[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