Document ID: EPA-HQ-OPP-2004-0306-0001
Agency: epa
Document Type: Rule
Title: Pyridalyl; Pesticide Tolerances
Posted Date: 2008-05-07T04:00Z

[Federal Register: May 7, 2008 (Volume 73, Number 89)]
[Rules and Regulations]               
[Page 25528-25533]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07my08-13]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2004-0306; FRL-8361-4]

 
Pyridalyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
pyridalyl in or on vegetables, leafy, except Brassica, group 4; 
Brassica, head and stem, subgroup 5A; vegetables, fruiting, group 8; 
mustard greens; and turnip greens. Valent U.S.A. Corporation and the 
International Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 7, 2008. Objections and 
requests for hearings must be received on or before July 7, 2008, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2004-0306. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at http://www.regulations.gov, or, 
if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket Facility 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Olga Odiott, Registration Division 
(7505P),

[[Page 25529]]

Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
(703) 308-9369; e-mail address: odiott.olga@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, any person may file an objection to 
any aspect of this regulation and may also request a hearing on those 
objections. You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in 40 CFR part 
178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2004-0306 in the subject line on the first page of 
your submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk as required by 40 CFR part 178 on or 
before July 7, 2008.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2004-0306, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of December 5, 2003 (68 FR 68044) (FRL-
7344-6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
2F6459 and 3E6592) (petition 3E6592 was inadvertently referred to as 
2E6592 in the December, 2003 FR notice) by Valent U.S.A. Corporation, 
1600 Riviera Ave., Suite 200, Walnut Creek, California 94596-8025 and 
the International Research Project Number 4 (IR-4), 681 U.S Highway 
1 South, North Brunswick, NJ, 08902-3390. Petition 2F6459 
requested that 40 CFR 180 be amended by establishing tolerances for 
residues of the insecticide pyridalyl, (pyridine, 2-[3-[2,6-dichloro-4-
[(3,3-dichloro-2-propenyl)oxy]phenoxy]propoxy]-5-(trifluoromethyl), in 
or on vegetables, leafy, except Brassica, group 4, at 20.0 parts per 
million (ppm); vegetables, fruiting, group 8, at 1.1 ppm; Brassica, 
head and stem, subgroup 5A, at 5.0 ppm; cotton seed at 0.4 ppm; meat at 
0.04 ppm; meat by-products at 0.05 ppm; animal fat at 1.0 ppm; and 
whole milk at 0.1 ppm; and to establish tolerances for residues of 
pyridalyl plus the metabolite 3,5-dichloro-4-[3-(5-trifluoromethyl-2-
pyridyloxy)]propoxy phenol (S-1812-DP) in or on the raw agricultural 
commodity cotton, gin byproducts at 23.0 ppm. Petition 3E6592 requested 
that 40 CFR 180 Part be amended by establishing tolerances for residues 
of pyridalyl in or on the raw agricultural commodities: Brassica, leafy 
greens, subgroup 5B, at 30 ppm; and turnip greens at 30 ppm. That 
notice referenced a summary of the petition prepared by Valent U.S.A. 
Corporation, the registrant, which is available to the public in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filing.
    Based upon review of the data supporting the petitions, EPA has 
determined that the proposed tolerances for Brassica, head and stem, 
subgroup 5A, and vegetables, fruiting, group 8, should be reduced to 
3.5 ppm; and 1.0 ppm respectively; that a tolerance for mustard greens 
at 30 ppm; should be proposed; and that the proposed tolerance for 
Brassica, leafy greens, subgroup 5B should be deleted. The reasons for 
these changes are explained in Unit IV.C. The Agency is evaluating 
additional environmental fate data and has not yet made a decision to 
register the outdoor uses associated with the proposed tolerances for 
cotton and related commodities. A decision to establish these 
tolerances will be made at such time when the Agency makes the 
determination to register these outdoor uses.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of 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) of FFDCA 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) of FFDCA 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

[[Page 25530]]

reasonable certainty that no harm will result to infants and children 
from aggregate exposure to the pesticide chemical residue....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, 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 and to 
make a determination on aggregate exposure for the following 
petitioned-for tolerances for residues of pyridalyl per se in or on 
vegetables, leafy, except Brassica, group 4, at 20 ppm; Brassica, head 
and stem, subgroup 5A at 3.5 ppm; vegetables, fruiting, group 8, at 1.0 
ppm; mustard greens at 30 ppm; and turnip greens at 30 ppm. EPA's 
assessment of exposures and risks associated with establishing 
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.
    Pyridalyl has low acute toxicity via the oral, dermal and 
inhalation routes of exposure but is a dermal sensitizer. There was no 
evidence of neurotoxicity seen in either the sub-chronic and chronic 
toxicity studies or the developmental and reproductive studies. There 
is low concern for prenatal and/or postnatal toxicity resulting from 
exposure to pyridalyl. Pyridalyl is classified as ``Not Likely to be 
Carcinogenic to Humans'' based on lack of carcinogenicity in mice and 
rats and overall negative findings in various mutagenicity studies.
    Specific information on the studies received and the nature of the 
adverse effects caused by pyridalyl as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in document pyridalyl in/on cotton, fruiting 
vegetables, leafy vegetables, head and stem Brassica vegetables, 
Brassica leafy greens, and turnip greens, shrubs, ornamentals and non-
bearing trees. HED Risk Assessment on page number 26 in docket ID 
number EPA-HQ-OPP-2004-0306.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed in the toxicology study identified as 
appropriate for use in risk assessment. However, if a NOAEL cannot be 
determined, the lowest dose at which adverse effects of concern are 
identified or a Benchmark Dose (BMD) approach is sometimes used for 
risk assessment. Uncertainty/safety factors (UFs) are used in 
conjunction with the POD to take into account uncertainties inherent in 
the extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. Safety is assessed for acute and chronic dietary 
risks by comparing aggregate food and water exposure to the pesticide 
to the acute population adjusted dose (aPAD) and chronic population 
adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the 
POD by all applicable UFs. Aggregate short-term, intermediate-term, and 
chronic-term risks are evaluated by comparing food, water, and 
residential exposure to the POD to ensure that the margin of exposure 
(MOE) called for by the product of all applicable UFs is not exceeded. 
This latter value is referred to as the Level of Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for pyridalyl used for 
human risk assessment is shown in Table 1 of this unit.

      Table 1.--Summary of Toxicological Doses and Endpoints for Pyridalyl for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of Departure and
          Exposure/Scenario               Uncertainty/Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-50 years of    An effect of concern attributable to a single exposure (dose) was not
 age)                                    identified from the oral toxicity studies, including the developmental
Acute dietary (general population                         toxicity studies in rats and rabbits.
 including infants and children).
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)      NOAEL= 3.4 mg/kg/day     cPAD = 0.034 mg/kg/day          Combined chronic
                                       UFA = 10x..............                                         toxicity/
                                       UFH = 10x..............                            carcinogenicity study-
                                       FQPA SF = 1x...........                                              rats
                                                                                         LOAEL = 17.1 miligrams/
                                                                                            kilogram/day (mg/kg/
                                                                                          day) on males and 21.1
                                                                                            mg/kg/day on females
                                                                                         based on decreased body
                                                                                           weights, weight gain,
                                                                                            and food efficiency.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)              Classified as ``Not likely to be Carcinogenic to Humans''
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a =
  acute, c = chronic). RfD = reference dose. LOC = level of concern.

[[Page 25531]]

C. Exposure Assessment

    Pyridalyl residues of concern for tolerance expression and risk 
assessment were determined to be: 3,5-dichloro-4-[3-(5-trifluoromethyl-
2-pyridyloxy)]propoxy phenol (S-1812-DP), 2-hydroxy-5-
trifluoromethylpyridine (HTFP), and 3-hydroxy-5-trifluoromethylpyridone 
(HPDO).
    Pyridalyl is the predominant residue in crops and livestock. S-
1812-DP is the only major metabolite observed in any of the metabolism 
studies and is found at significant levels in the cotton gin byproduct 
field trials. The toxicity of S-1812-DP is assumed to be comparable to 
the parent compound.
    Rotational crops did not take up parent pyridalyl or its metabolite 
S-1812-DP from the soil, but did take up metabolite HTFP. HTFP was then 
metabolized in rotational crops via oxidation to HPDO. Metabolites HTFP 
and HPDO are assumed to be of equivalent toxicity to the parent 
compound and are included as residues of concern.
    Pyridalyl is expected to be persistent in both soil and aquatic 
environments. However, S-1812-DP and HTFP, the major metabolites in the 
terrestrial field-dissipation studies, are expected to be more soluble 
and mobile than the parent compound, and therefore are included in the 
drinking water assessment.
    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to pyridalyl, EPA considered exposure under the petitioned-for 
tolerances for pyridalyl. EPA assessed dietary exposures from pyridalyl 
in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and 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 1-day or single exposure.
    No such effects were identified in the toxicological studies for 
pyridalyl; therefore, a quantitative acute dietary exposure assessment 
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the United States 
Department of Agricuulture (USDA) 1994-1996 and 1998 Continuing Surveys 
of Food Intake by Individuals (CSFII). As to residue levels in food, 
EPA used tolerance level residues and 100 percent crop treated (PCT) 
information for all commodities. In addition, Dietary Exposure 
Evaluation (DEEM/TM) (version 7.76) default processing 
factors were used for all processed commodities.
    iii. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for pyridalyl.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for pyridalyl in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of pyridalyl. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    The Agency used estimated environmental concentrations (EECs), 
which are the model estimates of a pesticide's concentration in water, 
to quantify pyridalyl drinking water exposure and risk as a Percent 
Reference Dose (%RfD) or %PAD. Drinking water levels of comparison 
(DWLOCs) were calculated and used as a point of comparison against the 
model estimates of the pesticide's concentration in water. DWLOCs are 
theoretical upper limits on a pesticide's concentration in drinking 
water in light of total aggregate exposure to a pesticide in food, and 
from residential uses. Since DWLOCs address total aggregate exposure to 
pyridalyl they are further discussed in the aggregate risk sections in 
Unit E.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models the EECs of pyridalyl for chronic exposures are estimated 
to be 1.64 parts per billion (ppb) for surface water and 3.4 ppb for 
ground water
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Pyridalyl is not registered for any specific use patterns that 
would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA 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.''
    EPA has not found pyridalyl to share a common mechanism of toxicity 
with any other substances, and pyridalyl does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that pyridalyl does not 
have a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see EPA's website at http://www.epa.gov/pesticides/
cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA safety 
factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There was low concern for 
the quantitative susceptibility in the 2-generation reproduction study, 
since there was clear NOAEL for the offspring toxicity, the effects of 
concern were well defined and used for risk assessment. Therefore, 
there are no concerns and no residual uncertainties with regard to 
prenatal and/or postnatal toxicity.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for pyridalyl is complete.
    ii. There is no indication that pyridalyl is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. There are no concerns and no residual uncertainties with 
regard to prenatal and/or postnatal toxicity.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground water and surface water modeling 
used to assess exposure to pyridalyl in drinking water. These

[[Page 25532]]

assessments will not underestimate the exposure and risks posed by 
pyridalyl.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to pyridalyl from food, 
drinking water, and residential uses, the Agency calculated DWLOCs 
which are used as a point of comparison against EECs. DWLOC values are 
not regulatory standards for drinking water. DWLOCs are theoretical 
upper limits on a pesticide's concentration in drinking water in light 
of total aggregate exposure to a pesticide in food and residential 
uses. In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water [e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure)]. This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the EPA's Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic term, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. No adverse effect resulting from a single-oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
pyridalyl is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to pyridalyl 
from food will utilize 35% of the cPAD for the U.S. population, 20% of 
the cPAD for all infants, and 59% of the cPAD for children 1-2 years 
old, the children subpopulation at greatest exposure. There are no 
residential uses for pyridalyl. There is potential for chronic dietary 
exposure to pyridalyl and its metabolites in drinking water. After 
calculating DWLOCs and comparing them to the EECs for surface water and 
ground water, EPA does not expect the aggregate exposure to exceed 100% 
of the cPAD, as shown in the following Table:

                                   Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Pyridalyl
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                     Surface       Ground
            Population Subgroup                                  cPAD mg/kg/day                          %cPAD        Water        Water       Chronic
                                                                                                         (Food)     EECa(ppb)    EECb(ppb)   DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population                                                                                0.034           35         1.64          3.4          780
--------------------------------------------------------------------------------------------------------------------------------------------------------
All infants (< 1 yr)                                                                           0.034           20         1.64          3.4          270
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 1-2 yrs.                                                                              0.034           59         1.64          3.4          140
--------------------------------------------------------------------------------------------------------------------------------------------------------
a Tier II PRZM-EXAMS - Index reservoir model, pyridalyl plus HTFP and S-1812-DP.
b Tier 1 SCI-GROW model, HTFP (highest value).

    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Pyridalyl is not registered for any use patterns that would result 
in residential exposure. Therefore, the short-term aggregate risk is 
the sum of the risk from exposure to pyridalyl through food and water 
and will not be greater than the chronic aggregate risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Pyridalyl is not registered for any use patterns that would result 
in intermediate-term residential exposure. Therefore, the intermediate-
term aggregate risk is the sum of the risk from exposure to pyridalyl 
through food and water, which has already been addressed, and will not 
be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. Pyridalyl is 
classified as ``not likely to be carcinogenic to humans'' by all 
relevant routes of exposure based on adequate studies in mice and rats 
and overall negative findings in various mutagenicity assays. 
Therefore, pyridalyl is not expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to pyridalyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography/nitrogen-
phosphorus detector (GC/NPD) methods RM-38P-1-1, RM-38M-1, and RM-38M-
1-1 for plant commodities; and RM-38P-2 and RM-38P-3-1 for livestock 
commodities) is available to enforce the tolerance expression. The 
methods may be requested from: Chief, Analytical Chemistry Branch, 
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; 
telephone number: (410) 305-2905; e-mail address: 
residuemethods@epa.gov. FDA multiresidue methods (protocols B, D, E, 
and F) are also available for enforcement of the tolerances (PAM Vol.I, 
Appendix II, 1/94).

[[Page 25533]]

B. International Residue Limits

    There are currently no U.S. or international Codex tolerances 
established for pyridalyl.

C. Revisions to Petitioned-For Tolerances

    Based on its review of submitted crop field trial data, EPA 
determined that the proposed tolerances for Brassica head and stem, 
subgroup 5A; and for fruiting vegetables, group 8 should be reduced to 
3.5 and 1.0 ppm, respectively. The Agency determined also that the data 
were not sufficient to support the proposed tolerance for Brassica 
leafy greens, subgroup 5B; although a mustard green tolerance at 30 ppm 
was supported by the data.

V. Conclusion

    Therefore, tolerances are established for residues of pyridalyl per 
se, in or on vegetables, leafy, except Brassica, group 4 at 20 ppm; 
Brassica, head and stem, subgroup 5A at 3.5 ppm; vegetables, fruiting, 
group 8 at 1.0 ppm; mustard greens at 30 ppm; and turnip greens at 30 
ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. 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). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, Actions Concerning Regulations 
That Significantly Affect Energy Supply, Distribution, or Use (66 FR 
28355, May 22, 2001) or Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). 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., nor does it require any special 
considerations under Executive Order 12898, entitled Federal Actions to 
Address Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, 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.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit 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 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: April 23, 2008.
Debra Edwards,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.640 is added to read as follows:

180.640  Pyridalyl; tolerances for residues.

    (a) General. Tolerances are established for residues of pyridalyl, 
pyridine,2-[3-[2,6-dichloro-4-[(3,3-dichloro-2-
propenyl)oxy]phenoxy]propoxy]-5-(trifluoromethyl, in or on the 
following raw agricultural commodities:)

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Brassica, head and stem, subgroup 5A.................                3.5
Mustard greens.......................................                 30
Turnip greens........................................                 30
Vegetable, fruiting, group 8.........................                1.0
Vegetables, leafy, except Brassica, group 4                           20
------------------------------------------------------------------------

    (b) Section 18 emergency exemption. [Reserved]
    (c) Tolerances with regional registration. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. E8-9823Filed 5-6-08; 8:45 am]