[Federal Register Volume 62, Number 70 (Friday, April 11, 1997)]
[Rules and Regulations]
[Pages 17730-17735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-9378]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180, 185 and 186
[OPP-300466; FRL-5597-9]
RIN 2070-AC78
Myclobutanil; 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 the fungicide myclobutanil in or on the raw agricultural
commodity strawberries in connection with EPA's granting of an
emergency exemption under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act authorizing use of myclobutanil on
strawberries in Florida. This regulation establishes a maximum
permissible level for residues of myclobutanil in this food 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 be revoked by EPA on March 31, 1998.
DATES: This regulation becomes effective April 11, 1997. Objections and
requests for hearings must be received by EPA on June 10, 1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP ], 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 document
control number, [OPP ], should be submitted to: Public Response and
Program Resources Branch, Field Operations 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 number
[OPP ]. 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: Stephen Schaible,
Registration Division (7505W), Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460. Office location, telephone number, and
e-mail address: Sixth Floor, Crystal Station #1, 2800 Jefferson Davis
Highway, Arlington, VA 22202. (703) 308-8337, e-mail:
schaible.stephen@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, 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
myclobutanil [alpha-butyl-alpha-(4-chlorophenyl)-1H-1,2,4-triazole-1-
propanenitrile] and its metabolite alpha-(3-hydroxybutyl)-alpha-(4-
chlorophenol)-1H-1,2,4-triazole-1-propanenitrile (free and bound),
hereafter referred to as myclobutanil, in or on strawberries at 0.5
part per million (ppm). This tolerance will expire and be revoked on
March 31, 1998.
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 CFR 58135, November 13, 1996)(FRL-5572-9).
New section 408(b)(2)(A)(i) 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, 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
[[Page 17731]]
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) 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. Section 408(l)(6) also requires EPA to promulgate regulations
by August 3, 1997, governing the establishment of tolerances and
exemptions under section 408(l)(6) and requires that the regulations be
consistent with section 408(b)(2) and (c)(2) and FIFRA section 18.
Section 408(l)(6) allows EPA to establish tolerances or exemptions
from the requirement for a tolerance, in connection with EPA's granting
of FIFRA section 18 emergency exemptions, without providing notice or a
period for public comment. Thus, consistent with the need to act
expeditiously on requests for emergency exemptions under FIFRA, EPA can
establish such tolerances or exemptions under the authority of section
408(e) and (l)(6) without notice and comment rulemaking.
In establishing section 18-related tolerances and exemptions during
this interim period before EPA issues the section 408(l)(6) procedural
regulation and before EPA makes its broad policy decisions concerning
the interpretation and implementation of the new section 408, EPA does
not intend to set precedents for the application of section 408 and the
new safety standard to other tolerances and exemptions. Rather, these
early section 18 tolerance and exemption decisions will be made on a
case-by-case basis and will not bind EPA as it proceeds with further
rulemaking and policy development. EPA intends to act on section 18-
related tolerances and exemptions that clearly qualify under the new
law.
II. Emergency Exemption for Myclobutanil on Strawberries and FFDCA
Tolerances
On January 14, 1997 the state of Florida availed itself of the
authority to declare the existence of a crisis situation within the
state, thereby authorizing use under FIFRA section 18 of myclobutanil
on strawberries to control powdery mildew (Sphaerotheca fuliginea).
Florida stated that emergency conditions developed due to planting of
powdery mildew-infected transplants purchased from Canadian suppliers
and the occurrence of weather conditions conducive to disease
development. Florida claims that the registered alternatives are either
not efficacious or are phytotoxic. Without the use of myclobutanil, it
is claimed that strawberry growers will suffer severe economic losses.
As part of its assessment of this crisis declaration, EPA assessed
the potential risks presented by residues of myclobutanil in or on
strawberries. In doing so, EPA considered the new safety standard in
FFDCA section 408(b)(2), and EPA decided to grant the section 18
exemption only after concluding that the necessary tolerance under
FFDCA section 408(l)(6) would be consistent with the new safety
standard and with FIFRA section 18. This tolerance for myclobutanil
will permit the marketing of strawberries treated in accordance with
the provisions of the section 18 emergency exemption. 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 be revoked
on March 31, 1998, under FFDCA section 408(l)(5), residues of
myclobutanil not in excess of the amounts specified in the tolerance
remaining in or on strawberries after that date will not be unlawful,
provided the pesticide is applied during the term of, and in accordance
with all the conditions of, the emergency exemption. 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.
EPA has not made any decisions about whether myclobutanil meets the
requirements for registration under FIFRA section 3 for use on
strawberries, or whether a permanent tolerance for myclobutanil for
strawberries would be appropriate. This action by EPA does not serve as
a basis for registration of myclobutanil by a State for special local
needs under FIFRA section 24(c). Nor does this action serve as the
basis for any State other than Florida to use this product 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 myclobutanil, 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. For many
of these 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.
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 margin of exposure 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.
[[Page 17732]]
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, and other non-
occupational exposures, such as where residues leach into groundwater
or surface water that is consumed as drinking water. 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. 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 percent
of every crop considered in the analysis is treated with the pesticide
being evaluated. 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 and that the market for pest control on any
given crop seldomly belongs to a single pesticide.
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.
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. Myclobutanil is already registered by EPA for numerous
food and feed uses, as well as residential use on annuals and
perennials, turf, shrubs and trees, and African violets (indoor). EPA
has received a petition requesting establishment of a tolerance for
myclobutanil on strawberries. The time-limited tolerance associated
with the current emergency exemption does not constitute a decision
regarding the pending petition for tolerance on strawberries. For the
purposes of this emergency exemption, EPA has sufficient data to assess
the hazards of myclobutanil and to make a determination on aggregate
exposure, consistent with section 408(b)(2), for a time-limited
tolerance for residues of myclobutanil on strawberries at 0.5 ppm.
EPA's assessment of the dietary exposures and risks associated with
establishing this tolerance follows.
A. Toxicological Profile
1. Chronic toxicity. The RfD of 0.025 milligrams per kilogram per
day (mg/kg/day) was established by the Agency based on the chronic
feeding study in rats with a NOEL of 2.5 mg/kg/day and an uncertainty
factor of 100. There was testicular atrophy at the lowest effect level
(LEL) of 9.9 mg/kg/day.
2. Acute toxicity. The Office of Pesticide Programs (OPP) has
determined that data do not indicate the potential for adverse effects
after a single dietary exposure.
3. Short-term toxicity. OPP has determined that short- and
intermediate-term risk assessments are appropriate for occupational and
residential routes of exposure. OPP recommends that the NOEL of 100 mg/
kg/day, taken from the 21-day dermal toxicity study in rats, be used
for the short term dermal MOE calculations. This dose level was the
highest tested in the study. For intermediate term MOE calculations,
OPP recommended using the NOEL of 10 mg/kg/day from the 2-generation
rat study. Effects seen at the LEL in this study (50 mg/kg/day) were
decreases in pup body weight, an increased incidence in number of
stillborns, and atrophy of the prostate and testes. Though these
endpoints have been identified, no acceptable reliable exposure data to
assess these potential risks are available at this time.
4. Carcinogenicity. Using its Guidelines for Carcinogen Risk
Assessment published September 24, 1986 (51 FR 33992), EPA has
classified myclobutanil as Group E chemical - ``no evidence of
carcinogenicity for humans'' - based on the results of carcinogenicity
studies in two species. The doses tested are adequate for identifying a
cancer risk.
B. Aggregate Exposure
Established U.S. tolerances for myclobutanil and its alcohol
metabolites (free and bound) are found in 40 CFR 180.443, and range
from 0.05 ppm for milk to 5 ppm for cherries (sweet and sour). The
proposed time-limited tolerance of 0.5 ppm is based on residue field
trial data on strawberries submitted in support of PP# 4E4302. There
are no livestock feed items associated with the proposed use on
strawberries, so no additional livestock dietary burden will result
from this section 18 registration. Therefore, existing meat, milk, and
poultry tolerances are adequate.
For the purpose of assessing potential chronic dietary exposure
from myclobutanil, EPA generally assumed tolerance level residues and
percent of crop treated refinements to estimate the Anticipated Residue
Contribution (ARC) from the proposed and existing food uses of
myclobutanil. The use of percent of crop treated data for most of the
existing food uses in this analysis, as well as the use of refined
residue information for the existing use on bananas, results in a more
refined estimate of exposure than the TMRC.
In conducting this exposure assessment, EPA has made conservative
assumptions--most all foods considered in the analysis were assumed to
have myclobutanil residues present at the level of the tolerance.
Percent crop treated data were used for many commodities with existing
myclobutanil tolerances (stone fruits, pome fruits, grapes, and
cottonseed) in the chronic exposure assessment, but were not considered
when calculating the dietary burden from which secondary residue
tolerances in meat, milk and poultry were derived or for the proposed
use on strawberries. Thus, in making a safety determination for the
subject section 18 tolerances, EPA is taking into account this
conservative exposure assessment.
In examining aggregate exposure, FQPA directs EPA to consider
available information concerning exposures from the pesticide residue
in food and all other non-occupational exposures. The primary non-food
sources of exposure the Agency looks at include drinking water (whether
from groundwater or surface water), and exposure through pesticide use
in gardens, lawns, or buildings (residential and other indoor uses).
Review of terrestrial field dissipation data by the Agency indicates
that myclobutanil did not leach into groundwater in either sandy loam
or coastal soil. There is no established Maximum Concentration Level
for residues of myclobutanil in drinking water. No drinking water
health advisories have been issued for myclobutanil. The ``Pesticides
in Groundwater Database (EPA 734-12-92-001, September 1992) has no
information concerning myclobutanil.
Because the Agency lacks sufficient water-related exposure data to
complete a comprehensive drinking water risk
[[Page 17733]]
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
to contaminated water, the ranges the Agency is continuing to examine
are all below the level that would cause myclobutanil 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 myclobutanil 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.
There are residential uses of myclobutanil and EPA acknowledges
that there may be short-, intermediate-, and long-term non-occupational
exposure scenarios. OPP has identified toxicity endpoints for short-
and intermediate-term residential risk assessment. However, no
acceptable, reliable exposure data to assess these potential risks are
available at this time. Given the time-limited nature of this request,
the need to make emergency exemption decisions quickly, and the
significant scientific uncertainty at this time about how to aggregate
non-occupational exposure with dietary exposure, the Agency will make
its safety determination for this tolerance based on those factors
which it can reasonably integrate into a risk assessment.
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 myclobutanil 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,
myclobutanil 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 myclobutanil has a common mechanism of
toxicity with other substances.
C. Determination of Safety for U.S. Population
EPA has calculated that chronic dietary exposure to myclobutanil
will utilize 14 percent of the RfD for the U.S. population. Available
information indicate that there will be little, if any exposure to
myclobutanil in drinking water and EPA has no reliable exposure
information regarding the level of exposure to myclobutanil from non-
occupational, non-dietary sources. EPA generally has no concern for
exposures below 100 percent 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. EPA concludes
that there is a reasonable certainty that no harm will result from
aggregate exposure to myclobutanil residues.
D. Determination of Safety for Infants and Children
In assessing the potential for additional sensitivity of infants
and children to residues of myclobutanil, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 2-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.
From the rat developmental study, the maternal (systemic) NOEL was
93.8 mg/kg/day, based on rough hair coat, and salivation at the lowest
observed effect level (LOEL) of 312.6 mg/kg/day. The developmental
(pup) NOEL was 93.8 mg/kg/day, based on increased incidences of 14th
rudimentary and 7th cervical ribs at the LOEL of 312.6 mg/kg/day. From
the rabbit developmental study, the maternal (systemic) NOEL was 60 mg/
kg/day, based on reduced weight gain, clinical signs of toxicity and
abortions at the LOEL of 200 mg/kg/day. The developmental (pup) NOEL
was 60 mg/kg/day, based on increases in number of resorptions,
decreases in litter size, and a decrease in the viability index at the
LEL of 200 mg/kg/day.
From the rat reproduction study, the maternal (systemic) NOEL was
2.5 mg/kg/day, based on increased liver weights and liver cell
hypertrophy at the LOEL of 10 mg/kg/day. The developmental (pup) NOEL
was 10 mg/kg/day, based on decreased pup body weight during lactation
at the LEL of 50 mg/kg/day. The reproductive (parental) NOEL was 10 mg/
kg/day, based on increased incidence of stillborns, and atrophy of the
testes, epididymides, and prostate at the LEL of 50 mg/kg/day.
[[Page 17734]]
FFDCA section 408 provides that EPA shall apply an additional
uncertainty factor for infants and children in the case of threshold
effects to account for pre- and post-natal toxicity and the
completeness of the data base unless EPA determines, based on reliable
data, that a different uncertainty factor would be appropriate.
Generally, EPA believes that reliable data support using the standard
hundredfold uncertainty factor for extrapolating from animal studies to
humans, where there is a complete data base and the effects of concern
are not such to indicate such a hundredfold uncertainty factor is
inadequate. Based on current toxicological data requirements, the data
base for myclobutanil relative to pre- and post-natal toxicity is
complete. The Agency notes that there is approximately a 25-fold
difference between the developmental NOEL of 60 mg/kg/day from the
rabbit developmental toxicity study and the NOEL of 2.5 mg/kg/day from
the chronic rat feeding study which was the basis of the RfD. It is
further noted that in both the rabbit and rat developmental toxicity
studies, the developmental NOEL and maternal NOEL are the same (60 mg/
kg/day for the rabbit and 93.8 mg/kg/day for the rat). In the rat
reproduction study, the maternal NOEL (2.5 mg/kg/day) was four times
lower than the developmental (pup) and reproductive NOELs (10 mg/kg/
day). These studies indicate that there does not appear to be
additional sensitivity for infants and children in the absence of
maternal toxicity and that there is no concern that a hundredfold
uncertainty factor will be inadequate. EPA concludes that a hundredfold
uncertainty factor is appropriate for infants and children.
EPA has calculated that the percent of the RfD that will be
utilized by chronic dietary exposure to residues of myclobutanil ranges
from 22 percent for children 7 to 12 years old, up to 73 percent for
non-nursing infants. Given that aggregate exposure is still below the
Agency's level of concern, EPA concludes that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to myclobutanil residues.
V. Other Considerations
The metabolism of myclobutanil in plants and animals is adequately
understood for the purposes of this tolerance. There is no Codex
maximum residue level established for residues of myclobutanil on
strawberries. There is a practical analytical method for detecting and
measuring levels of myclobutanil in or on food with a limit of
detection that allows monitoring of food with residues at or above the
levels set in this tolerance. EPA has provided information on this
method to the Food and Drug Administration. The method is available to
anyone who is interested in pesticide residue enforcement from: By
mail, Calvin Furlow, Public Response and Program Resources Branch,
Field Operations Division (7506C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location and telephone number: Crystal Mall #2, Rm. 1128, 1921
Jefferson Davis Highway, Arlington, VA 22202, (703) 305-5805.
VI. Conclusion
Therefore, a tolerance in connection with the FIFRA section 18
emergency exemption is established for residues of myclobutanil in
strawberries at 0.5 ppm. This tolerance will expire on March 31, 1998.
In addition to the new tolerance being established, since for
purposes of establishing tolerances FQPA has eliminated all
distinctions between raw and processed food, EPA is combining the
tolerances that now appear in Sec. Sec. 185.4350 and 186.4350 with the
tolerances in Sec. 180.443 and is eliminating Sec. Sec. 185.4350 and
186.4350.
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 June 10, 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
A record has been established for this rulemaking under docket
number [OPP ]. A public version of this record, 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 Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2,
1921 Jefferson Davis Highway, Arlington, VA.
The official record for this rulemaking, as well as the public
version, as described above, is kept in paper form. Accordingly, in the
event there are objections and hearing requests, 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. The official rulemaking
record is the paper record maintained at the address in `` ADDRESSES''
at the beginning of this document.
[[Page 17735]]
IX. Regulatory Assessment Requirements
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and, since this
action does not impose any information collection requirements as
defined by the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., it is
not subject to review by the Office of Management and Budget. In
addition, this action does not impose any enforceable duty or contain
any unfunded mandate as described in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104-4), or require prior consultation with State
officials as specified by Executive Order 12875 (58 FR 58093, October
28, 1993), or special considerations as required by Executive Order
12898 (59 FR 7629, February 16, 1994). Because FFDCA section 408(l)(6)
permits establishment of this regulation without a notice of proposed
rulemaking, the regulatory flexibility analysis requirements of the
Regulatory Flexibility Act, 5 U.S.C. 604(a), do not apply.
Under 5 U.S.C. 801(a)(1)(A) of the Small Business Regulatory
Enforcement Fairness Act of 1996 (Title II of Pub. L. 104-121, 110
Stat. 847), EPA 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 the rule in today's Federal Register.
This rule 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 and additives, Pesticides and pest.
40 CFR Part 186
Environmental protection, Animal feeds Pesticides and pest.
Dated: April 4, 1997.
Penelope A. Fenner-Crisp,
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. In part 180:
a. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
b. Section 180.443 is amended as follows:
i. In paragraph (a) by adding the heading.
ii. In paragraph (b) by transferring and alphabetically adding the
entry in the table to the table in paragraph (a) and by removing the
remaining text.
iii. In paragraph (c) by transferring and alphabetically adding the
entries in the table to the table in paragraph (a) and by removing the
remaining text.
iv. By redesignating paragraph (d) as paragraph (b) and by revising
newly redesignated paragraph (b).
v. By adding the headings and reserving new paragraphs (c) and (d).
Sec. 180.443 Myclobutanil; tolerances for residues.
(a) General. * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the fungicide myclobutanil, in connection
with use of the pesticide under section 18 emergency exemption granted
by EPA. The tolerances are specified in the following table. These
tolerances expire and are automatically revoked on the date specified
in the table.
------------------------------------------------------------------------
Parts per Expiration/Revocation
Commodity million Date
------------------------------------------------------------------------
Cucurbit vegetables............... 0.3 November 30, 1997
Strawberries...................... 0.5 March 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. 185.4350 [Removed]
b. The entries in the table to Sec. 185.4350 are transferred and
added alphabetically to the table in paragraph (a) of Sec. 180.443; the
remainder of Sec. 185.4350 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. 186.4350 [Removed]
b. The entries in the table to Sec. 186.4350 are transferred and
added alphabetically to the table in paragraph (a) of Sec. 180.443; the
remainder of Sec. 186.4350 is removed.
[FR Doc. 97-9378 Filed 4-11-97; 8:45 am]
BILLING CODE 6560-50-F
