I. Background

The Organic Foods Production Act of 1990 (OFPA), 7 U.S.C. 6501 et seq., authorizes the establishment of the National List of Allowed and Prohibited Substances (National List). The National List identifies synthetic substances that may be used in organic production and nonsynthetic (natural) substances that are prohibited in organic crop and livestock production. The National List also identifies nonagricultural nonsynthetic, nonagricultural synthetic and nonorganic agricultural substances that may be used in organic handling.

The exemptions and prohibitions granted under the OFPA are required to be reviewed every 5 years by the National Organic Standards Board (NOSB). The Secretary of Agriculture has authority under the OFPA to renew such exemptions and prohibitions. If they are not reviewed by the NOSB within 5 years of their inclusion on the National List and renewed by the Secretary, their authorized use or prohibition expires. This means that synthetic substances Hydrogen chloride (CAS # 7647-01-0) and Ferric phosphate (CAS # 10045-86-0), currently allowed for use in organic crop production, will no longer be allowed for use after the sunset date, September 12, 2011. This also means that Egg white lysozyme (CAS # 9001-63-2), L-Malic acid (CAS # 97-67-6), Microorganisms, Activated charcoal (CAS #s 7440-44-0; 64365-11-3), Cyclohexylamine (CAS # 108-91-8), Diethylaminoethanol (CAS # 100-37-8), Octadecylamine (CAS # 124-30-1), Peracetic acid/Peroxyacetic acid (CAS # 79-21-0), Sodium acid pyrophosphate (CAS # 7758-16-9), and Tetrasodium pyrophosphate (CAS # 7722-88-5), currently allowed for use in organic handling, will no longer be allowed for use after the sunset date, September 12, 2011.

This final rule reflects recommendations submitted to the Secretary by the NOSB concerning the continued use of 12 substances on the National List in organic production and handling. Consistent with the recommendations from the NOSB, this final rule renews 12 exemptions on the National List (along with any restrictive annotations).

Under the authority of the OFPA, as amended (7 U.S.C. 6501 et seq. ), the National List can be amended by the Secretary based on recommendations developed by the NOSB. Since established, the NOP has published fourteen amendments to the National List: October 31, 2003 (68 FR 61987); November 3, 2003 (68 FR 62215); October 21, 2005 (70 FR 61217); June 7, 2006 (71 FR 32803); September 11, 2006 (71 FR 53299); June 27, 2007 (72 FR 35137); October 16, 2007 (72 FR 58469); December 10, 2007 (72 FR 69569); December 12, 2007 (72 FR 70479); September 18, 2008 (73 FR 54057); October 9, 2008 (73 FR 59479); July 6, 2010 (75 FR 38693); August 24, 2010 (75 FR 51919); and December 13, 2010 (75 FR 77521). Additionally, proposed amendments to the National List were published on November 8, 2010 (75 FR 68505), and a final rule affirming a previous amendment was published on March 14, 2011 (76 FR 13504).

The following provides an overview of the renewals for designated sections of the National List regulations:

This final rule continues the exemptions at § 205.601, along with any restrictive annotations for the following synthetic substances allowed for use in organic crop production: Ferric phosphate (CAS # 10045-86-0); and Hydrogen chloride (CAS # 7647-01-0). This final rule continues the exemptions at § 205.605(a), along with any restrictive annotations, for the following nonsynthetic, nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients or food groups(s))”: Egg white lysozyme (CAS # 9001-63-2); L-Malic acid (CAS # 97-67-6); and Microorganisms. This final rule continues the exemptions at § 205.605(b), along with any restrictive annotations, for the following synthetic, nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients or food groups(s))”: Activated charcoal (CAS #s 7440-44-0; 64365-11-3); Cyclohexylamine (CAS # 108-91-8); Diethylaminoethanol (CAS # 100-37-8); Octadecylamine (CAS # 124-30-1); Peracetic acid/Peroxyacetic acid (CAS # 79-21-0); Sodium acid pyrophosphate (CAS # 7758-16-9); and Tetrasodium pyrophosphate (CAS # 7722-88-5).

The NOSB determined that a continuing need was demonstrated for the authorization of the 12 exemptions. In addition, most comments received on the proposed rule (76 FR 2880) supported renewal of all 12 exemptions. Accordingly, there are no nonrenewals.

One advanced notice of proposed rulemaking with request for comments was published in the Federal Register on March 14, 2008 (73 FR 13795), to make the public aware that the allowance for 12 synthetic and nonsynthetic substances in organic production and handling will expire, if not reviewed by the NOSB and renewed by the Secretary. The proposed rule for this final rule was published in the Federal Register on January 4, 2011 (76 FR 288).

The OFPA, as amended (7 U.S.C. 6501 et seq. ), authorizes the Secretary to make amendments to the National List based on proposed amendments developed by the NOSB. Sections 6518(k)(2) and 6518(n) of OFPA authorize the NOSB to develop proposed amendments to the National List for submission to the Secretary and establish a petition process by which persons may petition the NOSB for the purpose of having substances evaluated for inclusion on or deletion from the National List. The National List petition process is implemented under § 205.607 of the NOP regulations. The current petition process (72 FR 2167, January 18, 2007) can be accessed through the NOP Web site at http://www.ams.usda.gov/AMSv1.0/.

This action has been determined not significant for purposes of Executive Order 12866, and therefore, has not been reviewed by the Office of Management and Budget.

Executive Order 12988 instructs each executive agency to adhere to certain requirements in the development of new and revised regulations in order to avoid unduly burdening the court system. This final rule is not intended to have a retroactive effect.

States and local jurisdictions are preempted under the OFPA from creating programs of accreditation for private persons or State officials who want to become certifying agents of organic farms or handling operations. A governing State official would have to apply to USDA to be accredited as a certifying agent, as described in § 2115(b) of the OFPA (7 U.S.C. 6514(b)). States are also preempted under §§ 2104 through 2108 of the OFPA (7 U.S.C. 6503 through 6507) from creating certification programs to certify organic farms or handling operations unless the State programs have been submitted to, and approved by, the Secretary as meeting the requirements of the OFPA.

Pursuant to § 2108(b)(2) of the OFPA (7 U.S.C. 6507(b)(2)), a State organic certification program may contain additional requirements for the production and handling of organically produced agricultural products that are produced in the State and for the certification of organic farm and handling operations located within the State under certain circumstances. Such additional requirements must: (a) Further the purposes of the OFPA, (b) not be inconsistent with the OFPA, (c) not be discriminatory toward agricultural commodities organically produced in other States, and (d) not be effective until approved by the Secretary.

Pursuant to § 2120(f) of the OFPA (7 U.S.C. 6519(f)), this final rule would not alter the authority of the Secretary under the Federal Meat Inspection Act (21 U.S.C. 601 et seq. ), the Poultry Products Inspections Act (21 U.S.C. 451 et seq. ), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq. ), concerning meat, poultry, and egg products, nor any of the authorities of the Secretary of Health and Human Services under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq. ), nor the authority of the Administrator of EPA under the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136 et seq. ).

Section 2121 of the OFPA (7 U.S.C. 6520) provides for the Secretary to establish an expedited administrative appeals procedure under which persons may appeal an action of the Secretary, the applicable governing State official, or a certifying agent under this title that adversely affects such person or is inconsistent with the organic certification program established under this title. The OFPA also provides that the U.S. District Court for the district in which a person is located has jurisdiction to review the Secretary's decision.

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) requires agencies to consider the economic impact of each rule on small entities and evaluate alternatives that would accomplish the objectives of the rule without unduly burdening small entities or erecting barriers that would restrict their ability to compete in the market. The purpose is to fit regulatory actions to the scale of businesses subject to the action. Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities.

Pursuant to the requirements set forth in the RFA, the AMS performed an economic impact analysis on small entities in the final rule published in the Federal Register on December 21, 2000 (65 FR 80548). The AMS has also considered the economic impact of this action on small entities. The impact on entities affected by this final rule would not be significant. The effect of this final rule would be to allow the continued use of additional substances in agricultural production and handling. The AMS concludes that the economic impact of this addition of allowed substances, if any, would be minimal and beneficial to small agricultural service firms. Accordingly, USDA certifies that this rule will not have a significant economic impact on a substantial number of small entities.

Small agricultural service firms, which include producers, handlers, and accredited certifying agents, have been defined by the Small Business Administration (SBA) (13 CFR 121.201) as those having annual receipts of less than $7,000,000 and small agricultural producers are defined as those having annual receipts of less than $750,000.

According to USDA, Economic Research Service (ERS) data based on information from USDA-accredited certifying agents, the number of certified U.S. organic crop and livestock operations totaled nearly 13,000 and certified organic acreage exceeded 4.8 million acres in 2008. 1 ERS, based upon the list of certified operations maintained by the NOP, estimated the number of certified handling operations was 3,225 in 2007. 2 AMS believes that most of these entities would be considered small entities under the criteria established by the SBA.

The U.S. sales of organic food and beverages have grown from $3.6 billion in 1997 to nearly $21.1 billion in 2008. 3 The organic industry is viewed as the fastest growing sector of agriculture, representing over 3 percent of overall food sales in 2009. Between 1990 and 2008, organic food sales historically demonstrated a growth rate between 15 to 24 percent each year. In 2010, organic food sales grew 7.7%. 4

In addition, USDA has 94 accredited certifying agents who provide certification services to producers and handlers. A complete list of names and addresses of accredited certifying agents may be found on the AMS NOP Web site, at http://www.ams.usda.gov/nop. AMS believes that most of these accredited certifying agents would be considered small entities under the criteria established by the SBA.

No additional collection or recordkeeping requirements are imposed on the public by this final rule. Accordingly, OMB clearance is not required by § 350(h) of the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, et seq., or OMB's implementing regulations at 5 CFR part 1320.

AMS received nine comments on proposed rule AMS-TM-07-0136. Comments were received from an organic producer, trade associations, handlers, and private citizens. Most comments expressed positions in support of the 12 substances considered under this sunset review. One individual did not refer to subjects within the scope of this rulemaking.

Some commenters specifically supported substances that they promote, represent, or rely on. A comment submitted in support of Ferric phosphate emphasized the importance of the substance to reduce snail damage on organic crops. A comment received on Hydrogen chloride voiced that there are no good alternatives to the use of the substance for removal of residual lint from ginned cottonseed, a process necessary to facilitate mechanical planting. A comment received on Egg white lysozyme stated that the substance is essential for organic wine production. A comment submitted in support of L-Malic acid underscored that no alternatives exist for this substance and stated its importance as a processing aid for pH adjustment in organic products. Multiple comments received on Microorganisms emphasized the critical need for microorganisms in organic food processing for production of dairy, bread, fruit, vegetable, and meat products. Comments received in support of the allowance for Activated charcoal confirmed the necessity of this substance as a filtering aid in organic processing. Comments submitted supporting the allowance for the substances Cyclohexylamine, Diethylaminoethanol, and Octadecylamine, all boiler water additives, stated that these substances are important for packaging sterilization. Comments supporting the use of Peracetic acid/Peroxyacetic acid for sanitizing food contact surfaces indicated that there are no alternative materials with equivalent functionality. One comment submitted in support of Sodium acid pyrophosphate stated that without the allowance for this substance as a leavening agent, many organic baked goods would no longer be available because a satisfactory alternative does not exist. The same commenter also emphasized the necessity of Tetrasodium pyrophosphate in the manufacturing of meat analog products to facilitate proper flow in the extrusion process and ensure the development of suitable product texture. Overall, at least one comment was received in favor of renewal for all 12 substances considered under this sunset review.

One commenter opposed the continued use of six of the 12 substances: Cyclohexylamine, Diethylaminoethanol, Octadecylamine, Peracetic acid/Peroxyacetic acid, Sodium acid pyrophosphate, and Tetrasodium pyrophosphate. The commenter based their objection on the safety of the substances as described in the material safety data sheets (MSDS) for each substance and recommended removal of these substances from the National List. However, the NOSB reviewed these substances against the evaluation criteria in 7 U.S.C. 6517 and 6518 of the OFPA, and found that when these substances are used as limited by the annotations for each substance, they do not pose any danger to the environment or to manufacturing personnel or consumers. The NOSB concluded that these substances remain essential to organic production since no organic alternatives exist and recommended that the exemption for these substances on the National List continue. The NOP concurs with the NOSB's evaluation and recommendation of these substances and, therefore, does not find that sufficient information was provided by the commenter to justify the removal of these substances from the National List.

This final rule reflects recommendations submitted to the Secretary by the NOSB for the purpose of fulfilling the requirements of 7 U.S.C. 6517(e) of the OFPA. Section 7 U.S.C. 6517(e) requires the NOSB to review each substance on the National List within 5 years of its publication. The substances being reauthorized for use on the National List were initially authorized for use in organic agriculture on September 12, 2006. Because these substances are critical to organic production and handling operations, producers and handlers should be able to continue to use these substances for a full 5-year period beyond their expiration date of September 12, 2011.

Accordingly, pursuant to 5 U.S.C. 553, it is found and determined that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register . This rule shall be effective on September 12, 2011.

The authority citation for 7 CFR part 205 continues to read as follows:

I. Introduction

Section 14(a)(3)(B)(vi) of the CPSA, as added by section 102(a)(2) of the CPSIA, directs the CPSC to publish a notice of requirements for accreditation of third party conformity assessment bodies to assess children's products for conformity with “other children's product safety rules.” Section 14(f)(1) of the CPSA defines “children's product safety rule” as “a consumer product safety rule under [the CPSA] or similar rule, regulation, standard, or ban under any other Act enforced by the Commission, including a rule declaring a consumer product to be a banned hazardous product or substance.” Under section 14(a)(3)(A) of the CPSA, each manufacturer (including the importer) or private labeler of products subject to those regulations must have products that are manufactured more than 90 days after the Federal Register publication date of a notice of the requirements for accreditation, tested by a third party conformity assessment body accredited to do so, and must issue a certificate of compliance with the applicable regulations based on that testing. Section 14(a)(2) of the CPSA, as added by section 102(a)(2) of the CPSIA, requires that certification be based on testing of sufficient samples of the product, or samples that are identical in all material respects to the product. The Commission also emphasizes that, irrespective of certification, the product in question must comply with applicable CPSC requirements ( see, e.g., section 14(h) of the CPSA, as added by section 102(b) of the CPSIA).

This notice provides the criteria and process for Commission acceptance of accreditation of third party conformity assessment bodies for testing toys, pursuant to ASTM F 963-08, and for testing toy chests, pursuant to section 4.27 of ASTM F 963-07ε1. ASTM F 963-08 and section 4.27 of ASTM F 963-07ε1 are voluntary standards, but under section 106(a) of the CPSIA, they have become mandatory federal requirements, “except for section 4.2 and Annex 4 [of ASTM F 963], or any provision that restates or incorporates an existing mandatory standard or ban promulgated by the Commission or by statute.” Readers may obtain a copy of ASTM F 963-08 and/or ASTM F 963-07ε1 from ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA, 19428-2959; (610)-832-9500; http://www.astm.org.

Section 106(a) of the CPSIA states that, beginning 180 days after August 14, 2008—the date the CPSIA was enacted—ASTM F 963-07 shall be considered a consumer product safety standard issued by the Commission under section 9 of the CPSA. Under section 106(g) of the CPSIA, when ASTM proposes to revise ASTM F 963, it must notify the Commission of the proposed revision. The revised standard will be considered the consumer product safety standard effective 180 days after the date on which ASTM notified the Commission of the revision, unless the Commission objects within the first 90 days of the 180-day period. If the Commission determines that the proposed revision does not improve the safety of a consumer product, the Commission can notify ASTM that the already-existing standard will continue to be considered the consumer product safety standard.

ASTM proposed F 963-08 as a revised standard in February 2009, and on May 13, 2009, the Commission voted to accept F 963-08 as the consumer product safety standard for toys, except the revision omitting section 4.27 related to toy chests, which the Commission retained from the previous version of F 963 (ASTM F 963-07ε1). Accordingly, ASTM F 963-08 and section 4.27 of ASTM F 963-07ε1 (toy chests) are considered consumer product safety standards issued by the Commission under section 9 of the CPSA.

We anticipate the ASTM F963-08 standard is likely to be revised and updated in the future. Given this possibility, the Commission seeks comments now on how to make the transition in testing requirements as clear and efficient as possible should the standard change.

We note that ordinarily, when the Commission bases a mandatory requirement on a voluntary standard, we incorporate the voluntary standard by reference, in accordance with the rules of the Office of the Federal Register. See 1 CFR part 51. However, in this instance, ASTM F 963 became a consumer product safety standard by operation of law, rather than by an act of the Commission. See Public Law No. 110-314 § 106(a), (g). Therefore the Commission does not need to incorporate ASTM F 963 by reference.

We also note that certain provisions of ASTM F 963-08 and section 4.27 of ASTM F 963-07ε1 will not be subject to third party testing and therefore we will not be accepting accreditations to those excepted sections. The exceptions are as follows:

• Those sections of ASTM F 963-08 that address food and cosmetics, products traditionally outside the Commission's jurisdiction.

• Those sections of ASTM F 963-08 that pertain to the manufacturing process and thus, cannot be evaluated meaningfully by a test of the finished product (e.g., the purified water provision at section 4.3.6.1).

• Requirements for labeling, instructional literature, or producer's markings in ASTM F 963-08 or section 4.27 of ASTM F 963-07ε1. We have taken similar positions in other contexts. For example, the Commission has stated that it will not require testing and certification to the labeling requirements under the Federal Hazardous Substances Act, 15 U.S.C. 1261-1278. See 74 FR 68588, 68591 (Dec. 28, 2009) (Notice of Commission Action on the Stay of Enforcement of Testing and Certification Requirements). We also do not require third party testing for the labeling requirements for children's sleepwear under the Flammable Fabrics Act, 15 U.S.C. 1191-1204. See 75 FR 70911, 70913 (Nov. 19, 2010) (Third Party Testing for Certain Children's Products; Children's Sleepwear, Sizes 0 Through 6X and 7 Through 14: Requirements for Accreditation of Third Party Conformity Assessment Bodies).

• Those sections of ASTM F 963-08 that involve assessments that are conducted by the unaided eye and without any sort of tool or device.

• Section 4.3.8 of ASTM F 963-08, pertaining to a specific phthalate, because section 108 of the CPSIA specifically addresses phthalates and will be the subject of a separate notice of requirements.

In sum, the Commission will only require certain provisions of ASTM F 963-08 and Section 4.27 of ASTM F 963-07ε1 to be subject to third party testing and therefore we will only accept the accreditation of third party conformity assessment bodies for testing under the following toy safety standards:

We note that the ASTM toy safety standards cover toys intended for use by children under 14 years of age. See, e.g ., section 1.3 of ASTM F 963-08. However, only “children's products” are required to be third party tested in support of the children's product certificate required by section 14(a)(2) of the CPSA. Section 3(a)(2) of the CPSA defines “children's product,” to mean, inter alia, “a consumer product designed or intended primarily for children 12 years of age or younger.” To the extent that there are products subject to ASTM F 963-08 and/or section 4.27 of ASTM F 963-07ε1 that are not “children's products,” as that term is defined in the CPSA, such products do not need to be third party tested in support of the certification required by section 14 of the CPSA.

Although section 14(a)(3)(B)(vi) of the CPSA directs the CPSC to publish a notice of requirements for accreditation of third party conformity assessment bodies to assess conformity with “all other children's product safety rules,” this notice of requirements is limited to the safety standards identified immediately above.

The CPSC also recognizes that section 14(a)(3)(B)(vi) of the CPSA is captioned: “All Other Children's Product Safety Rules”; however, the body of the statutory requirement refers only to “other children's product safety rules.” Nevertheless, section 14(a)(3)(B)(vi) of the CPSA could be construed to require a notice of requirements for “all” other children's product safety rules, rather than a notice of requirements for “some” or “certain” children's product safety rules. However, whether a particular rule represents a “children's product safety rule” may be subject to interpretation, and Commission staff is continuing to evaluate which rules, regulations, standards, or bans are “children's product safety rules.” The CPSC intends to issue additional notices of requirements for other rules that the Commission determines to be “children's product safety rules.”

This notice of requirements applies to all third party conformity assessment bodies as described in section 14(f)(2) of the CPSA. Generally speaking, such third party conformity assessment bodies are: (1) Third party conformity assessment bodies that are not owned, managed, or controlled by a manufacturer or private labeler of a children's product to be tested by the third party conformity assessment body for certification purposes; (2) “firewalled” conformity assessment bodies (those that are owned, managed, or controlled by a manufacturer or private labeler of a children's product to be tested by the third party conformity assessment body for certification purposes and that seek accreditation under the additional statutory criteria for “firewalled” conformity assessment bodies); and (3) third party conformity assessment bodies owned or controlled, in whole or in part, by a government.

The Commission requires baseline accreditation of each category of third party conformity assessment body to the International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) Standard 17025:2005, “General Requirements for the Competence of Testing and Calibration Laboratories.” The accreditation must be by an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation-Mutual Recognition Arrangement (ILAC-MRA), and the scope of the accreditation must include clear references to those sections of ASTM F 963-08 and/or 4.27 of ASTM F 963-07ε1 identified earlier in part I of this document for which the third party conformity assessment body seeks CPSC acceptance.

(Descriptions of the history and content of the ILAC-MRA approach and of the requirements of the ISO/IEC 17025:2005 laboratory accreditation standard are provided in the CPSC staff briefing memorandum “Third Party Conformity Assessment Body Accreditation Requirements for Testing Compliance with 16 CFR part 1501 (Small Parts Regulations),” dated November 2008, and available on the CPSC's Web site at: http://www.cpsc.gov/library/foia/foia09/brief/smallparts.pdf ).

The Commission has established an electronic accreditation registration and listing system that can be accessed via its Web site at: http://www.cpsc.gov/ABOUT/Cpsia/labaccred.html.

The Commission stayed the enforcement of certain provisions of section 14(a) of the CPSA in a notice published in the Federal Register on February 9, 2009 (74 FR 6396); the stay applied to testing and certification of various products, including those covered by the safety standards in ASTM F 963. On December 28, 2009 the Commission published a notice in the Federal Register (74 FR 68588) revising the terms of the stay. One section of the December 28, 2009 notice addressed “Consumer Products or Children's Products Where the Commission Is Continuing the Stay of Enforcement Until Further Notice,” due to factors such as pending rulemaking proceedings affecting the product or the absence of a notice of requirements. The ASTM F 963 testing and certification requirements were included in that section of the December 28, 2009 notice. The absence of a notice of requirements prevented the testing and certification stay from being lifted with regard to toys subject to ASTM F 963. While the publication of this notice would have had the effect of lifting the testing and certification stay with regard to ASTM F 963, at the decisional meeting on July 20, 2011, the Commission voted to stay enforcement of the testing and certification requirements of section 14 of the CPSA with respect to toys subject to ASTM F 963 until December 31, 2011.

Accordingly, each manufacturer of a children's product covered by F 963-08 and/or section 4.27 of ASTM F 963-07ε1 (toy chests) must have any such product manufactured after December 31, 2011, tested by a third party conformity assessment body accredited to do so and must issue a certificate of compliance with applicable sections of ASTM F 963-08 and/or section 4.27 of ASTM F 963-07ε1 based on that testing. (Under the CPSA, the term “manufacturer” includes anyone who manufactures or imports a product.)

This notice of requirements is exempt from the notice and comment rulemaking requirements of the Administrative Procedure Act, 5 U.S.C. 553 ( see section 14(a)(3)(G) of the CPSA, as added by section 102(a)(2) of the CPSIA (15 U.S.C. 2063(a)(3)(G)).

For a third party conformity assessment body to be accredited to test children's products for conformity with one or more of the ASTM F 963 toy standards identified earlier in part I of this document, it must be accredited by an ILAC-MRA signatory accrediting body, and the accreditation must be registered with, and accepted by, the Commission. A listing of ILAC-MRA signatory accrediting bodies is available on the Internet at: http://ilac.org/membersbycategory.html. The accreditation must be to ISO Standard ISO/IEC 17025:2005, “General Requirements for the Competence of Testing and Calibration Laboratories,” and the scope of the accreditation must expressly include references to one or more of the following sections of ASTM F 963-08, Standard Consumer Safety Specification for Toy Safety, and/or 4.27 of ASTM F 963-07ε1, the consumer product safety standard for toy chests

The Commission will maintain on its Web site an up-to-date listing of third party conformity assessment bodies whose accreditations it has accepted and the scope of each accreditation. Subject to the limited provisions for acceptance of “retrospective” testing noted in part IV below, once the Commission adds a third party conformity assessment body to that list, the third party conformity assessment body may commence testing children's products to support the manufacturer's certification that the product complies with the applicable toy safety standards identified earlier in part I of this document.

In addition to the baseline accreditation requirements in part II.A of this document above, firewalled conformity assessment bodies seeking accredited status must submit to the Commission copies, in English, of their training documents, showing how employees are trained to notify the Commission immediately and confidentially of any attempt by the manufacturer, private labeler, or other interested party to hide or exert undue influence over the third party conformity assessment body's test results. This additional requirement applies to any third party conformity assessment body in which a manufacturer or private labeler of a children's product to be tested by the third party conformity assessment body owns an interest of 10 percent or more. While the Commission is not addressing common parentage of a third party conformity assessment body and a children's product manufacturer at this time, it will be vigilant to see if this issue needs to be addressed in the future.

As required by section 14(f)(2)(D) of the CPSA, the Commission must formally accept, by order, the accreditation application of a third party conformity assessment body before the third party conformity assessment body can become an accredited firewalled conformity assessment body.

In addition to the baseline accreditation requirements of part II.A of this document above, the CPSIA permits accreditation of a third party conformity assessment body owned or controlled, in whole or in part, by a government if:

• To the extent practicable, manufacturers or private labelers located in any nation are permitted to choose conformity assessment bodies that are not owned or controlled by the government of that nation;

• The third party conformity assessment body's testing results are not subject to undue influence by any other person, including another governmental entity;

• The third party conformity assessment body is not accorded more favorable treatment than other third party conformity assessment bodies in the same nation who have been accredited;

• The third party conformity assessment body's testing results are accorded no greater weight by other governmental authorities than those of other accredited third party conformity assessment bodies; and

• The third party conformity assessment body does not exercise undue influence over other governmental authorities on matters affecting its operations or on decisions by other governmental authorities controlling distribution of products based on outcomes of the third party conformity assessment body's conformity assessments.

The Commission will accept the accreditation of a governmental third party conformity assessment body if it meets the baseline accreditation requirements of part II.A of this document above, and meets the additional conditions stated here. To obtain this assurance, CPSC staff will engage the governmental entities relevant to the accreditation request.

The Commission has established an electronic accreditation acceptance and registration system accessed via the Commission's Internet site at: http://www.cpsc.gov/about/cpsia/labaccred.html. The applicant provides, in English, basic identifying information concerning its location, the type of accreditation it is seeking, and electronic copies of its accreditation certificate and scope statement from its ILAC-MRA signatory accreditation body, and firewalled third party conformity assessment body training document(s), if relevant.

Commission staff will review the submission for accuracy and completeness. In the case of baseline third party conformity assessment bodies and government-owned or government-operated conformity assessment bodies, when that review and any necessary discussions with the applicant are satisfactorily completed, the third party conformity assessment body in question is added to the CPSC's list of accredited third party conformity assessment bodies at: http://www.cpsc.gov/about/cpsia/labaccred.html. In the case of a firewalled conformity assessment body seeking accredited status, when staff's review is complete, staff transmits its recommendation on accreditation to the Commission for consideration. (A third party conformity assessment body that may ultimately seek acceptance as a firewalled third party conformity assessment body also can initially request acceptance as a third party conformity assessment body accredited for testing of children's products other than those of its owners.) If the Commission accepts a staff recommendation to accredit a firewalled conformity assessment body, the firewalled conformity assessment body will be added to the CPSC's list of accredited third party conformity assessment bodies. In each case, the Commission will notify the third party conformity assessment body electronically of acceptance of its accreditation. All information to support an accreditation acceptance request must be provided in the English language.

Subject to the limited provisions for acceptance of “retrospective” testing noted in part IV of this document below, once the Commission adds a third party conformity assessment body to the list, the third party conformity assessment body may begin testing children's products to support certification of compliance with the applicable toy safety standards identified earlier in part I of this document for which it has been accredited.

The Commission will accept a certificate of compliance with the applicable sections of Standard Consumer Safety Specification for Toy Safety, F 963-08 and/or section 4.27 (toy chests) from ASTM F 963-07ε1 based on testing performed by an accredited third party conformity assessment body (including a government-owned or -controlled conformity assessment body, and a firewalled conformity assessment body) before the Commission's acceptance of its accreditation if:

• At the time of product testing, the product was tested by a third party conformity assessment body that was ISO/IEC 17025 accredited by an accreditation body that is a signatory to the ILAC-MRA. For firewalled conformity assessment bodies, the firewalled conformity assessment body must be one that the Commission accredited, by order, at or before the time the product was tested, even though the order will not have included the test methods specified in this notice. If the third party conformity assessment body has not been accredited by a Commission order as a firewalled conformity assessment body, the Commission will not accept a certificate of compliance based on testing performed by the third party conformity assessment body before it is accredited, by Commission order, as a firewalled conformity assessment body;

• The third party conformity assessment body's application for testing to the toy standard section(s) under which the test(s) was conducted is accepted by the CPSC on or before October 3, 2011;

• With regard to tests conducted under F 963-08, the product was tested to the applicable section(s) on or after May 13, 2009; with regard to tests conducted under section 4.27 of F 963-07ε1, the product was tested on or after August 14, 2008;

• The accreditation scope in effect for the third party conformity assessment body at the time of testing expressly included testing to the toy standard section(s) under which the test(s) was conducted;

• The test results show compliance with the applicable current toy standards; and

• The third party conformity assessment body's accreditation, including inclusion in its scope of the toy standard section(s) under which the test(s) was conducted, remains in effect through the effective date for mandatory third party testing and manufacturer certification for conformity with ASTM F 963-08 and/or section 4.27 of ASTM F 963-07ε1.

We are adopting amendments to rules and forms under the Securities Act of 1933 (“Securities Act”), 1 and the Securities Exchange Act of 1934 (“Exchange Act”). 2 Under the Securities Act, we are adopting amendments to Rules 134, 3 138, 4 139, 5 168, 6 Form S-3, 7 Form S-4, 8 Form F-3, 9 and Form F-4. 10 We are rescinding Form F-9  11 and adopting amendments to the Securities Act and Exchange Act forms and rules that refer to Form F-9 to eliminate those references. 12 We are also amending Schedule 14A  13 under the Exchange Act.

We are adopting amendments today to remove references to credit ratings in rules and forms promulgated under the Securities Act and the Exchange Act. On February 9, 2011, we proposed amendments in light of Section 939A of the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank”)  14 to remove references to credit ratings in rules and forms under the Securities Act and the Exchange Act. 15 We proposed similar changes in 2008, prior to the enactment of the Dodd-Frank Act, but did not act on those proposals. 16

We have considered the role of credit ratings in our rules under the Securities Act on several previous occasions and even proposed removal of some references to credit ratings prior to the enactment of the Dodd-Frank Act. 17 While we recognize that credit ratings play a significant role in the investment decisions of many investors, we want to avoid using credit ratings in a manner that suggests in any way a “seal of approval” on the quality of any particular credit rating or rating agency, including any nationally recognized statistical rating organization (“NRSRO”). Similarly, the legislative history indicates that Congress, in adopting Section 939A, intended to “reduce reliance on credit ratings.”  18 The rules we are adopting today seek to reduce our reliance on credit ratings for regulatory purposes while also preserving the use of Form S-3 (and similar forms) for issuers that we believe are widely followed in the market.

As discussed in more detail below, we are adopting the amendments with certain changes from the proposals. We received 48 comment letters on the 2011 Proposing Release and have modified the final amendments in certain respects in response to the comments we received.

We are adopting amendments today to revise General Instruction I.B.2. of Form S-3 and Form F-3 to provide that an offering of non-convertible securities, other than common equity, is eligible to be registered on Form S-3 and Form F-3 if:

(i) The issuer has issued (as of a date within 60 days prior to the filing of the registration statement) at least $1 billion in non-convertible securities, other than common equity, in primary offerings for cash, not exchange, registered under the Securities Act, over the prior three years; or

(ii) The issuer has outstanding (as of a date within 60 days prior to the filing of the registration statement) at least $750 million of non-convertible securities, other than common equity, issued in primary offerings for cash, not exchange, registered under the Securities Act; or

(iii) The issuer is a wholly-owned subsidiary of a well-known seasoned issuer (“WKSI”) as defined in Rule 405 under the Securities Act;  19 or

(iv) The issuer is a majority-owned operating partnership of a real estate investment trust (“REIT”) that qualifies as a WKSI; or

(v) The issuer discloses in the registration statement that it has a reasonable belief that it would have been eligible to register the securities offerings proposed to be registered under such registration statement pursuant to General Instruction I.B.2 of Form S-3 or Form F-3 in existence prior to the new rules, discloses the basis for such belief, and files the final prospectus for any such offering on or before the date that is three years from the effective date of the amendments.

We are also rescinding Form F-9 under the Securities Act because we believe that regulatory changes have rendered the form unnecessary. Further, we are adopting amendments to Rules 138, 139 and 168 under the Securities Act and Schedule 14A under the Exchange Act so that they refer to the new eligibility criteria in Form S-3 and Form F-3. Finally, we are removing Rule 134(a)(17) under the Securities Act.

Form S-3 and Form F-3 are the “short forms” used by eligible issuers to register securities offerings under the Securities Act. These forms allow eligible issuers to rely on reports they have filed under the Exchange Act to satisfy many of the disclosure requirements under the Securities Act. Form S-3 and Form F-3 eligibility for primary offerings also enables eligible issuers to conduct primary offerings “off the shelf” under Securities Act Rule 415. 21 Rule 415 provides considerable flexibility in accessing the public securities markets in response to changes in the market and other factors. Issuers that are eligible to register these primary “shelf” offerings under Rule 415 are permitted to register securities offerings prior to planning any specific offering and, once the registration statement is effective, offer securities in one or more tranches without waiting for further Commission action. To be eligible to use Form S-3 or Form F-3, an issuer must meet the form's eligibility requirements as to registrants, which generally pertain to reporting history under the Exchange Act, 22 and at least one of the form's transaction requirements. 23 One such transaction requirement permits registrants to register primary offerings of non-convertible securities, if they are rated investment grade by at least one NRSRO. 24 General Instruction I.B.2. provides that a security is “investment grade” if, at the time of sale, at least one NRSRO has rated the security in one of its generic rating categories, typically the four highest, which signifies investment grade.

General Instruction I.B.2. to Form S-3 provides issuers of non-convertible securities whose public float does not reach the required threshold, or that do not have a public float, with an alternate means of becoming eligible to register offerings on Form S-3. Consistent with Form S-3, the Commission also adopted a provision in Form F-3 providing for the eligibility of a primary offering of investment grade non-convertible securities by eligible foreign private issuers. 25

Since the adoption of those rules relating to security ratings in Form S- 3 and Form F-3, other Commission forms and rules relating to securities offerings or issuer disclosures have included requirements that likewise rely on securities ratings. 26 Among them are Form F-9, 27 Forms S-4 and F-4, 28 and Exchange Act Schedule 14A. 29

In February 2011, we proposed to revise the instructions to Form S-3 and Form F-3 so that they would no longer refer to security ratings by an NRSRO as a transaction requirement to permit issuers to register primary offerings of non-convertible securities for cash. Instead, we proposed that these forms would be available to register primary offerings of non-convertible securities if the issuer has issued (as of a date within 60 days prior to the filing of the registration statement) for cash at least $1 billion in non-convertible securities, other than common equity, in offerings registered under the Securities Act, over the prior three years. The proposals in the 2011 Proposing Release were substantially similar to amendments that were proposed in 2008. 30

We received 48 comment letters on the 2011 Proposing Release. 31 We received nine comment letters from law firms, nine comment letters from associations or industry groups, 16 comment letters from utility companies, one comment letter from an institutional investor, two comment letters from banks or bank holding companies and 11 comment letters from other interested parties. The majority of the comments focused on the proposals to amend the eligibility criteria for Form S-3 and Form F-3.

All of the commentators suggested modifications to the proposals to amend Form S-3 and Form F-3. Several commentators believed that Congress did not intend to change the pool of issuers eligible to use Form S-3 and Form F-3. 32 Commentators generally did not believe that the Form S-3 and Form F-3 criteria needed to mirror the standard for issuers to qualify as WKSIs. 33 In particular, commentators noted that the proposed non-convertible securities (other than common equity) offering standard in the 2011 Proposing Release was disproportionately higher than the standard for primary offerings on Form S-3 and Form F-3 by issuers that have an aggregate market value of $75 million or more for their voting and non-voting common equity held by non-affiliates. 34 As a result, commentators raised concerns that the proposals would result in issuers who are currently eligible to use Form S-3 or Form F-3 losing that eligibility. 35

In the 2011 Proposing Release, we requested comment on whether we should adopt rules that would keep the pool of issuers currently eligible to use Form S-3 and Form F-3 substantially the same. Commentators suggested several alternatives to the proposals in the 2011 Proposing Release that may preserve Form S-3 and Form F-3 eligibility for certain issuers. The commentators generally believed that the alternatives suggested would reserve the use of Form S-3 and Form F-3 for issuers that were widely followed in the marketplace. Some of the alternatives suggested by commentators include:

• Allowing either wholly or majority-owned subsidiaries of WKSIs to use Form S-3 or Form F-3;  36

• Basing the eligibility standard on having $1 billion of non-convertible securities other than common equity outstanding;  37

• Lowering the $1 billion threshold (commentators suggested various thresholds with some as low as $250 million);  38

• Extending the measurement period for the $1 billion threshold to five years from three years;  39

• Allowing securities issued in unregistered offerings of non-convertible securities other than common equity to be included in the calculation of the $1 billion threshold;  40

• Allowing non-convertible securities other than common equity issued in registered exchange offerings to be included in the $1 billion calculation;  41

• Allowing U.S. dollar denominated non-convertible securities other than common equity issued in Regulation S offerings to be included in the $1 billion calculation;  42

• Adding an exception to allow regulated operating subsidiaries of utility companies to continue to use Form S-3 and Form F-3;  43

• Adding an exception that would allow insurance company issuers of certain insurance contracts to continue to use Form S-3 and Form F-3;  44 and

• Adding an exception that would allow operating partnership subsidiaries of REITs to continue to use Form S-3 and Form F-3. 45

Several commentators did not believe that the new eligibility criteria for Form S-3 and Form F-3 for primary offerings of non-convertible securities, other than common equity, should be based on the WKSI standard because it is disproportional to the criteria in Form S-3 and Form F-3 for primary offerings made in reliance on General Instruction I.B.1 of Form S-3 and Form F-3. 46 Commentators noted that the WKSI standard should be more stringent than the criteria for Form S-3 and Form F-3 eligibility because of the benefits, such as automatic shelf registration, that WKSI status confers. 47 Some commentators suggested that we should provide additional, alternative criteria for Form S-3 and Form F-3 eligibility. 48

In addition, some commentators believed the three-year look back for the $1 billion threshold in the 2011 Proposing Release was arbitrary and could have significant consequences. One commentator believed that the volume standard could be “volatile” particularly in times of financial uncertainty. 49 One commentator did not believe its following in the marketplace would be affected by the timing of its debt issuances and would not be significantly affected if it did not issue $1 billion in three years. 50 One commentator did not believe Form S-3 and Form F-3 eligibility should be based on the frequency of debt issuances and believed issuers would be followed on the basis of their debt outstanding. 51 Several utility company commentators noted that debt issuances within their industry are done on an irregular basis in connection with large capital projects, which would make the three-year test difficult to satisfy on a consistent basis. 52

Commentators generally believed that if issuers were unable to satisfy the proposed standard, they would seek to raise capital in the private markets instead of registering offerings on Form S-1. 53 Commentators believed that private offerings would be more efficient and take less time than a registered offering on Form S-1. 54 Commentators noted that using the private markets would make it difficult for issuers to ever gain eligibility for Form S-3 because the amount of non-convertible securities (other than common equity) issued in private offerings is not included in calculating the $1 billion threshold under the proposal. 55 Commentators also noted that if issuers were to use the private markets, it would be inconsistent with the Commission's policy preference for registered offerings. 56

We have reviewed and considered all of the comments we received on the proposed amendments. The adopted amendments reflect changes made in response to many of these comments. These changes are discussed in more detail below.

Today we are adopting amendments to revise the transaction eligibility criteria for registering primary offerings of non-convertible securities on Forms S-3 and F-3. After considering the comments we received on the 2011 Proposing Release, we believe that the amendments we are adopting today provide an appropriate and workable alternative to credit ratings for determining whether an issuer should be able to use Form S-3 and Form F-3 and have access to the shelf offering process.

The instructions to Forms S-3 and F-3 will no longer refer to security ratings by an NRSRO as a transaction requirement to permit issuers to register primary offerings of non-convertible securities for cash. Instead, these forms will be available to register primary offerings of non-convertible securities other than common equity if:

(i) The issuer has issued (as of a date within 60 days prior to the filing of the registration statement) at least $1 billion in non-convertible securities, other than common equity, in primary offerings for cash, not exchange, registered under the Securities Act, over the prior three years; or

(ii) The issuer has outstanding (as of a date within 60 days prior to the filing of the registration statement) at least $750 million of non-convertible securities, other than common equity, issued in primary offerings for cash, not exchange, registered under the Securities Act; or

(iii) The issuer is a wholly-owned subsidiary of a WKSI as defined in Rule 405 under the Securities Act; or

(iv) The issuer is a majority-owned operating partnership of a REIT that qualifies as a WKSI; or

(v) The issuer discloses in the registration statement that it has a reasonable belief that it would have been eligible to register the securities offerings proposed to be registered under such registration statement pursuant to General Instruction I.B.2 of Form S-3 or Form F-3 in existence prior to the new rules, discloses the basis for such belief, and files the final prospectus for any such offering on or before the date that is three years from the effective date of the amendments. 57

We are modifying eligibility criteria for use of Form S-3 and Form F-3 from the proposal because we are persuaded by commentators' arguments that the criteria from the 2011 Proposing Release could result in some issuers who should be eligible to use Form S-3 or Form F-3 because of their wide market following and who are currently eligible to no longer be eligible. As we noted in the 2011 Proposing Release, we are not aware of anything in the legislative history to indicate that Congress intended to substantially alter the pool of issuers eligible for short-form registration and access to the shelf registration process. 58 Accordingly, we believe that any alternative standard for Form S-3 and Form F-3 eligibility that does not refer to credit ratings should preserve the forms and access to the shelf registration process for issuers who have a wide following in the marketplace. 59 These modifications to the proposals should preserve short-form eligibility for widely followed issuers. In addition to adding a non-convertible securities issued criteria, as proposed, we are also adding other criteria intended to allow widely followed issuers access to Form S-3 and Form F-3 and the shelf registration process. 60 These criteria do not distinguish among issuers by the quality of their credit but instead focus on wide following in the marketplace. Those modifications are discussed in more detail below.

In the 2011 Proposing Release, we solicited comment specifically related to how the proposals would affect operating subsidiaries of utility companies, REITs and insurance company issuers of certain insurance contracts. Among other things, we asked whether we should adopt industry-specific provisions that would enable these companies to continue to file registration statements on Form S-3 and Form F-3. The revisions we have made to the proposals, including the addition of several alternative standards, would allow widely followed issuers to use Form S-3 and Form F-3, and we believe that most of the operating subsidiaries of utility companies, REITs and insurance company issuers of certain insurance contracts that may have been excluded under the proposals will be included under the amendments we are adopting today. 61

We are adopting the $1 billion of non-convertible securities, other than common equity, issued over three years criterion as proposed because we believe it would be an appropriate indicator of whether an issuer is widely followed. In addition, we are persuaded by commentators' arguments that focusing solely on issuances over the past three years may inappropriately limit use of Form S-3 or Form F-3. We agree that considering outstanding securities issued in primary registered offerings would result in issuers for whom short form registration is appropriate being eligible to use Form S-3 or Form F-3. As a result, we are amending General Instruction I.B.2. of Form S-3 and Form F-3 to provide that, among other things and in addition to the $1 billion of non-convertible securities, other than common equity, issued over three years criterion, an issuer that has at least $750 million of non-convertible securities, other than common equity, issued in primary offerings for cash, not exchange, registered under the Securities Act outstanding (as measured from a date within 60 days prior to the filing of the registration statement) will be eligible to register on Form S-3 or Form F-3 if the issuer meets the other requirements (such as those in General Instruction I.A.) of the form. For the non-convertible securities (other than common equity) outstanding criteria, we chose a level of $750 million because we believe this threshold will allow currently eligible issuers to continue to use Form S-3 and Form F-3 while preserving the forms' use for widely followed issuers. As noted above, several commentators supported a lower threshold than $1 billion. 62 While most of those commentators supported a threshold ranging from $250 million to $500 million, we believe setting the threshold to $750 million of non-convertible securities (other than common equity) outstanding will encourage registered offerings and assist in maintaining the availability of Form S-3 and Form F-3 for currently eligible issuers while also preserving Form S-3 and Form F-3 for widely followed issuers. This alternative will allow companies that have irregular issuances of non-convertible securities (other than common equity), but that still have significant amounts of non-convertible securities (other than common equity) issued in primary, registered offerings outstanding, to continue to have access to short-form registration and the shelf offering process. Similarly, by also adopting the $1 billion issued over three years threshold, we believe issuers who may issue a significant amount of non-convertible securities over a three-year period but then retire a portion of those securities based on prevailing market conditions will be able to continue to be eligible to use Form S-3 and Form F-3.

Consistent with the 2011 Proposing Release, the revised thresholds should be calculated consistent with the standards used to determine WKSI status. As a result, in determining compliance with both the $1 billion issued and the $750 million outstanding thresholds:

• Issuers can aggregate the amount of non-convertible securities, other than common equity, issued in registered primary offerings that were issued within the previous three years (measured as of a date within 60 days prior to the filing of the registration statement) or, for the non-convertible securities (other than common equity) outstanding threshold, that are outstanding as of a date within 60 days prior to the filing of the registration statement;

• Issuers can include only such non-convertible securities, other than common equity, that were issued in registered primary offerings for cash and not registered exchange offers;  63 and

• Parent company issuers only can include in their calculation the principal amount of their full and unconditional guarantees, within the meaning of Rule 3-10 of Regulation S-X, 64 of non-convertible securities, other than common equity, of their majority-owned subsidiaries issued in registered primary offerings for cash over the prior three years or, for the non-convertible securities (other than common equity) outstanding threshold, that are outstanding as of a date within 60 days prior to the filing of the registration statement.

In response to public comment, we have added an instruction to Form S-3 and Form F-3 clarifying how insurance company issuers should calculate the $1 billion issued and $750 million outstanding thresholds. Insurance company issuers, when registering offerings of insurance contracts, 65 will be permitted to include in their calculation the amount of insurance contracts, including variable insurance contracts, issued in offerings registered under the Securities Act over the prior three years, or for the non-convertible securities (other than common equity) outstanding threshold, that are outstanding as of a date within 60 days prior to the filing of the registration statement. 66 We believe that insurance company issuers that have a significant amount of registered contracts issued or outstanding receive sufficient scrutiny by the marketplace that short-form registration is appropriate for insurance contracts of those issuers. We also believe that calculating the eligibility thresholds in this manner will enable insurance company issuers that are currently eligible to use Form S-3 and Form F-3 to register insurance contract offerings, and that are unable to rely on the alternative eligibility criteria, to remain eligible to use those forms.

In calculating the $1 billion or the $750 million amount, as applicable, issuers generally will be permitted to include the principal amount of any debt and the greater of liquidation preference or par value of any non-convertible preferred stock that were issued in primary registered offerings for cash. 67 In calculating the $1 billion amount or the $750 million amount, as applicable, an insurance company, when using Form S-3 or Form F-3 to register insurance contracts, may include the purchase payments or premium payments for insurance contracts issued in offerings registered under the Securities Act over the prior three years, or for the non-convertible securities (other than common equity) outstanding threshold, the contract value as of the measurement date, of any outstanding insurance contracts issued in offerings registered under the Securities Act. 68

Several commentators asserted that we should allow issuers to include securities issued in unregistered transactions to be included in the eligibility threshold. 69 In addition, some commentators wanted us to permit the inclusion of registered exchange offers in the calculations, 70 and one commentator believed that U.S. dollar denominated securities issued in Regulation S offerings should be permitted to be included in the calculations. 71 These commentators generally believed that securities issued in these transactions play a role in whether an issuer is widely followed. 72 After considering the comments, we have decided not to allow securities issued in unregistered offerings, registered exchange offerings or Regulation S offerings to be included in the $1 billion or $750 million calculations. We are concerned that including such securities could result in the inclusion of some securities that are not indicative of wide market following, and thus do not benefit from the attendant scrutiny of the issuer's public filings by a broad section of market participants, such as privately negotiated placements to a small number of investors. We are also concerned that delineating when a private offering would, and would not, be included would be unworkable. Further, as noted above, the Commission has previously indicated a policy preference for registered offerings. 73 We believe that it would be inconsistent with that preference to allow securities issued in transactions not registered under the Securities Act to be included in the calculation of the $1 billion or $750 million thresholds. In addition, the calculation of the $1 billion and the $750 million standards are substantially similar to the calculation for WKSI status in which unregistered and registered exchange offerings are not permitted to be included.

Under the amendments as adopted, issuers that are wholly-owned subsidiaries of WKSIs will be eligible to use Form S-3 or Form F-3 for offerings of non-convertible securities other than common equity. Commentators noted that a wholly-owned subsidiary of a WKSI is likely to be followed by analysts who follow the WKSI as a part of the WKSI's operations, which supports allowing these companies access to Form S-3 and Form F-3. We also believe this will allow many utility company operating subsidiaries and insurance company issuers of certain insurance contracts to continue to be able to use Form S-3 and Form F-3, which would reduce the negative impact the proposals in the 2011 Proposing Release potentially could have had on these issuers' ability to raise capital and to offer securities.

Some commentators urged us to permit less than wholly-owned subsidiaries of WKSIs to have access to Form S-3 and Form F-3 under a new eligibility criteria for subsidiaries of WKSIs. 74 Except with respect to certain REIT structures discussed below, we have limited this eligibility to wholly-owned subsidiaries of WKSIs because we believe that a wholly-owned subsidiary is more likely to be followed by analysts in connection with its WKSI parent. Also, we note that the limitation does not appear to significantly impact the eligibility of WKSI subsidiaries currently eligible to use Form S-3 and Form F-3.

Although the new criteria for subsidiaries of WKSIs will generally be limited to wholly-owned subsidiaries, we are adopting a provision that will allow certain operating partnerships of REITs to continue to use Form S-3 and Form F-3. Given the partnership structure, REITs generally do not wholly own the operating partnerships; however, the REIT controls the operating partnership because it is the general partner. Further, the REIT generally conducts all of its business through the operating partnership and holds its properties in the operating partnership. As a result of this structure, one commentator representing the REIT industry explained that followers of the REIT parent analyze the operations of the operating partnerships in conjunction with following the REIT. 75 We are adopting a provision that will allow a majority-owned operating partnership subsidiary of a REIT to register offerings of non-convertible securities, other than common equity, on Form S-3 or Form F-3 so long as the REIT parent is a WKSI. In the limited context of REITs with operating partnerships, we believe permitting the use of Form S-3 and Form F-3 by majority-owned operating partnerships whose REIT parent is a WKSI is consistent with our goal of seeking to assure that entities using those forms are widely followed.

Finally, commentators expressed wide support for a temporary “grandfather” provision that would allow issuers that are currently eligible to use Form S-3 and Form F-3 to continue to use those forms for a period of time even if the issuers would not be eligible under the new rules. 76 As noted above, we are not aware of anything in the legislative history to indicate that Congress intended for Section 939A of the Dodd-Frank Act to substantially alter access to our short forms or the shelf registration process. Although we believe that the revisions to the proposal described above would not result in significant numbers of issuers losing access to those forms, we are nevertheless concerned that there could be some issuers that would no longer be eligible to use Form S-3 or Form F-3. In order to ease transition to the new rules and allow companies affected by the amendments time to adjust, we are adopting a temporary “grandfather” clause that will allow issuers who reasonably believe they would have been eligible to rely on General Instruction I.B.2. of Form S-3 or Form F-3 based on the criteria in existence prior to the new rules and who disclose that belief and the basis for it in the registration statement, to be able to use Form S-3 and Form F-3 if they file a final prospectus for an offering on Form S-3 or Form F-3 within three years from the effective date of the new rules. 77 We are adopting a “reasonable belief” standard because of the way in which some credit ratings work. Because some issuers would likely not obtain a credit rating until a deal is relatively certain (unless the issuer has an issuer rating), those issuers would not have a bright-line way of determining whether they were eligible to use Form S-3 and Form F-3 based on the criteria in effect prior to the new rules. We believe requiring the issuer to disclose its reasonable belief will prompt issuers to consider carefully whether the disclosure is accurate since they will be responsible for the disclosure under the Securities Act. As a result, as long as the issuer has a reasonable belief that it would have been eligible and discloses that belief (and the basis for it) in the registration statement, the issuer will be able use Form S-3 and Form F-3 for a period of three years from the effective date of the new rules. We believe three years will provide issuers with enough time to adjust to the new rules, including modifying how they might choose to offer securities. Factors that indicate a reasonable belief of eligibility would include, but not be limited to:

• An investment grade issuer credit rating;

• A previous investment grade credit rating on a security issued in an offering similar to the type the issuer seeks to register that has not been downgraded or put on a watch-list since its issuance; or

• A previous assignment of a preliminary investment grade rating.

We noted in the 2011 Proposing Release that we anticipated that under the proposed threshold, which was intended to capture widely followed issuers based on the amount of recently issued non-convertible securities other than common equity, some high yield debt issuers and issuers without credit ratings that are not currently eligible to use Form S-3 would become eligible and some issuers currently eligible to use Form S-3 and Form F-3 would become ineligible. We believe the changes we have made to the proposals, which include also considering the amount of outstanding non-convertible securities other than common equity, will reduce the likelihood of unnecessarily excluding issuers that are currently eligible to use Form S-3 and Form F-3. In the proposing release, based on a review of non-convertible securities, other than common equity, issued in the United States from January 1, 2006 through August 15, 2008, we estimated that approximately 45 issuers who were previously eligible to use Form S-3 (and who had made an offering during the review period) would no longer be able to use Form S-3 for offerings of non-convertible securities other than common equity securities. 78 We further estimated in the 2011 Proposing Release that approximately eight issuers who were previously ineligible to use Form S-3 or Form F-3 would be eligible to use those forms if the proposals were adopted. In connection with the changes to the proposals that we are adopting today, we reviewed the 45 companies we believed would become ineligible to use Form S-3 or Form F-3 under the proposals to determine how many companies would remain eligible to use Form S-3 and Form F-3. Based on our review, we estimate that of the 45 companies we previously estimated would be excluded under the proposal, 39 would remain eligible because they are wholly-owned subsidiaries of WKSIs and two would remain eligible because they have at least $750 million in non-convertible securities (other than common equity) outstanding. Thus, from the sample of 45 companies that would have lost their eligibility based on the standards in the proposing release, four companies would remain ineligible to use Form S-3 or Form F-3 with the changes we are making in this adopting release. Based on the review of offerings described above, we estimate that 16 issuers who have recently used Form S-1 will become newly eligible to use Form S-3 and Form F-3. The number of issuers who may become newly eligible to use Form S-3 or Form F-3 includes insurance company issuers of certain insurance contracts, a number of whom now file on Form S-1 but that will become eligible to use Form S-3 as a result of the changes made to the eligibility requirements being adopted. 79 As a result, we believe that the amendments will result in a net increase of 12 additional issuers becoming eligible to use Form S-3 and Form F-3.

Some commentators believed that our estimates in the proposing release understated the number of companies that would be affected by the proposals. 80 Another commentator reviewed data from March 2008 to March 2011 in the utility industry and believes that at least 60 utility companies would have been affected. 81 We acknowledged in the 2011 Proposing Release that reviewing offerings during a different time period would give different results. We also acknowledged that our data did not capture issuers who were eligible to use Form S-3 and Form F-3 but did not make offerings during the review period. However, we believe that the changes we are making to the proposals will reduce the impact on certain issuers, particularly utility companies, REITs and insurance company issuers of certain insurance contracts. We believe the provision to allow wholly-owned subsidiaries of WKSIs (or, in the case of REITs, majority owned operating partnerships of WKSIs) to continue to have access to Form S-3 and Form F-3 and the other changes we are making will allow these types of issuers continued access to short form registration and the shelf offering process. Because we do not believe Congress intended to substantially alter the companies eligible to use Form S-3 and Form F-3, we are adopting a standard that we believe balances the goals of preserving Form S-3 and Form F-3 eligibility for current users while reserving the forms for issuers that are widely followed in the marketplace.

General Instruction I.B.5. to Form S-3 provides transaction requirements for offerings of investment grade asset-backed securities. That instruction contains a cross-reference to the definition of “investment grade securities” that currently is found in General Instruction I.B.2. of Form S-3. As one commentator noted, the amendments we are adopting today would remove the definition of investment grade securities from General Instruction I.B.2. 82 In April 2010, we proposed to remove references to credit ratings as a requirement for shelf eligibility for offerings of asset-backed securities. 83 Among other things, the proposal would have required risk retention by the sponsor as a condition to shelf eligibility. Those proposals are still outstanding. As a result, such issuers still look to General Instruction I.B.5. for their offerings. Therefore, we are adopting an amendment to General Instruction I.B.5. of Form S-3 to move the definition of investment grade securities to that instruction until such time as new shelf eligibility requirements for asset-backed issuers are adopted that do not reference credit ratings.

Form F-9 allows certain Canadian issuers  84 to register investment grade debt or investment grade preferred securities that are offered for cash or in connection with an exchange offer, and which are either non-convertible or not convertible for a period of at least one year from the date of issuance. 85 Under the form's requirements, a security is rated “investment grade” if it has been rated investment grade by at least one NRSRO, or at least one Approved Rating Organization, as defined in National Policy Statement No. 45 of the Canadian Securities Administrators (“CSA”). 86 This eligibility requirement was adopted as part of a 1993 revision to the MJDS originally adopted by the Commission in 1991 in coordination with the CSA. 87

Under Form F-9, an eligible issuer has been able to register investment grade securities using audited financial statements prepared pursuant to Canadian generally accepted accounting principles (“Canadian GAAP”) without having to include a U.S. GAAP reconciliation. In contrast, a MJDS filer must reconcile its home jurisdiction financial statements to U.S. GAAP when registering securities on a Form F-10. 88 However, the CSA has adopted rules that will require Canadian reporting companies to prepare their financial statements pursuant to International Financial Reporting Standards as issued by the International Accounting Standards Board (“IFRS”) beginning in 2011. 89 Foreign private issuers that prepare their financial statements in accordance with IFRS are not required to prepare a U.S. GAAP reconciliation. 90 Since a Canadian issuer will not have to perform a U.S. GAAP reconciliation under IFRS, one of the primary differences between Form F-9 and Form F-10 will be eliminated. Once the Canadian IFRS-related amendments become effective, 91 the disclosure requirements for an investment grade securities offering registered on Form F-10 will be the same as the disclosure requirements for one registered on Form F-9.

In the 2011 Proposing Release, we proposed to rescind Form F-9 due to the Canadian regulatory developments described above. One commentator noted that Canadian issuers who have a later fiscal year end will have a later effective date for required IFRS financial statements. 92 If Form F-9 were to be rescinded before an issuer is required to prepare IFRS financial statements, then that issuer would be required to provide a reconciliation to U.S. GAAP in connection with the filing of a registration statement during the interim period before its IFRS financial statements are available. In order to address this concern and ease transition for these issuers, we are adopting a delayed effective date of December 31, 2012 for the rescission of Form F-9.

Commentators also noted that a gap remains between the eligibility requirements for Form F-9 and Form F-10. 93 Currently, issuers using Form F-9 are not required to have a public float while issuers using Form F-10 must either have a $75 million public float or be debt issuers with a guarantee from a parent meeting the requirements of Form F-10. As a result, to the extent a Form F-9 issuer does not have the requisite public float and does not have a parent guarantee of its debt, it would not be eligible to use Form F-10.

As we noted in the 2011 Proposing Release, MJDS issuers have infrequently used Form F-9. Of the 40 Form F-9s filed by 22 issuers since January 1, 2007, we believe only one of these issuers would not qualify to file on Form F-10 if Form F-9 is rescinded. Consistent with the temporary “grandfather” provision we are adopting for Form S-3 and Form F-3 filers, in order to address this concern and ease the transition, we are adopting a temporary “grandfather” provision in Form F-10 that would permit any issuer that discloses in the registration statement that it has a reasonable belief that it would have been eligible to file on Form F-9 as of the effective date of the amendments, and discloses the basis for that belief, to file a final prospectus for an offering on Form F-10 for a period of three years from the effective date of the new rules even if it does not satisfy the parent guarantee or public float requirements of Form F-10. 94

One commentator also noted that removing the reference to Form F-9 from Form 40-F (as was proposed in the 2011 Proposing Release) would result in former F-9 filers who do not have a public float of $75 million or a parent guarantee of their debt losing eligibility to file annual reports on Form 40-F. 95 Issuers who are not eligible to use Form 40-F use Form 20-F, which requires disclosure in accordance with standards set by the Commission rather than standards set by the Canadian securities regulators. In Form 40-F, Canadian MJDS filers file with the Commission their home jurisdiction periodic disclosure documents under cover of Form 40-F. In Form 20-F, foreign private issuers are subject to the Commission's special disclosure requirements for foreign private issuers, and have to prepare separate disclosure to comply with those requirements. Similar to the Form F-10 “grandfather” provision above, we believe this change to Form 40-F would result in a very small number of issuers no longer being able to use Form 40-F. In order to address this concern, we are adopting a permanent “grandfather” provision that would allow currently eligible Form 40-F filers to continue to use Form 40-F to satisfy their reporting obligations under Section 13 and Section 15(d) of the Exchange Act as to previously sold securities if they had filed and sold securities under a Form F-9 with the Commission before the effective date of the new rules. We believe a permanent “grandfather” provision is appropriate for these issuers because some issuers may have issued securities many years ago and may still be reporting pursuant to the requirements of Form 40-F, and given the design of the MJDS system, we do not believe it would be appropriate to change the requirements that these issuers relied on when the offering was made.

One commentator was opposed to rescinding Form F-9 because Form F-9 filers who are in the oil and gas industry are not required to provide the disclosure required by Accounting Standards Codification 932 “Extractive Activities—Oil and Gas” (ASC 932) that would be required for Form F-10 filers. 96 A review of issuers that have filed a Form F-9 since January 1, 2007 indicates that this change would affect very few issuers. As the commentator notes, the Commission has indicated that it will continue to monitor the necessity of providing ASC 932 disclosure as regulatory changes occur. 97 At this time we are not making any changes to the requirement for Form F-10 filers to provide ASC 932 disclosure or otherwise making special accommodations for previous Form F-9 filers. We are also not adopting a grandfather provision for this disclosure requirement because we believe the burden on former F-9 filers will not be significant and will impact a very small number of issuers.

Proposals relating to Form S-4, Form F-4 and Schedule 14A were also included in the 2011 Proposing Release. We did not receive significant separate comment on these proposals. Form S-4 and Form F-4 include the Form S-3 and Form F-3 eligibility criteria by allowing registrants that meet the registrant eligibility requirements of Form S-3 or F-3 and that are offering investment grade securities to incorporate by reference certain information. 98 Similarly, Schedule 14A permits a registrant to incorporate by reference if the Form S-3 registrant requirements in General Instruction I.A. are met and action is to be taken as described in Items 11, 12 and 14  99 of Schedule 14A, which concerns non-convertible debt or preferred securities that are “investment grade securities” as defined in General Instruction I.B.2. of Form S-3. 100 In addition, Item 13 of Schedule 14A allows financial information to be incorporated into a proxy statement if the requirements of Form S-3 (as described in Note E to Schedule 14A) are met. Because we are changing the eligibility requirements in Forms S-3 and F-3 to remove references to ratings by an NRSRO, we believe the same standard should apply to the disclosure options in Forms S-4 and F-4 based on Form S-3 or F-3 eligibility. That is, a registrant will be eligible to use incorporation by reference in order to satisfy certain disclosure requirements of Forms S-4 and F-4 to register non-convertible debt or preferred securities on Form S-4 or Form F-4 if:

(i) The issuer has issued (as of a date within 60 days prior to the filing of the registration statement) at least $1 billion in non-convertible securities, other than common equity, in primary offerings for cash, not exchange, registered under the Securities Act, over the prior three years; or

(ii) The issuer has outstanding (as of a date within 60 days prior to the filing of the registration statement) at least $750 million of non-convertible securities, other than common equity, issued in primary offerings for cash, not exchange, registered under the Securities Act;

(iii) The issuer is a wholly-owned subsidiary of a WKSI as defined in Rule 405 under the Securities Act;

(iv) The issuer is a majority-owned operating partnership of a REIT that qualifies as a WKSI; or

(v) The issuer discloses in the registration statement that it has a reasonable belief that it would have been eligible to register the securities offerings proposed to be registered under such registration statement pursuant to General Instruction I.B.2 of Form S-3 or Form F-3 in existence prior to the new rules, discloses the basis for such belief, and files the final prospectus for any such offering on or before the date that is three years from the effective date of the amendments.

Other Securities Act rules also reference credit ratings. Rules 138, 139, and 168 under the Securities Act provide that certain communications are deemed not to be an offer for sale or offer to sell a security within the meaning of Sections 2(a)(10)  101 and 5(c)  102 of the Securities Act when the communications relate to an offering of non-convertible investment grade securities. Under current rules, these communications include the following:

• Under Securities Act Rule 138, a broker's or dealer's publication about securities of a foreign private issuer that meets F-3 eligibility requirements (other than the reporting history requirements) and is issuing non-convertible investment grade securities;

• Under Securities Act Rule 139, a broker's or dealer's publication or distribution of a research report about an issuer or its securities where the issuer meets Form S-3 or F-3 registrant requirements and is or will be offering investment grade securities pursuant to General Instruction I.B.2. of Form S-3 or F-3, or where the issuer meets Form F-3 eligibility requirements (other than the reporting history requirements) and is issuing non-convertible investment grade securities; and

• Under Securities Act Rule 168, the regular release and dissemination by or on behalf of an issuer of communications containing factual business information or forward-looking information where the issuer meets Form F-3 eligibility requirements (other than the reporting history requirements) and is issuing non-convertible investment grade securities.

In the 2011 Proposing Release, we proposed to revise these rules to refer to the new proposed instructions in General Instruction I.B.2 of Form S-3 or Form F-3, as appropriate. We received little comment on these proposals. One commentator did not believe amendments to these rules were required by the Dodd-Frank Act. 103 The commentator was concerned that the amendments would be burdensome on firms that publish research because they would have to determine the issuer's form eligibility each time they wanted to publish research instead of relying on a published credit rating. 104

We do not believe that determining an issuer's form eligibility will be unduly burdensome for those seeking to publish research. A review of the issuer's or its parent company's publicly available filings, such as Forms 10-K or prospectuses, should indicate whether the issuer satisfies the eligibility requirements for Form S-3 or Form F-3. 105 We also believe that these revisions are appropriate both because of the Dodd-Frank Act's goal to reduce reliance on credit ratings and to promote regulatory consistency. As a result, we are adopting revisions to Rules 138, 139, and 168 to be consistent with the revisions we are adopting to the eligibility requirements in Forms S-3 and F-3.

Securities Act Rule 134(a)(17) 106 permits the disclosure of security ratings issued or expected to be issued by NRSROs in certain communications deemed not to be a prospectus or free writing prospectus. We proposed in the 2011 Proposing Release to remove this rule since we believe providing a safe harbor that explicitly permits the presence of a credit rating assigned by an NRSRO is not consistent with the purposes of Section 939A.

Commentators were opposed to this proposal. 107 Two commentators argued that removing Rule 134(a)(17) is not required by Section 939A of Dodd-Frank. 108 One commentator did not believe that allowing the inclusion of credit rating information encourages reliance on ratings but instead merely reflects the fact that ratings are relevant to investors. 109 Another commentator believed we should expand the rule to cover all credit ratings instead of those issued by NRSROs. 110 That commentator believed removing Rule 134(a)(17) would result in less information being available to investors. One commentator believed the amendment is not required by either the letter or spirit of Section 939A and would chill information available to investors. 111

Notwithstanding the comments we received, we believe it is appropriate to revise Rule 134 in order to remove the safe harbor for disclosure of credit ratings assigned by NRSROs. We believe providing a safe harbor that explicitly permits the presence of a credit rating assigned by an NRSRO is not consistent with the purposes of Section 939A to reduce reliance on credit ratings. We also do not believe this change will have a material impact on the information available to investors because issuers will (as is common now) be able to disclose a credit rating in a free writing prospectus. 112 In addition, as we noted in the 2011 Proposing Release, removing the safe harbor for this type of information would not necessarily result in a communication that included this information being deemed to be a prospectus or a free writing prospectus. The revision results in there no longer being a safe harbor for a communication that included this information. Instead, the determination as to whether such information constitutes a prospectus would be made in light of all of the circumstances of the communication.

Certain provisions of the rule amendments contain a “collection of information” within the meaning of the Paperwork Reduction Act of 1995 (PRA). 113 The Commission is submitting these amendments and rules to the Office of Management and Budget (OMB) for review in accordance with the PRA. 114 An agency may not conduct or sponsor, and a person is not required to comply with, a collection of information unless it displays a currently valid control number. The titles for the collections of information are: 115

I. Background

The Patient Protection and Affordable Care Act, Public Law 111-148, was enacted on March 23, 2010; the Health Care and Education Reconciliation Act (the Reconciliation Act), Public Law 111-152, was enacted on March 30, 2010 (collectively known as the “Affordable Care Act”). The Affordable Care Act reorganizes, amends, and adds to the provisions of part A of title XXVII of the Public Health Service Act (PHS Act) relating to group health plans and health insurance issuers in the group and individual markets. The term “group health plan” includes both insured and self-insured group health plans. 1 The Affordable Care Act adds section 715(a)(1) to the Employee Retirement Income Security Act (ERISA) and section 9815(a)(1) to the Internal Revenue Code (the Code) to incorporate the provisions of part A of title XXVII of the PHS Act into ERISA and the Code, and make them applicable to group health plans, and health insurance issuers providing health insurance coverage in connection with group health plans. The PHS Act sections incorporated by this reference are sections 2701 through 2728. PHS Act sections 2701 through 2719A are substantially new, though they incorporate some provisions of prior law. PHS Act sections 2722 through 2728 are sections of prior law renumbered, with some, mostly minor, changes.

Subtitles A and C of title I of the Affordable Care Act amend the requirements of title XXVII of the PHS Act (changes to which are incorporated into ERISA section 715). The preemption provisions of ERISA section 731 and PHS Act section 2724  2 (implemented in 29 CFR 2590.731(a) and 45 CFR 146.143(a)) apply so that the requirements of part 7 of ERISA and title XXVII of the PHS Act, as amended by the Affordable Care Act, are not to be “construed to supersede any provision of State law which establishes, implements, or continues in effect any standard or requirement solely relating to health insurance issuers in connection with group or individual health insurance coverage except to the extent that such standard or requirement prevents the application of a requirement” of the Affordable Care Act. Accordingly, State laws that impose requirements on health insurance issuers that are stricter than the requirements imposed by the Affordable Care Act are not superseded by the Affordable Care Act.

Section 2713 of the PHS Act, as added by the Affordable Care Act and incorporated under section 715(a)(1) of ERISA and section 9815(a)(1) of the Code, specifies that a group health plan and a health insurance issuer offering group or individual health insurance coverage provide benefits for and prohibit the imposition of cost-sharing with respect to:

• Evidence-based items or services that have in effect a rating of A or B in the current recommendations of the United States Preventive Services Task Force (Task Force) with respect to the individual involved. 3

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because waiting for a notice and comment period to run would be impracticable and contrary to the public interest. Notice of this fireworks display was not received in sufficient time for the Coast Guard to solicit public comments before the start of the event. Thus, waiting for a notice and comment period to run would be impracticable and contrary to the public interest because it would inhibit the Coast Guard's ability to protect the public from the hazards associated with these maritime fireworks displays.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30-days after publication in the Federal Register . For the same reasons discussed in the preceding paragraph, waiting for a 30 day notice period to run would be impracticable and contrary to the public interest.

The Discovery World Private Wedding fireworks are a City permitted fireworks display that will occur twice over Milwaukee's Harbor in Milwaukee, Wisconsin. The fireworks for these two events will be launched from 9:30 p.m. until 10:30 p.m. on both July 31, 2011 and August 26, 2011. The Captain of the Port, Sector Lake Michigan has determined that these firework displays present significant hazards to vessels and spectators in the vicinity of the launch site.

Because of the aforesaid hazards, the Captain of the Port, Sector Lake Michigan has determined that a temporary safety zone is necessary to ensure the safety of spectators and vessels during the setup, loading, and launching of the fireworks display. Accordingly, this temporary safety zone will encompass all waters of Milwaukee Harbor in the vicinity of the Discovery World pier in Milwaukee Wisconsin within a 700 foot radius from the fireworks launch site located on a land in position 43°02′11″ N, 087°53′37″ W. (DATUM: NAD 83).

All persons and vessels shall comply with the instructions of the Coast Guard Captain of the Port, Sector Lake Michigan, or his or her designated representative. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port, Sector Lake Michigan, or his or her designated representative. The Captain of the Port, Sector Lake Michigan, or his or her designated representative may be contacted via VHF Channel 16.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.

It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). We conclude that this rule is not a significant regulatory action because we anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone will be relatively small in size and will exist for only one hour on two specific days. Thus, restrictions on vessel movement within the particular area are expected to be minimal. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the Captain of the Port.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule will have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in the affected portion of Milwaukee Harbor near Discovery World pier in Milwaukee Wisconsin, between 9:30 p.m. and 10:30 p.m. on both July 31, 2011 and August 26, 2011.

This temporary safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: During each of the two displays, the zone in this regulation will only be in effect for 60 minutes, and vessel traffic can safely pass outside the safety zone during the event. In the event that this temporary safety zone affects shipping, commercial vessels may request permission from the Captain of The Port, Sector Lake Michigan, to transit through the safety zone. The Coast Guard will give notice to the public via a Broadcast to Mariners that the regulation is in effect.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not affect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not concern an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, 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.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction because it involves the establishment of a temporary safety zone.

An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under ADDRESSES .

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR Part 165 as follows:

The Board's regulations at 49 CFR 1002.3 provide for annual update of the Board's entire User-Fee schedule. Fees are generally revised based on the cost-study formula set forth at 49 CFR 1002.3(d). The fee changes adopted here reflect a combination of the unchanged wage and salary costs from the 2010 User Fee Update decision plus changes to the various Board overhead and publication costs (one increased and three decreased from their comparable 2010 levels), resulting from the mechanical application of the update formula in 49 CFR 1002.3(d). Results from the formula application indicate that justified fee amounts in this 2011 update decision either remain unchanged (113 fee or sub-fee items) or decreased (12 fee or sub-fee items) from their respective 2010 update levels. No new fees are proposed in this proceeding. Therefore, the Board finds that notice and comment are unnecessary for this proceeding. See Regulations Governing Fees For Services—1990 Update , 7 I.C.C.2d 3 (1990); Regulations Governing Fees For Services—1991 Update, 8 I.C.C.2d 13 (1991); and Regulations Governing Fees For Services—1993 Update , 9 I.C.C.2d 855 (1993).

The Board concludes that the fee changes adopted here will not have a significant economic impact on a substantial number of small entities because the Board's regulations provide for waiver of filing fees for those entities that can make the required showing of financial hardship.

Additional information is contained in the Board's decision. To obtain a free copy of the full decision, visit the Board's Web site at http://www.stb.dot.gov or call the Board's Information Officer at (202) 245-0245. Assistance for the hearing impaired is available through Federal Information Relay Services (FIRS): (800) 877-8339.

For the reasons set forth in the preamble, title 49, chapter X, part 1002, of the Code of Federal Regulations is amended as follows:

Section 12 of the Act (16 U.S.C. 1531 et seq. ) directed the Secretary of the Smithsonian Institution to prepare a report on those plants considered to be endangered, threatened, or extinct. On July 1, 1975, the Service published a notice in the Federal Register (40 FR 27824) accepting the Smithsonian report as a petition to list taxa named therein under section 4(c)(2) [now 4(b)(3)] of the Act and announced our intention to review the status of those plants. Echinacea tennesseensis was included in that report (40 FR 27873). Tennessee purple coneflower is the common name for E. tennesseensis; however, we will primarily use the scientific name of this species throughout this final rule.

On June 16, 1976, we published a proposed rule in the Federal Register (41 FR 24524) to designate approximately 1,700 vascular plant species, including Echinacea tennesseensis, as endangered under section 4 of the Act. On June 6, 1979, we published a final rule in the Federal Register (44 FR 32604) designating E. tennesseensis as endangered. The final rule identified the following threats to E. tennesseensis: Loss of habitat due to residential and recreational development; collection of the species for commercial or recreational purposes; grazing; no State law protecting rare plants in Tennessee; and succession of cedar glade communities in which E. tennesseensis occurred.

On February 14, 1983, we published the Tennessee Coneflower Recovery Plan (Service 1983, 41 pp.), a revision of which we published on November 14, 1989 (Service 1989, 30 pp.). On September 21, 2007, we initiated a 5-year status review of this species (72 FR 54057). On August 12, 2010, we published a proposed rule to remove Echinacea tennesseensis from the List of Endangered and Threatened Plants, provided notice of the availability of a post-delisting monitoring plan, and opened a 60-day public comment period (75 FR 48896).

A member of the sunflower family (Asteraceae), Echinacea tennesseensis is a perennial herb with a long, fusiform ( i.e., thickened toward the middle and tapered towards either end), blackened root. In late summer, the species bears showy purple flower heads on one-to-many hairy branches. Linear to lance-shaped leaves up to 20 centimeters (cm; 8 inches (in.)) long and 1.5 cm (0.6 in.) wide arise from the base of E. tennesseensis and are beset with coarse hairs, especially along the margins. The ray flowers ( i.e., petals surrounding the darker purple flowers of the central disc) are pink to purple and spread horizontally or arch slightly forward from the disc to a length of 2-4 cm (0.8-1.8 in.).

The following description of this species' life history is summarized from Hemmerly (1986, pp. 193-195): Seeds are shed from plants during fall and winter and begin germinating in early March of the following year, producing numerous seedlings by late March. Most of the seedling growth occurs during the first 6 or 7 weeks of the first year, during which plants will grow to a height of 2-3 cm (0.8-1.2 in) or less. Plants remain in a rosette stage and root length increases rapidly during these weeks. Plants can reach sexual maturity by the middle of their second growing season and only small losses in seed viability have been observed after a period of 5 years in dry storage (Hemmerly 1976, p. 17). However, Baskin and Baskin (1989, p. 66) suggest that Echinacea tennesseensis might not form persistent seed banks, based on results of field germination trials. Individuals of E. tennesseensis can live up to at least 6 years, but the maximum lifespan is probably much longer (Baskauf 1993, p. 37).

Echinacea tennesseensis was first collected in 1878 in Rutherford County, Tennessee, by Dr. A. Gattinger and later described by Beadle (1898, p. 359) as Brauneria tennesseensis on the basis of specimens collected by H. Eggert in 1897 from “a dry, gravelly hill” near the town of LaVergne. Fernald (1900, pp. 86-87) did not accept Beadle's identification of B. tennesseensis as a distinct species, instead he merged it with the more widespread E. angustifolia. This treatment was upheld by many taxonomists until McGregor (1968, pp. 139-141) classified the taxon as E. tennesseensis (Beadle) Small, based on examination of materials from collections discussed above and from collections by R. McVaugh in 1936. As McGregor (1968, p. 141) was unable to locate any plants while conducting searches during the months of June through August, 1959-1961, he concluded that the species was very rare or possibly extinct in his monograph of the genus Echinacea. The species went unnoticed until its rediscovery in a cedar glade in Davidson County as reported by Baskin et al. (1968, p. 70), and subsequently in Wilson County by Quarterman and Hemmerly (1971, pp. 304-305), who also noted that the area believed to be the type locality for the species was destroyed by the construction of a trailer park.

More recently, Binns et al. (2002, pp. 610-632) revised the taxonomy of the genus Echinacea and in doing so reduced Echinacea tennesseensis to one of five varieties of E. pallida. Their taxonomic treatment considers E. pallida var. tennesseensis (Beadle) Small to be a synonym of their E. tennesseensis (Beadle) Binns, B. R. Baum, & Arnason, comb. nov. (Binns et al. 2002, pp. 629). However, this has not been unanimously accepted among plant taxonomists (Estes 2008, pers. comm.; Weakley 2008, pp. 139-140). Kim et al. (2004) examined the genetic diversity of Echinacea species and their results conflicted with the division of the genus by Binns et al. (2002, pp. 617-632) into two subgenera, Echinacea and Pallida, one of which— Echinacea —included only E. purpurea. Mechanda et al. (2004, p. 481) concluded that their analysis of genetic diversity within Echinacea only supported recognition of one of the five varieties of E. pallida that Binns et al. (2002, pp. 626-629) described, namely E. pallida var. tennesseensis. While Mechanda et al. (2004, p. 481) would also reduce E. tennesseensis from specific to varietal status, the conflicting results between these two investigations point to a lack of consensus regarding the appropriate taxonomic rank of taxa within the genus Echinacea. Because clear acceptance of the taxonomic revision by Binns et al. (2002, pp. 610-632) is lacking, and Flora of North America ( http://www.efloras.org/florataxon.aspx?flora_id=1&taxon_id=250066491, accessed December 3, 2009) and a flora under development by Weakley (2008, pp. 139-140) both retain specific status for E. tennesseensis, we continue to recognize E. tennesseensis as a species for the purposes of this rule.

Echinacea tennesseensis is restricted to limestone barrens and cedar glades of the Central Basin, Interior Low Plateau Physiographic Province, in Davidson, Rutherford, and Wilson Counties in Tennessee (Tennessee Department of Environment and Conservation (TDEC) 2006, p. 2). These middle Tennessee habitats typically occur on thin plates of Lebanon limestone that are more or less horizontally bedded, though interrupted by vertical fissures in which sinkholes may be readily formed (Quarterman 1986, p. 124). Somers et al. (1986, pp. 180-189) described seven plant community types from their study of 10 cedar glades in middle Tennessee. They divided those communities into xeric (dry) communities, which occurred in locations with no soil or soil depth less than 5 cm (2 in.), and subxeric (moderately dry) communities that occurred on soils deeper than 5 cm (2 in.) (Somers et al. 1986, p. 186). Quarterman (1986, p. 124) noted that soil depths greater than 20 cm (8 in.) in the vicinity of cedar glades tend to support plant communities dominated by eastern red cedar ( Juniperus virginiana ) and other woody species. Somers et al. (1986, p. 191) found E. tennesseensis in four of the community types they classified, but could not determine the fidelity of the species to a particular community type because it only occurred on three of the glades they studied and was infrequently encountered in plots within those sites. The communities where E. tennesseensis occurred spanned two xeric and two subxeric types. The xeric community types, named for the dominant species that either alone or combined constituted greater than 50 percent cover, were the (1) Nostoc commune (blue-green algae)— Sporobolus vaginiflorus (poverty dropseed) and (2) Dalea gattingeri (purpletassels) communities. The subxeric types were the (1) S. vaginiflorus and (2) Pleurochaete squarrosa (square pleurochaete moss) communities. Mean soil depths across these communities ranged from 4.1 to 7.7 cm (1.6 to 3.0 in.) (Somers et al. 1986, pp. 186-188).

When Echinacea tennesseensis was listed as endangered in 1979 (44 FR 32604), it was known only from three locations, one each in Davidson, Rutherford, and Wilson Counties. When the species' recovery plan was completed in 1989, there were five extant populations ranging in size from approximately 3,700 to 89,000 plants and consisting of one to three colonies each (Clebsch 1988, p. 14; Service 1989, p. 2). The recovery plan defined a population as a group of colonies in which the probability of gene exchange through cross pollination is high, and a colony was defined as all E. tennesseensis plants found at a single site that are separated from other plants within the population by unsuitable habitat (Service 1989, p. 1). While analysis of genetic variability within E. tennesseensis did not reveal high levels of differentiation among these populations (Baskauf et al. 1994, p. 186), recovery efforts have been implemented and tracked with respect to these geographically defined populations. The geographic distribution of these populations and the colonies they are comprised of was updated in a status survey of E. tennesseensis by TDEC (1996, Appendix I) to include all known colonies at that time, including those from a sixth population introduced into glades at the Stones River National Battlefield. For the purposes of this rule, we have followed these population delineations and have assigned most colonies that have been discovered since the status survey was completed to the geographically closest population.

The six Echinacea tennesseensis populations occur within an approximately 400 square kilometer (km 2 ; 154 square miles (mi 2 )) area and include between 2 and 11 colonies each. In 2005, TDEC and the Service confirmed the presence of E. tennesseensis at 36 colonies and counted the number of flowering stems in each (TDEC 2006, pp. 4-5). Fifteen of these are natural colonies, and 21 of the 36 colonies have been established through introductions for the purpose of recovering E. tennesseensis (TDEC 1991, pp. 3-7; TDEC 1996, Appendix I; Lincicome 2008, pers. comm.). Three of these introduced colonies constitute the sixth population that was established at a Designated State Natural Area (DSNA) in the Stones River National Battlefield in Rutherford County (TDEC 1996, Appendix I). We do not consider 2 of the 21 introduced colonies as contributing to recovery and do not include them in our analysis of the current status of E. tennesseensis for reasons explained in the Recovery section of this rule. An additional introduced colony that was not monitored during 2005, but for which TDEC maintains an element occurrence record, brings the number of introduced colonies we consider here to 20 and the total number of colonies considered for this rulemaking to 35.

In assessing the status of Echinacea tennesseensis for this final rule, with respect to the recovery criterion described below, we use data from flowering stem counts conducted by the Service and TDEC (2006, pp. 4-5) in 2005 (Table 1), qualitative data collected at various times since the initial discovery of each colony (TDEC 1996, Appendix I), and quantitative monitoring data from nine natural colonies and five introduced colonies (Tables 2 and 3) (Drew 1991, p. 54; Clebsch 1993, pp. 11-16; Drew and Clebsch 1995, pp. 62-67; TDEC unpublished data). In order to address comments we received in response to the proposed delisting rule, the Service and TDEC undertook a thorough review of the monitoring data collected by TDEC and reanalyzed those data to produce ratios among juvenile and adult stage-classes (Table 2) and to produce density estimates with confidence intervals for each monitored site (Table 3).

Table 1 in the proposed rule to delist Echinacea tennesseensis (75 FR 48896, August 12, 2010) provided estimates of the numbers of individuals in each colony, which were produced based on relationships reported by TDEC (2006, p. 2) between numbers of flowering stems and other demographic classes. Table 1 is revised in this final rule to report only the numbers of flowering stems that were counted at each natural and introduced colony during 2005. We removed the estimates of numbers of adults and total numbers of plants that appeared in the proposed rule because those estimates were based on ratios among stage classes that were calculated using data from a single year, in which the ratio of other stage classes to adults was the highest observed during any year of monitoring for E. tennesseensis, and those data were only from naturally occurring colonies.

Natural colonies, or those not known to have been established through introductions, included 83,895 flowering stems in 2005 (TDEC 2006, p. 6). Introduced colonies, excluding the two mentioned above, accounted for 23,454 flowering stems (TDEC 2006, p. 6). Natural colonies constituted approximately 78 percent of the total flowering stems and introduced colonies approximately 22 percent. In this rule, we use the colony numbers reported by TDEC (1996, Appendix I) and have sequentially assigned additional colony numbers to those which have been discovered since that report was issued. In some instances, there are gaps evident in the sequence of colony numbers discussed, representing colonies that have been documented in the past but were either extirpated or of unknown status at the time of this rule.

Section 4(f) of the Act directs us to develop and implement recovery plans for the conservation and survival of endangered and threatened species unless we determine that such a plan will not promote the conservation of the species. The Act directs that, to the maximum extent practicable, we incorporate into each plan:

(1) Site-specific management actions that may be necessary to achieve the plan's goals for conservation and survival of the species;

(2) Objective, measurable criteria, which when met would result in a determination, in accordance with the provisions of section 4 of the Act, that the species be removed from the list; and

(3) Estimates of the time required and cost to carry out the plan.

However, revisions to the list (adding, removing, or reclassifying a species) must reflect determinations made in accordance with sections 4(a)(1) and 4(b) of the Act. Section 4(a)(1) requires that the Secretary determine whether a species is endangered or threatened (or not) because of one or more of five threat factors. Therefore, recovery criteria must indicate when a species is no longer endangered or threatened by any of the five factors. In other words, objective, measurable criteria, or recovery criteria contained in recovery plans, must indicate when we would anticipate an analysis of the five threat factors under section 4(a)(1) would result in a determination that a species is no longer endangered or threatened. Section 4(b) of the Act requires that the determination be made “solely on the basis of the best scientific and commercial data available.”

Thus, while recovery plans are intended to provide guidance to the Service, States, and other partners on methods of minimizing threats to listed species and on criteria that may be used to determine when recovery is achieved, they are not regulatory documents and cannot substitute for the determinations and promulgation of regulations required under section 4(a)(1) of the Act. Determinations to remove a species from the list made under section 4(a)(1) of the Act must be based on the best scientific and commercial data available at the time of the determination, regardless of whether that information differs from the recovery plan.

In the course of implementing conservation actions for a species, new information is often gained that requires recovery efforts to be modified accordingly. There are many paths to accomplishing recovery of a species, and recovery may be achieved without all criteria being fully met. For example, one or more recovery criteria may have been exceeded while other criteria may not have been accomplished, yet the Service may judge that, overall, the threats have been minimized sufficiently, and the species is robust enough, that the Service may reclassify the species from endangered to threatened or perhaps delist the species. In other cases, recovery opportunities may have been recognized that were not known at the time the recovery plan was finalized. These opportunities may be used instead of methods identified in the recovery plan.

Likewise, information on the species may be learned that was not known at the time the recovery plan was finalized. The new information may change the extent that criteria need to be met for recognizing recovery of the species. Overall, recovery of species is a dynamic process requiring adaptive management, planning, implementing, and evaluating the degree of recovery of a species that may, or may not, fully follow the guidance provided in a recovery plan.

Thus, while the recovery plan provides important guidance on the direction and strategy for recovery, and indicates when a rulemaking process may be initiated, the determination to remove a species from the Federal List of Endangered and Threatened Wildlife is ultimately based on an analysis of whether a species is no longer endangered or threatened. The following discussion provides a brief review of recovery planning for Echinacea tennesseensis as well as an analysis of the recovery criteria and goals as they relate to evaluating the status of the species.

We first approved the Tennessee Coneflower Recovery Plan on February 14, 1983 (Service 1983, 41 pp.) and revised it on November 14, 1989 (Service 1989, 30 pp.). The recovery plan includes one delisting criterion: Echinacea tennesseensis will be considered recovered when there are at least five secure wild populations, each with three self-sustaining colonies of at least a minimal size. A colony will be considered self-sustaining when there are two juvenile plants for every flowering one. Minimal size for each colony is 15 percent cover of flowers over 669 square meters (m 2 ; 800 square yards (yd 2 ); 7,200 square feet (ft 2 )) of suitable habitat. Establishing multiple populations during the recovery of endangered species serves two important functions:

(1) Providing redundancy on the landscape to minimize the probability that localized stochastic disturbances will threaten the entire species, and

(2) Preserving the genetic structure found within a species by maintaining the natural distribution of genetic variation among its populations.

In the case of Echinacea tennesseensis, the need for multiple distinct populations to maintain genetic structure is diminished, as Baskauf et al. (1994, p. 186) determined that the majority of genetic variability within this species is maintained within each population rather than distributed among them. These data were not available at the time the recovery plan was completed. With respect to redundancy, the current number of E. tennesseensis colonies exceeds the total number recommended by the recovery plan for delisting this species, and we believe the current distribution of secured colonies among geographically distinct populations, which are separated by distances of 1.8 to 9 miles (2.9-14.5 km), is adequate for minimizing the likelihood that isolated stochastic disturbances would threaten species.

The criterion in the recovery plan for delisting Echinacea tennesseensis has been met, as described below. Additionally, the level of protection currently afforded to the species and its habitat, as well as the current status of threats, are outlined below in the Summary of Factors Affecting the Species section.

There currently are six geographically defined Echinacea tennesseensis populations, including the five described in the recovery plan (Service 1989, pp. 3-7) and one introduced population at the Stones River National Battlefield (TDEC 1996, Appendix I). Within these populations, there currently are 19 colonies of E. tennesseensis that occur entirely or mostly on protected lands, with five of the populations containing three or more colonies each. The Allvan population is the lone exception, as only one of its two colonies is secure at this time. The 19 secured colonies accounted for 88,773 flowering stems in 2005, or approximately 83 percent of the flowering stems observed; whereas, colonies that we do not consider secure accounted for 18,576 flowering stems, or approximately 17 percent of the flowering stems observed (TDEC 2006, pp. 4-5).

While data on numbers of juvenile plants have not been collected from all colonies, monitoring data that have been collected for this demographic attribute (see Table 2 above) have typically exceeded the value used in defining self-sustaining in the recovery plan— i.e., that there be two juvenile plants for every flowering adult in a colony. The mean ratio of juvenile to adult plants in natural colonies, for a given year of monitoring, has ranged from 1.08 to 10.93, based on data collected at two to six sites per year in 1998, 2000, 2001, 2004, and 2008 (see Table 2 above). The mean of this ratio for each of these natural colonies across all years exceeds the ratio of two juveniles per adult. Ratios of juvenile to flowering adult plants in introduced colonies were first estimated during 2006, when the mean was found to be 6.44 juveniles per adult from a single year of data collected at six introduced colonies and the ratio for each of these colonies was greater than 4 juveniles per adult (see Table 2 above). Based on these data, we believe that those colonies for which ratios of juvenile to adult stage-classes are available meet the required ratio of two juveniles per adult that the recovery plan uses in defining self-sustaining. We believe that these data are representative of the status of Echinacea tennesseensis generally given the distribution of monitored colonies among each of the six populations used for tracking recovery efforts.

We reached our conclusion that this criterion has been achieved in spite of the 2008 assessment data which indicate that the ratio of juveniles to adults was less than 2.0 at the five colonies that were assessed. Drew and Clebsch (1995, p. 67) witnessed considerable variability in mortality rates among stage classes of permanently-tagged Echinacea tennesseensis individuals measured over the periods 1987-1988 and 1988-1989, which they attributed to interannual variability in rainfall. Based on observations in their first year of study, they determined that seedlings—plants with a cumulative leaf length less than 30 cm (11.8 in)—had a high probability ( i.e., approximately 50 percent) of dying during drought conditions (Drew and Clebsch 1995, p. 66) (reference “Summary of Factors Affecting the Species” section for the discussion of the coneflower mature plant's attributes that allow it to endure and remain viable through periods of drought).

However, we have not been able to establish a clear relationship between the amount of rainfall and the ratio of juveniles to adults. We acquired data for monthly departures from normal rainfall for the period 1985 through 2010, collected at the Nashville International Airport, from the National Climatic Data Center (2011) to use in assessing available quantitative monitoring data on Echinacea tennesseensis for patterns related to growing season precipitation data. Figure 1 presents data on the cumulative departure from normal rainfall during March through August for each year. In reviewing these data for potential influence of growing season rainfall on E. tennesseensis ratios of juveniles to adults, we find no clear pattern. For example, Figure 1 suggests that less than normal growing season rainfall during the period 1985 through 1987 would likely have created conditions in which moisture-related stress could have affected plant populations but that situation is not supported by the juvenile-to adult ratios provided in Table 2 for that same time span which show four out of five colonies sampled during 1987 exceeded the two-to-one ratio recommended by the recovery plan. This absence of a clear relationship leads us with no clear conclusion as to why the ratio of juveniles to adults declined in 2008 but we will track this ratio closely as part of our post-delisting monitoring program to ensure that the ratio of juveniles to adults remains at or above the target value in the future.

As part of the delisting criterion stated in the recovery plan, each self-sustaining colony should consist of 15 percent cover of flowers over 669 m 2 (800 yd 2 , 7,200 ft 2 ) of suitable habitat, which has not been met in all cases. However, we have determined that this recommendation of percent coverage of flowers over a particular habitat acreage does not reflect the best available scientific information. Drew and Clebsch (1995, pp. 61-67) conducted monitoring during 1987 through 1989 that established baseline conditions for five of the colonies included in the recovery plan (Service 1989, pp. 3-7); in doing so, they found that percent flower cover of Echinacea tennesseensis at these sites ranged from 2 to 12 percent, never exceeding the 15 percent threshold stipulated in the recovery plan. Total percent cover of all vegetation in the habitats where these colonies occur ranged from 42 to 59 percent, meaning that E. tennesseensis would have to have constituted 25 to 40 percent of the total vegetative cover to have occupied 15 percent flower cover in these sites. In contrast, E. tennesseensis only constituted between 5 and 22 percent of total vegetative cover in plots studied by Drew and Clebsch (1995, p. 63). In addition to the fact that the recovery plan articulated a standard for percent coverage of flowers that was not met by the reference colonies known to exist when the plan was published, a disadvantage of using cover estimates for monitoring a rare species such as E. tennesseensis is that this value can change during the course of a growing season; density estimates, on the other hand, remain fairly stable once seedlings have become established following germination (Elzinga et al. 1998, p. 178).

The recommendation that each colony occupy 669 m 2 (800 yd 2 , 7,200 ft 2 ) of suitable habitat does not reflect the range of variability observed in several natural colonies that have been discovered since the recovery plan was completed. Many of these colonies are constrained by the small patches of cedar glade habitat where they occur and provide evidence of a wider range of natural variability in habitat patch size and colony size in this species that was not recognized at the time the recovery plan was published.

We believe that either total counts of plants in various stage classes within a colony of Echinacea tennesseensis, or sampling within a known area to generate density estimates (TDEC 2005, pp. 3-4, 16-20), provide superior metrics over cover estimates for monitoring trends in population size. Various sampling designs have been used to estimate density per square meter in one or more colonies of each E. tennesseensis population, providing long-term monitoring data to use in judging their stability (Drew and Clebsch 1995, p. 62; TDEC unpublished data). We acknowledge that the confidence intervals are large, reflecting the variability in the data used to produce many of the density estimates (see Table 3 above) produced from the monitoring data for 1998 through 2008. Further, Drew and Clebsch (1995, p. 62) did not provide a measure of precision for the estimated densities they reported from 1987 for some colonies. However, these are the best scientific data available for judging the stability of these populations since initial monitoring data were collected in 1987. We believe that the available quantitative data demonstrate that while E. tennesseensis densities fluctuate over time, the species' density has remained comparable to reference values provided by Drew and Clebsch (1995, p. 62). The exception to this trend is colony 4.1, which was located in a heavily disturbed site and was destroyed sometime after monitoring was conducted during 2004 and before flowering stems were counted at each colony in 2005. Prior to its destruction, estimated densities at this colony exceeded the reference values. Despite the loss of this colony, the recovery criterion for Echinacea tennesseensis has been met.

While quantitative monitoring data are not available for all Echinacea tennesseensis colonies, we believe these monitoring results are indicative of the species' overall viability because they are distributed among its six populations. The monitoring data discussed above in relation to the recovery criterion definition of self-sustaining provide a measure of the sustainability of both natural and introduced populations and also demonstrate the temporal variability both in density and relative abundances of juvenile and adult stage classes. These data, combined with flowering stem counts at all colonies in 2005 (Table 1, TDEC 2006, pp. 4-5) and qualitative data (TDEC 1996, Appendix I, TDEC 2010) for all colonies documenting whether they have persisted over time, changed dramatically in abundance, or are threatened by natural or human-caused factors, are adequate for judging whether the colonies should be considered self-sustaining. Using these data we have determined that 31 out of the total 35 colonies are self-sustaining, 19 of which are the colonies described above as secure. We discuss the available data for each colony below under the subheading Recovery Action (5): Monitor colonies and conduct management activities, if necessary, to maintain the recovered state in each colony.

The current recovery plan identifies six primary actions necessary for recovering Echinacea tennesseensis:

(1) Continue systematic searches for new colonies;

(2) Secure each colony;

(3) Provide a seed source representative of each natural colony;

(4) Establish new colonies;

(5) Monitor colonies and conduct management activities, if necessary, to maintain the recovered state in each colony; and

(6) Conduct public education projects.

Each of these recovery actions has been accomplished. The Service entered into a cooperative agreement with TDEC in 1986, as authorized by section 6 of the Act, for the conservation of endangered and threatened plant species, providing a mechanism for TDEC to acquire Federal funds that have supported much of the work described here. The State of Tennessee and other partners have provided matching funds in order to receive funding from the Service under this agreement.

There were eight colonies of Echinacea tennesseensis known to exist when the recovery plan was completed (Service 1989, pp. 3-7). TDEC and its contractors conducted searches of cedar glades, identified through the use of aerial photography and topographic maps, during the late 1980s through 1990 and found five previously unknown colonies of Echinacea tennesseensis (TDEC 1991, p. 1). Two of these colonies were considered additions to the Vine population (TDEC 1991, p. 2), or population 3 as described in the recovery plan (Service 1989, pp. 4-5). One colony was considered an addition to the Mount View population (TDEC 1991, p. 2), or population 1 of the recovery plan (Service 1989, p. 3). A fourth colony was considered an addition to the Couchville population (TDEC 1991, p. 3), or population 5 of the recovery plan (Service 1989, p. 7). The fifth colony was smaller, not in a natural setting, and not assigned to any of the recovery plan populations in the TDEC report (1991, p. 2). Other colonies have been discovered during the course of surveys conducted in the cedar glades of middle Tennessee, and the number of extant natural colonies now totals 15. A summary of the currently known populations (as well as the natural and introduced colonies they are comprised of) is provided in Table 1 above, and in the discussion concerning recovery action number (5). Because systematic searches for new colonies have been conducted since the completion of the recovery plan and have led to the discovery of previously unknown colonies, we consider this recovery action to be completed.

We have assessed the security of each Echinacea tennesseensis colony based on observations about threats and defensibility ranks reported in the 1996 status survey of this species (TDEC 1996, Appendix I) and information in our files concerning protection actions, such as construction of fences. We consider 14 of the 16 colonies within DSNAs to be secure. The only exceptions to this determination are colonies 2.4 and 2.7, which lie within portions of the extensive Cedars of Lebanon State Forest DSNA that have been threatened by past outdoor recreational vehicle (ORV) use or are generally degraded cedar glade habitat. The State of Tennessee's Natural Area Preservation Act of 1971 (T.C.A. 11-1701) protects DSNAs from vandalism and forbids removal of endangered and threatened species from these areas. TDEC monitors these sites and protects them as needed through construction of fences or placement of limestone boulders to prevent illegal ORV access. We do not consider secure the nine colonies that exist only on private land and are not under some form of recovery protection agreement. The introduced population at the Stones River National Battlefield DSNA consists of three secured colonies requiring no protective management, as access is controlled by the National Park Service (NPS). The site where these colonies are located became a DSNA in 2003.

The recovery plan states that Echinacea tennesseensis will be considered recovered when there are “at least five secure wild populations, each with three self-sustaining colonies of at least a minimal size.” There are now 19 secure, self-sustaining colonies of E. tennesseensis distributed among six populations (see Table 1 above), fulfilling the recovery plan intentions of establishing a sufficient number and distribution of secure populations and colonies to remove the risk of extinction for this species within the foreseeable future. Therefore, we consider this recovery action completed.

The Missouri Botanical Garden (MOBOT), an affiliate institution of the Centers for Plant Conservation (CPC), collected accessions of seeds from each of the six populations currently in existence during 1994 (Albrecht 2008a pers. comm.) and from four of those populations during 2010 (Albrecht 2010, pers. comm.). This collection is maintained according to CPC guidelines (Albrecht 2008b, pers. comm.). Five of the accessions taken by MOBOT were provided to the National Center for Genetic Resource Preservation (NCGRP) in Fort Collins, Colorado, for long-term cold storage. The NCGRP protocol is to test seed viability every 5 years for accession, and MOBOT also tests seed viability on a periodic basis and collects new material for accessions every 10 to 15 years (Albrecht 2008b, pers. comm.).

While these accessions do not contain seed from every unique colony, they represent each of the populations of Echinacea tennesseensis. These accessions provide satisfactory material should establishment of colonies from reintroductions or additional introductions become necessary in the future, as Baskauf et al. (1994, pp. 184-186) concluded that there is a low level of genetic differentiation among populations of E. tennesseensis and the origin of seeds probably is not a critical concern for establishing new populations. Therefore, we consider this recovery action completed.

TDEC (2006, pp. 3-6) reported flowering stem counts for 21 introduced colonies, but we have eliminated two of these from our analysis of the current status of Echinacea tennesseensis. One of these excluded colonies was introduced into a privately owned glade well outside of the known range of the species in Marshall County, consists of only a few vegetative stems, and is of doubtful viability. The other introduced colony that we excluded is located in Rutherford County, approximately 7 miles from the nearest E. tennesseensis population, and is believed to contain hybrids with E. simulata. Hybridization between these two species has not been reported at any other site. The number of flowering stems reported from the monitored colonies during 2005 ranged from only 1 to 6,183, and only one of these colonies had fewer than 100 flowering stems (TDEC 2006, pp. 4-5). An additional introduced colony (2.9) that was not surveyed during 2005, but contained thousands of plants in 2006 (Lincicome 2006, pers. comm.), brings the number of extant introduced colonies to 20. These 20 colonies were established at various times since 1970, through the introductions of seed or transplanted individuals (TDEC 1991, pp. 3-7; TDEC 1996, Appendix I; Lincicome 2008, pers. com.), often from an undocumented or mixed origin with respect to the source populations (Hemmerly 1976, p. 81; Hemmerly 1990, pp. 1-8; TDEC 1991, pp. 4-8; Clebsch 1993, pp. 8-9). Numerous nurseries have grown E. tennesseensis for the purpose of providing seeds and plants for establishing new colonies (TDEC 1991, pp. 3-8). Baskauf et al. (1994, pp. 184-186) determined that less than 10 percent of the genetic variability of E. tennesseensis is distributed among populations and concluded from this low level of differentiation that the origin of seed used in establishing new populations probably is not a critical consideration. We summarize the distribution of these introduced colonies among E. tennesseensis populations in the discussion concerning recovery action number (5) below. Because 20 new colonies have been established, we consider this recovery action completed.

Drew and Clebsch (1995, pp. 62-67; Drew 1991, pp. 9-11) conducted the first monitoring of Echinacea tennesseensis during the summer of 1987, in the primary colony of each of the five populations included in the recovery plan (Service 1989, pp. 3-7). For this monitoring effort, all non-flowering E. tennesseensis were classified as juveniles during quadrat sampling. Clebsch (1993, pp. 11-16) sampled four additional colonies during 1992, and provided ratios among life stage-classes and estimates of total individuals for each, but did not estimate mean density per square meter. Based on results of demographic research by Drew (1991), Clebsch (1993, p. 11) modified stage-class definitions as follows: Adults were plants that produced flowering stems, juveniles were non-flowering plants with cumulative leaf length greater than 30 cm (11.8 in.), and seedlings were non-flowering plants with cumulative leaf length less than 30 cm (11.8 in.).

TDEC (unpublished data) monitored each of the colonies that Drew and Clebsch (1995, pp. 62-67) sampled and one of the colonies Clebsch (1993, pp. 9-11) sampled one or more times in the years 1998, 2000, 2001, 2004, and 2008, and conducted the first quantitative monitoring of five introduced colonies in 2006. TDEC characterized stage classes as follows: Adults are plants that produce flowering stems; juveniles are non-flowering plants with leaves greater than 2 cm (.79 in.) in length; seedlings are non-flowering plants with leaves less than 2 cm (.79 in.) in length.

Table 1, above, lists each of the populations and associated colonies, the date they were first recorded in the Tennessee Natural Heritage Inventory Database (TDEC 2010), the number of flowering stems observed at the colony in 2005 (TDEC 2006, pp. 4-5), whether they are of natural or introduced origin, and whether we consider them to be secure or self-sustaining. Tables 2 and 3, above, present ratios among juvenile and adult stage-classes and estimates of Echinacea tennesseensis mean density per square meter that have been produced from monitoring efforts.

The Mount View population (number 1 in the recovery plan) consisted of a single known colony when the recovery plan was completed (Service 1989, p. 3). This population now includes two more colonies, both introduced, in addition to the original colony 1.1, which is located in Mount View DSNA. These three colonies are located within an approximately 2.5 km 2 (1 mi 2 ) area in Davidson County. The total number of flowering stems counted in the Mount View population in 2005 was 6,278. In 1987, Drew and Clebsch (1995, p. 62) estimated the size of the population at colony 1.1 to be 12,000 plants occupying an area of 830 m 2 (8,934 ft 2 ). TDEC (2006, p. 4) reported 5,430 flowering stems at this site (colony 1.1) in 2005. The mean ratio of juveniles to adults for this colony over 5 years of monitoring is 3.45 (Table 2) and density estimates (Table 3) have remained comparable to or have exceeded the initial estimate provided by Drew and Clebsch (1995, p. 62) for 1987. Colony 1.2 was discovered on private land in 1990 (TDEC 1996, Appendix I, p. III), and Clebsch (1993, p. 18) estimated there were 9,057 plants, bearing 3,506 flowering heads, occupying an area of 682 m 2 (7,341 ft 2 ) in 1992. The colony on private land was bulldozed in 1999. Colony 1.2 now consists of plants introduced onto adjacent U.S. Army Corps of Engineers (COE) lands to provide long-term protection (TDEC 2003, p. 2). While colony 1.2 was reduced in size when the private lands where it occurred were developed, the colony has increased in size since it was relocated onto COE lands and a fence was constructed. TDEC (2006, p. 4) counted 252 flowering stems at colony 1.2 in 2005. Colony 1.4 also was established on COE lands, near a public use area at J. Percy Priest Reservoir, using plants grown at Tennessee Tech University and was estimated to have consisted of 70-80 plants in 1996 (TDEC 1996, Appendix I, p. V). TDEC (2006, p. 5) reported there were 596 flowering stems at colony 1.4 in 2005. Each of the colonies in the Mount View population is considered secure, and the available quantitative and qualitative data indicate they are self-sustaining.

The Vesta population (number 2 in the recovery plan) consisted of two known colonies when the recovery plan was completed (Service 1989, pp. 3-4). This population now consists of eight colonies primarily located within an area of approximately 3 km 2 (1.5 mi 2 ) in Wilson County. Five of these colonies (2.3, 2.4, 2.6, 2.7, and 2.9) were introduced. Colony 2.1 occurs primarily in the Vesta Cedar Glade DSNA, with approximately 15 percent lying outside the DSNA on private lands. Drew and Clebsch (1995, p. 62) estimated that this colony consisted of 20,900 plants occupying an area of 1,420 m 2 (15,285 ft 2 ) in 1987. TDEC (2006, p. 4) counted 7,790 flowering stems at this colony in 2005. The mean ratio of juveniles to adults for this colony over 6 years of monitoring is 3.21 (Table 2), and density estimates (Table 3) have remained comparable to the initial estimate provided by Drew and Clebsch for 1987 (1995, p. 62). Colonies 2.2 and 2.8 are located entirely within the Vesta Cedar Glade DSNA in glade openings that are separated by forested habitat; colony 2.2 was reported in the recovery plan to have consisted of approximately 5,000 plants occupying an area of approximately 140 m 2 (1,500 ft 2 ), in addition to several small clumps that Hemmerly (1976, pp. 81) established from seed. TDEC (1996, Appendix I, p. VII) estimated this colony occupied an area of 374 m 2 (4,026 ft 2 ) in 1996, and counted 4,274 flowering stems at this colony in 2005 (TDEC 2006, p. 4). Colony 2.8 is located in a glade opening, approximately one-tenth of a mile southwest of colony 2.2, and TDEC (2006, p. 5) counted 2,143 flowering stems at this colony in 2005. Colonies 2.3, 2.4, and 2.7 are located in the Cedars of Lebanon State Forest DSNA. Colony 2.3 was planted in 1983 with seeds produced in a Tennessee Valley Authority greenhouse from Vesta population stock; in 1996, TDEC (1996, Appendix I, p. VIII) observed 50 to 100 plants occupying an area of approximately 15 m 2 (161 ft 2 ). TDEC (2006, p. 5) reported there were 139 flowering stems here in 2005. Only one flowering stem was observed at colony 2.4 in 2005 (TDEC 2006, p. 5). Colony 2.7 is a small occurrence believed to have been introduced, but for which no reliable data prior to 2005 exist, at which time 6 flowering stems were counted at this site (TDEC 2006, p. 5). Colony 2.6 was planted at the entrance to Cedars of Lebanon State Park prior to 1982 and was observed in 1996 to include approximately 100 plants (TDEC 1996, Appendix I, p. XI); in 2005 there were 252 flowering stems (TDEC 2006, p. 5). Colony 2.9 was introduced into a powerline right-of-way on private land adjacent to Cedars of Lebanon State Forest in 1994, and was brought to TDEC's attention in 2006, at which time there were thousands of plants (Lincicome 2006, pers. comm.). Of the four secure colonies (2.1, 2.2, 2.3, and 2.8) in this population, available quantitative and qualitative data demonstrate that three are self-sustaining. We do not have historic data for colony 2.8, which was first observed in 2003, but the large number of flowering stems at this colony in 2005 suggests that it also should be self-sustaining. The total number of flowering stems counted in the four secure and self-sustaining colonies of the Vesta population was estimated to be 14,346 in 2005. Colonies that we do not consider secure accounted for 259 flowering stems in 2005.

The Vine population (number 3 in the recovery plan) consisted of three known colonies at the time the recovery plan was completed (Service 1989, pp. 4-6). This population now consists of 11 colonies located within an area of approximately 17 km 2 (7 mi 2 ) in Wilson and Rutherford Counties. Three of these colonies (3.7, 3.8, and 3.9) were introduced. Approximately two-thirds of the land on which colony 3.1 is located lies within Vine Cedar Glade DSNA, with the remaining one-third on private land. Drew and Clebsch (1995, p. 62) estimated that colony 3.1 consisted of 20,200 plants occupying an area of 800 m 2 (8611 ft 2 ) in 1987. TDEC (1996, Appendix I, p. XI-XII) reported the plants occupied about 760 m 2 in 1996, and counted 7,555 flowering stems at this colony in 2005 (TDEC 2006, p. 4). The mean ratio of juveniles to adults for this colony over 5 years of monitoring is 4.54 (Table 2) and density estimates (Table 3) have remained comparable to the initial estimate provided by Drew and Clebsch for 1987 (1995, p. 62). Most of colony 3.2 is located in a site recently acquired by TDEC using a Recovery Land Acquisition Grant and matching State funds for addition to the State's natural areas system and was estimated in the recovery plan to contain as many as 50,000 plants (Service 1989, p. 5). Data are summarized here for four element occurrences that TDEC tracks and which make up this colony. Clebsch (1993, p. 16) estimated a total of 94,537 plants at this colony in 1996, with 29,014 flowering heads, occupying an area of 5,889 m 2 (63,389 ft 2 ), and found that the ratio of juveniles to adults was 1.94; in 2005 there were 25,956 flowering stems (TDEC 2006, p. 4). The portions of the colony that lie entirely or mostly within the recently protected lands contained 24,914 of these flowering stems. Colonies 3.3 through 3.7 occur on private land. Colony 3.3 is located in a site that was highly disturbed and consisted of 90 plants in 1996 (TDEC 1996, Appendix I, p. XIV). This colony contained 11 flowering stems in 2005 (TDEC 2006, p. 4), and remains a small colony of questionable viability today. Colony 3.4 is located in the Gattinger Glade and Barrens DSNA, which is owned by the developers of the Nashville Super Speedway who donated a conservation easement to the State of Tennessee. Clebsch (1993, p. 16) estimated there were 71,576 plants at colony 3.4 in 1992, with 13,355 flowering heads. TDEC estimated this colony occupied an area of 2,723 m 2 (23,310 ft 2 ) in 1996, and reported there were 12,979 flowering stems at this colony in 2005 (TDEC 2006, p. 4). The mean ratio of juveniles to adults for this colony over 3 years of monitoring is 4.78 (Table 2). Clebsch (1993, pp. 9-11) did not provide density estimates for this colony in 1992; however, density estimates produced from monitoring conducted by TDEC in 2004 and 2008 are comparable to those generated for other long-term monitoring sites (Table 3). While damage from ORV use has been observed at this colony in the past (TDEC 1996, Appendix I, p. XV), it has not been noted since the site became a DSNA, and we consider it secure. Clebsch (1993, p. 18) estimated a total of 15,769 plants bearing a total of 3,058 flowering heads at colony 3.5 in 1992, with a ratio of 1.88 juveniles to adults, occupying an estimated area of 669 m 2 (7,201 ft 2 ). TDEC (1996, Appendix I, p. XVI) observed that the density of plants had decreased at this colony in 1996, while the plants occupied a larger area—an estimated 1,483 m 2 (15,963 ft 2 ). TDEC (2006, p. 4) reported 2,529 flowering stems were present at this colony in 2005. TDEC (1996, Appendix I, p. XVII) observed about 50 plants in a 1-m 2 (11-ft 2 ) area at colony 3.6 in 1996, and in 2005 there were 157 flowering stems counted in this colony. Colony 3.7 was established from seeds planted in 1978 and 1979, on private property owned by a native plant enthusiast. While many plants were killed during drought conditions in 1980, TDEC (1996, Appendix I, p. XVIII) reported that there were approximately 250 plants at this colony in 1985, and between 300 and 500 plants in 1996. TDEC (2006, p. 4) reported there were 1,705 flowering stems at this colony in 2005. Colonies 3.8 and 3.9 were established from seeds planted into two sites at Cedars of Lebanon State Forest in 1990 and 1991. In 1996, TDEC (1996, Appendix I, p. XIX) counted 452 plants by surveying eight glades/barrens within the larger complex where colony 3.8 is located. TDEC (2006, p. 5) reported there were 1,863 flowering stems at colony 3.8 in 2005. TDEC (1996, Appendix I, p. XX) observed approximately 200 to 300 plants occupying an estimated area of 51 m 2 (549 ft 2 ) at colony 3.9 in 1996; in 2005, there were 2,744 flowering stems counted at this colony (TDEC 2006, p. 5). We have no data prior to 2005 for colonies 3.10 and 3.11, both of which are located on private land. In 2005, TDEC (2006, p. 5) reported there were 5,374 flowering stems at colony 3.10, which is located near the Nashville Super Speedway; there were 1,935 flowering stems at colony 3.11. Available quantitative and qualitative data indicate that the four secure colonies ( i.e., 3.1, 3.2, 3.4, and 3.9) in this population are self-sustaining, as are six of the non-secure colonies (Table 1). The total number of flowering stems in secured and self-sustaining colonies of the Vine population was 48,192 in 2005. Colonies that we do not consider secure accounted for 14,616 flowering stems in 2005.

The Allvan population (number 4 in the recovery plan) consisted of one known colony (4.1) at the time the recovery plan was completed; two other colonies had been extirpated from this population (Service 1989, p. 6). This population now consists of two introduced colonies on public lands, as colony 4.1 has been lost to disturbance. Drew and Clebsch (1995, pp. 62-64) estimated a total of 3,700 plants at colony 4.1 in 1987, occupying an estimated area of 470 m 2 (5,059 ft 2 ), and noted the vegetation at this site differed from the other colonies probably as a result of human disturbance. TDEC (1996, Appendix I, p. XXI) noted the poor condition of Echinacea tennesseensis plants during a site visit to colony 4.1 in 1996, and observed no plants at this colony in 2005 (TDEC 2006, p. 4). The mean ratio of juveniles to adults for this colony over 4 years of monitoring was 4.52 (Table 2) and density estimates (Table 3) were comparable to or exceeded the initial estimate provided by Drew and Clebsch for 1987 (1995, p. 62), until the colony was destroyed sometime after monitoring was conducted during 2004 and before flowering stems were counted at each colony in 2005. Colonies 4.2 and 4.3 were established from seeds and cultivated juveniles planted on COE lands at J. Percy Priest Reservoir in the years 1989 through 1991 (TDEC 1991, pp. 5-6), and earthen berms have been constructed at both sites to deter ORV traffic and reduce visibility of these colonies. In 1996, colony 4.2 contained many robust adult plants, but few seedlings and non-flowering adults, in an area of 32 m 2 (344 ft 2 ) (TDEC 1996, Appendix I, p. XXII). In 2005, TDEC reported there were 6,183 flowering stems at colony 4.2. TDEC first conducted quantitative monitoring at this colony in 2006, when the ratio of juveniles to adults they sampled was 4.78 (Table 2). The estimated mean density was 11.60 E. tennesseensis per square meter (Table 3). This secure colony is located in the Elsie Quarterman Cedar Glade DSNA, on COE lands at J. Percy Priest Reservoir, and appears to be self-sustaining based on the quantitative and qualitative data available. Colony 4.3 is located near the COE Hurricane Public Access Area. In 1996, this colony consisted of many robust adult plants and abundant juveniles in an area of about 68 m 2 (732 ft 2 ) (TDEC 1996, Appendix I, p. XXIII). In 2005, TDEC (2006, p. 5) counted 385 flowering stems at this colony. TDEC (unpublished data) first conducted quantitative monitoring at this colony in 2006, when the ratio of juveniles to adults they sampled was 11.95 (Table 2). The estimated mean density was 19.50 E. tennesseensis per square meter (Table 3). However, we acknowledge that the confidence intervals for the density estimates at both sites are large, reflecting a high degree of variability among the transects that were sampled at each colony. We believe that colony 4.3 is self-sustaining; however, it is vulnerable to impacts from illegal ORV access as noted above. Based on available data, colony 4.2 is the only secure and self-sustaining colony in the Allvan population.

The Couchville population (number 5 in the recovery plan) consisted of a single known colony spanning approximately eight privately owned tracts when the recovery plan was completed (Service 1989, p. 7). This population now consists of three natural and five introduced colonies, all located within an approximately 2.8-km 2 (1.1-mi 2 ) area of Davidson and Rutherford Counties on lands owned by the State of Tennessee (except for colony 5.2, which is on private land). Drew and Clebsch (1995, p. 62) estimated a total of 89,300 plants at colony 5.1 in 1987, occupying an estimated area of 13,860 m 2 (149,189 ft 2 ). TDEC (2006, p. 4) reported there were 7,353 flowering stems at this site in 2005. The mean ratio of juveniles to adults for this colony over 6 years of monitoring is 3.87 (Table 2) and density estimates (Table 3) have remained comparable to the initial estimate provided by Drew and Clebsch for 1987 (1995, p. 62). Colony 5.2 is divided between two privately owned properties. The plants in this colony are found in habitats of varying quality, having been subjected to past disturbance in some places, and in 1993, vegetative plants were observed occupying an area of approximately 1,823 m 2 (19,623 ft 2 ) (TDEC 1996, Appendix I, p. XXV). TDEC (2006, p. 4) reported there were 392 flowering stems at this colony in 2005. Colonies 5.3 through 5.6 were established from seed and juveniles planted at Long Hunter State Park during 1989 through 1991. TDEC (1996, Appendix I, p. XXVI) observed 428 plants at colony 5.3 in 1996, and noted that they were spread out over a wide area; in 2005, TDEC (2006, p. 4) reported there were 1,607 flowering stems at this colony. TDEC (1996, Appendix I, p. XXVII) observed that a thriving population containing thousands of individuals had become established at colony 5.4 by 1996, and that the plants north of the road dividing this colony occupied an area of 2,153 m 2 (23,175 ft 2 ); in 2005, TDEC (2006, p. 5) counted 863 and 987 flowering stems on the north and south sides of the road, respectively. Colony 5.5 consisted of less than 200 total plants occupying an estimated area of 53 m 2 (570 ft 2 ) in 1996 (TDEC 1996, Appendix I, pp. XXVIII-XXIX); in 2005, there were 1,300 flowering stems (TDEC 2006, p. 4). TDEC (unpublished data) first conducted quantitative monitoring at this colony in 2006, when the ratio of juveniles to adults they sampled was 4.12 (Table 2) and the estimated density was 12.03 Echinacea tennesseensis per square meter (Table 3). Colony 5.6 consisted of approximately 2,000 plants occupying an area of 51 m 2 (549 ft 2 ) in 1996 (TDEC 1996, Appendix I, p. XXIX-XXX); in 2005, there were 846 flowering stems (TDEC 2006, p. 5). Colony 5.7, for which no historic monitoring data are available, is the only naturally occurring colony at Long Hunter State Park. TDEC (2006, p. 4) counted 17 flowering stems here in 2005. Colony 5.8 was established in 2000 at the Fate Sanders Barrens DSNA, located on COE lands at J. Percy Priest Reservoir. This colony is located approximately 3.5 km (2.8 mi) southeast of colony 5.3 in the Couchville population. TDEC planted 199 plants into two areas at this colony in 2000 (Lincicome 2008, pers. comm.) and counted 101 flowering stems in 2005 (TDEC 2006, p. 5). Based on available qualitative and quantitative data, we believe that the secure colonies (5.1, 5.4, 5.6, and 5.8) in the Couchville population are self-sustaining,. We believe that three of the four colonies we consider not secure are also self-sustaining. The total number of flowering stems from the Couchville population in secure and self-sustaining colonies was 10,150 in 2005. Colonies that we do not consider secure accounted for an estimated 3,316 flowering stems in 2005.

The Stones River National Battlefield population ( i.e., population 6, not included in the recovery plan) consists of three colonies established through introductions into an area that is now a DSNA. Colony 6.1 was established from seeds introduced by Hemmerly in 1970 (1976, pp. 10, 81) as part of investigations into seedling survival under field conditions. This colony consists of two groupings of plants, one of which consisted of 3,880 plants and the other of 28 plants in 1995; the colony occupied an area of 39 m 2 (420 ft 2 ) in 1996 (TDEC 1996, Appendix I, p. XXXI). TDEC (2006, p. 4) counted 2,535 flowering stems at this colony in 2005. TDEC first conducted quantitative monitoring at colony 6.1 in 2006, when the ratio of juveniles to adults they sampled was 5.18 (Table 2). The estimated mean density was 41.37 Echinacea tennesseensis per square meter (Table 3), but the confidence interval at this site was large, reflecting a high degree of variability among the sampled transects, some of which contained no plants. Colonies 6.2 and 6.3 are thought to have been established by a neighbor of the battlefield in the mid-1990s (Hogan 2008, pers. comm.) and consisted of 134 and 401 plants, respectively, in 1995 (TDEC 1996, Appendix I, p. XXXII). In 2005, TDEC (2006, p. 4) counted 237 flowering stems at colony 6.2 and 852 flowering stems at colony 6.3. The total number of flowering stems in the Stones River National Battlefield population in 2005 was 3,624 (TDEC 2006, 4). Based on available quantitative and qualitative data, we believe all colonies in this population are secure and self-sustaining.

Numerous partners are involved in managing Echinacea tennesseensis populations on their lands. TDEC compared management options at the Vesta Cedar Glade DSNA, including mowing, discing, burning, and application of selective herbicides for removal of grasses (Clebsch 1993, pp. 2-8). TDEC and TNC have used grazing of goats, mechanical removal, and herbicide applications to control woody species encroachment on the margins of cedar glade openings at Mount View Glade DSNA (TDEC 2003, pp. 4-9). TDEC applies prescribed fire or mechanical removal, as needed and within constraints imposed by locations within the urban interface, to control woody species, including the invasive exotic privet ( Ligustrum sp.), at many DSNAs where E. tennesseensis occurs; these include Mount View Glade, Vesta Cedar Glade, Vine Cedar Glade, Cedars of Lebanon State Forest Natural Area, Gattinger's Cedar Glade and Barrens, Elsie Quarterman Cedar Glade, Fate Sanders Barrens, and Couchville Cedar Glade and Barrens. TDEC works with the Tennessee Division of Forestry (TDF) to ensure that colonies in the Cedars of Lebanon State Forest, which includes three DSNAs, receive necessary management and collaborates with TDF to implement all prescribed burns that are conducted on DSNAs. TDEC also has cooperated with COE on construction of fences or earthen berms around sites at J. Percy Priest Reservoir that have been threatened by urban encroachment and illegal ORV use. The NPS monitors the introduced population at the Stones River National Battlefield and controls woody plant encroachment and vegetation succession in the glade openings where the colonies occur, as necessary.

Because TDEC and other entities have monitored Echinacea tennesseensis populations many times since the time of listing and have managed colonies on protected lands to minimize threats from vegetation succession and ORV use, and will continue to do so in the foreseeable future, we consider this recovery action completed.

Echinacea tennesseensis was featured in newspaper (Paine 2002, p. 6B) and magazine (Simpson and Somers 1990, pp. 14-16; Campbell 1992, p. 32; Daerr 1999, p. 50) articles to educate the general public about the species, the cedar glade ecosystem it occupies, and the conservation efforts directed towards them. The Service published “An Educator's Guide to the Threatened and Endangered Species and Ecosystems of Tennessee,” which includes instructional materials about the cedar glades of middle Tennessee and two Federally listed plant species found in the glades, E. tennesseensis and Astragalus bibullatus (Pyne's ground-plum) (Service no date, pp. 50-53). TDEC personnel periodically lead guided wildflower walks in the cedar glades DSNAs and educate the public about E. tennesseensis and other Federal and State listed plant species during those walks. In 2000, TDEC published 10,000 copies of an educational poster featuring Tennessee's rare plants, including E. tennesseensis. Because numerous public education projects have been conducted, we consider this recovery action completed.

During the open comment period for the proposed rule (75 FR 48896, August 12, 2010), we requested that all interested parties submit comments or information concerning the proposed delisting of Echinacea tennesseensis. We directly notified and requested comments from the State of Tennessee. We contacted all appropriate State and Federal agencies, county governments, elected officials, scientific organizations, and other interested parties and invited them to comment. We also published a newspaper notice in The Tennesseean, a newspaper serving the middle Tennessee region where E. tennesseensis occurs, inviting public comment.

As stated in the proposed rule (75 FR 48896, August 12, 2010), we accepted comments for 60 days, ending October 12, 2010. During the comment period, we received comments from two individuals.

In accordance with our peer review policy published on July 1, 1994 (59 FR 34270), and the Office of Management and Budget's (OMB) December 16, 2004, Final Information Quality Bulletin for Peer Review, we solicited independent opinions from 4 knowledgeable individuals who have expertise with the species, who are within the geographic region where the species occurs, or are familiar with the principles of conservation biology. We received comments from one of the peer reviewers.

We reviewed all comments received from the peer reviewer and the public for substantive issues and new information regarding the proposed delisting of Echinacea tennesseensis. Substantive comments received during the comment period are addressed below and, where appropriate, incorporated directly into this final rule and into the post-delisting monitoring plan.

Issue 1: One commenter requested that we address the site quality for the colonies that comprise the Allvan population and the growth of these colonies over time compared to other colonies, despite the fact that this population is not needed to meet the criteria in the recovery plan that there must be five populations with three secure and self-sustaining colonies each. This request was made because Drew and Clebsch (1995, p. 64) observed during surveys conducted in 1987 that the Allvan site, where colony 4.1 was located, had a much different plant community assemblage than other Echinacea tennesseensis sites due to human disturbance and because the commenter apparently believed that colonies 4.2 and 4.3 also were located at this disturbed site.

Response: Drew and Clebsch (1995, p. 62) concluded that human disturbance had altered the vegetation community at the site where the original colony (4.1) of the Allvan population was located. The dominant species they observed at the Allvan site ( Grindelia lanceolata, Silphium trifoliatum, and Aster pilosus var. priceae ) were absent or present in low frequency at other sites. Conversely, the dominant species from the other sites were only present in low frequency and numbers at the site of colony 4.1. These differences were likely attributable to the intensive use that this site, owned by a trucking company, had experienced. The portion of the property where E. tennesseensis once occurred was used in the past as a discard site for old engine parts and other assorted scrap materials (TDEC 1996, Appendix I, p. XXI). As noted above, the colony at this site was destroyed prior to flowering stem counts in 2005.

Colonies 4.2 and 4.3 of the Allvan site were both established on COE lands, in distinct sites from colony 4.1, from introductions during the years 1989 through 1991. In contrast to the site conditions where colony 4.1 was once located, TDEC (1996, Appendix I, pp. XXI-XXIV) described the habitat at these sites as “dry barrens and glades” (colony 4.2) and “open gravelly glades and barrens” (colony 4.3), but made no observations of atypical composition of associated species present at these sites. While we do not have numbers to specifically address growth rates in colonies 4.2 and 4.3, in the section above addressing recovery action (5), we discuss quantitative monitoring data collected at each of these sites in 2006. Both of these colonies are also included in the Post-delisting Monitoring Plan for Echinacea tennesseensis.

Issue 2: Two commenters supported the use of analyzing variability and trends over time in density metrics derived from count data as a measure of population size, rather than using the Recovery Plan criterion that minimal size for each colony be 15 percent cover of flowers over 800 square yards of suitable habitat. However, one of these commenters expressed concern that the proposed delisting rule reported only one census of the total number of flowering stems along with an extrapolated total number of plants and number of adults ( i.e., flowering plants). This commenter noted that “by choosing to report counts from only one year, annual count fluctuation and sample area size are not considered.” This commenter suggested that stem counts collected by Drew and Clebsch (1995) from their sample plots in the first census of the species in 1987 could be used to establish reference densities, and that more recent site densities calculated from flowering stem counts would be an acceptable substitute for the objective size criterion provided in the Recovery Plan.

Response: We have incorporated available quantitative data on density estimates and ratios of juveniles to adults into this final rule. We did not use data from the 2005 flowering stem counts conducted at all sites (TDEC 2006, pp. 4-5) to estimate flowering stem densities, because the area surveyed was not documented during that effort. We agree with the commenter that estimating the total number of individuals in a colony based on flowering stem counts from a single year is not appropriate and have removed those estimates from Table 1 in this rule, as explained above in the Species Information section.

Issue 3: Two commenters requested more information be presented on the status of the Echinacea tennesseensis populations as it relates to the Recovery Plan criterion that defines self-sustaining populations as those in which there are two juvenile plants for every flowering plant. Specifically, one commenter noted that the proposed rule to delist E. tennesseensis reported that six colonies were sampled once for the juvenile stage class, in 2006, and that the average of these colonies did not meet this criterion. This commenter noted that it was unclear whether these sampled colonies that did not meet the self-sustaining criterion were included in the group of colonies reported in the rule to be self-sustaining, adding that regular recruitment is required for the persistence of a population, or in this case, an introduced colony. The other commenter noted that one must assume that this criterion was applied when determining whether to classify a population as self-sustaining in Table 1 of the proposed rule. Both commenters also requested additional detail concerning how the ratios were derived that were used to estimate (1) numbers of adults based on counts of flowering stems, and (2) numbers of seedlings from estimated numbers of adults, in order to yield the estimated numbers of individuals that were reported in Table 1 of the proposed rule. Specifically, one of the commenters questioned whether the multiplier used to calculate the ratio was an average calculated across monitored colonies, whether multiple years of data were used in calculating this ratio, and whether the accuracy of the ratio in estimating population sizes had been field tested. This commenter also recommended reporting confidence intervals with these estimates to provide a measure of their precision.

Response: The Service and TDEC undertook a thorough review of the monitoring data collected by TDEC and reanalyzed those data to produce ratios among juvenile and adult stage-classes (Table 2, above) and to produce density estimates with confidence intervals for each monitored site (Table 3, above). In doing so, we found errors in the analysis used to determine ratios of juveniles to adults for the introduced colonies for the year 2006. We have incorporated those corrections and provide colony numbers for each colony for which these ratios have been calculated (Table 2, above). We have removed estimates of numbers of adults and total numbers of individuals from Table 1 in this rule, as explained above in the Species Information section. While quantitative data are not available for all colonies to use in determining whether they are self-sustaining, we believe that quantitative data from a representative sample of colonies combined with available qualitative data provide an adequate basis for determining whether the colonies are self-sustaining, as explained above in the Recovery section. Table 1, above, provides a list of all colonies considered in this rule along with our determination of whether each colony is secure, self-sustaining, or both.

Issue 4: Two commenters raised issues related to potential threats associated with climate change, including possible disruption of pollinator services due to potential changes in flowering periods and pollinator behavior; lack of a persistent seed bank to provide resilience to multiple drought years or extreme climatic events; and the potential for increased drought frequency or severity to impact juvenile plants. One of these commenters noted the findings of Drew and Clebsch (1995) that plants with total leaf length < 30 cm were susceptible to a higher rate of mortality due to low drought tolerance. This commenter also pointed out that, according to National Drought Mitigation Center (2010) data, middle Tennessee experienced drought years in 2007 and 2008, including an exceptional drought period from August to September of 2007, and that this drought could have impacted juvenile and other stage classes.

Response: To the extent possible, we address threats related to climate change in the section Summary of Factors Affecting the Species. We do not have sufficient data concerning pollinators of Echinacea tennesseensis, their phenology in relation to phenology of E. tennesseensis, or potential for changes to the phenology of either to specifically address this comment. However, we have no specific data to suggest that climate change is currently a threat to E. tennesseensis or will be in the foreseeable future. We have incorporated information on drought conditions in Middle Tennessee during 2007 and 2008, as well as data on monthly departures from normal rainfall for the period 1985 through 2010, into this rule in the section Recovery and discuss them in relation to available monitoring data.

Section 4 of the Act and its implementing regulations (50 CFR part 424) set forth the procedures for listing, reclassifying, or removing species from the Federal Lists of Endangered and Threatened Wildlife and Plants. “Species” is defined by the Act as including any species or subspecies of fish or wildlife or plants, and any distinct vertebrate population segment of fish or wildlife that interbreeds when mature (16 U.S.C. 1532(16)). Once the “species” is determined we then evaluate whether that species may be endangered or threatened because of one or more of the five factors described in section 4(a)(1) of the Act. We must consider these same five factors in reclassifying or delisting a species. We may delist a species according to 50 CFR 424.11(d) if the best available scientific and commercial data indicate that the species is neither endangered nor threatened for the following reasons: (1) The species is extinct; (2) the species has recovered and is no longer endangered or threatened; and/or (3) the original scientific data used at the time the species were classified was in error.

Under section 3 of the Act, a species is “endangered” if it is in danger of extinction throughout all or a “significant portion of its range” and is “threatened” if it is likely to become endangered within the foreseeable future throughout all or a “significant portion of its range.” The word “range” refers to the range in which the species currently exists, and the word “significant” refers to the value of that portion of the range being considered to the conservation of the species. The “foreseeable future” is the period of time over which events or effects reasonably can or should be anticipated, or trends extrapolated. A recovered species is one that no longer meets the Act's definition of endangered or threatened. Determining whether or not a species is recovered requires consideration of the same five categories of threats specified in section 4(a)(1) of the Act. For species that are already listed as endangered or threatened, the analysis for a delisting due to recovery must include an evaluation of the threats that existed at the time of listing, the threats currently facing the species, and the threats that are reasonably likely to affect the species in the foreseeable future following the delisting or downlisting and the removal of the Act's protections.

The following analysis examines all five factors currently affecting, or that are likely to affect Echinacea tennesseensis within the foreseeable future. In making this final determination, we have considered all scientific and commercial information available, which includes information received during the public comment period on our proposed delisting rule (75 FR 48896, August 12, 2010), reanalyzed data from monitoring conducted during 1998 through 2004, and monitoring data collected in 2008 (TDEC unpublished data).

The final rule to list Echinacea tennesseensis as endangered (44 FR 32604) identified the following habitat threats: Habitat loss due to residential and recreational development and succession of cedar glade communities in which the species occurred.

Losses of cedar glade habitat and colonies of Echinacea tennesseensis to residential development have posed a significant threat to E. tennesseensis. At the time of listing, one population of E. tennesseensis had been reduced in size due to housing construction and another was destroyed during the construction of a trailer park. The three extant occurrences at that time were all located on private lands, one of which was imminently threatened by surrounding residential development. This Davidson County occurrence has since been protected as a DSNA. Approximately two-thirds of the Wilson County occurrence that was on public lands is now a DSNA, and one-third remains on private lands. The Rutherford County occurrence was located in a gravel parking lot of a commercial property and has been destroyed. Since the time of listing, protection of natural colonies on publicly owned conservation lands and establishment of additional colonies through introductions have effectively diminished the threat residential development once posed to the survival of E. tennesseensis.

The final listing rule for Echinacea tennesseensis described recreational development as a threat facing the Davidson County ( i.e., Mount View) population, but did not specifically address the nature of the recreational development. The Mount View, Allvan, and Couchville populations occur in close proximity to J. Percy Priest Reservoir, construction of which was completed in 1967. It is possible that development of recreational facilities following completion of the reservoir presented a threat to E. tennesseensis or cedar glade habitats. However, four of the secure and self-sustaining colonies ( i.e., colonies 1.2, 1.4, 4.2, and 5.8) are located within the now-protected lands buffering the reservoir, three of which were designated as Environmentally Sensitive Areas in the J. Percy Priest 2007 Master Plan Update (U.S. Army Corps of Engineers 2007, pp. 3-1—4-3). Therefore, recreational development no longer poses a threat to the survival of E. tennesseensis.

There are now 27 colonies, distributed among the six populations of Echinacea tennesseensis, which occur entirely or primarily on conservation lands in either State or Federal ownership. The lone exception to public ownership of these conservation lands is the Gattinger Glade DSNA, which is managed by TDEC but privately owned and protected under a conservation easement. We consider 19 of these colonies to be secure and self-sustaining. Sixteen colonies, all but two of which are secure, are located entirely or primarily within DSNAs that were designated at various times between 1974 and 2009. TDEC manages most of these DSNAs, in some cases cooperatively with TDF, for the purpose of conserving E. tennesseensis and the cedar glades and barrens ecosystem that the species depends on for its survival. All but one of these DSNAs lie within or adjacent to State or Federal conservation lands that provide complementary conservation benefits by maintaining functioning ecosystems within which these colonies occur and harboring additional protected colonies of E. tennesseensis.

The non-DSNA lands in the Cedars of Lebanon State Forest also contain three colonies, therefore providing a large, protected cedar glade and forest ecosystem connected to the Vesta Cedar Glade, Vine Cedar Glade, and Cedars of Lebanon State Forest DSNAs. An additional colony is located at the Cedars of Lebanon State Park, which is adjacent to the Cedars of Lebanon State Forest. Long Hunter State Park contains six colonies and provides a functioning ecosystem buffer to the Couchville Cedar Glade and Barrens DSNA. COE lands at J. Percy Priest Reservoir provide habitat for three colonies in addition to the colonies in the Elsie Quarterman Cedar Glade and Fate Sanders Barrens DSNAs that lie within these lands. The Gattinger Cedar Glade is the only DSNA on private land that contains a colony of Echinacea tennesseensis. While this property is not buffered by other public lands, it lies within a large tract of land owned by the Nashville Super Speedway, which has been a partner in the conservation of E. tennesseensis. The three colonies at Stones River National Battlefield are included among the 16 within DSNAs, and lie within a protected buffer provided by NPS lands.

We believe the colonies that are located in DSNAs or on recently acquired lands that will be added to Tennessee's natural area system, with the exceptions of colonies 2.4 and 2.7, will receive adequate long-term protection and necessary management to control vegetation succession and disturbance from human activities, given the statutory protections afforded these lands and TDEC's demonstrated commitment to protecting lands through this mechanism and to maintaining the quality of habitats in the DSNAs. Colonies 2.4 and 2.7 contain an estimated 1 and 6 flowering stems, respectively. The lack of long-term protection and management for these two colonies will not have a significant effect on the status of the species, as these two colonies represent less than one percent of the Vesta population. We expect that the delisting of Echinacea tennesseensis would not weaken TDEC's commitment to the conservation of these DSNAs, several of which harbor one or more Federally listed plant species other than E. tennesseensis. We have also identified five colonies on public lands outside of DSNAs that we consider secure.

Illegal ORV activity remains an issue for three colonies on public lands, which we have not counted among the 19 secure colonies. TDEC has worked to reduce this threat in several DSNAs by constructing barbed wire fences and barriers using limestone boulders. The COE has also extended efforts in the form of constructing fences or earthen berms or both near three colonies on lands at J. Percy Priest Reservoir to reduce this threat. Damage from ORV activity was noted by TDEC (1996, Appendix I) at only one of the 9 colonies located exclusively on private lands that are not under recovery protection agreements, none of which were counted among the 19 secure colonies in this rule. While illegal ORV use remains a concern throughout the range of Echinacea tennesseensis (TDEC 1996, p. 21 and Appendix I), we do not have evidence to suggest that such activity is occurring at a magnitude that makes E. tennesseensis likely to become endangered in the foreseeable future.

Habitat loss or modification in the form of ORV activity has been observed at four colonies (TDEC 1996, Appendix I), and recovery protection agreements are lacking at nine colonies that exist solely on private lands, leaving them vulnerable to habitat disturbance. However, we believe that Echinacea tennesseensis is neither endangered nor threatened as a result of habitat loss or modification because there are 19 secure and self-sustaining colonies distributed among six geographically defined populations. Management of these colonies to reduce threats to E. tennesseensis and its habitat is coordinated by TDEC in cooperation with other partners. Examples of these management activities were provided under number (5) in the Recovery section.

The listing rule for Echinacea tennesseensis (44 FR 32604) identified vegetation succession as a threat to the species and the cedar glades it depends on for its survival. A status survey for the species, completed in 1996 (TDEC 1996, p. 22), did not address this threat in its analysis of factors affecting the survival of the species, but it did recommend controlling vegetation succession at some sites in the appendix containing population and site status reports. TDEC has developed a program for managing vegetation succession and other threats to cedar glades on DSNAs inhabited by E. tennesseensis and two other Federally listed species, and continues to work cooperatively with TDF, Tennessee State Parks, and COE to manage potential threats in habitats where colonies exist on properties belonging to these agencies. Further, we are not aware of any colonies of E. tennesseensis that have been lost to vegetation succession.

Summary of Factor A: Because we expect that the lands containing the 19 secure and self-sustaining colonies, which accounted for approximately 83 percent of the total flowering stems estimated to exist in 2005, will remain permanently protected and will be managed to maintain cedar glade habitat and no known colonies have been lost to vegetation succession, we find that the present or threatened destruction, modification, or curtailment of its habitat or range has been effectively diminished to the point that it is no longer a threat to Echinacea tennesseensis.

The final rule to list Echinacea tennesseensis as endangered (44 FR 32604) identified collection for commercial and recreational purposes as a threat to the species. Limited digging, presumably for horticultural purposes, has been observed in the past at five colonies of E. tennesseensis, three ( i.e., colonies 5.3, 5.5, and 5.6) of which are located in high visibility areas within Long Hunter State Park (TDEC 1996, p. 21). We do not consider these three colonies or a fourth ( i.e., colony 3.5) located on private land to be secure for the purposes of this rule. We consider colony 4.2, where digging has been observed in the past, to be secure because it became a DSNA in 1998, and no evidence of digging at this site has been recorded since 1996. Echinacea tennesseensis that originated from natural populations, but is now grown from seed or vegetative propagules produced in nurseries, is available for interstate commerce from one nursery under the authority of the Act through a section 10(a)(1)(A) permit. These plants are also for sale by multiple nurseries only within Tennessee, thus not requiring a permit under section 10(a)(1)(A) of the Act. TDEC regulates commerce of plants listed as endangered by the State of Tennessee through issuance of permits for this purpose, as authorized by the Tennessee Rare Plant Protection Act of 1985 (T.C.A. 11-26-201). There are also at least two cultivars of E. tennesseensis, which are of hybrid origin, now available for interstate commerce and easily found on the Internet. We do not believe cultivars are a threat to the Tennessee purple coneflower because planting of these individuals is not allowed on public and state owned property where wild populations occur.

The genus Echinacea has long been used for medicinal purposes by Native Americans and is commercially available as a popular homeopathic supplement. However, the primary species used in commercial medicinal applications and studied for their medicinal properties do not include E. tennesseensis (Senchina et al. 2006, p. 1). We are not aware of collections of this species being taken for this purpose and do not believe this poses a threat to this species currently or into the foreseeable future.

Summary of Factor B: Echinacea tennesseensis and hybrids displaying the attractive traits of the species are readily available commercially, and poaching has been observed in the past at only five colonies, one of which we counted as secure in our analysis for this delisting rule because this colony became a DSNA in 1998, and no evidence of activity has occurred since 1996. In addition, E. tennesseensis is not among the primary species of Echinacea used for medicinal applications. Therefore, we find that overutilization for commercial, recreational ( i.e., gardening), scientific, or educational purposes is no longer a threat to E. tennesseensis.

The listing rule for Echinacea tennesseensis (44 FR 32604) stated that light grazing occurred at colony 3.2 but acknowledged that the degree of threat, if any, posed by this grazing was uncertain. A robust population of E. tennesseensis remains at this site today, much of which was recently acquired by TDEC for addition to Tennessee's natural area system. Deer browse has been identified as an impact at the three colonies in Stones River National Battlefield (TDEC 1996, Appendix I, pp. XXXI-XXXIII) and at colony 5.5 (TDEC 2007, p. 5). However, we have no data to suggest that such browsing currently threatens these colonies, which have persisted since being established by introductions 10 or more years ago.

Summary of Factor C: Because we have no data to suggest that either grazing or deer browse threaten any colonies, we find that disease or predation is not a threat to Echinacea tennesseensis.

When Echinacea tennesseensis was listed, the final rule to list E. tennesseensis as endangered (44 FR 32604) identified the lack of State protections as a threat to the species. Echinacea tennesseensis is now listed as endangered by the State of Tennessee and is protected under the Tennessee Rare Plant Protection Act of 1985 (T.C.A. 11-26-201), which forbids persons from knowingly uprooting, digging, taking, removing, damaging, destroying, possessing, or otherwise disturbing for any purpose, any endangered species from private or public lands without the written permission of the landowner. While this legislation does not forbid the destruction of E. tennesseensis or its habitat with landowner permission, neither does the Act afford such protection to listed plants. Regardless, as discussed in Factor A above, destruction, modification, or curtailment of its habitat or range is no longer a threat. Furthermore, those colonies located in DSNAs are afforded additional protection by the State of Tennessee's Natural Area Preservation Act of 1971 (T.C.A. 11-1701), which protects DSNAs from vandalism and forbids removal of State endangered and threatened species from these areas.

Summary of Factor D: While it is possible that the State of Tennessee could determine that Echinacea tennesseensis should be removed from the State's endangered plant list of Tennessee if the species is removed from the Federal List of Endangered and Threatened Plants, we believe that the protected status of the lands where the 19 secure colonies currently exist will continue to provide adequate regulatory protection for those colonies even if State delisting occurs. Therefore, we find that the inadequacy of existing regulatory mechanisms is no longer a threat to E. tennesseensis.

TDEC (1996, p. 2) identified low levels of genetic variability in Echinacea tennesseensis as a threat but did not report any deleterious effects of diminished genetic variability, such as inbreeding depression, that would indicate this factor poses a threat to this species. Baskauf et al. (1994, p. 186) documented low levels of genetic variability in E. tennesseensis, but also observed that this species is not devoid of genetic variability and is evidently well adapted to its cedar glade habitat. They noted that given the relatively large sizes of many of the naturally occurring populations, random genetic drift should not erode genetic variability in E. tennesseensis very rapidly. They suggested that dramatic population fluctuations or extinction and colonization events could have occurred historically and eroded genetic variability (Baskauf et al. 1994, p. 186). However, it is possible that this species might never have possessed high levels of genetic variability (Walck et al. 2002, p. 62). Reduction of genetic diversity could affect the viability of the introduced colonies, as they could be subject to losses in genetic variability that result from establishing colonies from a subset of the total genetic structure found in the species ( i.e., the founder effect) (Allendorf and Luikart 2007, p. 129). We have no information concerning the genetic structure of introduced colonies compared to naturally occurring ones, but this could be a factor to investigate if introduced colonies are found to be less stable than natural colonies through future monitoring. At this time, however, we do not believe that low genetic variability threatens E. tennesseensis.

The Intergovernmental Panel on Climate Change (IPCC) concluded that evidence of warming of the climate system is unequivocal (IPCC 2007a, p. 30). Numerous long-term climate changes have been observed including changes in arctic temperatures and ice, widespread changes in precipitation amounts, ocean salinity, wind patterns and aspects of extreme weather including droughts, heavy precipitation, heat waves, and the intensity of tropical cyclones (IPCC 2007b, p. 7). While continued change is certain, the magnitude and rate of change is unknown in many cases. Species that are dependent on specialized habitat types, that are limited in distribution, or that have become restricted to the extreme periphery of their range will be most susceptible to the impacts of climate change. As stated above, Echinacea tennesseensis is only found in limestone barrens and cedar glades habitats of the Central Basin, Interior Low Plateau Physiographic Province, in Davidson, Rutherford, and Wilson Counties in Tennessee. Within this ecosystem, E. tennesseensis inhabits both xeric (dry) communities, where there is no soil or soil depth less than 5 cm (2 in.) and subxeric (moderately dry) communities on soils deeper than 5 cm (2 in.).

Estimates of the effects of climate change using available climate models lack the geographic precision needed to predict the magnitude of effects at a scale small enough to discretely apply to the range of Echinacea tennesseensis. However, data on recent trends and predicted changes for the Southeast United States (Karl et al. 2009, pp. 111-116) provide some insight for evaluating the potential threat of climate change to E. tennesseensis. Since 1970, the average annual temperature of the region has increased by about 2 °F, with the greatest increases occurring during winter months. The geographic extent of areas in the Southeast region affected by moderate to severe spring and summer drought has increased over the past three decades by 12 and 14 percent, respectively (Karl et al. 2009, p. 111). These trends are expected to increase.

Rates of warming are predicted to more than double in comparison to what the Southeast has experienced since 1975, with the greatest increases projected for summer months. Depending on the emissions scenario used for modeling change, average temperatures are expected to increase by 4.5 °F to 9 °F by the 2080s (Karl et al. 2009, pp. 111). While there is considerable variability in rainfall predictions throughout the region, increases in evaporation of moisture from soils and loss of water by plants in response to warmer temperatures are expected to contribute to the effect of these droughts (Karl et al. 2009, pp. 112).

Despite the observations of Drew and Clebsch (1995, p. 66) that seedlings had an approximately 50-percent probability of dying during the drought conditions that occurred during their first year of study, we believe there is biological and historical evidence to suggest that Echinacea tennesseensis is well-adapted to endure predicted effects of climate change. First, Drew and Clebsch (1995, p. 66) found that stage-specific mortality rates during the drought conditions of their first year of study for non-reproductive E. tennesseensis plants with a cumulative leaf length greater than 30 cm (12 in) ( i.e., non-seedling, vegetative plants) and plants that were reproductively active ranged from 17 to 31 percent, considerably lower than rates observed in seedlings. Second, Hemmerly (1976, p. 12) found that mature plants possessed several roots averaging 38.4 cm (15.1 in.) length and extending an average depth of 23.1 cm (9.1 in.) into the soil, often branching horizontally after reaching an impenetrable rock layer. These observations suggest that while seedlings face higher risks of mortality to drought conditions, this species possesses biological characteristics that increase drought resistance in later life-history stages. That non-seedling life stages of E. tennesseensis are more resilient to drought than seedlings is supported by Drew and Clebsch's (1995, p. 67) observation of demographic patterns in flowering individuals. During 1988, 41 percent of the plants that they observed flowering during 1987 failed to do so, presumably influenced by drought. However, 68 percent of those plants that failed to flower during 1988 produced flowers again during 1989, when annual rainfall levels increased. This ability to vary flower production in relation to annual rainfall levels, combined with its apparently long-lived habit (Baskauf 1993, p. 37), should enable E. tennesseensis to remain viable through periods of drought.

Studies examining the influence of genetic, ecological, and physiological factors on the distribution of Echinacea tennesseensis have not found sufficient differences between this species and more widespread congeners to explain its endemism in the cedar glades of middle Tennessee based on these factors alone (Baskin et al. 1997, p. 385; Baskauf and Eickmeier 1994, p. 963; Snyder et al. 1994, p. 64). Rather, it has been suggested that historical and ecological factors contributed to the evolution of this species and its subsequent restriction to cedar glade habitats in middle Tennessee (Baskin et al. 1997, p. 385). Baskin et al. (1997, pp. 390-391) suggested that an ancestral form of E. tennesseensis migrated to and became established in middle Tennessee during the Hypsithermal Interval ( i.e., the period of greatest post-glacial warming, ca. 8,000 to 5,000 years before present), and that as temperatures became cooler, the only members of this ancestral taxon that survived were those growing in the cedar glades of the region — i.e., the plants that eventually gave rise to E. tennesseensis.

While predictions of increased drought frequency, intensity, and duration suggest that seedling survival could be a limiting factor for Echinacea tennesseensis, the species possesses other biological traits ( i.e., long life span, interannual reproductive variability) to provide resilience to this threat. In their analyses of life-history traits in relation to potential vulnerability to variability in demographic vital rates caused by increased variability in climatic patterns, Morris et al. (2008, p. 22) and Dalgleish et al. (2010, p. 216) concluded that longer-lived species should be less influenced by climate-driven increases in demographic variability. Further, predicted climate changes for the Southeast could, similar to what is believed to have taken place during the Hypsithermal Interval (Delcourt et al. 1986, p. 135), lead to an expansion of openings within forested areas of middle Tennessee, potentially increasing the area occupied by cedar glades communities. This presumably would increase the amount of suitable habitat available for E. tennesseensis. Based on these factors and the fact that we have no evidence that climate changes observed to date have had any adverse impact on E. tennesseensis or its habitat, we do not believe that climate change is a threat to E. tennesseensis now or within the foreseeable future.

Summary of Factor E: Because (1) management activities take place to prevent the loss of 19 secure Echinacea tennesseensis colonies, (2) 31 colonies are considered self-sustaining, as measured by persistence and demographic stability over time (despite low levels of genetic variation within the species), (3) there is biological and historical evidence to suggest that E. tennesseensis is well-adapted to endure predicted effects of climate change, and (4) we have no evidence that climate changes observed to date have had any adverse impact on E. tennesseensis or its habitat, we find that other natural or manmade factors considered here are no longer a threat to E. tennesseensis. Post delisting monitoring will also afford an opportunity to monitor the impacts of any natural events that occur, such as a drought similar to the one in 2007 and 2008, for five growing seasons to ensure that E. tennesseensis no longer requires protection as a listed species.

We have carefully assessed the best scientific and commercial information available regarding the threats faced by Echinacea tennesseensis in developing this rule. As identified above, site protection and habitat management efforts by TDEC, working cooperatively with TDF, TNC, COE, the Service, and private landowners, has reduced habitat loss from residential and recreational development so that it is no longer a threat. Potential effects of ORV use, illegal and otherwise, in habitats containing colonies of E. tennesseensis remain. While disturbance from ORV use has been observed in the past and remains unaddressed at four colonies ( i.e., colonies 2.4, 3.6, 3.8, and 4.3) on publicly and privately owned lands harboring E. tennesseensis, these four colonies accounted for only 2 percent of the species' total distribution in 2005. Most of the largest colonies are located in DSNAs and are protected from this threat by fences or other barriers that TDEC has constructed and maintained. At the time the 1989 recovery plan was written, there were five extant populations ranging in size from approximately 3,700 to 89,000 plants and consisting of one to three colonies each (Clebsch 1988, p. 14; Service 1989, p. 2). There was an estimated total of 146,000 individual plants in 1989 (Drew and Clebsch 1995, p. 62). Recovery efforts have secured habitat for 19 colonies that are self-sustaining and distributed among six geographically defined populations. These 19 secured colonies accounted for 88,773 flowering stems in 2005, or approximately 83 percent of the flowering stems observed; whereas, colonies that we do not consider secure accounted for 18,576 flowering stems, or approximately 17 percent of the flowering stems observed (TDEC 2006, pp. 4-5). The number of secured plants and colonies is adequate to ensure that Factor A is no longer a threat to the species overall. Thus, destruction and modification of habitat from ORV use is not a threat to the species throughout all its range now or into the foreseeable future.

The final rule that listed Echinacea tennesseensis as endangered (44 FR 32604) identified the overuse of this species for commercial or scientific ( i.e., medicinal) purposes as a potential threat to this species. This threat has not materialized, and we do not believe it will in the future due to the emphasis on use of three other species from the genus Echinacea for this purpose. Neither do livestock grazing, as identified in the listing rule, nor browse by herbivores threaten E. tennesseensis.

The State of Tennessee enacted the Rare Plant Protection Act of 1985, addressing the inadequacy of existing regulatory mechanisms for protecting this species at the time it was listed. Should the State of Tennessee remove Echinacea tennesseensis from its List of Endangered Plants, we believe that the protected status of the lands where the 19 secure colonies currently exist will continue to provide adequate regulatory protection for those colonies. Also, TDEC's program for managing vegetation succession and other threats to cedar glade habitats on DSNAs inhabited by E. tennesseensis and their cooperative efforts with TDF, Tennessee State Parks, and COE to manage threats in habitats where colonies exist on properties under their jurisdictions have been effective in maintaining habitats in the absence of disturbances from ORV activity.

Baskauf et al. (1994, p. 186) documented low levels of genetic variability in Echinacea tennesseensis, but also observed that this species is not devoid of genetic variability and is evidently well adapted to its cedar glade habitat. They noted that given the relatively large sizes of many of the naturally occurring populations, random genetic drift should not erode genetic variability in E. tennesseensis very rapidly. We do not believe that low genetic variability threatens E. tennesseensis now or within the foreseeable future.

Based on biological evidence and historical factors discussed above in relation to the potential threat of climate change, and the fact that we have no evidence that climate changes observed to date have had any adverse impact on Echinacea tennesseensis or its habitat, we do not believe that climate change is a threat to E. tennesseensis now or within the foreseeable future.

With respect to Echinacea tennesseensis, we have sufficient evidence (see Summary of Factors Affecting the Species section above) to show that all of the threats identified at or since the time of listing are no longer significant threats to the species, and are not likely to become threats in the foreseeable future. We believe that the 19 secure, self-sustaining colonies distributed among six populations are secure for the foreseeable future from the threats currently affecting the species and those identified at the time of listing. These 19 colonies are located on protected conservation lands, the long-term management of which we believe precludes threats due to residential or recreational development and succession of cedar glade communities for the foreseeable future. Based on the analysis above and given the reduction in threats, Echinacea tennesseensis does not currently meet the Act's definition of endangered in that it is not in danger of extinction throughout all of its range, nor the definition of threatened in that it is not likely to become endangered in the foreseeable future throughout all its range.

Having determined that Echinacea tennesseensis does not meet the definition of endangered or threatened throughout its range, we must next consider whether there are any significant portions of its range that are in danger of extinction or likely to become endangered. A portion of a species' range is significant if it is part of the current range of the species and is important to the conservation of the species as evaluated based upon its representation, resiliency, or redundancy.

If we identify any portions of a species' range that warrant further consideration, we then determine whether in fact the species is endangered or threatened in any significant portion of its range. Depending on the biology of the species, its range, and the threats it faces, it may be more efficient for the Service to address the significance question first and in others the status question first. Thus, if the Service determines that a portion of the range is not significant, the Service need not determine whether the species is endangered or threatened there. If the Service determines that the species is not endangered or threatened in a portion of its range, the Service need not determine if that portion is significant.

For Echinacea tennesseensis, we applied the process described above to determine whether any portions of the range warranted further consideration. The potential threats identified above are fairly uniform throughout the range of the species; however, they are more pronounced on privately owned lands where the species occurs. As discussed above, a portion of a species' range is significant if it is part of the current range of the species and is important to the conservation of the species because it contributes meaningfully to the representation, resiliency, or redundancy of the species. The contribution must be at a level such that its loss would result in a decrease in the ability to conserve the species. While there is some variability in the habitats occupied by E. tennesseensis across its range, the basic ecological components required for the species to complete its life cycle are present throughout the habitats occupied by the six populations. No specific location within the current range of the species provides a unique or biologically significant function that is not found in other portions of the range. The currently occupied range of E. tennesseensis encompasses approximately 400 km 2 (154 mi 2 ) in Davidson, Rutherford, and Wilson Counties, Tennessee. We have determined that 19 secure and self-sustaining colonies presently are distributed among the six populations of E. tennesseensis, which accounted for approximately 83 percent of the total individuals estimated to exist in 2005. Sixteen additional colonies account for the remaining 17 percent of the total individuals estimated to exist in 2005 and are not considered secure. However, we do not consider these unsecured colonies to be a significant portion of the range of this species because these colonies provide no unique or biologically significant function that is not provided by the 19 secured and self-sustaining colonies.

In conclusion, major threats to Echinacea tennesseensis have been reduced, managed, or eliminated. Although the impacts to E. tennesseensis habitat are fairly uniform throughout the range of the species, they are more pronounced on privately owned lands where the species occurs. However, we do not consider these unsecured colonies to be a significant portion of the range of this species. Therefore, we have determined that E. tennesseensis is not in danger of becoming extinct throughout all or a significant portion of its range nor is it likely to become endangered now or within the foreseeable future throughout all or any significant portion of its range. On the basis of this evaluation, we believe E. tennesseensis no longer requires the protection of the Act, and we remove E. tennesseensis from the Federal List of Endangered and Threatened Plants (50 CFR 17.12(h)).

This rule will revise 50 CFR 17.12(h) to remove Echinacea tennesseensis from the List of Endangered and Threatened Plants. Because no critical habitat was ever designated for this species, this rule will not affect 50 CFR 17.96.

The Act and its implementing regulations set forth a series of general prohibitions and exceptions that apply to all endangered plants. The prohibitions under section 9(a)(2) of the Act make it illegal for any person subject to the jurisdiction of the United States to import or export, transport in interstate or foreign commerce in the course of a commercial activity, sell or offer for sale in interstate or foreign commerce, remove and reduce Echinacea tennesseensis to possession from areas under Federal jurisdiction, or remove, cut, dig up, or damage or destroy E. tennesseensis on any other area in knowing violation of any State law or regulation such as a trespass law. Section 7 of the Act requires that Federal agencies consult with us to ensure that any action authorized, funded, or carried out by them is not likely to jeopardize the species' continued existence. This rule will revise 50 CFR 17.12(h) to remove (delist) E. tennesseensis from the Federal List of Endangered and Threatened Plants and these prohibitions would no longer apply. Delisting E. tennesseensis is expected to have positive effects in terms of increasing management flexibility by State and Federal governments.

Section 4(g)(1) of the Act requires us to monitor for at least 5 years species that are delisted due to recovery. Post-delisting monitoring refers to activities undertaken to verify that a species delisted due to recovery remains secure from the risk of extinction after the protections of the Act no longer apply. The primary goal of post-delisting monitoring is to monitor the species so that its status does not deteriorate, and if a decline is detected, to take measures to halt the decline so that proposing it as endangered or threatened is not again needed. If at any time during the monitoring period, data indicate that protective status under the Act should be reinstated, we can initiate listing procedures, including, if appropriate, emergency listing.

Section 4(g) of the Act explicitly requires cooperation with the States in development and implementation of post-delisting monitoring programs, but we remain responsible for compliance with section 4(g) and, therefore, must remain actively engaged in all phases of post-delisting monitoring. We also seek active participation of other entities that are expected to assume responsibilities for the species' conservation after delisting. In August 2008, TDEC agreed to be a cooperator in the post-delisting monitoring of E. tennesseensis.

We have finalized a Post-Delisting Monitoring Plan (Plan) for Echinacea tennesseensis (USFWS 2011, entire). The Plan: (1) Summarizes the species' status at the time of delisting; (2) defines thresholds or triggers for potential monitoring outcomes and conclusions; (3) lays out frequency and duration of monitoring; (4) articulates monitoring methods, including sampling considerations; (5) outlines data compilation and reporting procedures and responsibilities; and (6) depicts a post-delisting monitoring implementation schedule, including timing and responsible parties.

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. The OMB regulations at 5 CFR 1320.3(c) define a collection of information as the obtaining of information by or for an agency by means of identical questions posed to, or identical reporting, recordkeeping, or disclosure requirements imposed on, 10 or more persons. Furthermore, 5 CFR 1320.3(c)(4) specifies that “ten or more persons” refers to the persons to whom a collection of information is addressed by the agency within any 12-month period. For purposes of this definition, employees of the Federal government are not included. This rule and our final Post-Delisting Monitoring Plan do not contain any new collections of information that require approval by OMB under the Paperwork Reduction Act. This rule will not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

We have determined that we do not need to prepare an environmental assessment or environmental impact statement, as defined in the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ), in connection with regulations adopted pursuant to section 4(a) of the Endangered Species Act. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244).

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 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.

A complete list of references cited is available on http://www.regulations.gov under docket number FWS-R4-ES-2010-0059.

The primary author of this document is Geoff Call, Tennessee Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT ).

Accordingly, we hereby amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below: