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 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 EPAHQOPP20070116 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 February 26, 2008.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPAHQOPP20070116, by one of the following methods:

II. Petition for Tolerance

In the Federal Register of April 4, 2007 (72 FR 16352) (FRL8119 2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6E7152) by IR4. The petition requested that 40 CFR 180.464 be amended by establishing a tolerance for residues of the herbicide dimethenamid, 1 (R,S)2chloroN[(1methyl2methoxy) ethyl]N(2,4dimethylthien3 yl)acetamide) in or on hop, dried cones at 0.05 parts per million (ppm); pumpkin at 0.01 ppm; radish, roots at 0.01 ppm; radish, tops at 0.01 ppm; rutabaga, roots at 0.01 ppm; rutabaga, tops at 0.1 ppm; turnip, greens at 0.1 ppm; turnip, roots at 0.01 ppm; turnip, tops at 0.1 ppm; and winter squash at 0.01 ppm. That notice referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available to the public in the docket, http://www.regulations.gov. There were no comments received in response to the

notice of filing.

Based upon review of the data supporting the petition, EPA has approved regionally restricted tolerances for pumpkin and winter [[Page 73628]]
squash for States of Oregon and Washington only, in that supporting data are limited to EPA growing Region 12. The reason for these changes is further explained in the supporting document for this action, entitled, ``DimethenamidP. Petition for Registration for Uses Turnips and Hops. Summary of Analytical Chemistry and Residue Data. Petition 6E7152,'' in docket ID number EPAHQOPP20070116.

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 section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitionedfor tolerance for residues of dimethenamid on hop, dried cones at 0.05 ppm; pumpkin at 0.01 ppm; radish, roots at 0.01 ppm; radish, tops at 0.01 ppm; rutabaga, roots at 0.01 ppm; rutabaga, tops at 0.1 ppm; turnip, greens at 0.1 ppm; turnip, roots at 0.01 ppm; turnip, tops at 0.1 ppm; and winter squash at 0.01 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered the 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 dimethenamid as well as the no observedadverseeffectlevel (NOAEL) and the lowestobservedadverse effectlevel (LOAEL) from the toxicity studies can be found at http://www.regulations.gov. The referenced document is available in the docket
established by this action, which is described under ADDRESSES, and is identified as EPAHQOPP20070116 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 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 dimethenamid used for human risk assessment can be found at http://www.regulations.gov in document, ``DimethenamidP. Amended Human Health Risk Assessment for a Proposal for the Establishment of Tolerances for DimethenamidP Use on Winter Squash, Pumpkin, Radish (Roots and Tops), Rutabaga (Roots and Tops), Turnip (Roots, Tops and Greens) and on Hops, Dried Cones,'' at docket ID number EPAHQOPP20070116.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to dimethenamid, EPA considered exposure under the petitioned for tolerances as well as all existing dimethenamid tolerances in (40 CFR 180.464). EPA assessed dietary exposures from dimethenamid 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.

In estimating acute dietary exposure, EPA used Dietary Exposure Evaluation Model/Food Consumption Intake Database (DEEM/FCID) Version 2.03 which incorporates food consumption information from the U.S. Department of Agriculture (USDA) 19941996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). An appropriate acute endpoint attributable to a single dose was selected for the population subgroup females 1349. The acute dietary analysis was conducted for dimethenamid assuming tolerance level residues, default processing factors, and 100% crop treated (CT) information.

ii. Chronic exposure. In conducting the chronic dietary exposure (food and drinking water assessment), EPA used consumption data from the USDA 19941996 and 1998 Nationwide CSFII. The chronic dietary exposure assessment was conducted for dimethenamid assuming tolerance level residues, default processing factors, and 100%CT information.

iii. Cancer. Dimethenamid is a category ``C'' possible human carcinogen. The chronic reference dose (cRfD) of 0.05 milligram/ kilogram/day (mg/kg/day) used for risk assessment is based on non cancer precursor effects in the liver; therefore, the cRfD is considered protective of both cancer and noncancer effects. A separate cancer exposure assessment was not performed.

2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure [[Page 73629]]
analysis and risk assessment for dimethenamid 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 dimethenamid. 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 EPA's Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCIGROW) models, the estimated drinking water concentrations (EDWCs) of dimethenamid for acute exposures are estimated to be 66.7 parts per billion (ppb) for surface water and 1.0 ppb for ground water. The EDWCs for chronic exposures are estimated to be 20.2 ppb for surface water and 1.0 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. The EDWCs for use sites with the highest values were used. For acute dietary risk assessment, the water concentration value of 66.7 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 20.2 ppb was used to assess the contribution to drinking water.

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).

Dimethenamid 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.''

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to dimethenamid and any other substances and dimethenamid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that dimethenamid has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative .

D. Safety Factor for Infants and Children

1. In general. Section 408 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. There is no concern for increased qualitative and/or quantitative susceptibility following prenatal and postnatal exposure to dimethenamid in rats and rabbits. In the developmental toxicity study in rats there was an increased incidence of postimplantation loss and minor skeletal variations. In the developmental toxicity study in rabbits, late resorptions and minor skeletal variations were observed at the highest dose tested. In the rabbit, the developmental effects occurred at the same dose as maternal toxicity; whereas in the rat, the developmental effects occurred at much higher doses than in the dams. The reproduction study showed decreases in body weight in both pups and parental animals at the same dose levels.

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 dimethenamid is complete.

ii. There is no indication that dimethenamid 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 dimethenamid 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 which results in very highend estimates of dietary exposure. The dietary drinking water assessment utilizes values generated by modeland associated modeling parameters which are designed to provide health protective, highend estimates of water concentrations. These assessments will not underestimate the exposure and risks posed by dimethenamid.

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 dimethenamid will occupy < 1 % of the aPAD at the 95th percentile for females 1349 years old, the population group of concern for acute dimethenamid exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to dimethenamid from food and water will utilize 3% of the cPAD for all infants (< 1 year old), the subpopulation group with greatest exposure. There are no residential uses for dimethenamid that result in chronic residential exposure to dimethenamid.

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). Dimethenamid 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 (LOC). A
[[Page 73630]]

shortterm aggregate risk assessment is not required.

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).

Dimethenamid 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. An intermediateterm aggregate risk assessment is not required.

5. Aggregate cancer risk for U.S. population. The chronic reference dose (cRfD) of 0.05 mg/kg/day used for risk assessment is based on non cancer precursor effects in the liver; therefore, the cRfD and chronic risk assessment are considered protective of both cancer and noncancer effects.

6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to dimethenamid residues.
IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (gas chromatography with a nitrogen phosphorus detector (GC/NPD) Method AM088401931) 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

There are no established or proposed Codex, Canadian or Mexican maximum residue limits (MRLs) for dimethenamid on any of the crops/ commodities being proposed in this petition.

V. Conclusion

Therefore, tolerances are established for residues of the herbicide dimethenamid, 1 (R,S)2chloroN[(1methyl2methoxy) ethyl]N(2,4 dimethylthien3yl)acetamide) in or on hop, dried cones at 0.05 parts per million (ppm); pumpkin at 0.01 ppm; radish, roots at 0.01 ppm; radish, tops at 0.01 ppm; rutabaga, roots at 0.01 ppm; rutabaga, tops at 0.1 ppm; turnip, greens at 0.1 ppm; turnip, roots at 0.01 ppm; turnip, tops at 0.1 ppm; and winter squash at 0.01 ppm. The existing timelimited tolerance for winter squash shall be deleted as a permanent tolerance is being established by this action.

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 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).

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: December 14, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows:
PART 180[AMENDED]
1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.464 is amended by alphabetically adding the following commodities to the table in paragraph (a), removing the text in paragraph (b), and reserving it, and adding text to paragraph (c) to read as follows:
Sec. 180.464 Dimethenamid; tolerances for residues.
(a) * * *
Parts per Commodity million * * * * *
Hop, dried cones........................................... 0.05 * * * * *
Radish, roots.............................................. 0.01 Radish, tops............................................... 0.01 [[Page 73631]]
Rutabaga, roots............................................ 0.01 Rutabaga, tops............................................. 0.1 * * * * *
Turnip, greens............................................. 0.1 Turnip, roots.............................................. 0.01 Turnip, tops............................................... 0.1 * * * * *
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. Tolerances with regional registration are established for residues of dimethenamid, 1 (R,S)2chloroN[(1methyl2methoxy) ethyl]N(2,4dimethylthien3
yl)acetamide) in or on the following raw agricultural commodities: Parts per Commodity million Pumpkin.................................................... 0.01 Squash, winter............................................. 0.01 * * * * *
[FR Doc. E725090 Filed 122707; 8:45 am]
BILLING CODE 656050S

FOR FURTHER INFORMATION CONTACT Sidney Jackson, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 204600001; telephone number: (703) 3057610; email address: jackson.sidney@epa.gov.