[Federal Register Volume 62, Number 163 (Friday, August 22, 1997)]
[Rules and Regulations]
[Pages 44552-44558]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22373]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300527; FRL-5736-9]
RIN 2070-AB78


Pyridate; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes a time-limited tolerance for 
combined residues of pyridate in or on chickpeas . This action is in 
response to EPA's granting of an emergency exemption

[[Page 44553]]

under section 18 of the Federal Insecticide, Fungicide, and Rodenticide 
Act authorizing use of the pesticide on chickpeas. This regulation 
establishes a maximum permissible level for residues of pyridate in 
this food commodity pursuant to section 408(l)(6) of the Federal Food, 
Drug, and Cosmetic Act, as amended by the Food Quality Protection Act 
of 1996. The tolerance will expire and is revoked on December 31, 1998.

DATES: This regulation is effective August 22, 1997. Objections and 
requests for hearings must be received by EPA on or before October 21, 
1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300527], 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-300527], must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7506C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. In person, 
bring a copy of objections and hearing requests to Rm. 1132, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: <a href="/cdn-cgi/l/email-protection#adc2dddd80c9c2cec6c8d9edc8ddccc0ccc4c183c8ddcc83cac2db"><span class="__cf_email__" data-cfemail="28475858054c474b434d5c684d584945494144064d5849064f475e">[email protected]</span></a>. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect 5.1 file 
format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket control 
number [OPP-300527]. 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: Andrew Ertman, 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) 308-9367, e-mail: 
<a href="/cdn-cgi/l/email-protection#86e3f4f2ebe7e8a8e7e8e2f4e3f1c6e3f6e7ebe7efeaa8e3f6e7a8e1e9f0"><span class="__cf_email__" data-cfemail="c3a6b1b7aea2adeda2ada7b1a6b483a6b3a2aea2aaafeda6b3a2eda4acb5">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing a tolerance for 
combined residues of the herbicide pyridate (O- (6-chloro-3-phenyl-4-
pyridazinyl)-S-octyl-carbonothioate), the metabolite 6-chloro-3-phenyl-
pyridazine-4-ol and conjugates of 6-chloro-3-phenyl-pyridazine-ol, 
expressed as pyridate, in or on chickpeas at 0.1 part per million 
(ppm). This tolerance will expire and is revoked on December 31, 1998. 
EPA will publish a document in the Federal Register to remove the 
revoked tolerance from the Code of Federal Regulations.

I. Background and Statutory Authority

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

    The applicants state that chickpea growers in the irrigated region 
of central Washington and north-central Oregon face an immediate crisis 
with broadleaf weeds infesting their chickpea crop. The problem 
occurred when there was a period of unusually cool, wet weather after 
planting in late March to mid-April, causing a delay in both crop and 
weed emergence. This delay, coupled with the breakdown in the pre-
emergence herbicide used, created a condition where broadleaf weeds 
were competing on an equal basis with the chickpea crop. Chickpeas are 
poor competitors with broadleaf weeds. The applicants state that the 
pre-emergence herbicides that were used (Sonalan and Prowl) have a 
shorter period of soil activity than the most effective pre-emergence 
herbicide available (Pursuit). However, because crop rotation includes 
potatoes, Pursuit could not be used.
    Because there are no post-emergence herbicides that are currently 
registered for use on chickpeas to control broadleaf weeds, the 
applicants assert that left uncontrolled, the broadleaf weed 
infestation could reduce crop yields by 50 to 60%. EPA has authorized 
under FIFRA section 18 the use of pyridate on

[[Page 44554]]

chickpeas for control of broadleaf weeds in Washington and Oregon. 
After having reviewed the submission, EPA concurs that emergency 
conditions exist for these states.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of pyridate in or on 
chickpeas. In doing so, EPA considered the new safety standard in FFDCA 
section 408(b)(2), and EPA decided that the necessary tolerance under 
FFDCA section 408(l)(6) would be consistent with the new safety 
standard and with FIFRA section 18. Consistent with the need to move 
quickly on the emergency exemption in order to address an urgent non-
routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing this tolerance without notice and opportunity 
for public comment under section 408(e), as provided in section 
408(l)(6). Although this tolerance will expire and is revoked on 
December 31, 1998, under FFDCA section 408(l)(5), residues of the 
pesticide not in excess of the amounts specified in the tolerance 
remaining in or on chickpeas 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 pyridate meets EPA's 
registration requirements for use on chickpeas 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 pyridate by a State for special local needs under FIFRA 
section 24(c). Nor does this tolerance serve as the basis for any 
States other than Washington and Oregon 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 pyridate, contact the Agency's 
Registration Division at the address provided above.

III. Risk Assessment and Statutory Findings

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides based primarily on toxicological studies using 
laboratory animals. These studies address many adverse health effects, 
including (but not limited to) reproductive effects, developmental 
toxicity, toxicity to the nervous system, and carcinogenicity. Second, 
EPA examines exposure to the pesticide through the diet (e.g., food and 
drinking water) and through exposures that occur as a result of 
pesticide use in residential settings.

A. Toxicity

    1. Threshold and non-threshold effects. For many animal studies, a 
dose response relationship can be determined, which provides a dose 
that causes adverse effects (threshold effects) and doses causing no 
observed effects (the ``no-observed effect level'' or ``NOEL'').
    Once a study has been evaluated and the observed effects have been 
determined to be threshold effects, EPA generally divides the NOEL from 
the study with the lowest NOEL by an uncertainty factor (usually 100 or 
more) to determine the Reference Dose (RfD). The RfD is a level at or 
below which daily aggregate exposure over a lifetime will not pose 
appreciable risks to human health. An uncertainty factor (sometimes 
called a ``safety factor'') of 100 is commonly used since it is assumed 
that people may be up to 10 times more sensitive to pesticides than the 
test animals, and that one person or subgroup of the population (such 
as infants and children) could be up to 10 times more sensitive to a 
pesticide than another. In addition, EPA assesses the potential risks 
to infants and children based on the weight of the evidence of the 
toxicology studies and determines whether an additional uncertainty 
factor is warranted. Thus, an aggregate daily exposure to a pesticide 
residue at or below the RfD (expressed as 100% or less of the RfD) is 
generally considered acceptable by EPA. EPA generally uses the RfD to 
evaluate the chronic risks posed by pesticide exposure. For shorter 
term risks, EPA calculates a margin of exposure (MOE) by dividing the 
estimated human exposure into the NOEL from the appropriate animal 
study. Commonly, EPA finds MOEs lower than 100 to be unacceptable. This 
100-fold MOE is based on the same rationale as the 100-fold uncertainty 
factor.
    Lifetime feeding studies in two species of laboratory animals are 
conducted to screen pesticides for cancer effects. When evidence of 
increased cancer is noted in these studies, the Agency conducts a 
weight of the evidence review of all relevant toxicological data 
including short-term and mutagenicity studies and structure activity 
relationship. Once a pesticide has been classified as a potential human 
carcinogen, different types of risk assessments (e.g., linear low dose 
extrapolations or MOE calculation based on the appropriate NOEL) will 
be carried out based on the nature of the carcinogenic response and the 
Agency's knowledge of its mode of action.
    2. Differences in toxic effect due to exposure duration. The 
toxicological effects of a pesticide can vary with different exposure 
durations. EPA considers the entire toxicity data base, and based on 
the effects seen for different durations and routes of exposure, 
determines which risk assessments should be done to assure that the 
public is adequately protected from any pesticide exposure scenario. 
Both short and long durations of exposure are always considered. 
Typically, risk assessments include ``acute'', ``short-term'', 
``intermediate term'', and ``chronic'' risks. These assessments are 
defined by the Agency as follows.
    Acute risk, by the Agency's definition, results from 1-day 
consumption of food and water, and reflects toxicity which could be 
expressed following a single oral exposure to the pesticide residues. 
High end exposure to food and water residues are typically assumed.
    Short-term risk results from exposure to the pesticide for a period 
of 1-7 days, and therefore overlaps with the acute risk assessment. 
Historically, this risk assessment was intended to address primarily 
dermal and inhalation exposure which could result, for example, from 
residential pesticide applications. However, since enaction of FQPA, 
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from 
food, water, and residential uses when reliable data are available. In 
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all 3 
sources are not typically added because of the very low probability of 
this occurring in most cases, and because the other conservative 
assumptions built into the assessment assure adequate protection of 
public health. However, for cases in which high-end exposure can 
reasonably be expected from multiple sources (e.g. frequent and 
widespread homeowner use in a specific geographical area), multiple 
high-end risks will be aggregated and presented as part of the 
comprehensive risk assessment/characterization. Since the toxicological 
endpoint considered in this assessment reflects exposure over a period 
of at least 7 days, an additional

[[Page 44555]]

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 (children 1-6 
years 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 pyridate 
and to make a determination on aggregate exposure, consistent with 
section 408(b)(2), for a time-limited tolerance for combined residues 
of pyridate on chickpeas at 0.1 ppm. EPA's assessment of the dietary 
exposures and risks associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by pyridate are 
discussed below.
    1. Chronic toxicity. EPA has established the RfD for pyridate at 
0.11 milligrams/kilogram/day (mg/kg/day). This RfD is based on a two 
year chronic feeding study in rats with a NOEL of 10.8 mg/kg/day and an 
uncertainty factor of 100 based on body weight depression in the males 
at the lowest effect level (LEL) of 67.5 mg/kg/day. The 3-generation 
reproduction study was considered co-critical with a NOEL of 10.8 mg/
kg/day and an lowest observed effect level (LOEL) of 67.5 mg/kg/day. 
Depressed maternal and pup body weight gains were observed at the LOEL.
    2. Carcinogenicity. Pyridate has not been to the Office of 
Pesticide Program's Cancer Peer Review Committee. However, mouse and 
rat oncogenicity studies indicate that pyridate was negative in both 
species for carcinogenic effects.

B. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.462) for the combined residues of pyridate (O- (6-chloro-3-
phenyl-4-pyridazinyl)-S-octyl-carbonothioate), the metabolite 6-chloro-
3-phenyl-pyridazine-4-ol and conjugates of 6-chloro-3-phenyl-
pyridazine-ol, expressed as pyridate, in or on a variety of raw 
agricultural commodities including cabbage, corn (grain, fodder, 
forage, silage) and peanuts (nutmeats, hulls), all at 0.03 ppm. Risk 
assessments were conducted by EPA to assess dietary exposures and risks 
from pyridate as follows:
    Chronic exposure and risk. In conducting this chronic dietary risk 
assessment, EPA has made very conservative assumptions -- 100% of 
chickpeas and all other commodities having pyridate tolerances will 
contain 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.
    The existing pyridate tolerances (published, pending, and including 
the necessary Section 18 tolerance(s)) result in a Theoretical Maximum 
Residue Contribution (TMRC) that is equivalent to the following 
percentages of the RfD:
    U.S. population at <1.0%; nursing infants at <1.0%; non-nursing 
infants (<1 year old) at <1.0%; children (1-6 years old) at <1.0%; and, 
children (7-12 years old) at <1.0%
    The subgroups listed above are: (1) the U.S. population (48 
states); (2) those for infants and children; and, (3) the other 
subgroups for which the percentage of the RfD occupied is greater than 
that occupied by the subgroup U.S. population (48 states).
    2. From drinking water. Based on information available to the 
Agency, pyridate is not persistent and not mobile. There is no 
established Maximum Contaminant Level for residues of (pyridate) in 
drinking water. No health advisory levels for pyridate in drinking 
water have been established.
     Chronic exposure and risk. Because the Agency lacks sufficient 
water-related exposure data to complete a comprehensive drinking water 
risk assessment for many pesticides, EPA has commenced and nearly 
completed a process to identify a reasonable yet conservative bounding 
figure for the potential contribution of water-related

[[Page 44556]]

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 pyridate 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 pyridate 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. Pyridate is not registered for any 
residential uses at this time. Therefore, no non-dietary, non-
occupational exposure is anticipated.
    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 pyridate 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, 
pyridate 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 pyridate has a common mechanism of toxicity 
with other substances.

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

    1. Acute risk. An acute aggregate risk is not required for pyridate 
as no acute toxicity endpoint has been identified. There are also no 
non-dietary non-occupational exposures. The Agency acknowledges the 
potential for exposure to pyridate in drinking water, but does not 
expect that exposure would result in an aggregate (margin of exposure) 
MOE (food plus water) that would exceed the Agency's level of concern 
for acute dietary exposure.
    2. Chronic risk. Using the conservative TMRC exposure assumptions, 
and taking into account the completeness and reliability of the 
toxicity data, EPA has concluded that aggregate exposure to pyridate 
from food will utilize <1.0% 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 pyridate 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 chronic aggregate exposure to pyridate residues.

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

    1. Safety factor for infants and children-- a. In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of pyridate, EPA considered data from 
developmental toxicity studies in the rat and rabbit and a three-
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.
    b. Developmental toxicity studies. In the developmental study in 
rats, the maternal (systemic) NOEL was 165 mg/kg/day, based on 
mortality and decreased body weight at the LOEL of 400 mg/kg/day. The 
developmental (fetal) NOEL was 165 mg/kg/day, based on increased 
incidence of missing and/or unossified sternabrae and decreased

[[Page 44557]]

fetal body weight at the LOEL of 400 mg/kg/day.
    In the developmental toxicity study in rabbits, the maternal 
(systemic) NOEL was 300 mg/kg/day, based on body weight depression at 
the LOEL of 600 mg/kg/day. The developmental (pup) NOEL was 600 mg/kg/
day, the highest dose tested.
    c. Reproductive toxicity study. In the 3-generation reproductive 
toxicity study in rats, the maternal (systemic) NOEL was 10.8 mg/kg/
day, based on body weight depression at the LOEL of 67.5 mg/kg/day. The 
developmental/reproductive (pup) NOEL was 10.8 mg/kg/day, based on body 
weight loss at the LOEL of 67.5 mg/kg/day.
    d. Pre- and post-natal sensitivity. The toxicological data base for 
evaluating pre- and post-natal toxicity for pyridate is complete with 
respect to current 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 3-generation rat 
reproductive toxicity study. Based on the developmental and 
reproductive toxicity studies discussed above, there does not appear to 
be an extra sensitivity for pre- or post-natal effects.
    e. Conclusion. EPA concludes that reliable data support use of the 
standard 100-fold margin of exposure/uncertainty factor and that an 
additional margin/factor is not needed to protect infants and children.
    2. Chronic risk. Using the conservative exposure assumptions 
described above, EPA has concluded that aggregate exposure to pyridate 
from food will utilize less than 1% 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 pyridate 
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 pyridate residues.

V. Other Considerations

A. Metabolism In Plants and Animals

    The nature of the pyridate residue in plants and ruminants is 
adequately understood. The total toxic residue consists of pyridate (O- 
(-chloro-3-phenyl-4-pyridazinyl) -S-octyl-carbonothioate), its 
metabolite 6-chloro-3-phenyl-pyridazine-4-ol (aka CL9673), and 
conjugates of that metabolite, all expressed as pyridate. .

B. Analytical Enforcement Methodology

    A total residue method using UV--HPLC is available for residue data 
gathering and enforcement purposes. The method has been adequately 
validated by recovery data, has passed a successful method trial, and 
has been forwarded to FDA for publication in PAM-II. The limit of 
quantitation is 0.03 ppm..

C. Magnitude of Residues

    Residues of pyridate, its metabolite 6-chloro-3-phenyl-pyridazine-
4-ol and conjugates of that metabolite all expressed as pyridate are 
not expected to exceed 0.1 ppm in/on chickpeas. 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, Mexican, or Canadian MRLs established for 
pyridate in/on chickpeas.

VI. Conclusion

    Therefore, the tolerance is established for combined residues of 
pyridate (O- (6-chloro-3-phenyl-4-pyridazinyl)-S-octyl-carbonothioate), 
the metabolite 6-chloro-3-phenyl-pyridazine-4-ol and conjugates of 6-
chloro-3-phenyl-pyridazine-ol, expressed as pyridate in/on chickpeas 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 October 21, 1997, file written objections to any 
aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of 
the objections and/or hearing requests filed with the Hearing Clerk 
should be submitted to the OPP docket for this rulemaking. The 
objections submitted must specify the provisions of the regulation 
deemed objectionable and the grounds for the objections (40 CFR 
178.25). Each objection must be accompanied by the fee prescribed by 40 
CFR 180.33(i). If a hearing is requested, the objections must include a 
statement of the factual issues on which a hearing is requested, the 
requestor's contentions on such issues, and a summary of any evidence 
relied upon by the requestor (40 CFR 178.27). A request for a hearing 
will be granted if the Administrator determines that the material 
submitted shows the following: There is genuine and substantial issue 
of fact; there is a reasonable possibility that available evidence 
identified by the requestor would, if established, resolve one or more 
of such issues in favor of the requestor, taking into account 
uncontested claims or facts to the contrary; and resolution of the 
factual issues in the manner sought by the requestor would be adequate 
to justify the action requested (40 CFR 178.32). Information submitted 
in connection with an objection or hearing request may be claimed 
confidential by marking any part or all of that information as 
Confidential Business Information (CBI). Information so marked will not 
be disclosed except in accordance with procedures set forth in 40 CFR 
part 2. A copy of the information that does not contain CBI must be 
submitted for inclusion in the public record. Information not marked 
confidential may be disclosed publicly by EPA without prior notice.

VIII. Public Docket

    EPA has established a record for this rulemaking under docket 
control number [OPP-300527] (including any comments and data submitted 
electronically). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Room 1132 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7506C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    Electronic comments may be sent directly to EPA at:
    <a href="/cdn-cgi/l/email-protection#94fbe4e4b9f0fbf7fff1e0d4f1e4f5f9f5fdf8baf1e4f5baf3fbe2"><span class="__cf_email__" data-cfemail="d0bfa0a0fdb4bfb3bbb5a490b5a0b1bdb1b9bcfeb5a0b1feb7bfa6">[email protected]</span></a>.

    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.

[[Page 44558]]

    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer any copies of objections and hearing requests 
received electronically into printed, paper form as they are received 
and will place the paper copies in the official rulemaking record which 
will also include all comments submitted directly in writing. The 
official rulemaking record is the paper record maintained at the 
Virginia address in ``ADDRESSES'' at the beginning of this document.

IX. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d). 
The Office of Management and Budget (OMB) has exempted these types of 
actions from review under Executive Order 12866, entitled Regulatory 
Planning and Review (58 FR 51735, October 4, 1993). This final rule 
does not contain any information collections subject to OMB approval 
under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or 
impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Pub. L. 104-4). Nor does it require any prior consultation as 
specified by Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or 
special considerations as required by Executive Order 12898, entitled 
Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994), 
or require OMB review in accordance with Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997).
    In addition, since these tolerances and exemptions that are 
established under FFDCA section 408 (l)(6), such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. Nevertheless, the Agency has previously assessed 
whether establishing tolerances, exemptions from tolerances, raising 
tolerance levels or expanding exemptions might adversely impact small 
entities and concluded, as a generic matter, that there is no adverse 
economic impact. The factual basis for the Agency's generic 
certification for tolerance 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: August 12, 1997.

James Jones,
Acting Director, Registration Division, 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. Section 180.462 is amended to read as follows:
    a. By designating the existing text as paragraph (a) and adding a 
heading.
    b. By adding paragraph (b).
    c. By adding the headings and reserving paragraphs (c) and (d).
    Section 180.462, as amended, reads as follows:


Sec. 180.462  Pyridate; tolerances for residues.

    (a) General  . * * * 
    (b) Section 18 emergency exemptions. A time-limited tolerance is 
established for the residue of the herbicide pyridate in connection 
with use of the pesticide under section 18 emergency exemptions granted 
by EPA. This tolerance will expire and is revoked on the date specified 
in the following table:

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    revocation
                                                  million        date   
------------------------------------------------------------------------
Chickpeas.....................................          0.1     12/31/98
------------------------------------------------------------------------

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

[FR Doc. 97-22373 Filed 8-21-97; 8:45 am]
BILLING CODE 6560-50-F


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>