[Federal Register Volume 62, Number 168 (Friday, August 29, 1997)]
[Rules and Regulations]
[Pages 45741-45747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23096]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300532; FRL-5738-5]
RIN 2070-AB78
Desmedipham; 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 the
herbicide desmedipham in or on garden beet roots
[[Page 45742]]
and tops. 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 garden beet roots
and tops. This regulation establishes a maximum permissible level for
residues of desmedipham 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 30, 1998.
DATES: This regulation is effective August 29, 1997. Objections and
requests for hearings must be received by EPA on or before October 28,
1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300532], 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-300532], 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-300532]. No Confidential Business Information (CBI) should
be submitted through e-mail. Electronic copies of objections and
hearing requests on this rule may be filed online at many Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Pat Cimino, Registration
Division 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) 308-9357, e-mail:
cimino.pat@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing tolerances for
the herbicide desmedipham, in or on garden beet roots and tops at 0.2
and 15.0 part per million (ppm) respectively. These tolerances will
expire and are revoked on August 30, 1998. EPA will publish a document
in the Federal Register to remove the revoked tolerances from the Code
of Federal Regulations.
I. Background and Statutory Authority
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq . The FQPA amendments went into effect immediately. Among other
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures. These activities are described below and discussed in
greater detail in the final rule establishing the time-limited
tolerance associated with the emergency exemption for use of
propiconazole on sorghum (61 FR 58135, November 13, 1996)(FRL-5572-9).
New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such tolerance to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemption for Desmedipham on Garden Beet Roots and
Tops and FFDCA Tolerances
The New York State Department of Environmental Conservation
requested the use of the herbicide desmedipham (Betanex 1.3 EC) for
postemergence control of hairy galinsoga, redroot pigweed, common
ragweed, common lambsquarters, wild mustard, eastern black nightshade,
hairy nightshade and velvetleaf weeds in red garden beets in New York.
These weeds were controlled by diethatyl-ethyl (Antor); however, this
product was voluntarily canceled in 1993 and existing stocks have been
exhausted. Alternatives do not provide effective control and growers
will experience significant economic losses without the use of
desmedipham. 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 desmedipham in or on
garden beet roots and tops. In doing so, EPA considered the new safety
standard in FFDCA section 408(b)(2), and EPA decided that the necessary
tolerances 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
[[Page 45743]]
non-routine situation and to ensure that the resulting food is safe and
lawful, EPA is issuing these tolerances without notice and opportunity
for public comment under section 408(e), as provided in section
408(l)(6). Although these tolerances will expire and are revoked on
August 30, 1998, under FFDCA section 408(l)(5), residues of the
pesticide not in excess of the amounts specified in the tolerances
remaining in or on garden beet roots and tops 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 these tolerances
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 desmedipham meets EPA's
registration requirements for use on garden beet roots and tops or
whether permanent tolerances for this use would be appropriate. Under
these circumstances, EPA does not believe that these tolerances serve
as a basis for registration of desmedipham by a State for special local
needs under FIFRA section 24(c). Nor do these tolerances serve as the
basis for any State other than New York 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 desmedipham, contact the Agency's
Registration Division at the address provided above.
III. Risk Assessment and Statutory Findings
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. Second,
EPA examines exposure to the pesticide through the diet (e.g., food and
drinking water) and through exposures that occur as a result of
pesticide use in residential settings.
A. Toxicity
1. Threshold and non-threshold effects. For many animal studies, a
dose response relationship can be determined, which provides a dose
that causes adverse effects (threshold effects) and doses causing no
observed effects (the ``no-observed effect level'' or ``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to 10 times more sensitive to pesticides than the
test animals, and that one person or subgroup of the population (such
as infants and children) could be up to 10 times more sensitive to a
pesticide than another. In addition, EPA assesses the potential risks
to infants and children based on the weight of the evidence of the
toxicology studies and determines whether an additional uncertainty
factor is warranted. Thus, an aggregate daily exposure to a pesticide
residue at or below the RfD (expressed as 100% or less of the RfD) is
generally considered acceptable by EPA. EPA generally uses the RfD to
evaluate the chronic risks posed by pesticide exposure. For shorter
term risks, EPA calculates a margin of exposure (MOE) by dividing the
estimated human exposure into the NOEL from the appropriate animal
study. Commonly, EPA finds MOEs lower than 100 to be unacceptable. This
100-fold MOE is based on the same rationale as the 100-fold uncertainty
factor.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short-term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low dose
extrapolations or MOE calculation based on the appropriate NOEL) will
be carried out based on the nature of the carcinogenic response and the
Agency's knowledge of its mode of action.
2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity data base, and based on
the effects seen for different durations and routes of exposure,
determines which risk assessments should be done to assure that the
public is adequately protected from any pesticide exposure scenario.
Both short and long durations of exposure are always considered.
Typically, risk assessments include ``acute'', ``short-term'',
``intermediate term'', and ``chronic'' risks. These assessments are
defined by the Agency as follows.
Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
High end exposure to food and water residues are typically assumed.
Short-term risk results from exposure to the pesticide for a period
of 1-7 days, and therefore overlaps with the acute risk assessment.
Historically, this risk assessment was intended to address primarily
dermal and inhalation exposure which could result, for example, from
residential pesticide applications. However, since enaction of FQPA,
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from
food, water, and residential uses when reliable data are available. In
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. 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
[[Page 45744]]
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
desmedipham and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for time-limited tolerances for
desmedipham on garden beet roots and tops at 0.2 and 15.0 ppm
respectively. EPA's assessment of the dietary exposures and risks
associated with establishing the tolerances 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 desmedipham are
discussed below.
1. Acute toxicity. For acute dietary risk assessment, the Agency
recommended use of the NOEL of 150 mg/kg/day, based on slight increase
in skeletal variations in developing pups at the lowest effect level
(LEL) of 450 mg/kg/day, from the developmental study in rabbits. This
NOEL is used to evaluate the Margin of Exposure (MOE) from the acute
dietary risk to pregnant women (females 13+ years or older).
2. Short - and intermediate - term toxicity. No short- or
intermediate-term non-dietary, non-occupational exposure scenario
exists for desmedipham.
3. Chronic toxicity. EPA has established the RfD for desmedipham at
0.04 milligrams/kilogram/day (mg/kg/day). This RfD is based on a
reproduction study in rats with a NOEL of 4 mg/kg/day and an
uncertainty factor of 100. The effects observed at the LEL of 20 mg/kg/
day were significant increases in splenic weights and compensatory
functioning of the thyroid.
4. Carcinogenicity. Cancer risks have not been identified by the
Agency. Desmedipham has been classified as a Group ``E'' chemical, no
evidence of carcinogenicity, based on the results from two acceptable
studies with two species.
B. Exposures and Risks
1. From food and feed uses. A permanent tolerance of 0.2 ppm has
been previously established (40 CFR 180.353) for negligible residues of
the herbicide desmedipham, in or on sugar beet roots and tops. Risk
assessments were conducted by EPA to assess dietary exposures and risks
from desmedipham 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 dietary exposure endpoint of
concern for desmedipham is a slight increase in skeletal variations in
developing pups which was observed in the rabbit developmental study.
The population subgroup of concern is females 13+ years old (women of
childbearing age). Acute dietary exposure (food only) was calculated
using the high end exposure value and TMRC (worst case) assumptions.
Therefore, this risk assessment is considered conservative. Despite the
potential for acute exposure to desmedipham in drinking water, EPA does
not expect the aggregate acute exposure to exceed the Agency's level of
concern.
ii. Chronic exposure and risk. In conducting exposure assessments
for this section 18 request, EPA used tolerance level residues and
assumed that 100% of the crop would be treated with the pesticide (TMRC
worst-case analysis assumptions, as described above).
2. From drinking water. Based on information from the Weed Science
Society Handbook (7th ed., 1994), desmedipham has the following
environmental fate characteristics: 1) soluble in water to the extent
of 7 mg/L at 20 C and pH 7; 2) half-life of 1 month in silty
loam, sandy loam, and silty clay loam soils; and 3) exhibits no
appreciable leaching with residues remaining in the top 2 inches of
soil.
No Maximum Concentration Level or Health Advisory Level has been
established for residues of desmedipham in drinking water. There is no
entry for desmedipham in the ``Pesticides in Groundwater Database''
(EPA 34-12-92-001, Sept. 1992).
Because the Agency lacks sufficient water-related exposure data to
complete a comprehensive drinking water risk assessment for many
pesticides, EPA has commenced and nearly completed a process to
identify a reasonable yet conservative bounding figure for the
potential contribution of water-related exposure to the aggregate risk
posed by
[[Page 45745]]
a pesticide. In developing the bounding figure, EPA estimated residue
levels in water for a number of specific pesticides using various data
sources. The Agency then applied the estimated residue levels, in
conjunction with appropriate toxicological endpoints (RfD's or acute
dietary NOEL's) and assumptions about body weight and consumption, to
calculate, for each pesticide, the increment of aggregate risk
contributed by consumption of contaminated water. While EPA has not yet
pinpointed the appropriate bounding figure for exposure from
contaminated water, the ranges the Agency is continuing to examine are
all below the level that would cause desmedipham to exceed the RfD if
the tolerances being considered in this document were granted. The
Agency has therefore concluded that the potential exposures associated
with desmedipham 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
tolerances are granted.
3. From non-dietary exposure. Non-dietary, non-occupational
exposure is not expected because desmedipham is not registered for
indoor or outdoor residential uses.
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 desmedipham 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,
desmedipham 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 desmedipham 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 US population subgroup of concern, pregnant
females (13+ years of age), an MOE value of 375,000 was calculated
using the high end human exposure value of 0.0004 mg/kg/day. The Agency
generally considers MOEs over 100 (food only) acceptable. This acute
dietary (food only) risk assessment used tolerance level residues and
assumed 100% crop-treated (TMRC worst-case analysis, described above).
Despite the potential for risk from acute exposure to desmedipham
in drinking water, the Agency does not expect acute aggregate exposure
to exceed its level of concern. EPA concludes that there is a
reasonable certainty that no harm will result from acute aggregate
exposure to desmedipham.
2. Chronic risk. Using the TMRC exposure assumptions described
above, EPA has concluded that aggregate exposure to desmedipham from
food will utilize less than 1.0% of the RfD for the U.S. population.
Aggregate exposure to desmedipham from food utilizes less than 1% of
the RfD for all major identifiable subgroups, including infants and
children. EPA generally has no concern for exposures below 100% of the
RfD because the RfD represents the level at or below which daily
aggregate dietary exposure over a lifetime will not pose appreciable
risks to human health.
Despite the potential for exposure to desmedipham 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
exposure to desmedipham residues.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential exposure. Because no short- or intermediate-term non-
dietary, non-occupational exposure scenario exists for desmedipham, a
short- or intermediate-term aggregate risk assessment is not required.
E. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children-- a. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of desmedipham, 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
[[Page 45746]]
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.
b. Developmental toxicity studies-- i. Rat developmental toxicity.
The maternal (systemic) NOEL was 100 mg/kg/day, based on decreased
weight gain at the lowest observed effect level (LOEL) of 1,000 mg/kg/
day. The developmental (pup) NOEL was 100 mg/kg/day, based on decreased
fetal body weight and increased incidence of skeletal anomalies at the
LOEL of 1,000 mg/kg/day.
ii. Rabbit developmental toxicity. The maternal (systemic) NOEL was
150 mg/kg/day, based on decreased weight gain at the LOEL of 450 mg/kg/
day. The developmental (pup) NOEL was 150 mg/kg/day, based on a slight
increase in skeletal variations at the LEL of 450 mg/kg/day.
c. Reproductive toxicity study-- Rat reproduction toxicity. The
maternal (systemic) NOEL was 4 mg/kg/day, based on decreased body
weight and hemolytic anemia at the LOEL of 20 mg/kg/day. The
reproductive/developmental (pup) NOEL was 4 mg/kg/day, based on
decreased pup body weight and reduced litter size at the LEL of 20 mg/
kg/day.
d. Pre- and post-natal sensitivity. In the rat and rabbit
developmental studies, both the developmental and maternal NOELs and
LOELs (100 and 1,000 mg/kg/day for rats and 150 and 450 mg/kg/day for
rabbits), respectively, occurred at the same dose levels which
demonstrates that there is no special pre-natal sensitivity in infants
and children exposed to desmedipham.
In the rat reproductive study, both the pup and parental NOEL and
LOEL of 4 and 20 mg/kg/day, respectively, occurred at the same dose
level which demonstrates that there is no special post-natal
sensitivity in infants and children exposed to desmedipham.
e. Conclusion. The Agency concluded that the developmental and
reproductive findings in rats did not demonstrate any pre-natal or
post-natal acute risk concerns for infants and children.
The Agency concluded that the observed developmental effects in the
rabbit study, a slight increase in skeletal variations in developing
pups, presents a pre-natal acute risk concern for infants and children.
An acute dietary risk assessment evaluating margin of exposure (MOE)
for pregnant women 13+ years or older is required when the Agency
determines that there is a pre- or post- natal acute risk effect of
concern.
2. Acute risk. As described above, the acute dietary MOE for
pregnant women 13+ years old is 375,000 based on the rabbit
developmental NOEL of 150 mg/kg/day and the high end human exposure
value of 0.0004 mg/kg/day. This MOE is much higher than the minimal
acceptable MOE of 100 for acute exposure to food. Despite the potential
for acute exposure to desmedipham in drinking water, the Agency does
not expect acute aggregate exposure to exceed its level of concern. EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from acute aggregate exposure to desmedipham.
3. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that aggregate chronic exposure to
desmedipham from food will utilize less than 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 chronic exposure to
desmedipham in drinking water, EPA does not expect the aggregate
exposure to exceed 100% of the RfD. EPA concludes that there is a
reasonable certainty that no harm will result to infants and children
from chronic aggregate exposure to desmedipham residues.
4. Short- or intermediate-term risk. Because no short- or
intermediate-term non-dietary, non-occupational scenario exists for
desmedipham, a short- or intermediate-term aggregate risk assessment is
not required.
V. Other Considerations
A. Metabolism In Plants and Animals
The qualitative nature of the desmedipham residue in plants is
adequately understood. The residue of concern is desmedipham per se.
B. Analytical Enforcement Methodology
A desmedipham-specific analytical method (HPLC UV/VIS) is available
for enforcement.
C. Magnitude of Residues
Residues of desmedipham are not expected to exceed 0.2 ppm in
garden beet roots and 15.0 ppm in garden beet tops (leaves) as a result
of this Section 18 use. Secondary residues of desmedipham are not
expected in animal commodities as no livestock feed items are
associated with this Section 18 use.
D. International Residue Limits
There are no Codex, Canadian, or Mexican international residue
limits established for use of desmedipham on red (garden) beets.
VI. Conclusion
Therefore, the tolerances are established for desmedipham in garden
beet roots and tops at 0.2 and 15.0 ppm respectively.
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 October 28, 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
[[Page 45747]]
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-300532] (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 tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does
it require any prior consultation as specified by Executive Order
12875, entitled Enhancing the Intergovernmental Partnership (58 FR
58093, October 28, 1993), or special considerations as required by
Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), or require OMB review in
accordance with Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997).
In addition, since these tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408 (d),
such as the tolerances 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 acations published on May
4, 1981 (46 FR 24950), and was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
X. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted a
report containing this rule and other required information to the U.S.
Senate, the U.S. House of Representatives, and the Comptroller General
of the General Accounting Office prior to publication of this rule in
today's Federal Register. This is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: August 13, 1997.
James Jones,
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 180.353 is amended to read as follows:
a. By designating the existing text as paragraph (a) and adding a
heading.
b. By adding paragraph (b).
c. By adding the headings and reserving paragraphs (c) and (d).
The added text reads as follows:
Sec. 180.353 Desmedipham; tolerances for residues.
(a) General . * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the herbicide desmedipham in connection
with use of the pesticide under section 18 emergency exemptions granted
by EPA. The tolerances will expire and are revoked on the date
specified in the following table:
------------------------------------------------------------------------
Expiration/
Commodity Parts per revocation
million date
------------------------------------------------------------------------
Garden beet roots............................. 0.2 8/30/98
Garden beet tops.............................. 15.0 8/30/98
------------------------------------------------------------------------
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 97-23096 Filed 8-28-97; 8:45 am]
BILLING CODE 6560-50-F
