[Federal Register Volume 62, Number 80 (Friday, April 25, 1997)]
[Rules and Regulations]
[Pages 20111-20117]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10749]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300476; FRL-5712-7]
RIN 2070-AB78


Fenoxycarb; 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 
combined residues of the insecticide fenoxycarb in or on the commodity 
pear in connection with EPA's granting of emergency exemptions under 
section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act 
authorizing use of fenoxycarb on pears in Oregon and Washington. This 
regulation establishes maximum permissible levels for residues of 
fenoxycarb 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 is revoked on April 30, 
1998.
DATES: This regulation becomes effective April 25, 1997. Objections and 
requests for hearings must be received by EPA on or before June 24, 
1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300476], 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-300476], must also 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: [email protected]. Such copies of objections and 
hearing requests must be

[[Page 20112]]

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-300476]. 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: Pat Cimino, Registration 
Division (7505W), Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location, telephone number, and e-mail: 
Sixth Floor, Crystal Station #1, 2800 Jefferson Davis Highway, 
Arlington, VA 22202. (703) 308-8328, e-mail: 
[email protected].
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 tolerances for residues of the insecticide 
fenoxycarb, ethyl(2-[4-phenoxyphenoxy] ethyl) carbamate, in or on 
pears, at 0.10 part per million (ppm). This tolerance will expire and 
be revoked by EPA on April 30, 1998. After April 30, 1998, EPA will 
publish a document in the Federal Register to remove the revoked 
tolerance from the Code of Federal Regulations.

I. Background and Statutory Authority

    The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170) 
was signed into law August 3, 1996. FQPA amends both the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et 
seq. The FQPA amendments went into effect immediately. Among other 
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting 
activities under a new section 408 with a new safety standard and new 
procedures. These activities are described below and discussed in 
greater detail in the final rule establishing the time-limited 
tolerance associated with the emergency exemption for use of 
propiconazole on sorghum (61 FR 58135, November 13, 1996) (FRL-5572-9).
    New section 408(b)(2)(A)(i) 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 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 Fenoxycarb on Pears and FFDCA 
Tolerances

    The Oregon and Washington Departments of Agriculture requested 
specific exemptions under FIFRA section 18 for the use of fenoxycarb on 
pears to control pear psylla. Oregon and Washington stated that an 
emergency situation was present due to the pests' resistance to 
pesticides registered for this use. Pear psyllas reduce pear tree vigor 
and yield by injecting a toxin into the trees during feeding. They also 
secrete honeydew which causes deformed fruit, russeting, and growth of 
black sooty mold, leading to downgrading of fruit and increased 
cullage. If the pest is left totally uncontrolled, it will cause 
eventual tree debilitation and dramatic yield decreases. After 
reviewing the applicants' submissions, the Agency concluded that an 
emergency condition existed which would result in significant economic 
loss.
    As part of its assessment of these crisis declarations, EPA 
assessed the potential risks presented by residues of fenoxycarb in or 
on pears. In doing so, EPA considered the new safety standard in FFDCA 
section 408(b)(2), and EPA decided to grant the section 18 exemptions 
only after concluding that the necessary tolerance under FFDCA section 
408(l)(6) would clearly be consistent with the new safety standard and 
with FIFRA section 18. This tolerance for fenoxycarb will permit the 
marketing of pears treated in accordance with the provisions of the 
section 18 emergency exemptions. Consistent with the need to move 
quickly on the emergency exemptions 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 for 
in section 408(l)(6). Although this tolerance will expire and is 
revoked on April 30, 1998, under FFDCA section 408(l)(5), residues of 
fenoxycarb not in excess of the amount specified in the tolerance 
remaining in or on pears 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 exemptions. EPA will take action to 
revoke this tolerance earlier if any experience with, scientific

[[Page 20113]]

data on, or other relevant information on this pesticide indicate that 
the residues are not safe.
    EPA has not made any decisions about whether fenoxycarb meets the 
requirements for registration under FIFRA section 3 for use on pears, 
or whether a permanent tolerance for fenoxycarb for pears would be 
appropriate. This action by EPA does not serve as a basis for 
registration of fenoxycarb 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 Oregon and Washington 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 exemptions for fenoxycarb, 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% or less of the RfD) is 
generally considered by EPA to pose a reasonable certainty of no harm.
    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 
relationships. 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 (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.
    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% 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.

IV. Aggregate Risk Assessments, Cumulative Risk Discussion, 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. Fenoxycarb is registered by EPA for indoor and outdoor 
residential use. The registrant, Novartis, has proposed voluntarily 
canceling all home-owner applied uses of fenoxycarb. There are no 
permanent fenoxycarb food tolerances at this time. EPA is not in 
possession of a registration application for fenoxycarb on pears; 
however, the Agency has received petitions to establish tolerances for 
use of fenoxycarb on citrus fruits crop group, tree nut crops group, 
almond hulls, grass forage crop group and grassy hays. Based on 
information submitted to the Agency, EPA has sufficient data to assess 
the hazards of fenoxycarb and to make a determination on aggregate 
exposure, consistent with section 408(b)(2), for the time-limited 
tolerance for residues of fenoxycarb on pears at 0.10 ppm. EPA's 
assessment of the dietary exposures and risks associated with 
establishing this tolerance follows.

A. Toxicological Profile

    1. Acute toxicity. No appropriate acute dietary endpoint was 
identified by the Agency. This risk assessment is not required.
    2. Short- and intermediate term toxicity. For short-and 
intermediate-term inhalation MOE calculations, the Agency (March 28, 
1994) recommended use of the 21-day inhalation NOEL of 1.13 milligrams 
per liter (mg/L) (186 milligrams per kilogram per day (mg/kg/day)), the 
highest dose tested, from the 21-day inhalation study in rats. A risk 
assessment is not required for dermal exposure. The following equation 
was used to calculate the MOEs: MOE = NOEL (21-day inhalation study)/
dietary exposure.
    3. Chronic risk. Based on the available chronic toxicity data, the 
Office of Pesticide Programs (OPP) has established the RfD for 
fenoxycarb at 0.8 mg/kg/day. The RfD is based on a 2-year chronic 
toxicity/carcinogenicity study in rats with a NOEL of 8.1 mg/kg/day and 
an uncertainty factor of 100. The LEL was 24.7 mg/kg/day based on liver 
toxicity in male rats.
    4. Cancer risk. Fenoxycarb has been classified as a Group B2 
chemical by the Agency's Cancer Peer Review Committee based on lung 
carcinomas and Hardeian gland carcinomas in mice. The Committee 
recommended using the Q1* approach for calculating cancer risk

[[Page 20114]]

estimates. The Q1* is 5.6  x  10-2 (mg/kg/day)-1.

B. Aggregate Exposure

    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).
    There are no permanent fenoxycarb food tolerances at this time. 
There are no livestock feed items associated with these Section 18 
requests. Fenoxycarb is registered for indoor and outdoor residential 
uses (lawns, turf, pets, and inside domestic dwellings).
    In conducting this exposure assessment, EPA has made very 
conservative assumptions - 100% of pears will contain fenoxycarb 
tolerance residues and those residues would be at the level of the 
tolerance - which result in an overestimate of human dietary exposure. 
Thus, in making a safety determination for this tolerance, EPA is 
taking into account this conservative exposure assessment.
    1. Acute exposure. The Agency has determined that there are no 
acute dietary endpoints of concern and an acute assessment is not 
required.
    2. Chronic exposure.-- i. Dietary-food exposure. Given the 
emergency nature of these requests for the use of fenoxycarb and the 
resulting need for a timely analysis and risk assessment, EPA has 
utilized the TMRC to estimate chronic dietary exposure from the 
tolerance for fenoxycarb on pears at 0.10 ppm. The TMRC is obtained by 
multiplying the tolerance level residue for pears by the average 
consumption data, which estimate the amount of pears eaten by various 
population subgroups. The risk assessment is therefore considered to be 
overestimated.
    ii. Drinking water exposure. Available studies indicate that 
fenoxycarb is moderately persistent (half lives ranging from 24 to 37 
days) and does not appear to be very mobile. The most likely routes of 
dissipation are sorption to soil particles, aerobic and anaerobic soil 
metabolism and aerobic aquatic metabolism to CO2. There is no 
established Maximum Concentration Level for residues of fenoxycarb in 
drinking water and there have been no drinking water Health Advisory 
Levels established for fenoxycarb. The ``Pesticides in Groundwater 
Database'' (EPA 734-12-92-001, September 1992) has no information 
concerning fenoxycarb.
    The Agency has reviewed these section 18 requests and concluded 
that for these uses, fenoxycarb has little potential for contamination 
of ground water. There is a slight potential for surface water 
contamination by erosion of soil particles to which fenoxycarb is 
sorbed. However for these section 18 requests, the potential is 
lessened by: (a) The requirement of a 100 yard buffer strip between 
treated areas and water bodies, and (b) the practice of growing grass 
cover crops in most pear orchards.
    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 
consumption of contaminated water, the ranges the Agency is continuing 
to examine are all below the level that would cause fenoxycarb 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 fenoxycarb 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.
    iii. Non-dietary, non-occupational exposure. Fenoxycarb is 
registered for use on lawns, turf, pets, and inside domestic dwellings. 
The Agency, at this time, does not have exposure data with which to 
determine risk from these non-dietary, non-occupational uses. However, 
upon considering the registered uses, formulation types, persistence, 
and toxicological endpoints, the Agency has determined that, in the 
absence of exposure data, the registered non-dietary, non-occupational 
uses of fenoxycarb will be assigned a value of 20% of the acceptable 
aggregate chronic, and short- and intermediate-term risk. The 
registrant, Novartis, has proposed voluntarily canceling all home-owner 
applied uses of fenoxycarb.
    iv. Cancer considerations. Fenoxycarb has been classified as a 
Group B2 chemical by the Agency's Cancer Peer Review Committee based on 
lung carcinomas and Hardeian gland carcinomas in mice. The Committee 
recommended using the Q1* approach for calculating cancer risk 
estimates. The Q1* is 5.6  x  10-2 (mg/kg/day)-1. A 
dietary (food only) cancer risk assessment was calculated for the U.S. 
population and was adjusted for the duration of exposure of the Section 
18 (5 years) over a 70 year lifetime. The total oncogenic risk (food 
only) is 4.9  x  10-8. In the best scientific judgment of the 
Agency, chronic exposure to fenoxycarb residues resulting from 
potential residential and/or water exposure would not increase the 
total cancer risk so that it exceeds the Agency's level of concern.
    3. Short- and intermediate-term exposure. 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.
    The Agency considers dietary (food) MOEs of greater than 100 to be 
acceptable for fenoxycarb. In the absence of data for drinking water 
and non-dietary, non-occupational sources of exposure, 20% of the 
acceptable short-term risk will be reserved for indoor and outdoor non-
dietary, non-occupational exposure and the ranges of exposure for 
consumption of contaminated water, described above, will be reserved 
for drinking water. The aggregate MOE level of concern for dietary plus 
indoor and outdoor residential exposure is 125 and the addition of 
drinking water is not likely to raise the MOE level of concern above 
200. Despite the potential for short- and intermediate-term exposure to 
fenoxycarb in drinking water and from indoor and outdoor residential 
use, EPA does not expect the aggregate exposure to exceed the Agency's 
level of concern if the tolerance being considered in this document 
were granted. The Agency has therefore concluded that the potential 
short- and intermediate-term exposures associated with fenoxycarb in 
water, even at the higher levels the Agency is considering as a 
conservative upper bound, and from indoor and outdoor residential uses 
would not prevent the Agency from determining that there is a 
reasonable certainty of no harm if the tolerance is granted.

[[Page 20115]]

C. Cumulative Exposure to Substances with Common Mechanism of Toxicity

    Section 408(b)(2)(D)(v) requires that, when considering whether to 
establish, modify, or revoke a tolerance, the Agency consider 
``available information'' concerning the cumulative effects of a 
particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.'' The Agency believes that ``available 
information'' in this context might include not only toxicity, 
chemistry, and exposure data, but also scientific policies and 
methodologies for understanding common mechanisms of toxicity and 
conducting cumulative risk assessments. For most pesticides, although 
the Agency has some information in its files that may turn out to be 
helpful in eventually determining whether a pesticide shares a common 
mechanism of toxicity with any other substances, EPA does not at this 
time have the methodologies to resolve the complex scientific issues 
concerning common mechanism of toxicity in a meaningful way. EPA has 
begun a pilot process to study this issue further through the 
examination of particular classes of pesticides. The Agency hopes that 
the results of this pilot process will increase the Agency's scientific 
understanding of this question such that EPA will be able to develop 
and apply scientific principles for better determining which chemicals 
have a common mechanism of toxicity and evaluating the cumulative 
effects of such chemicals. The Agency anticipates, however, that even 
as its understanding of the science of common mechanisms increases, 
decisions on specific classes of chemicals will be heavily dependent on 
chemical specific data, much of which may not be presently available.
    Although at present the Agency does not know how to apply the 
information in its files concerning common mechanism issues to most 
risk assessments, there are pesticides as to which the common mechanism 
issues can be resolved. These pesticides include pesticides that are 
toxicologically dissimilar to existing chemical substances (in which 
case the Agency can conclude that it is unlikely that a pesticide 
shares a common mechanism of activity with other substances) and 
pesticides that produce a common toxic metabolite (in which case common 
mechanism of activity will be assumed).
    EPA does not have, at this time, available data to determine 
whether fenoxycarb 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, 
fenoxycarb 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 fenoxycarb has a common mechanism of toxicity 
with other substances.

D. Determination of Safety for U.S. Population

    1. Acute risk. The Agency has determined that there are no acute 
dietary endpoints of concern and an acute assessment is not required.
    2. Short- and intermediate-term risk. The calculated aggregate MOEs 
for short- and intermediate-term exposure were greater than 1,000,000 
(one million). The Agency typically considers dietary MOEs greater than 
100 to be acceptable. Despite the potential for short- and 
intermediate-term exposure to fenoxycarb in drinking water and from 
indoor and outdoor residential use, the calculated MOEs (>1,000,000) 
are well above the Agency's aggregate MOE level of concern.
    3. Chronic risk. Using the conservative TMRC exposure assumptions 
described above and taking into account the completeness and 
reliability of the toxicity data, EPA has concluded that aggregate 
dietary exposure to fenoxycarb will utilize < 1% of the RfD for the 
U.S. population. 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 fenoxycarb 
in drinking water and from non-dietary/non-occupational exposure, EPA 
does not expect the aggregate exposure to exceed 100% of the RfD. EPA 
concludes that there is a reasonable certainty that no harm will result 
from aggregate exposure to fenoxycarb residues.
    4. Cancer risk. Fenoxycarb has been classified as a Group B2 
chemical by the Agency's Cancer Peer Review Committee based on lung 
carcinomas and Hardeian gland carcinomas in mice. The Committee 
recommended using the Q1* approach for calculating cancer risk 
estimates. The Q1* is 5.6  x  10-2 (mg/kg/day)-1. A 
dietary (food only) cancer risk assessment was calculated for the U.S. 
population and was adjusted for the duration of exposure of the section 
18 (5 years) over a 70 year lifetime. The total oncogenic risk (food 
only) is 4.9  x  10-8. In the best scientific judgment of the 
Agency, chronic exposure to fenoxycarb residues resulting from 
potential residential and/or water exposure would not increase the 
total cancer risk so that it exceeds the Agency's level of concern.

E. Determination of Safety for Infants and Children

    In assessing the potential for additional sensitivity of infants 
and children to residues of fenoxycarb, EPA considered data from 
developmental toxicity studies in the rat and rabbit and a two-
generation reproduction study in the rat. The developmental toxicity 
studies are designed to evaluate adverse effects on the developing 
organism resulting from 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. The pre- 
and post-natal toxicology data base for fenoxycarb is complete with 
respect to current toxicological data requirements. There are no pre- 
or post-natal toxicity concerns for infants and children, based on the 
results of the rat and rabbit developmental toxicity studies and the 
two-generation rat reproduction study. The NOEL for developmental 
toxicity in rats was 500 mg/kg/day, the highest dose tested. The NOEL 
for maternal toxicity in rats was also 500 mg/kg/day, the highest dose 
tested. In the rabbit developmental study, the developmental NOEL was 
300 mg/kg/day, the highest dose tested, whereas the maternal toxicity 
NOEL/lowest observed effect level (LOEL) in rabbits was 100/300 mg/kg/
day based on decreased weight gain.
    In the two-generation rat reproduction study, the parental NOEL was 
10 mg/kg/day and the pup NOEL was 30 mg/kg/day. The parental LOEL was 
30 mg/kg/day based on decreased weight gain and the pup LOEL was 90 mg/
kg/day based on decreased weight gain and developmental delays. This 
study demonstrates that both the parental effects and the pup effects 
are the same and that parental rats are more sensitive than pups to the 
effects of fenoxycarb. There are no indications for post-natal 
sensitivity with respect to infants and children.
    1. Chronic risk. Using the conservative exposure assumptions 
described above, taking into account the completeness and reliability 
of the toxicity data, EPA has concluded that aggregate dietary exposure 
to fenoxycarb will utilize <1% of the RfD for infants and children. EPA 
generally has no

[[Page 20116]]

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 fenoxycarb in drinking water and from non-
dietary, non-occupational exposure, EPA does not expect the aggregate 
exposure to exceed 100% of the RfD. EPA concludes that there is a 
reasonable certainty that no harm will result to infants and children 
from aggregate exposure to fenoxycarb residues.
    2. Short- and intermediate-term risk. At present, the aggregate 
MOEs for short- and intermediate-term risk are >1,000,000. The Agency 
typically considers dietary MOEs greater than 100 to be acceptable. 
Despite the potential for short- and intermediate-term exposure to 
fenoxycarb in drinking water and from indoor and outdoor residential 
use, the calculated MOEs (> 1,000,000) are well above the Agency's 
aggregate MOE level of concern.
    This MOE calculation assumed TMRC dietary contributions, a value of 
20% reserved for indoor and outdoor residential uses and considered a 
range of exposure contributions from drinking water. These assumptions 
result in a risk assessment which over-estimates dietary exposure and 
provides conservative estimates for contributions from drinking water 
and indoor and outdoor residential uses. The large aggregate MOE 
calculated for this use of fenoxycarb provides assurance that there is 
a reasonable certainty of no harm for infants and children.

F. Safety Factor Considerations

    FFDCA section 408 provides that EPA shall apply an additional 
tenfold MOE (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 
exposure (safety) will be safe for infants and children. Margins of 
exposure (safety) are often referred to as uncertainty (safety) 
factors. EPA believes that reliable data support using the standard 
margin of exposure (usually 100x for combined inter- and intra-species 
variability) and not the additional tenfold margin of exposure 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 MOE. Based on current toxicological data 
requirements, the database for fenoxycarb relative to pre- (provided by 
rat and rabbit developmental studies) and post-natal (provided by the 
rat reproduction study) toxicity is complete. The data indicate that 
exposure pre- and post-natally to fenoxycarb did not result in 
unusually toxic or severe effects and that parents were more sensitive 
to fenoxycarb than infants and children. The additional uncertainty 
factor is not needed to protect the safety of infants and children. EPA 
concludes that there is reasonable certainty that no harm will result 
to infants and children from aggregate exposure to fenoxycarb residues.

V. Other Considerations

    There are no Mexican, Canadian, or Codex maximum residue levels 
established for residues of fenoxycarb on pears. There is a practical 
analytical method for detecting and measuring levels of fenoxycarb in 
or on food with a limit of detection that allows monitoring of food 
with residues at or above the levels set in these tolerances. EPA has 
provided information on this method to FDA. 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 Hwy., Arlington, VA 22202, 703-305-5805.

VI. Conclusion

    Therefore, a tolerance in connection with the FIFRA section 18 
emergency exemptions is established for residues of fenoxycarb in/on 
pears at 0.1 ppm.

VII. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
new section 408(e) and (l)(6) as was provided in the old section 408 
and in section 409. However, the period for filing objections is 60 
days, rather than 30 days. EPA currently has procedural regulations 
which govern the submission of objections and hearing requests. These 
regulations will require some modification to reflect the new law. 
However, until those modifications can be made, EPA will continue to 
use those procedural regulations with appropriate adjustments to 
reflect the new law.
    Any person may, by June 24, 1997, file written objections to any 
aspect of this regulation (including the automatic revocation 
provision) 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 
control number [OPP-300476]. 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

[[Page 20117]]

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.

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. This 
action does not impose any enforceable duty, or contain any ``unfunded 
mandates'' as described in Title II of the Unfunded Mandates Reform Act 
of 1995 (Pub. L. 104-4), or require prior consultation as specified by 
Executive Order 12875 (58 FR 58093, October 28, 1993), entitled 
Enhancing the Intergovernmental Partnership, or special consideration 
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. Nonetheless, the Agency has previously 
assessed whether establishing tolerances or exemptions from tolerance, 
raising tolerance levels, or expanding exemptions adversely impact 
small entities and concluded, as a generic matter, that there is no 
adverse impact. (46 FR 24950, May 4, 1981).
    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 in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: April 16, 1997.

Stephen L. Johnson,

Acting Director, Office of Pesticide Programs.
    Therefore, 40 CFR Chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:
    Authority: 21 U.S.C. 346a and 371.


    2. By adding Sec. 180.504 as follows:


Sec. 180.504 Fenoxycarb; tolerances for residues.

    (a) General. [Reserved]
    (b) Section 18 emergency exemptions. A time-limited tolerance is 
established for residues of the insecticide fenoxycarb, ethyl(2-[4-
phenoxyphenoxy]ethyl) carbamate, in or on the following commodity:

------------------------------------------------------------------------
                                     Parts per    Expiration/ Revocation
             Commodity                million              Date         
------------------------------------------------------------------------
Pears.............................          0.1           April 30, 1998
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 97-10749 Filed 4-24-97; 8:45 am]
BILLING CODE 6560-50-F