[Federal Register Volume 62, Number 185 (Wednesday, September 24, 1997)]
[Rules and Regulations]
[Pages 49931-49937]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25235]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180, 185 and 186
[OPP-300556; FRL-5745-6]
RIN 2070-AB78
Fenarimol; 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 fenarimol in or on hops . 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 hops. This regulation establishes a maximum
permissible level for residues of fenarimol 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 December 31, 1998.
DATES: This regulation is effective September 24, 1997. Objections and
requests for hearings must be received by EPA on or before November 24,
1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300556], 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-300556], 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: [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 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-300556]. 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: Olga Odiott, 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) 308-9363, 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 fenarimol, in or on hops at 5 part per
million (ppm). This tolerance will expire and is revoked on December
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-55729).
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
[[Page 49932]]
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 Fenarimol on Hops and FFDCA Tolerances
The States of Washington, Oregon and Idaho availed themselves of
the authority to declare a crisis exemption to use fenarimol for
control of the Powdery mildew (Sphaeroteca macularis) in hops. Powdery
mildew is a serious hop disease in many hop growing areas in the world.
The elimination of commercial hop production in New York during the
early part of this century is largely blamed on this disease. Since
this disease has not been observed in the Pacific Northwest until very
recently, no effective fungicides are registered to control it. Sulfur
is the only pesticide available, but does not provide effective
control. The pathogen is airborne and spreads very quickly, primarly
during the months of July and August, which are critical to hop
production. EPA has authorized under FIFRA section 18 the use of
fenarimol on hops for control of powdery mildew in Washington, Oregon
and Idaho. After having reviewed their submissions, 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 fenarimol in or on hops.
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 December 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
hops 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 fenarimol meets EPA's
registration requirements for use on hops 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 fenarimol 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 Washington, Oregon and Idaho 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 fenarimol, 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
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toxicological data including short-term and mutagenicity studies and
structure activity relationship. Once a pesticide has been classified
as a potential human carcinogen, different types of risk assessments
(e.g., linear low dose extrapolations or MOE calculation based on the
appropriate NOEL) will be carried out based on the nature of the
carcinogenic response and the Agency's knowledge of its mode of action.
2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity data base, and based on
the effects seen for different durations and routes of exposure,
determines which risk assessments should be done to assure that the
public is adequately protected from any pesticide exposure scenario.
Both short and long durations of exposure are always considered.
Typically, risk assessments include ``acute'', ``short-term'',
``intermediate term'', and ``chronic'' risks. These assessments are
defined by the Agency as follows.
Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
High end exposure to food and water residues are typically assumed.
Short-term risk results from exposure to the pesticide for a period
of 1-7 days, and therefore overlaps with the acute risk assessment.
Historically, this risk assessment was intended to address primarily
dermal and inhalation exposure which could result, for example, from
residential pesticide applications. However, since enaction of FQPA,
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from
food, water, and residential uses when reliable data are available. In
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all 3
sources are not typically added because of the very low probability of
this occurring in most cases, and because the other conservative
assumptions built into the assessment assure adequate protection of
public health. However, for cases in which high-end exposure can
reasonably be expected from multiple sources (e.g. frequent and
widespread homeowner use in a specific geographical area), multiple
high-end risks will be aggregated and presented as part of the
comprehensive risk assessment/characterization. Since the toxicological
endpoint considered in this assessment reflects exposure over a period
of at least 7 days, an additional degree of conservatism is built into
the assessment; i.e., the risk assessment nominally covers 1-7 days
exposure, and the toxicological endpoint/NOEL is selected to be
adequate for at least 7 days of exposure. (Toxicity results at lower
levels when the dosing duration is increased.)
Intermediate-term risk results from exposure for 7 days to several
months. This assessment is handled in a manner similar to the short-
term risk assessment.
Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated considering average exposure from all sources for
representative population subgroups including infants and children.
B. Aggregate Exposure
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, residues in groundwater
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). Dietary exposure to
residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an
estimate of the level of residues consumed daily if each food item
contained pesticide residues equal to the tolerance. In evaluating food
exposures, EPA takes into account varying consumption patterns of major
identifiable subgroups of consumers, including infants and children.The
TMRC is a ``worst case'' estimate since it is based on the assumptions
that food contains pesticide residues at the tolerance level and that
100% of the crop is treated by pesticides that have established
tolerances. If the TMRC exceeds the RfD or poses a lifetime cancer risk
that is greater than approximately one in a million, EPA attempts to
derive a more accurate exposure estimate for the pesticide by
evaluating additional types of information (anticipated residue data
and/or percent of crop treated data) which show, generally, that
pesticide residues in most foods when they are eaten are well below
established tolerances.
Percent of crop treated estimates are derived from federal and
private market survey data. Typically, a range of estimates are
supplied and the upper end of this range is assumed for the exposure
assessment. By using this upper end estimate of percent of crop
treated, the Agency is reasonably certain that exposure is not
understated for any significant subpopulation group. Further, regional
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations
including several regional groups, to pesticide residues. For this
pesticide, the most highly exposed population subgroup (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 fenarimol
and to make a determination on aggregate exposure, consistent with
section 408(b)(2), for a time-limited tolerance for residues of
fenarimol on hops at 5 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 fenarimol are
discussed below.
1. Acute toxicity. The Agency determined that the NOEL of 13 mg/kg/
day, based on hydronephrosis at the lowest effect level (LEL) of 35 mg/
kg/day, from a developmental study in rats should be used to assess
acute dietary risks from residues of fenarimol. This risk assessment
will evaluate risk to females 13+ years old, the population subgroup of
concern.
2. Short - and intermediate - term toxicity. The Agency determined
that the NOEL of 13 mg/kg/day from the rat developmental study should
be used to assess risks from short- and intermediate-term exposures to
residues
[[Page 49934]]
of fenarimol. At the LEL of 35 mg/kg/day, there was hydronephrosis.
3. Chronic toxicity. EPA has established the RfD for fenarimol at
0.065 milligrams/kilogram/day (mg/kg/day). This RfD is based on a 2
year rat feeding study with a NOEL of 6.5 mg/kg/day and an uncertainty
factor of 100 based on fatty change in the liver at the LEL of 13 mg/
kg/day.
4. Carcinogenicity. The Agency's Carcinigenicity Peer Review
Committee (CPRC) has classified fenarimol as a Group E (non-
carcinogenic in humans) chemical.
B. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.421) for the residues of fenarimol (alpha-(2 chlorophenyl)-
alpha-(4-chlorophenyl)-5-pyrimidinemethanol), in or on a variety of raw
agricultural commodities at levels ranging from 0.003 ppm in milk to
0.1 ppm in apples, pears and pecans. Tolerances have also been
established (40 CFR 180.421(b)) for residues of fenarimol and its
metabolites (alpha-(2-chlorophenyl)-alpha-(4-chlorophenyl)-1,4-dihydro-
5-pyrimidinemethanol, and 5-[2-chlorophenyl)-(4-chloro- phenyl)methyl]-
3,4-dihydro-4-pyrimidinol measured as the total of fenarimol and 5-[(2-
chlorophenyl)-(4-chlorophenyl)methyl]-3,4-dihydro-4-pyrimidine
(calculated as fenarimol)) ranging from 1.0 ppm for cherries to 0.02
ppm for grapes. For this Section 18 only, the Agency determined that
the residue of concern in hops is parent fenarimol. Risk assessments
were conducted by EPA to assess dietary exposures and risks from
fenarimol 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 (food only) risk
assessment used TMRC estimates. The resulting high-end exposure
estimate of 0.01 mg/kg/day results in a dietary (food only) MOE of 1300
for females 13+ years. This MOE should be viewed as a conservative risk
estimate. Refinement of the risk assessment using anticipated residue
values and percent crop-treated data would result in a lower acute
dietary risk estimate.
ii. Chronic exposure and risk. For the chronic dietary ( food only)
risk assessment, the Agency assumed that 100% of hops and all other
commodities having fenarimol tolerances will contain fenarimol residues
and those residues would be at the tolerance level. These assumptions
result in an over estimate of human dietary exposure. Thus, in making a
safety determination for this tolerance, HED is taking into account
this conservative exposure assessment. The existing fenarimol
tolerances (published and pending, and including the necessary Section
18 tolerance) result in a TMRC that is equivalent to percentages of the
RfD that range from 1% for the U.S. population to 3% for non-nursing
infants < 1 year old.
2. From drinking water. Based on available data used in EPA's
assessment of environmental risk, fenarimol is not expected to leach to
groundwater. Information on its persistence is inconclusive. There is
no information on the persistence/mobility of fenarimol metabolites/
degradates. There are no established Maximum Contaminant Levels for
residues of fenarimol in drinking water and no Health Advisory Levels
for this active ingredient in drinking water have been issued.
Chronic exposure and risk. 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 (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 fenarimol 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 fenarimol 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. Fenarimol is currently registered for
use on the following residential non-food sites: ornamentals, turf and
lawns. There are no indoor residential uses for fenarimol. Based on the
nature of the outdoor residential uses, the EPA concludes that chronic
residential exposure scenarios do not exist for fenarimol. Short and/or
intermediate term exposure scenarios may exist. However, the Agency
currently lacks sufficient residential-related exposure data to
complete a comprehensive residential risk assessment for many
pesticides, including fenarimol.
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
[[Page 49935]]
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 fenarimol has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. For the purposes of this tolerance action, therefore, EPA
has not assumed that fenarimol has a common mechanism of toxicity with
other substances.
C. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. For the population subgroup of concern, females 13+
years, the Agency estimated an MOE value of 1300 for the acute
aggregate dietary (food only) risk from exposures to fenarimol
residues. Despite the potential for exposure to fenarimol in drinking
water and from non-dietary, non-occupational exposure, EPA does not
expect the aggregate exposure to exceed the Agency's level of concern.
2. Chronic risk. Using the TMRC exposure assumptions described
above, EPA has concluded that aggregate exposure to fenarimol from food
will utilize 1% of the RfD for the U.S. population. The major
identifiable subgroup with the highest aggregate exposure is non-
nursing infants < 1 year old. EPA generally has no concern for
exposures below 100% of the RfD because the RfD represents the level at
or below which daily aggregate dietary exposure over a lifetime will
not pose appreciable risks to human health. Despite the potential for
exposure to fenarimol 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 fenarimol 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.
Based on the registered uses of fenarimol short and/or intermediate
term exposure scenarios may exist. However, the Agency currently lacks
sufficient residential-related exposure data to complete a
comprehensive residential risk assessment for many pesticides,
including fenarimol.
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 fenarimol, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 3-generation
reproduction study in the rat and reproduction studies in mice and
guinea pigs. The developmental toxicity studies are designed to
evaluate adverse effects on the developing organism resulting from
maternal pesticide exposure during gestation. Reproduction studies
provide information relating to effects from exposure to the pesticide
on the reproductive capability of mating animals and data on systemic
toxicity.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for pre-and post-natal toxicity and the
completeness of the database unless EPA determines that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA risk assessments either directly
through use of a MOE analysis or through using uncertainty (safety)
factors in calculating a dose level that poses no appreciable risk to
humans. EPA believes that reliable data support using the standard 100-
fold safety factor and not the additional tenfold safety factor when
EPA has a complete data base under existing guidelines and when the
severity of the effect in infants or children or the potency or unusual
toxic properties of a compound do not raise concerns regarding the
adequacy of the standard safety factor.
ii. Developmental toxicity studies-- Rats: The maternal (systemic)
NOEL was 13 mg/kg/day, based on decreased weight gain at the lowest
observed effect level (LOEL) of 35 mg/kg/day. The developmental (fetal)
NOEL was 13 mg/kg/day based on hydronephrosis at the LOEL of 35 mg/kg/
day.
Rabbits: The maternal (systemic) NOEL was 35 mg/kg/day, the highest
dose tested (HDT). The developmental (fetal) NOEL was 35 mg/kg/day
(HDT).
iii. Reproductive toxicity study-- Rats: In a 3-generation rat
reproduction study, the maternal (systemic) NOEL was 5.0 mg/kg/day,
based on increased gestation time, and delayed onset of parturition at
the LOEL of 17.5 mg/kg/day. The developmental (pup) NOEL was 5.0 mg/kg/
day, based on decreased pup survival and hydronephrosis at the LOEL of
17.5 mg/kg/day. The reproductive NOEL was 2.5 mg/kg/day, based on anti-
fertility effects in males, and dystocia in females at the LEL of 5.0
mg/kg/day.
iv. Pre- and post-natal sensitivity. Based on the developmental
toxicity studies discussed above, for fenarimol there does not appear
to be a special sensitivity for pre-natal effects. However, based on
the developmental finding of hydronephrosis in the rat study, an acute
dietary risk assessment was performed for females 13+ years of age.
Based on the reproductive toxicity studies discussed above and
other reviewed data for fenarimol, there does not appear to be a
special sensitivity for post-natal effects. The major reproductive
findings in the rat (post-natal male infertility and dystocia and
related effects in females) were concluded to be species-specific
findings by the Agency. Reproduction studies in mice, rabbits, and
guinea pigs did not demonstrate the reproductive concerns. Mechanistic
data also substantiate the species-specific conclusion.
v. Conclusion. The EPA concludes that reliable data support use of
the standard 100-fold margin of exposure/uncertainty factor and that an
additional margin/factor is not needed to protect infants and children.
2. Acute risk. The acute dietary MOE (food only) was calculated to
be 1300 for females 13+ years (accounts for both maternal and fetal
exposure). These MOE calculations were based on the developmental NOEL
in rats of 13 mg/kg/day. This risk assessment assumed 100% crop-
treatment with tolerance level residues on all treated crops consumed,
resulting in an over-estimate of dietary exposure. The large acute
dietary MOE calculated for females 13+ years provides assurance that
there is a reasonable certainty of no harm for females 13+ years.
Despite the potential for exposure to fenarimol in drinking water, the
Agency does not expect the aggregate exposure (food plus water) to
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 fenarimol
from food will utilize a percentage of the RfD that ranges from 1% for
children (1-6 yrs.), up to 3% for non-nursing infants <1 year old. EPA
generally has no concern for exposures below 100% of the RfD because
the RfD represents the level at or below which daily aggregate dietary
exposure over a lifetime will not pose appreciable risks to human
health. Despite the potential for exposure to fenarimol 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
[[Page 49936]]
chronic aggregate exposure to fenarimol residues.
4. Short- or intermediate-term risk. Based on the registered uses
of fenarimol short and/or intermediate term exposure scenarios may
exist. However, the Agency currently lacks sufficient residential-
related exposure data to complete a comprehensive residential risk
assessment for many pesticides, including fenarimol.
V. Other Considerations
A. Metabolism In Plants and Animals
The nature of the residue of fenarimol in hops has not been
directly determined. Metabolism studies with fenarimol in apples and
cherries indicate that the parent compound is the only significant
residue. For the purpose of this tolerance, EPA will translate these
data to hops. For this tolerance only, EPA concludes that the residue
of concern in hops is parent fenarimol. According to Table 1 (OPPTS
860.1000), there are no livestock feedstuffs derived from hops. Thus,
the livestock metabolism and magnitude of residues in meat, milk,
poultry and eggs are not a concern for this Section 18 .
B. Analytical Enforcement Methodology
Analytical methodology exists for the enforcement of currently
established tolerances for fenarimol. The method (GC/ECD) is published
in PAM vol II (Method R039). For the purposes of this tolerance, Method
R039 may be used to enforce the required tolerance for fenarimol in
hops.
C. Magnitude of Residues
Residues of fenarimol are not expected to exceed 5 ppm in/on dried
hop cones as a result of this Section 18 use.
D. International Residue Limits
There are no Mexican or Canadian Maximum Residue Limits (MRL) for
fenarimol in/on hops. Thus, harmonization with Mexico and Canada is not
an issue for this Section 18. A CODEX MRL of 5 ppm is established for
fenarimol per se in/on hops. As EPA has concluded that a tolerance
level of 5 ppm should be established for residues of fenarimol in/on
hops as a result of this Section 18 exemption, harmonization with CODEX
is not an issue.
VI. Conclusion
Therefore, the tolerance is established for residues of fenarimol
in hops at 5 ppm.
VII. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation issued by EPA under
new section 408(e) and (l)(6) as was provided in the old section 408
and in section 409. However, the period for filing objections is 60
days, rather than 30 days. EPA currently has procedural regulations
which govern the submission of objections and hearing requests. These
regulations will require some modification to reflect the new law.
However, until those modifications can be made, EPA will continue to
use those procedural regulations with appropriate adjustments to
reflect the new law.
Any person may, by November 24, 1997, file written objections to
any aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of
the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). If a hearing is requested, the objections must include a
statement of the factual issues on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the requestor (40 CFR 178.27). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is genuine and substantial issue
of fact; there is a reasonable possibility that available evidence
identified by the requestor would, if established, resolve one or more
of such issues in favor of the requestor, taking into account
uncontested claims or facts to the contrary; and resolution of the
factual issues in the manner sought by the requestor would be adequate
to justify the action requested (40 CFR 178.32). Information submitted
in connection with an objection or hearing request may be claimed
confidential by marking any part or all of that information as
Confidential Business Information (CBI). Information so marked will not
be disclosed except in accordance with procedures set forth in 40 CFR
part 2. A copy of the information that does not contain CBI must be
submitted for inclusion in the public record. Information not marked
confidential may be disclosed publicly by EPA without prior notice.
VIII. Public Docket
EPA has established a record for this rulemaking under docket
control number [OPP-300556] (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:
[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 record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
IX. Regulatory Assessment Requirements
This final rule establishes a time-limited tolerance under FFDCA
section 408 (l)(6). The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., or impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does it require any
prior consultation as specified by Executive Order 12875, entitled
Enhancing the Intergovernmental Partnership (58 FR
[[Page 49937]]
58093, October 28, 1993), or special considerations as required by
Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), or require OMB review in
accordance with Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997).
In addition, since these tolerances and exemptions that are
established under FFDCA section 408 (l)(6), such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. Nevertheless, the Agency has previously assessed
whether establishing tolerances, exemptions from tolerances, raising
tolerance levels or expanding exemptions might adversely impact small
entities and concluded, as a generic matter, that there is no adverse
economic impact. The factual basis for the Agency's generic
certification for tolerance 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
40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
40 CFR Part 185
Environmental protection, Food additives, Pesticides and pests.
40 CFR Part 186
Environmental protection, Animal feeds, Pesticides and pests.
Dated: September 16, 1997.
James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. In part 180:
a. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
b. Section 180.421 is amended as follows:
i. By adding a heading to paragraph (a) and designating the
existing text as paragraph (a)(1).
ii. By redesignating paragraph (b) as paragraph (a)(2) and by
adding a new paragraph (b).
iii. By adding and reserving paragraphs (c) and (d).
Section 180.421, as amended, reads as follows:
Sec. 180.421 Fenarimol; tolerances for residues.
(a) General. * * *
(b) Section 18 emergency exemptions. A time-limited tolerance is
established for residues of the fungicide fenarimol in connection with
use of the pesticide under section 18 emergency exemptions granted by
EPA. The tolerance will expire and be revoked on the date specified in
the following table:
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Hops............................ 5 December 31, 1998
------------------------------------------------------------------------
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
PART 185--[AMENDED]
2. In part 185:
a. The authority citation for part 185 continues to read as
follows:
Authority: 21 U.S.C. 346a and 348.
Sec. 185.3200 [Removed]
b. In Sec. 185.3200:
i. The entries in the table are transferred and alphabetically
added to the table in paragraph (a)(2) of Sec. 180.421.
ii. The remainder of Sec. 185.3200 is removed.
PART 186--[AMENDED]
3. In part 186:
a. The authority citation for part 186 continues to read as
follows:
Authority: 21 U.S.C. 342, 348, and 701.
Sec. 186.3200 [Removed]
b. In Sec. 186.3200:
i. The entry in the table of paragraph (a) is transferred and
alphabetically added to the table in paragraph (a)(1) of Sec. 180.421.
ii. The entries in the table of paragraph (b) are transferred and
alphabetically added to the table in paragraph (a)(2) of Sec. 180.421.
iii. The remainder of Sec. 186.3200 is removed.
[FR Doc. 97-25235 Filed 9-23-97; 8:45 am]
BILLING CODE 6560-50-F