[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: <a href="/cdn-cgi/l/email-protection#a9c6d9d984cdc6cac2ccdde9ccd9c8c4c8c0c587ccd9c887cec6df"><span class="__cf_email__" data-cfemail="a3ccd3d38ec7ccc0c8c6d7e3c6d3c2cec2cacf8dc6d3c28dc4ccd5">[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 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: 
<a href="/cdn-cgi/l/email-protection#325d565b5d46461c5d5e5553725742535f535b5e1c5742531c555d44"><span class="__cf_email__" data-cfemail="2f404b46405b5b014043484e6f4a5f4e424e4643014a5f4e01484059">[email protected]</span></a>.

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

[[Page 49933]]

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:
    <a href="/cdn-cgi/l/email-protection#701f00005d141f131b1504301500111d11191c5e1500115e171f06"><span class="__cf_email__" data-cfemail="4b243b3b662f2428202e3f0b2e3b2a262a2227652e3b2a652c243d">[email protected]</span></a>.


    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


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