SBA adopted the NAICS industry definitions as a basis for its table of small business size standards effective October 1, 2000, as a replacement to the discontinued Standard Industrial Classification (SIC) System (65 FR 30836, May 15, 2000). Since that time, OMB has issued two updates modifying the NAICS. SBA incorporated OMB's first updated modifications, termed NAICS 2002 (66 FR 3825, January 16, 2001), in its table of size standards effective October 1, 2002 (67 FR 52597, August 13, 2002). OMB published its most recent updates, termed NAICS 2007, on May 16, 2006 (71 FR 28532). SBA is adopting those updated modifications in its table of small business size standards, as explained below.

For complete information on the relationship between NAICS 2002 and NAICS 2007, please see the U.S. Bureau of the Census (Census Bureau) Web site at http://www.census.gov/epcd/www/naicsdoc.htm#fedreg . That Census Bureau Web site provides complete information on its establishment and implementation of NAICS 2007, including its notice of final action in the March 16, 2006 Federal Register . The Census Bureau also provides the following correspondence tables: (1) 2007 NAICS-US matched to 2002 NAICS-US; and (2) 2002 NAICS-US matched to 2007 NAICS-US.

On October 22, 1999, SBA published in the Federal Register (64 FR 57188) a proposed rule to establish a new table of small business size standards based on the NAICS. SBA developed guidelines to transition from the SIC System to NAICS. The guidelines were intended to minimize the impact of a new industry classification system on SBA's small business size standards. Table 1, below, lists those guidelines. SBA received no negative comments to the guidelines specified in the proposed rule. Because the guidelines produced the desired results and received public acceptance, SBA published a final rule on May 5, 2000 (65 FR 3825) (corrected on September 5, 2000, 65 FR 53533) establishing a new table of size standards based on NAICS without change from its proposed rule. For purposes of adopting NAICS 2007, SBA is applying the same guidelines in this direct final rule.

It is important to note the following:

1. NAICS 2007 changes affect 59 NAICS 2002 industries.

2. One NAICS 2002 Subsector and 12 NAICS 2002 industries were eliminated and their activities reclassified in other more appropriate or new NAICS 2007 industries as listed in Table 2:

3. The following eight industries listed in Table 3 are new in NAICS 2007:

Most of the industries in NAICS 2002 remain unchanged under NAICS 2007. This direct final rule adopting NAICS 2007 will change size standards for only three industries and four activities from parts of industries. Other changes in NAICS 2007 consist of revised industry descriptions or the reclassification of industry activities in other industries having the same size standard.

Table 4 lists all of OMB's modifications to the NAICS 2002 industries. The first three columns show the modified NAICS 2002 industry's six-digit code, its current size standard, and its industry description. The last three columns show the NAICS 2007 industry (new, existing and revised) that incorporates the modified NAICS 2002 industry, its industry description, and new size standard. By comparing the modified NAICS 2002 industry and size standard with the related NAICS 2007 industry and size standard, a user can identify the size standard SBA is adopting for the applicable NAICS 2007 industries. Following Table 4, SBA explains the basis for the limited number of cases that do result in a change to the size standard.

As shown in Table 4, the NAICS 2007 modifications lead to a revision in the current size standard for a limited number of industries or activities. The basis for the revisions to seven size standards are discussed below:

1. NAICS 339111, “Laboratory Apparatus and Furniture Manufacturing,” (part) laboratory freezers. NAICS 2007 eliminated NAICS 339111. The various activities of NAICS 339111 are reclassified in other NAICS 2007 codes having the same 500 employee size standard, except for laboratory freezer manufacturing. Laboratory freezer manufacturing is reclassified in NAICS 333415, “Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing,” having a size standard of 750 employees. SBA is adopting the 750 employee size standard for NAICS 333415 because laboratory freezer manufacturing represents a small part of that industry (Rule #3).

2. NAICS 334220, “Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing,” (part) communications signal testing and evaluation equipment. The current size standard for NAICS 334220 is 750 employees. The activity of “communications signal testing and evaluation equipment manufacturing” in NAICS 2007 is reclassified in NAICS 334515, “Instrument Manufacturing for Measuring and Testing Electricity and Electrical Signals,” having a size standard of 500 employees. SBA is adopting the 500 employee size standard for NAICS 334515 because “communications signal testing and evaluation equipment manufacturing” represents a small part of that industry (Rule #3).

3. NAICS 518111, “Internet Service Providers,” (part) broadband Internet service providers (e.g., cable, DSL). The current size standard for NAICS 518111 is $23.0 million in average annual receipts. The activity, “broadband Internet services providers ( e.g., cable, DSL),” in NAICS 2007 is reclassified in NAICS 517110, “Wired Telecommunications Carriers,” having a 1,500 employee size standard. SBA is adopting the 1,500 employee size standard for NAICS 517110 because broadband Internet services providers represent a small part of that industry (Rule #3).

4. NAICS 517510, “Cable and Other Program Distribution.” NAICS 2007 eliminated NAICS 517510. The current size standard for NAICS 517510 is $13.5 million in average annual receipts. In NAICS 2007, all activities of NAICS 517510 are reclassified in 517110, “Wired Telecommunications Carriers,” having a 1,500 employee size standard. SBA is adopting the 1,500 employee size standard for NAICS 517110 because the Cable and Other Program Distribution industry is much smaller than the Wired Telecommunications Carriers industry (Rule #3).

5. NAICS 517910, “Other Telecommunications.” NAICS 2007 eliminated NAICS 517910. NAICS 2007 establishes a new industry titled “All Other Telecommunications,” NAICS 517919, comprising all activities of NAICS 517910 having a size standard of $13.5 million and most activities from NAICS 518111, “Internet Service Providers (ISP),” having a size standard of $23 million. As discussed in # 3 above, the activity of “broadband Internet services providers” in NAICS 518111 is reclassified in NAICS 517110. SBA is adopting the $23 million size standard for that industry because ISP establishments providing services via client-supplied telecommunications connections represent the larger component of the new NAICS 517919 (Rule #3).

6. NAICS 518112, “Web Search Portals.” NAICS 2007 eliminated NAICS 518112 and NAICS 516110, “Internet Publishing and Broadcasting,” having size standards of $6.5 million and 500 employees, respectively. NAICS 2007 combines these two industries to form a new six-digit industry—NAICS 519130, “Internet Publishing and Broadcasting and Web Search Portals.” SBA is adopting the 500 employee size standard for NAICS 519130 because the Internet Publishing and Broadcasting industry is much larger than the Web Search Portals industry (Rule #3).

7. NAICS 525930, “Real Estate Investment Trusts,” (part) hybrid or equity REITs primarily leasing miniwarehouses and self-storage units. NAICS 2007 eliminated NAICS 525930. The various activities of NAICS 525930 are reclassified in NAICS 2007 codes having the same $6.5 million size standard, except for the activity of hybrid or equity REITs primarily leasing miniwarehouses and self-storage units. That activity is reclassified in NAICS 531130, “Lessors of Miniwarehouses and Self-Storage Units,” having a $23.5 million size standard. SBA is adopting the $23.5 million size standard for NAICS 531130 because hybrid or equity REITs primarily leasing miniwarehouses and self-storage units represent a small part of that industry (Rule #3).

If adopted in final form, SBA's table of small business size standards matched to NAICS 2007 will be effective on and will apply to all solicitations issued on or after October 1, 2007, because:

1. Federal Government recordkeeping and statistics would be more consistent and more comparable with other data for analyzing small business activity. October 1, 2007 is the start of the first Federal Government fiscal year after the NAICS 2007 January 1, 2007 effective date.

2. SBA and other users of size standards could collect data on their small business programs using the more recent NAICS format and can compare those data with future Federal statistics that will be based on NAICS 2007 industry classifications. The availability of such comparable data would ensure the credibility of analyses comparing program and industry data.

3. Federal agencies that use NAICS and SBA's small business size standards for their programs, as most of them do, will need time to implement the new size standards and to develop training tools necessary to do so. SBA believes that publishing this direct final rule now provides sufficient time for agencies to determine its impact on their programs and to convert and update their databases and tracking systems for implementation by the beginning of FY 2008.

4. To evaluate and establish small business size standards, SBA uses data that the U.S. Bureau of the Census (Census Bureau) compiles for the Agency from its quinquennial Economic Census of U. S. industry and businesses. SBA acquires this special compilation from the Census Bureau every five years, after each Economic Census. To evaluate and establish meaningful small business size standards, SBA requires the same data and on the same basis as the Census Bureau collects them. Because the next compilation that SBA will obtain from the Census Bureau will be based on NAICS 2007, SBA needs to use NAICS 2007 as the basis for its table of small business size standards.

SBA considered retaining the NAICS 2002 codes as the basis for small business size standards. However, SBA believes that doing so will lead to inconsistency among Federal agencies that adopt NAICS 2007 for their programs. More importantly, if SBA does not adopt NAICS 2007 it will not be able to analyze and evaluate small business size standards adequately because available Census Bureau data based on NAICS 2007 industries will not be comparable with NAICS 2002 industry data. Without useful data, SBA cannot properly analyze size standards and their effects on businesses.

SBA considered segmenting the modified NAICS 2002 size standard for cases where the size standard changes instead of applying the guidelines used in previous NAICS revisions. SBA believes this alternative is impractical because it would complicate size standards for minor reasons. Furthermore, the application of the guidelines for NAICS 2007 results in the loss of eligibility for currently-defined small businesses in only one minor industry activity. That occurs for “communications signal testing and evaluation equipment manufacturing,” a part of NAICS 334220, “Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing.” The size standard for that activity decreases from 750 employees to 500 employees. A search of the Dynamic Small Business Search (DSBS) reveals that there are 38 small businesses out of 2,200 small businesses registered in NAICS 334220 having more than 500 employees. However, it is unlikely that many of these businesses, if any, will be affected given the limited activity of “communications signal testing and evaluation equipment manufacturing.” All other activities in NAICS 334220 will continue to have a size standard of 750 employees.

This is a direct final rule, but SBA will consider comments. SBA believes that this rule is routine and non-controversial, and SBA anticipates no significant adverse comments to this action. If SBA receives significant any adverse comments, it will withdraw this direct final rule. SBA is publishing concurrently in this issue of the Federal Register a proposed rule to modify its Small Business Size Regulations as contemplated in this direct final rule. If SBA does receive significant adverse comments, it will consider the comment(s) before making a final decision. If SBA decides to adopt NAICS 2007 as proposed, or with limited modifications, it will publish a final rule that addresses the comments and explains the basis for its final decision.

OMB has determined that this direct final rule is not a “significant” regulatory action for purposes of Executive Order (E.O.) 12866. This direct final rule incorporates the latest revisions of the NAICS, which SBA uses to identify industries in the United States economy for purposes of establishing small business size standards. As discussed in the preamble, the size standard of a limited number of activities would change because of the NAICS revisions. Almost all businesses currently defined as small under the NAICS 2002 industries would continue to be small under the NAICS 2007 industries, if adopted for size standards. The rule also affects Federal Government programs that provide a benefit for small businesses. SBA welcomes comments describing the impact on small businesses of the size standard changes resulting from this rule.

For purposes of E.O. 12988, SBA has determined that this rule is drafted, to the extent practicable, in accordance with the standards set forth in that order.

For purposes of E.O. 13132, SBA has determined that this rule does not have any federalism implications warranting the preparation of a Federalism Assessment.

For purposes of the Paperwork Reduction Act, 44 U.S.C. Ch. 35, SBA has determined that this rule does not impose any new reporting or recordkeeping requirements.

When an agency promulgates a rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) requires the agency to prepare an initial regulatory flexibility analysis (IRFA) describing the potential economic impact of the rule on small entities and alternatives that may minimize that impact. Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an IRFA, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities. SBA has determined that this direct final rule as drafted, including the alternatives discussed in the supplementary information above, would not have a significant impact on a substantial number of small entities.

OMB's NAICS 2007 modifications will result in size standards changes to a minimal number of activities within certain NAICS industries detailed above in the supplementary information, with little, if any, affect on small businesses. Those activities are now part of other, more appropriate or new NAICS codes and their industry descriptions. There will be no changes to the size standards for most NAICS industries and their economic activities. For those that would change, they would create a larger number of enterprises that can qualify for Federal government programs reserved for small businesses.

As stated above, a search of the Dynamic Small Business Search (DSBS) reveals that there are 38 small businesses out of 2,200 small businesses registered in NAICS 334220 having more than 500 employees. However, it is unlikely that many of these businesses, if any, will be affected given the limited activity of “communications signal testing and evaluation equipment manufacturing.” All other activities in NAICS 334220 will continue to have a size standard of 750 employees. Therefore, SBA believes that the impact on small businesses will be minimal because these activities represent relatively minor components of the NAICS 2002 industries.

When SBA published a direct final rule to replace the table of small business size standards based on NAICS 1997 with a new one based on NAICS 2002, it certified that for purposes of the Regulatory Flexibility Act, the rule would affect a significant number of small businesses, but that the impact on each business would not be substantial. (67 FR 52597 to 52606, 62292, 67253 and 67102) SBA received no comments to the contrary. No changes have occurred since then. Adopting NAICS 2007 to replace NAICS 2002 as the basis for its table of size standards would have, SBA believes, an even smaller impact.

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 .

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 .

Under section 408(g) of the 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-2005-0157 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 October 29, 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 EPA-HQ-OPP-2005-0157, 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.

In the Federal Register of June 27, 2007 (72 FR 35242) (FRL-8133-4), 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 5F6904) by Aberco, Incorporated, 9430 Lanham-Severn Road, Seabrook, MD 20706. The petition requested that 40 CFR 180.491 be amended by establishing a tolerance for residues of the post-harvest fumigant propylene oxide, in or on fig; grape, raisin; and plum, prune, dried at 3.0; 1.0; and 2.0; respectively parts per million (ppm); and that the directions for use currently listed in 40 CFR 180.491 under paragraphs (a)(2) and (a)(4) be deleted. The petition also identified propylene chlorohydrin as a metabolite and included an enforcement method for determination of residues of propylene oxide, propylene chlorohydrin, and propylene bromohydrin in nutmeats, cocoa, and dried spices. That notice referenced a summary of the petition prepared by Aberco, Incorporated, 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.

The current propylene oxide tolerances include some specific directions for use regarding fumigation frequency, duration and temperature. These directions are currently on affected labels. Because these directions are already on the label, they do not need to be duplicated as part of the tolerance. Furthermore, the propylene oxide Reregistration Eligibility Document (RED) of August 2006 found that these directions should be modified on the label to exactly match the conditions under which residue trials were conducted. Therefore, all directions in 40 CFR 180.491, paragraphs (a)(2) and (a)(4) are no longer needed and can be removed. Similarly, the use directions and other information in paragraphs (a)(1), and (a)(5) can also be removed. As noted in the petition and the RED, use of propylene oxide can result in residues of propylene oxide as well as the reaction product propylene chlorohydrin. Commodities that contain salts that are treated with propylene oxide can react with chloride ion to form the propylene chlorohydrin. Propylene oxide and propylene chlorohydrin are considered separately as residues of concern for risk assessment and tolerance assessment. Based on the differences in physical-chemical properties and toxicological effects, propylene oxide and propylene chlorohydrin were assessed separately, and, EPA is establishing separate tolerances for these chemicals within different paragraphs of tolerance regulation for propylene oxide.

Section 408(b)(2)(A)(i) of the 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 the 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 the 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 the FFDCA by the Food Quality Protection Act (FQPA) of 1996.

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in 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 tolerance for residues of propylene oxide in or on fig; grape, raisin; and plum, prune, dried at 3.0; 1.0; and 2.0 ppm, respectively; and in addition, for residues of the reaction product propylene chlorohydrin at 3.0; 4.0; and 2.0, ppm, respectively. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

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 propylene oxide and propylene chlorohydrin, 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 under the docket number for this rule .

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 (UF) 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 uncertainty/safety factors. 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 uncertainty/safety factors 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/oppfead1/trac/science. http://www.epa.gov/pesticides/factsheets/riskassess.htm . http://www.epa.gov/pesticides/trac/science/aggregate.pdf .

A summary of the toxicological endpoints for propylene oxide and propylene chlorohydrin used for human risk assessment can be found at www.regulations.gov in the risk assessment document “Propylene Oxide-Revised HED Risk Assessment for Reregistration Eligibility Decision Document, July 31, 2006” at Table 4.4.10 on page 49/95 in Docket ID EPA-HQ-OPP-2005-0157. This identical table can also be found in the Propylene oxide RED document at the following website address: http://www.epa.gov/oppsrrd1/REDs/propylene_oxide_red.pdf.

1. Dietary exposure from food and feed uses . In evaluating dietary exposure to propylene oxide and propylene chlorohydrin, EPA considered exposure under the petitioned-for tolerances as well as all existing propylene oxide tolerances in (40 CFR 180.491). EPA assessed dietary exposures from propylene oxide and propylene chlorohydrin 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.

In estimating acute dietary exposure for propylene oxide and propylene chlorohydrin, EPA used food consumption information from the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA relied upon average field trial residue data and percent crop treated information for all commodities covered by existing tolerances.

ii. Chronic exposure . In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 Nationwide (CSFII). As to residue levels in food, EPA relied upon average field trial residue data for propylene oxide, tolerance level residues for propylene chlorohydrin, and percent crop treated information for all commodities covered by existing propylene oxide tolerances.

iii. Cancer . The cancer assessment for propylene oxide incorporated new residue and percent crop treated data for nutmeats and omitted guar (edible gums) as a fumigated commodity. No cancer exposure assessment is needed for propylene chlorohydrin because the cancer data which were negative for both rats and mice, showed no cancer risk to humans.

iv. Anticipated residue and percent crop treated (PCT) information . Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must pursuant to section 408(f)(1) require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data Call-Ins as are required by FFDCA section 408(b)(2)(E) and authorized under section 408(f)(1) of FFDCA. Data will be required to be submitted no later than 5 years from the date of issuance of this tolerance.

Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:

a. The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue;

b. The exposure estimate does not underestimate exposure for any significant subpopulation group; and

c. Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit data on PCT.

The Agency used PCT information as follows:

The percent crop treated values used were as follows: Herbs, spices, and bulb vegetables at 1%; tree nuts at 2%; cocoa bean at 1.3%; and 100% for the new proposed uses — fig grape; raisin; and plum, prune, dried.

The Agency believes that the three conditions listed above have been met. With respect to Condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which propylene oxide may be applied in a particular area.

2. Dietary exposure from drinking water . For propylene oxide fumigations, residues of propylene oxide and propylene chlorohydrin from drinking water are expected to be negligible because

i. Fumigations are either in closed chambers with emission reduction technology, or in temporary/intermittent outdoor field locations (tents, tarps, rail cars, etc.) at a use rate 53 times lower than that used in closed chambers, both of which result in minimal emissions, and

ii. Due to atmospheric dilution and the physical-chemical characteristics of propylene oxide, negligible residues are expected to be able to enter soil and any nearby water. Therefore, water exposures were not included in the risk assessment.

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).

Propylene oxide and propylene chlorohydrin are not registered for use on any residential sites. However, exposure could occur to people residing near fumigation facilities. Propylene oxide and propylene chlorohydrin emissions monitoring data necessary to quantitatively estimate exposures and risks from sterilization/fumigation facilities are unavailable. Therefore, a qualitative assessment was conducted comparing the risks associated with fugitive emissions from the use of a similar chemical, ethylene oxide, in similar commercial fumigation scenarios. With the use of required buffer zones at designated distances to be added to labels, the assessment found that propylene oxide and propylene chlorohydrin residential exposure risks are not expected to be of concern.

4. Cumulative effects from substances with a common mechanism of toxicity . Section 408(b)(2)(D)(v) of the 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 propylene oxide or propylene chlorohydrin and any other substances and propylene oxide or propylene chlorohydrin do not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that propylene oxide or propylene chlorohydrin have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative .

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 uncertainty/safety factors and/or special FQPA safety factors, as appropriate.

2. Prenatal and postnatal sensitivity . For propylene oxide, there is no quantitative susceptibility between the rat fetuses and the dams from the rat developmental study. The study indicated a possible qualitative susceptibility since the skeletal variations (increased litter incidence for the accessory 7th cervical rib) were observed at the same dose which produced maternal toxic effects (ie. decreased body weight gain, food consumption and food efficiency). The effects in the rat fetuses are being treated as only possible evidence of qualitative sensitivity because it is questionable as to whether an accessory 7th cervical rib, which is a developmental variation, is properly characterized as a more severe effect than decreased body weight gain. Although further analysis, including consideration of historical control information on this effect, might resolve this question, in the absence of this analysis, EPA is taking the conservative position that this particular skeletal variation is possible evidence of qualitative sensitivity.

Susceptibility in rabbits could not be adequately ascertained due to the absence of an acceptable rabbit developmental study. In the 2-generation reproduction study, there is no evidence for quantitative or qualitative susceptibility in pups exposed to propylene oxide since no offspring effects were seen at doses which produced significant systemic toxicity in parents. The degree of concern for the possible qualitative susceptibility effects seen after in utero exposures in rats was low because the effects (ie. increased incidence of the 7th cervical rib) are:

i. Skeletal variations and not malformations,

ii. Were seen in the presence of maternal toxicity,

iii. A clear NOAEL was identified, and

iv. This endpoint is used for assessing potential acute dietary risk to the population of concern (Females 13-49). For propylene chlorohydrin, in the reproduction study, quantitative susceptibility effects were evident because decreased pup weights were observed at a dose which had no systemic toxicity in the dams. However, the degree of concern is low for the quantitative susceptibility seen in the reproduction study because a clear NOAEL was identified, and that dose and the endpoint of this study is used for assessing chronic dietary risk in conjunction with the retaining of a 10X database uncertainty factor.

3. Conclusion . For both propylene oxide and propylene chlorohydrin, EPA has determined it is necessary to retain the additional 10X safety factor for the protection of infants and children due to the absence of a propylene oxide developmental toxicity study in rabbits, and a chronic study in non-rodents by the oral route; and for propylene chlorohydrin, due to the absence of a developmental toxicity study in rats and rabbits, a chronic toxicity study in nonrodents, and a chronic carcinogenicity study in rats and mice (because the doses used in the existing studies found in the literature are inadequate). Because no acute endpoint has been identified for propylene chlorohydrin, EPA has applied the additional 10X safety factor to the chronic endpoint in assessing acute risk for propylene chlorohydrin. This is a very conservative approach to assessing acute risk because repeated exposure to a pesticide would typically result in lower NOAELs than an acute exposure. For propylene oxide, there is no evidence for quantitative or qualitative susceptibility in pups exposed to the chemical. For propylene chlorohydrin, the degree of concern is also low for the quantitative susceptibility seen in the reproduction study since the dose and the endpoint of this study is used for assessing chronic dietary risk in conjunction with the retaining of the 10X database uncertainty factor. No additional FQPA factor above 10X is required for either propylene oxide or propylene chlorohydrin. Propylene oxide is missing an adequate rabbit developmental study and a chronic study in a non-rodent species, but an existing developmental study in rabbits indicates effects occur at high doses and a chronic study in rodents is available, therefore a factor of 10X is sufficient. For propylene chlorohydrin, although there are data gaps, there are acceptable longer term studies including chronic studies in rats and mice and a reproduction study in rats. Given these chronic data, an additional safety factor of 10X should be sufficient for the protection of infants and children, as well as the general population and other major identifiable subgroups, from chronic exposure to propylene chlorohydrin. Further, use of the chronic endpoint and the additional 10X safety factor to assess acute risk is such a conservative approach to assessing acute risk that no further safety factor for this risk assessment. Other relevant factors here are that:

i. There is no indication that propylene oxide or propylene chlorohydrin are neurotoxic chemicals and there is no need for developmental neurotoxicity studies or additional uncertainty factors to account for neurotoxicity; and

ii. The exposure databases is unlikely to underestimate exposure because it is based on reliable data on anticipated residues and percent crop treated information.

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 uncertainty/safety factors. 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 uncertainty/safety factors is not exceeded. As discussed prior, because propylene oxide and propylene chlorohydrin residues which could enter water are expected to be negligible, water exposures were not included in the aggregate risk assessments.

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from only food to propylene oxide will occupy 7% of the aPAD for the population group (females 13-49 years old) receiving the greatest exposure. Because no acute endpoint has been identified for propylene chlorohydrin, EPA has assessed acute risk for propylene chlorohydrin using the cPAD for propylene chlorohydrin. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from only food to propylene chlorohydrin will occupy 90% of the cPAD for the population group receiving the greatest exposure (infants less than one year old).

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to propylene oxide from only food will utilize 14% of the cPAD for the population group (children 3-5 years). Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to propylene chlorohydrin from only food will utilize 29% of the cPAD for the population group (children 1-2 years). There are no residential uses for propylene oxide or propylene chlorohydrin, but residential bystanders may be exposed to air emissions from fumigation facilities or structures. However, dietary and bystander exposure for either propylene oxide or propylene chlorohydrin cannot be combined for this assessment because the endpoints selected for these exposures are not based on a common effect. Therefore, risk from dietary and inhalation routes were not aggregated.

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).

Though residential exposure could occur with the use of propylene oxide, the potential short-term exposures to propylene oxide and propylene chlorohydrin were not aggregated with chronic dietary food and water exposures for the same because the toxic effects are different.

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).

Though residential exposure could occur with the use of propylene oxide, the potential intermediate-term exposures propylene oxide and propylene chlorohydrin were not aggregated with chronic dietary food and water exposures for the same because the toxic effects are different.

5. Aggregate cancer risk for U.S. population . The cancer dietary risk estimates for propylene oxide are below EPA's level of concern; the cancer dietary excess lifetime risk estimate for the U.S. general population is 4x10 -7 . EPA considers risks in the range of 1 x 10 -6 (such as the cancer risk for propylene oxide) to be negligible and thus pose a reasonable certainty of no harm. There is no cancer risk for propylene chlorohydrin as evidenced by the cancer data which were negative for both rats and mice.

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 propylene oxide and propylene chlorohydrin residues.

Adequate enforcement methodology is available to enforce the tolerance expression. An acceptable method was submitted (ABC.METHOD 46306-PPO/Hydrins Rev 1.0; MRID 45301902) which is able to quantify propylene oxide and propylene chlorohydrin residues in various commodities using headspace gas chromatography with flame ionization detection. 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 .

There are no Codex Maximum Residue Levels (MRLs) for residues of propylene oxide and propylene chlorohydrin in any commodity. No Canadian or Mexican MRLs have been established.

Therefore, tolerances are established for residues of propylene oxide when used as a post harvest fumigant, in or on fig; grape, raisin; and plum, prune, dried, at 3.0; 1.0; and 2.0; respectively ppm, and separate tolerances are established for the reaction product, propylene chlorohydrin, in or on fig; grape, raisin; and plum, prune, dried, at 3.0, 4.0, and 2.0 ppm, respectively. The use directions currently listed in 40 CFR 180.491 paragraphs (a)(1), (a)(2), (a)(4) and (a)(5) are also being removed.

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).

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).

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 .

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 .

Under section 408(g) of the 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-2007-0349 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 October 29, 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 EPA-HQ-OPP-2007-0349, 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.

In the Federal Register of May 9, 2007 (72 FR 26375) (FRL-8128-1), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 7F7191) by Dow AgroSciences LLC, 9330 Zionsville Rd., Indianapolis, IN 46268-1053. The petition requested that 40 CFR 180.495 be amended by establishing tolerances for residues of the insecticide spinosad in or on fish; fish-shellfish, molluscs and fish-shellfish crustaceans at 4.0 parts per million (ppm). Spinosad is a fermentation product of Saccharopolyspora spinosa , consisting of two related active ingredients: Spinosyn A (Factor A; CAS #131929-60-7) or 2-[(6-deoxy-2,3,4-tri- O -methyl-α- L -manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-tetrahydro-6-methyl-2 H -pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1 H -as-Indaceno[3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D (Factor D; CAS #131929-63-0) or 2-[(6-deoxy-2,3,4-tri- O -methyl-α- L -manno-pyranosyl)oxy]-13-[[5-(dimethyl-amino)-tetrahydro-6-methyl-2 H -pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-methyl-1 H -as-Indaceno[3,2-d]oxacyclododecin-7,15-dione. That notice referenced a summary of the petition prepared by Dow AgroSciences LLC, 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.

Section 408(b)(2)(A)(i) of the 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 the 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 the 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 the FFDCA by the Food Quality Protection Act (FQPA) of 1996.

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in 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 residues of spinosad on fish; fish-shellfish, crustacean; and fish-shellfish, mollusc at 4.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

On March 21, 2007 the Agency published a final rule (72 FR 13168 FRL-8114-4) establishing tolerances for residues of spinosad in or on hop, dried cones at 22 ppm and amaranth, grain, stover at 10 ppm; cattle, meat at 2.0 ppm; sheep, meat at 2.0 ppm; goat, meat at 2.0 ppm; horse, meat at 2.0 ppm; poultry, meat at 0.10 ppm; cattle, fat at 50 ppm; sheep, fat at 50 ppm; goat, fat at 50 ppm; horse, fat at 50 ppm; poultry, fat at 1.3 ppm; milk at 7.0 ppm; milk, fat at 85 ppm; egg at 0.30 ppm; cattle, meat byproducts, except liver at 5.0 ppm; sheep, meat byproducts, except liver at 5.0 ppm; goat, meat byproducts, except liver at 5.0 ppm; horse, meat byproducts, except liver at 5.0 ppm; poultry meat byproducts at 0.10 ppm; cattle, liver at 10 ppm; sheep, liver at 10 ppm; goat, liver at 10 ppm; and horse, liver at 10 ppm. When the Agency conducted the risk assessments in support of this tolerance action it assumed that spinosad residues would be present on fish and shellfish (crustacean and mollusc) as well as on all foods covered by the proposed and established tolerances. Residues on fish and shellfish were included because there was a pending application under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq ., to register spinosad for aquatic use as a mosquito larvacide, a use the Agency determined could result in residues in fish and shellfish. Therefore, establishing the fish and shellfish tolerances will not change the most recent estimated aggregate risks resulting from use of spinosad, as discussed in the Federal Register of March 21, 2007. Refer to the March 21, 2007 (72 FR 13168) Federal Register document, available at http://www.regulations.gov , for a detailed discussion of the aggregate risk assessments and determination of safety. EPA relies upon those risk assessments and the findings made in the Federal Register document in support of this action.

Based on the risk assessments discussed in the final rule published in the Federal Register of March 21, 2007 (72 FR 13168), EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to spinosad residues.

Adequate enforcement methodology (Liquid Chromatography/Mass Spectroscopy - Accelerated Climate Prediction Initiative) 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 .

There are no established or proposed CODEX Maximum Residue Limits (MRLs) or Canadian or Mexican MRLs for residues of spinosad in or on fish or shellfish.

Therefore, tolerances are established for residues of spinosad, consisting of the related active ingredients Spinosyn A, 2-[(6-deoxy-2,3,4-tri- O -methyl-α- L -manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1 H -as-Indaceno[3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D, 2-[(6-deoxy-2,3,4-tri- O -methyl-α- L -manno-pyranosyl)oxy]-13-[[5-(dimethyl-amino)-tetrahydro-6-methyl-2 H -pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-methyl-1 H -as-Indaceno[3,2-d]oxacyclododecin-7,15-dione, in or on fish; fish-shellfish, crustacean; and fish-shellfish, mollusc at 4.0 ppm.

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).

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).

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

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 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr .

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2007-0428 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before October 29, 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 your copies, identified by docket ID number EPA-HQ-OPP-2007-0428, 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.

EPA, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing tolerances for residues of the fungicide flusilazole, (1-[[bis(4-fluorophenyl)methylsilyl]methyl]-1H-1,2,4-triazole), in or on soybean seed at 0.04 parts per million (ppm), soybean aspirated grain fractions at 2.6 ppm, and soybean oil at 0.10 ppm. These tolerances expire and are revoked on December 31, 2010. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations (CFR).

Section 408(l)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related tolerances to set binding precedents for the application of section 408 of the FFDCA and the new safety standard to other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.

Section 408(b)(2)(A)(i) of the 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 the 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 the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

Section 18 of the FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” This provision was not amended by the Food Quality Protection Act of 1996 (FQPA). EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

Australasian soybean rust (SBR) is a plant disease caused by 2 fungal species, Phakopsora pachyrhizi and P. meibomiae , and is spread primarily by windborne spores that can be transported over long distances. SBR models suggest that most of the soybean acreage in the U.S. could be compromised by an SBR epidemic. In accordance with the 2002 Agricultural Bioterrorism Protection Act, SBR was identified by the United Stated Department of Agriculture (USDA) as a select biological agent with the potential to pose a severe threat to the soybean industry and livestock production, in general. As such, USDA has invested in extensive readiness and outreach activities among soybean producers. EPA has authorized under FIFRA section 18 the use of flusilazole on soybeans for control of Australasian Soybean Rust in Minnesota and South Dakota. After having reviewed the states' submissions, EPA concurs that emergency conditions exist for these States.

As part of its assessment of these emergency exemptions, EPA assessed the potential risks presented by residues of flusilazole in or on soybean seed, aspirated grain fractions, and oil. In doing so, EPA considered the safety standard in section 408(b)(2) of the FFDCA, and EPA decided that the necessary tolerances under section 408(l)(6) of the FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing these tolerances without notice and opportunity for public comment as provided in section 408(l)(6) of the FFDCA. Although these tolerances expire and are revoked on December 31, 2010, under section 408(l)(5) of the FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on soybean seed, aspirated grain fractions, and oil after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed levels that were authorized by these tolerances at the time of that application. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because these tolerances are being approved under emergency conditions, EPA has not made any decisions about whether flusilazole meets EPA's registration requirements for use on soybean or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that these tolerances serve as the basis for registration of flusilazole by a State for special local needs under FIFRA section 24(c). Nor do these tolerances serve as the basis for use of this pesticide on this crop under section 18 of FIFRA by any State other than those following all provisions of EPA's regulations implementing FIFRA section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for flusilazole, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT .

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm .

Consistent with section 408(b)(2)(D) of the 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 flusilazole and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for time-limited tolerances for residues of flusilazole in or on soybean seed at 0.04 ppm, soybean aspirated grain fractions at 2.6 ppm, and soybean oil at 0.10 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerances follows.

The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological endpoint. However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect 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. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences.

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is applied in order to protect infants and children, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF.

For non-dietary risk assessments (other than cancer) the UF is used to determine the level of concern (LOC). For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10 6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated.

A summary of the toxicological endpoints for flusilazole used for human risk assessment is discussed in Table 2.3 on page 15 of the human health risk assessment found at http://www.regulations.gov Docket No. EPA-HQ-OPP-2007-0428-0001.

1. Dietary exposure from food and feed uses . There are currently no tolerances established for this chemical, and it is not registered in the US. Risk assessments were conducted by EPA to assess dietary exposures from flusilazole in food as follows:

i. Acute exposure . Acute dietary 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 one day or single exposure. EPA used the Dietary Exposure Evaluation Model (DEEM TM ) and data on individual food consumption as reported by respondents in the USDA 1994-1996 and 1998 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) to estimate exposure to the chemical for each commodity. This acute risk assessment used conservative and high end assumptions to estimate acute exposure and risk, as follows: It was assumed that flusilazole residues in soybean commodities would be at proposed tolerance levels or higher; default processing factors were applied to account for effects that may occur on flusilazole residues from processing into soybean oil; an additional factor was incorporated to account for potential residues of the metabolite of flusilazole, which may occur in soybean commodities; and it was assumed that 100% of the soybean crop grown in the US would be treated. No refinements such as incorporating anticipated residue values or percent of crop treated (PCT) assumptions were used. A high-end estimate for contribution to dietary exposure from residues occurring in drinking water, was incorporated directly into the dietary assessment using the 30-year average annual concentration for surface water generated by the Agency's computer simulation, the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM-EXAMS).

ii. Chronic exposure . In conducting this chronic dietary risk assessment EPA used the DEEM TM and data on individual food consumption as reported by respondents in the USDA 1994-1996 and 1998 nationwide CSFII to estimate exposure to the chemical for each commodity. The chronic risk assessment also used the same conservative and high-end assumptions as described above in Unit IV.B.1.i., for calculation of the acute exposure estimates and risk.

iii. Cancer . The cancer risk assessment incorporated the same dietary exposure estimates as used for the chronic assessment, and used conservative and high-end assumptions to calculate cancer risk estimates over a lifetime of exposure, as described above in Unit IV.B.1.i.

2. Dietary exposure from drinking water . Since this exemption is the only use of a new pesticide in the US, there are no residues in drinking water, and thus there are no monitoring exposure data to use for a comprehensive dietary exposure analysis and risk assessment for flusilazole in drinking water. Because of this, the Agency calculated drinking water concentration estimates which may occur from this use, by reliance on simulation or modeling taking into account data on the physical characteristics of flusilazole.

None of the models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health LOC.

Based on available data, and for this section 18 use only, the Agency determined that the residue of concern for drinking water is flusilazole per se . Some surface and ground water contamination may occur based on the proposed application rates and the environmental fate properties of flusilazole, although mobility in soil is expected to be low.

Based on Tier II screening-level surface water modeling for drinking water, the Agency estimated concentrations in surface water to be used for acute, chronic non-cancer, and cancer exposure assessment. Tier II surface water concentrations for parent flusilazole were calculated using PRZM-EXAMS. PRZM/EXAMS incorporates an index reservoir environment and includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin. EPA used the Screening Concentration Ground Water (SCI-GROW2) model to estimate ground water concentrations. These results for both surface and ground water are consistent with the fate and transport properties of flusilazole.

Modeled estimates of drinking water concentrations were incorporated directly into the dietary assessments using the estimated drinking water concentrations (EDWC) for surface water generated by the PRZM-EXAMS model. For the acute assessment, the peak concentration of 1.81 parts per billion (ppb) was used to assess the contribution to surface drinking water; for the chronic assessment, the annual mean value of 0.92 ppb was used to assess the contribution to surface drinking water. The EDWC for groundwater was estimated by SCI-GROW2 at 0.05 ppb. Since the EDWC estimated by SCI-GROW2 for groundwater was lower, at 0.05 ppb, the higher, more conservative, surface water estimate of 1.81 ppb was used for assessing contribution to dietary exposures.

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). Flusilazole 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 the 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.”

Flusilazole is a member of the triazole-containing class of pesticides. Although triazole pesticides act similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between this pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same sequence of major biochemical events (EPA, 2002). In triazoles a variable pattern of toxicological responses is found. Some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. Furthermore, the triazoles produce a diverse range of biochemical events including altered cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood whether these biochemical events are directly connected to their toxicological outcomes. Thus, there is currently no evidence to indicate that triazoles share common mechanisms of toxicity and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the triazole pesticides. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's website at http://www.epa.gov/pesticides/cumulative .

Flusilazole is a triazole-derived pesticide. This class of compounds can form the common metabolites 1,2,4-triazole conjugates (triazole alanine and triazole acetic acid). To support existing tolerances and to establish new tolerances for triazole-derived pesticides, EPA conducted a human health risk assessment for exposure to 1,2,4-triazole, triazole alanine, and triazole acetic acid resulting from the use of all current and pending uses of any triazole-derived fungicide. The risk assessment is highly conservative, screening-level evaluation in terms of hazards associated with common metabolites (e.g., use of a maximum combination of uncertainty factors) and potential dietary and non-dietary exposures (i.e., high end estimates of both dietary and non-dietary exposures). In addition, on the assessment involving the 1,2,4-triazole metabolites, the Agency retained the additional 10X FQPA safety factor for the protection of infants and children. The assessment includes evaluations of risks for various subgroups, including those comprised of infants and children. The Agency's complete risk assessment may be found at http://www.epa.gov/opprd001/factsheets/tetraHHRA.pdf .

In that risk assessment, EPA concluded that, based upon the available information and on conservative estimates of hazard and exposure, there are no human health risk issues associated with 1,2,4-triazole or its metabolites that would preclude re-registration of the triazole-derivative fungicides registered to date or conditional registrations of the triazole-derivative fungicides that have been proposed as of September 1, 2005, which included the use of flusilazole on soybean.

1. In general . Section 408 of the FFDCA provides that EPA shall apply an additional 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 data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.

2. Developmental and Reproductive toxicity studies . There are several developmental and 2-generation reproduction studies in rats and rabbits that provide evidence of increased susceptibility to in utero and/or pre-, postnatal exposure to flusilazole. Developmental effects such as cleft palate, resorption and skeletal malformations were observed in rats. In rabbits, increased resorptions were observed. In both species, these effects occurred either in the absence of maternal toxicity and/or at a dose that caused only marginal maternal toxicity (decreased food consumption, body weight gain). In a multi-generation reproduction study in rats a decrease in pup viability at birth and decreased post-natal survival were observed either in the absence of maternal toxicity and/or at a dose that caused only marginal maternal toxicity.

3. Prenatal and postnatal sensitivity . The evidence of increased susceptibility observed in rats and rabbits is off-set because EPA has set the acute (0.02 milligrams/kilograms (mg/kg) and chronic (0.002 mg/kg) RfDs below the dose at which these developmental effects were observed, and these are therefore protective with respect to these effects. Although NOAELs were not identified in some developmental and 2-generation reproduction studies, there are well established NOAELs in most of the developmental and 2-generation reproduction studies, and the RfDs are below these NOAELs. Because EPA has set the RfDs well below the levels at which developmental effects are observed, the increased susceptibility seen in these studies does not warrant retaining the 10X FQPA safety factor (i.e., it is 1X).

4. Conclusion . For the purpose of this emergency quarantine exemption, EPA relied on studies reviewed by the European Union as well as some preliminary internal study reviews. Therefore, the stated toxicological endpoints are applicable for this emergency section 18 use only, since upon detailed review of the new and existing data, the final conclusions may change. EPA determined that, in terms of hazard, there are low concerns and no residual uncertainties with regard to pre-and/or post-natal toxicity. EPA determined that the FQPA 10X safety factor to protect infants and children should be removed (reduced to 1X) based on the following:

i. The toxicity database for flusilazole is complete.

ii.The dietary food exposure assessment utilizes proposed tolerance-level or higher residues and 100% CT information for all commodities. By using these screening-level assessments, acute and chronic exposures/risks will not be underestimated.

iii.The dietary drinking water assessment (Tier 2 estimates) utilizes values generated by model and associated modeling parameters which are designed to provide conservative, health-protective, high-end estimates of water concentrations.

iv.There are no residential uses of flusilazole.

The Agency currently has two ways to estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses. First, a screening assessment can be used, in which the Agency calculates drinking water levels of comparison (DWLOCs), which are used as a point of comparison against estimated drinking water concentrations (EDWCs). The DWLOC values are not regulatory standards for drinking water, but are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. More information on the use of DWLOCs in dietary aggregate risk assessments can be found at http:/www.epa.gov/oppfead1/trac/science/screeningsop.pdf .

More recently, the Agency has used another approach to estimate aggregate exposure through food, residential and drinking water pathways. In this approach, modeled surface water and ground water EDWCs are directly incorporated into the dietary exposure analysis, along with food. This approach provides a more realistic estimate of exposure because actual body weights and water exposures are then added to estimates and water consumption from the CSFII are used. The combined food and water exposures are then added to estimated exposure from residential sources to calculate aggregate risks. The resulting exposure and risk estimates are still considered to be high end, due to the assumptions used in developing drinking water modeling inputs. The risk assessment for flusilazole used in this tolerance document uses this approach of incorporating water exposure directly in to the dietary exposure analysis.

There are no registered or proposed uses of flusilazole, which result in residential exposures, so the aggregate exposure assessment required by FFDCA section 408(b)(2)(D)(vi) consists solely of dietary (food + drinking water) exposures.

Aggregate exposure risk assessments were conducted by incorporating the drinking water concentrations directly into the dietary exposure assessment for the acute and chronic aggregate exposures (food + drinking water). These aggregate exposures do not exceed the Agency's LOC since they were less than 100% of the acute and chronic population adjusted doses (PADs).

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and drinking water to flusilazole is estimated at 0.000326 mg/kg/day, and occupies 1.6% of the aPAD for females 13-49 years, the population subgroup of concern. There were no acute toxicity concerns for other population subgroups noted, based upon the available toxicology studies, and therefore, no acute toxicology endpoints assigned. Therefore, EPA does not expect aggregate dietary exposure for this population subgroup of concern to exceed the LOC of 100% of the aPAD.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to flusilazole from food and water will utilize 8.1% of the cPAD for the U.S. population, 21% of the cPAD for All Infants <1 year old (the most highly exposed subpopulation), and 17% of the cPAD for Children 1-2 years old, and Children 3-5 years old (both subgroups). Flusilazole is unregistered, and therefore there are no residential uses or exposures. EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table of this unit:

3. Short-term and intermediate risks . Short-term and intermediate aggregate exposures take into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Flusilazole 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 were previously addressed.

4. Aggregate cancer risk for U.S. population . In its cancer analysis, EPA assumed 100% of the soybean crop in the US would be treated with flusilazole. EPA used the DEEM 7.81 default processing factors to estimate residues that might occur in processed commodities (i.e. soybean oil) and assumed that flusilazole residues in or on soybean commodities would be equal to the proposed tolerance levels. Drinking water was incorporated directly into the dietary assessment using the 30-year average annual concentration for surface water generated by the PRZM-EXAMS model as a high-end estimate. The resulting cancer risk estimate for the general U.S. population (4.5 x 10 - 7 ) was less than EPA's LOC (generally 1 x 10 - 6 ).

5. 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, and to infants and children from aggregate exposure to flusilazole residues.

Adequate enforcement methodologies (gas chromatography/nitrogen-phosphorus detector; and gas chromatography/mass-selective detector) are available to enforce the tolerance expression. The methods 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 .

There are no Codex, Canadian, or Mexican maximum residue limits (MRLs) for the residues of flusilazole on soybean commodities. Therefore, there are no international harmonization concerns at this time.

Therefore, the tolerances are established for residues of flusilazole, (1-[[bis(4-fluorophenyl)methylsilyl]methyl]-1H-1,2,4-triazole), in or on soybean seed at 0.04 parts per million (ppm), soybean aspirated grain fractions at 2.6 ppm, and soybean oil at 0.10 ppm.

This final rule establishes tolerances 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 tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .) do not apply.

This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 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).

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).

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

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 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr .

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2007-0327 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before October 29, 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 your copies, identified by docket ID number EPA-HQ-OPP-2007-0327, 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.

EPA, on its own initiative, in accordance with sections 408 (e) and 408 (l)(6) of the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 346a 21 U.S.C. 346a, is establishing a time-limited tolerance for residues of the fungicide flutriafol per se in or on soybean at 0.10 parts per million (ppm). The tolerance will expire and is revoked on December 31, 2010.

Section 408(l)(6) of the FFDCA allows EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related tolerances to set binding precedents for the application of section 408 of the FFDCA and the new safety standard to other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.

Section 408 (b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance or exemption from the requirement for a tolerance for pesticide (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 the 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 the 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. . . .”

EPA has authorized under section 18 of FIFRA the use of flutriafol on soybeans for control of Australasian soybean rust initially in Minnesota and South Dakota and subsequently in multiple states. After having reviewed the submissions, EPA concurs that emergency conditions exist for these States.

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of flutriafol per se in or on soybean seed. In doing so, EPA considered the safety standard in section 408(b)(2) of the FFDCA, and EPA decided that the necessary tolerance under section 408(l)(6) of the FFDCA would be consistent with the safety standard and with section 18 of FIFRA. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6) of the FFDCA. Although this tolerance will expire and is revoked on December 31, 2010, under section 408(l)(5) of the FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on soybean after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by this tolerance at the time of that application. EPA will take action to revoke this tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicates that the residues are not safe.

Because this tolerance is being approved under emergency conditions EPA has not made any decisions about whether flutriafol meets EPA's registration requirements for use on soybeans or whether a permanent tolerance for this use would be appropriate. Under these circumstances, EPA does not believe that this tolerance serves as a basis for registration of flutriafol by a State for special local needs under section 24(c) of FIFRA. Nor does this tolerance serve as the basis for any States other than those following all provisions of EPA's regulations implementing FIFRA section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for flutriafol, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT .

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm .

Consistent with section 408(b)(2)(D) of the 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, consistent with section 408(b)(2) of the FFDCA, for a tolerance for residues of flutriafol per se on soybean at 0.10 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

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 toxic effects caused by flutriafol 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 in the docket at http://www.regulations.gov , docket ID number EPA-HQ-OPP-2007-0327 (see memo from Tyler, et al. dated March 30, 2006).

For hazards that have a threshold below which there is no appreciable risk, the dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the LOAEL is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect 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.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, and estimates risk in terms of the probability of occurrence of additional cancer cases. Under certain specific circumstances, margin of exposure (MOE) calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for flutriafol used for human risk assessment is shown as follows:

1. Dietary exposure from food and feed uses . Flutriafol is a new pesticide ingredient for the U.S. Therefore, there are no existing tolerances for flutriafol in 40 CFR part 180. Based on the available residue data on soybeans, residues of flutriafol are not expected to exceed 0.10 ppm on soybeans that have been treated in accordance with the emergency exemption use directions. Risk assessments were conducted by EPA to assess dietary exposures from flutriafol 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 one day or single exposure. The Dietary Exposure Evaluation Model (DEEM TM ) analysis evaluated the individual food consumption as reported by respondents in the United States Department of Agriculture (USDA) Nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: An acute dietary exposure assessment was performed for females 13-49 years old using tolerance level residue, and 100 per cent treated (PCT) information for all soybean commodities. Dietary Exposure and Risk Assessment, DP#322530, J. Tyler, 3/30/06.

This assessment concludes that the acute dietary exposure estimates are below the Agency's level of concern ( < 100% aPAD) for the general U.S. population and all population subgroups.

ii. Chronic exposure . In conducting this chronic dietary exposure and risk assessment the DEEM TM analysis evaluated the individual food consumption as reported by respondents in the USDA Nationwide CSFII and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: A chronic dietary exposure assessment was performed for the general U.S. population and various population subgroups using tolerance level residue, and 100% CT information for all soybean commodities.

This assessment concludes that the chronic dietary exposure estimates are below the Agency's level of concern ( < 100% cPAD) for the general U.S. population and all population subgroups. The most highly exposed population subgroup is all infants ( < 1 year old) at 2.7% cPAD

iii. Cancer . Preliminary analysis of tumor data indicated a significant increased trend in combined adenomas and carcinomas in male rat liver tumors. However, there were no significant differences noted in pair-wise comparison with controls in either male or female liver tumors. Thus, based on lack of evidence of carcinogenicity in both rats and mice carcinogenicity studies, the chemical was considered as “not likely” to be carcinogenic to humans.

2. Dietary exposure from drinking water . This emergency exemption use of flutriafol is the first use for this fungicide in the U.S. As such, there are no monitoring exposure data for water for this ingredient. Thus, in this risk assessment, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of flutriafol. 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 .

The Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and (SCI-GROW) screening models were used to estimate surface water and ground water concentrations of flutriafol. Based on the PRZM/EXAMS and SCI-GROW models the estimated environmental concentrations (EECs) of flutriafol for acute exposures are estimated to be 4.0 μg/L for surface water and 2.0 μg/L for ground water. The EECs of flutriafol for chronic exposures are estimated to be 2.0 μg/L for surface water and 1.0 μg/L 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 4.0 μg/L was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 2.0 μg/L was used to assess the contribution to drinking water.

3. From non-dietary exposure . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Flutriafol 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 the 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 flutriafol and any other substances Flutriafol is a member of the triazole-containing class of pesticides commonly referred to as the conazoles. Although conazoles act similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between their pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same, sequence of major biochemical events (EPA, 2002). In conazoles, however, a variable pattern of toxicological responses is found. Some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. Furthermore, the conazoles produce a diverse range of biochemical events including altered cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood whether these biochemical events are directly connected to their toxicological outcomes. Thus, there is currently no evidence to indicate that conazoles share common mechanisms of toxicity and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the conazoles. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's website at http://www.epa.gov/pesticides/cumulative/.

Flutriafol is a triazole-derived pesticide. This class of compounds can form the common metabolite 1,2,4-triazole and two triazole conjugates (triazole alanine and triazole acetic acid). To support existing tolerances and to establish new tolerances for triazole-derivative pesticides. U.S. EPA conducted a human health risk assessment for exposure to 1,2,4-triazole, triazole alanine, and triazole acetic acid resulting from the use of all current and pending uses of any triazole-derived fungicide. The risk assessment is a highly conservative, screening-level evaluation in terms of hazards associated with common metabolites (e.g., use of a maximum combination of uncertainty factors) and potential dietary and non-dietary exposures (i.e., high end estimates of both dietary and non-dietary exposures). In addition, in assessing the risks for this group of chemicals the Agency retained the additional 10X FQPA safety factor for the protection of infants and children. The assessment includes evaluations of risks for various subgroups, including those comprised of infants and children. The Agency's complete risk assessment for the conazole group is found in the propiconazole reregistration docket at http://www.regulations.gov , Docket ID Number EPA-HQ-OPP-2005-0497.

1. In general . Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for pre-natal and post-natal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.

2. Pre-natal and post-natal sensitivity . There is no evidence of increased susceptibility in the developmental study in rabbits or in the 2-generation reproduction study in the rat. Although some effects were seen in the rat developmental study, in the rat 2-generation reproduction toxicity study the effects occurred at the same dose that caused maternal toxicity indicating there was no increased susceptibility. These effects were considered to be study variations, and the Agency also retained the 10X safety factor to account for these variations due to the lack of a well defined NOAEL in the critical study. Therefore, there is no residual uncertainty for pre-natal and/or post-natal susceptibility. (See memo from Tyler, et al . dated March 30, 2006.

3. Conclusion . The Agency evaluated the quality of the hazard and exposure data and determined that based on the available hazard and exposure data, the FQPA SF should be retained.

EPA conducted human-health risk assessments for acute and chronic dietary exposures (food and drinking water only). Because there are no uses of flutriafol that are expected to result in residential exposures, this aggregate risk assessment takes into consideration dietary food and drinking water exposure only. Therefore, the acute and chronic aggregate estimates would be the same as the dietary exposure results. All aggregate exposure and risk estimates are below EPA's level of concern.

1. Acute risk . Including the proposed use on soybeans, human-health risk assessments have been conducted for the following exposure scenarios: Acute and chronic dietary exposures (food and drinking water only). All aggregate exposure and risk estimates are below the Agency's level of concern. Because there are no uses of flutriafol that are expected to result in residential exposures, this aggregate risk assessment takes into consideration dietary food and drinking water exposure only. The acute (95 th percentile) dietary exposure estimates are below HED's level of concern < 100% aPAD for females 13-49 year old (10% aPAD).

2. Chronic risk . The chronic dietary exposures estimates are below HED's level of concern < 100% chronic population adjusted dose (cPAD) for the general population and all population subgroups. The most highly-exposed population subgroup is all infants ( < 1 year old) at 2.7% cPAD:

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).

4. Aggregate cancer risk for U.S. population . For this assessment, EPA has concluded that flutriafol is, “not likely to be carcinogenic to humans.”

5. 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, and to infants and children from aggregate exposure to flutriafol residues.

Adequate enforcement methodology (Method RAM 219/04) submitted by the registrant, (email from C. Rodia to J. Tyler, 3/23/06) 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 .

There are currently tolerances of 0.10 ppm for soybean in Brazil and South Africa.

Therefore, the tolerance is established for residues of flutriafol, in or on soybean at 0.10 ppm.

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).

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).

A final rule concerning applications to engage in the coastwise trade under the lease financing provisions of 46 U.S.C. 12119 became effective on November 17, 2006, with the exception of the collection of information requirements in the amendments to 46 CFR 68.65, 68.70, 68.75, 68.100, 68.107, and 68.109. Title 46 CFR 68.65 requires a vessel owner who seeks an initial, or renewal of, coastwise endorsement, to submit a certification of ownership in writing to the Director of the NVDC. 46 CFR 68.70 requires an owner of a vessel other than a barge qualified to engage in coastwise trade under the lease financing provisions of 46 U.S.C. 12119 to submit a certified application for the coastwise operation of a vessel under a demise charter. 46 CFR 68.75 requires an owner of a barge qualified to engage in coastwise trade under the lease financing provisions of 46 U.S.C. 12119 to submit certifications and documents supporting an application for the coastwise operation of a barge under a demise charter. 46 CFR 68.100 sets out applicability provisions and phase-in dates. 46 CFR 68.107 requires an owner of a vessel other than a barge qualified to engage in coastwise trade under the lease financing provisions of 46 U.S.C. 12119 to submit certifications, certain supporting documents, and a certified application for the coastwise operation of a vessel under a demise charter. 46 CFR 68.109 requires an owner of a barge qualified to engage in coastwise trade under the lease financing provisions of 46 U.S.C. 12119 to submit certifications, certain supporting documents, and a certified application for the coastwise operation of a vessel under a demise charter.

The final rule that contained the provisions for these certifications, supporting documents and applications was published in the Federal Register on October 18, 2006 (71 FR 61413), and is available electronically through the docket (USCG-2005-20258) at http://dms.dot.gov/ . As required by 44 U.S.C. 3507(d), we submitted a copy of the final rule to OMB for its review. On January 10, 2007, after reviewing the rule, OMB approved the collection-of-information required in §§ 68.65, 68.70, 68.75, 68.100, 68.107, and 68.109 of the final rule under OMB control number 1625-0027.

This is a synopsis of the Commission's Report and Order, MB Docket No. 07-79, adopted August 8, 2007, and released August 10, 2007. The full text of this Commission decision is available for inspection and copying during regular business hours at the FCC's Reference Information Center, Portals II, 445 Twelfth Street, SW., Room CY-A257, Washington, DC 20554. The complete text of this decision may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-378-3160 or www.BCPIWEB.com. The Commission will send a copy of this Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

We published a final rule in the Federal Register of Wednesday, April 11, 2007 (72 FR 18317) that published harvest regulations for migratory bird subsistence hunting in Alaska for the 2007 season.

In that rule, the DATES section incorrectly established an August 31, 2007, expiration date for amendments to subpart A of 50 CFR part 92. Subpart A of 50 CFR part 92 sets forth the general provisions for migratory bird subsistence harvest in Alaska, and we intended the amendments we made to subpart A of 50 CFR part 92 to be permanent.

Therefore, in rule FR Doc. E7-6667 published on April 11, 2007 (72 FR 18318), make the following correction. On page 18318, in the first column, revise the DATES section to read: