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dicloran Pesticide Tolerances for Emergency Exemptions 12/97


[Federal Register: January 5, 1998 (Volume 63, Number 2)]
[Rules and Regulations]               
[Page 156-162]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05ja98-6]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300596; FRL-5762-4]
RIN 2070-AB78

 
Dicloran; 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 dicloran, 2,6-dichloro-4-nitroaniline in or on peanuts. 
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 peanuts. This regulation 
establishes a maximum permissible level for residues of dicloran 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 October 31, 1999.

DATES: This regulation is effective January 5, 1998. Objections and 
requests for hearings must be received by EPA on or before March 6, 
1998.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300596], 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-300596], must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. In person, 
bring a copy of objections and hearing requests to Rm. 1132, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1 
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-300596]. 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: Virginia Dietrich, 
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) 308-9359, e-mail: 
dietrich.virginia@epamail.epa.gov.

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, dicloran, 2,6-dichloro-4-nitroaniline, in or 
on peanuts at 3 part per million (ppm) for peanuts and 6 ppm for peanut 
oil. This tolerance will expire and is revoked on October 31, 1999. 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) 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

[[Page 157]]

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 dicloran on peanuts and FFDCA 
Tolerances

    The Oklahoma Department of Agriculture requested a specific 
exemption for the use of dicloran on peanuts due to the high rainfall 
and corresponding high fungal disease incidence in Oklahoma this year. 
After having reviewed the submission, EPA has authorized under FIFRA 
section 18 the use of dicloran on peanuts for control of Sclerotinia 
blight in Oklahoma.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of dicloran in or on peanuts. 
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 October 31, 1999, 
under FFDCA section 408(l)(5), residues of the pesticide not in excess 
of the amounts specified in the tolerance remaining in or on peanuts 
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 dicloran meets EPA's 
registration requirements for use on peanuts 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 dicloran 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 Oklahoma 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 dicloran, 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 
hundredfold MOE 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 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

[[Page 158]]

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 three 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 less than 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 dicloran 
and to make a determination on aggregate exposure, consistent with 
section 408(b)(2), for a time-limited tolerance for residues of 2,6-
dichloro-4-nitroaniline on peanuts at 3 ppm for peanuts and 6 ppm for 
peanut oil. 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 dicloran are 
discussed below.
    1. Acute toxicity. No acute dietary toxicity (risk) endpoints have 
been identified at this time for Dicloran (dichloronitroaniline; DCNA). 
Therefore, this assessment is not required.
     2. Short - and intermediate - term toxicity. No short- or 
intermediate-term toxicity end points were found to be appropriate by 
the Agency's Ad Hoc Toxcity Endpoint Selection Committee (AHTESC).
    3. Chronic toxicity. For dietary risk, EPA has established the 
Reference dose (RfD) for dicloran at 0.025 milligrams/kilogram/day (mg/
kg/day). This RfD is based on a 2-year feeding study in dogs with a 
NOEL of 2.5 mg/kg/day and an uncertainty factor of 100. The lowest 
observed effect level (LOEL) is based on increased liver weights and 
histological changes at 75.0 mg/kg/day. The Agency also determined that 
a chronic toxicity endpoint and risk assessment for dicloran is not 
required since the use of dicloran on a short-term basis for this 
emergency exemption does not present a chronic occupational exposure 
scenario.
    4. Carcinogenicity. Dicloran has not been classified by the Cancer 
Peer Review Committee. However, no cancer risks have been identified in 
either the mouse or the rat study by the Agency's Ad Hoc Toxicity 
Endpoint Selection Committee.

B. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.200) for the residues of 2,6-dichloro-4-nitroaniline, in or on 
a variety of raw agricultural commodities at levels ranging from 0.1 
ppm in cottonseed to 20 ppm in several fruits. Risk assessments were 
conducted by EPA to assess dietary exposures and risks from dicloran 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. After reviewing data available on the 
acute toxicity of dicloran, the Agency concluded that no such 
toxicological endpoint of concern was demonstrated. The Agency further 
concluded that a risk assessment for this endpoint was not necessary.
    ii. Chronic exposure and risk. In conducting this chronic dietary 
risk assessment, the Agency has made

[[Page 159]]

conservative assumptions -- 100% of the peanuts treated. For most other 
commodities having Dicloran tolerances, anticipated residues from 
monitoring data were utilized. For several crops where it appears that 
no registrations exist, tolerance levels were used even though zero may 
have been more appropriate. Even though monitoring data were used for a 
number of commodities, the risk assessment still results in an 
overestimation of human dietary exposure. Thus, in making a safety 
determination for this tolerance, the Agency is taking into account 
this conservative exposure assessment.
    The existing Dicloran tolerances (published, pending, and including 
the necessary section 18 tolerance(s)) result in an Anticipated Residue 
Contribution (ARC) that is equivalent to the following percentages of 
the RfD:

------------------------------------------------------------------------
                                                              Percentage
                         Subgroups                              of RFD  
------------------------------------------------------------------------
U.S. Population (48 States)................................          2.6
Nursing Infants (< 1 year old).............................          7.1
Non-Nursing Infants (< 1 year old).........................         11.3
Children (1-6 years old)...................................          5.6
Children (7-12 years old)..................................          3.7
------------------------------------------------------------------------

    2. From drinking water. Based on information in the Agency's files, 
Dicloran is persistent and somewhat mobile. There are no established 
Maximum Contaminant Levels for residues of Dicloran in drinking water. 
No health advisory levels for Dicloran in drinking water have been 
established.
    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 (RfDs 
or acute dietary NOELs) 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 well below the level that would cause Dicloran 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 Dicloran 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. Dicloran currently has no registered 
uses on residential non-food sites. Therefore, there is no residential 
non-food exposure.
    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 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 dicloran 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, 
dicloran 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 dicloran has a common mechanism of toxicity 
with other substances.

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

    1. Acute risk. The Agency's Ad Hoc Toxicity Selection Committee 
(TESC) did not identify an acute dietary end point for dicloran and 
determined that this risk assessment is not appropriate.
    2. Chronic risk. Using the ARC exposure assumptions described 
above, EPA has concluded that aggregate exposure to dicloran from food 
will utilize 2.6% of the RfD for the U.S. population. The major 
identifiable subgroup with the highest aggregate exposure is non-
nursing infants which is 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 dicloran 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 dicloran residues.
    3. Short- and intermediate-term risk. The ad hoc TESC determined 
that there are no short term or intermediate term toxicological 
endpoints. Additionally, the ad hoc TESC has determined that there are 
no non-dietary, non-occupational, i.e. residential uses registered for 
Dicloran. Therefore no short term or intermediate term aggregate 
exposure assessments were conducted.

D. Aggregate Cancer Risk for U.S. Population

     The Cancer Peer Review Committee has not reviewed or classified 
Dicloran

[[Page 160]]

as to its cancer potential. However, no carcinogenicity potential has 
been identified in either the long term mouse or rat studies.

E. 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 dicloran, 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.
    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 MOE 
and uncertainty factor (usually 100 for combined inter- and intra-
species variability) and not the additional tenfold MOE/uncertainty 
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 MOE/safety factor.
    ii. Developmental toxicity studies. In the developmental study in 
rats, the maternal (systemic) NOEL was 100 mg/kg/day, based on CNS 
depression at the LOEL of 200 mg/kg/day. The developmental (fetal) NOEL 
was 100 mg/kg/day, based on decreased body weight, skeletal variations 
and visceral variations at the LOEL of 200 mg/kg/day. In the 
developmental (feeding) toxicity study in rabbits, the maternal 
(systemic) NOEL was 1,000 ppm which was equivalent to 30 mg/kg/day, the 
highest dose tested. The developmental (pup) NOEL was 30 mg/kg/day. The 
reproductive (pup) NOEL was 30 mg/kg/day, the highest dose tested.
    iii. Reproductive toxicity study. In the 3 generation (single dose) 
reproductive toxicity study in rats, the maternal (systemic) NOEL was 
100 ppm which was equivalent to 5.0 mg/kg/day. The developmental (pup) 
NOEL was 5.0 mg/kg/day. The reproductive (pup) NOEL was 5.0 mg/kg/day.
    iv. Pre- and post-natal sensitivity. The toxicological data base 
for evaluating pre- and post-natal toxicity for DCNA is not complete 
with respect to the current data requirements. However, there are no 
pre- or post-natal toxicity concerns for infants and children, based on 
the results of the available rat and rabbit developmental toxicity 
studies and the three generation rat reproductive study. The NOEL for 
maternal and developmental toxicity are at the same dose level in rat 
and rabbit. This indicates no extra pre-natal sensitivity for infants 
and children. The request for a rabbit gavage study to replace the 
dietary developmental study does not suggest any extra pre-natal 
sensitivity is present in the current study but is required to fulfill 
current guideline requirements. The current three generation rat 
reproduction study demonstrated no additional pre- or post-natal extra 
sensitivity for infants and children since the maternal reproductive 
and developmental NOELs occurred at the same dose levels. The 
replacement study is being requested to fulfill current guideline 
requirements (e.g. for the reproduction study, a study testing two 
generations and three doses is being conducted). Based on the 
developmental and reproductive studies discussed above for DCNA there 
does not appear to be an extra sensitivity for pre- and post-natal 
effects.
    v. Conclusion. Based on the above EPA concludes that the available 
data support use of the standard hundredfold margin of exposure/
uncertainty factor and that an additional factor/margin of safety is 
not needed to protect infants and children.
    2. Acute risk. The ad hoc TESC did not identify an acute dietary 
end point for DCNA and determined that this risk assessment is not 
required. Therefore no aggregate acute risk assessment was performed.
    The Agency acknowledges the potential for exposure to Dicloran in 
drinking water, but does not expect that exposure would result in 
aggregate MOEs (food plus water) that would 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 dicloran 
from food will utilize from 11.3% for non-nursing infants less than 1 
year old, to 5.6% for children 1-6 years old 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 dicloran 
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 dicloran residues.
    4. Short- or intermediate-term risk. The Agency's ad hoc TESC 
determined that there are no short term or intermediate term 
toxicological endpoints. Additionally, the ad hoc TESC has determined 
that there are no non-dietary, non-occupational, i.e. residential, uses 
registered for Dicloran. Therefore no short term or intermediate term 
aggregate exposure assessments were conducted.

V. Other Considerations

A. Metabolism In Plants and Animals

    For this section 18 request only, the nature of the residue in 
plants is adequately understood. The residue of concern is the parent 
compound 2,6-dichloro-4-nitroanaline as specified in 40 CFR 180.200.

B. Analytical Enforcement Methodology

    Adequate enforcement methodology is available in PAM II to enforce 
the tolerance expression.

C. Magnitude of Residues

    Residues of Dicloran are not expected to exceed 3.0 ppm in/on 
peanuts or 6.0 ppm in its processed byproducts peanuts, oil as a result 
of this section 18 use. A time-limited tolerance should be established 
at this level. Secondary residues are not expected in animal 
commodities as no feed items are associated with this section 18 use.

D. International Residue Limits

    There are no CODEX, Canadian or Mexican limits for Dicloran on 
peanuts.

E. Rotational Crop Restrictions.

    The planting of spinach is restricted as a follow-up crop to 
onions, garlic and shallots, and the planting of tomatoes is restricted 
as a follow-up crop to sweet potatoes.

VI. Conclusion

    Therefore, the tolerance is established for residues of 2,6-
dichloro-4-

[[Page 161]]

nitroaniline in peanuts at 3 ppm for peanuts and 6 ppm for peanut oil.

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 March 6, 1998, 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 Record and Electronic Submissions

    EPA has established a record for this rulemaking under docket 
control number [OPP-300596] (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 (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments may be sent directly to EPA at:
    opp-docket@epamail.epa.gov.

    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 action finalizes a tolerance under FFDCA section 408(e). 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, under 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. The factual basis for the Agency's generic certification for 
tolerance actions 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 in 40 CFR Part 180

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

Dated: December 17, 1997.
James Jones
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. In Sec. 180.200, by revising the section heading, designating 
the existing text as paragraph (a), adding a paragraph heading, 
designating the text following the heading as paragraph (a)(1),

[[Page 162]]

designating the text following the table as paragraph (a)(2), and by 
adding paragraph (b), and by adding and reserving paragraphs (c) and 
(d) with headings to read as follows:


Sec. 180.200  Dicloran; tolerances for residues.

    (a) General. (1) *    *    *
    (2) *    *    *
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for combined residues of the fungicide, dicloran, 2,6-
dichloro-4-nitroaniline 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 
------------------------------------------------------------------------
Peanut, oil.............................          6.0           10/31/99
Peanuts.................................          3.0           10/31/99
------------------------------------------------------------------------

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

[FR Doc. 98-73 Filed 1-2-98; 8:45 am]
BILLING CODE 6560-50-F