        DEPARTMENT OF THE INTERIOR
        Fish and Wildlife Service
        50 CFR Part 17
        [FWS-R3-ES-2011-0034; 92220-1113-0000; ABC Code: C3]
        RIN 1018-AX79
        Endangered and Threatened Wildlife and Plants; Establishment of a Nonessential Experimental Population of American Burying Beetle in Southwestern Missouri

          AGENCY:
          Fish and Wildlife Service, Interior.

          ACTION:
          Proposed rule.

          SUMMARY:
          We, the U.S. Fish and Wildlife Service (Service), propose to reestablish the American burying beetle, a Federally listed endangered insect, into its historical habitat in Wah'kon-tah Prairie in southwestern Missouri. We propose to reestablish the American burying beetle under section 10(j) of the Endangered Species Act of 1973, as amended (Act), and to classify that reestablished population as a nonessential experimental population (NEP) within St. Clair, Cedar, Bates, and Vernon Counties, Missouri. This proposed rule provides a plan for establishing the NEP and provides for allowable legal incidental taking of the American burying beetle within the defined NEP area.

          DATES:

            Comments: We will consider public comments that we receive on or before August 22, 2011.

            Public meeting: We will hold a public meeting on August 11, 2011, from 6 to 8 p.m. in El Dorado Springs, Missouri (see ADDRESSES).

          ADDRESSES:

            Written Comments: You may submit information by one of the following methods:

            Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments on Docket No. FWS-R3-ES-2011-0034.

            U.S. mail or hand-delivery: Public Comments Processing, Attn: FWS-R3-ES-2010-0034; Division of Policy and Directives Management, U.S. Fish and Wildlife Service, 4401 N. Fairfax Drive, Suite 222, Arlington, VA 22203.
          We will post all comments that we receive on http://www.regulations.gov. This generally means that we will post any personal information you provide us (see the Public Comments section below for more details).

            Copies of Documents: The proposed rule is available on http://www.regulations.gov and available from our Web site at http://www.fws.gov/midwest/endangered. In addition, the supporting file for this proposed rule will be available for public inspection, by appointment, during normal business hours, at the Columbia, Missouri, Ecological Services Office, 101 Park DeVille Dr., Suite B, Columbia, MO 65203, telephone 573-234-2132. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Services (FIRS) at 800-877-8339.

            Public meeting: The public meeting will take place at El Dorado Springs Community Center, 135 W. Spring Street, El Dorado Springs, MO 64744.

            Copies of Documents: The proposed rule is available on http://www.regulations.gov and available from our Web site at http://www.fws.gov/midwest/endangered. In addition, the supporting file for this proposed rule will be available for public inspection, by appointment, during normal business hours, at the Columbia, Missouri, Ecological Services Office, 101 Park DeVille Dr., Suite B, Columbia, MO 65203, telephone 573-234-2132. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Services (FIRS) at 800-877-8339.

          FOR FURTHER INFORMATION CONTACT:
          Scott Hamilton, Fish and Wildlife Biologist, at the Columbia, Missouri Ecological Services Office, 101 Park DeVille Dr., Suite B, Columbia, MO 65203, telephone 573-234-2132; facsimile 573-234-2181.

        SUPPLEMENTARY INFORMATION:

        Public Comments
        We want any final rule resulting from this proposal to be as effective as possible. Therefore, we invite Tribal and governmental agencies, the scientific community, industry, and other interested parties to submit comments or recommendations concerning any aspect of this proposed rule. Comments should be as specific as possible.
        To issue a final rule to implement this proposed action, we will take into consideration all comments and any additional information we receive. Such communications may lead to a final rule that differs from this proposal. All comments, including commenters' names and addresses, if provided to us, will become part of the supporting record.

        You may submit your comments and materials concerning the proposed rule by one of the methods listed in the ADDRESSES section. We will not accept comments sent by e-mail or fax or to an address not listed in the ADDRESSES section. Comments must be submitted to http://www.regulations.gov before 11:59 p.m. (Eastern Time) on the date specified in the DATES section. We will not consider hand-delivered comments that we do not receive, or mailed comments that are not postmarked by the date specified in the DATES section.

        We will post your entire comment—including your personal identifying information—on http://www.regulations.gov. If you provide personal identifying information in your comment, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so.

        Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection on http://www.regulations.gov, or by appointment, during normal business hours at the U.S. Fish and Wildlife Service, Columbia, Missouri Ecological Services Office (see ADDRESSES and FOR FURTHER INFORMATION CONTACT).
        Public Meeting

        We will hold a public meeting from 6 to 8 p.m. on August 11, 2011, at the El Dorado Springs Community Center in El Dorado Springs, Missouri (see ADDRESSES). Persons needing reasonable accommodations in order to attend and participate in a public meeting should contact the Columbia, Missouri Ecological Services Office, at the address or phone number listed in the FOR FURTHER INFORMATION CONTACT section as soon as possible. In order to allow sufficient time to process requests, please call no later than one week before the meeting. Information regarding this proposal is available in alternative formats upon request.
        Background
        Regulatory Background
        The American burying beetle (Nicrophorus americanus, ABB) was listed as endangered throughout its range on July 13, 1989 (154 FR 29652), under the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq.), without critical habitat (USFWS 2008, p. 2). The Act provides that species listed as endangered are afforded protection primarily through the prohibitions of section 9 and the requirements of section 7. Section 9 of the Act, among other things, prohibits the take of endangered wildlife. “Take” is defined by the Act as harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or attempt to engage in any such conduct. Section 7 of the Act outlines the procedures for Federal interagency cooperation to conserve Federally listed species and protect designated critical habitat. It mandates that all Federal agencies use their existing authorities to further the purposes of the Act by carrying out programs for the conservation of listed species. It also states that Federal agencies must, in consultation with the Service, ensure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat. Section 7 of the Act does not affect activities undertaken on private land unless they are authorized, funded, or carried out by a Federal agency.
        Under section 10(j) of the Act, the Secretary of the Interior can designate reestablished populations outside the species' current range, but within its historical range, as “experimental.” With the experimental population designation, the relevant population is treated as threatened for purposes of section 9 of the Act, regardless of the species' designation elsewhere in its range. Threatened designation allows us discretion in devising management programs and special regulations for such a population. Section 4(d) of the Act allows us to adopt whatever regulations are necessary and advisable to provide for the conservation of a threatened species. In these situations, the general regulations that extend most section 9 prohibitions to threatened species do not apply to that species, and the 10(j) rule contains the prohibitions and exemptions necessary and appropriate to conserve that species.
        Based on the best scientific and commercial data available, we must determine whether the experimental population is essential or nonessential to the continued existence of the species. The regulations (50 CFR 17.80(b)) state that an experimental population is considered essential if its loss would be likely to appreciably reduce the likelihood of survival of that species in the wild. All other populations are considered nonessential. We have determined that this proposed experimental population would not be essential to the continued existence of the species in the wild. This determination has been made because, since the time the species was listed, wild populations of the ABB are now found in seven additional States, three of which are considered robust and suitable for donor populations (USFWS 2008, p. 14). Therefore, the Service is proposing to designate a nonessential experimental population (NEP) for the species in southwestern Missouri.
        For the purposes of section 7 of the Act, we treat an NEP as a threatened species when the NEP is located within a National Wildlife Refuge or unit of the National Park Service, and Federal agency conservation requirements under section 7(a)(1) and the Federal agency consultation requirements of section 7(a)(2) of the Act apply. Section 7(a)(1) requires all Federal agencies to use their authorities to carry out programs for the conservation of listed species. Section 7(a)(2) requires that Federal agencies, in consultation with the Service, ensure that any action authorized, funded, or carried out is not likely to jeopardize the continued existence of a listed species or adversely modify its critical habitat. When NEPs are located outside a National Wildlife Refuge or National Park Service unit, then, for the purposes of section 7, we treat the population as proposed for listing and only section 7(a)(1) and section 7(a)(4) apply. In these instances, NEPs provide additional flexibility because Federal agencies are not required to consult with us under section 7(a)(2). Section 7(a)(4) requires Federal agencies to confer (rather than consult) with the Service on actions that are likely to jeopardize the continued existence of a species proposed to be listed. The results of a conference are in the form of conservation recommendations that are optional as the agencies carry out, fund, or authorize activities. Because the NEP is, by definition, not essential to the continued existence of the species, the effects of proposed actions affecting the NEP will generally not rise to the level of jeopardizing the continued existence of the species. As a result, a formal conference will likely never be required for ABBs established within the NEP area. Nonetheless, some agencies voluntarily confer with the Service on actions that may affect a proposed species. Activities that are not carried out, funded, or authorized by Federal agencies are not subject to provisions or requirements in section 7.
        American burying beetles used to establish an experimental population will come from a captive-rearing facility at the St. Louis Zoo, which propagates this species under the Federal Fish and Wildlife Permit #TE135297-0. The donor population for the Zoo is a wild population from Ft. Chaffee, Arkansas. Each spring, Ft. Chaffee Maneuver Training Center (MTC) will provide the St. Louis Zoo with up to 15 ABB pairs provided their removal is not likely to jeopardize the continued existence of the species, and appropriate permits are issued in accordance with our regulations (50 CFR 17.22) prior to their removal. If this proposal is adopted, we would ensure, through our section 10 permitting authority and the section 7 consultation process, that the use of individuals from donor populations for release is not likely to jeopardize the continued existence of the species in the wild. ABBs will be transported to St. Louis Zoo staff to augment the St. Louis Zoo's captive population, or possibly for direct reintroduction to Wah'kon-tah Prairie. The purpose of the captive population is to provide stock for reintroductions in “suitable areas” within the species' historical range, in accordance with recovery action 7.2 of the American Burying Beetle Recovery Plan (USFWS 1991, p. 52).
        We have not designated critical habitat for the ABB. Section 10(j)(2)(C)(ii) of the Act states that critical habitat shall not be designated for any experimental population that is determined to be nonessential. Accordingly, we cannot designate critical habitat in areas where we establish an NEP.
        Biological Information
        The ABB is the largest member of the family Silphidae in North America, and the largest among a guild of species that breed and rear their young on vertebrate carcasses. Because carrion is a scarce and ephemeral resource, ABBs must traverse large areas in search of it. By necessity, they are strong flyers capable of covering several miles overnight. The farthest recorded dispersal in a year for reintroduced ABBs is 3 miles (4.8km) (McKenna-Foster et al. 2007, p. 9). Data from the Nantucket reintroduction show that the farthest dispersal in one season was 3 miles (4.8 km) (McKenna-Foster et al. 2007, p. 9). Data from Nebraska indicate that the vast majority (92 percent) of ABB were recaptured within 0.6 miles (1 km) of their initial capture within the same season (Bedick et al. 1999, p. 176). After ABBs find an appropriate-sized carcass, a pair of beetles cooperatively buries and prepares the carcass by removing its fur or feathers and coating it with antibacterial secretions. These activities require soil excavation, consequently soils must be conducive for excavation and plant roots systems must not hinder excavation. Reproductive habitat activities also require soil that is appropriately moist. Both parents may remain to feed the larva with regurgitated meat until they are capable of feeding themselves. After pupation, new adults emerge within 30-45 days. ABBs are generally considered univoltine (having one brood or generation per year) in the wild, with a life span of about 12 months. They are a habitat generalist with regards to vegetation, and will eat all classes of vertebrate carcasses (USFWS 2008, pp. 8, 11).
        The ABB's historical range included 35 States and three Canadian provinces in the eastern temperate areas of North America (USFWS 1991, p. 4). At the time of listing, only two ABB populations were known, one on Block Island, Rhode Island, and one in Latimer County, Oklahoma. Subsequent monitoring in other States documented additional populations in Arkansas, Nebraska, Texas, South Dakota, and Kansas (USFWS 2008, p. 16). The population on Block Island is the only naturally occurring population east of the Mississippi River. The ABB also occurs in captive-breeding populations. Currently, captive populations are maintained at the Roger Williams Park Zoo in Providence, Rhode Island; St. Louis Zoo in St. Louis, Missouri; The Wilds in Ohio; and the Cincinnati Zoo in Cincinnati, Ohio.
        The reasons for the decline of the ABB during the 1900s are still unknown. Many hypotheses for the decline have been suggested, such as the widespread use of dichloro-diphenyl-trichloroethane (DDT) and other pesticides, habitat loss and fragmentation, decrease in the availability of carrion, increased use of artificial lighting, an unidentified pathogen, increase in competition from vertebrate scavengers, and an increase in competition from other carrion insects (Sikes and Raithel 2002, pp. 104-109). Confounding most of these hypotheses is the historical and continued presence of other Nicrophorus species. The pattern of disappearance from the center of the population to the eastern and western edges of its range is also difficult to explain.
        Predation is not believed to be an important mortality factor for the ABB, although interaction with fire ants, whether through competition or predation, is thought to adversely affect ABB populations. Disease is not known to be a factor in the decline of the ABB, but knowledge of diseases of insects is in its infancy (USFWS 2008, p. 31). Competition for carrion by scavengers is thought to be an important factor in the decline of ABB (Sikes and Raithel 2002, p. 111). Competition with ants, flies, and vertebrate scavengers, as well as other species of burying beetles, can be limiting factors for ABBs (Sikes and Raithel 2002, p. 111). Weather extremes, such as drought, wildfire, hurricanes, and ice storms may affect the viability of existing populations (USFWS 2008, p. 33).
        Recovery Efforts
        Restoring an endangered or threatened species to the point where it is recovered is a primary goal of our endangered species program. The ABB recovery plan was developed within 2 years of the listing of the species and reflects the best information available at that time. The recovery objectives of the 1991 plan are to (1) “reduce the immediacy of the threat of extinction * * *” and (2) “improve its status so that it can be reclassified from endangered to threatened.” The recovery plan did not include delisting criteria, however, criteria for the reclassification are:
        (a) Three populations of N. americanus have been reestablished (or additional populations discovered) within each of four broad geographical areas of its historical range: The Northeast, the Southeast, the Midwest, and the Great Lakes States;
        (b) Each population contains a minimum of 500 adults as estimated by capture rates per trap night and black lighting effort; and
        (c) Each population is demonstrably self-sustaining for at least 5 consecutive years (or is sustainable with established long-term management programs) (USFWS 1991, pp. 31-32).
        The 1991 Recovery Plan considers conducting additional reintroductions a top priority (Priority 1) (USFWS 1991, p. 63). The first reintroduction site for the ABB was Penikese Island, Massachusetts, in 1990. After ABBs were released on Penikese for 4 years, the population persisted there for about 8 years (until 2002). No ABBs were subsequently found there during modest trapping efforts from 2003 to 2006. Nantucket Island was the next ABB reintroduction site, which was initiated in 1994. Release of ABBs ended in 2006, and the population has persisted. Since 1998, there have been sporadic efforts to reintroduce a population in Ohio, but ABBs have yet to be recaptured after overwintering (USFWS 2008, p. 5).
        Reestablishment Area
        Historically, the ABB was recorded in 13 counties throughout Missouri, and was most likely found throughout the State. The last documented ABB occurrence in the State was collected in a light-trap from Newton County (southwest Missouri) in the mid 1970s (Simpson 1991, p. 1). Monitoring for existing ABB populations has been ongoing in Missouri since 1991. A concerted monitoring effort has been conducted by the St. Louis Zoo since 2002, and monitoring began on Wah'kon-tah Prairie in 2004. During the period 2002-2009, researchers monitored 49 sites from 25 counties in Missouri for ABB (Merz 2009, p. 8). No ABBs were observed or collected in any of the sites surveyed in Missouri since the 1970s.

        The proposed reintroduction site, Wah'kon-tah Prairie, is a 3,030-acre (1,226-hectares) site jointly owned and managed by the Missouri Department of Conservation (MDC) and The Nature Conservancy (TNC). It is a designated special focus area, where TNC is working to restore a greater prairie chicken (Tympanuchus cupido) population and native tallgrass prairie. Wah'kon-tah Prairie straddles the border of St. Clair and Cedar Counties, and is very close to Bates and Vernon Counties, all within southwestern Missouri. The area within these four counties, 2,885 square miles (7,472 square kilometers (km)), is the proposed area for the nonessential experimental population (NEP). The minimum distance from the reintroduction site to outside of the designated experimental population boundary is 17 miles (27 km); the greatest distance is 52 miles (84 km). This NEP area was selected because of the proximity to the last recorded ABB sighting in Missouri, the quantity of recent ABB monitoring, and the relative abundance of carrion (Hamilton and Merz 2010, pp. 4-5).

        According to the St. Louis Zoo's American Burying Beetle Activity Summary in 2009, 12 sites within the proposed NEP area were monitored for carrion beetles (Jean et. al. 2009, p. 1). Five of these sites were on Wah'Kon-Tah Prairie, one of which was sampled for 66 days throughout the season. The pitfall traps within the proposed NEP area collected 46,522 individuals: Of which 86 percent were other species of the beetle family Silphidae (to which the ABB belongs); the remainder were other insects and spiders. No ABBs were found (Jean et. al. 2009, p. 1).

        Section 10(j) of the Act requires that an experimental population be wholly separate geographically from other wild populations of the same species. Because there are no known populations of ABB in Missouri, and there are no records of ABB in the bordering counties of eastern Kansas, this proposed NEP is geographically separate from all other known ABB populations. Based on the movement data of other ABB populations, we do not believe the reintroduced ABBs will move beyond the designated NEP area. If monitoring shows that the reintroduced ABB are moving toward a border of the NEP, we will seek to amend the NEP boundaries, after monitoring the possible new NEP areas.
        Release Procedures

        Captive-bred beetles from St. Louis Zoo, wild beetles from Ft. Chaffee, or both will be brought to the release site in late spring by representatives of the St. Louis Zoo or the Service. ABBs will be paired 24 hours in advance of release. These beetles will be marked by clipping the elytra (the modified forewings that encase the thin hind wings used in flight) to distinguish between captive-bred and wild beetles, and between the release transects. For the release, a soil plug is dug and removed, and paired ABBs are provisioned with a 120-200 gram (4-7 ounce) carcass and placed into the hole. The soil plug is then placed back over the hole and a wire screen stapled over the area to keep out scavenging animals and birds. These holes will be dug in several lines, or transects. The number of transects will be determined by the number of beetles available, and apportioned in equal numbers (Hamilton and Merz 2010, p. 7). The ABB Reintroduction Plan contains additional information on the release procedures and monitoring protocols (see FOR FURTHER INFORMATION CONTACT for copies of this document or go to http://www.regulations.gov at Docket No. FWS-R3-ES-2011-03034).
        Status of Proposed Population
        If this proposal is adopted, we would ensure, through our section 10 permitting authority and the section 7 consultation process, that the use of ABBs from the donor population at Ft. Chaffee, Arkansas, for releases into Wah'kon-tah Prairie is not likely to jeopardize the continued existence of the species in the wild. These donor populations are closely monitored by the Service, and over-collection would not be permitted. Establishing additional ABB populations within the species' historical range is an important step in recovery (USFWS 1991, p. 52).
        The special rule that accompanies this section 10(j) rule is designed to broadly exempt from the section 9 take prohibitions any take of ABBs that is accidental and incidental to otherwise lawful activities. We provide this exemption because we believe that such incidental take of members of the NEP associated with otherwise lawful activities is necessary and advisable for the conservation of the species, as activities that currently occur or are anticipated in the NEP area, such as haying, grazing, and occasional burning of pastures, are generally compatible with ABB recovery.
        This designation is justified because no adverse effects to extant wild or captive ABB populations will result from release of progeny from the captive flock. We also expect that the reintroduction effort into Missouri will result in the successful establishment of a self-sustaining population, which will contribute to the recovery of the species.
        Management
        Management issues related to the ABB NEP that have been considered include:
        (a) Mortality: The regulations implementing the Act define “incidental take” as take that is incidental to, and not the purpose of, carrying out an otherwise lawful activity (50 CFR 17.3), such as agricultural activities and other rural development, and other activities that are in accordance with Federal, Tribal, State, and local laws and regulations. If this 10(j) rule is finalized, incidental take of the ABB within the NEP area would not be prohibited, provided that the take is unintentional and is in accordance with the special rule that is a part of this 10(j) rule. However, if there is evidence of intentional take of an ABB within the NEP that is not authorized by the special rule, we would refer the matter to the appropriate law enforcement entities for investigation.
        (b) Special handling: In accordance with 50 CFR 17.21(c)(3), any employee or agent of the Service, any other Federal land management agency, or State personnel, designated for such purposes, may in the course of their official duties, handle ABBs to aid sick or injured ABBs, or to salvage dead ABBs. However, non-Service personnel and their agents would need to acquire permits from the Service for these activities.
        (c) Coordination with landowners and land managers: Through informal meetings, the Service and cooperators have identified issues and concerns associated with the proposed ABB population establishment. The proposed population establishment was discussed with potentially affected State agencies and private landowners. Affected State agencies, landowners, and land managers have either indicated support for, or no opposition to, the proposed population establishment, provided an NEP is designated and a special rule is promulgated to exempt incidental take from the section 9 take prohibitions.
        (d) Monitoring: If this proposal is finalized and the reintroduction takes place, we would implement several monitoring strategies. Surveys conducted prior to releasing the ABBs will assess the over-wintering population from the prior year's release. During reintroduction, carcasses will be exhumed 10-12 days after burial to determine breeding success and the number of third instar (a developmental stage in insects representing their third molt) larvae present. This should provide a close estimate of the number of offspring produced in that first generation.
        During the period from June through August, each reintroduction site will be surveyed for at least three nights in duration. In addition to sampling at the release site(s), surrounding areas will be sampled in four directions, approximately 1 mile (1.6 km) away, for at least three consecutive nights. Monitoring at the release sites and 1 mile (1.6 km) distant should detect the majority of the released beetles. Monitoring using pitfall trap surveys in the subsequent early summer and fall following release will provide an estimate of breeding pair productivity by collecting young adults following emergence. This will also allow for an estimate of overwinter survival of progeny. Beetles captured in the late summer and fall will be paired, provisioned with a carcass, and held until all pairs can be reintroduced back to the original release sites. We intend to reintroduce at least 50 pair each year for 5 years, or until data suggest a viable population of more than 1,000 individuals has been established. At year five, the cooperators will evaluate the project's successes and failures and make adjustments to the ABB reintroduction project, if necessary.
        (e) Public awareness and cooperation: Public outreach for the ABB reintroduction project will be conducted in the spring of 2011, concurrent with the public comment period for the proposed rule. The State conservation department has conducted preliminary discussions with landowners in the NEP area, and the majority of the responses were positive. As part of the proposal process, we plan to conduct a public meeting in El Dorado Springs, Missouri, which is close to the reintroduction site. Additionally, we will distribute press releases to local media, announce the meeting and proposed rule in local newspapers, and post information on the Service's Web site (http://www.fws.gov/midwest/endangered) and a Web site hosted by the St. Louis Zoo (http://www.stlzoo.org/wildcareinstitute/centerforamericanburyingbe/americanburyingbeetlerecov.htm).
        Fact sheets on the species and the proposed project were distributed to the local conservation department office and to some of the landowners neighboring the NEP area. Those materials will be distributed more widely upon publication of this proposal.
        Peer Review
        In accordance with our policy on peer review, published on July 1, 1994 (59 FR 34270), we will provide copies of this proposed rule to three or more appropriate and independent specialists in order to solicit comments on the scientific data and assumptions relating to the supportive biological and ecological information for this proposed NEP designation. The purpose of such review is to ensure that the proposed NEP designation is based on the best scientific information available. We will invite these peer reviewers to comment during the public comment period and will consider their comments and information on this proposed rule during preparation of a final determination.
        Required Determinations
        Regulatory Planning and Review (E.O. 12866)
        The Office of Management and Budget (OMB) has determined that this proposed rule is not significant and has not reviewed this proposed rule under Executive Order 12866 (E.O. 12866). OMB bases its determination on the following four criteria:
        (a) Whether the proposed rule will have an annual effect of $100 million or more on the economy or adversely affect an economic sector, productivity, jobs, the environment, or other units of the government.
        (b) Whether the proposed rule will create inconsistencies with other Federal agencies' actions.
        (c) Whether the proposed rule will materially affect entitlements, grants, user fees, loan programs, or the rights and obligations of their recipients.
        (d) Whether the proposed rule raises novel legal or policy issues.
        Regulatory Flexibility Act (5 U.S.C. 601 et seq.)

        Under the Regulatory Flexibility Act (as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996; 5 U.S.C. 601 et seq.), whenever a Federal agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare, and make available for public comment, a regulatory flexibility analysis that describes the effect of the rule on small entities (small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of an agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule will not have a significant economic impact on a substantial number of small entities. We are certifying that this rule will not have a significant economic effect on a substantial number of small entities. The following discussion explains our rationale.
        The area that would be affected if this proposed rule is adopted includes the release areas at Wah'kon-tah Prairie and adjacent areas into which ABBs may disperse, which over time could include significant portions of the NEP. Because of the regulatory flexibility for Federal agency actions provided by the NEP designation and the exemption for incidental take in the special rule, we do not expect this rule to have significant effects on any activities within Federal, State, or private lands within the NEP. In regard to section 7(a)(2), the population is treated as proposed for listing, and Federal action agencies are not required to consult on their activities. Section 7(a)(4) requires Federal agencies to confer (rather than consult) with the Service on actions that are likely to jeopardize the continued existence of a proposed species. However, because the NEP is, by definition, not essential to the survival of the species, conferring will likely never be required for the ABB populations within the NEP area. Furthermore, the results of a conference are advisory in nature and do not restrict agencies from carrying out, funding, or authorizing activities. In addition, section 7(a)(1) requires Federal agencies to use their authorities to carry out programs to further the conservation of listed species, which would apply on any lands within the NEP area. As a result, and in accordance with these regulations, some modifications to proposed Federal actions within the NEP area may occur to benefit the ABB, but we do not expect projects to be halted or substantially modified as a result of these regulations.
        If adopted, this proposal would broadly authorize incidental take of the ABB within the NEP area. The regulations implementing the Act define “incidental take” as take that is incidental to, and not the purpose of, the carrying out of an otherwise lawful activity such as, agricultural activities and other rural development, camping, hiking, hunting, vehicle use of roads and highways, and other activities in the NEP area that are in accordance with Federal, Tribal, State, and local laws and regulations. Intentional take for purposes other than authorized data collection or recovery purposes would not be permitted. Intentional take for research or recovery purposes would require a section 10(a)(1)(A) recovery permit under the Act.
        The principal activities on private property near the NEP area are agriculture, rural development, and recreation. We believe the presence of the ABB would not affect the use of lands for these purposes because there would be no new or additional economic or regulatory restrictions imposed upon States, non-Federal entities, or members of the public due to the presence of the ABB, and Federal agencies would only have to comply with sections 7(a)(1) and 7(a)(4) of the Act in these areas. Therefore, this rulemaking is not expected to have any significant adverse impacts to activities on private lands within the NEP area.
        Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq.)

        In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq.):

        (a) If adopted, this proposal will not “significantly or uniquely” affect small governments. We have determined and certify under the Unfunded Mandates Reform Act, 2 U.S.C. 1502 et seq., that this proposed rulemaking will not impose a cost of $100 million or more in any given year on local or State governments or private entities. A Small Government Agency Plan is not required. As explained above, small governments would not be affected because the proposed NEP designation will not place additional requirements on any city, county, or other local municipalities.

        (b) This rule will not produce a Federal mandate of $100 million or greater in any year (i.e., it is not a “significant regulatory action” under the Unfunded Mandates Reform Act). This proposed NEP designation for the ABB would not impose any additional management or protection requirements on the States or other entities.

        Takings (E.O. 12630)
        In accordance with Executive Order 12630, the proposed rule does not have significant takings implications. When populations of Federally listed species are designated as NEPs, the Act's regulatory requirements regarding those populations are significantly reduced. This reduction of regulatory burden allows landowners to continue using their lands in ways that may adversely impact the ABB, but are otherwise lawful. For example, this proposed rule would not prohibit the taking of ABBs in the NEP area when such take is incidental to an otherwise legal activity, such as agricultural activities and other rural development, camping, hiking, hunting, vehicle use of roads and highways, and other activities that are in accordance with Federal, State, Tribal, and local laws and regulations. Because of the substantial regulatory relief provided by the NEP designations, we do not believe the reestablishment of this species will conflict with existing or proposed human activities or hinder public use of lands within the NEP.
        A takings implication assessment is not required because this rule (1) Will not effectively compel a property owner to suffer a physical invasion of property and (2) will not deny all economically beneficial or productive use of the land or aquatic resources. This rule would substantially advance a legitimate government interest (conservation and recovery of a listed species) and would not present a barrier to all reasonable and expected beneficial use of private property.
        Federalism (E.O. 13132)
        In accordance with Executive Order 13132, we have considered whether this proposed rule has significant Federalism effects and have determined that a Federalism assessment is not required. This rule would not have substantial direct effects on the States, on the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government. In keeping with Department of the Interior policy, we requested information from and coordinated development of this proposed rule with the affected resource agencies in Missouri. Achieving the recovery goals for this species would contribute to its eventual delisting and its return to State management. No intrusion on State policy or administration is expected; roles or responsibilities of Federal or State governments would not change; and fiscal capacity would not be substantially directly affected. The special rule operates to maintain the existing relationship between the State and the Federal Government and is being undertaken in coordination with the State of Missouri. Therefore, this rule does not have significant Federalism effects or implications to warrant the preparation of a Federalism Assessment under the provisions of Executive Order 13132.
        Civil Justice Reform (E.O. 12988)
        In accordance with Executive Order 12988, the Office of the Solicitor has determined that this rule would not unduly burden the judicial system and would meet the requirements of sections (3)(a) and (3)(b)(2) of the Order.
        Government-to-Government Relationship With Tribes
        In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), Executive Order 13175, and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. We have determined that there are no Tribal lands affected by this rule.
        Paperwork Reduction Act

        Office of Management and Budget (OMB) regulations at 5 CFR 1320, which implement provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), require that Federal agencies obtain approval from OMB before collecting information from the public. This proposed rule does not contain any new information collections that require approval. OMB has approved our collection of information associated with reporting the taking of experimental populations (50 CFR 17.84) and assigned control number 1018-0095. We may not collect or sponsor, and you are not required to respond to, a collection of information unless it displays a currently valid OMB control number.
        National Environmental Policy Act
        The reintroduction of native species into suitable habitat within their historical or established range is categorically excluded from NEPA documentation requirements consistent with 40 CFR 1508.4, 516 DM 2.3A, 516 DM 2 Appendix 1, and 516 DM 8 Appendix 1.4.
        Energy Supply, Distribution or Use (E.O. 13211)
        Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. This rule is not expected to significantly affect energy supplies, distribution, and use. Because this action is not a significant energy action, no Statement of Energy Effects is required.
        Clarity of This Regulation (E.O. 12866)
        We are required by E.O. 12866, E.O. 12988, and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:
        (1) Be logically organized;
        (2) Use the active voice to address readers directly;
        (3) Use clear language rather than jargon;
        (4) Be divided into short sections and sentences; and
        (5) Use lists and tables wherever possible.

        If you feel that we have not met these requirements, send us comments by one of the methods listed in the ADDRESSES section. To better help us revise the rule, your comment should be as specific as possible. For example, you should tell us the numbers of the sections and paragraphs that are unclearly written, which sections or sentences are too long, or the sections where you feel lists and tables would be useful.
        References Cited

        A complete list of all references cited in this proposed rule is available at http://www.regulations.gov at Docket No. FWS-R3-ES-2011-0034.
        Authors

        The primary authors of this proposed rule are staff members of the Service's Columbia, Missouri, Ecological Services Field Office (see ADDRESSES and FOR FURTHER INFORMATION CONTACT).

          List of Subjects in 50 CFR Part 17
          Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements.

        Proposed Regulation Promulgation
        Accordingly, we propose to amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:

          PART 17—[AMENDED]
          1. The authority citation for part 17 continues to read as follows:

            Authority:
             16 U.S.C. 1361-1407; 16 U.S.C. 1531-1544; 16 U.S.C. 4201-4245; Pub. L. 99-625, 100 Stat. 3500; unless otherwise noted.

          2. Amend § 17.11(h) by revising the entry for “Beetle, American Burying” under “INSECTS” in the List of Endangered and Threatened Wildlife to read as follows:

            § 17.11
            Endangered and threatened wildlife.

            (h) * * *

                Species
                Common name
                Scientific name
                Historic range
                Vertebrate population where endangered or
                  threatened

                Status
                When listed

                Critical habitat
                Special rules

                *         *         *         *         *         *         *

                  Insects

                Beetle, American Burying

                  Nicrophorus americanus

                U.S.A. (eastern States south to FL, west to SD and TX), eastern Canada
                Entire, except where listed as an experimental population
                E
                351

                NA

                Beetle, American Burying

                  Nicrophorus americanus

                U.S.A. (eastern States south to FL, west to SD and TX), eastern Canada
                In southwestern Missouri, the counties of Cedar, St. Clair, Bates, and Vernon
                XN

                NA
                17.85(c)

                *         *         *         *         *         *         *

            3. Amend § 17.85 by adding paragraph (c) to read as follows:

            § 17.85
            Special rules—invertebrates.

            (c) American Burying Beetle (Nicrophorus americanus).
            (1) Where is the American burying beetle designated as a nonessential experimental population (NEP)?

            (i) The NEP area for the American burying beetle is within the species' historical range and is defined as follows: the Missouri Counties of Cedar, St. Clair, Bates, and Vernon.
            (ii) The American burying beetle is not known to currently exist in Cedar, St. Clair, Bates, or Vernon Counties in Missouri. Based on its habitat requirements and movement patterns, we do not expect this species to become established outside this NEP area. However, if individuals of this population move outside the designated NEP area, we would presume that they came from the reintroduced population. We would then amend this regulation to enlarge the boundaries of the NEP area to include the entire range of the expanded population.
            (iii) We will not change the NEP designations to “essential experimental,” “threatened,” or “endangered” within the NEP area without a public rulemaking. Additionally, we will not designate critical habitat for this NEP, as provided by 16 U.S.C. 1539(j)(2)(C)(ii).
            (2) What activities are not allowed in the NEP area?

            (i) You may not possess, sell, deliver, carry, transport, ship, import, or export by any means, American burying beetles, or parts thereof, that are taken or possessed in violation of paragraph (c)(3) of this section or in violation of the applicable State fish and wildlife laws or regulations or the Act.
            (ii) You may not attempt to commit, solicit another to commit, or cause to be committed any offense defined in paragraph (c)(2)(i) of this section.
            (3) What take is allowed in the NEP area? Take of this species that is accidental and incidental to an otherwise legal activity, such as agriculture, forestry and wildlife management, land development, recreation, and other activities, is allowed.
            (4) How will the effectiveness of these reintroductions be monitored? We will prepare periodic progress reports and fully evaluate these reintroduction efforts after 5 years to determine whether to continue or terminate the reintroduction efforts.
            (5) Note: Map of the NEP area for the American burying beetle follows:

              EP22JY11.011

            Dated: July 11, 2011.
            Gregory E. Siekaniec,
            Acting Director, Fish and Wildlife Service.

      [FR Doc. 2011-18561 Filed 7-21-11; 8:45 am]
      BILLING CODE 4310-55-P


        DEPARTMENT OF TRANSPORTATION
        National Highway Traffic Safety Administration
        49 CFR Part 571
        [Docket No. NHTSA-2020-0109]
        RIN 2127-AM04
        Federal Motor Vehicle Safety Standards; Test Procedures; Reopening of Comment Period

          AGENCY:
          National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).

          ACTION:
          Reopening of comment period.

          SUMMARY:

          In response to a request from the Alliance for Automotive Innovation (Auto Innovators), NHTSA is announcing a reopening of the comment period on an advance notice of proposed rulemaking (ANPRM) published December 10, 2020. The ANPRM requests public comment on whether any test procedure for any Federal Motor Vehicle Safety Standard (FMVSS) may be a candidate for replacement, repeal, or modification, for reasons other than for considerations relevant only to automated driving systems (ADS). The comment period for the ANPRM was originally scheduled to end on February 8, 2021. It will now be reopened and will end on April 9, 2021.

          DATES:
          The comment period for the ANPRM published on December 10, 2020 at 85 FR 79456 is reopened and extended to April 9, 2021.

          ADDRESSES:
          Comments must be submitted by one of the following methods:
          • Federal eRulemaking Portal: go to http://www.regulations.gov. Follow the online instructions for submitting comments.
          • Mail: Docket Management Facility, M-30, U.S. Department of Transportation, West Building, Ground Floor, Rm. W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
          • Hand Delivery or Courier: West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, between 9 a.m. and 5 p.m. Eastern Time, Monday through Friday, except Federal holidays. To be sure someone is there to help you, please call (202) 366-9322 before coming.
          • Fax: (202) 493-2251.
          Regardless of how you submit your comments, you must include the docket number identified in the heading of this document.

          Note that all comments received, including any personal information provided, will be posted without change to http://www.regulations.gov. Please see the “Privacy Act” heading below.

          You may call the Docket Management Facility at (202) 366-9322. For access to the docket to read background documents or comments received, go to http://www.regulations.gov or the street address listed above. We will continue to file relevant information in the docket as it becomes available. To be sure someone is there to help you, please call (202) 366-9322 before coming. We will continue to file relevant information in the Docket as it becomes available.

            Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to inform its decision-making process. DOT posts these comments, without edit, including any personal information the commenter provides, to http://www.regulations.gov, as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78).

          FOR FURTHER INFORMATION CONTACT:

          For technical issues, you may contact Ms. Mary Versailles, Office of Rulemaking, 1200 New Jersey Avenue SE, Washington, DC 20590; mary.versailles@dot.gov. For legal issues, you may contact Ms. Callie Roach, Attorney-Advisor, Vehicle Rulemaking and Harmonization, Office of Chief Counsel, (202) 597-1312, 1200 New Jersey Avenue SE, Washington, DC 20590; callie.roach@dot.gov.

        SUPPLEMENTARY INFORMATION:
        On December 10, 2020, NHTSA published an ANPRM to obtain public comments on whether any test procedure for any FMVSS may be a candidate for replacement, repeal, or modification, for reasons other than for considerations relevant only to automated driving systems (ADS) (85 FR 79456). The ANPRM provided examples of test procedures found in FMVSS Nos. 103, 104, 105/135, 121, and 126 to facilitate responses and asked commenters to consider whether the agency should make changes to these test procedures or to any other test procedure. The ANPRM also asked commenters to provide research, evidence, and data to support why such change may be necessary. The ANPRM stated that the closing date for comments was February 8, 2021.
        NHTSA received on January 14, 2021 a petition from Auto Innovators for a 30-day extension of the comment period. The request states that additional time is necessary to permit Auto Innovators to conduct a comprehensive review of the extensive number of regulations and FMVSS that contain detailed test procedures, including standards that reference industry standards. Auto Innovators also notes that its efforts to organize group meeting have been hampered by working inefficiencies induced by COVID meeting restrictions. The request can be found in the docket for the ANPRM identified in the heading of this document.

        In accordance with NHTSA's rulemaking procedures in 49 CFR part 553, subpart B, the agency is granting this request to reopen and extend the comment period. We have determined that the requestors have shown good cause for an extension, and that the extension is consistent with the public interest (49 CFR 553.19). A 30-day reopening and extension appropriately balances NHTSA's interest in providing the public with sufficient time to comment on the notice with its interest in proceeding with this rulemaking in a timely manner. Accordingly, NHTSA is reopening and extending the comment period to the date shown in the DATES section of this document.

          Issued in Washington, DC pursuant to authority delegated in 49 CFR 1.95 and 501.8.
          Raymond R. Posten,
          Associate Administrator for Rulemaking.

      [FR Doc. 2021-04933 Filed 3-9-21; 8:45 am]
      BILLING CODE 4910-59-P


        ENVIRONMENTAL PROTECTION AGENCY
        40 CFR Part 180
        [EPA-HQ-OPP-2008-0647; FRL-8382-4]
        Chlorantraniliprole; Proposed Time-Limited Pesticide Tolerance

          AGENCY:
          Environmental Protection Agency (EPA).

          ACTION:
          Proposed rule.

          SUMMARY:
          This document proposes to establish time-limited tolerances for residues of chlorantraniliprole in or on cowpeas, forage and hay; field peas, vines and hay; forage, fodder and straw of cereal grains, crop group 16; grass forage, fodder and hay, crop group 17; leaves of root and tuber vegetables, crop group 2, leeks, nongrass animal feeds (forage, fodder, straw and hay), crop group 18; okra; onions, green; onions, Welsh; peanuts, hay; shallots; soybeans, forage and hay; strawberries and sugarcane, sugar under the Federal Food, Drug, and Cosmetic Act (FFDCA). The tolerances expire on April 25, 2010.

          DATES:
          Comments must be received on or before December 1, 2008.

          ADDRESSES:
          Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2008-0647, 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.

            Instructions: Direct your comments to docket ID number EPA-HQ-OPP-2008-0647. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

            Docket: All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.

          FOR FURTHER INFORMATION CONTACT:

          Kable Bo Davis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave, NW., Washington, DC 20460-0001; telephone number: (703) 306-0415; e-mail address: davis.kable@epa.gov.

        SUPPLEMENTARY INFORMATION:
        I. General Information
        A. Does this Action Apply to Me?
        You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:
        •  Crop production (NAICS code 111).
        • Animal production (NAICS code 112).
        • Food manufacturing (NAICS code 311).
        • Pesticide manufacturing (NAICS code 32532).

        This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.
        B. What Should I Consider as I Prepare My Comments for EPA?
        1.  Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
        2.  Tips for preparing your comments. When submitting comments, remember to:

        i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).
         ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
        iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
        iv. Describe any assumptions and provide any technical information and/or data that you used.
        v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
        vi. Provide specific examples to illustrate your concerns and suggest alternatives.
        vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
        viii. Make sure to submit your comments by the comment period deadline identified.
        II. Background and Statutory Findings

        EPA on its own initiative, under section 408(e) of FFDCA, 21 U.S.C. 346a(e), is proposing to establish a tolerances for residues of the insecticide chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, in or on cowpeas, forage and hay at 0.20 parts per million (ppm); field peas, vines and hay at 0.20 ppm; forage, fodder and straw of cereal grains, crop group 16 at 0.20 ppm, grass forage, fodder and hay, crop group 17 at 0.20 ppm; leaves of root and tuber vegetables, crop group 2 at 0.20 ppm; leeks at 0.20 ppm; nongrass animal feeds (forage, fodder, straw and hay), crop group 18 at 0.20 ppm; okra at 0.70 ppm; onions, green at 0.20 ppm; onions, Welsh at 0.20 ppm; peanuts, hay at 0.20 ppm; shallots at 0.20 ppm; soybeans, forage and hay at 0.20 ppm; strawberries at 1.2 ppm; and sugarcane, sugar at 0.20 ppm.
        Recently, EPA established tolerances for chlorantraniliprole on apple, wet pomace; brassica, head and stem, subgroup 5A; brassica, leafy greens, subgroup 5B; cotton, gin byproduct; cotton, hulls; cotton undelinted seed; fruit, pome, group 11; fruit, stone, group 12; grape; grape, raisen; potato; vegetable, cucurbit, group 9; vegetable, fruiting, group 8; vegetable, leafy, except brassica, group 4; milk; meat; meat byproduct and fat. At that time EPA determined rotational crop tolerances were required, and that the petitioner needed to conduct extensive field rotational crop trials. The Agency concluded that until the requested data are submitted, a restriction should be imposed on labels prohibiting the rotation to any crop not on the label. In response, the registrant submitted proposals for the establishment of tolerances for inadvertent residues for a number of crops pending submission of the requested data. After considering the registrant's submission, EPA is now proposing time-limited tolerances to address rotated crops.

        EPA has decided to propose time-limited rotational crop tolerances for chlorantraniliprole. Rotational crop trials (2003, 2004, 2005) were conducted in Canada and the United States on leafy vegetables (Swiss chard, lettuce, spinach), root vegetables (radish, beet, turnip), cereal grains (wheat, oat) and soybean. Based on the data on chlorantraniliprole, the Agency believes that the residue data would not underestimate residues on rotated crops. Thus the Agency believes that the 0.20 ppm tolerances on rotational crops are appropriate and protective. EPA also determined that adding these proposed tolerances would not change its prior safety finding for chlorantraniliprole. EPA's updated risk assessment can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0647.
        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. . . . ”

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

        Consistent with 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, consistent with section 408(b)(2) of FFDCA, for a tolerance for residues of chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, in or on cowpeas, forage and hay at 0.20 ppm; field peas, vines and hay at 0.20 ppm; forage, fodder and straw of cereal grains, crop group 16 at 0.20 ppm, grass forage, fodder and hay, crop group 17 at 0.20 ppm; leaves of root and tuber vegetables, crop group 2 at 0.20 ppm; leeks at 0.20 ppm; nongrass animal feeds (forage, fodder, straw and hay), crop group 18 at 0.20 ppm; okra at 0.70 ppm; onions, green at 0.20 ppm; onions, Welsh at 0.20 ppm; peanuts, hay at 0.20 ppm; shallots at 0.20 ppm; soybeans, forage and hay at 0.20 ppm; strawberries at 1.20 ppm; and sugarcane, sugar at 0.20 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows:
        A. Toxicological Profile
        EPA has evaluated the available toxicity data and considered 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.

        Chlorantraniliprole has no significant acute toxicity via the oral, dermal, and inhalation routes of exposure. This substance is not an eye or skin irritant and does not cause skin sensitization. In short-term studies, the most consistent effects are those associated with non adverse pharmacological response to the xenobiotic, induction of liver enzymes and subsequent increase in liver weights. Chlorantraniliprole is not genotoxic, neurotoxic, immunotoxic, carcinogenic, or teratogenic. Furthermore, it is not uniquely toxic to the conceptus as there were no maternal or fetal effects in studies conducted in rats and rabbits. Based on the results of a 28-day dermal study in rats, as well as the dermal LD50 study, chlorantraniliprole has relatively low dermal toxicity.

        Overall, chlorantraniliprole exhibits minimal mammalian toxicity after long-term exposure. The only consistent observation in the mammalian toxicology studies is an increased degree of microvesiculation of the adrenal cortex after dermal or dietary administration of chlorantraniliprole. Based on the lack of adverse effect on the function of the adrenal gland, this observation was considered treatment related, but not “adverse.”In addition to the adrenal effects, liver effects (e.g., increased liver weight and induction of cytochrome P450 enzymes) were reported in the 90-day oral subchronic studies across species and only at the highest dose tested (HDT) >1,000 milligram/kilogram/day (mg/kg/day). While in the subchronic studies, these effects were considered adaptive, the liver effects were more pronounced in the 18-month chronic mouse study at the HDT. Increased eosinophilic foci (preneoplastic foci) were noted in male mice at 935 mg/kg/day and liver hypertrophy and weight increase were evident at the next lower dose (158 mg/kg/day), but progression to tumors was not apparent for these effects. Therefore, the eosinophilic foci appear to be an adverse effect only seen in the HDT and was graded minimal in severity.

        Specific information on the studies received and the nature of the toxic effects caused by chlorantraniliprole as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov. The referenced document is available in the docket established by this action, which is described under ADDRESSES, and is identified as EPA-HQ-OPP-2007-0275 in that docket.
        B. Toxicological Endpoints

        For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern (LOC) is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the LOC to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. Short-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded.

        For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.

        A summary of the toxicological endpoints for chlorantraniliprole used for human risk assessment can be found at http://www.regulations.gov in document Chlorantraniliprole (DPX-E2Y45): Human Health Risk Assessment for Proposed Uses on pome fruit, stone fruit, leafy vegetables, brassica leafy vegetables, cucurbit vegetables, fruiting vegetables, cotton, grapes, potatoes, rice, turf and ornamentals pages 22-24 in docket ID number EPA-HQ-OPP-2007-0275.
        C. Exposure Assessment
        1. Dietary exposure from food and feed uses. In evaluating dietary exposure to chlorantraniliprole, EPA considered exposure under the petitioned-for tolerances as well as all existing chlorantraniliprole tolerances in (40 CFR 180.628). EPA assessed dietary exposures from chlorantraniliprole 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 chlorantraniliprole; 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 United States Department of Agriculture (USDA) 1994-1996 and 1998 CSFII. As to residue levels in food, EPA assumed all foods for which there are tolerances were treated and contain tolerance-level residues.
        The inclusion of additional livestock feeds such as forage, fodder and straw from cowpea, field pea, soybean, cereal grains, nongrass animal feeds or peanut does not increase the livestock dietary burdens and thus the meat and milk tolerances. While the addition of strawberries, sugarcane, leek, onions, shallot, and okra that are considered human food results in a miniscule increase in exposure, a DEEM analysis that incorporates all the new commodities does not change the risk outcome which remains at 1% of the cPAD for the most highly exposed population, children ages 1-2. In addition, the dietary exposure from leeks, onions and shallots is negligible.
        iii. Cancer. Because chlorantraniliprole has been classified as a “not likely human carcinogen”, a quantitative exposure assessment relative to cancer risk is not necessary.
        2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for chlorantraniliprole in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the environmental fate characteristics of chlorantraniliprole. 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 environmental concentrations (EECs) of chlorantraniliprole for acute exposures are estimated to be 26.862 parts per billion (ppb) for surface water and 1.06 ppb for ground water. The EECs for chronic exposures are estimated to be 3.650 ppb for surface water and 1.06 ppb for ground water.
        Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. Because no acute hazard, attributable to a single dose, was identified; acute dietary risk was not assessed. For chronic dietary risk assessment, the water concentration value 3.650 ppb was used to access 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).
        Chlorantraniliprole is registered for use on the following residential non-dietary sites: Turfgrass and ornamental plants. Although residential exposure could occur, due to the lack of toxicity identified for short-term and intermediate-term durations via the relevant routes of exposure, no risk is expected from these exposures.

        Additional information on residential exposure assumptions can be found at www.regulations.gov (Docket ID EPA-HQ-OPP-2007-0275, pages 36 through 37).
        4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

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

        D. Safety Factor for Infants and Children
        1. In general. Section 408 of FFDCA provides that EPA shall apply an additional (10X) tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional UFs and/or special FQPA safety factors, as appropriate.
        2. Prenatal and postnatal sensitivity. There were no effects on fetal growth or postnatal development up to the limit dose of 1,000 mg/kg/day in rats or rabbits in the developmental or 2-generation reproduction studies. Additionally, there were no treatment related effects on the numbers of litters, fetuses (live or dead), resorptions, sex ratio, or post-implantation loss and no effects on fetal body weights, skeletal ossification, and external, visceral, or skeletal malformations or variations.
        3. Conclusion. EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings:
        i. The toxicology database for chlorantraniliprole is complete for the purposes of this risk assessment and the characterization of potential prenatal and postnatal risks to infants and children.
        ii. No susceptibility was identified in the toxicological database, and there are no residual uncertainties re: prenatal and/or postnatal exposure.
        iii. There are no treatment-related neurotoxic findings in the acute and subchronic oral neurotoxicity studies in rats.
        iv. The exposure assessment is protective: The dietary food exposure assessment utilizes tolerance level residues and 100 percent crop treated (PCT) information for all commodities. The submitted field rotational crop studies do not match those recommended in the guidelines. However, data from confined rotational crop studies and field rotational crop studies show that uptake of chlorantraniliprole is below the quantification level in roots and grains, and range of 0.01 to 0.15 ppm in tops of root vegetables and forage, fodder and straw of cereal grains and soybean. The 0.20 ppm tolerances based on the collective data should be conservative. Also, the tolerances on rotational crops strawberry and okra are conservative since the strawberry tolerance is based on residues in grape from direct application of chlorantraniliprole and the okra tolerance is based on residues resulting from direct treatment on tomato and pepper. An exposure assessment using conservative residue values is expected to be protective.
        The drinking water assessment utilizes values generated by models and associated modeling parameters which are designed to provide conservative, health protective, high-end estimates of water concentrations. By using these screening-level exposure assessments, the chronic dietary (food and drinking water) risk is not underestimated.
        v. Although residential exposure is expected over the short- and possibly intermediate-term (via the dermal and/or incidental oral route), there is no hazard expected via these routes/durations, and therefore no risk for these scenarios.
        E. Aggregate Risks and Determination of Safety
        Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable UFs is not exceeded.
        1. Acute risk. No acute risk is expected because no acute hazard, attributable to a single dose, was identified.
        2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to chlorantraniliprole from food and water will utilize <1% of the cPAD for the population group children 1-2 years (the highest exposed subpopulation). Based the use pattern, chronic residential exposure to residues of chlorantraniliprole is not expected.
        3. Short-term/intermediate risk. Short-term aggregate and intermediate-term exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).
        There is potential for short-term and intermediate-term post-application dermal (adults and children) and incidental oral (children only) exposure to chlorantraniliprole. However, due to the lack of toxicity via dermal route, as well as the lack of toxicity over the acute, short-term and intermediate-term via the oral route - no risk is expected from these exposures. Inhalation exposure is not expected due to the low vapor pressure of chlorantraniliprole (so applied/deposited residues are not expected to volatilize into the air).
        4. Aggregate cancer risk for U.S. population. Chlorantraniliprole has been classified as a “not likely human carcinogen.” It is not expected to pose a cancer risk to humans.
        5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to chlorantraniliprole residues.
        IV. Other Considerations
        A. Analytical Enforcement Methodology

        Adequate enforcement methodology liquid chromatography/mass spectrometry (LC/MS) is 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.
        B. International Residue Limits
        There are no international residue limits that affect the Agency's recommendations at this time. There are no CODEX or Mexican maximum residue limits (MRLs) for chlorantraniliprole that exists at this time.
        C. Conditions
        Tolerances may be made permanent following submission of rotational crop residue data suitable for establishing tolerances.
        V. Conclusion

        Time-limited tolerances are proposed for residues of chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, in or on cowpea, forage and hay at 0.20 ppm; field pea, vines and hay at 0.20 ppm; forage, fodder and straw of cereal grains, crop group 16 at 0.20 ppm, grass forage, fodder and hay, crop group 17 at 0.20 ppm; leaves of root and tuber vegetables, crop group 2 at 0.20 ppm; leek at 0.20 ppm; nongrass animal feeds (forage, fodder, straw and hay), crop group 18 at 0.20 ppm; okra at 0.70 ppm; onion, green at 0.20 ppm; onion, Welsh at 0.20 ppm; peanut, hay at 0.20 ppm; shallot at 0.20 ppm; soybean, forage and hay at 0.20 ppm; strawberries at 1.20 ppm; and sugarcane, sugar at 0.20 ppm.
        VI. Statutory and Executive Order Reviews

        This proposed rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this proposed rule has been exempted from review under Executive Order 12866 due to its lack of significance, this proposed 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). This proposed rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or 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). 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); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). 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 Agency hereby certifies, under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), that this proposed action will not have significant negative economic impact on a substantial number of small entities. A tolerance is one of the regulatory requirements needed for use of a pesticide and thus establishing a tolerance is expected to have no adverse economic impact. In addition, the Agency has determined that this action will not have a substantial direct effect on 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, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that 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.” This proposed rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this proposed rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000). Executive Order 3175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This proposed rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this proposed rule.

          List of Subjects in 40 CFR Part 180
          Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

          Dated: September 19, 2008.
          Donald R. Stubbs,
          Acting Director, Registration Division, Office of Pesticide Programs.

          Therefore, it is proposed that 40 CFR chapter I be amended as follows:

            PART 180—[AMENDED]
            1. The authority citation for part 180 continues to read as follows:

              Authority:
              21 U.S.C. 321(q), 346a and 371.

          2. Section 180.628 is amended by revising paragraph (d) to read as follows:

            § 180.628
            Chlorantraniliprole; tolerances for residues.

          (d) Indirect or inadvertent resisues. Time-limited tolerances are established for indirect or inadvertent residues of the insecticide chlorantraniliprole (3-bromo-N-[4-chloro-2-methyl-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide) in or on the following commodities. The tolerances will expire and are revoked on the dates specified in the following table.

              Commodity
              Parts per million
              Expiration/revocation date

              Animal feed, nongrass, group 18
              0.20
              4/25/10

              Cowpea, forage
              0.20
              4/25/10

              Cowpea, hay
              0.20
              4/25/10

              Field pea, hay
              0.20
              4/25/10

              Field pea, vine
              0.20
              4/25/10

              Grain, cereal, forage, fodder and straw, group 16
              0.20
              4/25/10

              Grass, forage, fodder and hay, group 17
              0.20
              4/25/10

              Leek
              0.20
              4/25/10

              Okra
              0.70
              4/25/10

              Onion, green
              0.20
              4/25/10

              Onion, Welsh
              0.20
              4/25/10

              Peanut, hay
              0.20
              4/25/10

              Shallot
              0.20
              4/25/10

              Soybean, forage
              0.20
              4/25/10

              Soybean, hay
              0.20
              4/25/10

              Strawberry
              1.20
              4/25/10

              Sugarcane
              0.20
              4/25/10

              Vegetable, leaves of root and tuber, group 2
              0.20
              4/25/10

      [FR Doc. E8-22946 Filed 9-30-08; 8:45 am]
      BILLING CODE 6560-50-S