Karnal bunt is a fungal disease of wheat (Triticum aestivum), durum wheat (Triticum durum), and triticale (Triticum aestivum X Secale cereale), a hybrid of wheat and rye. Karnal bunt is caused by the fungus Tilletia indica (Mitra) Mundkur and is spread primarily through the planting of infected seed followed by very specific environmental conditions matched during specific stages of wheat growth. The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) regulates the movement of articles in the United States that could spread Karnal bunt and works toward eventual eradication of Karnal bunt through bio-sanitary measures.

In an interim rule 1 effective and published in the Federal Register on June 4, 2009 (74 FR 26774-26777, Docket No. APHIS-2009-0036), we amended the Karnal bunt regulations contained in 7 CFR 301.89-1 through 301.89-16 by removing certain areas or fields in Riverside County, CA, from the list of regulated areas in § 301.89-3(g). That action was based on our determination that these fields or areas are eligible for release from regulation under the criteria in § 301.89-3(f). The interim rule relieved restrictions on fields within those areas that were no longer necessary. As a result of the interim rule, 286 fields and 8,226 acres were removed from the list of regulated areas in Riverside County, CA; 35,271 acres in Riverside County remain regulated for Karnal bunt.

Comments on the interim rule were required to be received on or before August 3, 2009. We received one comment by that date, from a wheat industry organization. The commenter supported the interim rule. Therefore, for the reasons given in the interim rule, we are adopting the interim rule as a final rule without change.

This action also affirms the information contained in the interim rule concerning Executive Order 12866 and the Regulatory Flexibility Act, Executive Orders 12372 and 12988, and the Paperwork Reduction Act.

Further, for this action, the Office of Management and Budget has waived its review under Executive Order 12866.

Done in Washington, DC, this 11th day of December 2009.

Bovine tuberculosis is a contagious and infectious granulomatous disease caused by the bacterium Mycobacterium bovis. Although commonly defined as a chronic debilitating disease, bovine tuberculosis can occasionally assume an acute, rapidly progressive course. While any body tissue can be affected, lesions are most frequently observed in the lymph nodes, lungs, intestines, liver, spleen, pleura, and peritoneum. Although cattle are considered to be the true hosts of M. bovis, the disease has been reported in several other species of both domestic and nondomestic animals, as well as in humans.

At the beginning of the past century, tuberculosis caused more losses of livestock than all other livestock diseases combined. This prompted the establishment in the United States of the National Cooperative State/Federal Bovine Tuberculosis Eradication Program for tuberculosis in livestock.

In carrying out the national eradication program, the Animal and Plant Health Inspection Service (APHIS) issues and enforces regulations. The regulations require the testing of cattle and bison for tuberculosis, define the Federal tuberculosis status levels for States or zones (accredited-free, modified accredited advanced, modified accredited, accreditation preparatory, and nonaccredited), provide the criteria for attaining and maintaining those status levels, and contain testing and movement requirements for cattle and bison leaving States or zones of a particular status level. These regulations are contained in 9 CFR part 77 (referred to below as the regulations) and in the Bovine Tuberculosis Eradication Uniform Methods and Rules, 1999 (UMR), which is incorporated by reference into the regulations. The regulations restrict the interstate movement of cattle, bison, and captive cervids to prevent the spread of tuberculosis. Subpart B of the regulations contains requirements for the interstate movement of cattle and bison not known to be infected with or exposed to tuberculosis. The interstate movement requirements depend upon whether the animals are moved from an accredited-free State or zone, modified accredited advanced State or zone, modified accredited State or zone, accreditation preparatory State or zone, or nonaccredited State or zone.

The status of a State or zone is based on its freedom from evidence of tuberculosis in cattle and bison, the effectiveness of the State’s tuberculosis eradication program, and the degree of the State’s compliance with the standards for cattle and bison contained in the UMR. In addition, the regulations allow that a State may request split-State status via partitioning into specific geographic regions or zones with differential status designations if bovine tuberculosis is detected in a portion of a State and the State demonstrates that it meets certain criteria with regard to zone classification.

The State of Michigan is currently divided into three zones with different classifications. The first zone, which is classified as accredited-free, is comprised of an area in Michigan known as the Upper Peninsula that comprises Alger, Baraga, Chippewa, Delta, Dickinson, Gogebic, Houghton, Iron, Keweenaw, Luce, Mackinac, Marquette, Menominee, Ontonagon, and Schoolcraft Counties. The second zone, which is classified as modified accredited, comprises Alcona, Alpena, Antrim, Charlevoix, Cheboygan, Crawford, Emmet, Montmorency, Oscoda, Otsego, and Presque Isle Counties and those portions of Iosco and Ogemaw Counties that are north of the southernmost boundary of the Huron National Forest and the Au Sable State Forest. The third zone covers the remainder of the State and is classified as modified accredited advanced.

We have received a request from the State of Michigan for an addition to the modified accredited advanced zone. Specifically, State animal health officials asked that the status of Antrim, Charlevoix, Cheboygan, Crawford, Emmet, and Otsego Counties be raised from modified accredited to modified accredited advanced. In their request, Michigan officials demonstrated to APHIS that the counties listed above meet the criteria for modified accredited advanced status set forth in the definition of modified accredited advanced State or zone in § 77.5 of the regulations, which provides that the Administrator may allow a State or zone with fewer than 30,000 herds to have up to 3 affected herds for each of the most recent 2 years. The six counties listed in Michigan’s status upgrade request contain a total of 570 herds of cattle and bison. In accordance with the regulations, Michigan has demonstrated that each of these counties, which have been classified as modified accredited, has had fewer than 3 affected herds for each of the most recent 2 years. Additionally, the State complies with the conditions of the UMR.

Based on our evaluation of Michigan’s request in light of the criteria set forth in the regulations, we have determined that Antrim, Charlevoix, Cheboygan, Crawford, Emmet, and Otsego Counties meet the requirements listed in the regulations for modified accredited advanced status. Therefore, we are classifying those counties as modified accredited advanced and removing them from Michigan’s modified accredited zone.

Immediate action is warranted to relieve restrictions on the interstate movement of cattle and bison from the newly classified modified accredited advanced zone in Michigan. Under these circumstances, the Administrator has determined that prior notice and opportunity for public comment are contrary to the public interest and that there is good cause under 5 U.S.C. 553 for making this action effective less than 30 days after publication in the Federal Register.

We will consider comments we receive during the comment period for this interim rule (see DATES above). After the comment period closes, we will publish another document in the Federal Register. The document will include a discussion of any comments we receive and any amendments we are making to the rule.

For this action, the Office of Management and Budget has waived its review under Executive Order 12866.

In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities.The analysis is summarized below.The full analysis may be viewed on the Regulations.gov Web site (see ADDRESSES above for instructions for accessing Regulations.gov) or obtained from the person listed under FOR FURTHER INFORMATION CONTACT.

Michigan currently has three bovine tuberculosis status zones: Accredited-free, modified accredited advanced, and modified accredited. This rule will reclassify six counties from modified accredited to modified accredited advanced. The elevation of an area to modified accredited advanced status from modified accredited status removes certain interstate movement and whole herd bovine tuberculosis testing requirements. Cattle owners will benefit from time savings and reduced costs associated with bovine tuberculosis testing. The annual cost savings to all producers could be between $266,000 and $400,000. However, the six counties covered in this rule account for less than 4 percent of cattle operations and less than 2 percent of the total number of cattle in the State of Michigan. In addition, bovine tuberculosis testing costs are about 1 percent or less of the value of the cattle tested. Thus, the expected savings will be relatively small.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities.

This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.)

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Has no retroactive effect and (2) does not require administrative proceedings before parties may file suit in court challenging this rule.

This rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

Done in Washington, DC, this 11th day of December 2009.

The Code provides general nonrecognition treatment for reorganizations specifically described in section 368(a). Section 368(a)(1)(D) describes as a reorganization a transfer by a corporation (transferor corporation) of all or a part of its assets to another corporation (transferee corporation) if, immediately after the transfer, the transferor corporation or one or more of its shareholders (including persons who were shareholders immediately before the transfer), or any combination thereof, is in control of the transferee corporation; but only if stock or securities of the controlled corporation are distributed in pursuance of a plan of reorganization in a transaction that qualifies under section 354, 355, or 356.

Section 354(a)(1) provides that no gain or loss shall be recognized if stock or securities in a corporation that is a party to a reorganization are, in pursuance of the plan of reorganization, exchanged solely for stock or securities in such corporation or in another corporation that is a party to the reorganization. Section 354(b)(1)(B) provides that section 354(a)(1) shall not apply to an exchange in pursuance of a plan of reorganization described in section 368(a)(1)(D) unless the transferee corporation acquires substantially all of the assets of the transferor corporation, and the stock, securities, and other properties received by such transferor corporation, as well as the other properties of such transferor corporation, are distributed in pursuance of the plan of reorganization.

Further, section 356 provides that if section 354 or 355 would apply to an exchange but for the fact that the property received in the exchange consists not only of property permitted by section 354 or 355 without the recognition of gain or loss but also of other property or money, then the gain, if any, to the recipient shall be recognized, but not in excess of the amount of money and fair market value of such other property. Accordingly, in the case of an acquisitive transaction, there can only be a distribution to which section 354 or 356 applies where the target shareholder(s) receive at least some property permitted to be received by section 354.

On December 19, 2006, the IRS and Treasury Department published a notice of proposed rulemaking (REG-125632-06) in the Federal Register (71 FR 75898) that included regulations under section 368 (the Temporary Regulations) providing guidance regarding whether the distribution requirement under sections 368(a)(1)(D) and 354(b)(1)(B) is satisfied if there is no actual distribution of stock and/or securities. The Temporary Regulations provide that the distribution requirement will be satisfied even though no stock and/or securities is actually issued in the transaction if the same persons or persons own, directly or indirectly, all of the stock of the transferor and transferee corporations in identical proportions. In such cases, the transferee will be deemed to issue a nominal share of stock to the transferor in addition to the actual consideration exchanged for the transferor's assets. The nominal share is then deemed distributed by the transferor to its shareholders and, when appropriate, further transferred through chains of ownership to the extent necessary to reflect the actual ownership of the transferor and transferee corporations. The IRS and Treasury Department issued the Temporary Regulations in response to taxpayer requests regarding whether certain acquisitive transactions can qualify as reorganizations described in section 368(a)(1)(D) where no stock of the transferee corporation is issued and distributed in the transaction pending a broader study of issues related to acquisitive section 368(a)(1)(D) reorganizations in general. In the notice of proposed rulemaking, the IRS and Treasury Department requested comments on the Temporary Regulations as well as on several broader issues discussed below relating to acquisitive section 368(a)(1)(D) reorganizations.

On February 27, 2007, the IRS and Treasury Department published a clarifying amendment to the Temporary Regulations (REG-157834-06) in the Federal Register (72 FR 9284-9285) providing that the deemed issuance of the nominal share of stock of the transferee corporation in a transaction otherwise described in section 368(a)(1)(D) does not apply if the transaction otherwise qualifies as a triangular reorganization described in § 1.358-6(b)(2) or section 368(a)(1)(G) by reason of section 368(a)(2)(D).

No public hearing regarding the Temporary Regulations was requested or held. However, comments were received. After consideration of all of the comments, the Temporary Regulations are adopted as revised by this Treasury decision. The principal comments and changes are discussed in this preamble.

These final regulations retain the rules of the Temporary Regulations, but make certain modifications to the Temporary Regulations in response to comments received. The following paragraphs describe the most significant comments received and the extent to which they have been incorporated into these final regulations.

Notwithstanding the requirement in section 368(a)(1)(D) that “stock or securities of the corporation to which the assets are transferred are distributed in a transaction which qualifies under section 354, 355, or 356”, the IRS and the courts have not required the actual issuance and distribution of stock and/or securities of the transferee corporation in circumstances where the same person or persons own all the stock of the transferor corporation and the transferee corporation. In such circumstances, the IRS and the courts have viewed an issuance of stock by the transferee corporation to be a “meaningless gesture” not mandated by sections 368(a)(1)(D) and 354(b). See James Armour, Inc. v. Commissioner, 43 T.C. 295, 307 (1964); Wilson v. Commissioner, 46 T.C. 334 (1966); Rev. Rul. 70-240, 1970-1 CB 81. In the notice of proposed rulemaking, the IRS and Treasury Department requested comments on whether the meaningless gesture doctrine is inconsistent with the distribution requirement in sections 368(a)(1)(D) and 354(b)(1)(B), especially in situations in which the cash consideration received equals the full fair market value of the property transferred such that there is no missing consideration for which the nominal share of stock deemed received and distributed could substitute. See § 601.601(d)(2)(ii).

Commentators noted that the doctrine is appropriate in the case where there is some excess in value of the assets transferred over the amount of cash received. In cases where the cash received is equal to the fair market value of the assets transferred, commentators agree that it is the proper approach because as a policy or administrative matter it is inappropriate to require a different outcome when the only factual difference is whether there is a nominal difference between the value of the assets and the cash consideration received. Commentators noted that deeming the distribution requirement to be satisfied in order to prevent an asset sale from being treated as a taxable exchange is not problematic enough to warrant a change from Rev. Rul. 70-240. Commentators have also suggested that the final regulations clarify that the rules apply to transactions regardless of whether the sum paid for the transferor's assets is exactly equal to their value.

The IRS and Treasury Department agree with the comments received regarding the meaningless gesture doctrine. Accordingly, these final regulations retain the rules of the Temporary Regulations which are based in part on the meaningless gesture doctrine. In addition, consistent with the IRS and Treasury Department's view of such transactions and in response to comments, the final regulations provide that if no consideration is received, or the value of the consideration received in the transaction is less than the fair market value of the transferor corporation's assets, the transferee corporation will be treated as issuing stock with a value equal to the excess of the fair market value of the transferor corporation's assets over the value of the consideration actually received in the transaction. The final regulations further provide that if the value of the consideration received in the transaction is equal to the fair market value of the transferor corporation's assets, the transferee corporation will be deemed to issue a nominal share (discussed in this preamble) of stock to the transferor corporation in addition to the actual consideration exchanged for the transferor corporation's assets.

As described in this preamble, if the same person or persons own, directly or indirectly, all of the stock of the transferor and transferee corporations in identical proportions in a transaction otherwise described in section 368(a)(1)(D), the transferee will be deemed to issue a nominal share of stock to the transferor in addition to the actual consideration exchanged for the transferor's assets. The nominal share is then deemed distributed by the transferor to its shareholders and, when appropriate, further transferred through the chains of ownership to the extent necessary to reflect the actual ownership of the transferor and transferee corporations.

Commentators have asked for clarification as to whether the deemed issuance of a nominal share has any tax significance beyond satisfying the distribution requirement of section 354(b)(1)(B). Commentators have suggested that instead of deeming a stock issuance in a purported section 368(a)(1)(D) reorganization, the final regulations should simply state that such transactions are deemed to be transactions described in section 356. Furthermore, commentators believe that if the transferor corporation owns stock of the transferee corporation before the reorganization and the transferor corporation distributes such transferee corporation stock (and no other stock) to its shareholders, the transaction would qualify under section 354(b)(1)(B) and therefore would qualify under section 368(a)(1)(D). Commentators believe the IRS and Treasury Department have the authority to reach that result without deeming a nominal share to be issued as this approach has been adopted elsewhere. See § 1.368-2(d)(4) (a subsidiary liquidation not subject to section 332 can qualify as a section 368(a)(1)(C) reorganization by effectively treating old and cold subsidiary stock that the parent holds as exchanged for hypothetical parent voting stock issued in exchange for the subsidiary's assets). Commentators have suggested that if the final regulations retain the nominal share concept, then the final regulations should clarify that the nominal share has no significance other than to meet the distribution requirement of section 354(b)(1)(B).

The IRS and Treasury Department have carefully considered the comments regarding the nominal share concept and believe that it is preferable to an approach that simply deems the statutory requirements satisfied because the nominal share also provides a useful mechanism with respect to stock basis consequences to the exchanging shareholder. As noted above, following the deemed issuance of the nominal share, it is deemed distributed by the transferor to its shareholders and, when appropriate, further transferred through the chains of ownership to the extent necessary to reflect the actual ownership of the transferor and transferee corporation (the final regulations provide similar treatment where, in a transaction involving no consideration or partial consideration, the transferee corporation is deemed to issue stock). Beyond satisfying section 354(b)(1)(B), the IRS and Treasury Department believe that the nominal share should be treated as nonrecognition property under section 358(a), and thus substituted basis property. Following basis adjustments (for example, under section 358 or § 1.1502-32), the nominal share preserves remaining basis, if any, and facilitates future stock gain or loss recognition by the appropriate shareholder.

With respect to the comment regarding previously owned stock of the transferee by the transferor qualifying under section 354(b)(1)(B), this raises issues that are beyond the scope of this regulation project and therefore are not addressed in this document. Accordingly, the final regulations retain the rule that if the same persons or persons own, directly or indirectly, all of the stock of the transferor and transferee corporations in identical proportions, the transferee will be deemed to issue a nominal share of stock to the transferor in addition to the actual consideration exchanged for the transferor's assets.

While the IRS and Treasury Department believe that all of the normal tax consequences occur from the issuance of a nominal share in a transaction described in these final regulations, commentators have noted that such consequences are unclear with respect to the allocation of basis in the shares of the stock or securities surrendered when the consideration received in the transaction consists solely of cash. While commentators believe that the basis in the shares of the stock or securities surrendered should be preserved in the basis of the stock of the transferee, the mechanics of achieving this result are unclear.

The regulations under § 1.358-2(a)(2)(iii) address how basis is determined in the case of a reorganization in which no property is received or property (including property permitted by section 354 to be received without the recognition of gain or “other property” or money) with a fair market value less than that of the stock or securities surrendered is received in the transaction. The regulations treat the acquiring corporation as issuing an amount of stock equal to the fair market value of the stock surrendered, less any amount of consideration actually received by the exchanging shareholder in the form of stock, securities, other property, or money. The basis of that deemed issued stock is determined by reference to the basis of the shares surrendered in the reorganization, and adjusted as provided in the regulations. The shareholder's stock in the acquiring corporation is then treated as being recapitalized. In the recapitalization, the shareholder is treated as surrendering all of its shares of the acquiring corporation, including those shares owned immediately prior to the reorganization and those shares the shareholder is deemed to receive, in exchange for the shares that the shareholder actually holds immediately after the reorganization. The basis of the shares that the shareholder actually owns is determined under the rules that would have applied had the recapitalization actually occurred with respect to the shareholder's actual shares and the shares the shareholder is deemed to have received. However, these rules do not literally apply to a transaction involving solely other property or money because the rules address situations in which a shareholder of the target corporation receives no property or property with a fair market value less than that of the stock or securities the shareholder surrendered in the transaction.

The IRS and Treasury Department agree with the commentators that the basis in the shares of the stock surrendered should be preserved in the basis of the stock of the transferee in a transaction described in these final regulations. The IRS and Treasury Department also agree that current law does not adequately address the manner in which the basis in the shares of the stock or securities surrendered is preserved in the basis of the stock of the transferee. Accordingly, the regulations under § 1.358-2(a)(2)(iii) are amended to provide that in the case of a reorganization in which the property received consists solely of non-qualifying property equal to the value of the assets transferred (as well as a nominal share described in these final regulations), the shareholder or security holder may designate the share of stock of the transferee to which the basis, if any, of the stock or securities surrendered will attach. The IRS and Treasury Department believe this approach is the most consistent with current law regarding basis determination as a similar result would occur under § 1.358-2 if stock was actually issued in the transaction. Nonetheless, as part of its broader study of basis issues, the IRS and Treasury Department will re-examine these regulations and the rules may change upon completion of this broader study.

In the notice to proposed rulemaking, the IRS and Treasury Department requested comments on whether the Temporary Regulations should apply when the parties to the reorganization are members of a consolidated group. Commentators have stated that the Temporary Regulations should apply because there is no reason to distinguish a consolidated group member's reorganization treatment from that of a member of a nonconsolidated affiliated group. Commentators have suggested that the consolidated return regulations should be coordinated with the Temporary Regulations. Specifically, § 1.1502-13(f)(3) provides that, in the case of an acquisitive intercompany reorganization involving the receipt of money or other property (boot), boot is taken into account immediately after the reorganization in a separate transaction. See § 1.1502-13(f)(7), Example 3 (an intercompany reorganization with boot is treated as if the acquirer had issued only its stock in the reorganization, and the deemed shares were then redeemed by the acquirer in exchange for the boot). The effect of this rule is to remove the boot from section 356 (dividend within gain treatment) and treat it as received in a redemption which is in turn taxed as a section 301 distribution.

Commentators have suggested that the nominal share concept under the Temporary Regulations is consistent with the deemed shares in Example 3 under § 1.1502-13(f)(7) as the nominal share fiction deems a transaction to qualify as a section 368 reorganization, and the shares deemed issued under the § 1.1502-13(f)(3) fiction determine the consequences of the reorganization. Commentators have requested that an example be added to § 1.1502-13 to illustrate the interaction of the Temporary Regulations and § 1.1502-13(f)(3). Specifically, commentators have requested that the example clarify that the nominal share does not exist for any purpose other than to satisfy the distribution requirement of section 354(b)(1)(B). Therefore, § 1.1502-13(f)(3) should apply in the same way to the post-reorganization deemed redemption of stock in exchange for the boot actually received (that is, as if the distributee did not own the nominal share). Commentators believe that any remaining stock basis or ELA in the deemed shares under the § 1.1502-13(f)(3) fiction should shift to the member(s) that actually own stock in the transferee corporation under the principles of § 1.302-2(c).

As discussed in this preamble, the IRS and Treasury Department believe that the nominal share has significance beyond satisfaction of the distribution requirement of section 354(b)(1)(B), most notably for purposes of determining stock basis consequences to the appropriate shareholder. In an all cash sale of assets between members of a consolidated group, the IRS and Treasury Department believe that giving significance to the nominal share for purposes beyond the distribution requirement is consistent with the fundamental premise underlying the intercompany transaction deferral system which is to preserve the location of gain or loss within a consolidated group. Therefore, if an all cash transaction described in these final regulations occurs between members of a consolidated group, the selling member (S) will be treated as receiving the nominal share and additional stock of the buying member (B) under § 1.1502-13(f)(3), which it will distribute to its shareholder member (M) in liquidation. Immediately after the sale, the B stock (with the exception of the nominal share which is still held by M) received by M is treated as redeemed, and the redemption is treated under section 302(d) as a distribution to which section 301 applies. M's basis in the B stock will be reduced under § 1.1502-32(b)(3)(v). Under the rules of § 1.302-2(c), any remaining basis will attach to the nominal share. If applicable, the nominal share will be further transferred through chains of ownership to the extent necessary to reflect the actual ownership of B. An example has been added to § 1.1502-13 to illustrate the interaction of these final regulations and the consolidated return regulations.

The IRS and Treasury Department also requested comments on the extent, if any, to which the continuity of interest requirement should apply to a reorganization described in section 368(a)(1)(D) as well as the continued vitality of various liquidation-reincorporation authorities after the enactment of the Tax Reform Act of 1986, Public Law 99-514 (100 Stat. 2085 (1986)). Comments were received on these issues. The IRS and Treasury Department continue to study these issues as part of a broad study of reorganizations under section 368(a)(1)(D).

The IRS and Treasury Department request comments on the application of the final regulations to reorganizations involving foreign corporations or shareholders, including comments regarding: (1) Whether any section 1248 amount attributable to the stock of the transferor corporation can be preserved in the nominal share deemed issued by the transferee corporation; (2) the manner in which earnings and profits (E&P) are (or should be) taken into account for purposes of section 902 when an exchanging shareholder recognizes gain under section 356(a) that is treated as a dividend under section 356(a)(2) from the E&P of the transferor and transferee corporations (including whether the E&P of the corporation is combined for this purpose or whether an ordering rule applies); (3) whether and how section 902 should apply when an exchanging shareholder does not actually own stock in the transferee corporation but the exchanging shareholder recognizes gain under section 356(a) that is treated as a dividend from the E&P of the transferee corporation (including whether a limitation similar to that of section 304(b)(5) is appropriate in such cases); (4) whether and how, under section 959, an exchanging shareholder should be able to access previously taxed E&P of a foreign transferor and/or transferee corporation before any non-previously taxed E&P of either corporation; and (5) whether and how section 897 applies if the transferor corporation is a United States real property holding corporation with at least one foreign shareholder.

It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It is hereby certified that these regulations do not have a significant economic impact on a substantial number of small entities. This certification is based on the fact that these regulations primarily affect affiliated groups of corporations that have elected to file consolidated returns, which tend to be larger businesses, and, moreover, that any burden on taxpayers is minimal. Therefore, a Regulatory Flexibility Analysis under the Regulatory Flexibility Act (5 U.S.C. chapter 6) is not required. Pursuant to section 7805(f) of the Internal Revenue Code, the notice of proposed rulemaking preceding these regulations was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.

The principal author of these regulations is Bruce A. Decker, Office of Associate Chief Counsel (Corporate). However, other personnel from the IRS and the Treasury Department participated in their development.

The 2000 National Forest System Land and Resource Management Planning Rule as amended (2000 rule) is available online at http://www.fs.fed.us/emc/nfma/2000_planning_rule.html. See also final rule at 65 FR 67568 (Nov. 9, 2000); amendments at 67 FR 35434 (May 20, 2002); 68 FR 53297 (Sept. 10, 2003); and interpretative rules at 66 FR 1865 (Jan. 10, 2001) and 69 FR 58057 (Sept. 29, 2004). Although this rule is now in effect as a consequence of a court injunction, it is not found in the most recent version of the Code of Federal Regulations (CFR). This final rule reinstates the rule in the Code of Federal Regulations. In addition, the Department is making several technical amendments to the final rule.

The Forest and Rangeland Renewable Resources Planning Act of 1974 (88 Stat. 476 et seq.), as amended by the National Forest Management Act of 1976 (NFMA) (90 Stat. 2949 et seq.; 16 U.S.C. 1601-1614), requires the Secretary of Agriculture (the Secretary) to issue regulations under the principles of the Multiple-Use Sustained-Yield Act of 1960 (MUSYA) that set up the process for the development and revision of land management plans (16 U.S.C. 1604(g)).

The first planning rule, adopted in 1979, was amended on September 30, 1982 (47 FR 43037) (1982 rule). The 1982 rule was itself amended, in part, on June 24, 1983 (48 FR 29122) and on September 7, 1983 (48 FR 40383). The 1982 rule, as amended, has guided the development, amendment, and revision of all the land management plans currently in effect throughout the National Forest System (NFS).

The Department has undertaken rulemaking several times to revise the planning rule provisions. The Forest Service published an advance notice of proposed rulemaking on February 15, 1991 (56 FR 6508) for possible revisions to the 1982 rule. The Forest Service published a proposed rule on April 13, 1995 (60 FR 18886); however, the Secretary chose not to continue with that proposal. Another proposed rule was published on October 5, 1999 (64 FR 54074), and the 2000 rule was issued on November 9, 2000 (65 FR 67514). Shortly after the issuance of the 2000 rule, a review of the rule found that it would be unworkable. The Department proposed a new planning rule on December 6, 2002 (67 FR 72770).

In the meantime, on February 16, 2001, a coalition of twelve environmental groups sued the Department in Federal District Court to challenge the validity of the 2000 rule. The district court did not rule on the merits of plaintiffs' claims. Instead, the plaintiffs stipulated to a dismissal shortly after the Department issued a new planning rule to take the place of the 2000 rule (Citizens for Better Forestry v. USDA, No. 01-0728 (N.D. Cal. March 7, 2005) (Stipulation and Order dismissing case with prejudice)).

The 2005 rule, intended to replace the 2000 rule, was issued on January 5, 2005 (70 FR 1055). Shortly thereafter, Citizens for Better Forestry and others challenged it in Federal District Court. On March 30, 2007, the United States District Court for the Northern District of California enjoined the Department from further carrying out the 2005 rule pending additional steps to comply with the court's opinion with respect to the Administrative Procedure Act (APA), the Endangered Species Act (ESA), and the National Environmental Policy Act (NEPA) (Citizens for Better Forestry v. USDA, 481 F. Supp. 2d 1059 (N.D. Cal. 2007)). The effect of the injunction against the 2005 rule was to reinstate the 2000 rule (the rule previously in effect).

To respond to the district court's injunction of the 2005 rule, the Forest Service proposed a new planning rule. A notice of intent to prepare an environmental impact statement (EIS) was published in the Federal Register on May 11, 2007 (72 FR 26775) with a public comment period ending June 11, 2007. The proposed rule was published on August 23, 2007 (72 FR 48514), and the notice of availability for the supporting draft EIS was published in the Federal Register on August 31, 2007 (72 FR 50368). The notice of availability of the final EIS was published in the Federal Register on February 15, 2008 (73 FR 8869) and the final rule was issued and published in the Federal Register on April 21, 2008 (73 FR 21468). Citizens for Better Forestry and others promptly challenged the 2008 rule in court.

On June 30, 2009, the United States District Court for the Northern District of California invalidated the Forest Service's 2008 rule, holding that it was developed in violation of NEPA and ESA. The district court vacated the 2008 rule, enjoined the USDA from further implementing it and remanded it to the USDA for further proceedings (Citizens for Better Forestry v. USDA, 632 F. Supp. 2d 968 (N.D. Cal. 2009)). The court stated that, although the effect of invalidating an agency rule is to reinstate the rule previously in force, the Agency may choose whether to reinstate the 2000 rule or the 1982 rule. (See court decision available online at http://www.fs.fed.us/emc/nfma/index.htm.)

The district court's order allowing the Forest Service to choose either the 2000 rule or the 1982 rule did not eliminate the responsibility to follow appropriate procedures involved in making that choice. Under established legal principles, in circumstances like those here, the 2000 rule was immediately back in effect, without any process: “The effect of invalidating an agency rule is to reinstate the rule previously in effect,” Paulsen v. Daniels, 413 F. 3d 999, 1008 (9th Cir. 2005). A return to the 1982 rule, however, would require the entire lengthy process of notice and comment rulemaking, which includes issuing a proposed rule for public review and comment before issuing a final rule. Re-issuing the 1982 rule is unnecessary because the transition provision of the 2000 rule will allow the Forest Service to use the provisions of the 1982 rule in revising and amending plans until a new rule is issued. Furthermore, because the Department has announced that a new rulemaking is in order, as announced elsewhere in today's Federal Register, to re-issue the 1982 rule for an interim time period would be a costly and time-consuming distraction.

Therefore, the Department has determined that the 2000 rule, as amended in 2002 and 2003 and as clarified by interpretative rules issued in 2001 and 2004, is now in effect, and should be reinstated in the Code of Federal Regulations.

The 2000 rule included provisions for an orderly transition from planning under the prior, 1982 rule (36 CFR 219.35). The Forest Service expects that until the Department issues a new rule, responsible officials will continue to take advantage of the 2000 rule's transition provisions to amend or revise plans. See Forest Service memorandum of July 15, 2009, signed by Joel Holtrop, Deputy Chief for National Forest System. The memorandum is available online at http://www.fs.fed.us/emc/nfma/2000_planning_rule.html.

However, the time frames described in the transition provisions are out of date. Therefore, the Department has decided to update the wording of the 2000 rule's transition provisions to provide that the transition will extend until a new planning rule is issued. In addition, unnecessary wording is deleted in the transition section and interpretative rules issued in 2001 and 2004 and the reference in the 2001 interpretative rule to the optional appeal procedures is being corrected.

36 CFR 219.35(a). The Department is not changing paragraph (a) of section 219.35, but acknowledges that a definitive interpretation is in order. Paragraph (a) provides that the transition period ends upon completion of the revision process for each unit of the NFS, and that during that period the responsible official must consider the best available science in implementing and, if appropriate, amending the current plan. The Tenth Circuit Court of Appeals has interpreted this paragraph to mean that the transition period for each unit of the NFS ends upon a plan revision developed and completed under provisions of the 1982 rule, as well as revisions completed in accordance with the 2000 rule process (Utah Environmental Congress v. Troyer, 479 F. 3d 1269 (10th Cir. 2007)). The court held that as a consequence, paragraph (a)'s requirement that the best available science be considered in amending and implementing current plans “encompass[ed] only plans that pre-dated the 2000 planning rules,” 479 F. 3d at 1281. Under this reasoning, the requirement to consider the best available science would not apply on a forest that completed revision after the issuance of the 2000 rule even if the 1982 rule provisions were used for the revision.

The Department's position is that the purpose of section 219.35(a) has always been, and continues to be, that the transition period for each forest ends upon the completion of the revision using the process of the 2000 rule. That intent is made evident by the cross-reference in paragraph (a) to section 219.9, the revision section of the 2000 rule. If a forest plan has not been revised using the 2000 rule process, the transition periods of sections 219.35(b) and (d) apply. Furthermore, on a unit where the plan has not been revised under the 2000 rule process, there must be consideration of the best available science when making project decisions or amending the plan. The reference in the paragraph to “the current plan” simply means the plan in effect during transition, prior to plan revision using the 2000 rule process.

36 CFR 219.35(b). The transition provision at 219.35(b) originally provided that planning initiated under the 1982 rule prior to November 9, 2000, the date the 2000 rule was issued, may continue under the provisions of that rule, instead of adjusting to the requirements of the 2000 rule (65 FR 67579 (Nov. 9, 2000)). However, shortly after the 2000 rule was issued, the Department determined that it was unworkable and announced the intent to issue a new rule in the December 3, 2001, Semiannual Unified Agenda of Federal Regulatory and Deregulatory Actions. So that planning need not comply with the requirements of the 2000 rule, the Department extended the rule's transition period until the issuance of the new rule, and allowed the responsible official to elect, not only to continue, but also to initiate, plan amendments or revisions under the provisions of the 1982 rule.

The Department extended the transition provisions in paragraph (b) twice; the most recent extension, issued as an interim final rule on May 20, 2002, provides that the plan amendment or revision process may be continued or initiated under the provisions of the 1982 planning regulations under certain circumstances. The interim final rule said use of the transition provisions can continue “[u]ntil the Department promulgates the revised final planning regulations announced in the December 3, 2001, Semiannual Unified Agenda of Federal Regulatory and Deregulatory Actions” at 219.35(b) 67 FR 35434 (May 20, 2002). This transition provision also explained what was meant by initiation of a plan amendment or revision.

Because paragraph (b) refers to the rulemaking process that resulted in the 2005 rule, which the district court held invalid, the Department is updating this paragraph to clarify that the transition will extend until the issuance of a rule replacing the current 2000 rule. The notice of intent to prepare an EIS for a new rule appears elsewhere in today's Federal Register. The Department is also deleting the unnecessary explanation regarding initiation of plan amendment or revision.

Simply put, the changes to paragraph (b) ensure that, until a new planning rule is issued, responsible officials may continue to revise or amend land management plans under either the 1982 rule provisions or the 2000 rule provisions.

36 CFR 219.35(d). The 2000 rule includes project-specific provisions, and, at 219.35(d), set November 9, 2003, as the deadline for compliance with those provisions at 65 FR 67579 (November 9, 2000). On September 10, 2003, the Department extended this transition period “until the Department promulgates the final planning regulations published as proposed on December 6, 2002 (67 FR 72770,” by amending the wording of 36 CFR 219.35(d) at 68 FR 53297 (Sept. 10, 2003). Because this provision refers to the rulemaking process that resulted in the 2005 rule, which was held invalid, the Department is updating 36 CFR 219.35(d) to clarify that the transition will extend until the issuance of a rule superseding the current 2000 rule.

Therefore, until the Department issues a new planning rule, the transition wording of the 2000 rule exempts project and activity decisions from the rule's project-specific requirements. As provided in paragraph (a), during the transition the responsible official must consider the best available science when developing and carrying out projects.

Note that 36 CFR 219.35(g) says that within 1 year of November 9, 2000, the Chief of the Forest Service must establish a schedule for completion of the revision process for each unit of the National Forest System. The Chief established the schedule, and the Chiefs schedule is now available online at http://www.fs.fed.us/emc/nfma/includes/LRMPschedule.pdf.

36 CFR 219.35 Appendix A. On January 10, 2001 (66 FR 1864), the Department published a interpretative rule related to 36 CFR 219.35(b) to make explicit its intent that a responsible official's option of using the provisions of the 1982 rule included the further option of providing an administrative appeal opportunity, in accordance with 36 CFR part 217, in effect before the 2000 rule was issued, or the objection opportunity set out in the 2000 rule. This interpretative rule was published as Appendix A to Section 219.35, “Interpretive Rule Related to Paragraph 219.35(b)” to explain how section 219.32 (regarding objections) and section 219.35(b) (a transition provision) operate together.

This interpretative rule cites “36 CFR part 217” twice. However, citing 36 CFR part 217 is not appropriate because that part no longer exists and has not been codified in the CFR since 2000, and refers to the July 1, 2000, revision of the CFR that is out of date. This reference is likely to confuse the public. Therefore, the Department is correcting Appendix A to Section 219.35 of the 2000 rule.

In the place of 36 CFR part 217 the corrected interpretative rule identifies these procedures as the “optional appeal procedures available during the planning rule transition period” and references the Federal Register notices that had established the procedures formerly codified at 36 CFR part 217. The “optional appeal procedures available during the planning rule transition period,” are 54 FR 3357 (January 23, 1989), as amended at 54 FR 13807 (April 5, 1989); 54 FR 34509 (August 21, 1989); 55 FR 7895 (March 6, 1990); 56 FR 4918 (February 6, 1991); 56 FR 46550 (September 13, 1991); and 58 FR 58915 (November 4, 1993). The “optional appeal procedures available during the planning rule transition period,” are available at http://www.fs.fed.us/emc/applit/includes/PlanAppealProceduresDuringTransition.pdf.

The interpretative rule also explained what was meant by initiation of a plan amendment or revision; the Department is deleting this unnecessary provision.

The effect of these changes is simply that responsible officials can continue to choose either the appeals process for plan revisions or the objections process for plan revisions established in the 2000 rule.

36 CFR 219.35 Appendix B. On September 29, 2004, the Department published an interpretative rule related to 36 CFR 219.35(a) and (b), to clarify the intent of the transition provisions in those paragraphs. The Department published the interpretative rule as “Appendix B to Section 219.35, Interpretative Rule Related to Paragraphs 219.35(a) and (b)” (69 FR 58057). In explaining the duration of the transition, the interpretative rule included two sentences that referred to the proposed rule published on December 6, 2002, and stated that a final rule had yet to be issued. The Department is deleting these unnecessary sentences.

The Department has determined, pursuant to 5 U.S.C. 553(b), that prior notice and opportunity for public comment on this rulemaking are “impractical, unnecessary, and contrary to the public interest.” This rulemaking is undertaken to reinstate in the Code of Federal Regulations the planning rule now in effect and to update and clarify the transition time periods set out in that rule. This rulemaking also identifies the optional appeal process available during the transition.

As explained earlier in this notice, the 2000 rule is currently in effect. The reinstatement of the entire 2000 rule in the Code of Federal Regulations, therefore, is simply a housekeeping matter, to make the rule readily available to the public.

Notice and comment opportunities for the transition updates in paragraphs (b) and (d) are unnecessary, as they simply reflect the Department's long held intent, evidenced by the 2001, 2002, and 2003 extensions and the 2004 interpretative rule, to allow the continued use of the 1982 planning rule provisions until a successful rulemaking to replace the 2000 rule is accomplished. Additionally, the deletion in paragraph (b) of the explanation of “initiation” of plan amendments or revisions does not in any way change the effect of the rule. Furthermore, notice and comment rulemaking for this planning rule is impractical and against the public interest, as it would distract the Department's and the public's attention from the more pressing task at hand: to develop, through notice and comment rulemaking, a new, replacement planning rule. Notice and comment rulemaking to reinstate the 2000 rule would delay the issuance of a new rule. It is also likely that the confusion caused by two simultaneous notice and comment rulemakings for planning would not be in the public interest. With respect to the interpretative rules, good cause is not needed to exempt them from the notice and comment requirements of the Administrative Procedure Act. In any event, the minor changes to the interpretative rules do not affect the Department's interpretation of the 2000 rule.

This rulemaking merely continues the status quo for forest planning by updating 36 CFR Part 219 to reflect the fact that the 2008 rule has been held invalid and the 2000 rule is therefore in place until new planning regulations are issued.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and is, therefore, not subject to review by the Office of Management and Budget. Because the Agency has made a “good cause” finding that this action is not subject to notice-and-comment requirements under the Administrative Procedure Act or any other statute, it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (5 U.S.C. 601, et seq.), or to sections 202 and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it is not economically significant.

In addition, this action does not significantly or uniquely affect small governments or impose a significant intergovernmental mandate, as described in sections 203 and 204 of Unfunded Mandates Reform Act of 1995. This rule also does not significantly or uniquely affect the communities of tribal governments, as specified by Executive Order 13175 (65 FR 67249, November 6, 2000). This rule will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).

The rule also does not involve special consideration of environmental justice related issues as required by Executive Order 12898 (59 FR 7629, February 16, 1994).

This rule has been analyzed in accordance with the principles and criteria contained in Executive Order 12630, and it has been determined that the rule does not pose the risk of a taking of constitutionally protected private property.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the information collection or reporting requirements included in the rule have been approved by the Office of Management and Budget (OMB) and assigned control number 0596-0158.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. As adopted, (1) All state and local laws and regulations that are in conflict with this rule or which would impede its full implementation are to be preempted; (2) No retroactive effect is given to this rule; and (3) It does not require administrative proceedings before parties may file suit in court challenging its provisions. Several respondents commented about the Federal Government's authority to preempt state and local laws. The Department has carefully reviewed this language and finds that this is entirely consistent with the legal responsibilities of the Federal Government.

The Department's compliance with these statutes and Executive orders for the rule is discussed in the November 9, 2000, Federal Register notice.

Section 203 of the Veterans Benefits and Services Act of 1988 (Pub. L. 100-322) added former section 223 to title 38, United States Code (recodified in 1991 as 38 U.S.C. 515), permitting the Secretary of Veterans Affairs to settle tort claims not exceeding an amount to be delegated by the Attorney General of the United States (with the delegation not to exceed the maximum delegated to the United States Attorneys). In 1988, the Attorney General delegated $100,000 in settlement authority to the Secretary. 53 FR 37753, Sept. 28, 1988. In 1999, VA published a final rule reflecting that the Attorney General increased the delegation to $200,000. 64 FR 47111, Aug. 30, 1999. In 2008, the Attorney General increased the delegation of settlement authority to $300,000. 73 FR 70278, Nov. 20, 2008.

Current § 14.600 does not reflect the Attorney General's 2008 delegation or VA's determination regarding the necessary redelegations to Office of the General Counsel (OGC) personnel. The purpose of this rulemaking is to update VA regulations in light of the Attorney General's action increasing the amount of VA's settlement authority for tort claims and also to allow for the further delegation of this authority within OGC as necessary.

This amendment to 38 CFR 14.600(c)(2) delegates to the General Counsel, Deputy General Counsel, Assistant General Counsel (Professional Staff Group I), or those authorized to act for them, authority to consider, ascertain, adjust, determine, compromise, and settle a claim arising under the Federal Tort Claims Act; provided that any award, compromise, or settlement in excess of $300,000 shall be effected only with the prior written approval of the Attorney General or his or her designee. The amendment also provides for the execution of a memorandum explaining the basis for settlement of a claim in excess of $100,000 to be sent to the Department of Justice (DOJ), as required by the Attorney General's delegation to the Secretary.

Authority is also delegated to the Regional Counsels, or those authorized to act for them, and to the Deputy Assistant General Counsel (Professional Staff Group I) to consider, ascertain, adjust, determine, compromise, and settle any claim under the Federal Tort Claims Act; provided that any award, compromise, or settlement does not exceed $150,000; and provided, further, that whenever a settlement is effected in an amount in excess of $100,000, a memorandum fully explaining the basis for the action taken shall be sent to the DOJ, as required by the Attorney General's delegation to the Secretary.

This rule further amends § 14.600 to incorporate notes (1), (2), and (3) into the regulation text. We have determined that the notes, which prescribe the requirement for notifying DOJ of the basis for any settlement of a tort action under VA's delegated authority, are more appropriate for regulation text. Accordingly, we have amended § 14.600(c) and (d) to incorporate the DOJ notification requirement and delete the notes.

This final rule concerns agency organization, management, procedure, or practice, specifically delegation of authority to employees of the Department to perform certain acts or render decisions. Accordingly, because this amendment merely reflects a delegation change and makes other non-substantive changes, this rule is exempt from the prior notice-and-comment and delayed-effective-date requirements of 5 U.S.C. 553.

This document contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

Because this document is limited to agency organization and management, it is not within the definition of “regulation” in section 3(d) of Executive Order 12866 and therefore not subject to that Executive Order's requirements for regulatory actions.

The initial and final regulatory flexibility analysis requirements of sections 603 and 604 of the Regulatory Flexibility Act, 5 U.S.C. 601-612, are not applicable to this rule because a notice of proposed rulemaking is not required for this rule. Even so, the Secretary of Veterans Affairs hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act. This final rule will not affect any small entities. Only VA employees could be directly affected. Therefore, pursuant to 5 U.S.C. 605(b), this final rule is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

The Unfunded Mandates Reform Act of 1995, codified at 2 U.S.C. 1532, requires that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any year. This final rule would have no such effect on State, local, and tribal governments, or on the private sector.

There is no Catalog of Federal Domestic Assistance number for this final rule.

On July 13, 2009 (74 FR 33332), EPA published an update of materials submitted by Virginia that are incorporated by reference (IBR) into the Virginia State implementation plan (SIP) as of June 1, 2009. The regulations, source-specific requirements, and non-regulatory requirements affected by this update (summarized in the tables cited as 40 CFR 52.2420(c), (d), and (e) respectively) had been previously submitted by the Virginia Department of Environmental Quality (DEQ) and approved by EPA. In this update action, EPA announced the following revisions to entries listed in the paragraph 52.2420(c), (d) and (e) tables:

• Correction of typographical errors to the text and the dates published in these tables.

• Removal of the quotation marks from the terms listed in the “Explanation [former SIP section]” column.

• Removal of entries 5-80-1835, 5-80-1845, and 5-80-1855, from the paragraph (c) table, since they are designated as “reserved,” and contain no text that is incorporated by reference.

• Correction of the date format in the paragraph (c), (d) and (e) tables so that there were no placeholder zeros in the month or day (e.g., the date format would be 1/1/08, not 01/01/08).

However, the tables cited as 40 CFR 52.2420(c) through (e), and published on pages 33334 through 33364, still contained entries that did not reflect the described revisions. This action corrects those tables in 40 CFR 52.2420(c) through (e), as described herein:

1. Page 33334—a. Entry 5-10-20—in the “Explanation [former SIP citation]” column, remove the quotation marks from “volatile organic compound.”

b. Entries 5-20-203 and 5-20-204—revise the date in the “State effective date” column from “7/29/08” to “12/12/07.”

2. Page 33335—a. Entries 5-20-205—revise the date format in the “State effective date” column from “01/01/98,” “04/01/98,” “01/01/99,” and “08/25/04” to “1/1/98,” “4/1/98,” “1/1/99” and “8/25/04,” respectively.

b. Entry 5-20-206—revise the date format in the “State effective date” column from “10/04/06” to “10/4/06.”

3. Page 33338—a. The first entry for 5-40-1670, in the “Title/subject” column, capitalize the first word in each listed definition.

b. Entries 5-40-1670 (second entry), and 5-40-1750—revise the date format in the “State effective date” column from “4/01/99” to “4/1/99.”

4. Page 33339—Entry 5-40-1810—revise the date format in the “State effective date” column from “4/01/99” to “4/1/99.”

5. Page 33345—a. Entry 5-40-5610—in the “Explanation [former SIP citation]” column, move the term “clean wood” from list of “terms added” to the list of “terms revised.”

b. Remove the first entry for 5-40-5700 from the table in paragraph (c).

6. Page 33347—Entry 5-40-7810—in the “Title/subject” column, capitalize the first word in each listed definition.

7. Page 33350—Remove “reserved” entries 5-80-1835, 5-80-1845 and 5-80-1855 from the table in paragraph (c).

8. Page 33355—Entry 5-140-1150—restore the EPA approval date and page citation (12/28/07, 72 FR 73602) in the “EPA approval date” column.

9. Page 33356—Entry 5-140-1800—restore the State effective date and the EPA approval date and page citation in the “State effective date” and “EPA approval date” columns, respectively.

10. Pages 33361 and 33362—Revise the date format in the “EPA approval date” column from “1/02/01” to “1/2/01” for the following entries in the paragraph (d) table:

11. Page 33363—In the entry for Documents Incorporated by Reference (9 VAC 5-20-21, Paragraphs E.4.a. (21) and (22)), revise the date format in the “State submittal date” and “Additional explanation” column from “05/14/07” and “10/04/06” to “5/14/07” and “10/4/06,” respectively.

12. Page 33364—In the entry for Attainment Demonstration and Early Action Plan for the Northern Shenandoah Valley Ozone Early Action Compact Area, revise the date format in the “State submittal date” column from “02/15/05” to “2/15/05.”

Section 553 of the Administrative Procedure Act, 5 U.S.C. 553(b)(B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. We have determined that there is good cause for making today's rule final without prior proposal and opportunity for comment because this rule is not substantive and imposes no regulatory requirements, but merely corrects a citation in a previous action. Thus, notice and public procedure are unnecessary. We find that this constitutes good cause under 5 U.S.C. 553(b)(B).

All SIP materials incorporated by reference in paragraphs (c) and (d) are available for public inspection at the Air and Radiation Docket and Information Center located at EPA Headquarters in Washington, DC, the EPA Regional Office, and the National Archives and Records Administration.

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

The Congressional Review Act (5 U.S.C. 801 et seq.), as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Section 808 allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. This determination must be supported by a brief statement. 5 U.S.C. 808(2). As stated previously, EPA had made such a good cause finding, including the reasons therefore, and established an effective date of December 18, 2009. 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 the rule in the Federal Register. This action to correct the tables in 40 CFR 52.2420(c), (d), and (e) for Virginia 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).

• 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 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 electronically available documents 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 e-CFR cite at http://www.gpoaccess.gov/ecfr.

Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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-2009-0009 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before February 16, 2010.

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-2009-0009, 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 Facility'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 April 8, 2009 (74 FR 15971) (FRL-8407-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PPs 8F7430 and 8F7439) by E.I. du Pont de Nemours and Company, Laurel Run Plaza, P.O. Box 80038, Wilmington, DE 19880-0038. The petitions requested that 40 CFR 180.429 be amended by establishing tolerances for residues of the herbicide chlorimuron ethyl, ethyl 2-[[[[(4-chloro-6-methoxypyrimidin-2yl)amino]carbonyl]sulfonyl]benzoate], in or on (PP 8F7430) corn, field grain at 0.01 parts per million (ppm); corn, field, forage at 0.5 ppm; corn, field, stover at 2.0 ppm; corn, field, meal at 0.014 ppm; corn, field, flour at 0.015 ppm; corn, aspirated grain fractions at 1.28 ppm; and (PP 8F7439) soybean, seed at 0.01 ppm; soybean, forage at 0.45 ppm; soybean, hulls at 0.04 ppm; soybean, aspirated grain fractions at 2.79 ppm; and soybean, hay at 1.8 ppm. That notice referenced a summary of the petition prepared by E.I. du Pont de Nemours and Company, the registrant, which is available to the public in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has determined that tolerances are not needed for residues of chlorimuron ethyl on the following: Corn, field, meal; corn, field, flour; and soybean, hulls. EPA has also determined that the presently established tolerance of 0.05 ppm is appropriate for soybean in lieu of the proposed tolerance of 0.01 ppm for soybean, seed. Because soybean, seed is the designated EPA term for soybeans, the existing soybean tolerance is being amended to use that term. Additionally, EPA has determined that a single tolerance of 3.0 ppm should be established for grain, aspirated fractions in lieu of the proposed separate tolerances on corn, aspirated grain fractions; and soybean, aspirated grain fractions. EPA has also revised the tolerance expression for chlorimuron ethyl to clarify the chemical moieties that are covered by the tolerances and specify how compliance with the tolerances is to be measured. The reasons for these changes are explained in Unit IV.C.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerances for residues of chlorimuron ethyl, including its metabolites and degradates on corn, field forage at 0.5 ppm; corn, field, grain at 0.01 ppm; corn, field, stover at 2.0 ppm; grain, aspirated fractions at 3.0 ppm; soybean, forage at 0.45 ppm; and soybean, hay at 1.8 ppm. EPA's assessment of exposures and risks associated with establishing tolerances 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.

Chlorimuron ethyl has low or minimal acute toxicity via the oral, dermal and inhalation routes of exposure. It is mildly irritating to the eye and non-irritating to the skin; it is not a skin sensitizer.

In subchronic toxicity studies with chlorimuron ethyl: No adverse effects were observed up to the limit dose tested in mice; decreased body weight gain and liver pathology (margination of hepatocyte cytoplasmic content in the centrilobular areas) were observed in rats (males only); and mild hemolytic anemia, atrophy of the thymus and prostate and increased liver weights were seen in dogs. Chronic exposure of dogs to chlorimuron ethyl also led to mild anemia (decreased erythrocyte count, hematocrit, and hemoglobin concentration), but atrophy of the thymus and prostate were not seen. In rats, treatment-related effects observed were limited to decreased body weight and body weight gain in both sexes after long-term exposure. Prostatitis (males) and fatty replacement in the pancreas (both sexes) were also observed but considered incidental occurrences. Biliary hyperplasia/fibrosis seen in females was attributed to aging. In mice, there were no treatment-related effects observed up to the highest dose tested (216 milligrams/kilograms/day (mg/kg/day)). There were no treatment-related increases in tumors in rat and mouse carcinogenicity studies after exposure to chlorimuron ethyl. Chlorimuron ethyl is classified as “Not Likely to be Carcinogenic to Humans.”

In the developmental toxicity studies, decreases in maternal body weight gain and delayed ossification in fetuses were observed in rats at the same dose (150 mg/kg/day). In rabbits, decreases in maternal body weight gain were seen at 300 mg/kg/day, while delayed ossification was seen in fetuses at a lower dose of 48 mg/kg/day, indicating increased quantitative susceptibility. In a guideline 2-generation reproduction study in rats, decreased body weight and histopathology in the cerebellum (cellular changes in the internal granular and external germinal layers) were seen in pups at 177 mg/kg/day. These effects were seen in the absence of maternal toxicity, indicating potential increased quantitative susceptibility of the pups to chlorimuron ethyl. However, these effects were not associated with any neurotoxicity or neurobehavioral changes and were not observed in other reproduction studies in rats. In a non-guideline reproduction toxicity study (1-generation) in rats, decreased body weight (females) and liver histopathology (males) were seen in parental animals at 173 mg/kg/day, along with decreases in litter weights. In another reproduction study (1-year interim sacrifice) in rats, decreases in maternal and pup body weights were observed at 195 mg/kg/day.

There is no indication of neurotoxicity in the toxicity database for chlorimuron ethyl. In a 2-generation reproduction study in rats, histopathological alterations were seen in the cerebellum (cellular changes in the internal granular and external germinal layers) of F2 pups at 177 mg/kg/day; however, these findings were not associated with any neurobehavioral changes or any indications of neurotoxicity. In addition, these histopathological alterations were not observed in two other reproduction studies, and there was no evidence of neurotoxicity observed in other rat toxicity studies or toxicity studies in other species (rabbits, mice, or dogs).

Hematological changes (indicative of mild anemia) and atrophy of the thymus were observed in dogs after subchronic exposure. However, atrophy of the thymus was not associated with any histopathology and not seen after chronic exposure. No other potential immunotoxic effects were observed in the toxicology database.

Specific information on the studies received and the nature of the adverse effects caused by chlorimuron ethyl 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 in document “Chlorimuron ethyl. Human Health Risk Assessment for Proposed Uses on Field Corn and Soybean, PPs 8F7430 and 8F7439,” page 45 in docket ID number EPA-HQ-OPP-2009-0009.

For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as 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) or a Benchmark Dose (BMD) approach is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the POD 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 dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-, intermediate-, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC).

For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected in a lifetime. 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/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for chlorimuron ethyl used for human risk assessment can be found at http://www.regulations.gov in document “Chlorimuron ethyl. Human Health Risk Assessment for Proposed Uses on Field Corn and Soybean, PPs 8F7430 and 8F7439,” page 20 in docket ID number EPA-HQ-OPP-2009-0009.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to chlorimuron ethyl, EPA considered exposure under the petitioned-for tolerances as well as all existing chlorimuron ethyl tolerances in 40 CFR 180.429. EPA assessed dietary exposures from chlorimuron ethyl in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for chlorimuron ethyl; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 Continuing Surveys of Food Intakes by Individuals (CSFII). As to residue levels in food, EPA assumed tolerance-level residues and 100 percent crop treated (PCT) for all existing and new uses of chlorimuron ethyl.

iii. Cancer. Based on the results of carcinogenicity studies in rats and mice, EPA classified chlorimuron ethyl as “Not Likely to be Carcinogenic to Humans.” Therefore, an exposure assessment for evaluating cancer risk is not needed for this chemical.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for chlorimuron ethyl in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of chlorimuron ethyl. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm

Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of chlorimuron ethyl were determined for acute exposures and chronic exposures for non-cancer assessments assuming a maximum seasonal use rate of 0.25 lb chlorimuron ethyl per acre. EDWCs for acute exposures are estimated to be 11.98 parts per billion (ppb) for surface water and 6.99 ppb for ground water. EDWCs for chronic exposures for non-cancer assessments are estimated to be 5.02 ppb for surface water and 6.99 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the most conservative water concentration value of 6.99 ppb was used to assess the contribution to chlorimuron ethyl dietary exposure from drinking water. Acute dietary risk assessments were not conducted since no toxicological endpoint attributable to a single dose of chlorimuron ethyl has been identified. Cancer dietary risk assessments were not conducted since there is no cancer concern for chlorimuron ethyl.

In a summary of results from a pilot monitoring program conducted by the U.S. Geological Survey, data show that chlorimuron ethyl has been detected in drinking water of water supply reservoirs, but only at maximum concentrations magnitudes lower than those predicted by the FIRST model.

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). Chlorimuron ethyl is not registered for any specific use patterns that would result in residential exposure.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found chlorimuron ethyl to share a common mechanism of toxicity with any other substances, and chlorimuron ethyl does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that chlorimuron ethyl does not 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(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) 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 SF. In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. The prenatal and postnatal toxicity database for chlorimuron ethyl includes guideline rat and rabbit developmental toxicity studies and a 2-generation reproduction toxicity study in rats, as well as two additional non-guideline reproduction studies in rats (a 1-generation study and 1-year interim sacrifice study). No evidence of increased prenatal or postnatal susceptibility was seen in the developmental toxicity study in rats or in the non-guideline reproduction toxicity studies in rats. In the rabbit developmental study, delayed ossification was observed in fetuses at 48 mg/kg/day, while maternal effects (decreased body weight gain) were seen at 300 mg/kg/day, suggesting increased quantitative susceptibility of fetuses. In the 2-generation rat reproduction study, decreased body weight and histopathology findings in the cerebellum were observed in pups at 177/214 mg/kg/day (male/female) in the absence of maternal toxicity, also suggesting increased quantitative susceptibility of the pups.

Although the data suggest increased quantitative susceptibility in the developmental rabbit study and the 2-generation rat reproduction study, there are no residual uncertainties with regard to prenatal toxicity following in utero exposure of rats or rabbits or prenatal and/or postnatal exposures of rats. The fetal effect seen in rabbits was limited to delayed ossification, and, although effects (histopathology in the cerebellum) were seen in a rat reproduction study, there was no evidence of increased susceptibility observed in two additional reproduction studies in rats. Additionally, there are clear NOAELs for the offspring effects seen in rabbits (NOAEL=13 mg/kg/day) and rats (17 mg/kg/day). Finally, the NOAEL (9 mg/kg/day) used to establish the chronic Reference Dose of 0.09 mg/kg/day is considered protective of potential developmental effects observed at the higher doses. Considering the overall toxicity database and doses selected for risk assessment, the degree of concern for the effects observed in the studies is low.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

The toxicity database for chlorimuron ethyl is adequate to characterize potential prenatal and postnatal risk for infants and children. Acceptable/guideline studies for developmental toxicity in rats and rabbits and reproduction toxicity in rats are available for FQPA assessment.

On December 26, 2007, EPA began requiring functional immunotoxicity testing and acute and subchronic neurotoxicity testing of all food and non-food use pesticides. These studies are not yet available for chlorimuron ethyl. In the absence of specific immunotoxicity and neurotoxicity studies, EPA has evaluated the available chlorimuron ethyl toxicity data and determined that an additional uncertainty factor is not required to account for the lack of these studies. The reasons for this determination are explained below:

i. Hematological changes (indicative of mild anemia) and atrophy of the thymus were observed in dogs following subchronic exposure to chlorimuron-ethyl at a dose of 45.8/42.7 (M/F) mg/kg/day, indicating potential immunotoxicity. However, atrophy of the thymus was not associated with any histopathology and was not seen after chronic exposure; and no other potential immunotoxic effects were observed in the toxicology database. Therefore, EPA does not believe that conducting immunotoxicity testing will result in a NOAEL less than the NOAEL of 9 mg/kg/day already established for chlorimuron ethyl, and an additional factor (UFDB) for database uncertainties is not needed to account for potential immunotoxicity.

ii. There is no indication in the toxicity database that chlorimuron ethyl is a neurotoxic chemical. No signs indicative of neurotoxicity were seen in subchronic and chronic studies conducted with dogs, mice and rats. In a 2-generation reproduction study in rats, histopathological alterations were seen in the cerebellum of F2 pups at the high dose (177 mg/kg/day). However, these findings were not associated with any neurobehavioral changes or any other indications of neurotoxicity. In addition, these histopathological alterations were not observed in two other reproduction studies with chlorimuron ethyl. Based on these considerations, EPA does not believe that a developmental neurotoxicity study is warranted at this time and there is no need for an additional UF to account for the lack of acute and subchronic neurotoxicity studies.

iii. Although there is evidence of increased quantitative susceptibility in the developmental rabbit study and the 2-generation rat reproduction study, the degree of concern for the effects observed in the studies is low, and there are no residual uncertainties with regard to prenatal toxicity following in utero exposure of rats or rabbits or prenatal and/or postnatal exposures of rats.

iv. There are no residual uncertainties identified in the exposure databases. The food exposure assessments were performed based on the assumptions of 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to chlorimuron ethyl in drinking water. Chlorimuron ethyl is not registered for residential use. These assessments will not underestimate the exposure and risks posed by chlorimuron ethyl.

EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded.

1. Acute risk. An acute aggregate risk assessment takes into account exposure estimates from acute dietary consumption of food and drinking water. No adverse effect resulting from a single-oral exposure was identified and no acute dietary endpoint was selected. Therefore, chlorimuron ethyl is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to chlorimuron ethyl from food and water will utilize 1% or less of the cPAD for the general population and all population subgroups, including infants and small children. There are no residential uses for chlorimuron ethyl.

3. Short/intermediate-term risk. Short-term and intermediate-term aggregate exposure take into account short-term or intermediate-term residential exposure plus chronic exposure from food and water (considered to be a background exposure level). Chlorimuron ethyl is not registered for any use patterns that would result in residential exposure. Therefore, the short-term or intermediate-term aggregate risk is the sum of the risk from exposure to chlorimuron ethyl through food and water and will not be greater than the chronic aggregate risk.

4. Aggregate cancer risk for U.S. population. Based on a lack of evidence for carcinogenicity in mice and rats following long-term dietary administration, chlorimuron ethyl is not expected to pose a cancer risk.

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, or to infants and children from aggregate exposure to chlorimuron ethyl residues.

Adequate enforcement methodology (high performance liquid chromatography (HPLC) using a photoconductivity detector with a method limit of quantitation (LOQ) of 0.01 ppm (AMR-459-85)) 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 or Mexican maximum residue limits (MRLs) for residues of chlorimuron ethyl for corn or soybean commodities; however, there is a Canadian MRL for soybeans (0.05 mg/kg), which harmonizes with the current U.S. tolerance on soybeans.

EPA has determined that tolerances are not needed for the following: Corn, field, meal; corn, field, flour; and soybean, hulls. Tolerances for the processed commodities of corn, field, meal and corn, field, flour are not needed because these commodities are not expected to have residues greater than the tolerance on the raw agricultural commodity, field corn grain. EPA has also determined that tolerances for corn and soybean aspirated grain fractions will not be listed individually, but will be combined under the single tolerance, grain, aspirated fractions at 3.0 ppm based on the soybean aspirated grain fraction data. The current tolerance for residues of chlorimuron ethyl on soybeans at 0.05 ppm is not being amended as requested. Although adequate residue data are available indicating that residues on soybean were less than 0.01 ppm in/on all seed samples following an application at the R1-R2 stage, the existing 0.05 ppm tolerance will cover this use and is additionally required for harmonization purposes with the Canadian MRL. However, the soybean tolerance is being amended to change the commodity name to “soybean, seed” which is the current EPA designated term for this commodity. A tolerance for residues in/on soybean, hulls is not required as this commodity will be covered by the existing 0.05 ppm tolerance on soybean, seed.

Finally, EPA is revising the tolerance expression for all new and existing commodities to clarify the chemical moieties that are covered by the tolerances and specify how compliance with the tolerances is to be measured. The revised tolerance expression makes clear that the tolerances cover “residues of chlorimuron ethyl, including its metabolites and degradates” and that compliance with the tolerance levels will be determined by measuring only chlorimuron ethyl, ethyl 2-[[[[(4-chloro-6-methoxypyrimidin-2yl)amino]carbonyl]sulfonyl]benzoate]. EPA has determined that it is reasonable to make this change final without prior proposal and opportunity for comment, because public comment is not necessary, in that the change has no substantive effect on the tolerance, but rather is merely intended to clarify the existing tolerance expression.

Therefore, tolerances are established for residues of chlorimuron ethyl, including its metabolites and degradates, in or on corn, field grain at 0.01 ppm; corn, field, forage at 0.5 ppm; corn, field, stover at 2.0 ppm; soybean, forage at 0.45 ppm; soybean, hay at 1.8 ppm, and grain, aspirated fractions at 3.0 ppm. In addition, the presently established tolerance term, “Soybean” is being revised to “Soybean, seed.” Compliance with the tolerance levels will be determined by measuring only chlorimuron ethyl, ethyl 2-[[[[(4-chloro-6-methoxypyrimidin-2yl)amino]carbonyl]sulfonyl]benzoate], in or on the commodity.

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 final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled 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 9, 2000) do not apply to this final rule. In addition, this final 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).

• 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 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.

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr.

Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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-2008-0937 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before February 16, 2010.

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-2008-0937, 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 Facility'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 April 8, 2009 (74 FR 15974) (FRL-8407-4), 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 8F7442) by BASF Corporation, 26 Davis Dr., P.O. Box 13528, Research Triangle Park, NC 27709-3528. The petition requested that 40 CFR 180.463 be amended by establishing tolerances for residues of the herbicide quinclorac, 3,7-dichloro-8-quinolinecarboxylic acid, in or on grass, forage at 105 and grass, hay at 70 parts per million (ppm). That notice referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available to the public in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has concluded that 40 CFR 180.463 can be amended by establishing tolerances for residues of the herbicide quinclorac in or on grass, forage at 150 ppm and grass, hay at 130 ppm instead of the petitioned for 105 ppm on grass, forage and 70 ppm on grass, hay. The reason for these changes are explained in Unit IV.C.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerances for residues of quinclorac on grass, forage at 150 ppm and grass, hay at 130 ppm. EPA's assessment of exposures and risks associated with establishing tolerances follows.

In the Federal Register of October 7, 2009 (74 FR 51485) (FRL-8434-3) the Agency published a final rule establishing tolerances for residues of quinclorac in or on cranberry at 15.0 ppm. The Agency conducted risk assessments to support that tolerance action.

The risk assessment associated with this 8F7442 petition request on grass, forage and grass, hay assessed the possibility that grass, forage and hay can be used as livestock feed stuffs and found that the current tolerances established for quinclorac for livestock commodities are adequate to cover the proposed new use on pasture and rangeland. In addition, the drinking water assessment conducted concluded that Estimated Drinking Water Concentrations (EDWCs) of quinclorac in surface water and ground water resulting from the new use are less than the previously assessed EDWCs from the use on cranberry. No new residential uses are requested in the 8F7442 petition. Therefore, no change in the dietary exposure (from food and water) is expected, and establishing tolerances on grass, forage and grass, hay will not change the most recent estimated aggregate risks resulting from use of quinclorac, as discussed in the October 7, 2009 Federal Register. Refer to the October 7, 2009 Federal Register document 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, along with the risk assessment completed on this petition request in support of this action. The risk assessment completed for this petition request can be found at http://www.regulations.gov in document “Human Health Risk Assessment for Quinclorac New Use on Pasture/Rangeland” in docket ID number EPA-HQ-OPP-2008-0937.

Therefore, based on the risk assessment discussed in the final rule published in the Federal Register of October 7, 2009, and the risk assessment completed in support of this petition request, 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 quinclorac residues.

Adequate analytical methods utilizing gas chromatography with electron capture detection (GC/ECD), are available to enforce the tolerance expression on plant (BASF Mehod A8902, Master Record Identification Number (MRID) 41063537) and livestock commodities (BASF Method 268/1, MRID 41063536), and the limit of quantitation (LOQ) for quinclorac is 0.05 ppm by these methods. Both methods have undergone successful agency method validation trials and have been submitted to the Food and Drug Administration (FDA) for publication in PAM II as the tolerance enforcement methods. Furthermore, the available FDA multi-residue method (MRM) testing data indicate that quinclorac is completely recovered using Method 402 in PAM, Vol. 1.

There are no Codex, Canadian, or Mexican maximum residue limits (MRLs) established for quinclorac on grass, forage and grass, hay.

Review of available field trial data indicate that the proposed tolerances for grass, forage at 105 ppm and grass, hay at 70 ppm are too low; tolerances of 150 ppm and 130 ppm, respectively, are appropriate based on the results of analysis of the field trial data using the Agency's Tolerance Spreadsheet in accordance with the Agency's Guidance for Setting Pesticide Tolerances Based on Field Trial Data.

Therefore, tolerances are established for residues of quinclorac, 3,7-dichloro-8-quinolinecarboxylic acid, in or on grass, forage at 150 ppm and grass, hay at 130 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 final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled 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 9, 2000) do not apply to this final rule. In addition, this final 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).

• 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 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.

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr. To access the OPPTS harmonized test guidelines referenced in this document electronically, please go to http://www.epa.gov/oppts and select “Test Methods & Guidelines” on the left-side navigation menu.

Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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-2008-0730 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before February 16, 2010.

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-2008-0730, 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 Facility'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 December 3, 2008 (73 FR 73644) (FRL-8386-9), 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 8E7419) by the IR-4, IR-4 Project Headquarters, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.293 be amended by establishing tolerances for combined residues of the herbicide endothall, mono (N,N-dimethylalkylamine) salt of endothall, and the dipotassium salt of endothall, in or on Vegetable Root, and Tuber Group 1 at 2 ppm (parts per million); Vegetable, Leaves of Root and Tuber, Group 2 at 3.5 ppm; Vegetable, Bulb, Group 3-07 at 2 ppm; Vegetable, Leafy, except Brassica, Group 4 at 3.5 ppm; Vegetable, Brassica, Leafy, Group 5 at 0.1 ppm; Turnip, greens at 0.1 ppm; Vegetable, Legume, Group 6 at 3 ppm; Vegetable, Fruiting, Group 8 at 0.05 ppm; Okra at 0.05 ppm; Vegetable, Cucurbit, Group 9 at 1.1 ppm; Fruit, Citrus, Group 10 at 0.05 ppm; Fruit, Pome, Group 11 at 0.05 ppm; Fruit, Stone, Group 12 at 0.25 ppm; Berry and Small Fruit Group 13-07 at 0.6 ppm; Nut, Tree, Group 14, at 0.05 ppm; Pistachio at 0.05 ppm; Almond, hulls at 10 ppm; Grain, Cereal, Group 15 at 2.5 ppm; Grain, Cereal, Forage, Fodder and Hay, Group 16, forage at 3.5 ppm, Grain, Cereal, Forage, Fodder and Hay, Group 16, hay at 5 ppm, Grain, Cereal, Forage, Fodder and Hay, Group 16, stover at 11 ppm, Grain, Cereal, Forage, Fodder and Hay, Group 16, straw at 6 ppm, Grain, aspirated fractions at 24 ppm; Grass, Forage, Fodder, and Hay, Group 17, forage at 3 ppm, Grass, Forage, Fodder and Hay, hay at 19 ppm; Nongrass Animal Feed, Group 18 forage at 3.5 ppm, Nongrass Animal Feed, Group 18 hay at 8 ppm; Grape at 0.9 ppm, Peppermint, tops at 7 ppm, Spearmint, tops at 7 ppm; and Rice, grain at 1.7 ppm and Rice, straw at 4.5 ppm. That notice referenced a summary of the petition prepared by United Phosphorus, Inc., the registrant, on behalf of IR-4 which is available to the public in the docket, http://www.regulations.gov. This petition for tolerances was filed in conjunction with an application under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) for use of endothall in irrigation water and thus the broad request for tolerances. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition as well as the proposed use to irrigation canals, EPA has determined that virtually all crops as well as most food and feed commodities could potentially be exposed to residues in endothall-laden irrigation water with EPA approval of this use. In consideration of these factors, the Agency is revising the proposed tolerances to include inadvertent endothall residues on any food commodities not otherwise listed at 5.0 ppm and any feed commodities not otherwise listed at 10.0 ppm. Additionally, based on the residue data submitted, EPA has revised proposed tolerance levels for certain food and feed commodities. Finally, EPA is not establishing certain petitioned-for tolerances after determining they are not needed. The reasons for these changes are explained in Unit IV.D.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....”

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with endothall follows.

EPA has evaluated the available toxicity data and considered their 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.

Endothall is a caustic chemical with toxicity being the result of a direct degenerative effect on tissue. By acute dermal application and inhalation exposure, it has mild toxicity. Dermally, it destroys the stratum corneum and then the underlying viable epidermis. Endothall is a skin sensitizer. Endothall is an extreme irritant by the acute oral, and ocular routes of administration. Orally, endothall attacks the digestive tract. In the eye irritation study, endothall was shown to be extremely irritating to the eye and was also lethal to 4 of 6 rabbits tested.

In the 21-day dermal rat study, systemic toxicity (hematology and clinical chemistry alterations) were noted at a dose level that was one order of magnitude greater than that causing dermal irritation. Available studies clearly demonstrate that local irritation (portal of entry effect) is the most sensitive and initial effect, occurring at dose levels lower than those associated with systemic toxicity. In dogs, gastric irritation developed at a dose level that was one order of magnitude lower than doses associated with clinical signs of toxicity (subdued behavior, poor condition, thin appearance and distended abdomen). In the rat, gastric irritation was noted at a dose level that was 1 to 2 orders of magnitude lower than doses resulting in kidney lesions. Besides gastric irritant effects, decreased body weight was also a sensitive effect following endothall administration. The decreased body weights were most likely attributable to the constant and direct irritation of the gastric lining. In a developmental rat study, pregnant rats exhibited decreased body weight and decreased body weight was noted in a 90-day dietary study in the rat. Body weight loss occurred in dogs following a 13 week oral treatment with endothall.

Endothall does not cause prenatal toxicity following in utero exposure to rats nor prenatal or postnatal toxicity following exposures to rats for 2-generations. In the developmental mouse study, there was severe maternal toxicity (i.e., greater than 30% mortality) at the highest dose tested; at this dose level, a slight increase in vertebral and rib malformations was observed in the offspring indicating that these effects were most likely secondary to severe maternal toxicity.

Available studies showed no evidence of neurotoxicity and do not indicate potential immunotoxicity. Endothall does not belong to the class of compounds (e.g., the organotins, heavy metals, or halogenated aromatic hydrocarbons) that would be expected to be toxic to the immune system. Endothall is classified as “not likely to be carcinogenic to humans” based on lack of evidence of carcinogenicity in mice or rats. It has no mutagenic potential.

Specific information on the studies received and the nature of the adverse effects caused by endothall 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 in document “Endothall: Revised Human Health Risk Assessment for the Section 3 Registration Action to Support a New Use of Endothall in Irrigation Canals with No Required Holding Period before that Water Can Be Used on Crops,” dated 11/09/2009, page 16 in docket ID number EPA-HQ-OPP-2008-0730-0004.

For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as 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) or a benchmark dose (BMD) approach is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the POD 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 dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-term, intermediate-term, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the level of concern (LOC).

For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected in a lifetime. 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/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for endothall used for human risk assessment can be found at http://www.regulations.gov in document entitled; “Endothall: Revised Human Health Risk Assessment for the Section 3 Registration Action to Support a New Use of Endothall in Irrigation Canals with No Required Holding Period before that Water Can Be Used on Crops,” dated 11/09/2009, page 21 in docket ID number EPA-HQ-OPP-2008-0730-0004.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to endothall, EPA considered exposure under the petitioned-for tolerances as well as all existing endothall tolerances in 40 CFR 180.293. EPA assessed dietary exposures from endothall in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

No systemic toxicity resulting from a single exposure was identified. An acute Reference Dose (RfD) was not established for any population subgroup because an appropriate endpoint attributable to a single endothall dose was not available from any study, including the prenatal developmental toxicity study in the rat or the mouse. Therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-FCID(TM), Version 2.03 which incorporates consumption data from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII).

Analyses were performed to support the use of endothall in irrigation canals with no holding period before the water may be used on crops. The resulting chronic exposure assessment for food is refined, using average residues from the field trials, and estimating residues in meat, milk, poultry and eggs (MMPE), and using average residues in the livestock feeds. The exposure estimate also includes an adjustment for the percent of the harvested crop that has been irrigated for some crops. Despite this refinement, the results remain very conservative for several reasons. First, the field residue trials were performed under highly conservative conditions. Second, the manner of taking percent of the crop irrigated into consideration was very conservative. For most commodities EPA assumed 100% of the crop would be irrigated. For the remaining crops, EPA used two different methods to estimate the percent of the crop that was irrigated. Where EPA had reliable data on the percent of a crop that is irrigated, EPA assumed that percentage of that crop is irrigated with endothall-treated water (i.e., assuming that 100% of irrigation water is treated with endothall). Where EPA did not have adequate data on the percent of a crop that is irrigated, EPA assumed that all crops grown in the western U.S. are irrigated with endothall-treated water. Endothall is unlikely to be used in treatment of irrigation water outside of the western U.S. This is a very conservative assumption because all of the crops grown in the western U.S. are not irrigated.

The average residue values used in the dietary exposure assessment were taken from 18 sets of field trials submitted by IR-4. Processing factors were taken from the appropriate processing studies submitted with these field trials. Because this assessment needed to cover all possible crops that might be irrigated in the U.S., the appropriate crop residues and processing studies were translated within each extant crop group, and in addition appropriate residue values were translated to other orphan crops outside of those crop groups as needed. For similar reasons appropriate processing factors were sometimes translated to similarly processed commodities. DEEM default concentration factors were used for any applicable processed commodities where no applicable processing factors could reasonably be translated, but default factors did exist. For certain crops no formal default values have been established, so the processing factors for these crops were left at 1.0, to be consistent with other contemporary assessments.

iii. Cancer. Endothall is considered “not likely to be carcinogenic to humans” based on lack of evidence of carcinogenicity in mice and rat studies. Endothall showed no mutagenic potential based on results from in vitro mammalian cell gene mutation assay in Chinese hamster ovary (CHO) cells and bacterial gene mutation assay (Salmonella typhimurium). Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated residue and percent crop treated (PCT) information. Section 408(b)(2)(E) of 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 require pursuant to FFDCA section 408(f)(1) 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 FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

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:

• Condition 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 the pesticide residue.

• Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.

• Condition 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 FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

The Agency used PCT information as follows:

Apple, fresh market 78%, apple, processing 44%, apple, juice 49%, apple, canned 14%, barley 36%, corn 19%, dry edible beans 32%, grape, fresh market 99%, grape, processing 94%, green peas 11%, oats 7%, peanuts 42%, sorghum 15%, soybeans 9%, sugarbeets 37%, sugarcane 54%, strawberry, fresh market 89% and wheat 14%, and watermelon 39%.

EPA is establishing tolerances on multiple commodities to support the application of the aquatic herbicide endothall to be used in irrigation canals without a holding period. For a new agricultural pesticide use, EPA typically estimates PCT by comparison with the amount of use of other pesticides for the same crop or site. That approach is inappropriate for the new use for endothall, because the use is on irrigation canals rather than crops and EPA does not have data on the frequency of use of aquatic herbicides on irrigation canals.

Instead, EPA has estimated PCT for endothall by estimating the percent crop irrigated which serves as an upperbound for crops that may be exposed to endothall in irrigation water. EPA used two methods to estimate percent crop irrigated. The preferred method, used where reliable data on irrigated production are available, is an estimate of the share of total production that is irrigated. Estimates from this method are provided for barley, corn, dry edible beans, oats, peanuts, rice, sorghum, soybeans, sugarbeets, sugarcane, and wheat. Where data on irrigated production are not available, EPA estimated the percent crop irrigated by determining the percentage of U.S. production of a crop that is grown in 17 western states where endothall may be used. The 17 western states are Arizona, California, Colorado, Idaho , Kansas, Montana, Nebraska, Nevada, New Mexico, North Dakota, Oklahoma, Oregon, South Dakota, Texas, Utah, Washington, and Wyoming. These states are the states where large scale water projects predominate, and where other chemicals are used in canals for weed control. These types of irrigation projects are relatively rare in other parts of the country.

Use of these estimates in the exposure assessment is conservative, because it is the equivalent of assuming 100% of irrigated crops have irrigated with water from endothall-treated canals. In fact, even in areas with surface water delivery systems, all irrigation canals may not be treated with endothall. Additionally, some crops, even in the heavily irrigated areas of the West, are not irrigated, such as dryland grain production.

The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, 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 b and c, 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 reliable information on the regional consumption of food to which endothall may be applied in a particular area.

2. Dietary exposure from drinking water. The maximum potential exposure of endothall in drinking water sources is expected to result from the direct application of endothall to drinking water reservoirs to control aquatic weeds. EPA assumed that the entire reservoir would be treated at the maximum rates, with no more than 10% of the reservoir treated at one time as stated on the label, so that 10 treatments were applied 7 days apart to treat the entire reservoir. Since the label specified that the community water system (CWS) could not supply treated drinking water unless the endothall residues were below 0.1 ppm (100 µg/L), EPA assumed 100 µg/L (0.1 ppm) as the acute (peak) exposure and the constant exposure during the treatment period and then modeled residue decline by degradation after the final treatment. This resulted in a chronic (annual average) concentration of 31 µg/L (0.031 ppm) for endothall. This represents the likely high-end chronic exposure from endothall from the use expected to generate the highest exposures (treatment of a reservoir).

Additional information on the drinking water exposure assessment can be found at http://www.regulations.gov in document entitled; “Drinking Water Assessment for the IR-4 Tolerance Petition for the Use of Endothall-treated Irrigation Water on a Variety of Crops,” dated 9/09/2009 in docket ID number EPA-HQ-OPP-2008-0730.

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).

Endothall is currently registered for the following uses that could result in residential exposures. There is a potential for exposure from registered uses in residential for homeowners who apply endothall products to control aquatic weeds and algae in ponds and garden pools. There is also a potential for exposure to adults and children from contacting water treated with endothall through swimming, wading, water skiing, etc. The Agency conducted risk assessments for both residential handler and post-application scenarios.

For residential handlers, exposure scenarios are only considered to be short-term in nature due to the episodic uses associated with homeowner products. In ponds and garden pools use patterns and under current product labeling, two likely residential exposure scenarios exist including; 1) loading/applying granules with a bellygrinder and 2) applying granules by hand. The quantitative exposure/risk assessment developed for residential handlers is based on these two scenarios.

In residential post-application scenarios, exposures to adults and children may be expected following applications of endothall to ponds and lakes. Only short-term exposures are expected since these scenarios are expected to be only episodic.

Of the possible post-application exposures, swimming in treated water is considered by EPA to be worse-case and is used as a surrogate for all other possible post-application exposures, such as wading, water skiing, etc. The Agency considered residential post-application exposure for different segments of the population using the Swimmer Exposure Assessment Model (SWIMODEL). Details on the SWIMODEL used in this assessment may be found at: http://www.epa.gov/oppad001/swimodel.htm.

Risks were calculated using the MOE approach, where a MOE of >100 is considered a level that does not pose a concern.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found endothall to share a common mechanism of toxicity with any other substances, and endothall does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that endothall does not 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(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) 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 SF. In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. There is no quantitative or qualitative evidence of increased susceptibility following prenatal exposure to rats in the developmental toxicity study. Endothall does not cause prenatal toxicity following in utero exposure to rats nor prenatal or postnatal toxicity following exposures to rats for 2-generations reproduction studies. Due to high mortality observed in a range finding study in rabbits even at low doses, a developmental toxicity study in this species was not conducted (i.e., acute direct irritative effects of the chemical could interfere with developmental toxicity in this susceptible species). A developmental toxicity study in mice showed no evidence for enhanced susceptibility in this species.

EPA concluded that there is not a concern for prenatal and/or postnatal toxicity resulting from exposure to endothall in rats. In the developmental mouse study, there was severe maternal toxicity (i.e., greater than 30% mortality) at the highest dose tested; at this dose level, a slight increase in vertebral and rib malformations was observed in the offspring indicating that these effects were likely secondary to severe maternal toxicity.

3. Conclusion. For chronic and intermediate-term risk assessments, EPA is retaining an additional safety factor for the protection of infants and children because it is relying on a LOAEL in the 2-generation reproduction study in assessing the risk of endothall. For short-term risk assessments, EPA has determined that reliable data show that the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. Based on the following factors, EPA has determined that an additional factor of 3X will be safe for infants and children for chronic and intermediate-term risk assessments and that a 1X factor will be safe for short-term risk assessments:

i. Despite the fact that a NOAEL was not identified in the 2-generation reproduction study for chronic and intermediate-term effects and EPA is relying on a LOAEL from that study, a 3X factor (as opposed to a 10X) was determined to be adequate because: The gastric lesions (most sensitive effect) are due to the direct irritant properties of endothall (i.e., portal effects) and not as a result of frank systemic toxicity;the severity of the lesions were minimal to mild; and there was no apparent dose-response for this effect.

Therefore, EPA is confident that the POD for chronic dietary and intermediate inhalation exposure risks will not underestimate risks following exposure to endothall. A NOAEL for short-term effects was identified in the 2-generation reproduction study and is being used as the POD for assessing short-term risks of endothall.

ii. The toxicity database for endothall is complete except for acute and subchronic neurotoxicity studies and immunotoxicity testing. Recent changes to 40 CFR part 158 make these studies (OPPTS Guideline 870.7800) required for pesticide registration; however, the available data for endothall do not show potential for neurotoxicity or immunotoxicity. Although neurotoxicity studies have not yet been submitted, there are no concerns for neurotoxicity. The EPA does not expect that these studies will demonstrate a potential neurotoxic effect that is more sensitive than direct local irritation (the most sensitive effect identified in the data base). The available acute subchronic and chronic studies showed no evidence of neurotoxicity. However, irritation was identified as the initial and most sensitive effect. In the absence of specific immunotoxicity studies, EPA has evaluated the available endothall toxicity database to determine whether an additional database uncertainty factor is needed to account for potential immunotoxicity. The available studies do not indicate potential immunotoxicity, and endothall does not belong to the class of compounds (e.g., the organotins, heavy metals, or halogenated aromatic hydrocarbons) that would be expected to be toxic to the immune system. Based on the available data, the required immunotoxicity study is not expected to provide a POD lower than that currently used (i.e., direct local irritation - the most sensitive effect) for overall risk assessments. Consequently, the EPA believes the existing data are sufficient for endpoint selection for exposure/risk assessment scenarios and for evaluation of the requirements under the FQPA, and an additional database uncertainty factor does not need to be applied.

iii. There is no indication that endothall is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iv. There is no evidence that endothall results in increased susceptibility in in utero rats or mice in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

v. There are no residual uncertainties identified in the exposure databases. While the chronic dietary exposure estimates are refined (average field trial residues and adjustment of the percent of the harvested crop that has been irrigated) the results are very conservative because the field trials were performed under highly conservative conditions, and it was assumed that 100% of all irrigation canals in the U.S. are treated at the maximum rate for endothall. Further, it was assumed that this maximally treated water is applied to the crops on the day of harvest, and all consumers are chronically exposed to simultaneous inadvertent residues of endothall through all possible food and water sources. For most commodities EPA assumed 100% of the crop would be irrigated. For the remaining crops, EPA used two different methods to estimate the percent of the crop that was irrigated which were very conservative estimates. Therefore, the estimated dietary exposure (food and drinking water) will not underestimate the potential risks for infants and children. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to endothall in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by endothall.

EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short-term, intermediate-term, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded.

1. Acute risk. An acute aggregate risk assessment takes into account exposure estimates from acute dietary consumption of food and drinking water. No adverse effect resulting from a single-oral exposure was identified and no acute dietary endpoint was selected. Therefore, endothall is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to endothall from food and water will utilize 84% of the cPAD for children 1 to 2 years old, the population group receiving the greatest exposure. The general U.S. population subgroup was exposed at a maximum of 32% of the cPAD.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Endothall is currently registered for uses that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to endothall.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures aggregated result in aggregate MOEs. For adults, estimated dietary exposures via food and drinking water were combined with inhalation exposures during application to a pond or lake and potential post-application exposures during swimming. For children, estimated dietary exposures via food and drinking water were combined with potential post-application exposures during swimming. The short term aggregate risk estimate (MOE) for adults is 290, and for children, it is 240. The LOC for short-term exposures is for MOEs < 100. Therefore, there are no short term aggregate (food + drinking water + residential) risk concerns for endothall.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Endothall is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for endothall.

5. Aggregate cancer risk for U.S. population. Endothall is considered not likely to be carcinogenic to humans. EPA does not expect endothall to pose a cancer risk.

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 endothall residues.

Adequate enforcement methodology (gas chromatography (GC) with microcoulometric nitrogen detection) is listed as Method I in the Pesticide Analytical Manual (PAM, Volume II) for the determination of endothall residues (total common moiety) in plant commodities, with a limit of quantitation (LOQ) of 0.1 ppm. A second liquid chromatography/mass spectrometry(LC/MS) method (Method No. KP218R0) is also available for determining residues of endothall and its monomethyl ester in fish and in plant commodities. The LOQ is 0.05 ppm for fish, and range from 0.01-0.10 ppm for plant commodities.

There are currently no established Codex, Canadian, or Mexican maximum residue limits for endothall on plant or animal commodities.

The Agency revised the proposed tolerance levels for the following commodities: Almond, hulls from 10 to 15 ppm; animal feed, nongrass, group 18, forage from 3.5 to 4.0 ppm; animal feed, nongrass, group 18, hay from 8.0 to 10.0 ppm; fruit, stone, group 12 from 0.25 to 0.3 ppm; grain, aspirated fractions from 24.0 to 35.0 ppm; grain, cereal, group 15, except corn from 1.9 to 4.0 ppm; grape from 0.9 to 1.0 ppm; grass, forage, fodder, and hay group 17, forage from 3.0 to 3.5 ppm; grass, forage, fodder, and hay group 17, hay from 19.0 to 18.0 ppm; peppermint, tops from 7.0 to 5.0 ppm; spearmint, tops from 7.0 to 5.0 ppm; vegetable, bulb, group 3 at 2.0 to bulb, group 3-07 at 0.5 ppm; vegetable, cucurbit, group 9 from 1.1 to 1.5 ppm; vegetable, leafy, except brassica, group 4 from 3.5 to 2.0 ppm; vegetable, leaves of root and tuber, group 2 from 3.5 to 3.0 ppm; and vegetable, root and tuber, group 1 from 2.0 to 1.0 ppm. For proposed tolerances for cereal, forage, fodder and straw, group 16, stover at 11.0 ppm; and cereal, forage, fodder and straw, group 16, except stover at 6.0 ppm, the Agency established a single tolerance for both as “grain, cereal, forage, fodder and straw, group 16” at 10 ppm.

The Agency revised the tolerance levels based on available data on maximum endothall residues in subject crop and/or representative crop including analysis of the residue field trial data using the Agency's Tolerance Spreadsheet in accordance with the Agency's Guidance for Setting Pesticide Tolerances Based on Field Trial Data.

Using the same resources and procedures, the Agency established tolerances for the following additional commodities: Apple, wet pomace at 0.15 ppm; beet, sugar, molasses at1.5 ppm; cattle, fat at 0.01 ppm; cattle, kidney at 0.20 ppm; cattle, liver at 0.1; cattle, meat at 0.03 ppm; corn, field, grain at 0.07 ppm; corn, pop, grain at 0.07 ppm; egg at 0.05 ppm; feed commodities not otherwise listed at 10.0 ppm; food commodities not otherwise listed at 5.0 ppm; goat, fat at 0.005; goat, kidney at 0.15 ppm; goat, fat at 0.015 ppm; goat, liver at 0.05 ppm; goat meat at 0.015 ppm; grape, raisin at 5.0 ppm; herb and spice, group 19 at 5.0 ppm; hog, fat at 0.005; hog, liver at 0.05; hog, kidney at 0.10; hog, meat at .01 ppm; milk at 0.03 ppm; pea and bean, succulent shelled , subgroup 6B; pea and bean , dried shelled , subgroup, 6C at 0.2 ppm; poultry, fat at 0.015 ppm; poultry, liver at 0.05 ppm; poultry, meat byproducts at 0.20 ppm; poultry, meat at 0.015 ppm; rice, hull at 8.0 ppm; sheep, fat at 0.005 ppm; sheep, kidney at 0.15 ppm; sheep, liver 0.05; sheep, meat 0.015 ppm; soybean, hulls at 0.5 ppm; soybean, seed at 0.2 ppm; tomato, paste at 0.1 ppm; tomato, puree at 0.1 ppm; brassica, head and stem subgroup 5A at 0.1 ppm; brassica, leafy, group 5B at 2.0 ppm; vegetable, foliage of legume group 7 at 4.0 ppm; vegetable, legume, edible, podded, subgroup 6A; and wheat, milled byproducts at 5.0 ppm. Some of these tolerances are being added because processing data indicated that residues in the processed food may exceed the raw commodity tolerance (grape, raisin; wheat, milled byproducts). The other tolerances are being added because use of an aquatic herbicide such as endothall in irrigation water may theoretically result in residues in these crops. The available data support these tolerances.

EPA has also determined that individual tolerances are not necessary for certain petitioned-for commodities. Proposed tolerances for cereal, forage, fodder and straw, group 16, hay; cereal, forage, fodder and straw, group 16, straw; and cereal, forage, fodder and straw, group 16, forage are combined into forage, hay and straw and, therefore individual tolerances are not required. Proposed tolerances for rice, grain and rice, straw are not needed as these commodities are covered by the tolerances for cereal grains and cereal grain straw. The Agency rejected a proposed tolerance for vegetable, legume group 6 and established separate tolerances for soybeans and the various legume subgroups including vegetable, legume, edible podded, subgroups 6A; pea and bean, succulent shelled, subgroup 6B; and pea and bean, dried shelled, subgroup 6C. Likewise, tolerances were established for brassica, head and stem subgroup 5A and brassica, leafy, group 5B in place of a proposed tolerance for vegetable, brassica, group 5.

The Agency established a tolerance for cattle, fat; cattle meat; cattle liver and cattle kidney based upon calculations for dairy cattle using metabolism data even though no tolerance was proposed by IR-4 for cattle meat products. Tolerances were also established for cereal, forage, fodder and straw, group 16.

No tolerance was petitioned for on corn, field, grain or corn, pop, grain. However, a 0.7 ppm tolerance is established for each based on tolerance spreadsheet for corn grain. Also, a tolerance is established for corn, sweet, kernel plus cob with husks removed at 0.3 ppm based on maximum residues in sweet corn K+CWHR of 0.17 ppm based on available data.

Additionally, the Agency has determined that the tolerances should be established in § 180.293(d) for direct and inadvertant residues and the tolerance expression should read: Tolerances are established for the indirect or inadvertant combined residues of the herbicide, endothall (7 -oxabicyclo[2.2.1] heptane-2,3-dicarboxylic acid) in potable water from use of its potassium, sodium, di-N, N -dimethylalkylamine, and mono-N-N, -dimethylalkylamine salts.

Therefore, tolerances are established for the indirect or inadvertent combined residues of endothall (7-oxabicyclo[2.2.1] heptane-2,3-dicarboxylic acid) in water, potable from use of its potassium, sodium, di-N,N-dimethylalkylamine, and mono- N-N, -dimethylalkylamine salts as algacides or herbicides to control aquatic plants in canals, lakes, ponds, and other potable water sources that may lead to endothall residues in or on almond, hulls at 15.0 ppm; animal feed, nongrass, group 18, forage at 4.0 ppm; animal feed, nongrass, group 18, hay at 10 ppm; apple, wet pomace at 0.15 ppm; beet, sugar at 1.5 ppm; bushberry subgroup 13-07B at 0.6 ppm; caneberry subgroup 13-07A at 0.6 ppm; cattle, fat at 0.01 ppm; cattle, kidney at 0.20 ppm; cattle, liver at 0.10 ppm; cattle, meat at 0. 03 ppm; grain, cereal, forage, fodder and straw, group 16 at 10.0 ppm; corn, field, grain at 0.07 ppm; corn, pop, grain at 0.07 ppm; corn, sweet, kernel plus cob with husks removed at 0.3 ppm; citrus, dried pulp at 0.1 ppm; egg at 0.05 ppm; feed commodities not otherwise listed at 10.0 ppm; food commodities not otherwise listed at 5.0 ppm; fruit, citrus group 10 at 0.05 ppm; fruit, pome, group 11 at 0. 05 ppm; fruit, stone, group 12 at 0.3 ppm; goat, fat at 0.005 ppm; goat, kidney at 0.15 ppm; goat, liver at 0.05 ppm; goat, meat at 0.015 ppm; grain, aspirated fractions at 35.0 ppm; grain, cereal, group 15, except corn at 35.0 ppm; grape at 1.0 ppm; grape, raisin at 5.0 ppm; grass, forage, fodder, and hay group 17, forage at 3.5 ppm; grass, forage, fodder, and hay group 17, hay at 18.0 ppm; herb and spice, group 19 at 5.0 ppm; hog, fat at 0.005 ppm; hog, liver at 0.05 ppm; hog, kidney at 0.10 ppm; hog, meat at 0.01 ppm; milk at 0.03 ppm; nut, tree, group 14 at 0.05 ppm; okra at 0.05 ppm; pea and bean, succulent shelled, subgroup 6B at 2.0 ppm; pea and bean, dried shelled, subgroup 6C at 0.2 ppm; peppermint, tops at 5.0 ppm; pistachio at 0. 05 ppm; poultry, fat at 0.015 ppm; poultry, liver at 0.05 ppm; poultry, meat byproducts at 0.28 ppm; poultry, meat at 0.15 ppm; rice, hull at 8.0 ppm; sheep, fat at 0.005 ppm; sheep, kidney at 0.15 ppm; sheep, liver at 0.05 ppm; sheep, meat at 0.015 ppm; soybean hulls at 0.5 ppm; soybean, seed at 0.2 ppm; tomato, paste at 0.1 ppm; tomato, puree at 0.1 ppm; brassica, head and stem subgroup 5A at 0.1 ppm; brassica, leafy, group 5B at 2.0 ppm; vegetable, bulb, group 3-07 at 0.5 ppm; vegetable, cucurbit, group 9 at 1.5 ppm; vegetable, foliage of legume, group 7 at 4.0 ppm; vegetable, fruiting, group 8 at 0. 05 ppm; vegetable, leafy, except brassica, group 4 at 2.0 ppm; vegetable, leaves of root and tuber, group 2 at 3.0 ppm; vegetable, legume, edible, podded, subgroup 6A at 2.0 ppm; vegetable, root and tuber, group 1 at 1.0 ppm; and wheat, milled byproduct at 5.0 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 final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled 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 9, 2000) do not apply to this final rule. In addition, this final 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).

• 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 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.

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr.

Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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-2009-0013 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before February 16, 2010.

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-2009-0013, 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 Facility'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 April 8, 2009 (74 FR 15971) (FRL-8407-4), 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 8E7433) by IR-4, IR-4 Project Headquarters, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.603 be amended by establishing tolerances for combined residues of the insecticide dinotefuran, (RS)-1-methyl-2-nitro-3-((tetrahydro-3-furanyl)methyl)guanidine and its major metabolites DN, 1-methyl-3-(tetrahydro-3-furylmethyl)guanidine, and UF, 1-methyl-3-(tetrahydro-3-furylmethyl)-urea, expressed as dinotefuran in or on Brassica, leafy greens, subgroup 5B at 17 parts per million (ppm) and turnip, greens at 17.0 ppm. That notice referenced a summary of the petition prepared by Valent USA Corporation and Mitsui Chemical Inc., the registrants on behalf of IR-4, which is available to the public in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has revised the proposed tolerance of 17.0 ppm for both Brassica, leafy greens, subgroup 5B, and turnip, greens to 15.0 ppm. The reason for these changes are explained in Unit IV.C.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerances for combined residues of dinotefuran in or on Brassica, leafy greens, subgroup 5B at 15.0 ppm and turnip, greens at 15.0 ppm. EPA's assessment of exposures and risks associated with establishing tolerances follows.

EPA has evaluated the available toxicity data and considered their 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.

Dinotefuran has low acute toxicity by oral, dermal, and inhalation exposure routes. It is not a dermal sensitizer, but causes a low level of skin irritation. The main target tissues are the nervous system and the immune system, with effects seen in several species. Nervous system toxicity is manifested as clinical signs and decreased motor activity seen after acute dosing (in both rats and rabbits) and increased motor activity seen after repeated dosing; these findings are consistent with effects on the nicotinic cholinergic nervous system. Immune system toxicity is manifested as decreases in spleen and thymus weights, seen in multiple studies and species (including dogs, rats, and mice). There are also indications of endocrine-related toxicity, manifested in the reproductive toxicity study (in rats) as decreases in primordial follicles and altered cyclicity in females, and abnormal sperm parameters in males at the Limit Dose; changes in testes or ovary weight were also seen in several species (mouse, dog, and rat).

No adverse effects in fetuses were seen in the developmental toxicity studies in rats or rabbits, at maternally toxic doses, and offspring effects in the reproduction study occurred at the same doses causing parental effects. Acceptable oncogenicity and mutagenicity studies provide no indication that dinotefuran is carcinogenic or mutagenic.

Review of available studies including developmental toxicity studies in rats and rabbits, a reproductive toxicity study in rats, and acute and subchronic neurotoxicity studies in rats led to the conclusions that there is low concern for prenatal and/or postnatal toxicity resulting from exposure to dinotefuran. However, there is a concern for neurotoxicity and developmental neurotoxicity resulting from exposure to dinotefuran. Considering the overall toxicity profile and the doses and endpoints selected for risk assessment for dinotefuran, the degree of concern for the effects observed in the rat reproduction study is characterized as low, noting these effects occurred in the presence of parental toxicity and only at the highest dose tested. For all toxicity endpoints established for dinotefuran, a NOAEL lower than this offspring NOAEL is used. No residual uncertainties were identified.

Specific information on the studies received and the nature of the adverse effects caused by dinotefuran 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 in the document “Dinotefuran: Human Health Risk Assessment for Proposed Uses on Brassica Leafy Vegetables Subgroup 5B and Turnip Greens,” dated August 6, 2009, page 11 in docket ID number EPA-HQ-OPP-2009-0013-0004.

For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as 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) or a Benchmark Dose (BMD) approach is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the POD 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 dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-, intermediate-, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC).

For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected in a lifetime. 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/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for dinotefuran used for human risk assessment can be found at http://www.regulations.gov in document “Dinotefuran: Human Health Risk Assessment for Proposed Uses on Brassica Leafy Vegetables Subgroup 5B and Turnip Greens,” dated August 6, 2009, page 14 in docket ID number EPA-HQ-OPP-2009-0013-0004.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to dinotefuran, EPA considered exposure under the petitioned-for tolerances as well as all existing dinotefuran tolerances in 40 CFR 180.603. EPA assessed dietary exposures from dinotefuran 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, EPA used food consumption information from the U.S. Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed 100 percent crop treated (PCT) and tolerance level residues of dinotefuran.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA assumed 100 PCT and tolerance level residues of dinotefuran in all registered raw agricultural commodity uses.

iii. Cancer. Dinotefuran is classified as “not likely to be a carcinogen” based on the absence of significant tumor increases in two acceptable rodent carcinogenicity studies. Therefore, no exposure assessment for quantifying cancer risk was performed.

iv. Anticipated residue and PCT information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for dinotefuran. Tolerance level residues and/or 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for dinotefuran in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of dinotefuran. 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 Agency has determined that it is appropriate to estimate for parent dinotefuran and its metabolites/degradates MNG, DN, UF, and DN-2-OH + DN-3-OH in drinking water.

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of dinotefuran and its metabolites for acute exposures are estimated to be 75.78 parts per billion (ppb) for surface water and 2.75 ppb for ground water.

For chronic exposures, non-cancer assessments are estimated to be 20.97 ppb for surface water and 2.75 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 75.78 ppb was used to assess the contribution to drinking water.

For chronic dietary risk assessment, the water concentration value of 20.97 ppb 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).

Dinotefuran is currently registered for the following uses that could result in residential exposures: Professional turf management, professional ornamental production, and residential lawns. The risk assessment was conducted using the following residential exposure assumptions: Outdoor uses for turf farms, golf courses, residential lawns, and ornamentals.

There is a potential for short-term and intermediate-term exposures to homeowners in residential settings during the application of pesticide products containing dinotefuran. There is also a potential for exposure from entering areas previously treated with dinotefuran such as lawns where children might play, or golf courses and home gardens that could lead to exposures for adults (gardens) or adults and youth (golf).

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found dinotefuran to share a common mechanism of toxicity with any other substances, and dinotefuran does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that dinotefuran does not 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(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) 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 SF. In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. Prenatal developmental toxicity studies in rats and rabbits provided no indication of increased susceptibility (qualitative or quantitative) following in utero exposure to dinotefuran. In the 2-generation reproduction study in the rat there was evidence of increased qualitative susceptibility in the offspring. However, the level of concern for the observed susceptibility (decreased body weight, decreased thymus weight, and decreased grip strength) is low because:

i. Clear NOAELs and LOAELS are established for the endpoints of concern for parental and offspring toxicity.

ii. The effects in the offspring were seen in the presence of parental toxicity.

iii. The effects were seen only at the highest dose tested (Limit Dose of 1,000 milligrams/kilograms/day (mg/kg/day).

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF was reduced to 1X for acute exposure, however, a safety factor of 10X has been retained for assessing chronic dietary and short- and intermediate-term inhalation exposure due to a lack of a NOAEL in the chronic dietary (dog) and 28-day inhalation toxicity studies. That decision is based on the following findings:

i. The toxicity database for dinotefuran is complete except for developmental neurotoxicity testing. The Agency has available a newly submitted dose-range finding developmental neurotoxicity and immunotoxicity study on dinotefuran in rats. Under the conditions of the study, dinotefuran did not affect the distribution of splenocyte subpopulations (total B cell, total T cells, helper/DTH T cells, cytotoxic T cells, and natural killer cells) in the weanlings of F1 generation. It did not affect the anti-SRBC antibody forming cell response (humoral immunity) and NK cell activity (innate immunity). Therefore, it was concluded that dinotefuran showed no evidence of an effect on the functionality of the immune system in rats that were exposed to dinotefuran during the prenatal, postnatal, and post-weaning periods. Although, this study was a dose-range-finding study for a developmental immunotoxicity study, it examined all the parameters which would have been required in a regular developmental immunotoxicity study and the highest tested dose (1,035 mg/kg) was slightly greater than the limit dose (1,000 mg/kg). Considering the results and conduct of the study, EPA believes that this range-finding study provides sufficient data for understanding the immunotoxic potential of dinotefuran in young animals and satisfies the data requirement for a developmental immunotoxicity study. With respect to the requirement for an adult immunotoxicity study, the Agency has analyzed the entire data base of dinotefuran and that of a structurally related chemical, clothianidin. Clothianidin was found to produce similar effects on the thymus and spleen as dinotefuran in the repeated dosing studies, and an immunotoxicity study was conducted in both adult and the offspring animals. No immunotoxicity was found in either the adults or the offspring treated with clothianidin. Based on the available information, EPA believes that conducting an immunotoxicity study in adult rats would probably not provide additional information on the immunotoxicity of dinotefuran and certainly would not impact the risk assessment of this pesticide.

ii. There is concern for developmental neurotoxicity following exposure to dinotefuran, and a developmental neurotoxicity (DNT) study in rats is required. Evidence of neurotoxicity in the dinotefuran data base includes changes in motor activity observed in acute and subchronic neurotoxicity studies, decreased grip strength in adult offspring in the 2-generation rat study and maternal clinical signs (prone position and tremor) in the rabbit developmental study. These effects occurred at doses ranging from approximately 300 to 1,500 mg/kg/day. Because of a concern for these neurotoxic effects, EPA required a DNT study to determine possible effects on the nervous system in the developing young. However, the Agency determined that a database uncertainty factor (UFDB) is not needed to account for the lack of the DNT study based on the following:

• The developmental neurotoxicity data for other neonicotinoid compounds (thiacloprid, imidacloprid and clothainadin) where neurotoxicity (in the presence of decreased pup body weight) was seen in only one compound (imidacloprid). Based on these data EPA concluded that the results of the required dinotefuran DNT study would not likely impact the regulatory doses selected for dinotefuran.

• No concerns for developmental neurotoxicity were seen in the range-finding DNT study for dinotefuran where the offspring LOAEL was the Limit Dose (1,035 mg/kg/day) based on decreased body weight and the offspring NOAEL was 317 mg/kg/day. Establishment of such a high LOAEL in the range-finding study clearly indicates that in order to elicit toxicity, dose selection for the definitive DNT study will likely result in a point of departure much higher than those currently used for overall risk assessment (range from 2.0 to 125 mg/kg/day).

In the current risk assessment, a point of departure for neurotoxicity was used in two risk assessment scenarios: (1) A NOAEL of 125 mg/kg/day was used for general population acute dietary risk based on transient clinical signs (prone position, tremor, erythema) seen at 300 mg/kg/day (LOAEL) following a single dose and no longer apparent after 24 hours; (2) a NOAEL of 33 mg/kg/day was used for short-term incidential oral risk based on increased motor activity seen at 327 mg/kg/day following multiple doses. Similar or lower points of departure for other systemic toxicities were used for the other risk assessment scenarios: The NOAEL of 33 mg/kg/day, which was used for assessment of short-term incidental oral risk, the chronic RfD is based on an extrapolated NOAEL of 2.0 mg/kg/day based on decreased thymus weight, the intermediate term incidental oral exposure is based on a NOAEL of 22 mg/kg/day based on changes in body weight/body weight gain, and the short and the intermediate inhalation exposure endpoints are based on an extrapolated NOAEL of 6.0 mg/kg/day based on decreased body weight and food consumption.

Therefore, the Agency believes there are reliable toxicity data showing that the points of departures used for the overall risk assessment of dinotefuran are protective of infants and children.

iii. There is no evidence that dinotefuran results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies. Although there is evidence of increased qualitative susceptibility in the two generation reproduction study in the rat, the degree of concern is low and the Agency did not identify any residual uncertainties after establishing toxicity endpoints and traditional UFs to be used in the risk assessment of dinotefuran.

iv. A safety factor of 10X has been retained for chronic dietary and short- and intermediate-term inhalation exposure due to a lack of a NOAEL in the chronic dietary (dog) and 28-day inhalation toxicity studies. For the chronic Reference Dose (RfD) the default 10X UF was deemed to be adequate based on the magnitude and the nature of response at the LOAEL in the study: (1) At the LOAEL, the decreased thymus weight was limited to one sex (males) with no corroborative histopathological lesions in the thymus glands; (2) this appears to be a species specific effect since no treatment-related effects on the thymus (weight or histopathology) was seen following chronic exposures to mice or rats; and (3) there is high confidence that the extrapolated NOAEL of 2.0 mg/kg/day (LOAEL = 20 ÷ 10; UF = 2.0) will be protective of the systemic toxicity seen at higher doses in mice (LOAEL = 34 mg/kg/day) and rats (LOAEL = 991 mg/kg/day) following chronic exposures.

For the short- and intermediate-term inhalation exposures, the default 10X UF is deemed to be adequate since following exposures for 28-days, no toxicity to the target organ (respiratory system) was seen at any concentration; and the endpoint of concern was generalized systemic toxicity characterized by decreased body weight gain and food consumption in one sex (males).

v. There are no residual uncertainties identified in the exposure databases. The acute and chronic dietary food exposure assessment utilized proposed and registered tolerance level residues and 100% crop treated information for all commodities. By using these screening-level assessments, acute and chronic exposure/risks will not be underestimated. Furthermore, EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to dinotefuran in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by dinotefuran.

EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded.

1. Acute risk. An acute aggregate risk assessment takes into account exposure estimates from acute dietary consumption of food and drinking water. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to dinotefuran will occupy 3.5% of the aPAD for children 1 to 2 years old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to dinotefuran from food and water will utilize 68% of the cPAD for children 1 to 2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of dinotefuran is not expected.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Dinotefuran is currently registered for uses that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to dinotefuran. Because there are existing residential uses of dinotefuran, short- and intermediate-term aggregate risk assessments based on exposure from oral, inhalation, and dermal routes were considered. However, the toxicological effects for oral and inhalation routes of exposure are different (i.e., neurotoxicity for oral and decrease in body weight for inhalation); and therefore, these exposure scenarios have not been combined. Also, because no systemic toxicity was seen at the limit dose in a 28-day dermal toxicity study, no quantification of short-term dermal risk is required. Therefore, only short-term oral residential hand-to-mouth exposures for toddlers need to be aggregated with chronic food and drinking water exposures. However, these exposures were not aggregated, and instead as a worst-case estimate of risk, intermediate-term dermal and oral residential hand-to-mouth exposures for toddlers were aggregated with chronic food and drinking water exposures. The point of departure for intermediate-term dermal and oral exposures is a NOAEL of 22 mg/kg/day versus the point of departure for short-term oral exposures which is 33 mg/kg/day.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). An intermediate-term aggregate risk assessment was performed as a screening level assessment. Intermediate-term aggregate risk assessments were performed for adults and children. For children, the subgroup with the highest estimated chronic dietary exposure (children 1 to 2 years old) was aggregated with residential exposures to children playing on treated lawns (dermal and oral hand-to-mouth exposures) in order to calculate the worst case intermediate-term aggregate risk to children. Intermediate term is a worst case because the short- and intermediate-term incidental oral exposures are the same and the POD for intermediate-term risk is lower than the POD for short term risk. Further, intermediate dermal plus incidental oral exposures are combined (same toxic effect), thus the total intermediate-term exposure is higher than short term exposure.The reciprocal MOE method was used to conduct the intermediate-term aggregate risk assessment for children, since the levels of concern are identical for all MOEs in the calculation. For adults, the aggregate risk index (ARI) method was used, since levels of concern are not identical for all types of exposure in the calculation. For children, the aggregate MOE is 430. Because the level of concern is for exposures with a MOE of less than 100, this MOE does not raise a safety concern. For adults, the total aggregate ARI is 5.9. Because the level of concern using the ARI approach is with an ARI of less than 1, the total aggregate ARI for dinotefuran does not raise a safety concern.

5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenic effects in two acceptable carcinogenicity studies, dinotefuran was classified as “not likely to be carcinogenic to humans” and is not expected to pose a cancer risk to humans.

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 dinotefuran residues.

Three methods for plants have been available for enforcement of tolerances: A high performnce liquid chromatography mass spectrometry (HPLC/MS/MS) method for the determination of residues of dinotefuran, DN, and UF; a HPLC/UV method for the determination of dinotefuran; and a HPLC/MS and HPLC/MS/MS method for the determination of DN and UF. An additional LC/MS/MS method was developed by Wildlife International, Ltd. (Project No. 236C-113), entitled “Laboratory Validation of Method(s) for the Analysis of MTI-446 and its metabolites DN and UF in Multiple Crop Substrates,” to quantitate residues in mustard greens. The method was validated using untreated mustard greens fortified separately with dinotefuran, DN and UF at 0.01 for each analyte. Adequate recovery data were provided. Based on the method validation data and concurrent recovery data, the submitted LC/MS/MS method for leafy Brassica greens is adequate for enforcement and data collection purposes.

Adequate enforcement methodologies as described above 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 currently no established Codex, Canadian, or Mexican maximum residue limits for residues of dinotefuran in or on plant commodities.

EPA has revised the tolerance levels for residues of dinotefuran from the, proposed 17 ppm for both Brassica, leafy greens, subgroup 5B and turnip greens to 15 ppm each based on analysis of field trial data and the North American Free Trade Agreement (NAFTA) MRL Spreadsheet.

Additionally, EPA has revised the tolerance expression to clarify, (1) that, as provided in section 408(a)(3) of FFDCA, the tolerance covers metabolites and degradates of dinotefuran not specifically mentioned; and (2) that compliance with the specified tolerance levels is to be determined by measuring only the specific compounds mentioned in the tolerance expression. These changes were made to both the tolerance expressions for plant commodities and animal commodities. They result in no substantive change to the meaning of the tolerance but clarify the existing language.

Therefore, tolerances are established for residues of dinotefuran, (RS)-1-methyl-2-nitro-3-((tetrahydro-3-furanyl)methyl)guanidine, including its metabolites and degradates, in or on the commodities listed below in § 180.603. Compliance with the tolerance levels specified is to be determined by measuring only the sum of dinotefuran and its metabolites DN, 1-methyl-3-(tetrahydro-3-furylmethyl)guanidine, and UF, 1-methyl-3-(tetrahydro-3-furylmethyl)urea, calculated as the stoichiometric equivalent of dinotefuran, in or on Brassica, leafy greens, subgroup 5B at 15.0 ppm and turnip, greens at 15.0 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 final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled 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 9, 2000) do not apply to this final rule. In addition, this final 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) (Pub. L. 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).

• 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 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 electronically available documents 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 e-CFR cite at http://www.gpoaccess.gov/ecfr. To access the OPPTS harmonized test guidelines referenced in this document electronically, please go to http://www.epa.gov/oppts and select “Test Methods & Guidelines” on the left-side navigation menu.

Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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-2008-0773 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before February 16, 2010.

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-2008-0773, 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 Facility’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 December 3, 2008 (73 FR 73640) (FRL-8390-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 8E7434 and 8E7436) by IR-4, 500 College Road East, Suite 201W, Princeton, New Jersey 08540. The petition requested that 40 CFR 180.222 be amended by establishing tolerances for residues of the herbicide prometryn, 2,4-bis(isopropylamino)-6-methylthio-s-triazine, in or on carrots at 0.7 parts per million (ppm); celeriac, roots at 0.05 ppm; celeriac, tops at 0.05 ppm; cilantro, fresh at 4.0 ppm, cilantro, dried at 15 ppm; okra at 0.05 ppm; parsley, leaves at 0.7 ppm, (all the preceding in PP 8E7434); and leaf petiole subgroup 4B at 0.5 ppm (PP 8E7436). That notice referenced a summary of the petition prepared by Syngenta Crop Protection, Inc., the registrant, on behalf of IR-4, which is available to the public in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has modified carrot, roots from 0.7 ppm to 0.45 ppm; celeriac, tops from 0.05 ppm to 0.20 ppm; cilantro, leaves from 4.0 ppm to 3.5 ppm; coriander, dried leaves from 15.0 ppm to 9.0 ppm; parsley, leaves from 0.7 ppm to 0.60 ppm. EPA also revised several commodity terms and determined that a tolerance is required for parsley, dried leaves at 1.5 ppm.The reasons for these changes are explained in Unit IV.C.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....”

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerances for residues of prometryn on carrot, roots at 0.45 ppm; celeriac, roots at 0.05 ppm; celeriac, tops at 0.20 ppm; cilantro, leaves at 3.5 ppm; coriander, dried leaves at 9.0 ppm; leaf petioles subgroup 4B at 0.50 ppm; okra at 0.05 ppm; parsley, leaves at 0.60 ppm; and parsley, dried leaves at 1.5 ppm. EPA's assessment of exposures and risks associated with establishing tolerances 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.

Prometryn demonstrated minimal acute toxicity via the oral, dermal, and inhalation routes. Prometryn is mildly irritating to the eyes, slightly irritating to the skin, and is not a skin sensitizer.

In a 28-day feeding study in mice, prometryn caused decreased body weight and/or mortality at doses that exceed the limit dose. No evidence of local or systemic toxicity was observed in a 21-day dermal toxicity study in rabbits. In a chronic oncogenicity study in mice, decreased body-weight gain at the highest dose tested was the only adverse effect observed. In a combined chronic toxicity/carcinogenicity study in rats, decreased body weight, body-weight gains, and renal toxicity (mineralized concretions) were observed at the highest dose only. There was no evidence of carcinogenicity in either study and prometryn was non-mutagenic when tested in a battery of genotoxicity assays. Following long-term exposure of dogs to prometryn, multi-organ toxicity (degenerative hepatic changes, renal tubule degeneration, bone marrow atrophy) was observed at the highest dose tested.

Prometryn is neither a developmental nor a reproductive toxicant. Adverse effects were observed primarily at the highest doses tested; offspring toxicity was observed at the same doses as maternal/parental toxicity. In the developmental toxicity study in the rat, decreased body weight and food consumption, and clinical signs of toxicity were observed in dams; decreased fetal body weight, and incomplete ossification of sternebrae and metacarpals were observed at the same dose in offspring. In the developmental toxicity study in rabbits, decreased food consumption and increased incidence of resorptions, abortions, and post-implantation loss were observed in maternal animals that led to a decreased number of viable litters and live fetuses at the highest dose tested. In the 2-generation rat production study, decreased food consumption, body weight, and body-weight gain were observed in parental animals, and decreased body weight was observed in offspring at the same dose. There was no evidence of toxicity to the reproductive organs in the study.

Specific information on the studies received and the nature of the adverse effects caused by prometryn 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 in the document “Section 3 Registration Request to Add New Uses on Carrot, Celeriac, Cilantro, Okra, Parsley, and Leaf Petioles (Crop Subgroup 4B). Human-Health Risk Assessment,” at page 36 in docket ID number EPA-HQ-OPP-2008-0773.

For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as 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) or a Benchmark Dose (BMD) approach is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the POD 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 dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-, intermediate-, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC).

For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected in a lifetime. 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/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for prometryn used for human risk assessment can be found at http://www.regulations.gov in the document “Section 3 Registration Request to Add New Uses on Carrot, Celeriac, Cilantro, Okra, Parsley, and Leaf Petioles (Crop Subgroup 4B). Human-Health Risk Assessment,” at page 19 in docket ID number EPA-HQ-OPP-2008-0773.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to prometryn, EPA considered exposure under the petitioned-for tolerances as well as all existing prometryn tolerances in 40 CFR 180.222. EPA assessed dietary exposures from prometryn 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. Such effects (increased incidence of resorptions, abortions, and post-implantation loss and decreased number of live fetuses) were identified in the toxicological studies for prometryn for the population subgroup females 13 to 49 years old; no such effects were identified for the general population or other population subgroups.

In estimating acute dietary exposure, EPA used food consumption information from the U.S. Department of Agriculture (USDA) 1994-1996 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed that all food commodities contain tolerance level residues and that 100% of all crops are treated with prometryn. EPA also used the default processing factors for all processed commodities.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA assumed that all food commodities contain tolerance level residues and that 100% of all crops are treated with prometryn. EPA also used the default processing factors for all processed commodities.

iii. Cancer. Prometryn was classified by the Agency in Group E (“Evidence of non-carcinogenicity for humans”), based on the lack of oncogenic effects at any dose in both rats and mice. Therefore an exposure assessment to evaluate cancer risks is not needed for this chemical.

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue or PCT information in the dietary assessment for prometryn. Tolerance level residues and 100% CT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for prometryn in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of prometryn. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

Based on the First Index Reservoir Screening Tool (FIRST), and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of prometryn for acute exposures are estimated to be 377.4 parts per billion (ppb) for surface water and 23.2 ppb for ground water. For chronic exposures for non-cancer assessments are estimated to be 157.9 ppb for surface water and 23.2 ppb for ground water.

For acute dietary risk assessment, the water concentration value of 377.4 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration value of 157.9 ppb 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).

Prometryn is not registered for any specific use patterns that would result in residential exposure.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found prometryn to share a common mechanism of toxicity with any other substances, and prometryn does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that prometryn does not 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(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) 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 SF. In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. Developmental toxicity studies showed no increased sensitivity of fetuses when compared to maternal animals following in utero exposures of rats or rabbits. The multi-generation reproduction study in rats showed no increased sensitivity of offspring when compared to parental animals. No evidence of developmental anomalies of the fetal nervous system was observed in the prenatal developmental toxicity studies in either rats or rabbits up to maternally toxic dose levels.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for prometryn is complete except for acute and subchronic neurotoxicity studies and immunotoxicity testing. Recent changes to 40 CFR part 158 make these studies (OPPTS Guideline 870.7800) required for pesticide registration; however, the toxicology database for prometryn does not show any evidence of treatment-related effects on the nervous or immune system. The overall weight-of-evidence suggests that this chemical does not directly target the nervous or the immune system. In addition, prometryn does not belong to a class of chemicals (e.g., the organotins, heavy metals, halogenated aromatic hydrocarbons) that would be expected to be immunotoxic. Although an immunotoxicity study and acute and subchronic neurotoxicity studies are required as a part of new data requirements in the 40 CFR part 158 for conventional pesticide registration, the Agency does not believe that conducting a functional immunotoxicity study or acute and subchronic neurotoxicity studies will result in a lower POD than that currently use for overall risk assessment, and therefore, a database uncertainty factor is not needed to account for lack of these studies.

ii. There is no indication that prometryn is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that prometryn results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to prometryn in drinking water. These assessments will not underestimate the exposure and risks posed by prometryn.

EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to prometryn will occupy 16% of the aPAD for females 13 to 49 years old, the population group receiving the greatest exposure. No adverse effect resulting from a single-oral exposure was identified for the remaining population groups and no acute dietary endpoint was selected. Therefore, prometryn is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to prometryn from food and water will utilize 30% of the cPAD for all infants < 1 year old, the population group receiving the greatest exposure. There are no residential uses for prometryn.

3. Short- and intermediate-term risk. Short- and intermediate-term aggregate exposure takes into account short-term and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Prometryn is not registered for any use patterns that would result in residential exposure. Therefore, the short- and intermediate-term aggregate risk is the sum of the risk from exposure to prometryn through food and water and will not be greater than the chronic aggregate risk.

4. Aggregate cancer risk for U.S. population. As discussed in Unit III.C.1.iii., the Agency has concluded that prometryn is not likely to be carcinogenic to humans, therefore, a cancer risk is not of concern for this chemical.

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, or to infants and children from aggregate exposure to prometryn residues.

Adequate enforcement methodology (gas chromatography/flame photometric detection/sulfur (GC/FPD/S)) 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 no established Codex MRLs for prometryn.

Based upon review of the data supporting the petition, EPA has modified carrot, roots from 0.7 ppm to 0.45 ppm; celeriac, tops from 0.05 ppm to 0.20 ppm; cilantro, leaves from 4.0 ppm to 3.5 ppm; coriander, dried leaves from 15.0 ppm to 9.0 ppm; parsley, leaves from 0.7 ppm to 0.60 ppm. EPA revised these tolerance levels based on analysis of the residue field trial data using the Agency’s tolerance spreadsheet in accordance with the Agency’s Guidance for Setting Pesticide Tolerances Based on Field Trial Data. EPA also revised the commodity term for cilantro dried to coriander, dried leaves, to be in compliance with correct commodity definition. Additionally, EPA determined that a tolerance is required for parsley, dried leaves at 1.5 ppm. Additionally, the tolerance for celery is removed since it is included in the leaf petioles subgroup 4B and the regional tolerance for parsley leaves is removed since it is superseded by the tolerance established in this action.

Therefore, tolerances are established for residues of prometryn, 2,4-bis(isopropylamino)-6-methylthio-s-triazine, in or on celeriac, roots at 0.05 ppm; celeriac, tops at 0.20 ppm; cilantro, leaves at 3.5 ppm; coriander, dried leaves at 9.0 ppm; leaf petioles subgroup 4B at 0.50 ppm; okra at 0.05 ppm; parsley, leaves at 0.60 ppm; parsley, dried leaves at 1.5 ppm and increases the tolerance level for carrot, root to 0.45 ppm. Additionally, the tolerance for celery is removed since it is included in the leafy petioles subgroup 4B and the regional tolerance for parsley leaves is removed since it is superseded by the tolerance established in this action.

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 final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled 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 9, 2000) do not apply to this final rule. In addition, this final 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).

• 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 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 electronically available documents 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 e-CFR cite at http://www.gpoaccess.gov/ecfr. To access the OPPTS harmonized test guidelines referenced in this document electronically, please go to http://www.epa.gov/oppts and select “Test Methods & Guidelines” on the left-side navigation menu.

Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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-2008-0704 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before February 16, 2010.

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-2008-0704, 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 Facility’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 December 3, 2008 (73 FR 73640) (FRL-8390-4), 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 8F7437) by Arysta LifeScience North America, LLC, 15401 Weston Parkway, Suite 150, Cary, NC 27513. The petition requested that 40 CFR 180.609 be amended by establishing tolerances for combined residues of the fungicide fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime and its Z isomer, (1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime, in or on corn, field, grain at 0.02 parts per million (ppm); corn, field, aspirated grain fractions at 0.50 ppm; corn, field, forage at 3.0 ppm; corn, field, fodder/stover at 4.5 ppm; soybean, seed at 0.05 ppm; soybean, aspirated grain fractions at 0.40 ppm; soybean, forage at 9.0 ppm; soybean, hay at 1.2 ppm; and soybean, hulls at 0.40 ppm.

Also in the Federal Register of December 3, 2008 (73 FR 73644) (FRL-8386-9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a another pesticide petition (PP 8F7406) by Arysta LifeScience North America, LLC. The petition requested that 40 CFR 180.609 be amended by establishing tolerances for the combined residues of the fungicide fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime and its Z isomer, (1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime , in or on low growing berries (crop subgroup 13-07G) at 1.9 ppm. Each notice referenced a summary of the appropriate petition which had been prepared by Arysta LifeScience North America, LLC, the registrant, and is available to the public in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has corrected the commodity and subgroup names, and replaced “corn, field, aspirated grain fractions” and “soybeans, aspirated grain fractions” with “aspirated grain fractions.” EPA has also substantially increased the tolerance for aspirated grain fractions and decreased the tolerance for soybean, hulls. The reasons for these changes are explained in Unit IV.C.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal upper limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....”

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerances for the combined residues of fluoxastrobin and its Z isomer in or on aspirated grain fractions at 20 ppm; berry, low growing, subgroup 13-07G at 1.9 ppm; corn, field, forage at 3.0 ppm; corn, field grain at 0.02 ppm; corn, field, stover at 4.5 ppm; soybean, forage at 9.0 ppm; soybean, hay at 1.2 ppm; soybean, hulls at 0.20 ppm; soybean, seed at 0.05 ppm. EPA's assessment of exposures and risks associated with establishing tolerances 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. Fluoxastrobin shows low acute toxicity via the oral, dermal, and inhalation routes of exposure; is a moderate eye irritant; and is neither a dermal irritant nor a sensitizer. Following repeated administration, fluoxastrobin has mild or low toxicity in all tested species other than the dog which displayed adverse liver toxicity at considerably lower doses than those noted for other testing species. The most common finding across all testing species is decreased body weight. In the available toxicity studies on fluoxastrobin, there is no estrogen, androgen, and/or thyroid mediated toxicity. Fluoxastrobin does not produce developmental toxicity in rats or rabbits. In the rat and rabbit developmental toxicity studies and the two-generation reproduction rat study, there is no increased susceptibility to prenatal or postnatal exposure to fluoxastrobin and no effects on reproduction. Fluoxastrobin is not neurotoxic following acute or repeated dosing in the rat. Fluoxastrobin is not genotoxic, and it is also not carcinogenic in rats or mice. Specific information on the studies received and the nature of the adverse effects caused by fluoxastrobin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in the final rule published in the Federal Register of September 16, 2005 (70 FR 54640) (FRL-7719-9).

For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as 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) or a Benchmark Dose (BMD) approach is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the POD 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 dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-, intermediate-, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC).

For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected in a lifetime. 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/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for fluoxastrobin used for human risk assessment can be found at http://www.regulations.gov in the document “Fluoxastrobin. Human Health Risk Assessment for Proposed Uses on Field Corn, Soybean, and the Low-Growing Berry Subgroup 13-07G,” at page 20 in docket ID number EPA-HQ-OPP-2008-0704.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to fluoxastrobin, EPA considered exposure under the petitioned-for tolerances as well as all existing fluoxastrobin tolerances in 40 CFR 180.609. EPA assessed dietary exposures from fluoxastrobin in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for fluoxastrobin; therefore, a quantitative acute dietary exposure assessment was not performed.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the United States Department of Agriculture 1994-1996 and 1998 CSFII. As to residue levels in food, EPA performed an unrefined dietary (food and drinking water) exposure assessment. The assumptions of this dietary assessment included tolerance level residues and 100% crop treated. Experimentally derived processing factors were applied for tomato puree, potato chips, dry potato granules/flakes, and potato flour. For all other processed commodities, DEEM version 7.81 default processing factors were assumed.

iii. Cancer. The Agency has concluded that fluoxastrobin is not likely to be carcinogenic to humans. Therefore cancer risk is not of concern for this chemical.

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue or less than 100% crop treated information in the dietary assessment for fluoxastrobin. Tolerance level residues and 100% CT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for fluoxastrobin in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of fluoxastrobin. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

Based on the FQPA Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of fluoxastrobin for chronic exposures for non-cancer assessments are estimated to be 28 parts per billion (ppb) for surface water and less than 1 ppb for ground water. The modeled estimate of surface drinking water concentration was directly entered into the dietary exposure model. For chronic dietary risk assessment, a water concentration value of 28 ppb was used to assess the contribution of 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, termite control, and flea and tick control on pets).

Fluoxastrobin is currently registered for the following uses that could result in postapplication residential exposures: Turf, including lawns and golf courses. No residential handler exposure uses have been registered because all applications to residential turf must be made by a certified pest control operator. EPA assessed residential exposure using the following assumptions: Maximum application rates, no dissipation of residues after the day of application, and no dissipation of residues because of periodic growth and recutting of the grass. The Agency believes that the calculated risks represent screening level estimates. Principal potential routes of exposure include dermal and incidental oral ingestion. The Agency has assumed that most residential use will result in short-term exposures but that intermediate-term exposures are also possible. It should be noted that the new fluoxastrobin uses assessed for this final rule do not include any residential uses.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found fluoxastrobin to share a common mechanism of toxicity with any other substances, and fluoxastrobin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that fluoxastrobin does not 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(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) 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 SF. In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. The toxicity database for fluoxastrobin, including acceptable developmental toxicity studies in rats and rabbits, as well as a two-generation reproduction toxicity study, provides no indication of prenatal and/or postnatal sensitivity.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for fluoxastrobin is considered adequate to support endpoint selection for risk assessment and FQPA evaluation. The submitted studies are of good quality and provide sufficient information to determine whether fluoxastrobin poses a human health hazard. The only data deficiency that exists is the requirement for additional information concerning the mouse subchronic immunotoxicity study, for potential upgrade of the study. To address the immunotoxicity data requirement as presented in 40 CFR part 158 the Agency has examined the entire toxicity database for fluoxastrobin and drawn the following conclusion: There is no evidence of biologically relevant effects on the immune system that are related to fluoxastrobin and the overall weight of the evidence indicates that this chemical does not directly target the immune system.

ii. There is no indication that fluoxastrobin is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no indication of increased quantitative or qualitative susceptibility in rats or rabbits following in utero and/or postnatal exposure to fluoxastrobin.

iv. There are no residual uncertainties identified in the exposure database. The chronic dietary food exposure assessment utilizes proposed tolerance-level residues and 100% crop treated information for all commodities. Use of these screening-level assessment values helps ensure that chronic exposures and risks will not be underestimated. EPA additionally made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to fluoxastrobin in drinking water. EPA used similarly conservative assumptions to assess residential post-application exposure of children as well as incidental oral exposure of toddlers to fluoxastrobin. These assessments will not underestimate the exposure and risks posed by fluoxastrobin.

EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded.

1. Acute risk. An acute aggregate risk assessment takes into account exposure estimates from acute dietary consumption of food and drinking water. No adverse effect resulting from a single-oral exposure was identified and no acute dietary endpoint was selected. Therefore, fluoxastrobin is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to fluoxastrobin from food and water will utilize 38% of the cPAD for children 1 to 2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of fluoxastrobin is not expected.

3. Short- and intermediate-term risk. Fluoxastrobin is currently registered for uses that could result in both short- and intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short- and intermediate-term residential exposures to fluoxastrobin. Short- and intermediate-term aggregate exposure assessments take into account short- and intermediate-term residential exposure, respectively, plus chronic exposure to food and water (considered to be a background exposure level). Because all short- and intermediate-term quantitative hazard estimates (via the dermal and incidental oral routes) for fluoxastrobin are based on the same endpoint, a screening-level, conservative aggregate risk assessment was conducted that combined the short-term incidental oral and intermediate-term exposure estimates (i.e., the highest exposure estimates). The Agency believes that most residential exposure will be short-term, based on the use pattern.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that the combined short- and intermediate-term food, water, and residential exposures aggregated result in aggregate MOEs of 750 for adult males, 840 for adult females, and 160 for children 1 to 2 years old. For adult males and adult females, residential exposure is via the oral (background) and dermal (primary) routes. For children 1 to 2 years old, residential exposure is via the oral (background) and incidental oral and dermal (primary) routes.

4. Aggregate cancer risk for the U.S. population. The Agency has concluded that fluoxastrobin is not likely to be carcinogenic to humans. Therefore cancer risk is not of concern for this chemical.

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, or to infants and children, from aggregate exposure to fluoxastrobin residues.

Adequate enforcement methodology (liquid chromatography/mass spectrometry/mass spectrometry method) is available to enforce the tolerance expression. Method No. 00604 is available for plant commodities and Method No. 00691, Modification 001, is available for animal commodities. 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 currently no established Codex, Canadian, or Mexican Maximum Residue Levels (MRLs) for fluoxastrobin for the low-growing berry subgroup 13-07G, soybean, or field corn commodities.

EPA converted “corn, field, fodder/stover” to “corn, field, stover” to conform to the terminology in the current pesticide commodity vocabulary. The Agency also replaced “corn, field, aspirated grain fractions” and “soybean, aspirated grain fractions” with “aspirated grain fractions” to conform to the terminology in the current pesticide commodity vocabulary. The proposed tolerances of 0.50 ppm in or on corn, field, aspirated grain fractions and 0.40 ppm in or on soybean, aspirated grain fractions were changed to a tolerance of 20 ppm in or on aspirated grain fractions based on current guidance, which recommends that the established tolerance be based on the aspirated grain fraction that has the highest residues. In this case it is soybean. The soybean highest available field trial (HAFT) residue of 0.031 ppm multiplied by the expected processing factor for aspirated grain fractions of 611x produces calculated expected residues in aspirated grain fractions of 18.9 ppm. The fluoxastrobin tolerance in/on aspirated grain fractions was therefore set at 20 ppm. The proposed tolerance of 0.40 ppm in/on soybean hulls was reduced to 0.20 ppm because the HAFT residue for soybean of 0.031 ppm is expected to concentrate 4x in soybean hulls. This produces a calculated residue of 0.124 ppm and a decision that a tolerance of 0.20 ppm is appropriate. In addition, the establishment of tolerances on field corn commodities requires that the tolerance for indirect and inadvertent residues for fluoxastrobin and its Z isomer in/on grain, cereal, forage, fodder, and straw, group 16, be modified to apply to grain, cereal, forage, fodder, and straw, group 16, except corn instead. The tolerance expressions in 40 CFR 180.609 are also being modified to conform to new Agency guidance on the language tolerance expressions should conform to, but this change does not have any other effect on the existing fluoxastrobin tolerances.

Therefore, tolerances are established for the combined residues of fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime and its Z isomer, (1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime, in or on aspirated grain fractions at 20 ppm; berry, low growing, subgroup 13-07G at 1.9 ppm; corn, field, forage at 3.0 ppm; corn, field, grain at 0.02 ppm; corn, field, stover at 4.5 ppm; soybean, forage at 9.0 ppm; soybean, hay at 1.2 ppm; soybean, hulls at 0.20 ppm; and soybean, seed at 0.05 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 final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled 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 9, 2000) do not apply to this final rule. In addition, this final 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).

• 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 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.

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr. To access the OPPTS harmonized test guidelines referenced in this document electronically, please go to http://www.epa.gov/oppts and select “Test Methods & Guidelines” on the left-side navigation menu.

Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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-2008-0276 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before February 16, 2010.

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-2008-0276, 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 Facility'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 August 13, 2008 (73 FR 47186) (FRL-8375-8), 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 5F4469) by Syngenta Crop Protection, Inc., PO Box 18300, Greensboro, NC 27419. The petition requested that 40 CFR 180.481 be amended by establishing tolerances for residues of the herbicide prosulfuron, 1-(4-methoxy-6-methyl-triazin-2-yl)-3-[2-(3,3,3-trifluoropropyl)-phenylsulfonyl]-urea, in or on field and popcorn grain, fodder, and forage at 0.01 parts per million (ppm); cereal grains group (except rice and wild rice), fodder at 0.01 ppm; forage at 0.10 ppm; grain at 0.01 ppm; hay at 0.20 ppm; straw at 0.02 ppm; cattle, goat, hog, horse, sheep fat, kidney, liver, meat, and meat byproducts at 0.05 ppm; and milk at 0.01 ppm. That notice referenced a summary of the petition prepared by Syngenta Crop Protection, the registrant, which is available to the public in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has determined that corn and livestock commodity tolerances proposed in the petition are not required. EPA has also revised the cereal grain commodity terms and the tolerance expression for prosulfuron. The reasons for these changes are explained in Unit IV.C.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....”

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerances for residues of prosulfuron and its metabolites and degradates on grain, cereal, forage, fodder, and straw, group 16, except rice, fodder at 0.01 ppm; grain, cereal, forage, fodder, and straw, group 16, except rice, forage at 0.10 ppm; grain, cereal, forage, fodder, and straw, group 16, except rice, hay at 0.20 ppm; grain, cereal, forage, fodder, and straw, group 16, except rice, straw at 0.02 ppm; and grain, cereal, group 15, except rice at 0.01 ppm. EPA's assessment of exposures and risks associated with establishing tolerances 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.

Toxicology studies indicate that prosulfuron has minimal toxicity under acute exposure conditions and that it is not a skin or eye irritant or dermal sensitizer. In chronic and subchronic studies with prosulfuron, some treatment-related effects were observed, most commonly effects on body weight. Evidence of neurotoxicity was also observed in gavage studies. Effects consistent with neurotoxicity (primarily gait and sensorimotor effects) were observed in rabbits in the developmental toxicity range-finding study and in rats in the acute neurotoxicity screening study. However, neurotoxic effects were not observed following oral exposure to prosulfuron, and there was no evidence from the developmental and reproductive studies of increased susceptibility to these effects in rat or rabbit fetuses or offspring.

Previously, EPA classified prosulfuron as a Group D Chemical (“Not Classifiable as to Human Carcinogenicity”), a classification consistent with the cancer guidelines in effect at the time (1995). This classification was based on the lack of evidence of carcinogenicity in male or female mice at the limit dose and equivocal evidence of carcinogenicity in female rats. In female rats, there was suggestive evidence of a possible treatment-related increase in the incidence of adenocarcinomas of the mammary glands at the mid dose but not at the high dose. This lack of dose-response (i.e. the relatively limited response in the high dose group and a more pronounced response in the middle-dose group) along with the lack of evidence of carcinogenicity in mice and the lack of evidence for in vivo or in vitro mutagenicity lowered the concern for the carcinogenic potential of prosulfuron. EPA has reviewed this evidence under the current 2005 guidelines for Carcinogen Risk Assessment and concluded that Prosulfuron should be classified as “Not Likely to Be Carcinogenic to Humans.”

Specific information on the studies received and the nature of the adverse effects caused by prosulfuron 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 in the document titled “Prosulfuron. Revised Human Health Risk Assessment for the Proposed Establishment of Permanent Tolerances for Uses in/on Cereal Grains (Crop Group 15), Except Rice”, page 33 in docket ID number EPA-HQ-OPP-2008-0276.

For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as 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) or a Benchmark Dose (BMD) approach is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the POD 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 dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-term, intermediate-term, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC).

For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected in a lifetime. 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/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for prosulfuron used for human risk assessment can be found at http://www.regulations.gov in the document titled “Prosulfuron. Revised Human Health Risk Assessment for the Proposed Establishment of Permanent Tolerances for Uses in/on Cereal Grains (Crop Group 15), Except Rice”, page 17 in docket ID number EPA-HQ-OPP-2008-0276.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to prosulfuron, EPA considered exposure under the petitioned-for tolerances. There are no other tolerances currently in effect for prosulfuron. Temporary tolerances on cereal grains and livestock commodities expired on December 31, 1999. EPA is establishing permanent tolerances on cereal grain commodities in this action but has determined that livestock tolerances are unnecessary, since there is no expectation of finite residues in livestock commodities from prosulfuron's use on cereal grains. EPA assessed dietary exposures from prosulfuron 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, EPA used food consumption information from the U. S. Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed that residues are present in cereal grains at the tolerance level and that 100% of cereal grains are treated with prosulfuron.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA assumed that residues are present in cereal grains at the tolerance level and that 100% of cereal grains are treated with prosulfuron.

iii. Cancer. Based on the results of carcinogenicity studies in rats and mice, EPA does not expect prosulfuron to pose a cancer risk. Therefore, an exposure assessment to evaluate cancer risk is unnecessary for this chemical.

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue or PCT information in the dietary assessment for prosulfuron. Tolerance level residues and 100% CT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for prosulfuron in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of prosulfuron. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of prosulfuron for acute exposures are estimated to be 1.872 parts per billion (ppb) for surface water and 0.655 ppb for ground water. The EDWCs for chronic exposures for non-cancer assessments are estimated to be 0.583 ppb for surface water and 0.655 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 1.872 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 0.655 ppb 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). Prosulfuron is not registered for any specific use patterns that would result in residential exposure.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found prosulfuron to share a common mechanism of toxicity with any other substances, and prosulfuron does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that prosulfuron does not 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(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) 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 SF. In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. The prenatal and postnatal toxicity database for prosulfuron includes a developmental toxicity study in the rat, two developmental toxicity studies and a range-finding developmental study in the rabbit, and a 2-generation reproduction toxicity study in the rat. There was no evidence of increased susceptibility of fetuses or offspring in any of these studies.

There were no maternal or fetal effects observed at any dose in the first of two rabbit developmental toxicity studies. In the second rabbit study and in the rat developmental toxicity study, a dose-related increase in small fetuses and skeletal effects was observed, but only in the presence of maternal toxicity (decreased body weight gain in the rat study; and increases in abortions, decreases in food consumption and decreased mean body weight gain in the rabbit study).

In the developmental range-finding study in rabbits, maternal effects consistent with neurotoxicity (hypoactivity, muscle weakness and incoordination of limbs/ataxia) were observed at all doses tested. Sciatic nerve degeneration and white matter degeneration of the spinal cord were also observed at higher dose levels. There was no evidence of neurotoxicity to fetuses or offspring observed in any of the developmental or reproduction toxicity studies.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for prosulfuron is adequate to assess prenatal and postnatal toxicity. In accordance with part 158 Toxicology Data requirements, an immunotoxicity study (870.7800) is required for prosulfuron. In the absence of specific immunotoxicity studies, EPA has examined the available prosulfuron toxicity data for evidence of immunotoxic effects. No evidence of immunotoxicity was found. Due to the lack of evidence of immunotoxicity for prosulfuron in available studies, EPA does not believe that conducting immunotoxicity testing will result in a NOAEL less than the chronic NOAEL of 5.3 milligrams/kilograms (mg/kg) bodyweight/day (bw/day) already established for prosulfuron, and an additional database uncertainty factor is not needed to account for the lack of this study.

ii. Although there was evidence of neurotoxicity following gavage exposure to prosulfuron in the rat (ataxia, decreased motor activity, decreased body temperature, impaired gait and righting reflex) and in the pregnant rabbit (ataxia, hypoactivity, neuropathology), there is low concern for these effects. The findings were observed only at high doses (at or above 250 mg/kg/day) following gavage dosing and were not observed following dietary exposure to levels up to 628 mg/kg/day. For example, the acute neurotoxicity study in rats involved gavage dosing and showed neurotoxic effects at 250 mg/kg/day but the subchronic neurotoxicity study in rats which did not involve gavage dosing did not show neurotoxic effects at the highest dose tested (628/313 male/female (M/F) mg/kg/day). The neurotoxicity findings in the pregnant rabbit were observed at a dose causing death, abortions and systemic toxicity, and the neuropathology did not show a dose-response. Furthermore, there was no evidence for neurotoxicity in offspring in the developmental studies or in the rat reproduction study, and increased prenatal and/or postnatal susceptibility was not observed. Based on these considerations, EPA has concluded that a developmental neurotoxicity (DNT) study is not required for prosulfuron and an additional uncertainty factor is not needed to account for potential neurotoxicity.

iii. There is no evidence that prosulfuron results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground water and surface water modeling used to assess exposure to prosulfuron in drinking water. Prosulfuron is not registered for residential uses. These assessments will not underestimate the exposure and risks posed by prosulfuron.

EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short-term, intermediate-term, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to prosulfuron will occupy less than 1% of the aPAD for the general population and all population subgroups, including infants and children's subgroups.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to prosulfuron from food and water will utilize less than 1% of the aPAD for the general population and all population subgroups, including infants and children's subgroups. There are no residential uses for prosulfuron.

3. Short-term and intermediate-term risk. Short-term and intermediate-term aggregate exposure take into account short-term or intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Prosulfuron is not registered for any use patterns that would result in residential exposure. Therefore, the short-term or intermediate-term aggregate risk is the sum of the risk from exposure to prosulfuron through food and water and will not be greater than the chronic aggregate risk.

4. Aggregate cancer risk for U.S. population. Based on a lack of evidence for carcinogenicity in mice and rats following long-term dietary administration, prosulfuron is not expected to pose a cancer risk.

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, or to infants and children from aggregate exposure to prosulfuron residues.

Adequate enforcement methodology (high-performance liquid chromatography (HPLC)) 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.

No CODEX maximum residue limits have been established for prosulfuron.

EPA has determined that the corn and livestock commodity tolerances proposed in the petition are not required. Field corn and popcorn are members of the Crop Group 15 (cereal grains); therefore, residues on corn commodities will be covered by the cereal grains (group 15) tolerances. Tolerances are not required for livestock commodities because there is no expectation of finite residues in livestock commodities from the use of prosulfuron on cereal grains. EPA has also revised the cereal grain commodity terms to agree with the Agency's Food and Feed Commodity Vocabulary.

Finally, EPA has revised the prosulfuron tolerance expression to clarify the chemical moieties that are covered by the tolerances and specify how compliance with the tolerances is to be measured. The revised tolerance expression makes clear that the tolerances cover residues of prosulfuron and its metabolites and degradates, but that compliance with the tolerance levels will be determined by measuring only prosulfuron, 1-(4-methoxy-6-methyl-triazin-2-yl)-3-[2-(3,3,3-trifluoropropyl)-phenylsulfonyl]-urea, in or on the commodities.

EPA has determined that it is reasonable to make this change final without prior proposal and opportunity for comment, because public comment is not necessary, in that the change has no substantive effect on the tolerance, but rather is merely intended to clarify the existing tolerance expression.

Therefore, tolerances are established for residues of prosulfuron and its metabolites and degradates in or on grain, cereal, forage, fodder, and straw, group 16, except rice, fodder at 0.01 ppm; grain, cereal, forage, fodder, and straw, group 16, except rice, forage at 0.10 ppm; grain, cereal, forage, fodder, and straw, group 16, except rice, hay at 0.20 ppm; grain, cereal, forage, fodder, and straw, group 16, except rice, straw at 0.02 ppm; and grain, cereal, group 15, except rice at 0.01 ppm. Compliance with these tolerances will be determined by measuring only prosulfuron, 1-(4-methoxy-6-methyl-triazin-2-yl)-3-[2-(3,3,3-trifluoropropyl)-phenylsulfonyl]-urea, in or on the commodities.

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 final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled 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 9, 2000) do not apply to this final rule. In addition, this final 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).

• 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 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 electronically available documents 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 e-CFR cite at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized Test Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/oppts/ and select “Test Methods & Guidelines” in the left side margin menu.

Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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-2008-0811 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before February 16, 2010.

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-2008-0811, 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 Facility'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 December 3, 2008 (73 FR 73648) (FRL-8391-3), 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 8F7456) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 27419. The petition requested that 40 CFR 180.571 be amended by establishing tolerances for residues of the herbicide, mesotrione, in or on soybeans at 0.01 parts per million (ppm). That notice referenced a summary of the petition prepared by Syngenta Crop Protection, 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.

To harmonize with the Food and Feed Commodity Vocabulary, http://www.epa.gov/opphed01/foodfeed/index.htm/, EPA has amended the commodity listing to read: Soybean, seed at 0.01 ppm.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue.”

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerances for residues of mesotrione, including its metabolites and degradates, in or on soybean, seed at 0.01 ppm. Compliance with the tolerance level is to be determined by measuring only mesotrione, 2-[4-(methylsulfonyl)-2-nitrobenzoyl]-1,3-cyclohexanedione, in the raw agricultural commodity. EPA's assessment of exposures and risks associated with establishing tolerances 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.

Mesotrione has a low acute toxicity via the oral, dermal, and inhalation routes. It is a mild eye irritant, but is not a dermal irritant or a dermal sensitizer. In subchronic and chronic oral studies, ocular lesions, liver and kidney effects, and/or body weight decrements were the major adverse effects seen in the rat, mouse, and dog. Plasma tyrosine levels were increased in the rat, mouse and dog in the chronic and reproduction studies in which levels were measured. The ocular, liver and kidney effects are believed to be mediated by the high tyrosine levels in the blood caused by inhibition of the enzyme HPPD. Even though the rat is the most sensitive species to this effect compared to the dog and the mouse, EPA concluded that the mouse is a more appropriate model for assessing human risk than is the rat.

There was no evidence of carcinogenic potential in either the rat chronic toxicity/carcinogenicity or mouse carcinogenicity studies and no concern for mutagenicity. No evidence of neurotoxicity or neuropathology was seen in the acute and subchronic neurotoxicity studies. In the multi-generation mouse reproduction study, one first generation male and one first generation female had retinal detachment with marked cataractous changes at the highest dose tested (>1,000 mg/kg/day). In the subchronic toxicity dog study, the high-dose females had decreased absolute and relative brain weights; however, no microscopic abnormalities were noted in any brain tissues from the high-dose group and effect was not observed in the chronic toxicity dog study. There is some concern about the effects of elevated plasma tyrosine levels on the developing nervous system in children due to a report that some patients with tyrosinemia III (an autosomal recessive disorder in which HPPD is deficient) were presented with mental retardation or neurological symptoms. There was evidence of increased susceptibility of rats, mice and rabbits to in utero and/or post-natal exposure to mesotrione.

Specific information on the studies received and the nature of the adverse effects caused by mesotrione 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 in the document “Mesotrione: Human Health Risk Assessment for Section 3 New Uses on Soybeans” in docket ID number EPA-HQ-OPP-2008-0811. Additionally, mesotrione toxicological data are discussed in the final rule published in the Federal Register of June 21, 2001 (66 FR 33187) (FRL-6787-7).

For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as 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) or a Benchmark Dose (BMD) approach is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the POD 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 dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-, intermediate-, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC).

For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected in a lifetime. 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/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for mesotrione used for human risk assessment is discussed in “Mesotrione: Human Health Risk Assessment for Section 3 New Uses on Soybeans” in docket ID number EPA-HQ-OPP-2008-0811. Additionally, mesotrione toxicological data are discussed in the final rule published in the Federal Register of June 21, 2001 (66 FR 33187) (FRL-6787-7)

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to mesotrione, EPA considered exposure under the petitioned-for tolerances as well as all existing mesotrione tolerances in 40 CFR 180.571. EPA assessed dietary exposures from mesotrione in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

No such effects were identified in the toxicological studies for mesotrione; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed that all foods were treated for which there are proposed and established tolerances and that all the foods contain tolerance-level residues.

iii. Cancer. Mesotrione was negative for carcinogenicity in feeding studies in rats and mice and was classified as “not likely” to be a human carcinogen. Therefore, a quantitative exposure assessment to evaluate cancer risk is unnecessary.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for mesotrione in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of mesotrione. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models for the experimental use permit issued for an experimental program with mesotrione on soybeans (100-EUP-114), the estimated drinking water concentrations (EDWCs) of mesotrione for chronic exposures are estimated to be 5.1 parts per billion (ppb) for surface water and 0.54 ppb for ground 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).

Mesotrione is currently registered for the following uses that could result in residential exposures: Golf course, commercial and residential turf. EPA assessed residential exposure using the following assumptions: Residential adult handlers (dermal and inhalation) as well as postapplication exposure to adults (dermal), youths (dermal), and toddlers (dermal and incidental oral) to residues on treated grass was assessed.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

Mesotrione, pyrasulfotole, isoxaflutole and topramezone belong to a class of herbicides that inhibit the liver enzyme, 4-hydroxyphenylpyruvate dioxygenase (HPPD), which is involved in the catabolism (metabolic breakdown) of tyrosine (an amino acid derived from proteins in the diet). Inhibition of HPPD can result in elevated tyrosine levels in the blood, a condition called tyrosinemia. HPPD-inhibiting herbicides have been found to cause a number of toxicities in laboratory animal studies including ocular, developmental, liver and kidney effects. Of these toxicities, it is the ocular effect (corneal opacity) that is highly correlated with the elevated blood tyrosine levels. In fact, rats dosed with tyrosine alone show ocular opacities similar to those seen with HPPD inhibitors. Although the other toxicities may be associated with chemically-induced tyrosinemia, other mechanisms may also be involved.

There are marked differences among species in the ocular toxicity associated with inhibition of HPPD. Ocular effects following treatment with HPPD inhibitor herbicides are seen in the rat but not in the mouse. Monkeys also seem to be recalcitrant to the ocular toxicity induced by HPPD inhibition. One explanation of this species-specific response in ocular opacity may be related to the species differences in the clearance of tyrosine. A metabolic pathway exists to remove tyrosine from the blood that involves a liver enzyme called tyrosine aminotransferase (TAT). In contrast to rats where ocular toxicity is observed following exposure to HPPD-inhibiting herbicides, mice and humans are unlikely to achieve the levels of plasma tyrosine necessary to produce ocular opacities because the activity of TAT in these species is much greater compared to rats. HPPD inhibitors (e.g., nitisinone) are used as an effective therapeutic agent to treat patients suffering from rare genetic diseases of tyrosine catabolism. Treatment starts in childhood but is often sustained throughout patient's lifetime. The human experience indicates that a therapeutic dose (1 mg/kg/day dose) of nitisinone has an excellent safety record in infants, children and adults and that serious adverse health outcomes have not been observed in a population followed for approximately a decade. Rarely, ocular effects are seen in patients with high plasma tyrosine levels; however, these effects are transient and can be readily reversed upon adherence to a restricted protein diet. This indicates that an HPPD inhibitor in and of itself cannot easily overwhelm the tyrosine-clearance mechanism in humans.

Therefore, exposure to environmental residues of HPPD-inhibiting herbicides are unlikely to result in the high blood levels of tyrosine and ocular toxicity in humans due to an efficient metabolic process to handle excess tyrosine. The Agency continues to study the complex relationships between elevated tyrosine levels and biological effects in various species. Nonetheless, as a worst case scenario, EPA has assessed aggregate exposure to mesotrione based on ocular effects in rats. For similar reasons, a semi-quantitative screening cumulative assessment was conducted using the rat ocular effects and 100% crop treated information. The results of this screening analysis did not indicate a concern. In the future, assessments of HPPD-inhibiting herbicides will consider more appropriate models and cross species extrapolation methods. For additional 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(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) 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 SF. In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. There is quantitative evidence of increased susceptibility of the young in the oral prenatal developmental toxicity studies in rats, mice, and rabbits and in the multi-generation reproduction study in mice. Quantitative evidence of increased susceptibility was not demonstrated in the multi-generation reproduction study in rats. The ocular discharge seen in the reproductive study in mice provided a highly conservative endpoint at 7,000 ppm. There is a well characterized NOAEL protecting offspring in the developmental and reproductive studies in mice (relevant species for human-health risk assessment). The endpoints and dose selected for the RfD, as well as incidental exposure assessments, will be protective of the effects seen in the developmental toxicity study in rabbits.

3. Conclusion. EPA concluded that an additional FQPA SF is needed to address uncertainty due to reliance on a LOAEL from the mouse two-generation reproduction study in establishing the POD for mesotrione. Nonetheless, EPA determined that there is reliable data showing that the default additional safety factor value of 10X can be safely reduced to 3X. This conclusion is based on the following:

i. The toxicity database for mesotrione is complete, except for immunotoxicity testing and a deficiency in the mouse two-generation reproduction study (lack of a NOAEL). EPA began requiring functional immunotoxicity testing of all food and non-food use pesticides on December 26, 2007. These studies are not yet available for mesotrione. In the absence of specific immunotoxicity studies, EPA has evaluated the available mesotrione toxicity data to determine whether an additional database uncertainty factor is needed to account for potential immunotoxicity of mesotrione. There was no evidence of adverse effects on the organs of the immune system in any study with mesotrione. Based on these considerations, EPA does not believe that conducting a special test guideline series, 870.7800 immunotoxicity study will result in a point of departure less than the LOAEL of 2.1 mg/kg/day used in calculating the cPAD for mesotrione; therefore, an additional database uncertainty factor is not needed to account for potential immunotoxicity.

ii. The LOAEL used to establish the level of concern is based on tyrosineanemia in mice caused by excess tyrosine in the blood. Mesotrione can lead to excess tyrosine because it inhibits the liver enzyme HPPD which metabolically breaks down tyrosine. Tyrosine can also be removed from the blood by the activity of tyrosine aminotransferase (TAT). EPA reviewed comparative data on TAT in the rat, mouse and human, and concluded that the mouse and the human were similar in their ability to remove the excess tyrosine from the blood, while the rat was more limited in this ability and thus more sensitive to the effects of HPPD inhibition. Because a 10X interspecies factor has been retained despite evidence that the mouse is not less sensitive than humans to these effects, it is not necessary to retain the full tenfold FQPA factor to account for the use of a LOAEL from the mouse two-generation reproduction study. In effect, by not reducing the interspecies factor and retaining a 3X FQPA SF, EPA is retaining an additional SF for the protection of infants and children that is at least equal to 10X.

iii. There is low concern for the susceptibility seen in the developmental studies in mice (relevant species for human health risk assessment) because there is a well characterized NOAEL protecting offspring in these studies. In the developmental toxicity study in New Zealand white rabbits and in rats, no NOAEL was established for the developmental effects. However, since the effects seen in the rabbits and rat studies were at much higher doses (twentyfold) than the dose used for establishing the POD, the POD is protective of the effects seen in the developmental toxicity studies in rats and rabbits.

iv. Mesotrione exerts its toxicity via the inhibition of HPPD, causing the build-up of tyrosine levels in the blood. There are data in the published literature indicating that children with elevated plasma tyrosine levels during development due to a genetic disorder may have mental retardation or neurological symptoms. However, by protecting against the excessive build-up of tyrosine in the blood, the human health risk assessment is protective of all adult and child populations. Further, because the data show that any potential developmental neurotoxicity of mesotrione is related to the build-up of tyrosine in the blood and nervous tissues, it is not necessary to conduct a DNT study.

v. There are no residual uncertainties identified in the exposure databases. The chronic dietary food exposure assessment utilizes proposed tolerance level residues and 100% crop treated for all commodities. EPA made conservative (protective) assumptions in the residue estimates used to assess exposure to mesotrione in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children including incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by mesotrione.

EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded.

1. Acute risk. There were no effects observed in oral toxicity studies including developmental toxicity studies in rats and rabbits that could be attributable to a single dose (exposure). Therefore, mesotrione is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to mesotrione from food and water will utilize 5.8% of the cPAD for (all infants less than 1 year old) the population group receiving the greatest exposure. Long-term aggregate risk was not calculated because residential post-application exposure over the long-term duration (more than 6 months) is not expected based on the potential residential use pattern of mesotrione.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Mesotrione is currently registered for use on golf course, commercial and residential turf that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to mesotrione. Residential handler (adult only) as well as postapplication exposure to adults, youths, and toddlers to residues on treated grass was assessed. A summary of the assumptions for residential handler (dermal and inhalation) and post application dermal and incidental oral (toddlers only) exposure from mesotrione use on turf grass can be found at http://www.regulations.gov in document “Mesotrione: Human-Health Risk Assessment for Section 3 New Uses on Soybeans” at page 23 in docket ID number EPA-HQ-OPP-2006-0811.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that the combined short-term food, water, and residential exposures aggregated result in aggregate MOEs of 370 for toddlers, 6,000 for youth, and 2,600 for adults. As EPA's Level of Concern (LOC) of 300 for mesotrione is below these MOEs, they are not of concern.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Mesotrione is currently registered for use on residential turf grass that could result in intermediate-term residential exposure to toddlers from ingestion of treated soil and the Agency has determined that it is appropriate to aggregate chronic exposure to mesotrione through food and water with intermediate-term exposures for mesotrione.

Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that the combined intermediate-term food, water, and residential exposures aggregated result in aggregate MOE of 9,000 for toddlers. As EPA's LOC of 300 for mesotrione is below this MOE, it is not of concern.

5. Aggregate cancer risk for U.S. population. Mesotrione is classified as “not likely” to be carcinogenic in humans based on the results of a carcinogenicity study in mice and the combined chronic toxicity and carcinogenicity study in the rat. Therefore, mesotrione is not expected to pose a cancer risk to humans.

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 mesotrione residues.

Adequate enforcement methodology, high-pressure liquid chromatography fluorescence detector (HPLC/FLD), 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 CODEX, Canadian, or Mexican tolerances/Maximum Residue Levels (MRLs) for mesotrione residues for the proposed crop. Thus, harmonization is not an issue at this time.

Therefore, a tolerance is established for residues of the herbicide, mesotrione, including its metabolites and degradates, in or on soybean, seed at 0.01 ppm. Compliance with the tolerance level is to be determined by measuring only mesotrione, 2-[4-(methylsulfonyl)-2-nitrobenzoyl]-1,3-cyclohexanedione, in the raw agricultural commodity.

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 final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled 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 9, 2000) do not apply to this final rule. In addition, this final 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).

• 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 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 electronically available documents 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 e-CFR cite at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized Test Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/oppts and select “Test Methods & Guidelines” on the left side navigation menu.

Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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-2009-0005 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before February 16, 2010.

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-2009-0005, 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 Facility’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 April 8, 2009 (74 FR 15971) (FRL-8407-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 8F7432 and PP 8F7441) by E.I. du Pont de Nemours and Company, Laurel Run Plaza, P.O. Box 80038, Wilmington, DE 19880-0038. The petitions requested that 40 CFR 180.451 be amended by establishing tolerances for residues of the herbicide tribenuron methyl, methyl-2-[[[[N-(4-methoxy-6-methyl-1,3,5-triazin-2-yl) methylamino] carbonyl] amino] sulfonyl] benzoate, (in PP 8F7441) in or on corn, field, grain at 0.01 parts per million (ppm); corn, field, forage at 0.2 ppm; corn, field, stover at 1.1 ppm; and corn, aspirated grain fractions at 3.55 ppm; and (in PP 8F7432) in or on soybean, seed at 0.01 ppm; soybean, forage at 0.06 ppm; soybean, hulls at 0.04 ppm; soybean, aspirated grain fractions at 3.46 ppm; and soybean, hay at 0.25 ppm. That notice referenced a summary of the petitions prepared by E.I. du Pont de Nemours and Company, the registrant, which is available to the public in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petitions, EPA has increased the proposed tolerances on soybean hay and forage, decreased the proposed tolerance on field corn forage, and determined that a tolerance should be established for “grain, aspirated fractions”, in lieu of the proposed tolerances on “soybean, aspirated grain fractions” and “corn, field, aspirated grain fractions.” EPA has also revised the tribenuron methyl tolerance expression for all existing and new tolerances. The reasons for these changes are explained in Unit IV.C.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerances for residues of tribenuron methyl and its metabolites and degradates on corn, field, forage at 0.15 ppm; corn, field, grain at 0.01 ppm; corn, field, stover at 1.1 ppm; grain, aspirated fractions at 1.5 ppm; soybean, forage at 0.07 ppm; soybean, hay at 0.35 ppm; soybean, hulls at 0.04 ppm and soybean, seed at 0.01 ppm. EPA's assessment of exposures and risks associated with establishing tolerances 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.

Tribenuron methyl has low to moderate acute toxicity via the oral, inhalation, and dermal routes of exposure. It is not a dermal irritant, but was found to be mildly irritating to the eye and is a skin sensitizer.

Repeated dose oral toxicity studies in rats and dogs resulted primarily in decreased body weights and body weight gains accompanied by decreased food consumption. There is no evidence that tribenuron methyl targets specific organs following repeated oral exposure. There is no evidence that tribenuron methyl is neurotoxic. Although increased spleen weights were observed in the 90-day oral toxicity study in rats and decreased spleen weights were observed in the reproduction study (both potential indications of immunotoxicity), these effects occurred in the absence of other potential indicators of immunotoxicity.

EPA has classified tribenuron methyl as a Group C (possible human) carcinogen, based on statistically significant increases in mammary gland adenocarcinomas in female rats at the highest dose tested (HDT) (76 milligram/kilogram/day (mg/kg/day)). There was no evidence of carcinogenicity observed in the mouse carcinogenicity study. Quantitative cancer risk assessment is not recommended for tribenuron methyl because the tumors observed in rats occurred at a dose resulting in excessive toxicity (i.e., greater than the maximum tolerated dose), there was no evidence of genotoxicity, and structurally similar compounds are not known to be carcinogenic in rats and mice. The no observed adverse effect level (NOAEL) (0.8 mg/kg/day) selected for chronic risk assessment is considered to be protective of any potential cancer risk.

Developmental and reproductive toxicity studies indicated no increased susceptibility of offspring to tribenuron methyl. At the lowest observed adverse effect level (LOAEL) of 125 mg/kg/day in the developmental study in rats, decreased fetal weights were observed in the presence of decreased maternal body weights. At the HDT (500 mg/kg/day), increased resorptions, fetal deaths, and incomplete ossifications were observed, but these effects may be secondary to maternal toxicity. In the developmental rabbit study, maternal toxicity consisted of decreased food consumption and abortions at the HDT. At this same dose there was a 10% decrease in fetal body weights (not statistically significant). Since the number of dead fetuses and resorptions per litter were not correlated with the dosing level, the increased incidence of abortions in the high dose group is likely due to maternal toxicity. In a two-generation reproduction study, reproductive effects of tribenuron methyl were limited to decreased body weight gain during lactation. There was no evidence of increased susceptibility, as parental, offspring and reproduction NOAELs and LOAELs were established at similar levels.

Specific information on the studies received and the nature of the adverse effects caused by tribenuron methyl as well as the NOAEL and the LOAEL from the toxicity studies can be found at http://www.regulations.gov in the document “Tribenuron methyl. Human Health Risk Assessment for the Proposed Use of Tribenuron methyl on Corn and Soybean,” page 33 in docket ID number EPA-HQ-OPP-2009-0005.

For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as 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) or a Benchmark Dose (BMD) approach is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the POD 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 dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-term, intermediate-term, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC).

For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected in a lifetime. 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/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for tribenuron methyl used for human risk assessment can be found at http://www.regulations.gov in the document “Tribenuron methyl. Human Health Risk Assessment for the Proposed Use of Tribenuron methyl on Corn and Soybean,” page 20 in docket ID number EPA-HQ-OPP-2009-0005.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to tribenuron methyl, EPA considered exposure under the petitioned-for tolerances as well as all existing tribenuron methyl tolerances in 40 CFR 180.451. EPA assessed dietary exposures from tribenuron methyl in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for tribenuron methyl; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the U.S Department of Agriculture (USDA) 1994-1996 and 1998 Continuing Surveys of Food Intakes by Individuals (CSFII). As to residue levels in food, EPA assumed that residues are present in all commodities at the tolerance level and that 100% of commodities are treated with tribenuron methyl. DEEMTM 7.81 default concentration factors were used to estimate residues of tribenuron methyl in processed commodities.

iii. Cancer. EPA classified tribenuron methyl as a Group C, possible human, carcinogen and determined that the chronic dietary risk assessment based on the cPAD would be protective of any potential cancer effects. Therefore, a separate exposure assessment to evaluate cancer risk is unnecessary. The weight of the evidence supporting this determination is discussed in Unit III.A.

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue or PCT information in the dietary assessment for tribenuron methyl. Tolerance level residues and 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for tribenuron methyl in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of tribenuron methyl. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI-GROW) models, the Estimated Drinking Water Concentrations (EDWCs) of tribenuron methyl for acute exposures are estimated to be 4.1 parts per billion (ppb) for surface water and 6.8 ppb for ground water. For chronic exposures for non-cancer assessments EDWCs are estimated to be 2.7 ppb for surface water and 6.8 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the only dietary exposure scenario for which a toxicological endpoint of concern was identified, the water concentration value of 6.8 ppb 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). Tribenuron methyl is not registered for any specific use patterns that would result in residential exposure.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found tribenuron methyl to share a common mechanism of toxicity with any other substances, and tribenuron methyl does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that tribenuron methyl does not 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(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) 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 SF. In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. The prenatal and postnatal toxicity database for tribenuron methyl includes guideline rat and rabbit developmental toxicity studies and a two-generation reproduction toxicity study in rats. As discussed in Unit III.A., there is no quantitative or qualitative evidence of increased susceptibility of fetuses or offspring in any of these studies.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for tribenuron methyl is adequate to assess prenatal and postnatal toxicity. In accordance with Part 158 Toxicology Data requirements, an immunotoxicity study (OPPTS Test Guideline 870.7800) and acute and subchronic neurotoxicity studies (OPPTS Test Guideline 870.6200) are required for tribenuron methyl. In the absence of specific immunotoxicity and neurotoxicity studies, EPA has evaluated the available tribenuron methyl toxicity data to determine whether an additional database uncertainty factor is needed to account for the lack of these studies.

a. Immunotoxicity: Increased spleen weights were observed in the 90-day oral toxicity study in rats at 118/135 (Male/Female) mg/kg/day, and decreased absolute spleen weights were observed in the offspring in the reproduction study at 250 mg/kg/day. These effects occurred in the absence of other potential indicators of immunotoxicity, including histopathology and alterations in hematology, and there were no accompanying effects on thymus weights. Finally, the dose selected for chronic risk assessment (cPAD of 0.008 mg/kg/day from the chronic dog toxicity study) is protective of any potential immunotoxicity (i.e., decreased spleen weights) from exposure to tribenuron methyl. Therefore, an additional UF is not needed to account for the lack of an immunotoxicity study.

b. Neurotoxicity: No evidence of neurotoxicity or neuropathology was observed in any of the toxicology studies for tribenuron methyl. Therefore, EPA has concluded that there is no need for a developmental neurotoxicity study or additional UFs to account for the lack of specific acute/subchronic neurotoxicity studies.

ii. There is no evidence that tribenuron methyl results in increased susceptibility in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

iii. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed assuming 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground water and surface water modeling used to assess exposure to tribenuron methyl in drinking water. Residential exposure to tribenuron methyl is not expected. These assessments will not underestimate the exposure and risks posed by tribenuron methyl.

EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short-term, intermediate-term, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded.

1. Acute risk. An acute aggregate risk assessment takes into account exposure estimates from acute dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, tribenuron methyl is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to tribenuron methyl from food and water will utilize less than 4% of the cPAD for the general U.S. population and less than 8% of the cPAD for infants less than 1 year old, the population group receiving the greatest exposure. There are no residential uses for tribenuron methyl.

3. Short-term/intermediate-term risk. Short-term/intermediate term aggregate exposure takes into account short-term/intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Tribenuron methyl is not registered for any use patterns that would result in residential exposure. Therefore, the short-term/intermediate-term aggregate risk is the sum of the risk from exposure to tribenuron methyl through food and water and will not be greater than the chronic aggregate risk.

4. Aggregate cancer risk for U.S. population. As explained in Unit III.A. risk assessments based on the endpoint selected for chronic risk assessment are considered to be protective of any potential carcinogenic risk from exposure to tribenuron methyl. Based on the results of the chronic risk assessment discussed above in Unit III.E.2. EPA concludes that tribenuron methyl is not expected to pose a cancer risk.

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, or to infants and children from aggregate exposure to tribenuron methyl residues.

Adequate enforcement methodology (liquid chromatography with tandem mass-spectrometric detection (LC/MS/MS) method, DuPont Method 13412 (Revision 1)) 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 CODEX, Canadian or Mexican maximum residue limits (MRLs) established on the commodities associated with these petitions.

EPA has increased the proposed tolerance on soybean, hay from 0.25 ppm to 0.35 ppm; increased the tolerance on soybean, forage from 0.06 ppm to 0.07 ppm; and decreased the proposed tolerance on corn, field, forage from 0.2 ppm to 0.15 ppm. EPA revised these tolerance levels based on analyses of the residue field trial data using the Agency’s Tolerance Spreadsheet in accordance with the Agency’s Guidance for Setting Pesticide Tolerances Based on Field Trial Data. EPA also determined that a single tolerance at 1.5 ppm should be established for “grain, aspirated fractions”, in lieu of the separately proposed tolerances of 3.46 ppm on “soybean, aspirated grain fractions” and 3.55 ppm on “corn, field, aspirated grain fractions.” The tolerance on grain, aspirated fractions (AGF) will cover residues on aspirated fractions of both corn and soybean. The tolerance level of 1.5 ppm was determined based on data for soybean indicating a concentration factor of 150x for AGF and the highest average field trial (HAFT) residue for of 0.01 ppm. Residues in corn AGF are expected to be lower, based on a concentration factor of only 13x and a HAFT of 0.01 ppm.

Finally, EPA has revised the tribenuron methyl tolerance expression for all existing and new commodities to clarify the chemical moieties that are covered by the tolerances and specify how compliance with the tolerances is to be measured. The revised tolerance expression makes clear that the tolerances cover “residues of tribenuron methyl and its metabolites and degradates,” but that compliance with the tolerance levels will be determined by measuring only “tribenuron methyl, methyl-2-[[[[N-(4-methoxy-6-methyl-1,3,5-triazin-2-yl) methylamino] carbonyl] amino] sulfonyl] benzoate, in or on the commodities.

EPA has determined that it is reasonable to make this change final without prior proposal and opportunity for comment, because public comment is not necessary, in that the change has no substantive effect on the tolerance, but rather is merely intended to clarify the existing tolerance expression.

Therefore, tolerances are established for residues of tribenuron methyl and its metabolites and degradates in or on corn, field, forage at 0.15 ppm; corn, field, grain at 0.01 ppm; corn, field, stover at 1.1 ppm; grain, aspirated fractions at 1.5 ppm; soybean, forage at 0.07 ppm; soybean, hay at 0.35 ppm; soybean, hulls at 0.04 ppm and soybean, seed at 0.01 ppm. Compliance with these tolerances will be determined by measuring only tribenuron methyl, methyl-2-[[[[N-(4-methoxy-6-methyl-1,3,5-triazin-2-yl) methylamino] carbonyl] amino] sulfonyl] benzoate, in or on the commodities.

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 final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled 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 9, 2000) do not apply to this final rule. In addition, this final 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).

• 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 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.

You may access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s e-CFR cite at http://www.gpoaccess.gov/ecfr.

Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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-2008-0385 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before February 16, 2010.

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-2008-0385, 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 Facility’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 13, 2008 (73 FR 33817) (FRL-8367-3), 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 7F7307) by E.I. DuPont de Nemours and Company, DuPont Crop Protection, Laurel Run Plaza, P. O. Box 80038, Wilmington, DE 19880-0038. The petition requested that 40 CFR 180.364 be amended by establishing tolerances for combined residues of the herbicide, glyphosate, N-(phosphonomethyl)glycine and its metabolite N-acetylglyphosate (N-acetyl-N-(phosphonomthyl)glycine) resulting from the application of glyphosate, the isopropylamine salt of glyphosate, the ethanolamine salt of glyphosate, the ammonium salt of glyphosate, and the potassium salt of glyphosate to OptimumTM GATTM field corn, in or on the food commodities field, corn, grain; field, corn, forage, aspirated grain fractions at levels already established alone. That notice referenced a summary of the petition prepared by E.I. DuPont de Nemours and Company. the registrant, which is available to the public in the docket, http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C. DuPont has requested a Section 3 registration under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for the preplant application of the herbicides glyphosate and pyrithiobac sodium to glyphosate tolerant field corn. The petitioner is also working to commercialize a genetically modified field corn designated as OptimumTM GATTM corn. N-acetyl glyphosate is produced when glyphosate is applied to Optimum GAT corn. As a result the petitioner is requesting that the currently established tolerances on field corn commodities be modified accordingly.

Based upon review of the data supporting the petition, EPA has reassigned the currently established tolerances for corn, field, grain at 5.0 parts per million (ppm) and corn, field, forage at 6.0 ppm in paragraph 40 CFR 180.364 (a)(1) to paragraph 40 CFR 180.364 (a)(2). The tolerance expression for paragraph (a)(2) reads “Tolerances are established for the combined residues of glyphosate, N-(phosophonomethyl)glycine and its metabolite N-acetyl-glyphosate (expressed as glyphosate) resulting from the application of glyphosate, the isopropylamine salt of glyphosate, the ethanolamine salt of glyphosate, the dimethylamine salt of glyphosate, the ammonium salt of glyphosate, and the potassium salt of glyphosate on the food commodities:”. The Agency is also establishing a tolerance for corn, field, stover at 100 ppm and assigning it to paragraph (a)(2). The Agency is also changing the current commodity definition for the currently established grain, cereal, forage, fodder and straw, group 16, except field corn, forage in paragraph (a)(1) to read: Grain, cereal, forage, fodder, and straw, group 16, except field corn, forage and field corn, stover. The currently established tolerance for grain, aspirated fractions at 310 ppm in paragraph (a)(2) will remain unchanged. The reasons for these changes are explained in Unit IV.D.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....”

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerances for combined residues of glyphosate, N-(phosophonomethyl)glycine and its metabolite N-acetyl-glyphosate (expressed as glyphosate) resulting from the application of glyphosate, the isopropylamine salt of glyphosate, the ethanolamine salt of glyphosate, the dimethylamine salt of glyphosate, the ammonium salt of glyphosate, and the potassium salt of glyphosate on the food commodities: corn, field, forage at 6.0 ppm; corn, field, grain at 5.0 ppm; corn, field , stover at 100 ppm; and for the combined residues glyphosate, phosophonomethyl)glycine resulting from the application of glyphosate, the isopropylamine salt of glyphosate, the ethanolamine salt of glyphosate, the dimethylamine salt of glyphosate, the ammonium salt of glyphosate, and the potassium salt of glyphosate on the food commodity grain, cereal, forage, fodder, and straw, group 16, except field corn, forage and field corn, stover at 100 ppm. EPA's assessment of exposures and risks associated with establishing tolerances 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 glyphosate per se and glyphosate and its metabolite N-acetyl-glyphosate as well as no-observed-effect-level (NOEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found in the documents in this unit.

The toxicological profile of glyphosate per se can be found in the risk assessments referenced in the final rule published in the Federal Register of December 3, 2008 (73 FR 73586) (FRL-8385-7) which establishes tolerances for glyphosate and its metabolite N-acetyl-glyphosate in or on cattle, meat byproducts and various other commodities and in the risk assessment referred to in the final rule published in the Federal Register of December 20, 2006 (71 FR 76180) (FRL-8105-9) which established tolerances for residues of glyphosate in or on noni at 0.20 ppm and various other commodities. The toxicological profile for the metabolite N-acetyl-glyphosate and N-acetyl amionomethylphosphonic acid (N-acetyl-AMPA), one of the metabolites formed following oral administration of N-acetyl-glyphosate can be found in the same rule making documents.

Amendment of the glyphosate corn tolerances to include N-acetyl-glyphosate in the tolerance expression does not result in changes in the exposure or risk estimates reported in the previous risk assessments for the reasons listed in this unit and discussed in the Agency review entitled Glyphosate and Pyrithiobac Sodium. Amended Section 3 Registration to Permit the Rotation to Glyphosate-Tolerant Field Corn and Glyphosate-Tolerant Soybean following Application to Glyphosate-Tolerant Cotton and Revison of the Field Corn Tolerance Expression. Summary of Analytical Chemistry and Residue Data., available at www.regulations.gov in Docket ID number EPA-HQ-OPP-2008-0385 and identified as document EPA-HQ-OPP-2008-0385-005.

1. The Agency has determined that N-acetyl-glyphosate has no greater toxicity than glyphosate and probably is of lower toxicity.

2. The numerical value of the currently-established tolerances for field corn commodities, livestock and poultry commodities, and feed commodities will remain unchanged.

3. The most recent dietary analysis assumed tolerance level residues and 100 percent crop treated.

4. The estimate of glyphosate in drinking water is based on a glyphosate use involving direct application to water at 3.75 pounds active ingredient per acre. Use of glyphosate on glyphosate-resistant corn will not result in higher levels in drinking water.

Accordingly, based on the risk assessments and findings discussed in the notices referenced in this unit, EPA concludes that no harm will result to the general population and to infants and children from aggregate exposure to the combined residues of glyphosate and its metabolite N-acetyl-glyphosate (expressed as glyphosate).

Adequate enforcement methodology (high performance liquid chromatography (HPLC) with tandem mass spectrometery (MS/MS)) 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 Codex Maximum Residue Levels (MRLS) established for glyphosate (sum of glyphosate and AMPA) on maize at 5 mg/kg and maize fodder (dry ) at 150 mg/kg. A Canadian MRL is established for glyphosate including the metabolite aminomethylphosphonic acid (AMPA) on corn at 3 mg/kg. A Mexican MRL is established for corn at 0.1 mg/kg for glyphosate. The glyphosate tolerances EPA is establishing in this action differ from the tolerance expression for the CODEX, Canadian, or Mexican MRLs, because of the inclusion of N-acetyl-glyphosate in the expression. Additionally, the EPA tolerances differ from the CODEX or Canadian MRLs in that the EPA tolerances do not include AMPA in the tolerance expression. At this time, harmonization between the U.S. tolerances and the CODEX, Canadian, or Mexican MRLs can not be achieved because the inclusion of N-acetyl-glyphosate in the EPA tolerance expression is necessary to support use patterns in the United States and because EPA has concluded that AMPA it not toxicologically significant and therefore, should not be included in the tolerance expression.

One commenter submitted two comments opposing the use of glyphosate and glyphosate resistant plants which have resulted in the increased use of glyphosate. The commenter also questions the effect of glyphosate on bee colonies. A similar comment concerning effect on bees was received previously and addressed in the notice published in the Federal Register on December 3, 2008. EPA does not regulate the effect of herbicide resistant plants on the environment. That function is handled by the United States Department of Agriculture (USDA) Animal and Plant Inspection Service (APHIS). The effect of herbicide resistant plants on the environment is not relevant to EPAs determination of safety of the pesticide glyphosate under section 408 of the FFDCA. The Agency’s database on the chemical glyphosate indicates that no harm will result to the general population and to infants and children from aggregate exposure to glyphosate per se or from glyphosate and its metabolite N-acetyl-glyphosate as discussed in the final rules and risk assessments referenced in this document. The commenter did not submit any information to support a revision of Agency conclusions.

Because the tolerance expression for field corn changes as a result of the inclusion of the metabolite N-acetyl-glyphosate into the expression, the Agency is deleting the currently established tolerances for corn, field, grain (5.0 ppm) and corn, field forage (6.0 ppm) from 40 CFR 180.364 (a)(1) and reestablishing them in 40 CFR 180.364(a)(2) and establishing a tolerance for corn, field, stover at 100 ppm and assigning it to paragraph (a)(2). Because a separate tolerance for corn, field, stover is being established under paragraph (a)(2), the commodity definition for the currently-established grain, cereal, forage, fodder, and straw, group 16, except field corn, forage in paragraph (a)(1) is being changed to read grain, cereal, forage, fodder and straw, group 16, except field corn, forage and field corn, stover. As discussed in the final rule published in the Federal Register of December 3, 2008, this change to the tolerance expression for glyphosate as it applies to these field corn commodities will not have any impact on these field corn tolerances in terms of how they apply to glyphosate applied to non-genetically modified field corn.

Therefore, tolerances are established for combined residues of glyphosate, N-(phosophonomethyl)glycine and its metabolite N-acetyl-glyphosate (expressed as glyphosate) resulting from the application of glyphosate, the isopropylamine salt of glyphosate, the ethanolamine salt of glyphosate, the dimethylamine salt of glyphosate, the ammonium salt of glyphosate, and the potassium salt of glyphosate on the food commodities: Corn, field, forage at 6.0 ppm; corn, field, grain at 5.0 ppm; corn, field , stover at 100 ppm; and for the combined residues glyphosate, phosophonomethyl)glycine resulting from the application of glyphosate, the isopropylamine salt of glyphosate, the ethanolamine salt of glyphosate, the dimethylamine salt of glyphosate, the ammonium salt of glyphosate, and the potassium salt of glyphosate on the food commodity grain, cereal, forage, fodder, and straw, group 16, except field corn, forage and field corn, stover at 100 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 final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled 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 9, 2000) do not apply to this final rule. In addition, this final 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).

• 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 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 electronically available documents 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 e-CFR cite at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized Test Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/oppts and select “Test Methods & Guidelines” in the left side navigation menu.

Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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-2009-0004 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before February 16, 2010.

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-2009-0004, 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 Facility'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 April 8, 2009 (74 FR 15971) (FRL-8407-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 8F7431 and PP 8F7440) by E.I du Pont de Nemours and Company, Laurel Run Plaza, P.O. Box 80038, Wilmington, DE 19880-0038. The petition requested that 40 CFR 180.478 be amended by establishing tolerances for residues of the herbicide rimsulfuron, N-((4,6-dimethoxypyrimidin-2-yl)aminocarbonyl)-3-(ethylsulfonyl)-2-pyridinesulfonamide, in or on corn, aspirated grain fractions at 1.02 parts per million (ppm); corn, field, forage at 0.4 ppm; corn, field grain at 0.01 ppm; and corn, field, stover at 2.5 ppm (PP 8F7440); and soybean, aspirated grain fractions at 4.51 ppm; soybean, forage at 0.25 ppm; soybean, hay at 1.2 ppm; soybean, hulls at 0.035 ppm; and soybean, seed at 0.01 ppm (PP 8F7431). That notice referenced a summary of the petition prepared by E.I. du Pont de Nemours and Company, the registrant, which is available to the public in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has removed the proposed tolerances for corn, aspirated grain fractions at 1.02 ppm and soybean, aspirated grain fractions at 4.51 ppm and has replaced them with a tolerance on grain, aspirated fractions at 4.5 ppm. The tolerance level for soybean, hulls was rounded up from 0.035 ppm to 0.04 ppm. The existing tolerance level for corn, field, grain was maintained at 0.1 ppm to remain harmonized with Mexico's maximum residue limit (MRL). Finally, EPA has revised the tolerance expression for all existing and new rimsulfuron tolerances. The reasons for these changes are explained in Unit IV.D.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue.”

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerances for residues of rimsulfuron and its metabolites and degradates in or on corn, field, forage at 0.4 ppm; corn, field, stover at 2.5 ppm; grain, aspirated fractions at 4.5 ppm; soybean, forage at 0.25 ppm; soybean, hay at 1.2 ppm; soybean, hulls at 0.04 ppm; and soybean, seed at 0.01 ppm. EPA's assessment of exposures and risks associated with establishing tolerances 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.

Rimsulfuron has low acute toxicity by oral, dermal, and inhalation routes of exposure. It is a moderate eye irritant and is not a dermal sensitizer. In subchronic and chronic toxicity studies in rats, toxic effects included decreased body weight, decreased body weight gain, increased relative liver and absolute kidney weights, and diuresis. At the higher dosage, decreased liver enzymes and bilirubin, fatty change, and hepatocellular hypertrophy were observed. In the chronic rat study, decreased body weight gain and increased liver weights were observed. At the higher dosage, increased mortality was observed in males. In the subchronic study in mice, increased red blood cell (RBC) and hemoglobin, and decreased body weight gain and food efficiency were observed. In the chronic study in mice, decreased body weight, increased incidences of dilation and cysts in the glandular stomach, and degeneration of the testicular artery and tunica albuginea were observed. In the subchronic study in dogs, diuresis was indicated by urinary volume, platelet concentration and kidney weights accompanied by decreased urinary osmolality. In the chronic study in dogs, increased absolute liver and kidney weights, increased seminiferous tubule degeneration, and increased number of spermatid giant cells present in epididymides in males were observed. At the higher dosage, decreased mean body weight, decreased body weight gain, as well as increases in serum cholesterol levels, alkaline phosphatase activity, absolute liver, and relative liver and kidney weights were observed.

In the developmental toxicity study in rats, no toxicity was seen at the highest dose tested. In the developmental toxicity study in rabbits, and in the 2-generation reproduction toxicity study in rats, developmental/offspring toxicity was seen in the presence of maternal/systemic toxicity and at similar dose levels. There is no quantitative or qualitative evidence of increased susceptibility following pre- and/or postnatal exposures, and there are no concerns or residual uncertainties.

There was no evidence of potential immunotoxicity or neurotoxicity in the submitted studies.

Rimsulfuron was classified by EPA as a “not likely” human carcinogen based on the lack of evidence of carcinogenicity in studies conducted in rats and mice.

Specific information on the studies received and the nature of the adverse effects caused by rimsulfuron 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 in document “Rimsulfuron Human Health Risk Assessment for Proposed Section 3 Uses on Genetically Modified Field Corn and Soybean” , page 28 in docket ID number EPA-HQ-OPP-2009-0004.

For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as 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) or a Benchmark Dose (BMD) approach is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the POD 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 dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-, intermediate-, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC).

For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected in a lifetime. 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/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for rimsulfuron used for human risk assessment can be found at http://www.regulations.gov in document “Rimsulfuron Human Health Risk Assessment for Proposed Section 3 Uses on Genetically Modified Field Corn and Soybean” , page 18 in docket ID number EPA-HQ-OPP-2009-0004.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to rimsulfuron, EPA considered exposure under the petitioned-for tolerances as well as all existing rimsulfuron tolerances in 40 CFR 180.478. EPA assessed dietary exposures from rimsulfuron in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

No such effects were identified in the toxicological studies for rimsulfuron; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA assumed tolerance-level residues and 100 percent crop treated (PCT) for all existing and new uses of rimsulfuron.

iii. Cancer. Based on the lack of evidence of carcinogenicity observed in the 2-year rat and 18-month mouse carcinogenicity studies, EPA classified rimsulfuron as a “not likely” human carcinogen. Therefore, an exposure assessment for evaluating cancer risk is not needed for this chemical.

iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for rimsulfuron. Tolerance level residues and 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for rimsulfuron in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of rimsulfuron. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of rimsulfuron for acute exposures are estimated to be 5.596 parts per billion (ppb) for surface water and 0.016 ppb for ground water; and for chronic exposures are estimated to be 0.120 ppb for surface water and 0.016 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 0.120 ppb was used to assess the contribution to drinking water. The surface water value was used in the chronic dietary assessment since it was higher than the groundwater value and, therefore, more protective. The acute surface water value is not relevant to this dietary assessment, as a toxic effect attributable to a single dose has not been identified for rimsulfuron. The cancer dietary risk assessment is also not relevant due to the lack of evidence of carcinogenicity in the conducted rat and mice toxicity studies.

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).

Rimsulfuron is not registered for any specific use patterns that would result in residential exposure.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found rimsulfuron to share a common mechanism of toxicity with any other substances, and rimsulfuron does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that rimsulfuron does not 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(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) 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 SF. In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. In the developmental toxicity in rats, no developmental toxicity was seen at the highest dose tested. In the developmental toxicity study in rabbits, and in the 2-generation study in rats, developmental/offspring toxicity was seen in the presence of maternal/systemic toxicity. In the rabbit study, fetal effects (production of only two viable fetuses) occurred at a higher dose (1,500 mg/kg/day) than the dose (500 mg/kg/day) resulting in maternal toxicity (death and reduced weight gain). In the reproduction study offspring effects (decreased mean body weight in F1 males, decreased body weight gain in F1 females, and decreased daily food consumption in F1 males) also occurred at a higher dose (1,316 mg/kg/day) than the dose (M: 830 mg/kg/day; F: 1,021 mg/kg/day) resulting in parental/systemic toxicity (decreased body weight gain in males and females). Consequently, there is no quantitative or qualitative evidence of increased susceptibility following pre- and/or postnatal exposure to rimsulfuron.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for rimsulfuron is adequate to assess potential for pre- and/or postnatal toxicity. In accordance with part 158 Toxicology Data requirements, an immunotoxicity study (870.7800), and acute and subchronic neurotoxicity studies (870.6200) are required for rimsulfuron. Despite the absence of specific immunotoxicity and neurotoxicity studies, EPA has evaluated the available toxicity data and has determined that there is no evidence that rimsulfuron either causes neurotoxic effects or directly targets the immune system, and, therefore, an additional UF is not needed to account for the lack of these studies.

ii. There is no indication that rimsulfuron is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that rimsulfuron results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. The chronic dietary food exposure assessments were performed based on 100% PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to rimsulfuron in drinking water. Residential exposure is not expected for rimsulfuron. These assessments will not underestimate the exposure and risks posed by rimsulfuron.

EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded.

1. Acute risk. An acute aggregate risk assessment takes into account exposure estimates from acute dietary consumption of food and drinking water. No adverse effect resulting from a single-oral exposure was identified and no acute dietary endpoint was selected. Therefore, rimsulfuron is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to rimsulfuron from food and water will utilize <1% of the cPAD for the general population and all population subgroups, including children 1-2 years old, the population group receiving the greatest exposure. There are no residential uses for rimsulfuron.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Rimsulfuron is not registered for any use patterns that would result in residential exposure. Therefore, the short-term aggregate risk is the sum of the risk from exposure to rimsulfuron through food and water and will not be greater than the chronic aggregate risk.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Rimsulfuron is not registered for any use patterns that would result in intermediate-term residential exposure. Therefore, the intermediate-term aggregate risk is the sum of the risk from exposure to rimsulfuron through food and water, which has already been addressed, and will not be greater than the chronic aggregate risk.

5. Aggregate cancer risk for U.S. population. Based on a lack of evidence for carcinogenicity in mice and rats following long-term dietary administration, rimsulfuron is not expected to pose a cancer risk.

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 rimsulfuron residues.

Adequate enforcement methodology (high performance liquid chromatography with ultraviolet (HPLC/UV) detection method AMR-1241-88) 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 no established or proposed Codex maximum residue limits (MRLs) for residues of rimsulfuron. There are Canadian MRLs for rimsulfuron residues on tomatoes and blueberries, and Mexican tolerances for residues on potatoes, tomatoes, and corn. The Mexican tolerance for corn (0.1 mg/kg) is identical to the existing U.S. tolerance for corn grain and harmonization will be maintained.

The proposed tolerances on corn, aspirated grain fractions at 1.02 ppm and soybean, aspirated grain fractions at 4.51 ppm have been revised to grain, aspirated fractions at 4.5 ppm. Rimsulfuron residues were shown to concentrate in aspirated grain fractions (AGF) in both corn grain and soybean seed. As the residues in soybean AGF are higher than in corn AGF, the tolerance was established at 4.5 ppm based on the soybean residue data. The proposed tolerance for soybean, hulls at 0.035 ppm was rounded up to 0.04 ppm. The tolerance level for corn, field, grain was maintained at 0.1 ppm, rather than the proposed 0.01 ppm, to remain harmonized with the MRL in Mexico.

EPA has also revised the tolerance expression for all existing and new rimsulfuron tolerances. The revised tolerance expression makes clear that the tolerances cover “residues of rimsulfuron, including its metabolites and degradates” and that compliance with the tolerance levels will be determined by measuring only rimsulfuron, N-((4,6-dimethoxypyrimidin-2-yl)aminocarbonyl)-3-(ethylsulfonyl)-2-pyridinesulfonamide. EPA has determined that it is reasonable to make this change in the tolerance expression final without prior proposal and opportunity for comment, because public comment is not necessary, in that the change has no substantive effect on the tolerance, but rather is merely intended to clarify the existing tolerance expression.

Therefore, tolerances are established for residues of rimsulfuron, including its metabolites and degradates, in or on corn, field, forage at 0.4 ppm; corn, field, stover at 2.5 ppm; grain, aspirated fractions at 4.5 ppm; soybean, forage at 0.25 ppm; soybean, hay at 1.2 ppm; soybean, hulls at 0.04 ppm; and soybean, seed at 0.01 ppm. Compliance with these tolerance levels will be determined by measuring only rimsulfuron, N-((4,6-dimethoxypyrimidin-2-yl)aminocarbonyl)-3-(ethylsulfonyl)-2-pyridinesulfonamide, in or on the commodities.

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 final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled “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 9, 2000) do not apply to this final rule. In addition, this final 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).

This notice is accessible via the Internet at the Office of the Federal Register's Website at http://www.gpoaccess.gov/fr/index.html.

This action is authorized by regulations implementing the Pacific Coast Groundfish Fishery Management Plan (FMP), which governs the groundfish fishery off Washington, Oregon, and California.

Regulations at 50 CFR 660.323(a)(2) divide the commercial Pacific whiting OY into separate allocations for the catcher/processor, mothership, and shore-based sectors. Each commercial sector receives a portion of the commercial OY. Regulations at 50 CFR 660.323 (c) provide for the reapportionment of Pacific whiting that the Regional Administrator determines will not be used during the year.

The shore-based sector was closed on July 7, 2009 (July 28, 2008; 74 FR 37176). The best available information on July 6, 2009 indicated that the 42,063 mt allocation for the shore-based sector would be reached by 10:00 a.m. on July 7, 2009. Data received after the closure indicated that the fishing rates slowed considerably in the last few days of the fishery, resulting in 1,382 mt of unharvested shore-based allocation.

This document announces the reapportionment of 1,325 mt of shore-based allocation to the catcher/processor sector resulting in the following commercial allocations for 2009: catcher/processor 35,376 mt, mothership 24,034 mt, and shore-based 40,738 mt. Facsimiles directly to fishing businesses and postings on the Northwest Regions internet site were used to provide actual notice to the affected fishers.

The determinations to take these actions were based on the most recent data available. The aggregate data upon which the determinations were based are available for public inspection at the Office of the Regional Administrator (see ADDRESSES) during business hours.

This action is authorized by the regulations implementing the FMP. The Assistant Administrator for Fisheries, NMFS, finds good cause to waive the requirement to provide prior notice and opportunity for comment on these actions pursuant to 5 U.S.C. 553 (3)(b)(B), because providing prior notice and opportunity would be impracticable. It would be impracticable because of the need for immediate action. NMFS has determined that providing an opportunity for prior notice and comment would be impractical and contrary to public interest. Delay of this action would leave Pacific whiting unharvested. In addition, the catcher/processors needed an immediate reallocation if they were to keep their workers employed. For these same reasons the agency finds good cause to waive the 30-day delay in effectiveness. These actions are taken under the authority of 50 CFR 660.323(c), and are exempt from review under Executive Order 12866. Actual notice of the reapportionments was provided to the affected fishers.

Groundfish fisheries in the Bering Sea and Aleutian Islands management area (BSAI) are managed under the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Area (FMP). The North Pacific Fishery Management Council (Council) prepared the FMP under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (MSA). Regulations implementing the FMP appear at 50 CFR part 679. General regulations governing U.S. fisheries also appear at 50 CFR part 600.

NMFS has determined that an error exists in the regulations at § 679.20(a)(8)(ii). This final rule will correct an error that resulted when NMFS inadvertently removed regulations that govern the maximum amount of Atka mackerel total allowable catch (TAC) that may be taken from the harvest limitation area (HLA) in the BSAI. NMFS published a final rule implementing HLA regulations on January 2, 2003 (68 FR 204), to ensure that fishery management of Atka mackerel in the BSAI is not likely to jeopardize the continued existence or adversely modify or destroy designated critical habitat for the Endangered Species Act (ESA)-listed western distinct population segment of Steller sea lions (Eumetopias jubatus). These regulations primarily focused on spatial and temporal harvest restrictions on Steller sea lion prey species, including Atka mackerel.

On September 14, 2007, NMFS published a final rule that attempted to modify regulations at 50 CFR 679.20(a)(8)(ii) to clarify the allocation of Atka mackerel between non-American Fisheries Act trawl catcher/processors, commonly known as the Amendment 80 sector, and other trawl vessels, commonly known as the BSAI trawl limited access sector (72 FR 52668). It was NMFS's intent to modify only regulations in the introductory text at § 679.20(a)(8)(ii) to address the allocation of Atka mackerel between the Amendment 80 sector and the BSAI trawl limited access sector, and not regulations in § 679.20(a)(8)(ii)(A) through (C) that established spatial and temporal harvest restrictions. However, the instructional text in the final rule published on September 14, 2007, inadvertently removed regulations in § 679.20(a)(8)(ii)(A) through (C) (72 FR 52719). NMFS's intent to keep regulations in § 679.20(a)(8)(ii)(A) through (C) intact was indicated in the preamble to the September 14, 2007, final rule in response to a public comment. NMFS stated that “NMFS did not propose regulations that would have modified existing regulations concerning management of Atka mackerel in the HLA as part of the [September 14, 2007 final rule]. NMFS will manage the HLA fisheries in compliance with existing regulations.” (72 FR 52705). This correcting amendment corrects the inadvertent removal of regulations in § 679.20(a)(8)(ii)(A) through (C), and reinstates them.

Pursuant to 5 U.S.C. 553(b)(B), the Acting Assistant Administrator of Fisheries (AA) finds good cause to waive prior notice and opportunity for public comment, as notice and comment would be impracticable and contrary to the public interest. Through this action, NOAA seeks to correct the inadvertent removal of regulations in § 679.20(a)(8)(ii)(A) through (C), and reinstate them. Prior notice and an opportunity for public comment on this action would be impracticable and contrary to the public interest for the following reasons. Corrections to ensure the rule's compliance with the intent of the HLA Program must be made immediately since establishing limits on Atka mackerel fishing in the HLA is critical for conservation and management of the groundfish fisheries off Alaska and for assessing the impact of these fisheries on other aspects of the marine environment. Failure to limit Atka mackerel fishing in the HLA would be inconsistent with management measures designed to avoid jeopardizing the continued existence and adverse modification of designated critical habitat for Steller sea lions as required under the ESA. Fishing in the HLA fishery is ongoing, and the lack of limitations in the HLA could result in greater harvest of Atka mackerel by vessels than allowed under current Steller sea lion management measures. Failure to limit fishing in the HLA would remove limitations on vessels that are currently constrained by those limitations and would provide an incentive for increased harvests in the HLA. As such, prior notice and an opportunity for public comment on these measures are impracticable and contrary to the public interest because NMFS only recently discovered these errors and must ensure the uninterrupted, comprehensive and rational management of the fisheries consistent with the MSA and ESA.

Additionally, for the reasons listed above, the AA finds good cause to waive the 30-day delay in the effective date under 5 U.S.C. 553(d)(3), as such procedures would be contrary to the public interest. Because prior notice and opportunity for public comment are not required for this rule by 5 U.S.C. 553, or any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. are inapplicable.

The Acting AA for NMFS has determined that this action is consistent with the MSA and other applicable law.

This final rule has been determined to be not significant for purposes of Executive Order 12866.

Alaska, Fisheries, Reporting and recordkeeping requirements.