to ethalfluralin 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 chronic exposure to
ethalfluralin residues.
[[Page 66013]]
V. Other Considerations
A. Metabolism In Plants and Animals
The nature of the residue of ethalfluralin in plants and animals is
adequately understood; the residue of concern is ethalfluralin per se,
as specified in 40 CFR 180.416.
B. Analytical Enforcement Methodology
Adequate enforcement methods gas-liquid chromatography with
electron capture detection are available to enforce the tolerance, in
both plant and animal tissues, and are listed in the Pesticide
Analytical Manual, Volume II PAM-II.
C. Magnitude of Residues
Residues of ethalfluralin are not expected to exceed 0.05 ppm in/on
canola seed as a result of this section 18 use. Residues are not
expected to concentrate in the processed commodities meal, refined oil
of canola, and no tolerances are required for these commodities.
D. International Residue Limits
There are no Codex, Canadian, or Mexican maximum residue limits
established for ethalfluralin.
E. Rotational Crop Restrictions
There are no plantback restrictions needed, and tolerances for
rotational crop commodities need not be established.
VI. Conclusion
Therefore, the tolerance is established for residues of
ethalfluralin in canola seed 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 February 17, 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 Docket
EPA has established a record for this rulemaking under docket
control number [OPP--300585] (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 Room 1132 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:
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 FFDCA section
408(l)(6). 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 under FFDCA section 408 (l)(6), such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. 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
[[Page 66014]]
generic certification for tolerance actions published on May 4, 1981
(46 FR 24950), and was provided to the Chief Counsel for Advocacy of
the Small Business Administration.
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: November 25, 1997.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180 -- [AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. Section 180.416, is amended as follows:
i. By designating the existing text as paragraph (a) and adding a
heading.
ii. By adding a new paragraph (b).
iii. By adding and reserving new paragraphs (c) and (d) with
headings to read as follows.
Sec. 180.416 Ethalfluralin; tolerances for residues.
(a) General. * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for the residues of the herbicide ethalfluralin, in
connection with use of the pesticide under section 18 emergency
exemptions granted by EPA. The tolerances will expire on the dates
specified in the following table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
Canola, seed.................... 0.05 10/31/98
------------------------------------------------------------------------
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 97-32933 Filed 12-16-97; 8:45 am]
BILLING CODE 6560-50-F