[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: <a href="/cdn-cgi/l/email-protection#b7d8c7c79ad3d8d4dcd2c3f7d2c7d6dad6dedb99d2c7d699d0d8c1"><span class="__cf_email__" data-cfemail="1f706f6f327b707c747a6b5f7a6f7e727e7673317a6f7e31787069">[email protected]</span></a>. 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: 
<a href="/cdn-cgi/l/email-protection#285b4b4049414a444d065b5c4d58404d46684d584945494144064d5849064f475e"><span class="__cf_email__" data-cfemail="6c1f0f040d050e0009421f18091c0409022c091c0d010d050042091c0d420b031a">[email protected]</span></a>.
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


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