Document ID: EPA-HQ-OPP-2007-0146-0003
Agency: epa
Document Type: Rule
Title: Alachlor; Pesticide Tolerance
Posted Date: 2007-09-26T04:00Z

[Federal Register: September 26, 2007 (Volume 72, Number 186)]
[Rules and Regulations]               
[Page 54579-54584]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26se07-17]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0146; FRL-8147-2]

 
Alachlor; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation revises and separates the tolerances for 
alachlor in Sec.  180.249 into paragraphs (a) through (d). This 
regulation also establishes several new tolerances under paragraph (a). 
It further establishes several new tolerances under paragraph (d). 
Details of these changes are outlined in Unit II. of this document. 
Monsanto Company requested these changes as submitted by petitions to 
EPA pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 26, 2007. Objections and 
requests for hearings must be received on or before November 26, 2007, 
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-2007-0146. 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: Vickie Walters, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5704; e-mail address: walters.vickie@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), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    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-2007-0146 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 November 26, 2007.

[[Page 54580]]

    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-2007-0146, 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 May 9, 2007 (72 FR 26372) (FRL-8121-5), 
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 0F2348, 
9F3776, 3F4179, 8F5000, 8F5025) by Monsanto Company, 1300 I St., NW., 
Suite 450 East, Washington, DC 2005. The petitions requested that 40 
CFR 180.249 be amended by establishing a tolerance for residues of the 
herbicide alachlor (2-chloro-2',6'-diethyl-N-
(methoxymethyl)acetanilide)and its metabolites which can be converted 
to 2,6-diethylaniline (DEA) or 2-ethyl-6-(1-hydroxyethyl)aniline (HEEA) 
upon basic hydrolysis, calculated as alachlor, in or on corn, fodder, 
and corn, forage at 2.0 ppm (0F2348); soybean at 1.0 ppm (9F3776); 
beans, dry and beans, succulent lima at 0.1 ppm; cowpea, forage and 
cowpea, hay at 5.0 ppm (3F4179); cotton, gin byproducts at 0.7 ppm; 
cotton, undelinted seed at 0.03 ppm; sunflower, seed at 2.5 ppm; and in 
the processed commodity sunflower, seed meal at 3.4 ppm (8F5000); 
grain, cereal group 15, except corn, rice, and sorghum forage at 0.05 
ppm; grain, cereal, forage, fodder, and straw, group 16, except corn, 
rice, and sorghum forage at 0.6 ppm; hay and straw at 0.8 ppm; and 
nongrass animal feed, crop group 18, forage at 1.4 ppm and hay at 1.2 
ppm (8F5025). PP 3F4179 also proposed that the current tolerances for 
bean, forage and bean, hay at 0.2 ppm be revoked, as these are no 
longer significant animal feed commodities. That notice referenced a 
summary of the petitions prepared by Monsanto Company, 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 is 
increasing the tolerance for peanut to 0.5 ppm. This tolerance will be 
listed in Sec.  180.249(a). The Agency is correcting the tolerance 
expression for Sec.  180.249(a) to read ``Tolerances are established 
for combined residues of the herbicide alachlor (2-chloro-2',6'-
diethyl-N-(methoxymethyl)acetanilide) and its metabolites which can be 
converted to 2,6-diethylaniline (DEA) or 2-ethyl-6-(1-
hydroxyethyl)aniline (1-HEEA) upon basic hydrolysis, calculated as 
alachlor in or on the following food commodities:'' The terminology for 
the current listings of corn, fresh, kernel plus cob with husk removed; 
sorghum, forage; and sorghum, grain (milo); are being updated to read 
corn, sweet (K+CWHR); sorghum, grain, forage; and sorghum, grain, 
grain; to conform to Agency procedures. Pending tolerances for beans, 
dry at 0.1 ppm and beans, succulent lima at 0.1 will replace the 
current entries for bean, dry, seed and bean, lima, succulent. These 
tolerances will be listed in paragraph (a).
    Based upon Agency procedures concerning commodity names, the Agency 
is correcting the pending crops under Sec.  180.249(a) as follows: 
Corn, field, forage at 2.0 ppm; corn, field, grain at 0.2 ppm; corn, 
field, stover at 2.0 ppm; corn, field, pop at 0.2 ppm; corn, pop, 
stover at 2.0 ppm; corn, sweet, forage at 2.0 ppm; corn, sweet, stover 
at 2.0 ppm; soybeans, seed at 1.0 ppm and sunflower, meal at 3.4 ppm. 
These listings will replace current listings for corn, forage; corn, 
grain; corn, stover; and soybean.
    The Agency also determined that the pending rotational crop 
tolerances should be placed in Sec.  180.249(d) Indirect and 
inadvertent residues. The tolerance expression and commodity listing 
for Sec.  180.249 (d) is revised to read: Tolerances are also 
established for indirect or inadvertent residues of alachlor (2-chloro-
2',6'-diethyl-N-(methoxymethyl)acetanilide) and its metabolites which 
can be converted to 2,6-diethylaniline (DEA) or 2-ethyl-6-(1-
hydroxyethyl)aniline (1-HEEA) upon basic hydrolysis, calculated as 
alachlor in or on the following raw agricultural commodities when 
present therein as a result of application of alachlor to the growing 
crops listed in paragraph (a) of this section animal feed, nongrass, 
group 18, forage at 1.4 ppm; animal feed, nongrass, group 18, hay at 
1.2 ppm; grain, cereal, group 15 except corn, sorghum, rice at 0.05 
ppm; grain, cereal, forage, fodder, and straw, group 16 except corn, 
sorghum, and rice, forage at 0.6 ppm; grain, cereal, forage, fodder and 
straw, group 16 except corn, sorghum, and rice, hay at 0.8 ppm; and 
grain, cereal, forage, fodder, and straw, group 16 except corn, 
sorghum, and rice, straw at 0.8 ppm.

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 reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.'' These provisions were added to FFDCA by the Food Quality Protection 
Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA 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 and to make a 
determination on aggregate exposure for the petitioned-for tolerances 
for combined residues of alachlor (2-chloro-2',6'-diethyl-N-
(methoxymethyl)acetanilide) and its metabolites which can be converted 
to 2,6-diethylaniline (DEA) or 2-ethyl-6-(1-hydroxyethyl)aniline (1-
HEEA) upon basic hydrolysis, calculated as alachlor. EPA's assessment 
of exposures and risks associated with establishing the tolerances 
follows.

[[Page 54581]]

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. Specific information on the studies received and the nature 
of the adverse effects caused by alachlor 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.
 The referenced document is entitled FQPA Human 

Health Risk Assessment for Section 3 New Uses on Cotton, Sunflower, and 
for Inadvertent Tolerances on Various Rotational Crops (Cereal Grains 
and Nongrass Animal Feeds and is available in the docket established by 
this action, which is described under ADDRESSES, and is identified as 
EPA-HQ-OPP-2007-0146-003 in that docket.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from 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) is 
sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the LOC 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 
risks by comparing aggregate 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 LOC by all 
applicable UFs. Short-, intermediate-, and long-term risks are 
evaluated by comparing aggregate exposure to the LOC to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. 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/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

    A summary of the toxicological endpoints for alachlor used for 
human risk assessment can be found at http://www.regulations.gov in 

document ``FQPA Human Health Risk Assessment for Section 3 New Uses on 
Cotton, Sunflower, and for Inadvertent Tolerances on Various Rotational 
Crops (Cereal Grains and Nongrass Animal Feeds'' on page 50 in docket 
ID number EPA-HQ-OPP-2007-0146.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to alachlor, EPA considered exposure under the petitioned-for 
tolerances as well as all reassessed tolerances and existing alachlor 
tolerances in (40 CFR 180.249). EPA assessed dietary exposures from 
alachlor 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 alachlor in the general 
population. Therefore, a quantitative acute dietary exposure is 
unnecessary for the general population. An effect attributable to a 
single dose was identified for females 13-49 in the developmental study 
in rats. In estimating acute dietary exposure for females 13-49, EPA 
used food consumption information from the U.S. Department of 
Agriculture (USDA) 1994-1996 or 1998 Nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII). As to residue levels in food, EPA 
assumed all foods for which there are tolerances were treated and 
contain tolerance-level residues. Percent crop treated (PCT) or 
anticipated residues were not used.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996, 
or 1998 CSFII. As to residue levels in food, EPA assumed all foods for 
which there are tolerances were treated and contain tolerance level 
residues. PCT or anticipated residues were not used.
    iii. Cancer. Alachlor has been classified as ``likely to be 
carcinogenic to humans at high dose, but not at low doses'', based on 
treatment-related increases in nasal olfactory epithelial thyroid, and 
gastric tumors at higher dose levels. The Agency used the MOE approach 
for quantification of cancer risk. The target MOE is 100. For nasal 
tumors, the point of departure selected was 0.5 milligrams/kilograms/
day (mg/kg/day), based on nasal tumors at 2.5 mg/kg/day in rats. For 
gastric tumors, a point of departure of 14 mg/kg/day was selected, 
based on stomach tumors seen at 42 mg/kg/day in rats. The cancer 
assessment was conducted using tolerance levels and 100% crop treated 
for all existing and proposed uses.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for alachlor in drinking water. Because 
the Agency does not have comprehensive monitoring data, drinking water 
concentration estimates are made by reliance on simulation or modeling 
taking into account data on the environmental fate characteristics of 
alachlor. 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
.

    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Groundwater (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
alachlor for acute exposures are estimated to be 123 parts per billion 
(ppb) for surface water and 2.48 ppb for ground water. The EDWCs for 
chronic exposures are estimated to be 75 ppb for surface water and 
< 2.48 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 123 ppb was used to access 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration value of 75 ppb was used to access 
the contribution to drinking water. For the cancer risk assessment, the 
30-year mean concentration of 64 ppb was used.
    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).
    Alachlor is not registered for use on any sites that would result 
in residential exposure.

[[Page 54582]]

    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.''
    Alachlor is a member of the chloroacetanilide cumulative assessment 
group (CAG) which includes alachlor, acetochlor, and butachlor. The 
Agency previously conducted a cumulative risk assessment for the CAG 
based on a common mode of action for the production of tumors of the 
nasal olfactory epithelium in rats. Butachlor was determined to be part 
of the CAG, however, there are currently no U.S. registrations for the 
chemical; therefore it was excluded from the cumulative risk 
assessment. This risk assessment is fully discussed in the document: 
``Cumulative Risks from Chloroacetanilide Pesticides'' dated March 6, 
2006 identified as document EPA-HQ-OPP-2005-0050-0061 which is 
available on the internet at http://www.regulations.gov in docket 

number EPA-HQ-OPP-2005-0050. Based on that cumulative risk assessment 
(CRA) the Agency concluded that the cumulative risks from alachlor and 
acetochlor did not exceed the Agency's level of concern since 
cumulative MOEs were above the Agency's level of concern of 100.
    A revised cumulative risk assessment was performed based on the new 
uses for alachlor addressed in this rule and the new uses for 
acetochlor established in the final rule published in the Federal 
Register of May 16, 2007 (72 FR 27463) (FRL-8126-2). The revised risk 
assessment includes only food and water, since there are no residential 
uses registered for these two chemicals. Because the endpoint of 
interest is a cancer endpoint that arises via a mode of action that 
requires prolonged exposure, only a chronic dietary analysis was 
performed. For food exposure, tolerance levels and some average 
residues were used. Acetochlor residues were converted to alachlor 
equivalents by multiplying a factor of 0.05. The total alachlor 
residues were obtained by adding the alachlor residues to acetochlor 
(alachlor equivalents) residues for crop that have both alachlor and 
acetochlor tolerances. DEEM default processing factors from DEEM 
(Version 7.81) were used for all processed commodities that do not have 
individual tolerances, except for soybeans and sunflower, where 
processing factors from available processing studies were used. For 
soybeans, processing factors used in DEEM are: 0.17 for soybean oil, 
0.32 for soybean protein concentrate, and 0.21 for soybean protein 
isolate. For sunflower, a processing factor of 0.07 was used for 
sunflower oil. For drinking water exposure, the 30 year mean 
concentration of 63.6 ppb from modeling for alachlor and degradates, 
plus 0.11 ppb (alachlor equivalent) from monitoring for acetochlor, 
totaling 64 ppb was used.
    The dietary exposure assessment was conducted using the Dietary 
Exposure Evaluation Model (DEEM-FCID, Version 2.03) which uses food 
consumption data from the USDA's CSFII from 1994-1996 and 1998. It was 
assumed that 100% crop treated (%CT) for all commodities. The MOE for 
nasal tumor (the most sensitive cancer endpoint among the group) for 
the general U.S. population is 330 which is greater than the target MOE 
of 100. Therefore, the cumulative risk is below EPA's level of concern. 
This analysis is considered conservative dietary exposure assessment 
with the use of average residues for some crops, 100% crop treated, and 
the use of drinking water modeling data. Based on the DEEM commodity 
analysis, the drinking water exposure from alachlor modeling value 
counts for 90% of the total risk. This risk assessment is fully 
discussed in the document entitled ``Acetochlor/Alachlor: Revised 
Cumulative Risk Assessment for the Chloroacetanilides to Support the 
Proposed New Uses on Alachlor and Acetochlor.'' PP 8F05000 and 8F5025 
(Alachlor), PP 6F4791, 1F6263, and 5F6918 (Acetochlor). The referenced 
document is available in the docket established by this action which is 
described under ADDRESSES and is identified as EPA-HQ-OPP-2007-0146-004 
in that docket.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional (``10X'') tenfold 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. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional FQPA 
safety factor value based on the use of traditional UFs and/or special 
FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. Available developmental 
toxicity in two species and multi-generation reproductive toxicity 
study in rat do not show evidence of increased susceptibility of the 
offspring. These studies, along with guideline toxicity studies in the 
adult animal, do not show evidence of neurotoxicity. Concern for 
increased susceptibility is low since toxicity to offspring was 
observed only at maternally toxic doses in the developmental toxicity 
studies in the rat and rabbit and in a rat multi-generation 
reproductive toxicity study. Clear NOELs for offspring and adults were 
observed in all studies.
    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings:
    i. The toxicity database for alachlor is complete.
    ii. There is no indication that alachlor is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. There is no evidence that alachlor results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    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. Conservative ground and surface 
water modeling estimates were used. These assessments will not 
underestimate the exposure and risks posed by alachlor.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-, intermediate-, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to 
ensure that the MOE called for by the product of all applicable UFs is 
not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to

[[Page 54583]]

alachlor will occupy 0.3% of the aPAD for the population group females 
(13-49) receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to alachlor 
from food and water will utilize 16% of the cPAD for the U.S. general 
population and 33% of the cPAD for children 1-2 years old. There are no 
residential uses for alachlor that result in chronic residential 
exposure to alachlor.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Alachlor is not registered for use on any sites that would result 
in residential exposure. Therefore, the aggregate risk is the sum of 
the risk from food and water.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Alachlor is not registered for use on any sites that would result 
in residential exposure. Therefore, the aggregate risk is the sum of 
the risk from food and water, which do not exceed the Agency's level of 
concern.
    5. Aggregate cancer risk for U.S. population. Using the exposure 
assumptions discussed in this unit for cancer risk, EPA has determined 
that the MOE for the U.S. population is 330 which does not exceed the 
EPA's level of concern (a MOE of 100).
    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 alachlor residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    There are adequate analytical methods for the purposes of tolerance 
enforcement and data collection. An HPLC method which determines DEA- 
and 1-HEEA-yeilding metabolites have been validated has been validated 
by the Agency and is considered acceptable for enforcement purposes. 
The method uses HPLC with oxidative coulometric electrochemical 
detection (HPLC-OCED) of both DEA and 1-HEEA-producing residues, and 
was recommended for inclusion in PAM Vol. II as Method III, the limit 
of detection is 0.01 ppm for each metabolite class.
    Adequate enforcement methodology (HPLC-OCED) is available to 
enforce the tolerance expression. 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

    No maximum residue limits (MRLs) for alachlor have been established 
by CODEX for any agricultural commodity.

V. Conclusion

    Therefore, the tolerance is established for combined residues of 
alachlor (2-chloro-2',6'-diethyl-N-(methoxymethyl)acetanilide) and its 
metabolites which can be converted to 2,6-diethylaniline (DEA) or 2-
ethyl-6-(1-hydroxyethyl)aniline (1-HEEA) upon basic hydrolysis, 
calculated as alachlor, as discussed in Unit II.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 rule has been 
exempted from review under Executive Order 12866, this 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 6, 2000) do not apply to this rule. In addition, This 
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: September 13, 2007.
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:

[[Page 54584]]

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

0
2. Section 180.249 is revised to read as follows:

Sec.  180.249  Alachlor; tolerances for residues.

    (a) General. Tolerances are established for combined residues of 
alachlor (2-chloro-2',6'-diethyl-N-(methoxymethyl)acetanilide) and its 
metabolites which can be converted to 2,6-diethylaniline (DEA) or 2-
ethyl-6-(1-hydroxyethyl)aniline (1-HEEA) upon basic hydrolysis, 
calculated as alachlor in or on the following raw agricultural 
commodities.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Beans, dry.................................................          0.1
Beans, succulent lima......................................          0.1
Cattle, fat................................................         0.02
Cattle, meat byproducts....................................         0.02
Cattle, meat...............................................         0.02
Corn, field, forage........................................          2.0
Corn, field, grain.........................................          0.2
Corn, field, pop...........................................          0.2
Corn, field, stover........................................          2.0
Corn, pop, stover..........................................          2.0
Corn, sweet (K+CWHR).......................................         0.05
Corn, sweet, stover........................................          2.0
Cotton, gin byproducts.....................................          0.7
Cotton, undelinted seed....................................         0.03
Cowpea, forage.............................................          5.0
Cowpea, hay................................................          5.0
Egg........................................................         0.02
Goat, fat..................................................         0.02
Goat, meat byproducts......................................         0.02
Goat, meat.................................................         0.02
Hog, fat...................................................         0.02
Hog meat byproducts........................................         0.02
Hog, meat..................................................         0.02
Horse, fat.................................................         0.02
Horse, meat byproducts.....................................         0.02
Horse, meat................................................         0.02
Milk.......................................................         0.02
Peanut.....................................................          0.5
Poultry, fat...............................................         0.02
Poultry, meat byproducts...................................         0.02
Poultry, meat..............................................         0.02
Sheep, fat.................................................         0.02
Sheep, meat byproducts.....................................         0.02
Sheep, meat................................................         0.02
Sorghum grain, forage......................................          2.0
Sorghum, grain, grain......................................          0.1
Sorghum, grain, stover.....................................          1.0
Soybeans, seed.............................................          1.0
Sunflower, meal............................................          3.4
Sunflower, seed............................................          2.5
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established 
for indirect or inadvertent residues of alachlor (2-chloro-2',6'-
diethyl-N-(methoxymethyl)acetanilide) and its metabolites which can be 
converted to 2,6-diethylaniline (DEA) or 2-ethyl-6-(1-
hydroxyethyl)aniline (1-HEEA) upon basic hydrolysis, calculated as 
alachlor, in or on the following raw agricultural commodities when 
present therein as a result of the application of alachlor to the 
growing crops in paragraph (a) of this section:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Animal feed, nongrass, group 18, forage....................          1.4
Animal feed, nongrass, group 18, hay.......................          1.2
Grain, cereal, forage, and straw, group 16 except corn,              0.8
 sorghum, rice, straw......................................
Grain, cereal, forage, fodder and straw, group 16 except             0.6
 corn, sorghum, rice, forage...............................
Grain, cereal, forage, fodder, and straw, group 16 except            0.8
 for corn, sorghum, rice, hay..............................
Grain, cereal, group 15 except corn, sorghum, rice.........         0.05
------------------------------------------------------------------------

[FR Doc. E7-18967 Filed 9-25-07; 8:45 am]

BILLING CODE 6560-50-S