[Federal Register Volume 63, Number 37 (Wednesday, February 25, 1998)]
[Rules and Regulations]
[Pages 9435-9441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4793]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300607; FRL-5767-6]
RIN 2070-AB78
Thiabendazole; 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 thiabendazole in or on lentils. 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 lentils. This regulation establishes a maximum
permissible level for residues of thiabendazole in this food commodity
[[Page 9436]]
pursuant to section 408(l)(6) of the Federal Food, Drug, and Cosmetic
Act, as amended by the Food Quality Protection Act of 1996. The
tolerance will expire and is revoked on October 31, 1998.
DATES: This regulation is effective February 25, 1998. Objections and
requests for hearings must be received by EPA on or before April 27,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300607], 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-300607], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 119, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: [email protected]. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1
or ASCII file format. All copies of objections and hearing requests in
electronic form must be identified by the docket control number [OPP-
300607]. 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:
[email protected].
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing a tolerance for
residues of the fungicide thiabendazole, in or on lentils at 0.1 part
per million (ppm). This tolerance will expire and is revoked on October
31, 1998. EPA will publish a document in the Federal Register to remove
the revoked tolerance from the Code of Federal Regulations.
I. Background and Statutory Authority
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. The FQPA amendments went into effect immediately. Among other
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures. These activities are described below and discussed in
greater detail in the final rule establishing the time-limited
tolerance associated with the emergency exemption for use of
propiconazole on sorghum (61 FR 58135, November 13, 1996) (FRL 5572-9).
New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance the legal limit for a pesticide chemical residue in or on a
food only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue.''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without 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 Thiabendazole on Lentils and FFDCA
Tolerances
The Applicants state that the ascochyta blight fungus is relatively
newly occurring in the U.S., and presently available fungicides do not
adequately control its spread in lentils, to prevent significant
economic loss. Additionally, the Applicants state that a recently
discovered strain which reproduces sexually is of even greater concern,
as this sexual stage releases spores, capable of traveling long
distances on the wind. This disease was initially of isolated
occurrence in the United States until the last several years. The
sexual strain has potential to lead to significant widespread infection
of lentils. The previously known asexual strain resulted mainly in
localized infections, being spread only through direct contact or
waterborne splash. The Applicants stated that without the requested use
of thiabendazole to control this disease, significant economic losses
would occur. EPA has authorized under FIFRA section 18 the crisis
provisions the use of thiabendazole on lentils for control of ascochyta
blight in Idaho, Washington, and North Dakota. After having reviewed
the submission, EPA concurs that emergency conditions exist for these
states.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of thiabendazole in or on
lentils. 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.
[[Page 9437]]
Consistent with the need to move quickly on the emergency exemption in
order to address an urgent non-routine situation and to ensure that the
resulting food is safe and lawful, EPA is issuing this tolerance
without notice and opportunity for public comment under section 408(e),
as provided in section 408(l)(6). Although this tolerance will expire
and is revoked on October 31, 1998, under FFDCA section 408(l)(5),
residues of the pesticide not in excess of the amounts specified in the
tolerance remaining in or on lentils after that date will not be
unlawful, provided the pesticide is applied in a manner that was lawful
under FIFRA, and the residues do not exceed a level that was authorized
by this tolerance at the time of that application. 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 thiabendazole meets EPA's
registration requirements for use on lentils 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 thiabendazole 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 Idaho, Washington, and North Dakota to use this
pesticide on this crop under section 18 of FIFRA without following all
provisions of section 18 as identified in 40 CFR part 166. For
additional information regarding the emergency exemption for
thiabendazole, 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 percent 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 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.)
[[Page 9438]]
Intermediate-term risk results from exposure for 7 days to several
months. This assessment is handled in a manner similar to the short-
term risk assessment.
Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated considering average exposure from all sources for
representative population subgroups including infants and children.
B. Aggregate Exposure
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, residues in groundwater
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). Dietary exposure to
residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an
estimate of the level of residues consumed daily if each food item
contained pesticide residues equal to the tolerance. In evaluating food
exposures, EPA takes into account varying consumption patterns of major
identifiable subgroups of consumers, including infants and children.
The TMRC is a ``worst case'' estimate since it is based on the
assumptions that food contains pesticide residues at the tolerance
level and that 100% of the crop is treated by pesticides that have
established tolerances. If the TMRC exceeds the RfD or poses a lifetime
cancer risk that is greater than approximately one in a million, EPA
attempts to derive a more accurate exposure estimate for the pesticide
by evaluating additional types of information (anticipated residue data
and/or percent of crop treated data) which show, generally, that
pesticide residues in most foods when they are eaten are well below
established tolerances.
Percent of crop treated estimates are derived from federal and
private market survey data. Typically, a range of estimates are
supplied and the upper end of this range is assumed for the exposure
assessment. By using this upper end estimate of percent of crop
treated, the Agency is reasonably certain that exposure is not
understated for any significant subpopulation group. Further, regional
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations
including several regional groups, to pesticide residues. For this
pesticide, the most highly exposed population subgroup non-nursing
infants < 1 year old was not regionally based.
IV. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action, EPA has sufficient data to assess the hazards of
thiabendazole and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerance for
residues of thiabendazole in or on lentils at 0.1 ppm. EPA's assessment
of the dietary exposures and risks associated with establishing the
tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by thiabendazole are
discussed below.
1. Acute toxicity. EPA has not yet established a toxicological
endpoint for acute toxicity.
2. Short- and intermediate- term toxicity. For the purposes of this
section 18 action the EPA has determined that short- and intermediate-
term toxicity risk assessments are not required.
3. Chronic toxicity. EPA has not established the RfD for
thiabendazole. However, for the purposes of this section 18 use, a RfD
was calculated at 0.035 milligrams/kilogram/day (mg/kg/day), based on a
human study, using 77 normal adult males, half of whom received a
placebo, and half of whom received thiabendazole in a double blind
manner, in divided doses over a 24 week period, at 250 mg daily. The
daily doses were well-tolerated, and there were no side reactions,
laboratory findings, or changes in physical findings related to the
drug intake during the study. At an estimated body weight of 70 kg,
this NOEL dose would be 3.5 mg/kg/day. Using an uncertainty factor of
10 to account for intraspecies differences and an additional factor of
10 due to data gaps, the provisional RfD is calculated to be 0.035 mg/
kg/day.
4. Carcinogenicity. There is no identifiable cancer risk associated
with exposure to thiabendazole because adequate studies are not
available. In 1993, the registrant submitted information under section
6(A)(2) of FIFRA, concerning increased incidence of benign thyroid
adenomas coupled with focal cystic follicular hyperplasia at the mid-
and high-dose levels in a 2-year rat feeding study. Review of the data
identified no concerns for carcinogenicity since the benign tumors
occurred at levels well above the RfD, and since exposure to
thiabendazole is expected to be short, less than 1-year.
B. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.242) for the residues of thiabendazole, in or on a variety of
raw agricultural commodities, ranging from 0.02 ppm in sweet potatoes
(for seed) to 150 ppm in grape pomace. Tolerances have also been
established for thiabendazole and its metabolite 5-hydroxythiabendazole
at 0.4 ppm in milk, 0.1 ppm in eggs, and 0.1 ppm in meat, fat, and meat
byproducts of livestock and poultry. Risk assessments were conducted by
EPA to assess dietary exposures and risks from thiabendazole 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. Since there have been no toxicological
endpoints identified for acute exposure to thiabendazole, an acute risk
assessment was not conducted.
ii. Chronic exposure and risk. In conducting this chronic dietary
risk assessment, refinements were used including anticipated residue
levels for oranges and apples, and percent of crop treated information
for grapefruit, lemons, oranges, and apples. The ARC is equivalent to
the following percentages of the RfD: overall U.S. population, 26.5;
nursing infants, 39.4; non-nursing infants, 83.1; children 1-6 years
old, 60.9; children 7-12 years old, 39.3; hispanics, 27.1; and non-
hispanic whites, 27.2.
2. From drinking water. Based on available information,
thiabendazole is persistent in the environment, but not mobile. There
are no established Maximum Contaminant or Health Advisory Levels for
thiabendazole in drinking water.
Because the Agency lacks sufficient water-related exposure data to
complete
[[Page 9439]]
a comprehensive drinking water risk assessment for many pesticides, EPA
has commenced and nearly completed a process to identify a reasonable
yet conservative bounding figure for the potential contribution of
water-related exposure to the aggregate risk posed by a pesticide. In
developing the bounding figure, EPA estimated residue levels in water
for a number of specific pesticides using various data sources. The
Agency then applied the estimated residue levels, in conjunction with
appropriate toxicological endpoints (RfD's or acute dietary NOEL's) and
assumptions about body weight and consumption, to calculate, for each
pesticide, the increment of aggregate risk contributed by consumption
of contaminated water. While EPA has not yet pinpointed the appropriate
bounding figure for exposure from contaminated water, the ranges the
Agency is continuing to examine are all below the level that would
cause thiabendazole 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 thiabendazole 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. Thiabendazole is currently registered
for use on the following residential non-food sites: ornamental bulbs
and turf; stored textiles, fabrics, and fibers; as a preservative/
additive to adhesives, paints, paper, and plastic products; laundry
equipment; and bathroom premises. However, due to the absence of
toxicological endpoints for short, intermediate, and chronic exposure
scenarios and sufficient residential-related quantitative exposure
data, a comprehensive aggregate risk assessment of residential exposure
is not possible at this time.
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).
Thiabendazole is a member of the benzimidazole class of pesticides;
however, EPA does not have, at this time, available data to determine
whether thiabendazole 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,
thiabendazole 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 thiabendazole has a common mechanism of
toxicity with other substances.
C. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. An acute dietary toxicological endpoint has not been
identified for thiabendazole, and therefore an acute aggregate risk
assessment was not conducted.
2. Chronic risk. Using the ARC exposure assumptions described
above, EPA has concluded that aggregate exposure to thiabendazole from
food will utilize 26.5% of the RfD for the U.S. population. The major
identifiable subgroup with the highest aggregate exposure is non-
nursing infants < 1 year 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 thiabendazole 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 thiabendazole 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 a pesticide, EPA generally considers 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 MOE
and uncertainty factor (usually 100 for combined inter- and intra-
species
[[Page 9440]]
variability)) and not the additional tenfold MOE/uncertainty factor
when EPA has a complete database 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. Pre- and post-natal sensitivity. The toxicology database for
evaluating pre- and post-natal toxicity for thiabendazole is incomplete
with respect to current data requirements. Based on this, EPA concludes
that lack of reliable data support use of an additional margin/factor
of 10; this additional factor was included in the analyses described
above.
iii. Conclusion. Due to the toxicology data gaps described above,
an additional tenfold uncertainty factor was used in conducting this
risk assessment for thiabendazole.
2. Acute risk. Although there is potential for exposure to
thiabendazole through drinking water, EPA does not expect that exposure
would result in aggregate MOEs (food plus water) that would exceed
levels of concern for acute dietary exposure.
3. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that aggregate exposure to
thiabendazole from food will utilize 83% 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
thiabendazole 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
thiabendazole residues.
V. Other Considerations
A. Metabolism in Plants and Animals
The nature of the residues of thiabendazole in plants and animals
is adequately understood. For the purposes of this section 18 use, the
residues are as set forth in 40 CFR 180.242: the residue for plants is
the parent, thiabendazole; for animal commodities, the residues of
concern are thiabendazole and its metabolite 5-hydroxythiabendazole.
B. Analytical Enforcement Methodology
Adequate enforcement methodology, spectrophotofluorometric,
detection for thiabendazole is available in PAM II Method I.
C. Magnitude of Residues
Residues of thiabendazole are not expected to exceed 0.1 ppm in or
on lentils as a result of this section 18 use. Secondary residues are
not expected to result in animal commodities from this use, since no
feed items are associated with lentils.
D. International Residue Limits
There are no Codex proposals, Canadian, or Mexican limits for
thiabendazole in or on lentils.
E. Rotational Crop Restrictions
Since this section 18 use is a seed treatment, rotational crop
restrictions are not a concern.
VI. Conclusion
Therefore, the tolerance is established for residues of
thiabendazole in or on lentils at 0.1 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 April 27, 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 Docket
EPA has established a record for this rulemaking under docket
control number [OPP-300607] (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 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments may be sent directly to EPA at:
[email protected].
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper
[[Page 9441]]
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: February 6, 1998.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.242 is amended by adding text to paragraph (b) to
read as follows:
Sec. 180.242 Thiabendazole; tolerances for residues.
(a) General . * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for the residues of thiabendazole, in connection with use
of the pesticide under section 18 emergency exemptions granted by EPA.
The tolerances are specified in the following table. The tolerances
will expire on the dates specified in the table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Lentils......................... 0.1 10/31/98
------------------------------------------------------------------------
* * * * *
[FR Doc. 98-4793 Filed 2-24-98; 8:45 am]
BILLING CODE 6560-50-F