Pendimethalin; Pesticide Tolerances for Emergency Exemptions, 11489-11494 [E9-5831]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 74, Number 51 (Wednesday, March 18, 2009)]
[Rules and Regulations]
[Pages 11489-11494]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-5831]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0513; FRL-8400-1]


Pendimethalin; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
combined residues of pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-
2,6-dinitrobenzenamine] and its metabolite 4-[(1-ethylpropyl)amino]-2-
methyl-3,5-dinitrobenzyl alcohol, in or on Bermuda grass forage and 
hay. This action is in response to crisis exemptions issued by the 
Texas Department of Agriculture and the Oklahoma Department of 
Agriculture under section 18 of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) authorizing use of the pesticide on Bermuda 
grass pastures and hay fields. This regulation establishes a maximum 
permissible level for residues of pendimethalin in these feed 
commodities. The time-limited tolerances expire and are revoked on 
December 31, 2009.

DATES: This regulation is effective March 18, 2009. Objections and 
requests for hearings must be received on or before May 18, 2009, 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-2008-0513. To access the 
electronic docket, go to https://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 either in the electronic docket at https://
www.regulations.gov, or, if only available in hard copy, at the Office 
of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One 
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The 
hours of operation of this Docket Facility are 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: Stacey Groce, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-2505; e-mail address: Groce.Stacey@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:
     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 provides 
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 https://
www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at https://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at https://
www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), 
any person may file an objection to any aspect of this regulation and 
may also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. 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-2008-0513 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 on or 
before May 18, 2009.
    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

[[Page 11490]]

may be disclosed publicly by EPA without prior notice. Submit your 
copies, identified by docket ID number EPA-HQ-OPP-2008-0513, by one of 
the following methods:
     Federal eRulemaking Portal: https://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. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing 
time-limited tolerances for combined residues of the herbicide, 
pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine], 
and its metabolite 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl 
alcohol, in or on Bermuda grass forage and hay at 25 parts per million 
(ppm) and 60 ppm, respectively. These time-limited tolerances expire 
and are revoked on December 31, 2009. EPA will publish a document in 
the Federal Register to remove the revoked tolerances from the Code of 
Federal Regulations (CFR).
    Section 408(l)(6) of 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. EPA does not intend for its actions on 
section 18 related time-limited tolerances to set binding precedents 
for the application of section 408 of FFDCA to other tolerances and 
exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance 
or an exemption from the requirement of a tolerance on its own 
initiative, i.e., without having received any petition from an outside 
party.
    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 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.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemptions for Pendimethalin on Bermuda Grass Forage and 
Hay and FFDCA Tolerances

    The Texas and Oklahoma Departments of Agriculture requested 
emergency exemptions for use of pendimethalin on Bermuda grass to 
control common sandbur and other sandbur species (Cenchrus echinatus), 
and issued crisis exemptions for this use pursuant to 40 CFR part 166, 
subpart C. The states provided information indicating that sandbur 
species is a serious pest that commonly infests Bermuda grass forage 
and hay fields. Pendimethalin has been authorized under FIFRA section 
18 for use on Bermuda grass forage and hay to control sandbur in Texas 
and Oklahoma under the crisis provision.
    As part of its evaluation of the emergency exemption applications, 
EPA assessed the potential risks presented by residues of pendimethalin 
in or on Bermuda grass forage and hay. In doing so, EPA considered the 
safety standard in section 408(b)(2) of FFDCA, and EPA decided that the 
necessary tolerances under section 408(l)(6) of FFDCA would be 
consistent with the safety standard and with FIFRA section 18. 
Consistent with the need to move quickly on the emergency exemptions in 
order to address urgent non-routine situations and to ensure that the 
resulting food is safe and lawful, EPA is issuing these tolerances 
without notice and opportunity for public comment as provided in 
section 408(l)(6) of FFDCA. Although these time-limited tolerances 
expire and are revoked on December 31, 2009, under section 408(l) (5) 
of FFDCA, residues of the pesticide not in excess of the amounts 
specified in the tolerances remaining in or on Bermuda grass forage and 
hay after that date will not be unlawful, provided the pesticide was 
applied in a manner that was lawful under FIFRA, and the residues do 
not exceed a level that was authorized by these time-limited tolerances 
at the time of that application. EPA will take action to revoke these 
time-limited tolerances earlier if any experience with, scientific data 
on, or other relevant information on this pesticide indicate that the 
residues are not safe.
    Because these time-limited tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether 
pendimethalin meets FIFRA's registration requirements for use on 
Bermuda grass forage and hay or whether permanent tolerances for this 
use would be appropriate. Under these circumstances, EPA does not 
believe that these time-limited tolerance decisions serve as a basis 
for registration of pendimethalin by a State for special local needs 
under FIFRA section 24(c). Nor do these tolerances serve as the basis 
for persons in any States other than Texas and Oklahoma to use this 
pesticide on the applicable crops under FIFRA section 18 absent the 
issuance of an emergency exemption applicable within that State. For 
additional information regarding the emergency exemption for 
pendimethalin, contact the Agency's Registration Division at the 
address provided under FOR FURTHER INFORMATION CONTACT.

IV. 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 11491]]

reasonable certainty that no harm will result to infants and children 
from aggregate exposure to the pesticide chemical residue....''
    Consistent with the factors specified in FFDCA section 
408(b)(2)(D), EPA has reviewed the available scientific data and other 
relevant information in support of these actions. EPA has sufficient 
data to assess the hazards of and to make a determination on aggregate 
exposure expected as a result of these emergency exemption requests and 
the time-limited tolerances for combined residues of pendimethalin [N-
(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine] and its metabolite 
4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol on Bermuda 
grass forage and hay at 25 ppm and 60 ppm, respectively. EPA's 
assessment of exposures and risks associated with establishing time-
limited tolerances follows.

A. 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 (the NOAEL) 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 (the LOAEL) 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 https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for pendimethalin used for 
human risk assessment can be found at https://www.regulations.gov in the 
May 20, 2008 document: Pendamethalin. Human Health Risk Assessment for 
the Proposed Food/Feed Use of the Herbicide (associated with Section 18 
Registration) on Bermuda Grass Forage and Hay Fields in Texas on pages 
6 and 7 of 22 in docket ID number EPA-HQ-OPP-2008-0513.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to pendimethalin, EPA considered exposure under the time-
limited tolerances established by this action as well as exposures 
pursuant to existing tolerances in (40 CFR 180.361). EPA assessed 
dietary exposures from pendimethalin in food as follows:
    i. Acute exposure. No acute effects were identified in the 
toxicological studies for pendimethalin; therefore, a quantitative 
assessment of acute dietary exposure was not conducted.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the United States 
Department of Agriculture (USDA) 1994-1996 and 1998 Continuing Survey 
of Food Intake by Individuals (CSFII). As to residue levels in food, 
EPA assumed tolerance-level residues of pendimethalin in or on all 
current and proposed raw agricultural commodities in 40 CFR 180.361, 
empirical processing factors obtained from processing studies, maximum 
theoretical concentration factor of 8.0 for wheat bran and wheat germ, 
and 1.4 for wheat flour, Dietary Exposure Evaluation Model (DEEM) 7.81 
default processing factors were used for the remaining processed 
commodities, 100% crop treated, and 0.006 ppm pendimethalin estimated 
drinking water concentration (EDWC).
    iii. Cancer. EPA has classified pendimethalin as a Group ``C'' 
possible human carcinogen, based on thyroid follicular cell adenomas 
observed in rats. The chronic dietary assessment using the cPAD is 
considered to be protective of any potential cancer effects because 
mode of action studies are available, which demonstrate that the 
thyroid tumors are due to a thyroid-pituitary imbalance. Pendimethalin 
has shown to be nonmutagenic in mammalian somatic cells and germ cells. 
Therefore, a separate cancer exposure assessment was not conducted.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for pendimethalin. Tolerance level residues and/or 
100 PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for pendimethalin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of pendimethalin. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the EDWCs of pendimethalin for acute exposures are 
estimated to be 77.7 parts per billion (ppb) for surface water and 
0.036 ppb for ground water. For chronic exposures non-cancer 
assessments are estimated to be 6.0 ppb for surface water and 0.036 ppb 
for ground water.
    Modeled EDWCs were directly entered into the dietary exposure 
model. An acute dietary endpoint was not identified; therefore a 
quantitative assessment of risk was not conducted for pendimethalin. 
For the chronic dietary risk assessment, the water concentration of 
value 6.0 ppb was used to assess the contribution to drinking 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).
    Pendimethalin is currently registered for the following uses that 
could result in residential exposures: Recreational and residential 
turf (including home lawns, golf courses, athletic fields, etc.), and 
ornamentals. EPA assessed residential exposure using the following 
assumptions: Exposures are short-term in duration, and consist of the 
following scenarios: (i) Dermal (adult and children) exposed to 
residential turf and (ii) oral exposure from hand-to-mouth, object-to-
mouth, and soil ingestion for children only. The Agency combined all 
non-dietary sources of handler and post-

[[Page 11492]]

application exposure to obtain an estimate of potential aggregate 
exposure. The LOC for oral, dermal and inhalation exposure is an MOE of 
less than 300. The residential exposure estimate for adults (consisting 
of dermal exposure only) results in a total MOE of 740, and is 
therefore not of concern. Inhalation post-application was not assessed 
because there are no indoor residential uses associated with 
pendimethalin products, and inhalation exposure resulting from outdoor 
uses is expected to be negligible. The residential exposure for 
children results in total MOEs (dermal + oral) >=400, based on 
application rates of 2 pounds active ingredient/acre (lbs. ai/acre) and 
3 lbs. ai/acre. Residential aggregate exposure is not of concern.
    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 pendimethalin to share a common mechanism of 
toxicity with any other substances, and pendimethalin does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
pendimethalin 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 the policy statements 
released by EPA's Office of Pesticide Programs concerning common 
mechanism determinations and procedures for cumulating effects from 
substances found to have a common mechanism on EPA's website at https://
www.epa.gov/pesticides/cumulative.

C. 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 pre-natal 
and post-natal 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 SF when reliable 
data available to EPA support the choice of a different factor.
    2. Pre-natal and post-natal sensitivity. The pre- and post-natal 
toxicology database for pendimethalin includes rat and rabbit 
developmental toxicity studies and a 2-generation reproduction toxicity 
study in rats. There was no indication of pre-/or post-natal 
qualitative or quantitative increased susceptibility in the 
developmental studies in rats and rabbits or the 2-generation 
reproduction studies in rats. However, because developmental LOAELs 
could not be determined in the developmental studies, the Agency has 
requested developmental thyroid toxicity data in order to determine 
potential thyroid toxicity following pre- and/or post-natal exposure to 
pendimethalin.
    The rabbit toxicity study with pendimethalin did not demonstrate 
maternal or developmental toxicity at doses up to 60 milligram/
kilogram/day (mg/kg/day) (highest dose tested). Since neither maternal 
nor developmental toxicity was seen at the highest dose tested, 
potential for increased sensitivity of the offspring could not be 
determined.
    In the 2-generation reproduction study in rats, there was no 
evidence of increased susceptibility of offspring. Effects in the pups 
(decreased pup body weight gain and possible decrease in number of pups 
born alive and pup survival) were seen at doses that also resulted in 
parental toxicity (decreased body weight).
    3. Conclusion. EPA has determined that the FQPA SF of 10X must be 
retained. This decision is based on the following findings:
    i. The toxicity database for pendimethalin contains all of the 
standard toxicity studies. However, there is uncertainty regarding 
potential thyroid effects seen in some of these studies. Based on the 
hormonal changes (alterations in thyroid weights and histopathological 
lesions) observed in several studies following oral administration of 
pendimethalin, it is likely that pendimethalin may cause disruption in 
the endocrine system. There is concern that perturbation of thyroid 
homeostasis may lead to hypothyroidism and possibly result in adverse 
effects on the developing nervous system. Consequently, EPA has 
recommended that a developmental thyroid assay be conducted to evaluate 
the impact of pendimethalin on thyroid hormones, structure, and/or 
thyroid hormone homeostasis during development. The 10X database UF 
will be retained for non-occupational exposure scenarios pending 
receipt of the study.
    ii. Although, there is no evidence that pendimethalin results in 
increased susceptibility in in-utero rats or rabbits in the pre-natal 
developmental studies or in young rats in the 2-generation reproduction 
study, the developmental studies were not adequate to fully assess the 
potential for susceptibility. Consequently, there is concern for 
potential increased sensitivity or susceptibility in offspring 
regarding thyroid effects.
    Although the exposure estimate is very conservative and there are 
no neurotoxic concerns for pendimethalin, there is sufficient 
uncertainty regarding thyroid effects, particularly thyroid effects in 
the young, that EPA is retaining the 10X FQPA safety factor. EPA has 
also determined that the traditional 10X UF to account for interspecies 
variation may be reduced to 3X since it has been established that rats 
are more susceptible to thyroid effects than humans. These factors, 
together with the traditional 10X UF to account for intraspecies 
variation, result in a total uncertainty factor of 300X (10X, 3X, and 
10X).

D. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-term, intermediate-term, and 
chronic-term risks are evaluated by comparing the estimated aggregate 
food, water, and residential exposure to the POD to ensure that the MOE 
called for by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. None of the toxicology studies available for 
pendimethalin has indicated the possibility of an effect of concern 
occurring as a result of a 1-day or single exposure was identified, 
therefore, dietary exposure presents no acute risks of concern.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic dietary 
exposure to

[[Page 11493]]

pendimethalin from food and water will utilize 15% of the cPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure. Based on the use patterns, chronic residential exposure to 
residues of pendimethalin is not expected, so chronic risk is a 
function of dietary exposure alone. Thus the chronic aggregate exposure 
for the most exposed group is below EPA's LOC.
    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).
    Pendimethalin is currently registered for uses that could result in 
short-term residential exposure and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to pendimethalin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that the combined short-term food, 
water, and residential exposures aggregated result in aggregate MOEs of 
650 for adult males, 580 for adult females, and for children (1 to 2 
years old) results in a total MOE of 350 or 340 depending on the 
application rate assessed at either 2 lbs. ai/acre or 3lbs. ai/acre. 
The aggregate MOEs for adults are based on the residential turf 
scenario and include combined food, drinking water and post-application 
dermal exposures. The aggregate MOEs for children include food, 
drinking water, post-application dermal and incidental oral exposures 
from entering turf areas previously treated with pendimethalin. Since 
the LOC for oral, dermal, and inhalation exposure is an MOE of less 
than 300, short-term aggregate exposure is not of concern for any of 
the population subgroups.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term non-dietary, non-occupational 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level).
    Pendimethalin 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 pendimethalin 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. Pendimethalin has 
been classified as a ``Group C'' possible human carcinogen based on 
thyroid follicular cell adenomas observed in rats. EPA concludes that 
the chronic dietary assessment is protective of any potential cancer 
effects.
    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 pendimethalin residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the 
tolerance expression. Methods I through IV in the Pesticide Analytical 
Manual (PAM) Volume II are gas chromatography with electron capture 
detection (GC/ECD) methods for the determination of pendimethalin 
residues of concern in plant commodities. The method 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.

B. International Residue Limits

    There are currently no Canadian, Mexican, or Codex maximum residue 
limits for pendimethalin on the commodities for which tolerances are 
being established.

VI. Conclusion

    Therefore, time-limited tolerances are established for combined 
residues of the herbicide pendimethalin, [N-(1-ethylpropyl)-3,4-
dimethyl-2,6-dinitrobenzenamine], and its metabolite 4-[(1-
ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol, in or on Bermuda 
grass forage and hay at 25 ppm and 60 ppm. These tolerances expire and 
are revoked on December 31, 2009.

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under sections 408(e) and 
408(l)(6) of FFDCA on EPA's own initiative. 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 in accordance 
with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerances 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).

VIII. 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.

[[Page 11494]]

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: February 12, 2009.
Lois Rossi,
Director, Registration Division, 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 180.361 is amended by revising paragraph (b) to read as 
follows:


Sec.  180.361  Pendimethalin; tolerances for residues

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for combined residues 
of the herbicide pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6-
dinitrobenzenamine], and its metabolite 4-[(1-ethylpropyl)amino]-2-
methyl-3,5-dinitrobenzyl alcohol, in or on the specified agricultural 
commodities, resulting from use of the pesticide pursuant to FIFRA 
section 18 emergency exemptions. The tolerances expire and are revoked 
on the date specified in the table.

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   revocation date
------------------------------------------------------------------------
Bermuda grass, forage.............                 25           12/31/09
Bermuda grass, hay................                 60           12/31/09
------------------------------------------------------------------------

* * * * *
[FR Doc. E9-5831 Filed 3-17-09; 8:45 am]
BILLING CODE 6560-50-S