dicloran Pesticide Tolerances for Emergency Exemptions 12/97
[Federal Register: January 5, 1998 (Volume 63, Number 2)]
[Rules and Regulations]
[Page 156-162]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05ja98-6]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300596; FRL-5762-4]
RIN 2070-AB78
Dicloran; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a time-limited tolerance for
residues of dicloran, 2,6-dichloro-4-nitroaniline in or on peanuts.
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 peanuts. This regulation
establishes a maximum permissible level for residues of dicloran 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, 1999.
DATES: This regulation is effective January 5, 1998. Objections and
requests for hearings must be received by EPA on or before March 6,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300596], 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-300596], 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
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-300596]. 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:
dietrich.virginia@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 fungicide, dicloran, 2,6-dichloro-4-nitroaniline, in or
on peanuts at 3 part per million (ppm) for peanuts and 6 ppm for peanut
oil. This tolerance will expire and is revoked on October 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
[[Page 157]]
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 dicloran on peanuts and FFDCA
Tolerances
The Oklahoma Department of Agriculture requested a specific
exemption for the use of dicloran on peanuts due to the high rainfall
and corresponding high fungal disease incidence in Oklahoma this year.
After having reviewed the submission, EPA has authorized under FIFRA
section 18 the use of dicloran on peanuts for control of Sclerotinia
blight in Oklahoma.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of dicloran in or on peanuts.
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, 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 peanuts
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 dicloran meets EPA's
registration requirements for use on peanuts 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 dicloran 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 Oklahoma 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 dicloran, 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
hundredfold MOE is based on the same rationale as the hundredfold
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
[[Page 158]]
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 three 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 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 dicloran
and to make a determination on aggregate exposure, consistent with
section 408(b)(2), for a time-limited tolerance for residues of 2,6-
dichloro-4-nitroaniline on peanuts at 3 ppm for peanuts and 6 ppm for
peanut oil. 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 dicloran are
discussed below.
1. Acute toxicity. No acute dietary toxicity (risk) endpoints have
been identified at this time for Dicloran (dichloronitroaniline; DCNA).
Therefore, this assessment is not required.
2. Short - and intermediate - term toxicity. No short- or
intermediate-term toxicity end points were found to be appropriate by
the Agency's Ad Hoc Toxcity Endpoint Selection Committee (AHTESC).
3. Chronic toxicity. For dietary risk, EPA has established the
Reference dose (RfD) for dicloran at 0.025 milligrams/kilogram/day (mg/
kg/day). This RfD is based on a 2-year feeding study in dogs with a
NOEL of 2.5 mg/kg/day and an uncertainty factor of 100. The lowest
observed effect level (LOEL) is based on increased liver weights and
histological changes at 75.0 mg/kg/day. The Agency also determined that
a chronic toxicity endpoint and risk assessment for dicloran is not
required since the use of dicloran on a short-term basis for this
emergency exemption does not present a chronic occupational exposure
scenario.
4. Carcinogenicity. Dicloran has not been classified by the Cancer
Peer Review Committee. However, no cancer risks have been identified in
either the mouse or the rat study by the Agency's Ad Hoc Toxicity
Endpoint Selection Committee.
B. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.200) for the residues of 2,6-dichloro-4-nitroaniline, in or on
a variety of raw agricultural commodities at levels ranging from 0.1
ppm in cottonseed to 20 ppm in several fruits. Risk assessments were
conducted by EPA to assess dietary exposures and risks from dicloran 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. After reviewing data available on the
acute toxicity of dicloran, the Agency concluded that no such
toxicological endpoint of concern was demonstrated. The Agency further
concluded that a risk assessment for this endpoint was not necessary.
ii. Chronic exposure and risk. In conducting this chronic dietary
risk assessment, the Agency has made
[[Page 159]]
conservative assumptions -- 100% of the peanuts treated. For most other
commodities having Dicloran tolerances, anticipated residues from
monitoring data were utilized. For several crops where it appears that
no registrations exist, tolerance levels were used even though zero may
have been more appropriate. Even though monitoring data were used for a
number of commodities, the risk assessment still results in an
overestimation of human dietary exposure. Thus, in making a safety
determination for this tolerance, the Agency is taking into account
this conservative exposure assessment.
The existing Dicloran tolerances (published, pending, and including
the necessary section 18 tolerance(s)) result in an Anticipated Residue
Contribution (ARC) that is equivalent to the following percentages of
the RfD:
------------------------------------------------------------------------
Percentage
Subgroups of RFD
------------------------------------------------------------------------
U.S. Population (48 States)................................ 2.6
Nursing Infants (< 1 year old)............................. 7.1
Non-Nursing Infants (< 1 year old)......................... 11.3
Children (1-6 years old)................................... 5.6
Children (7-12 years old).................................. 3.7
------------------------------------------------------------------------
2. From drinking water. Based on information in the Agency's files,
Dicloran is persistent and somewhat mobile. There are no established
Maximum Contaminant Levels for residues of Dicloran in drinking water.
No health advisory levels for Dicloran in drinking water have been
established.
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
consumption of contaminated water, the ranges the Agency is continuing
to examine are all well below the level that would cause Dicloran 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 Dicloran 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. Dicloran currently has no registered
uses on residential non-food sites. Therefore, there is no residential
non-food exposure.
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 dicloran 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,
dicloran 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 dicloran has a common mechanism of toxicity
with other substances.
C. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. The Agency's Ad Hoc Toxicity Selection Committee
(TESC) did not identify an acute dietary end point for dicloran and
determined that this risk assessment is not appropriate.
2. Chronic risk. Using the ARC exposure assumptions described
above, EPA has concluded that aggregate exposure to dicloran from food
will utilize 2.6% of the RfD for the U.S. population. The major
identifiable subgroup with the highest aggregate exposure is non-
nursing infants which is 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 dicloran in drinking water, EPA does not
expect the aggregate exposure to exceed 100% of the RfD. EPA concludes
that there is a reasonable certainty that no harm will result from
aggregate exposure to dicloran residues.
3. Short- and intermediate-term risk. The ad hoc TESC determined
that there are no short term or intermediate term toxicological
endpoints. Additionally, the ad hoc TESC has determined that there are
no non-dietary, non-occupational, i.e. residential uses registered for
Dicloran. Therefore no short term or intermediate term aggregate
exposure assessments were conducted.
D. Aggregate Cancer Risk for U.S. Population
The Cancer Peer Review Committee has not reviewed or classified
Dicloran
[[Page 160]]
as to its cancer potential. However, no carcinogenicity potential has
been identified in either the long term mouse or rat studies.
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 dicloran, 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. In the developmental study in
rats, the maternal (systemic) NOEL was 100 mg/kg/day, based on CNS
depression at the LOEL of 200 mg/kg/day. The developmental (fetal) NOEL
was 100 mg/kg/day, based on decreased body weight, skeletal variations
and visceral variations at the LOEL of 200 mg/kg/day. In the
developmental (feeding) toxicity study in rabbits, the maternal
(systemic) NOEL was 1,000 ppm which was equivalent to 30 mg/kg/day, the
highest dose tested. The developmental (pup) NOEL was 30 mg/kg/day. The
reproductive (pup) NOEL was 30 mg/kg/day, the highest dose tested.
iii. Reproductive toxicity study. In the 3 generation (single dose)
reproductive toxicity study in rats, the maternal (systemic) NOEL was
100 ppm which was equivalent to 5.0 mg/kg/day. The developmental (pup)
NOEL was 5.0 mg/kg/day. The reproductive (pup) NOEL was 5.0 mg/kg/day.
iv. Pre- and post-natal sensitivity. The toxicological data base
for evaluating pre- and post-natal toxicity for DCNA is not complete
with respect to the current data requirements. However, there are no
pre- or post-natal toxicity concerns for infants and children, based on
the results of the available rat and rabbit developmental toxicity
studies and the three generation rat reproductive study. The NOEL for
maternal and developmental toxicity are at the same dose level in rat
and rabbit. This indicates no extra pre-natal sensitivity for infants
and children. The request for a rabbit gavage study to replace the
dietary developmental study does not suggest any extra pre-natal
sensitivity is present in the current study but is required to fulfill
current guideline requirements. The current three generation rat
reproduction study demonstrated no additional pre- or post-natal extra
sensitivity for infants and children since the maternal reproductive
and developmental NOELs occurred at the same dose levels. The
replacement study is being requested to fulfill current guideline
requirements (e.g. for the reproduction study, a study testing two
generations and three doses is being conducted). Based on the
developmental and reproductive studies discussed above for DCNA there
does not appear to be an extra sensitivity for pre- and post-natal
effects.
v. Conclusion. Based on the above EPA concludes that the available
data support use of the standard hundredfold margin of exposure/
uncertainty factor and that an additional factor/margin of safety is
not needed to protect infants and children.
2. Acute risk. The ad hoc TESC did not identify an acute dietary
end point for DCNA and determined that this risk assessment is not
required. Therefore no aggregate acute risk assessment was performed.
The Agency acknowledges the potential for exposure to Dicloran in
drinking water, but does not expect that exposure would result in
aggregate MOEs (food plus water) that would exceed the Agency's level
of concern for acute dietary exposure.
3. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that aggregate exposure to dicloran
from food will utilize from 11.3% for non-nursing infants less than 1
year old, to 5.6% for children 1-6 years 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 dicloran
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 dicloran residues.
4. Short- or intermediate-term risk. The Agency's ad hoc TESC
determined that there are no short term or intermediate term
toxicological endpoints. Additionally, the ad hoc TESC has determined
that there are no non-dietary, non-occupational, i.e. residential, uses
registered for Dicloran. Therefore no short term or intermediate term
aggregate exposure assessments were conducted.
V. Other Considerations
A. Metabolism In Plants and Animals
For this section 18 request only, the nature of the residue in
plants is adequately understood. The residue of concern is the parent
compound 2,6-dichloro-4-nitroanaline as specified in 40 CFR 180.200.
B. Analytical Enforcement Methodology
Adequate enforcement methodology is available in PAM II to enforce
the tolerance expression.
C. Magnitude of Residues
Residues of Dicloran are not expected to exceed 3.0 ppm in/on
peanuts or 6.0 ppm in its processed byproducts peanuts, oil as a result
of this section 18 use. A time-limited tolerance should be established
at this level. Secondary residues are not expected in animal
commodities as no feed items are associated with this section 18 use.
D. International Residue Limits
There are no CODEX, Canadian or Mexican limits for Dicloran on
peanuts.
E. Rotational Crop Restrictions.
The planting of spinach is restricted as a follow-up crop to
onions, garlic and shallots, and the planting of tomatoes is restricted
as a follow-up crop to sweet potatoes.
VI. Conclusion
Therefore, the tolerance is established for residues of 2,6-
dichloro-4-
[[Page 161]]
nitroaniline in peanuts at 3 ppm for peanuts and 6 ppm for peanut oil.
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 March 6, 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
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 Record and Electronic Submissions
EPA has established a record for this rulemaking under docket
control number [OPP-300596] (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 action finalizes a tolerance under FFDCA section 408(e). The
Office of Management and Budget (OMB) has exempted these types of
actions from review under Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993). In addition, this
final rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4). Nor does it require any prior consultation as
specified by Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or
special considerations as required by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994),
or require special 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, under the Regulatory Flexibility Act (RFA) (5 U.S.C.
601 et seq.), the Agency 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 Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: December 17, 1997.
James Jones
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.200, by revising the section heading, designating
the existing text as paragraph (a), adding a paragraph heading,
designating the text following the heading as paragraph (a)(1),
[[Page 162]]
designating the text following the table as paragraph (a)(2), and by
adding paragraph (b), and by adding and reserving paragraphs (c) and
(d) with headings to read as follows:
Sec. 180.200 Dicloran; tolerances for residues.
(a) General. (1) * * *
(2) * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for combined residues of the fungicide, dicloran, 2,6-
dichloro-4-nitroaniline in connection with use of the pesticide under
section 18 emergency exemptions granted by EPA. The tolerances will
expire and are revoked on the dates specified in the following table.
------------------------------------------------------------------------
Parts per Expiration/
Commodity million Revocation Date
------------------------------------------------------------------------
Peanut, oil............................. 6.0 10/31/99
Peanuts................................. 3.0 10/31/99
------------------------------------------------------------------------
(c) Tolerances with regional registrations. Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 98-73 Filed 1-2-98; 8:45 am]
BILLING CODE 6560-50-F
Disclaimer: Please read
the pesticide label prior to use. The information contained at this web
site is not a substitute for a pesticide label. Trade names used herein
are for convenience only; no endorsement of products is intended, nor is
criticism of unnamed products implied. Most of this information is historical
in nature and may no longer be applicable.
To Top
For more information relative to pesticides and their use in New York State, please contact the PMEP staff at:
| |
5123 Comstock Hall
Cornell University
Ithaca, NY 14853-0901
(607) 255-1866
|
|
 |
This site is supported, in part, by funding from the
 |
Questions regarding the development of this web site should be directed to the
PMEP Webmaster
