[Federal Register Volume 62, Number 100 (Friday, May 23, 1997)]
[Rules and Regulations]
[Pages 28355-28361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13643]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300493; FRL-5718-5]
RIN 2070-AB78


Pendimethalin; Pesticide Tolerance for Emergency Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of the herbicide pendimethalin and its 3,5-dinitrobenzyl 
alcohol metabolite (CL 202, 347) in or on fresh mint hay and mint oil 
in connection with EPA's granting an emergency exemption under section 
18 of the Federal Insecticide, Fungicide, and Rodenticide Act 
authorizing use of the pesticide on mint in Idaho, Oregon, South Dakota 
and Washington. These tolerances will expire and are revoked on May 31, 
1998.
DATES: This regulation becomes effective May 23, 1997. Objections and 
requests for hearings must be received by EPA on or before July 22, 
1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300493], 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-300493], must be submitted to: Public Information 
and Records Integrity Branch, Information Resources and Services 
Division, (7506C), Office of Pesticide Programs, Environmental

[[Page 28356]]

Protection Agency, 401 M St., SW., Washington, DC 20460. In person, 
bring a copy of objections and hearing requests to Rm. 1132, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: [email protected]. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect 5.1 file 
format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket control 
number [OPP-300493]. 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), Office of Pesticide Programs, 
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: [email protected].
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing tolerances for 
the combined residues of the herbicide pendimethalin and its 3,5-
dinitrobenzyl alcohol metabolite (CL 202, 347), hereafter referred to 
in this document as pendimethalin, in or on fresh mint hay at 0.1 parts 
per million (ppm) and in or on mint oil at 5.0 ppm. These tolerances 
will expire and be revoked by EPA on May 31, 1998. After May 31, 1998, 
EPA will publish a document in the Federal Register removing 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 FFDCA, 21 
U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. Among other things, FQPA 
amends FFDCA to bring all EPA pesticide tolerance-setting activities 
under 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) 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 
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 Pendimethalin on Mint and FFDCA 
Tolerances

    On March 3, 1997, the Idaho, Oregon, and Washington State 
Departments of Agriculture availed of themselves the authority to 
declare the existence of a crisis situation within their states, 
thereby authorizing use under FIFRA section 18 of pendimethalin on mint 
to control kochia (Kochia scoparia) and redroot pigweed (Amaranthus 
retroflexus). The South Dakota Department of Agriculture has since 
requested a specific exemption for the same use. Kochia and redroot 
pigweed have become serious pests for mint growers in these states. The 
loss of mechanical control as a weed control option (due to potential 
spread of Verticillium wilt by tillage equipment), lack of a 
satisfactory herbicide, and the presence of herbicide-resistant pigweed 
and kochia have all contributed to the development of this emergency 
condition. Additionally, the presence of these weeds in the harvested 
mint results in reduction in quality and price of the mint oil. Without 
effective control of these weeds, yield losses of up to 35% in these 
states are expected, resulting in significant economic losses to the 
mint growers.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of pendimethalin in or on 
mint. In doing so, EPA considered the new safety standard in FFDCA 
section 408(b)(2), and EPA decided that the necessary tolerances under 
FFDCA section 408(l)(6) would be consistent with the new safety 
standard and with FIFRA section 18. These tolerances will permit the 
marketing of mint 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 these tolerances without notice and opportunity 
for public comment under section 408(e), as provided in section 
408(l)(6). Although these tolerances will expire and are revoked on May 
31, 1998, under FFDCA section 408(l)(5), residues of the pesticide not 
in excess of the amounts specified in the tolerances remaining in or on 
mint hay and mint oil after that date will not be unlawful, provided 
the pesticide is applied during the term of, and in accordance with all 
the conditions of, section 18 of FIFRA. EPA will take action to revoke 
these tolerances 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 pendimethalin meets 
EPA's registration requirements for use on mint or whether permanent 
tolerances for this use would be appropriate. These tolerances do not 
serve as a basis for registration of

[[Page 28357]]

pendimethalin by a State for special local needs under FIFRA section 
24(c). Nor do these tolerances serve as the basis for any States other 
than Idaho, Oregon, South Dakota or Washington 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 pendimethalin, 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 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 
hundredfold margin of exposure is based on the same rationale as the 
hundredfold 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 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.
    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. 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. Pendimethalin is already registered by EPA for numerous 
food and feed uses, as well as residential use on ornamental lawns, 
grasses, ground covers, turf, and ornamental plantings. For the purpose 
of this emergency exemption, EPA has sufficient data to assess the 
hazards of pendimethalin and to make a determination on aggregate 
exposure, consistent with 408(b)(2), for time-limited tolerances for 
residues of pendimethalin on fresh mint (peppermint, spearmint) hay at 
0.1 ppm and mint (peppermint, spearmint) oil at 5.0 ppm. EPA's 
assessment of the dietary exposures and risks associated with 
establishing these tolerances 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 pendimethalin are 
discussed below.
    1. Acute toxicity. For acute dietary risk assessment, the Agency 
has determined that there are no toxicological endpoints of concern and 
that this risk assessment is not required.
    2. Short- and intermediate-term toxicity. OPP has determined that 
short- and intermediate-term risk assessments are appropriate for non-
occupational, non-dietary routes of exposure. OPP recommends that the 
NOEL of 10 milligrams per kilogram per day (mg/kg/day), taken from the 
56-day thyroid function study in rats, be used for the

[[Page 28358]]

short and intermediate term MOE calculations. The lowest effect level 
(LEL) of 31 mg/kg/day from a 14-day intrathyroid metabolism study in 
rats was based on thyroid hormonal effects occurring as early as Day 3. 
Though these endpoints have been identified, no acceptable reliable 
exposure data to assess these potential risks are available at this 
time.
    3. Chronic toxicity. The RfD of 0.1 mg/kg/day was established based 
on a combination of three studies in male rats: (i) A 56-day oral 
thyroid function study; (ii) a 92-day thyroid function study; and (iii) 
a 14-day intrathyroidal metabolism study. The NOEL was established at 
10 mg/kg/day. The LOEL of 31 mg/kg/day was based on thyroid hormonal 
changes and histologic thyroid changes. An Uncertainty Factor (UF) of 
100 was applied to account for both interspecies and intraspecies 
variability.
    4. Carcinogenicity. Pendimethalin has been classified as a Group C, 
``possible human carcinogen'', chemical by OPP, based on a 
statistically significant increased trend and pairwise comparison 
between the high dose group and controls for thyroid follicular cell 
adenomas in male and female rats. OPP recommends using the RfD approach 
for quantification of human risk. Therefore, the RfD is deemed 
protective of all chronic human health effects, including cancer.

B. Aggregate Exposure

    Tolerances have been established (40 CFR 180.361) for the combined 
residues of pendimethalin and its 3,5-dinitrobenzyl alcohol metabolite 
(CL 202, 347), in or on a variety of raw agricultural commodities at 
levels ranging from 0.05 ppm in rice grain to 0.1 ppm in corn, peanuts, 
soybeans and other commodities. The proposed time-limited tolerances 
are based on residue data provided with the section 18 submissions. 
There are no livestock feed items associated with this section 18 use, 
so no additional livestock dietary burden is expected.
    For the purpose of assessing potential chronic dietary exposure 
from pendimethalin, EPA assumed tolerance level residues and 100% crop 
treated to estimate the Theoretical Maximum Residue Contribution (TMRC) 
for major identifiable subgroups of consumers, including infants and 
children, from the proposed and existing food uses of pendimethalin. 
The use of these assumptions results in a conservative dietary exposure 
assessment, which EPA takes into consideration when making a safety 
determination for the subject section 18 tolerances.
    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). 
Based on information in the Herbicide Handbook of the Weed Science 
Society of America (7th ed, 1994), pendimethalin has low solubility in 
water and strong absorption to soil. Pendimethalin is essentially 
immobile in all soil types, being strongly bound to organic matter and 
clay, thus minimizing its potential to runoff to surface water or leach 
to ground water.
    No Maximum Concentration Level and no Health Advisory Level has 
been established for residues of pendimethalin in drinking water. 
Information in the Pesticides in Groundwater Database (EPA 734-12-92-
001, 9/92) indicates that 1,405 wells were sampled for residues of 
pendimethalin. Detectable residues were reported (0.02 to 0.9 
/L) in only 1% (14) of those sampled wells.
    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 exposure from pendimethalin 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 pendimethalin 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.
    Pendimethalin is currently registered for use on the following 
residential non-food sites: ornamental lawns, grasses, ground covers, 
turf, and ornamental plantings. While EPA does not consider that these 
types of outdoor residential uses constitute a chronic residential 
exposure scenario, EPA acknowledges that there may be short- and 
intermediate-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 
these tolerances based on those factors which it can reasonably 
integrate into a risk assessment.

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

[[Page 28359]]

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 pendimethalin 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, 
pendimethalin 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 pendimethalin has a common mechanism of 
toxicity with other substances.

D. Aggregate Risks and Determination of Safety for U.S. Population

    1. Chronic risk. Using the conservative exposure assumptions 
described above, EPA has concluded that aggregate exposure to 
pendimethalin from food will utilize less than 1% of the RfD for the 
U.S. population. The major identifiable subgroup with the highest 
aggregate exposure is non-nursing infants less than 1 year old 
(discussed below). 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 pendimethalin 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 
pendimethalin residues.
    2. Cancer risk. Pendimethalin has been classified as a Group C, 
``possible human carcinogen'', chemical by OPP; it is recommended that 
the RfD approach for quantification of human risk be used. Given that 
the RfD is considered protective of all chronic human health effects, 
including cancer, and that EPA does not expect aggregate exposure to 
the U.S. population to exceed 100% of the RfD, carcinogenicity 
resulting from aggregate exposure to pendimethalin residues is not of 
concern.

E. Aggregate Risks and Determination of Safety for Infants and Children

    In assessing the potential for additional sensitivity of infants 
and children to residues of pendimethalin, 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.
    The pre- and post-natal toxicology data base for pendimethalin is 
complete with respect to current toxicological data requirements. The 
data base does not indicate a potential for increased sensitivity from 
pre- and post-natal exposure.
    No developmental toxicity was observed in either the rat or rabbit 
developmental toxicity studies, nor was there any evidence in the 2-
generation toxicity study that there was developmental or reproductive 
toxicity at dose levels below those in which parental toxicity was 
observed. For rabbits, the developmental toxicity NOEL was > 60 mg/kg/
day, at the highest dose tested (HDT). The maternal NOEL was > 60 mg/
kg/day, based upon mortality observed at 125 mg/kg/day in a pilot 
study. For rats, there were no maternal or developmental effects at any 
dose level and the NOELs were  500 mg/kg/day, the highest 
dose tested.
    In the 2-generation reproductive toxicity study in rats, the 
parental (systemic) NOEL could not be determined at the doses tested. 
The reproductive NOEL was 172 mg/kg/day. The reproductive LOEL of 346 
mg/kg/day was based on decreased pup weight, which occurred in the 
presence of parental (systemic) toxicity at 346 mg/kg/day.
    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 margin of exposure 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 margin of exposure and uncertainty factor (usually 
100 for combined inter- and intra-species variability)) and not the 
additional tenfold margin of exposure/uncertainty factor when EPA has a 
complete database 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 margin of exposure/safety factor.
    The reproductive NOEL of 172 mg/kg/day is seventeenfold higher than 
the NOEL of 10 mg/kg/day used for the RfD. Additionally, the 
reproductive LOEL occurred in the presence of parental (systemic) 
toxicity and there was no evidence of developmental toxicity in either 
the rat or the rabbit studies. Therefore, OPP concludes that these 
section 18 requests do not represent any unacceptable pre- or post-
natal risk to infants and children.
    Using the conservative exposure assumptions described above, EPA 
has concluded that aggregate exposure to pendimethalin from food will 
utilize less than 2% of the RfD for infants and children. 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 pendimethalin 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 pendimethalin residues.

V. Other Considerations

    The nature of the residue in plants is adequately understood. The 
regulable residue in mint is pendimethalin and its 3,5-dinitrobenzyl 
alcohol metabolite (CL 202,347), as per 40 CFR 180.361(a). Adequate 
enforcement methodology, GC/ECD, is available in the Pesticide

[[Page 28360]]

Analytical Manual, Vol. II, to enforce the tolerance expression. The 
combined residues of pendimethalin plus its regulated metabolite (CL 
202,347) are not expected to exceed 0.1 ppm in/on fresh mint 
(peppermint, spearmint) hay or 5.0 ppm in mint (peppermint, spearmint) 
oil as a result of these section 18 uses. There are no Codex, Canadian, 
or Mexican international residue limits established for residues of 
pendimethalin in/on mint.

VI. Conclusion

    Therefore, tolerances in connection with the FIFRA section 18 
emergency exemptions are established for residues of pendimethalin in 
fresh mint hay at 0.1 ppm and in mint oil at 5.0 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 July 22, 1997, file written objections to any 
aspect of this regulation (including the 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 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

    The official record for this rulemaking, as well as the public 
version, has been established for this rulemaking under docket control 
number [OPP-300493] (including comments and data submitted 
electronically as described below). 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 official rulemaking record is located at the address in 
``ADDRESSES'' at the beginning of this document.
    Electronic comments can be sent directly to EPA at:
    [email protected]

    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption. Comment and data 
will also be accepted on disks in Wordperfect 5.1 file format or ASCII 
file format. All comments and data in electronic form must be 
identified by the docket number [OPP-300493]. Electronic comments on 
this proposed rule may be filed online at many Federal Depository 
Libraries.

IX. Regulatory Assessment Requirements

    This action finalizes a tolerance under section 408 of the FFDCA. 
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). In addition, 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 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 special 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, pursuant to the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.), the Agency 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 (46 FR 24950, May 4, 1981). In accordance with Small Business 
Administration (SBA) policy, this determination will be provided to the 
Chief Counsel for Advocacy of the SBA upon request.

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 in 40 CFR Part 180

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

    Dated: May 15, 1997.

Peter Caulkins,

Acting Director, Registration Divison, 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:

[[Page 28361]]

    Authority: 21 U.S.C. 346a and 371.

    2. Section 180.361 is amended as follows:
    i. In paragraph (a) by adding a paragraph heading.
    ii. In paragraph (b) by transferring the entry in the table for 
``Peanuts, hulls'' to the table in paragraph (a), and by revising the 
remainder of paragraph (b).
    iii. In paragraph (c) by adding a paragraph heading.
    iv. By adding and reserving paragraph (d).


Sec. 180.361  Pendimethalin, tolerances for residues.

    (a) General.  *  *  *
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the herbicide pendimethalin in connection 
with use of the pesticide under section 18 emergency exemptions granted 
by EPA. The tolerances will expire and are revoked on the dates 
specified in the following table:

------------------------------------------------------------------------
                                           Parts per      Expiration/   
                Commodity                   million     Revocation Date 
------------------------------------------------------------------------
Mint hay, fresh.........................      0.1 ppm            5/31/98
Mint oil................................      5.0 ppm            5/31/98
------------------------------------------------------------------------

    (c)  Tolerances with regional registrations. *  *  *
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 97-13643 Filed 5-22-97; 8:45 am]
BILLING CODE 6560-50-F