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EPA ID: [EPA-HQ-OPP-2007-0146; FRL-8147-2]
SUBJECT CATEGORY: Alachlor; Pesticide Tolerance
DOCUMENT 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).
SUMMARY: Alachlor,
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:
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.
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 eCFR
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 EPAHQOPP20070146 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.
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 EPAHQOPP20070146, by one of the following methods:
In the Federal Register of May 9, 2007 (72 FR 26372) (FRL81215),
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 (2chloro2',6'diethylN
(methoxymethyl)acetanilide)and its metabolites which can be converted
to 2,6diethylaniline (DEA) or 2ethyl6(1hydroxyethyl)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
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 (2chloro2',6'
diethylN(methoxymethyl)acetanilide) and its metabolites which can be converted to 2,6diethylaniline (DEA) or 2ethyl6(1
hydroxyethyl)aniline (1HEEA) 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 (2chloro
2',6'diethylN(methoxymethyl)acetanilide) and its metabolites which can be converted to 2,6diethylaniline (DEA) or 2ethyl6(1
hydroxyethyl)aniline (1HEEA) 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.
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 petitionedfor tolerances for combined residues of alachlor (2chloro2',6'diethylN
(methoxymethyl)acetanilide) and its metabolites which can be converted
to 2,6diethylaniline (DEA) or 2ethyl6(1hydroxyethyl)aniline (1
HEEA) upon basic hydrolysis, calculated as alachlor. EPA's assessment
of exposures and risks associated with establishing the tolerances follows.
[[Page 54581]]
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 noobserved
adverseeffectlevel (NOAEL) and the lowestobservedadverseeffect
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 EPAHQOPP20070146003 in that docket.
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 longterm 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 nonthreshold 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 nonthreshold. 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/EPAPEST/1997/November/Day26/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 EPAHQOPP20070146.
1. Dietary exposure from food and feed uses. In evaluating dietary exposure to alachlor, EPA considered exposure under the petitionedfor 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 fooduse pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1day 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 1349 in the developmental study in rats. In estimating acute dietary exposure for females 1349, EPA used food consumption information from the U.S. Department of Agriculture (USDA) 19941996 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 tolerancelevel 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 19941996, 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 treatmentrelated 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 30year mean concentration of 64 ppb was used.
3. From nondietary exposure. The term ``residential exposure'' is used in this document to refer to nonoccupational, nondietary 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.
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 EPAHQOPP200500500061 which is
available on the internet at http://www.regulations.gov in docket
number EPAHQOPP20050050. 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) (FRL81262). 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 (DEEMFCID, Version 2.03) which uses food consumption data from the USDA's CSFII from 19941996 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 EPAHQOPP20070146004 in that docket.
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 multigeneration 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 multigeneration 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 2generation 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 tolerancelevel residues. Conservative ground and surface water modeling estimates were used. These assessments will not underestimate the exposure and risks posed by alachlor.
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 (1349) 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 12 years old. There are no residential uses for alachlor that result in chronic residential exposure to alachlor.
3. Shortterm risk. Shortterm 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. Intermediateterm risk. Intermediateterm 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
There are adequate analytical methods for the purposes of tolerance enforcement and data collection. An HPLC method which determines DEA and 1HEEAyeilding 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 (HPLCOCED) of both DEA and 1HEEAproducing 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 (HPLCOCED) 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 207555350; telephone number: (410) 3052905; email address: residuemethods@epa.gov. B. International Residue Limits
No maximum residue limits (MRLs) for alachlor have been established by CODEX for any agricultural commodity.
Therefore, the tolerance is established for combined residues of alachlor (2chloro2',6'diethylN(methoxymethyl)acetanilide) and its metabolites which can be converted to 2,6diethylaniline (DEA) or 2 ethyl6(1hydroxyethyl)aniline (1HEEA) upon basic hydrolysis, calculated as alachlor, as discussed in Unit II.
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 LowIncome 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 1044).
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 104113, section 12(d) (15 U.S.C. 272 note).
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).
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. Therefore, 40 CFR chapter I is amended as follows:
PART 180AMENDED
1. The authority citation for part 180 continues to read as follows: [[Page 54584]]
Authority: 21 U.S.C. 321(q), 346a and 371.
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 (2chloro2',6'diethylN(methoxymethyl)acetanilide) and its
metabolites which can be converted to 2,6diethylaniline (DEA) or 2
ethyl6(1hydroxyethyl)aniline (1HEEA) 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 (2chloro2',6'
diethylN(methoxymethyl)acetanilide) and its metabolites which can be converted to 2,6diethylaniline (DEA) or 2ethyl6(1
hydroxyethyl)aniline (1HEEA) 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. E718967 Filed 92507; 8:45 am]
BILLING CODE 656050S
FOR FURTHER INFORMATION CONTACT Vickie Walters, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 204600001; telephone number: (703) 3055704; email address: walters.vickie@epa.gov.
14 CFR Part 39 40 CFR Part 52 14 CFR Part 71 33 CFR Part 165 50 CFR Part 679 26 CFR Part 1 40 CFR Part 180 47 CFR Part 73 50 CFR Part 17 33 CFR Part 117 44 CFR Part 67 50 CFR Part 648 14 CFR Part 97 33 CFR Part 100 40 CFR Part 63 26 CFR Part 301 50 CFR Part 622 39 CFR Part 111 40 CFR Part 300 44 CFR Part 65 50 CFR Part 660 40 CFR Part 271 40 CFR Parts 52 and 81 47 CFR Part 64 50 CFR Part 665 49 CFR Part 571 44 CFR Part 64 14 CFR Part 23 47 CFR Part 76 50 CFR Part 229