[Federal Register Volume 62, Number 185 (Wednesday, September 24, 1997)]
[Rules and Regulations]
[Pages 49925-49931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25236]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 185
[OPP-300544; FRL-5740-8]
RIN 2070-AB78
Endothall; 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 endothall in or on canola seed. 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 canola in Minnesota. This regulation establishes a
maximum permissible level for residues of endothall 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 August 31, 1998.
DATES: This regulation is effective September 24, 1997. Objections and
requests for hearings must be received by EPA on or before November 24,
1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300544], 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-300544], must also 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-300544]. 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 endothall, in or on canola seed at 0.3 part
per million (ppm). This tolerance will expire and is revoked on August
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
[[Page 49926]]
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 Exemption for Endothall on Canola and FFDCA
Tolerances
The Applicant states that over the past several years, unusually
cool and wet weather during the early part of the year has delayed
planting of canola which allows smartweed to become established in
fields, both competing with the canola plants and then contaminating
the seed. The smartweed seed, about the same size as canola seed,
cannot be removed using standard grain cleaning equipment. Increasing
levels of conspicuous admixture result in lower grading of the canola
seed, and thus lower prices for producers. In 1995, nearly all
Minnesota canola was excluded from the export market due to dockage
attributable to high contamination with smartweed and wild buckwheat,
which significantly reduced grower revenues. The Applicant states that
there are no other products registered for this use, nor are there
effective alternative control measures available. The Applicant
estimates that significant economic losses will be suffered by canola
growers if endothall is not available for control of smartweed. EPA has
authorized under FIFRA section 18 the use of endothall on canola for
control of smartweeds in Minnesota. After having reviewed the
submission, EPA concurs that emergency conditions exist for this state.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of endothall 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 August
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 endothall 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 endothall 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 Minnesota 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 endothall, 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
[[Page 49927]]
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. 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 (Children 1 - 6
years 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 endothall
and to make a determination on aggregate exposure, consistent with
section 408(b)(2), for a time-limited tolerance for residues of
endothall on canola seed at 0.3 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
[[Page 49928]]
toxic effects caused by endothall are discussed below.
1. Acute toxicity. An acute dietary risk endpoint has not been
identified, and an acute risk assessment is not required.
2. Short - and intermediate - term toxicity. For dermal short- and
intermediate- term MOE calculations, the NOEL of 40.0 mg/kg/day (no
effects seen at this, the Highest Dose Tested) was chosen from the 21-
day dermal toxicity study in rats.
3. Chronic toxicity. EPA has established the RfD for endothall at
0.02 milligrams/kilogram/day (mg/kg/day). This RfD is based on a 2-year
feeding study in dogs with an NOEL of 2.0 mg/kg/day, using an
uncertainty factor of 100. At the lowest observed effect level (LOEL)
of 6.0 mg/kg/day, increased relative and absolute weight of the stomach
and small intestine was observed.
4. Carcinogenicity. Endothall has not yet been reviewed by the
Cancer Peer Review Committee. However, review of available data
indicate that tumors observed in both the rat and the mouse studies are
within the historical control range for these species. Thus, there is
no concern for carcinogenic effects at this time.
B. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.293) for the residues of endothall, in or on a variety of raw
agricultural commodities, including rice grain and straw, potatoes,
hops, cottonseed at levels from 0.05 to 0.1 ppm; and 40 CFR 180.319,
interim tolerance for sugarbeets at 0.2 ppm. Risk assessments were
conducted by EPA to assess dietary exposures and risks from endothall
as follows:
Chronic exposure and risk. In conducting this chronic dietary risk
assessment, refinements used included percent of crop treated figures
for all crops except canola and sugar beets. Aside from this, the
conservative assumptions were made that 100% of the crops would have
residues at tolerance levels. Using these conservative assumptions, the
ARC estimates occupy the following percentages of the RfD: Overall U.S.
Population, 1.1%; Nursing Infants <1 year="" old,="" 0.6%;="" non-nursing="" infants=""><1 year="" old,="" 1.5%;="" children="" age="" 1-6="" years="" (highest="" exposed="" subgroup),="" 2.1%;="" and="" children="" 7-12="" years="" old,="" 1.6%.="" although="" these="" estimates="" are="" well="" below="" levels="" of="" concern,="" additional="" refinement="" using="" anticipated="" residue="" levels="" and="" percent="" of="" crop="" treated="" information="" for="" all="" crops="" would="" result="" in="" much="" lower="" dietary="" exposure="" estimates.="" 2.="" from="" drinking="" water.="" there="" is="" an="" interim="" tolerance="" for="" residues="" of="" endothall="" in="" potable="" water="" at="" 0.2="" ppm,="" and="" epa="" has="" also="" established="" a="" maximum="" contaminant="" level="" (mcl)="" for="" water="" at="" 0.1="" mg/l.="" chronic="" exposure="" and="" risk.="" chronic="" exposure="" levels="" for="" the="" u.s.="" population="" and="" children="" were="" calculated="" assuming="" concentrations="" at="" the="" mcl="" of="" 100.0="">g/L in drinking water; adult and child body
weights of 70 and 10 kg, respectively; and adult and child drinking
water consumption of 2 and 1 L per day, respectively. Based on these
assumptions, adult exposure was calculated to be 2.9 x 10-3
mg/kg/day, and child exposure to be 1.0 x 10-2 mg/kg/day.
These exposure values correspond to 14.3% of the RfD for adults, and
50.0% of the RfD for children.
3. From non-dietary exposure. Endothall is currently registered for
use on the following residential non-food sites: Granular formulations
of endothall are applied to lakes and ponds that have recreational
uses. Concentrations of endothall ranging from 0.5 to 5 mg/L are used
to control various aquatic weeds.
i. Chronic exposure and risk. Chronic non-dietary exposure is not
expected with this use. Therefore, it is not necessary to conduct a
chronic risk assessment, in association with the non-dietary exposure,
which is expected to be short- and intermediate-term. This risk is
discussed in the following paragraph.
ii. Short- and intermediate-term exposure and risk. The non-dietary
swimmer exposure of a child (1-6 years), while swimming in water
treated with this chemical is estimated as follows: Dermal Exposure =
(Concentration of endothall) x (Surface area of child) x (hours
exposed) x (body weight (kg)). Assumptions were used of 0.5 - 5 mg/L
endothall concentrations in the water, surface area and body weight of
the child 9,000 cm2, and 22 kg, respectively. Based upon
these assumptions, dermal exposure is estimated at a range of 0.0044 to
0.044 mg/kg/day. Oral Exposure = (Concentration of endothall) x
(Ingestion rate of water) x (exposure time) / (body weight(kg)).
Assumptions were 0.05 L/hr ingestion, 5 hr/day exposure time, and 22 kg
bodyweight. Based on these assumptions, oral exposure is estimated at a
range of 0.0057 to 0.057 mg/kg/day. Total Exposure, both dermal and
oral, for a child 1-6 years old, is estimated at 0.01 to 0.1 mg/kg/day.
From these exposure estimates, the MOE for short-term and intermediate-
term exposure is calculated to be a range of 400 to 4,000.
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).
EPA does not have, at this time, available data to determine
whether endothall has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides
[[Page 49929]]
for which EPA has followed a cumulative risk approach based on a common
mechanism of toxicity, EPA cannot at this time determine whether
endothall produces a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has not assumed
that endothall has a common mechanism of toxicity with other
substances.
C. Aggregate Risks and Determination of Safety for U.S. Population
1. Chronic risk. Using the ARC exposure assumptions described
above, EPA has concluded that aggregate exposure to endothall from food
and drinking water will utilize 15.4% of the RfD for the U.S.
population. The major identifiable subgroup with the highest aggregate
exposure is Children 1 to 6 Years Old, 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 endothall 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 acute aggregate exposure to
endothall residues.
2. 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.
Based upon assumptions given above, the MOEs for adults from
exposures contributed by food plus drinking water plus swimming
exposure, range from 384 to 3,033. For children, the MOEs range from
359 to 1,950. Since these MOEs are well above the acceptable level of
100, EPA concludes that there is reasonable certainty that no harm will
result from short- and intermediate-term exposure to endothall
residues.
D. 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 endothall, EPA considered data from
developmental toxicity studies in the rat and rabbit and a two-
generation reproduction study in the rat. The developmental toxicity
studies are designed to evaluate adverse effects on the developing
organism resulting from maternal pesticide exposure during gestation.
Reproduction studies provide information relating to effects from
exposure to the pesticide on the reproductive capability of mating
animals and data on systemic toxicity.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for pre-and post-natal toxicity and the
completeness of the database unless EPA determines that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA risk assessments either directly
through use of a 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 safety factor (usually 100 for combined inter- and intra-species
variability)) and not the additional tenfold 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 study in
rats, the maternal (systemic) NOEL was 12.5 mg/kg/day, based upon
decreased body weight gain at the LOEL of 25.0 mg/kg/day. The
developmental (fetal) NOEL was 25.0 mg/kg/day, the highest dose tested.
iii. Reproductive toxicity study. In the 2-generation reproductive
toxicity study in rats, the parental (systemic) NOEL was not determined
since there were proliferative lesions of the gastric epithelium in
both sexes at the lowest dose tested (2.0 and 2.3 mg/kg/day for males
and females respectively). The developmental/reproductive (pup) NOEL
was 9.4 mg/kg/day, based on decreased pup body weights (both sexes) at
the LOEL of 60.0 mg/kg/day.
iv. Pre- and post-natal sensitivity. The available developmental
and reproductive toxicity data available do not indicate that there are
pre- or post-natal toxicity concerns for infants and children.
v. Conclusion. Based on the currently available developmental and
reproductive toxicity studies discussed above and best scientific
judgment of EPA scientists, there does not appear to be an extra
sensitivity for pre- or post-natal effects, and an additional tenfold
safety factor is not warranted.
2. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that aggregate exposure to endothall
from food and drinking water will utilize 52.1% 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 endothall
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 endothall residues.
3. Short- or intermediate-term risk. Granular formulations of
endothall are applied to lakes and ponds that have recreational uses.
Concentrations of endothall ranging from 0.5 to 5 mg/L are used to
control various aquatic weeds.
Short- and intermediate-term exposure and risk. The non-dietary
swimmer exposure estimate for a child (1-6 years), while swimming in
water treated with this chemical, through both dermal and oral
exposure, results in MOEs from 400 to 4,000 (further discussed above).
V. Other Considerations
A. Metabolism In Plants and Animals
The qualitative nature of the residues of endothall in plants
appears to be adequately understood; the nature of the residue in
animals is adequately understood based on acceptable studies with
lactating goats and laying hens. The residue to be regulated is
endothall per se, as stated in 40 CFR 180.293 .
B. Analytical Enforcement Methodology
Adequate analytical methods are available for tolerance enforcement
in plant commodities ( a GC method with nitrogen detection is available
in the Pesticide Analytical Manual (PAM) Vol. II, as Method I.) No
tolerances have been established for animal commodities, or are
required with this section 18 use; therefore, no analytical methods are
required for livestock commodities.
C. Magnitude of Residues
Residues of endothall are not expected to exceed 0.3 ppm in canola
and in its processed products canola oil and meal, as a result of this
use. Secondary resides are not expected in animal commodities.
D. International Residue Limits
There are no Codex, Canadian, or Mexican Maximum Residue Levels
(MRLs) established for endothall on canola.
[[Page 49930]]
E. Rotational Crop Restrictions
There are no rotational crop restrictions with this use or on the
federal label for endothall.
VI. Conclusion
Therefore, the tolerance is established for residues of endothall
in canola seed at 0.3 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 November 24, 1997, 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
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-300544] (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 (7506C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Hwy., 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 time-limited tolerance under FFDCA
section 408(1)(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 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 Parts 180 and 185
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Food additives, Pesticides and pests,
Reporting and recordkeeping requirements.
[[Page 49931]]
Dated: September 12, 1997.
Daniel Barolo,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. In part 180:
a. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
b. In Sec. 180.293:
i. By designating the existing text as paragraph (a)(1) and adding
a heading to paragraph (a).
ii. By adding paragraph (b).
iii. By adding and reserving paragraphs (c) and (d).
Section 180.293, as amended, reads as follows:
Sec. 180.293 Endothall; tolerances for residues.
(a) General. * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for the residues of the herbicide endothall, 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.................... 0.3 8/31/98
------------------------------------------------------------------------
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
PART 185--[AMENDED]
2. In part 185:
a. The authority citation for part 185 continues to read as
follows:
Authority: 21 U.S.C. 346a and 348.
Sec. 185.2650 [Removed]
b. In Sec. 185.2650:
i. By desginating the existing text as paragraph (a)(2) to
Sec. 180.293.
ii. By removing Sec. 185.2650.
[FR Doc. 97-25236 Filed 9-23-97; 8:45 am]
BILLING CODE 6560-50-F
