I. Background

On December 21, 2000, the Secretary established within the National Organic Program (NOP) (7 CFR part 205), the National List regulations §§ 205.600 through 205.607. This National List identifies synthetic substances that may be used and nonsynthetic (natural) substances that may not be used in organic production. The National List also identifies nonagricultural synthetic, nonsynthetic nonagricultural and nonorganic agricultural substances that may be used in organic handling. The Organic Foods Production Act of 1990 (OFPA), as amended, (7 U.S.C. 6501 et seq. ), and the NOP regulations, in § 205.105, specifically prohibit the use of any synthetic substance in organic production and handling unless the synthetic substance is on the National List. Section 205.105 also requires that any nonorganic agricultural and any nonsynthetic nonagricultural substance used in organic handling must also be on the National List.

Under the authority of the OFPA, as amended (7 U.S.C. 6501-6522), the National List can be amended by the Secretary based on recommendations developed by the NOSB. Since established, the NOP has published multiple 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); December 13, 2010 (75 FR 77521); March 14, 2011 (76 FR 13504); August 3, 2011 (76 FR 46595); February 14, 2012 (77 FR 8089); May 15, 2012 (77 FR 28472); and June 6, 2012 (77 FR 33290). Additionally, proposed amendments to the National List were published on January 12, 2012 (77 FR 1980), and on February 6, 2012 (77 FR 5717).

This final rule amends the National List to enact three recommendations submitted to the Secretary by the NOSB on October 28, 2010, and April 29, 2011. One recommendation addressed the annotation for tetracycline in organic crop production. The other recommendations pertained to the addition of two substances, formic acid for use in organic livestock production and attapulgite for use in organic handling.

Tetracycline is a broad-spectrum antibiotic for control of bacteria, fungi and mycoplasma-like organisms which functions by inhibiting protein synthesis in bacteria and altering bacterial membranes so that vital genetic material is leaked. For regulatory purposes, Environmental Protection Agency (EPA) uses the term oxytetracycline to refer to pesticides containing either calcium oxytetracycline or hydroxytetracycline monohydrochloride (oxytetracycline hydrochloride). Oxytetracycline is registered with the EPA for the following agronomic uses: fire blight of apples, pears, peaches and nectarines; pear decline; bacterial spot on peaches and nectarines; lethal yellowing of coconut palm; and lethal decline of pritchardia palm.

The current listing for tetracycline on the National List at § 205.601(i)(12) is as follows:

Tetracycline, for fire blight control only and for use only until October 21, 2012.

Tetracycline (oxytetracycline calcium complex) was added to the National List by a final rule published in the Federal Register on December 21, 2000 (65 FR 80548). Since 2000, four notices have been published announcing the meetings of the NOSB and its planned deliberations involving the use of tetracycline in organic crop production. The four notices were published in the Federal Register as follows: (1) 71 FR 14493, March 22, 2006 (to consider the sunset recommendation for the continued listing of oxytetracycline calcium complex for fire blight control); (2) 73 FR 18491, April 4, 2008 (to consider a recommendation to add a second form of tetracycline, oxytetracycline hydrochloride, as plant disease control for all diseases on the crops registered by EPA); (3) 73 FR 54781, September 23, 2008 (to consider a recommendation to add a second form of tetracycline, oxytetracycline hydrochloride, for fire blight control and to place an expiration date on the use of all forms); and (4) 76 FR 12013, March 4, 2011 (to consider removal of the expiration date of tetracycline for fire blight control). The most recent final rule pertaining to tetracycline added an allowance for the use of oxytetracycline hydrochloride, and added an expiration date of October 21, 2012. This rule was published in the Federal Register on July 6, 2010 (75 FR 38693).

In October 2010, a petition was submitted to the NOSB to remove the expiration date for tetracycline. In effect, the petitioner requested an allowance for the use of tetracycline to control fire blight in organic apples and pears beyond the substance's current expiration date of October 21, 2012. On April 29, 2011, the NOSB issued a recommendation to extend the use of tetracycline to control fire blight in apples and pears only until October 21, 2014, by a vote of 13 in favor and 1 against. Consistent with this NOSB recommendation, AMS published a proposal on November 8, 2011 to amend the annotation for tetracycline by extending its use for fire blight control in apples and pears only until October 21, 2014 (76 FR 61941).

Formic acid was petitioned for use in May 2010, as a pesticide for suppression of Varroa mites. 1 The Environmental Protection Agency (EPA) has exempted synthetic formic acid from the requirement of a tolerance in or on honey and honeycomb when used to control tracheal mites and suppress Varroa mites in bee colonies, and applied in accordance with label use directions (40 CFR 180.1178). 2

At its October 25-28, 2010, meeting, the NOSB recommended adding formic acid to the National List for use in organic livestock production solely as a pesticide within honeybee hives. Consistent with this NOSB recommendation, AMS published a proposal on November 8, 2011 to amend § 205.603(b) of the National List by adding formic acid, with a restrictive annotation (76 FR 61941).

Attapulgite was petitioned in May 2009 for two uses: (1) as a nonsynthetic processing aid in organic handling for purifying vegetable and animal oils; and (2) as a livestock feed additive. 3 The FDA has listed this substance in the database, “Everything Added to Food in the United States (EAFUS) (Doc. No. 1943)” and references this substance among those generally regarded as safe in 21 CFR Part 582.99 when used as an adjuvant for pesticide chemicals. The EPA permits attapulgite as an inert ingredient eligible in minimum risk pesticides applied for food and non-food uses which are exempt from federal registration under Section 25(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The EPA has determined that attapulgite is exempt from the requirement of a tolerance when used as an inert ingredient in pesticide formulations applied pre- and post-harvest per 40 CFR 180.910. 4

At its April 26-29, 2011, meeting, the NOSB recommended adding attapulgite to the National List for use as a processing aid in organic handling of plant and animal oils. Consistent with this NOSB recommendation, AMS published a proposal on November 8, 2011, to amend § 205.605(b) the National List by adding attapulgite, with a restrictive annotation (76 FR 61941).

The following provides an overview of the amendments made to designated sections of the National List regulations:

This final rule amends § 205.601(i)(12) of the National List regulations by: (1) Inserting the qualifying words “in apples and pears”; between the words “control” and “only,” in the current annotation and (2) replacing the current expiration date of “October 21, 2012” with the new expiration date, “October 21, 2014”, after which tetracycline may not be used in organic crop production.

This final rule amends § 205.603 of the National List regulations by redesignating current paragraphs (b)(2) through (b)(7) as paragraphs (b)(3) through (b)(8) for the purpose of adding the following substance as an external parasiticide at (b)(2):

Formic acid (CAS #64-18-6)—for use as a pesticide solely within honeybee hives.

This final rule amends § 205.605(a) of the National List by adding attapulgite as follows:

Attapulgite—as a processing aid in the handling of plant and animal oils.

The OFPA, as amended (7 U.S.C. 6501-6522), 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 the 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/nop.

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 section 6514(b) of the OFPA. States are also preempted under sections 6503 through 6507 of the OFPA 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 section 6507(b)(2) of the OFPA, 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 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. 601-624), the Poultry Products Inspection Act (21 U.S.C. 451-471), or the Egg Products Inspection Act (21 U.S.C. 1031-1056), 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. 301-399), nor the authority of the Administrator of the EPA under the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136-136(y)).

Section 6520 of the OFPA 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 Agricultural Marketing Service (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). 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 use of additional substances in agricultural production and handling. This action would modify the regulations published in the final rule and would provide small entities with more tools to use in day-to-day operations. 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, AMS 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 NOP's Accreditation and International Activities Division, the number of certified U.S. organic crop and livestock operations totaled over 17,000 in 2010. According to USDA, Economic Research Service (ERS) data based on information from USDA-accredited certifying agents, certified organic acreage exceeded 4.8 million acres in 2008. 5 In 2009, U.S. certified organic apple acreage exceeded 21,000 acres, primarily concentrated in Washington and California. 6 ERS, based upon the list of certified operations maintained by the NOP, estimated the number of certified handling operations was 3,225 in 2007. 7 AMS believes that most of these entities would be considered small entities under the criteria established by the SBA.

U.S. sales of organic food and beverages have grown from $1 billion in 1990 to $26.7 billion in 2010. Sales in 2010 represented 7.7 percent growth over 2009 sales. 8 The USDA has 93 accredited certifying agents who provide certification services to producers and handlers under the NOP. 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 proposed rule. Accordingly, OMB clearance is not required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, Chapter 35.

This final rule has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this regulation will not have substantial and direct effects on Tribal governments and will not have significant Tribal implications.

AMS received 25 comments on proposed rule AMS-11-0058; NOP-11-09PR. Comments were received from organic crop producers, crop distributors, consumers, accredited certifying agents, trade associations, non-profit organizations, growers associations, advocacy groups and an industry working group.

Twenty one of the comments submitted addressed tetracycline. Seventeen comments supported a continued allowance for tetracycline in organic crop production after its current expiration date of October 21, 2012. Two commenters opposed any use of tetracycline in organic crop production, and asserted that antibiotic use is contrary to organic principles. These two comments concurred with the NOSB's concerns over engendering antibiotic resistance and supported the eventual prohibition of all antibiotic use, including that for tetracycline, in organic crop production. One commenter specifically supported the 2014 expiration date on the grounds that current research efforts are too heavily focused on antibiotic product replacement instead of on the NOSB's principle of achieving agro-ecosystems that are ecologically, socially, and economically sustainable. 9 The same commenter stated that, in the absence of alternative materials that could meet organic standards, organic consumers would support the planting of existing varieties that are more resistant to fire blight than those varieties favored by the conventional market.

One commenter expressed support for the use of formic acid as a pesticide in bee hives, stating that the substance is a safe and effective treatment that is easy to apply. The commenter also conveyed that an allowance for this use of formic acid under the NOP regulations would be consistent with other international organic standards. In the proposed rule on November 8, 2011 (76 FR 61941), AMS specifically sought comments on the appropriate placement of formic acid on § 205.603 of the National List. No comments were received addressing this topic, therefore the proposal to list formic acid at § 205.603(b) of the National List is retained in this final rule. No comments were received regarding attapulgite.

Two comments stated their general opposition to the allowance of synthetics in organic production and handling, and two comments submitted statements unrelated to the proposed rulemaking action.

Many comments supportive of continuing the allowance for tetracycline recommended that the substance be listed without an expiration date. Such an action would, in effect, extend the allowance for the substance until October 2017 under the five year sunset review process for the National List. These commenters believe that more alternatives to tetracycline could be available to organic producers by 2017. These comments further stated that an October 21, 2014 expiration date for tetracycline will not provide a sufficient timeframe for development and implementation of suitable alternatives. These commenters described the following as specific concerns with the expiration of tetracycline from the National List: (1) An increase in streptomycin resistance by the pathogen, which will further limit the ability of producers to control fire blight; 10 (2) consumer preference for apple and pear varieties which are more susceptible to fire blight; and (3) the lack of fire blight resistant root stocks and effective biological controls. Many of these comments stated that the expiration of tetracycline in 2014 could result in a reduced volume of U.S. organic apples and pears. Some commenters cited the potential costs to organic apple and pear growers (e.g. cost to replant trees, reduced productivity in existing trees) and organic handlers (e.g. constrained domestic supply of organic apples and pears) following the expiration of tetracycline from the National List in 2014. The commenters suggested that the slow development and limited availability of alternatives to control fire blight control in organic orchards could also trigger conversion to conventional production.

Several commenters expressed their preference that tetracycline be allowed beyond 2014 (e.g. until 2015, 2016, or 2017) to allow the industry time to develop more alternatives to this substance. Listing tetracycline with a later date or without an expiration date would not meet the intent of the NOSB to phase out the use of this substance in organic apple and pear production over time. Therefore, consistent with the NOSB recommendation, AMS is codifying the October 21, 2014 expiration date to the listing for tetracycline through this final rule. AMS notes that extending the allowance for the use of tetracycline after the October 21, 2014, expiration date would require a petition to the NOSB. This process can be initiated in accordance with the Notice of Guidelines on Procedures for Submitting National List Petitions (72 FR 2167).

Some commenters also stated that allowing the substance to expire on October 21, 2014 would have a negative economic impact on small businesses and that this rulemaking action should therefore be classified as “significant”. AMS disagrees. This action does not further restrict the use of this substance. This action extends the allowance for the substance in organic crop production for an additional two years after its current expiration date of October 21, 2012. Parties interested in requesting an extension for the authorized use of tetracycline in organic crop production after October 21, 2014 may submit a petition to the NOSB. The petition process is outlined in 72 FR 2167 (January 18, 2007).

Based on the public comments received, commenters remain concerned regarding the availability and efficacy of alternatives to tetracycline for fire blight control. Several commenters specifically requested that the NOSB reconsider the October 21, 2014 expiration date for tetracycline. Further, commenters asked that the NOP and the NOSB develop a phase-out plan for the use of antibiotics in fruit trees that has benchmarks and timelines based on consultations with appropriate stakeholders to ensure that the methods proposed to reach them are feasible. The NOSB recommended that tetracycline is allowed for fire blight control in apples and pears through October 21, 2014. Parties interested in requesting an extension for the authorized use of tetracycline in organic crop production after October 21, 2014 may submit a petition to the NOSB. Parties interested in having the NOSB develop a phase-out plan for the use of antibiotics in tree fruit production may submit public comments to the NOSB at any of their public meetings. The public comment process is outlined on the NOP Web site.

Commenters also requested that the NOP establish a Fire Blight Task Force to assist in development of alternatives. After the NOSB issued their recommendation on tetracycline in April 2011, stakeholders from the research community and organic tree fruit industry established a working group to consolidate efforts and develop alternatives to tetracycline for fire blight control. This working group is expected to provide updates to the public on their progress at future NOSB meetings. Furthermore, in response to the requests by the NOSB and to comments from the public for additional resources to support research on alternatives to tetracycline in organic production, AMS submitted requests to the USDA Agricultural Research Service (ARS) and the National Institute of Food and Agriculture (NIFA) in May 2011 for assistance in prioritizing research in the following areas: (1) The efficacy of combinations of substances for fire blight management; (2) breeding, production, and propagation of resistant cultivars and rootstocks that are commercially viable; and (3) cultural practices, crop management, disease forecasting and other production practices that can optimize control of this disease. 11 In fiscal year 2011, NIFA funded a project through the Organic Agriculture Research and Extension Initiative (OREI) for research on the development of non-antibiotic treatments for the control of fire blight in organic apple and pear crops. In January 2012, NIFA included a targeted request for additional research proposals on alternatives to the use of tetracycline for fire blight control in organic production as part of their solicitation for proposals under OREI. 12 AMS will continue to seek assistance across USDA as appropriate on this issue.

A few commenters requested that the NOP address concerns with the current use of antibiotics in organic tree fruit production through ensuring compliance with § 205.206(a)(3). Section 205.206(a) requires producers to use management practices to prevent disease through crop rotation, sanitation measures and cultural practices. Section 205.206(a)(3) lists specific cultural practices that enhance crop health, including selection of plant species and varieties with regard to suitability to site-specific conditions and resistance to prevalent pests, weeds, and diseases. Certifying agents are responsible for ensuring that all organic producers use management practices to prevent disease. Certifying agents verify that organic producers are meeting all USDA organic requirements including utilizing preventative management practices to prevent disease.

These same commenters also stated that, as part of a strategy for addressing fire blight in organic apple and pear production, the NOP should consider variances under § 205.290 to allow antibiotic use in instances when fire blight disease puts orchards at risk. Temporary variances for the use of a synthetic substance that is not on the National List (i.e. use of tetracycline after October 21, 2014) cannot be granted per the current requirements at § 205.290(e).

This final rule reflects recommendations submitted to the Secretary by the NOSB. The amendment to the listing of one exempted substance and the addition of two substances to the National List were based on petitions from the industry and evaluated by the NOSB using criteria in OFPA and the NOP regulations. Because the amendments have been subject to extensive discussion and public comment and are considered vital to organic crops, processing and livestock production, AMS believes that producers and handlers should be able to use them on their operations as soon as possible. Furthermore, tetracycline is due to expire from the National List on October 21, 2012; this action must be finalized by October 21, 2012, to ensure that organic apple and pear producers have access to this substance for two additional years beyond its current expiration date. Accordingly, AMS finds that good cause exists under 5 U.S.C. 553(d)(3) for not postponing the effective date of this rule until 30 days after publication in the Federal Register .

For the reasons set forth in the preamble, 7 CFR part 205, Subpart G is amended as follows:

I. Background

Title VIII of the Dodd-Frank Act, titled the “Payment, Clearing, and Settlement Supervision Act of 2010,” was enacted to mitigate systemic risk in the financial system and to promote financial stability, in part, through enhanced supervision of designated FMUs. 1 Section 803 of the Dodd-Frank Act defines an FMU as a person that manages or operates a multilateral system for the purpose of transferring, clearing, or settling payments, securities, or other financial transactions among financial institutions or between financial institutions and the person. The basic risks that FMUs must manage include credit risk, liquidity risk, settlement risk, operational risk, and legal risk. These risks arise between financial institutions and FMUs as they settle payments and other financial transactions. In order to maintain financial stability, FMUs must be well-designed and operated in a safe and sound manner. If a systemically important FMU fails to measure, monitor, and manage its risks effectively, it could pose significant risk to its participants and the financial system more broadly.

Under section 805(a)(1) of the Dodd-Frank Act, the Board is required to promulgate risk-management standards governing the operations related to the payment, clearing, and settlement (“PCS”) activities of certain FMUs that are designated as systemically important by the Council. Section 805(a)(1) of the Act also requires the Board to take into consideration relevant international standards and existing prudential requirements in prescribing the regulations. For a designated FMU that is a derivatives clearing organization (“DCO”) registered under section 5b of the Commodity Exchange Act or a clearing agency registered under section 17A of the Securities Exchange Act of 1934 (collectively, “designated clearing entities”), the Commodity Futures Trading Commission (“CFTC”) or the Securities and Exchange Commission (“SEC”), respectively, are granted authority to prescribe regulations, in consultation with the Council and the Board, containing applicable risk-management standards. 2

Section 805(b) of the Act sets out the following objectives and principles for the risk-management standards: (a) Promote robust risk management, (b) promote safety and soundness, (c) reduce systemic risks, and (d) support the stability of the broader financial system. Section 805(c) of the Act states that risk-management standards may address areas such as (1) risk-management policies and procedures, (2) margin and collateral requirements, (3) participant or counterparty default policies and procedures, (4) the ability to complete timely clearing and settlement of financial transactions, (5) capital and financial resource requirements for designated FMUs, and (6) other areas that are necessary to achieve the objectives and principles for risk-management standards.

In addition, section 806(e)(1) of the Dodd-Frank Act requires a designated FMU to provide 60 days' advance notice to its Supervisory Agency of any proposed change to its rules, procedures, or operations that could, as defined in rules of each Supervisory Agency, materially affect the nature or level of risks presented by the designated FMU. Under section 803(b) of the Act, a “Supervisory Agency” means the federal agency that has primary jurisdiction over a designated FMU under federal banking, securities, or commodity futures laws. 3

In April 2011, the Board published for comment a notice of proposed rulemaking (“NPRM”) to propose a new part to the Code of Federal Regulations (12 CFR part 234, Regulation HH) to establish risk-management standards for designated FMUs and requirements for advance notice of material changes to a designated FMU's rules, procedures, or operations. 4 The public comment period closed on May 19, 2011.

The Board received twelve public comment letters on the NPRM. Comments were submitted by two payment systems, seven industry and other groups, one bank, and two other commenters. In general, the comments pertained broadly to three categories: (i) Risk-management standards, (ii) advance notice requirements and the materiality definition, and (iii) other miscellaneous comments. The Board considered these comments in developing its final rule as discussed in more detail below. 5

Proposed § 234.3 sets out risk-management standards for designated FMUs that are payment systems, and proposed § 234.4 sets out risk-management standards for central counterparties (“CCPs”) and central securities depositories (“CSDs”), based on the international risk-management standards developed by the Committee on Payment and Settlement Systems (“CPSS”) and the Technical Committee of the International Organization of Securities Commissions (“IOSCO”). These international standards were the Core Principles for Systemically Important Payment Systems (the “Core Principles”) developed by the CPSS in 2001, and the Recommendations for Securities Settlement Systems and the Recommendations for Central Counterparties (collectively, the “CPSS-IOSCO Recommendations”) developed jointly by the CPSS and IOSCO in 2001 and 2004, respectively. The Board believes these standards are the appropriate basis for setting initial risk-management standards under Title VIII for several reasons. First, section 805(a)(1) of the Act directs the Board to consider relevant international standards in prescribing risk-management standards under Title VIII. As explained in the NPRM, the Core Principles and the CPSS-IOSCO Recommendations were the international standards most relevant to risk management of FMUs. 6 Second, FMUs are familiar with these standards as the long-standing basis for Part I of the Federal Reserve Policy on Payment System Risk (“PSR policy”). 7 Third, the Board has significant experience applying these international standards to large-value payment and settlement systems pursuant to its PSR policy.

CPSS and IOSCO recently conducted a comprehensive review of risk-management standards for PCS systems. On April 16, 2012, CPSS and IOSCO issued the final report on the “Principles for Financial Market Infrastructures,” which includes an updated, harmonized, and strengthened set of international risk-management standards (the “PFMI”). 8 CPSS and IOSCO intend for the PFMI to replace the Core Principles and CPSS-IOSCO Recommendations. As noted in the NPRM, the Board anticipates that it will review the new international standards, consult with other appropriate agencies and the Council, and seek public comment on the adoption of revised standards for designated FMUs based on the new international standards.

Commenters generally appeared to support the Board's approach of using the Core Principles and CPSS-IOSCO Recommendations as a basis for its risk-management standards for designated FMUs under section 805 of the Act. Two commenters explicitly stated their support for the Board's approach. Two other commenters stated that the proposed risk-management standards were largely prudent and sensible.

One commenter was also supportive of the Board's intention to evaluate the new international standards once they are final for the purposes of revising Regulation HH. Two other commenters expressed some general reservations with respect to the new international standards; one of the commenters cautioned the Board against adopting the new international standards “in full,” because doing so would include principles that may not directly relate to the risks posed by the designated FMUs and contemplated by Title VIII.

After considering the public comments and for the reasons stated above, the Board continues to believe that the most suitable approach to establishing initial risk-management standards under Title VIII of the Act is to use the Core Principles and CPSS-IOSCO Recommendations as the basis for the standards promulgated by this notice, and to proceed with consideration of the PFMI as the basis for any future revisions. The Board agrees with commenters that international standards that are not, in some way or to some degree, related to existing or potential risks posed to or by a designated FMU should not be adopted for purposes of section 805 of the Act. As noted in the NPRM, the Board acknowledged that the scope of the Core Principles and CPSS-IOSCO Recommendations is broad and proposed to adopt by regulation particular standards, or portions thereof, that relate to the risks presented to or by a designated FMU, rather than those standards, or portions thereof, that apply more generally to financial markets or regulators. Similarly, the Board anticipates evaluating the appropriateness of each of the new PFMI for the purpose of possible revisions to Regulation HH.

Proposed § 234.3 is based on the entire set of the Core Principles. Some commenters questioned whether three standards included in the Core Principles could be applied to retail payment systems, particularly automated clearinghouses (“ACH”) and check clearinghouses, should those systems be designated as systemically important by the Council. Specifically, proposed § 234.3(a)(3) would require any FMU that is designated on the basis of its role as operator of a payment system to have clearly defined procedures for the management of credit risks and liquidity risks, which specify the respective responsibilities of the system operator and the participants and which provide appropriate incentives to manage and contain those risks. Proposed § 234.3(a)(4) would require any designated FMU that is designated on the basis of its role as operator of a payment system to provide prompt final settlement on the day of value, preferably during the day and at a minimum at the end of the day. Proposed § 234.3(a)(5) would require any designated FMU that is designated on the basis of its role as operator of a payment system, and in which multilateral netting takes place, to, at a minimum, be capable of ensuring the timely completion of daily settlements in the event of an inability to settle by the participant with the largest single settlement obligation.

The Board received several comments on the applicability of these risk-management standards to retail payment systems, should they be designated by the Council. Several commenters stated their support for an exemption for retail payment systems from designation as systemically important by the Council under the Dodd-Frank Act. The Council, however, determined not to categorically exclude FMUs operating retail payment or other systems in its rule regarding the FMU designation process. 9 As a result, commenters provided feedback on the ability of retail payment systems to meet certain of the Board's proposed risk-management standards in the event the Council decides to designate them.

One commenter specifically referenced proposed § 234.3(a)(3)-(5) as risk-management standards that, while appropriate risk controls for truly systemically important payment systems, were generally inapplicable (or had no relevance) to payments systems such as ACH clearing arrangements that permit the return of transactions within a certain timeframe. One commenter argued that the standard in proposed § 234.3(a)(3) regarding the management of credit and liquidity risk would have no application where a system that did not assume credit and liquidity risks in the first place by committing to pay funds that it had not received and where the payment system participants expect to manage their own credit and liquidity risks. Two commenters also stated that proposed § 234.3(a)(4) on settlement finality contradicts long-standing and established practices of ACH rules that allow for certain transactions to be reversed or returned for any reason until the banking day after the settlement date. One commenter stated that application of proposed § 234.3(a)(5) regarding the ability to complete settlement in the event the single largest participant is unable to settle would require a fundamental change in the nature of ACH debit transactions and the abolishment of the right to return the transaction. In general, these commenters stated that they do not believe that, if designated, retail payment systems would be able to comply with these proposed standards and, accordingly, asked that such systems be exempted from them.

The Board notes that the proposed risk-management standards were designed to apply to large-value payment systems. This approach is consistent with the direction of the Council expressed in its final rule on the FMU designation process. Specifically, the Council stated that, within payment systems, it expects to focus at this time on FMUs that operate large-value systems and not on FMUs that operate low-value systems (such as check and ACH). 10 The Council also decided not to include considerations more narrowly tailored to the characteristics of retail payment systems because the Council did not believe they were necessary or appropriate given the current focus for designations.

Given the Council's focus on large-value systems, the Board does not anticipate that the Council will designate a FMU under Title VIII on the basis of its role as operator of a retail payment system. However, because the authority to designate systemically important FMUs resides with the Council, not the Board, the Board cannot be assured of the type of FMU the Council may designate in the future. In the event that the Council designates an FMU on the basis of its role as operator of a retail payment system, the Board would review, at that time, whether the risk-management standards in § 234.3 were appropriate for that designated FMU, as it would for any type of newly designated FMU.

In order to accommodate this review in the event that an unanticipated type of FMU is designated, and in consideration of the comments, the Board is adopting in the final rule a modification to proposed §§ 234.3(b) and 234.4(b) that clarifies that the application of individual risk-management standards could be waived in a situation where such standards could not appropriately be applied to a particular designated FMU. Both §§ 234.3(b) and 234.4(b) will be amended by inserting text that states “[t]he Board, by order, may waive the application of a standard or standards to a particular designated financial market utility where the risks presented by or the design of that designated financial market utility would make the application of the standard or standards inappropriate.” This revision is intended to bridge any gap between Council designation of a new type of designated FMU and the process of promulgating regulations appropriate for the new type of designated FMU, if necessary.

In addition, the Board notes that with respect to a designated FMU that operates more than one payment system (e.g., one large-value and one retail), standards would apply only with respect to the system that provided the basis for the Council's designation of the FMU. The Board is modifying § 234.3(a) and (b) to clarify this point. The Board also is making a parallel modification to § 234.4(a) and (b). 11

The Board is also modifying §§ 234.3(a) and 234.4(a) to require a designated FMU to “implement rules, procedures, or operations designed to ensure that it meets or exceeds” the risk-management standards set forth in these sections. In addition, the word “should” has been deleted from the individual standards to clarify that these are requirements with which a designated FMU must comply.

As noted above, the proposed risk-management standards for designated FMUs that operate as payment systems, CCPs, or CSDs are based on the Core Principles and CPSS-IOSCO Recommendations. Each set includes separate standards relating to efficiency, access criteria, and governance. Several commenters suggested that the Board eliminate some or all of these three proposed standards for payment systems, arguing that they address system operating issues that are outside the scope of the systemic risk issues contemplated by Title VIII of the Dodd-Frank Act. Specifically, the commenters questioned whether proposed § 234.3(a)(8), (9), and (10) regarding efficiency, access criteria, and governance, respectively, were relevant to systemic risk. 12 The applicability of the efficiency standard was a common concern of the commenters that raised questions about the scope of the risk-management standards; a subset of these commenters also questioned whether either the access criteria or governance standard was within the scope of risk management. These standards in general were viewed as admirable goals that designated FMUs should aim to achieve, but nevertheless as goals that should be driven by market forces and not by regulatory mandate.

Efficiency. The efficiency standard in proposed § 234.3(a)(8) states that an FMU that is designated on the basis of its role as operator of a payment system should provide a means of making payments that is practical for its users and efficient for the economy. Several commenters argued that the efficiency standard exceeds the Act's objectives because it addresses operating system issues and not risk matters. One commenter argued that whether a form of payment is practical and efficient is largely a matter of judgment that is better left to the market and its participants.

The Board believes the efficiency standard furthers the objectives set out in Title VIII of the Act to reduce systemic risks and support the stability of the broader financial system.

A designated FMU supports the ongoing functioning and stability of the market it serves by providing effective, reliable PCS services to its participants and, in particular, completing timely clearing and settlement of financial transactions. An FMU that is designed or managed inefficiently or impractically may ultimately distort financial activity and market structure, increasing not only the financial and other risks of an FMU's participants, but also the risks of their customers and end users. To avoid such outcomes, a designated FMU should consider the tradeoffs between, and seek a reasonable balance of, safety (i.e., risk management) and efficiency (i.e., direct and indirect costs) when designing and managing the system. For example, overly demanding financial resource requirements may create a liquidity demand so high that it would be impractical for participants to meet. Although liquidity is very important, an FMU that accumulates excessive liquid resources from its participants intraday may increase the participants' opportunity cost of sending each payment. In such cases, participants that become liquidity constrained may be forced to delay submitting certain time- or mission-critical payments.

Additionally, an FMU's design, operating structure, scope of PCS activities, and use of technology can influence its efficiency and can ultimately provide incentives for market participants to use, or not use, the FMU's services. For example, in certain cases, inefficiently designed systems may increase costs to the point where it would be cost-prohibitive for participants to use the FMU, and possibly drive market participants toward less safe alternatives, such as bilateral clearing or settlement on the books of the participants. In such cases, risks to the market participants increase as they seek less safe opportunities to lower direct costs; this behavior may reintroduce risk into the market that the FMU was intended to mitigate.

As these examples suggest, a designated FMU must function efficiently, as well as safely, and provide services that are appropriate to the needs of its users without becoming cost-prohibitive to use. A designated FMU that is inefficient can have a direct, negative impact on financial stability. Accordingly, the Board believes that it is appropriate for a supervisor of a designated FMU to take into account the need for practical and efficient design of the designated FMU as part of the set of risk-management standards set forth in Regulation HH. For these reasons, the Board is adopting the efficiency standards in proposed §§ 234.3(a)(8) and 234.4(a)(6) essentially as set out in the NPRM.

Access criteria. The access criteria standard in proposed § 234.3(a)(9) states that a payment system should have objective and publicly disclosed criteria for participation, which permit fair and open access. Some commenters argued that the access criteria standard did not relate to any of the risks contemplated by Title VIII of the Act. One commenter stated that the actions taken by the payment system, CSD, or CCP, create or mitigate risk, not the rules governing who can participate in them. Another commenter noted that the participation structure for payment systems can vary broadly and, while the participation criteria for these systems could be an issue for competition law, it was difficult to see how the criteria could directly affect the risks that were the focus of Title VIII.

The Board believes that access criteria are important to a designated FMU's risk-management framework and affect the level of risk a designated FMU presents to the financial system. Access criteria are typically referred to as an FMU's “first line of defense” in ensuring it admits financial institutions that will be able to meet their obligations and not expose the FMU or its other participants to unacceptable risk. Access criteria need to be designed to ensure that participants meet appropriate operational, financial, and legal requirements to allow them to meet their obligations on a timely basis. 13 However, these criteria need to be balanced against the FMU's ability to effectively serve the market it supports, in particular markets that are subject to a statutory requirement for central clearing or settlement through an FMU. Although a designated FMU may use risk-based measures to control access, requirements that are unnecessarily discriminatory or overly restrictive can minimize the FMU's overall effectiveness.

Criteria that allow for fair and open access also may help achieve the Title VIII objectives of reducing systemic risk and supporting the overall stability of the financial system. A fair and open approach to participation criteria may help prevent the concentration of financial activity (and therefore risk) into a few large participants. By encouraging the reduction of risk concentration, the proposed standard helps lower the likelihood that a few financial institutions will be perceived as “too big to fail.” Broad participation in a designated FMU can, for example, increase the effectiveness of multilateral netting, facilitate crisis management by applying a consistent set of rules and procedures (e.g., default management, loss mutualization), and improve overall market transparency by increasing the number of transactions processed by the FMU. Accordingly, access criteria that do not permit fair and open access may reduce the overall risk-reduction benefits that a designated FMU can offer.

For these reasons, the Board is adopting the access criteria standards in proposed §§ 234.3(a)(9) and 234.4(a)(2) essentially as set out in the NPRM.

Governance. The governance standard in proposed § 234.3(a)(10) states that a payment system's governance arrangements should be effective, accountable, and transparent. Some commenters claimed that although the decisions made by a designated FMU's governing body can affect the risks it presents, the particular governance structure itself presents no such risks. Conversely, one commenter supported inclusion of the governance standard, stating that weak governance practices and poor risk-management procedures at designated FMUs could pose hazards both to participating financial institutions and to the market as a whole. Another commenter stated that risk management effectively encompasses governance, among other areas.

The Board believes that effective, accountable, and transparent governance arrangements are critical to the effective risk management of a designated FMU. A strong governance arrangement provides a sound basis for compliance with the other risk-management standards in Regulation HH. A number of tools or techniques discussed in the Core Principles with respect to the governance standard have proved to be effective in ensuring effective governance, such as written strategic objectives and plans for achieving them and separation of risk management and audit functions from day-to-day operations. The Board expects supervisors to review a designated FMU's governance arrangements against the background of these and other relevant techniques in order to promote robust risk management. In addition, given the role of the FMU's board of directors in setting the overall risk-management framework of the designated FMU, the Board believes that a weak or ineffective governance structure could have systemic implications for the participants of the service, other FMUs, and other markets. Accordingly, the Board believes that a supervisor should consider a designated FMU's governance arrangements when performing its systemic risk review. For these reasons, the Board is adopting the governance standard in proposed §§ 234.3(a)(10) and 234.4(a)(8) essentially as set out in the NPRM.

Proposed § 234.4(a)(17) requires a designated FMU that operates as a CCP to use margin requirements to limit its credit exposures to participants in normal market conditions and use risk-based models and parameters that are reviewed regularly. In addition, proposed § 234.4(a)(17)(i) would require a CCP to provide for annual model validation consisting of evaluating the performance of the CCP's margin models and the related parameters and assumptions associated with such models by a qualified person who does not perform functions associated with the CCP's margin models (except as part of the annual model validation) and also does not report to such a person. 14 Two commenters noted that proposed § 234.4(a)(17)(i), although on the right track, should stress explicitly the complete independence of the organization conducting the validation. One of the commenters believed models must be validated annually by a qualified and independent organization with no financial stake in the outcome because no employee of a systemically important CCP should be expected to resist the inevitable direct and indirect pressures of management who may have incentives to achieve a less-appropriate and less-independent outcome. The other commenter also stated that model validation must be performed by a truly independent party with no financial stake in the outcome of the validation and expressed concern that a validator that is not sufficiently independent would face the conflict of interest that would lead designated FMUs to lower their margins in order to attract business and increase profits.

The Board believes that a validator must be able to offer independent, unbiased conclusions and recommendations as part of the margin model validation process. It is unlikely that the person who was responsible for initially developing the margin model would be able to provide an independent, unbiased assessment of the product. Similarly, it appears unlikely that a person under the functional control of the developer would be able to provide independent, unbiased validation of the model without the influence of the developer and concern for employment security. Accordingly, proposed § 234.4(a)(17)(i) would require that the model validation be conducted by a qualified person who does not perform functions associated with the CCP's margin model, such as development and implementation, and does not report to such a person. 15

On August 6, 2009, a notice of proposed policy was published in the Federal Register (74 FR 39242) in which the FAA proposed to specify Alaskan fuel hauling as a restricted category special purpose operation under 14 CFR 21.25(b)(7). The comment period closed September 8, 2009. This notice of policy addresses only one of the three special purpose operations proposed in 2009. The other two proposals are still under consideration and are not addressed at this time in this notice.

The FAA received comments from six commenters, in three major areas. One of the comments submitted was, “The transport of the fuel could be made safer by limiting the payload on each flight to say 35% of the aircraft weight so there won't be problems with takeoff and landing”. Another commenter proposed that Alaska fuel hauling be limited to aircraft having a maximum certificated takeoff weight (“MTOW”) of 20,000 lb or less. The FAA does not agree with setting an arbitrary maximum weight limit for this special purpose, nor does the FAA see a need to operate below the certificated capabilities of the aircraft. To provide for safe operations, each aircraft used to transport fuel will be required to receive FAA certification for the purpose of fuel hauling. During certification the airplane payload and performance limits will be specified as part of the certification process. All aircraft must be operated within their certificated weight and balance limitations, and airfield performance limitations. No overweight operations will be permitted.

One commenter suggested that the special purpose of fuel hauling be expanded to include operations outside the State of Alaska, while another commenter requested that the proposal be strictly limited to operations conducted solely within the state. The FAA will limit this proposed special purpose to operations in the State of Alaska only. Alaska has a unique dependence on aviation for delivery of essential supplies to remote villages that are not serviced by roads or rail. Most of these villages are served by airports with runways less than 3,000 feet long. The remoteness and limited transportation infrastructure means that air transportation of fuel is the only method to deliver fuel to these areas during many times of the year.

One commenter requested that the FAA confirm that restricted category aircraft certificated for the special purpose of Alaskan fuel hauling would be permitted to conduct these operations in view of the provisions of § 91.313, which provides the operating limitations for aircraft certificated in restricted category. Section 91.313(a) states that no person may operate a restricted category civil aircraft for any purpose other than the special purpose for which it is certificated. Section 91.313(c) states that a restricted category aircraft cannot be used to carry persons or property for compensation or hire. However, this paragraph goes on to say that for the purposes of § 91.313(c) the definition of “for compensation or hire” changes if the special purpose requires the carriage of material necessary for that special purpose. Then carriage of that material is not considered carriage “for compensation or hire”, but only in regards to the limitations in § 91.313(c). For example, an airplane with a restricted category airworthiness certificate for the special purpose of Alaska fuel hauling may carry fuel for commercial gain. However, the operation must comply with 14 CFR part 119, which addresses commercial operations. Since Alaskan fuel hauling does not meet any of the exclusions in 14 CFR part 119, the operation would need to meet the requirements of 14 CFR part 135 or part 121. Operational approval for Alaskan fuel hauling must be obtained from FAA Flight Standards Service in accordance with the operating regulations.

The special purpose of Alaskan fuel hauling was considered for aircraft type-certificated under § 21.25(a)(1). This limitation will result in a higher level of safety than surplus military aircraft type-certificated under § 21.25(a)(2). Compliance with 14 CFR part 36 noise requirements is required for this special purpose. The fuel hauling system must be shown to meet the applicable airworthiness regulations as required by §§ 21.25(a)(1), and 21.101 if appropriate. Upon approval of the fuel hauling configuration of an aircraft for Alaskan fuel hauling, the operator must obtain an airworthiness certificate for the new special purpose.

Accordingly, the Aircraft Engineering Division hereby specifies, under authority delegated by the Administrator, that Alaskan fuel hauling is a restricted category special purpose flight operation under the provisions of § 21.25(b)(7). This approval is limited to aircraft type-certificated under § 21.25(a)(1). This action will enable bulk fuel to be carried to isolated individuals and locations (such as villages, towns, and mining facilities) in the State of Alaska, during times when other methods are impractical.

This rule amends Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or revoking SIAPS, Takeoff Minimums and/or ODPS. The complete regulators description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA Forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A.

The large number of SIAPs, Takeoff Minimums and ODPs, in addition to their complex nature and the need for a special format make publication in the Federal Register expensive and impractical. Furthermore, airmen do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their depiction on charts printed by publishers of aeronautical materials. The advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA forms is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAPs and the effective dates of the associated Takeoff Minimums and ODPs. This amendment also identifies the airport and its location, the procedure, and the amendment number.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as contained in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPS and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.

Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPS and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedures before adopting these SIAPs, Takeoff Minimums and ODPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making some SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) Is not a “significant regulatory action” under Executive Order 12866;(2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or revoking Standard Instrument Approach Procedures and/or Takeoff Minimums and/or Obstacle Departure Procedures effective at 0902 UTC on the dates specified, as follows:

This rule amends Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (FDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and § 97.20 of Title 14 of the Code of Federal Regulations.

The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained in FAA form documents is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAP and the corresponding effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP as modified by FDC/P-NOTAMs.

The SIAPs, as modified by FDC P-NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for all these SIAP amendments requires making them effective in less than 30 days.

Because of the close and immediate relationship between these SIAPs and safety in air commerce, I find that notice and public procedure before adopting these SIAPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making these SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97, 14 CFR part 97, is amended by amending Standard Instrument Approach Procedures, effective at 0901 UTC on the dates specified, as follows:

Table of Contents I. Background II. Overview of the Final Rule III. Comments on the Proposed Rule IV. Legal Authority V. Analysis of Economic Impacts VI. Paperwork Reduction Act of 1995 VII. Environmental Impact VIII. Federalism IX. References I. Background

We originally published establishment registration regulations for medical devices in the Federal Register of September 3, 1976 (41 FR 37458) (proposed rule) and August 23, 1977 (42 FR 42520) (final rule), and device listing regulations in the Federal Register of September 30, 1977 (42 FR 52808) (proposed rule), and August 25, 1978 (43 FR 37990) (final rule).

These regulations called for establishment registration and device listing information to be submitted to the Center for Devices and Radiological Health (CDRH) on several paper forms: FDA 2891, Registration of Device Establishment; FDA 2891a, Annual Registration of Device Establishment; and FDA 2892, Device Listing. Once these forms were completed and submitted to FDA, FDA then forwarded them to a data entry contractor who entered the information into FDA's device registration and listing database.

In June 2002, section 321 of the Bioterrorism Act (Pub. L. 107-188) amended section 510(i) of the FD&C Act (21 U.S.C. 360(i)) to require those foreign establishments who are required to register with FDA to do so by electronic means, and to include additional information identifying certain parties involved in the importation of the foreign establishment's devices into the United States as part of their registration. Subsequently, in October 2002, section 207 of the Medical Device User Fee and Modernization Act (MDUFMA) (Pub. L. 107-250) further amended section 510 of the FD&C Act by extending the requirement for electronic submission of registration information to include domestic firms as well as foreign firms. However, when adding these new electronic submission requirements, which appear in section 510(p) of the FD&C Act, Congress chose to delay their implementation so that FDA would have an opportunity to first put systems in place to accommodate the electronic receipt of registration information. This was accomplished by including a requirement in section 510(p) of the FD&C Act for the Secretary of the Department of Health and Human Services (the Secretary) to make a finding that the electronic receipt of registration information was feasible before implementing electronic registration.

As reflected in FDAAA (Pub. L. 110-85), the most recent legislation establishing changes to FDA's device registration and listing program, FDA has now developed a system that makes the electronic receipt of device registration and listing information feasible. FDAAA amended section 510(p) of the FD&C Act by eliminating the need for a feasibility finding, and requiring both foreign and domestic establishment registration and device listing information to be submitted using electronic means unless FDA grants a waiver request. In accordance with FDAAA, FDA's Unified Registration and Listing System (FURLS) for devices, which is a new Internet-based system, became operational on October 1, 2007. FDA believes this electronic system will ultimately make the process of submitting registration and listing information for devices more efficient for industry and will provide faster access to this information for both FDA and industry.

In addition, the new electronic system will allow FDA to more effectively gather information concerning marketed devices. We rely on having complete and accurate registration and listing information to accomplish a number of important statutory and regulatory objectives. For example, we use registration and listing information to:

• Identify establishments producing marketed medical devices;

• Identify establishments producing a specific device when that device is in short supply or is needed for a national emergency. This information helps us facilitate prompt shipment of devices to the places where they are needed most. For example, during a bioterrorism incident, we could use device listing information to identify establishments that could be helpful in preventing or counteracting the deadly effects of biological weapons; with this information, we could facilitate prompt shipment of the devices as needed;

• Facilitate the recall of devices marketed by owners or operators of device establishments;

• Identify and catalogue marketed devices;

• Administer our postmarketing surveillance programs for devices;

• Identify devices marketed in violation of the law;

• Identify and control devices imported or offered for import into the country from foreign establishments; and

• Schedule and plan inspections of registered establishments under section 704 of the FD&C Act (21 U.S.C. 374).

We also rely on registration and listing information to help us comply with several other statutory provisions. For example, we use this information to generate accurate estimates of the number of businesses that are affected by our rulemaking activities. These estimates help us assess the impact of our regulations on regulated industry, which we are required to do under the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (5 U.S.C. 601-612), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (Title II of Pub. L. 104-121); the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) (2 U.S.C. 1501 et seq. ); the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520); Executive Order 12866 (September 30, 1993); and the Congressional Review Act (section 251 of Pub. L. 104-121).

Registration and listing information will continue to be used for all of the important public health purposes outlined in this document. The electronic submission of registration and listing information allows us to use such information more quickly and effectively to carry out all of the activities described in this document.

In addition, electronic submission of registration and listing information furthers the purpose of the Government Paperwork Elimination Act of 1998 (Pub. L. 105-277, Title XVII) (GPEA). GPEA requires Federal Agencies to give persons who are required to maintain, submit, or disclose information, the option of doing so electronically when practicable as a substitute for paper, and to use electronic authentication (electronic signature) methods to verify the identity of the sender and the integrity of the electronic content. We believe that electronic submission of registration and listing information furthers the purpose of this law and makes the registration and listing processes more efficient and effective both for industry and us.

To implement the FDAAA and Bioterrorism Act amendments to section 510 of the FD&C Act, FDA published in the Federal Register of March 26, 2010 (75 FR 14510), a proposed rule to amend its regulations governing medical device establishment registration and device listing (the March 2010 proposed rule). The comment period closed on June 24, 2010.

FDA made no significant changes to the proposed rule.

This final rule updates the regulations to conform to the requirement in section 510(p) of the FD&C Act, as amended by FDAAA, that registration and listing information be provided to FDA electronically unless FDA grants a request for a waiver.

As part of the new electronic registration and listing system, each owner or operator establishes an account on FDA's online device establishment registration and device listing system, FURLS, which the owner or operator uses to create and update his or her device establishment registration and device listing information. Information submitted to FDA prior to September 15, 2007, has already been migrated to the new FURLS electronic database and thus there is no need for owners or operators to reenter this information.

In accordance with section 510 of the FD&C Act, as amended by sections 222 through 224 of FDAAA, device establishment owners and operators have been using FURLS to submit their establishment registration and device listing information electronically since the system became operational on October 1, 2007. In addition, in accordance with section 510(p) of the FD&C Act, as amended by FDAAA section 224, FDA is granting waivers from the new electronic submission requirements only to those owners or operators for whom electronic registration and listing is not reasonable.

Before its devices will be allowed into the United States, each foreign establishment that is required to register must supply to FDA the registration information required by part 807, including the name and contact information for its U.S. agent. Section 321 of the Bioterrorism Act affected foreign establishment registration in part by amending section 510(i) of the FD&C Act to require, as part of an establishment's registration, the name of each importer of the device that is known to the establishment and the name of each person who imports or offers to import the device into the United States. This final rule amends part 807 to reflect in our regulations the Bioterrorism Act requirement that foreign establishments whose devices are imported or offered for import into the United States must identify: (1) All importers known to the foreign establishment and (2) the name of each person who imports or offers to import the foreign establishment's device into the United States. The final rule revises § 807.3 to add specific definitions for these two new categories of information that need to be submitted by foreign establishments.

The final rule eliminates the exemption in § 807.40(a) for foreign establishments whose devices enter a foreign trade zone and are re-exported from the foreign trade zone without entering U.S. commerce, and also eliminates the exemption in § 807.40(c) for devices that are imported under section 801(d)(3) of the FD&C Act (21 U.S.C. 381(d)(3)). Removing the exemptions from registration and listing requirements for devices entering foreign trade zones and for products imported under section 801(d)(3) of the FD&C Act is consistent with Congress' desire, as reflected in the Bioterrorism Act, to increase the Nation's ability to prepare for and effectively respond to bioterrorism and other public health emergencies by requiring foreign establishments to provide more, rather than less, information for imported products. For example, registration and listing information for devices imported into foreign trade zones and devices imported under section 801(d)(3) of the FD&C Act will help us identify and contact foreign establishments that export to the U.S. devices for which there may be a domestic shortage in an emergency.

The final regulation also amends part 807 to modify § 807.20(a)(2) and removes § 807.20(c)(1) and (c)(2) such that all contract manufacturers and contract sterilizers are required to register their establishments and list their devices. FDA relies on having a complete and accurate registration of device establishments and listing information for devices processed at those establishments in order to accomplish a number of important statutory and regulatory objectives. For example, when an establishment experiences a problem, it can have a significant impact on the product lines for one or multiple firms for which it is contracted to provide manufacturing or sterilization services. Knowing which products are manufactured or sterilized at the affected site could facilitate the recall of the impacted devices. FDA also believes that knowing that these manufacturing sites exist would be critical information when a device is in short supply or needed in the event of a national emergency.

The new electronic system requires exempt devices to be identified by product code rather than by classification name and number. The product code is already requested for such devices. This change to the regulation codifies the existing practice.

Section 807.25(g)(4) of the final regulation also codifies the practice of including the 510(k) number when listing a medical device that has gone through premarket clearance or the approved HDE number in the electronic device registration and listing system. This change also provides FDA with a tool to help ensure that devices that lack a required premarket clearance or premarket approval are not marketed.

As a result of the passage of FDAAA, FDA began collecting device registration and listing information using FURLS beginning in October 2007. When using FURLS, an owner or operator needs to identify not only an official correspondent for the establishment but also a contact person for the owner or operator. The contact person is the only person who can administer the owner or operator's user accounts in FURLS.

In instances where owners or operators have only one establishment, they may choose the same person to serve as both the contact person for the user account and the official correspondent for the establishment. For owners or operators with multiple establishments, the contact person for the owner or operator may also serve as the official correspondent for any or all of the owner or operator's establishments. Alternatively, using the accounts management software for FURLS, the owner or operator may create subaccounts in which different official correspondents are identified for each establishment.

Proper control of access to accounts and control of the ability to update an establishment's online information is necessary to avoid errors. Therefore, the final rule requires that each owner or operator identify only one contact person within the owner or operator's organization who will be responsible for creating the master account in FURLS for the owner or operator and assigning subaccounts to each establishment, if needed. Once the contact person creates the master account and any needed subaccounts, the official correspondent can then use the accounts to submit the owner or operator's establishment registration and device listing information to FDA.

The final rule requires owners or operators to identify the operations or activities their establishments engage in only as part of their device listings. This is because the new electronic system has been designed to automatically migrate the information provided in the device listing to the owner or operator's registration, thus saving the owner or operator from having to provide the same information twice. Because under the new system owners or operators would only have to supply such information once, this change will save time and help avoid inconsistencies between the registration and listing information for a single establishment.

FDAAA section 212 requires that certain medical device establishments pay a registration user fee when they initially register with FDA and for each annual registration thereafter. The final rule, therefore, removes the sentence at the beginning of § 807.20(b) that states “[n]o registration or listing fee is required.”

The final rule revises the definition of “restricted device” in § 807.3(i) to more accurately reflect the provisions of the FD&C Act that provide us with authority to restrict devices.

In the March 2010 proposed rule, FDA proposed to amend its regulations governing medical device establishment registration and device listing. FDA provided 90 days for the submission of comments from interested parties. FDA received three sets of comments which FDA summarizes and discusses in this section of this document.

(Comment 1) Two comments objected that it is not necessary for contract manufacturers and contract sterilizers to list all products, since these contractors are typically not responsible for putting the contracted products into the marketplace. The comments stated that such a requirement would: (1) Duplicate information already submitted by the manufacturer; (2) increase the risk that inaccurate information was submitted to FDA because contract manufacturers are not in the best position to inform FDA when commercial distribution of a device has commenced, ceased, or resumed; and (3) reveal confidential business partnerships to competitors.

(Response) FDA disagrees with these comments. FDA does not consider the requirement that contract sterilizers and manufacturers list devices to be duplicative. While registration provides valuable information regarding, for example, the location of device establishments, this value is limited if we do not also know what devices are being manufactured and sterilized at the establishments. FDA relies on having a complete and accurate registry of device establishments and a list of devices processed at those establishments in order to accomplish a number of important statutory and regulatory objectives. For example, having basic information about where devices are made and cleaned will enable us to respond in a more timely and effective fashion in the case of an adverse event or defect associated with a particular device or if there is a shortage of a particular device in the event of a national emergency.

FDA does not believe that the final rule will increase the risk that inaccurate listing information is submitted to FDA. Contract manufacturers and contract sterilizers, as with other establishments, will be required to register and list within 30 days of entering into such operation and review and update listing information annually. Contracting entities will be responsible for providing accurate information to FDA and should know what devices they manufacture or sterilize at their establishment.

Finally, requiring contract manufacturers and sterilizers to submit listing information to FDA will not reveal confidential business partnerships to competitors. Under 21 CFR 20.116, public disclosure of establishment registration and device listing information is governed entirely by § 807.37, which addresses how such information will be subject to inspection in accordance with section 510(f) of the FD&C Act. FDA has revised § 807.37 to reflect its plans to exclude from public inspection or posting on the FDA Web site brand names and premarket submission numbers of devices manufactured or sterilized by a contractor that would reveal confidential business relationships, and plans to add a mechanism in FURLS to allow entities to indicate whether they believe information should not be made public under this standard. We also revised § 807.37 to make clear that FDA-assigned listing numbers will also not be publicly available or posted on the public FURLS Web site. Listing numbers serve important governmental functions that may be harmed if they were made public.

(Comment 2) One comment questioned requiring contract manufacturers to register because contract manufacturers have a one-to-one relationship with finished device manufacturers that would not be of benefit in providing enhanced manufacturing when devices are in short supply.

(Response) FDA disagrees. By statute, all establishments engaged in the manufacture, preparation, propagation, compounding, or processing of a device (including repackaging and relabeling) are required to register unless specifically exempted by regulation. See sections 510(a) to (d), (i) and (g) of the FD&C Act. Contract manufacturers are engaged in these activities, and FDA believes that the registration of their establishments is not unnecessary to the protection of the public health. For example, this information would provide us with basic information about the entities that make devices, facilitating a timely and effective response to adverse events, shortage, or other device problems associated with one of these establishments, in addition to potentially assisting with device shortages. The information would also assist us in our fundamental regulatory activities, such as planning and scheduling inspections.

(Comment 3) One comment suggested that FDA add a new registration type for foreign establishments that import devices into foreign trade zones.

(Response) FDA believes that foreign establishments that import devices into foreign trade zones should be treated the same as other establishments that must register and list. FDA agrees, however, that it is important to capture whether an establishment is importing devices into foreign trade zones and will add an establishment type to the existing list of establishment types in FURLS to cover this activity.

(Comment 4) One comment disagreed with FDA's proposed revocation of the exemption in § 807.40(a) for devices from foreign establishments that enter a foreign trade zone and are re-exported from that foreign trade zone without having entered U.S. commerce. The comment questioned whether the Bioterrorism Act would require the revocation of the exemption and whether the U.S. Customs and Border Protection Customs-Trade Partnership Against Terrorism and the Customs Advance Manifest Rule would provide FDA access to verification that devices for export are re-exported and information about the shipper, cargo, and consignee.

(Response) FDA disagrees. The removal of the exemption increases the United States' ability to defend against and respond to bioterrorism by providing FDA with additional information regarding foreign establishments and devices manufactured at those establishments that are shipped into the United States, which is consistent with the goals of the Bioterrorism Act. For example, this information could be used to address a device shortage in an emergency.

(Comment 5) One comment urged FDA to revise § 807.40 to include a list of activities that require foreign establishment registration that parallels the list in § 807.20(a) of activities that require registration of domestic establishments.

(Response) FDA declines to revise the rule as suggested by the comment, as the list of activities in § 807.20(a), which is not all-inclusive, already applies to both domestic and foreign establishments. FDA does want to emphasize, however, that it considers a foreign establishment that only exports devices to the United States to be engaged in the manufacture, preparation, propagation, compounding, or processing of a device, and it therefore must register and list. Further, § 807.40(c) prohibits a device from being imported or offered for import into the United States unless it is the subject of a device listing and is manufactured, prepared, propagated, compounded, or processed at a registered foreign establishment. Thus, a device may not enter the country unless valid registration and listing information are provided. This information is used, for example, by verifying that medical devices entering the United States are exported from legitimate sources, are not counterfeit, and are legally marketed in the United States.

(Comment 6) One comment urged that § 807.25(a) discuss the part 11 (21 CFR part 11), Electronic Records, Electronic Signatures responsibilities of a party using the FDA-supplied FURLS system.

(Response) FDA declines to revise the rule as suggested by the comment. Under § 807.25(a), the submission of registration and listing information must be made in accordance with part 11, with certain exceptions. See discussion in the preamble to the March 2010 proposed rule (75 FR 14510 at 14523) and FDA's guidance on part 11 referenced therein.

(Comment 7) Citing the preamble to the March 2010 proposed rule (75 FR 14510 at 14516), one comment expressed concerns about combination products having to register and list with, and pay fees to, more than one Center. The comment urged FDA to add a flag to a listing that identifies a combination product.

(Response) As reflected in the preamble to the March 2010 proposed rule, the Agency is currently working to develop and implement a more streamlined approach to facility registration and product listing for combination products. User fees are outside the scope of this rule. We intend to address these issues in the future. For efficient, effective regulation of combination products, FDA intends to add a flag to identify whether a listing is for a combination product.

(Comment 8) One comment urged FDA to revise § 807.25(g)(4) to list the submission types.

(Response) FDA declines to revise the rule as suggested by the comment. However, we revised §§ 807.25(g)(4) and 807.3(w) to make clear that they include the premarket submission number for granted de novo petitions for classification under section 513(f) of the FD&C Act (21 U.S.C. 360c(f)), which are currently given a number preceded by the letter “K.”

(Comment 9) One comment urged that owner-operators be given the ability to assign individuals to have “View Only” access to FURLS.

(Response) This comment asks for a change beyond the scope of this rulemaking.

(Comment 10) One comment urged that private label manufacturers should not have to submit brand names considered trade confidential under § 807.25(b). Alternatively, the comment urged FDA to restrict access to information considered to be trade confidential to FDA and the FURLS account owner.

(Response) FDA declines to remove this requirement from the rule. Requiring private label manufacturers to submit brand names to FDA will not reveal this information to the public. FDA has revised § 807.37 to reflect its plans to exclude from public inspection or posting on the FDA Web site brand names and premarket submission numbers of devices marketed by a private label manufacturer that would reveal confidential business relationships, and plans to include a mechanism in FURLS to allow entities to indicate whether they believe information should not be made public under this standard.

(Comment 11) One comment urged FDA to describe the timeline that applies to establishment registration and provide acknowledgment of successful registration.

(Response) FDA agrees that describing the timeline that applies to establishment registration is important, which is why § 807.22, “Times for establishment registration and device listing,” provides timelines for registration. To be clear that § 807.28 governs conditions that require that listing information be updated, and not the time at which listing must be updated, which is governed by § 807.22, we changed four occurrences of “when” to “if” in § 807.28(a) and (b). We also want to be clear that, though changes to listing information must be reported to FDA between October 1 and December 31 of each year, the information that must be reported includes any changes that occur since the previous annual listing. For example, if a manufacturer begins producing a device in January and ceases (temporarily or permanently) producing such device in June, this would have to be reported to FDA between October 1 and December 31 of that year.

When an establishment successfully completes a process (e.g., registers and lists for the first time, completes annual registration, creates a new listing, etc.) in FURLS, a confirmation screen appears indicating successful completion of the process. In some cases, the establishment may also receive an email in addition to the confirmation screen. These instances include when an establishment registers and lists for the first time and when FDA sends an email to confirm that they have completed their annual registration. If an establishment does not successfully make it through the process it is trying to complete (e.g., registering and/or listing devices, updating information in the software, etc.), it would not be provided with an email or confirmation screen and would know it was not successfully processed or that an error occurred.

(Comment 12) One comment urged FDA to make available a test or training version of FURLS online that provides access to simulated data or an instruction manual that includes screen shots of the steps in the registration and listing process.

(Response) FDA agrees. Already available, the FURLS Device Registration and Listing Module (DRLM) has online instructions that include screen shots that may be viewed by clicking on the help icon located near the top right of the screen. FDA's DRLM Web site: ( http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm ) provides instruction on who must register and list, who must pay the annual registration user fee and how to register, list, and pay the fee. Assistance is available by sending an email to reglist@cdrh.fda.gov or by calling 301-796-7400.

We have the legal authority to amend our regulations on foreign and domestic establishment registration and listing for human devices. The statutory basis for our authority includes sections 201, 301, 501, 502, 510, 512, 513, 515, 519-520, 701, 704, 801, and 903 of the FD&C Act (21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i-360j, 371, 374, 381, and 393); and sections 361 and 368 of the Public Health Service Act (42 U.S.C. 264 and 271) (the PHS Act).

Section 510(c) of the FD&C Act requires every person upon first engaging in the manufacture, preparation, propagation, compounding, or processing of a device to immediately register with the Secretary his name, place of business, and the establishment. The provisions in section 510(b) and (d) of the FD&C Act require annual registration and registration of additional establishments, respectively. As amended by section 222 of FDAAA, section 510(b) of the FD&C Act requires that annual registration take place during the period beginning on October 1 and ending on December 31 of each year. Section 510(i) of the FD&C Act, as amended by section 222 of FDAAA, requires any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a device that is imported or offered for import into the United States, upon first engaging in such activity, to immediately register with the Secretary through electronic means, and thereafter to register annually during the period beginning on October 1 and ending on December 31 of each year. These provisions, together with section 701(a) (among others) of the FD&C Act (21 U.S.C. 371(a)), authorize us to require the submission of the registration information specified in the final rule. The information specified in this final rule will help us identify who is manufacturing, preparing, propagating, compounding, processing, repacking, or relabeling devices and where those operations are being performed. In addition, some information (e.g., official correspondent information) would help us communicate with establishments more effectively and schedule inspections more efficiently.

Section 510(j)(1) of the FD&C Act requires every person who registers to file with the Secretary of the Department of Health and Human Services (the Secretary), at the time of registration, a list of all devices that are being manufactured, prepared, propagated, compounded, or processed by the registrant for commercial distribution. That list must be prepared in the form and manner prescribed by the Secretary and must be accompanied by a copy of labeling (or the label and package insert) and, in some cases, advertising. Section 510(j)(2) of the FD&C Act, as amended by section 223 of FDAAA, requires each person who registers with the Secretary under this section to report listing information updates once each year during the period beginning on October 1 and ending on December 31 of each year. Listing information gives us a current inventory of marketed devices. These provisions and others of the FD&C Act, together with section 701(a) of the FD&C Act, provide authority for requiring the submission of the listing information set forth in this final rule. The device listing information specified in this final rule will help us: (1) Develop a more current, robust inventory of devices as a counter-terrorism measure; (2) administer our postmarket surveillance programs more effectively; (3) facilitate recalls of products; (4) identify devices in short supply in the event of a national emergency; and (5) identify devices marketed in violation of the FD&C Act.

Section 510(p) of the FD&C Act, as amended by section 224 of FDAAA, requires that registration and listing information be submitted electronically, subject to FDA's grant of waivers to individual requestors who meet the criteria set forth in section 510(p). Electronic receipt of registration and listing information will enable us to shift resources from performing more ministerial tasks, such as data entry, to pursuing important public health objectives such as those described in section I of this document. Electronic receipt of registration and listing information also will help us with the efficient enforcement of the FD&C Act because we would be able to distinguish situations where there has been noncompliance with registration and listing requirements from situations where there have been no changes in information. The failure to register or list is a prohibited act under section 301(p) of the FD&C Act (21 U.S.C. 331(p)) and the failure to do either generally renders a device misbranded under section 502(o) of the FD&C Act (21 U.S.C. 360(o)).

FDA has examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency believes that this final rule is not a significant regulatory action under Executive Order 12866.

The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the cost of this final rule is expected to be very small, the Agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $139 million, using the most current (2011) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.

We received no comments on the analysis of impacts in the March 2010 proposed rule. We have updated but have not made substantial changes to the analysis for this final rule. We used the same baseline as we did in the proposed rule; costs and benefits are estimated relative to the system of paper forms that existed prior to FDA's Internet-based electronic listing and registration system. The new system became operational on October 1, 2007.

We contracted with the Eastern Research Group, Inc. (ERG), to collect data, interview industry experts, and estimate the costs and benefits of the rule. The analysis in support of the effects of the final rule (ERG Memo) is on file with the Division of Dockets Management. ERG identified several very small impacts, both costs and benefits, most of which are too small to generate meaningful numeric estimates. 1 The ERG Memo identified recurring costs associated with this final rule, plus additional costs that would not apply to U.S. establishments. After updating ERG's findings with more recent cost information, we find annual costs of $340,000 associated with this final rule, and an additional $138,000 that would only affect non-U.S. establishments. We were unable to quantify specific benefits attributable to the final rule, but the ultimate use of electronic registration and listing data, the mandate under the Bioterrorism Act to collect additional pieces of registration data, and the requirement under the Bioterrorism Act and FDAAA that information be submitted to FDA electronically justify taking this action.

As discussed elsewhere in this preamble, section 224 of FDAAA amended section 510(p) of the FD&C Act to require establishment registrations and device listings to be submitted to FDA by electronic means unless the Secretary grants a waiver from electronic submission requirements. We currently maintain databases that contain establishment registration and device listing information obtained from owners and operators of device establishments. Prior to FDAAA, these databases relied on paper forms submitted by the owners and operators to us, which were then forwarded by us to a data entry contractor for input into our device registration and listing databases.

Our device registration and listing databases play an important role in our efforts to accomplish many regulatory and statutory objectives. For example, we can use this information to identify device manufacturers to facilitate recalls or information alerts in the case of potential safety concerns. We also use it to plan and conduct inspections, administer postmarket surveillance, generate estimates of the number of businesses that are affected by our rulemaking, and to otherwise exercise competent oversight of the device industry.

The quality and completeness of these databases depends on prompt submission of information and the immediate inclusion of the data in our system. Under a paper-based registration and listing system, we were unable to readily verify the accuracy of the information submitted and, in some instances, manufacturers were not timely in informing us of changes. In addition, because we were using physical paper forms, it was possible for information to be mishandled or lost before being added to the system, thereby further reducing the reliability of the databases.

In accordance with FDAAA, the Agency began collecting device establishment registration and device listing information using FURLS, FDA's new Internet-based electronic device establishment registration and device listing system which became operational on October 1, 2007. The electronic submission of information makes the registration and listing process more efficient for industry and allows us to review and use such information more quickly, thus helping to ensure that medical devices will be safe and effective.

Despite the obvious public health advantages to society of using an electronic device registration and listing system, the private returns alone would not be adequate to move the entire device industry to a new registration and listing format that would meet the requirements of section 510(i) and (p) of the FD&C Act. Because the social benefits are largely external to the firms, the large number of entities operating individually cannot be expected to voluntarily move to a new uniform standard. Few entities would choose to adopt a new format without significant private benefits.

Revisions to the existing device registration and listing regulations would affect owner-operators of all registered device establishments. Based on a review of our internal databases on September 12, 2011, there are approximately 21,254 owner-operators of approximately 24,000 registered device establishments, and 121,300 listed devices. Of the 24,000 registered establishments, approximately 14,000 are registered as domestic and 10,000 are registered as foreign.

Under the existing regulations, with certain exceptions, owners or operators of establishments that engage in the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for human use must, in addition to other requirements, register their establishments and submit listing information for each of their devices in commercial distribution. Foreign device establishments engaged in the manufacture, preparation, propagation, compounding, or processing of a device that is imported or offered for import into the United States must comply with the registration and listing requirements, including the requirement to identify a U.S. agent. Until the recent change to electronic submissions mandated by section 224 of FDAAA, all domestic and foreign registration and listing information was submitted using paper forms.

A major objective of this final rule is to update FDA's regulations at part 807 to reflect the requirement for electronic submission of establishment registration and device listing information as required by FDAAA. A paper-based system of registering and listing is costly. It does not facilitate timely updates, which does not allow for the best use of these data in inspections and recalls. Electronic submission of registration and listing information improves the quality and timeliness of information available to FDA. In addition, a system of electronic registration and listing improves the quality and timeliness of information available to health care professionals and consumers. Furthermore, to the extent that these quality improvements to the registration and listing process facilitate device recalls, complement postmarketing surveillance programs, help ensure the safety of imported devices, improve the scheduling and planning of inspections, and otherwise assist the Agency in carrying out its statutory and regulatory objectives, there is a broad public health benefit. Moreover, the development and maintenance of high quality databases of information about devices and device establishments would enhance future uses of technology in the delivery of health care. An electronic database that contains current and accurate information about devices could, for example, facilitate the development of technology that would allow for communication among devices, giving them additional functionality and the potential for interoperability.

This final regulation will also slightly modify the types of information that would need to be submitted as registration and listing information. However, these modifications would be minor and are generally consistent with achieving a more accurate and useful database of device industry information.

The ERG Memo identifies eight areas where revisions to the current device registration and listing provisions may affect the cost of compliance. 2 These impacts would stem from provisions associated with:

• The creation of an account on FURLS;

• The requirement for submission of additional information as part of the annual registration process;

• Modifications to requirements relating to registration information updates;

• The requirement for submission of additional information when listing a device;

• Changes relating to the requirement for review and update of device listing information;

• The waiver from the requirement to register and list by electronic means;

• The elimination of the exemptions from registration and listing requirements for foreign establishments whose devices enter a foreign trade zone and are re-exported from the foreign trade zone without having entered U.S. commerce and the exemption for devices that are imported under section 801(d)(3) of the FD&C Act (import-for-export provision); and

• The elimination of the exemption from registration and listing requirements for contract manufacturers and contract sterilizers who do not commercially distribute the devices.

Because most of the identified regulatory impacts only slightly increase or decrease the costs of registering and listing, sometimes involving offsetting impacts, we present the impacts grouped by the eight impact areas identified previously, as opposed to trying to present the impacts as distinct groups of costs and benefits.

Under the final rule, establishments go through the one-time process of creating a FURLS account. According to ERG, the costs associated with setting up the FURLS account are negligible. 3

This final rule could affect the cost to establishments by changing the information they submit in the annual registration process. ERG found that differences in the information collected currently and the requirements under the final rule would be minor and should not increase the time spent completing the registration. 4 Some of the additional information in the final rule, such as email addresses for the establishment's official correspondent and owner-operator and the universal resource locator (URL) for the establishment's Web site, are currently collected by FDA and there will be little if any additional cost for those establishments not currently providing this information. There will be modest savings associated with the annual registration process, as establishments will be able to access and edit registration information online and will no longer have to wait for physical forms to be mailed from FDA, review them, make edits, and mail the forms back to FDA.

As amended by section 321 of the Bioterrorism Act, section 510(i) of the FD&C Act requires foreign establishments whose devices are imported or offered for import to the United States to identify and provide contact information for importers of the establishment's device that are known to the establishment and also those persons who import or offer for import the device into the United States. According to the ERG memo, foreign establishments identifying importers known to them and persons who import or offer for import the establishments' devices would typically be identifying one or two entities of each type with readily available contact information, so the impact would be negligible. 5 OMB Circular A-4 directs us to carefully evaluate new U.S. rules that might act as non-tariff barriers to imported goods. As the cost to these foreign establishments will be quite small and will not have a significant adverse effect on trade, the impact on U.S. consumers from this provision will be negligible.

Under § 807.22(b)(2), establishments would be required to update their registration within 30 days if their registration information were to change. Current § 807.26 requires that establishments update registration information for a change in ownership or a change in the location of the establishment. As the final rule includes a broader set of circumstances requiring a mandatory update, it has the potential to be slightly more costly. Under the final rule, however, establishments will provide updates electronically, as opposed to submitting such information to FDA using a paper form as required by current § 807.26. ERG found that the ability to submit updated information through FURLS rather than completing and mailing paper forms to result in a net reduction in administrative burden and, therefore, a cost savings to establishments. ERG did not quantify the savings, but we estimate it will negate any cost increase from the greater likelihood of a mandatory update.

Under § 807.25, establishments will be required to submit additional information, including 510(k) numbers and HDE numbers among the types of premarket submission numbers submitted to FDA for non-exempt devices. Establishments will also submit all proprietary and brand names under which each device is marketed. Although the Agency already collects proprietary or brand names as part of device listings, the device listing form specified for use under the existing regulation has a single block of 80 characters for proprietary and brand names. which may have been restricting the amount of information establishments have been providing. Establishments using FURLS to list their devices electronically have an unlimited amount of space to provide information and could submit more data. According to the ERG memo, electronic device listings will rarely have more than three proprietary or brand names, so the additional information that establishments will be providing under the final rule is limited. 6

Under § 807.25(g)(4), establishments will be required to submit 510(k) and HDE numbers for non-exempt devices as part of the listing process. We do not attempt to quantify this very small burden, as owners or operators need only a few minutes to retrieve this information from readily available sources. 7 Many establishments are already submitting this information electronically and others have been voluntarily submitting this information since FDA began to collect it on a voluntary basis in 2005. The inclusion of the 510(k) number in the device listing will result in significant benefits. Such information would improve our postmarket surveillance efforts by permitting devices to be tracked based on the submission number assigned to the particular device. Absent the 510(k) number, tracking would be done by reported product codes, which do not necessarily correspond to the product codes under which a device was cleared. The process of having the registrant supply the premarket submission number and FDA determine the appropriate product code saves time and saves costs FDA had been incurring addressing incorrectly entered product codes.

Section 510(j)(2) of the FD&C Act, as amended by section 223 of FDAAA, now requires device listings to be updated once each year during the period beginning on October 1 and ending on December 31. Previously, as reflected in the current registration and listing regulations, registrants had to review and update their device listings on a semiannual basis, during June and December. FDA had not strictly enforced this requirement but did encourage establishments to update their listings throughout the year whenever information had changed. The required updates under this final rule are less frequent. Despite this, there is a potential increase in cost from increased enforcement. Any additional impact will be too small to reliably quantify.

Under the final rule, parties for whom registering and listing by electronic means is not reasonable may request a waiver from FDA. Because one would only need to have access to a computer, Internet access, and an email address to register and list by electronic means, we do not anticipate many requests for waivers.

For the first few months of operation (i.e., October through December 2007) of the Web-based system, FDA received fewer than 10 requests for waivers from the requirement to submit registration and listing information electronically. As FDA received electronic submissions for more than 16,000 establishments over that period, these requests amount to about 0.06 percent of the total number of establishments that responded.

Based on information taken from our databases as of September 2011, FDA estimated there were 21,254 owners or operators who collectively registered a total of 24,000 device establishments. If 0.06 percent of the 24,000 total device establishments would request waivers from FDA, there would be 14 requests (24,000 × 0.0006). We estimate submitting a waiver requires an hour of time from a mid-level manager to draft, approve, and mail a letter. At a benefit-adjusted hourly wage of $41 for a regulatory affairs official, 14 waivers cost $583. 8

Additional firms will enter the device industry over the next several years and would need to list and register. Some may request waivers, resulting in small additional costs in the future.

Under current § 807.40(a), foreign establishments are not required to comply with the registration and listing requirements if their device enters a foreign trade zone and is re-exported from that foreign trade zone without having entered U.S. commerce. This final rule revises this section to eliminate the exemption.

Current § 807.40(c) exempts devices imported under section 801(d)(3) of the FD&C Act (“import-for-export” provision) from registration and listing requirements. This final rule eliminates this exemption; devices currently exempted will have to be listed and the foreign establishments that manufacture these devices will have to register with FDA. Listing a device requires approximately 2.5 hours. 9 At $41 per hour, the cost of listing a device is $103.

We do not possess a precise estimate of the number of devices affected by the loss of these exemptions. According to the databases maintained by FDA's Division of Import Operations and Policy, 1,344 shipments of devices entered the United States under the “import-for-export” provision in 2006, about 0.13 percent of device shipments. 10 Using 1,344 as a rough estimate of the devices affected by the loss of the “import for export” exemption, the cost to foreign exporters is about $138,000 (1,344 shipments × 2.5 hours per shipment × $41/hour). These are one-time costs, as subsequent shipments of the same device would not require an additional registration and listing. The continuing introduction of new devices from foreign exporters will result in some additional costs each year. These additional annual costs, which we do not quantify, will be a small fraction of the one-time $138,000 cost to foreign exporters.

We do not have a reliable estimate for the number of devices and firms affected by the loss of the exemption for devices imported into foreign trade zones. We expect the number of affected devices and firms to be small. We believe the overall impact on individual foreign firms from the loss of this exemption will be very small.

The elimination of these exemptions will not be costly for domestic device establishments. As these devices are not intended for U.S. commerce, there will be no impact on the domestic market for these devices. The cost per affected device will be small, so the elimination of these exemptions will have a negligible impact on U.S. industries doing “import-for-export” and operating in foreign trade zones. There would potentially be a cost to U.S. industry if an affected foreign establishment was actually a foreign presence of a domestic entity, but we have no knowledge of such establishments.

Under current § 807.20(a)(2), (c)(1), and (c)(2), contract manufacturers and contract sterilizers are exempt from registration and listing obligations if they make or sterilize a device according to another person's specifications for commercial distribution by the person who developed the specifications. This final rule will eliminate the exemption from registration and listing for contract manufacturers and contract sterilizers who do not commercially distribute. Contract manufacturers and contract sterilizers not currently registering will be required to do so. Registration and listing is a recurring obligation, so there are annual costs associated with this impact.

As of October 2007, there were 1,304 registered contract manufacturers in our registration and listing database who had not previously listed any products. Of these 1,304 establishments, 736 re-registered in 2006. A small number of additional contract manufacturers may not be in our database, but will be registering for the first time because of the loss of an exemption. We use the 736 establishments as our estimate for the contract manufacturers that will need to register and initially list products.

The registration and listing database in September 2011 contained about 121,300 listed devices and 24,000 registered establishments, or about 5.05 devices per establishment. If the estimated 736 affected contract manufacturers have an average of 5.05 devices, there will be 3,717 additional device listings.

Between 1999 and 2006, there was an average of 306 initial contract manufacturer registrations each year. Assuming 306 contract manufacturers initially register each year and there are 5.05 devices per establishment, there will be 1,545 additional listings each year. In the first year of our analysis, we assume 736 existing contract manufacturers and 306 contract manufacturers initially registering for a total of 1,042. At 5.05 devices per establishment, there would be 1,566 additional listings for a total of 5,262 the first year. 11

There are 116 registered establishments that perform contract sterilizations only and have no listed devices. Our databases also include 114 contract sterilizers associated with 533 device listings, an average of 4.68 listings per establishment. We assume that the 116 contract sterilizers with no listed devices are establishments currently not required to list but will be required to list under the final rule. Assuming these establishments also have an average of 4.68 listings, there will be 543 additional listings from the loss of the exemption for contract sterilizers.

We assume registration and listing requires 2.5 hours of time per listed device each year. 12 At a labor rate of $41 per hour, including benefits, registration and listing costs $103 per device or $520 per contract manufacturing establishment ($103 per listing × 5.05 listings) and $482 per contract sterilizing establishment ($103 per listing × 4.68 listings). Across all affected contract manufacturers the cost will be a recurring $539,000 ($41 per hour × 2.5 hours × 5,262 listings). For contract sterilizers, the cost will be $56,000 ($41 per hour × 2.5 hours × 543 listings). Thus, the impact on contract manufacturers and contract sterilizers will be an annual $595,000 ($539,000 + $56,000). We may not be aware of some contract sterilizers that have never registered, but there are likely few such firms and do not account for them in our analysis.

The loss of the exemption for contract manufacturers and sterilizers who do not commercially distribute the devices will not only result in social economic costs, but will also result in transfers associated with the payment of user fees. Contract manufacturers and sterilizers that are required to register will be required to pay user fees. According to section 212 of FDAAA, the FY 2012 establishment registration fee is $2,029. At that rate, we estimate FY 2012 fees of $2.35 million, $2.11 million paid by the 1,042 contract manufacturers and $235,000 paid by the 116 contract sterilizers.

Table 1 of this document summarizes the projected quantified impacts of this final rule. The total annual costs are $340,000. Foreign establishments will face an additional annual burden of $138,000 due to the loss of the exemptions from registration and listing requirements relating to devices entering a foreign trade zone that are later re-exported without having entered U.S. commerce and devices that are imported into the United States under section 801(d)(3) of the FD&C Act. There would also be a transfer of $2.14 million in additional user fees paid by contract manufacturers and sterilizers.

The final rule will result in benefits associated with an electronic registration and listing database that would provide more up-to-date and complete information. The electronic registration and listing database system could also support future medical and health information technology initiatives. The final rule will increase the efficiency of the registration and listing process by eliminating all or nearly all paper submissions. With registration and listing in an electronic format, we are able to review the submitted information more quickly and can contact submitting firms immediately through email if any additional information is needed. In addition, a more accurate and more complete database of registered establishments and listed devices benefits patient safety by facilitating timely notification of recalls of certain unsafe devices and prompt identification of the affected manufacturers.

Although the scope of the final rule does not extend beyond registration and listing, the resulting high-quality, electronic database will facilitate future uses of technology for the public benefit. A current electronic database of device information could, for example, facilitate the development of future devices utilizing wireless connectivity and the interoperation of such devices with hospital information systems, or with handheld personal digital assistant (PDA)-type clients used by health care providers or those managing hospital inventories.

Additionally, having a paper-based registration and listing system is inconsistent with section 510(p) of the FD&C Act, as amended by section 224 of FDAAA, and might deter the medical device industry and healthcare providers from investing in new initiatives that would make use of electronic device listing and establishment registration data.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. The impact of this final rule is almost entirely attributable to the requirement that contract manufacturers and contract sterilizers register and list. We have estimated the impacts on small entities and find that the costs associated with registering and listing will not be a significant burden for even the smallest of contract manufacturers and contract sterilizers. Moreover, failing to remove this exemption for contract manufacturers and sterilizers would reduce the benefits of this final rule. These benefits include improving the quality and timeliness of information, facilitating device recalls, complementing postmarket surveillance programs, ensuring the safety of imported devices, and improving the scheduling and planning of inspections. Requiring contract manufacturers and sterilizers to register and list allows for the appropriate oversight of these types of facilities. For other elements of this final rule, the costs per entity are very small and we do not believe that this final rule will have a significant economic impact on a substantial number of small entities.

As described earlier in this preamble, this final rule will revise the Agency's regulations at part 807 to make them consistent with the requirement under FDAAA that the Agency shift to an electronic registration and listing format. The incremental costs to establishments making this switch to electronic registration and listing are so small as to be difficult to quantify. Certain elements of the final rule may be costly to some entities, but the actual incremental costs are estimated to be extremely small. We estimate the cost of submitting a waiver claiming electronic listing and registration to be $41. The cost of registering and listing a device because of the loss of the exemptions from registration and listing requirements for devices imported into foreign trade zones or imported under section 801(d)(3) of the FD&C Act is not expected to have an effect on domestic establishments. Other elements of the final rule involve the submission of information not currently required but readily available and the estimated cost of compliance will be so small as to be difficult to estimate.

Contract manufacturers and contract sterilizers who do not commercially distribute the devices they make or sterilize will be faced with a new requirement to register and list. We do not know how many of the affected contract manufacturers and contract sterilizers would be categorized as small. As shown in table 1 of this document, we estimate 1,042 affected contract manufacturers and 116 affected contract sterilizers. Our internal databases include some contract manufacturers and sterilizers that have in the past voluntarily registered. A review of the contract sterilizers in this database indicate many are described in external databases as being part of NAICS code 339113 (Surgical Appliance and Supplies Manufacturing). Because of the specific expertise, capital requirements, and economies of scale associated with contract sterilization, we expect contract sterilizers will have more employees and more revenues per employee than would a typical establishment in this class. Medical device contract manufacturers fit in NAICS code 339112 (Surgical and Medical Instrument Manufacturing). For both of these industry classifications, the U.S. Small Business Administration has defined a small business as one with 500 or fewer employees. 13

According to the U.S. Census there are 1,340 establishments in class 339112 with 1,293 of them (96 percent) having fewer than 500 employees. 14 Census information on class 339113 lists 2,219 establishments, with 2,189 of them (99 percent) having fewer than 500 employees. 15 Applying these profiles to our estimated contract manufacturers and contract sterilizers, there would be 1,000 small affected contract manufacturers (96 percent of 1,042) and 116 small affected contract sterilizers (99 percent of 118).

For class 339112, we consider the establishment group of establishments with 10 to 19 employees, the smallest group for which data are provided. According to Census data, there are 183 establishments with a total value of shipments of $468 million. The average value of shipments is $2.6 million. As discussed in section V.D of this document, establishment registration user fees are $2,029 for FY 2012, and as shown in table 1 of this document, the estimated annual burden of listing a device is 2.5 hours at $41 per hour, or $103. A small contract manufacturer with a single listed device would face an annual burden of $2,029 plus $103, or $2,132, which is 0.08 percent of annual revenues.

For class 339113, considering establishments with 10 to 19 employees, the smallest group for which data are provided, there are 302 establishments a total value of shipments of approximately $798 million. The average value of shipments is $2.6 million. Contract sterilizers will face an annual establishment fee of $2,029 plus a cost of $103 per listed device. A small contract sterilizer with 2 listed devices will face an annual burden of $2,029 plus $206, $2,235. This amount is equal to 0.17 percent of annual revenues, well below typical thresholds cited for significant impacts.

A $41 burden associated with a waiver request is be about 0.01 percent of revenues for a small entity with revenues in the hundreds of thousands of dollars. As discussed earlier in section V.D of this document, other impacts associated with this final rule are all extremely small. We therefore conclude that the final rule will not have a significant impact on a substantial number of small entities. Affected entities currently possess the skills required to comply with the provisions of this final rule.

FDA considered regulatory alternatives such as not regulating and not requiring registration and listing by contract manufacturers and contract sterilizers who do not commercially distribute devices. As explained earlier in this preamble, the electronic submission of information is mandated under FDAAA. The benefits associated with Agency oversight of contract manufacturers and contract sterilizers justify the estimated costs of requiring that they register and list.

This final rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title, description, and respondent description of the information collection provisions are shown in the following paragraphs with an estimate of the annual reporting and recordkeeping burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.

Title: Implementation Electronic Submission of Medical Device Registration and Listing (OMB Control No. 0910-0625)—Revision

Description: In accordance with the collection of information entitled “Electronic Submission of Medical Device Registration and Listing,” medical device establishment owners and operators will be required to electronically submit establishment registration and device listing information.

Section 510(c) of the FD&C Act requires owners or operators of domestic establishments upon first engaging in the “manufacture, preparation, propagation, compounding, or processing” of a device or devices in those establishments to immediately register their name and place of business and such establishment. Section 510(a)(1) of the FD&C Act defines the term “manufacture, preparation, propagation, compounding, or processing” to include “repackaging or otherwise changing the container, wrapper, or labeling of any * * * device package in furtherance of the distribution of the * * * device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user.”

Section 510(a)(2) of the FD&C Act mandates that the term “name” include, among other things, the name of each partner of a partnership, and the name of each corporate officer and director of a corporation. An owner or operator of a registered establishment must also immediately register any additional establishment that he owns or operates in any State and in which he begins the “manufacture, preparation, propagation, compounding, or processing” of a device (section 510(d) of the FD&C Act). An owner or operator of any establishment that engages in these activities must also re-register its establishment once each year during the period beginning on October 1 and ending on December 31 of each year (section 510(b) of the FD&C Act, as amended by FDAAA).

Section 510(i) of the FD&C Act contains certain registration requirements pertaining to foreign establishments (e.g., submission of the name of each importer of the establishment's device in the United States that is known to the establishment, submission of the name of each person who imports or offers for import the establishment's device to the United States for purposes of importation). Section 510(g) of the FD&C Act provides for certain exemptions from the registration requirements. In addition, section 510(p) of the FD&C Act, as amended by FDAAA, requires the electronic submission of device registration and listing information unless the Secretary grants a request for a waiver because use of electronic means is not reasonable for the person requesting the waiver.

Section 510(j)(1) of the FD&C Act requires that every person who registers must, at the time of registration, submit a list of all devices that are being manufactured, prepared, propagated, compounded, or processed by him or her for commercial distribution which have not been previously listed by him or her. This information must be submitted in the form and manner prescribed by the Secretary (section 510(j)(1) of the FD&C Act). Prior to FDAAA, section 510(j)(2) of the FD&C Act required certain changes in listing information to be reported every June and December, including any material changes in information previously submitted under the listing provisions. This information must now be provided only once each year during the period beginning on October 1 and ending on December 31.

Section 510(e) of the FD&C Act permits the Secretary to prescribe a uniform system for the identification of devices intended for human use and may require that persons who are required to list such devices under section 510(j) shall list such devices in accordance with such a system. The disclosure provision in section 510(f) of the FD&C Act requires the Secretary to make available for inspection any registration filed under section 510. Section 510(f) also provides that certain listing information must be exempt from disclosure unless the Secretary finds that such exemption would be inconsistent with protection of the public health.

Complete and accurate registration and listing information is necessary to accomplish a number of statutory and regulatory objectives, such as: Identification of establishments producing marketed medical devices, identification of establishments producing a specific device when that device is in short supply or is needed for national emergency, facilitation of recalls for devices marketed by owners and operators of device establishments, identification and cataloguing of marketed devices, administering postmarketing surveillance programs for devices; identification of devices marketed in violation of the law; identification and control of devices imported into the country from foreign establishments; and scheduling and planning inspections of registered establishments under section 704 of the FD&C Act.

The electronic collection of establishment registration and device listing information from medical device establishment owners and operators also furthers the purpose of several statutes, including: The FDAAA, the Bioterrorism Act, MDUFMA, and GPEA.

Description of Respondents: Owners or operators of establishments that engage in the manufacturing, preparation, propagation, compounding, or processing of a device or devices must register their establishments and submit listing information for each of their devices in commercial distribution. Notwithstanding certain exceptions, foreign device establishments that manufacture, prepare, propagate, compound, or process a device that is imported or offered for import into the United States must also comply with the registration and listing requirements.

The total annual estimated burden imposed by this collection of information is 99,470 hours annually.

FDA estimates the burden of this collection of information as follows:

The reporting and recordkeeping estimated burden for electronic registration and listing under OMB number 0910-0625 for the proposed rule is larger for reporting and smaller for recordkeeping than the burden estimated for the final rule (7,911 and 11,977 smaller, respectively) because of more accurate re-estimates using information from our FURLS database.

The currently approved reporting and recordkeeping burden for electronic registration and listing under OMB number 0910-0625 is 71,319. The estimated reporting and recordkeeping burden for electronic registration and listing under the rule is 99,470 hours, an increase of 28,151 hours. This increase is due to the incremental increase of respondents no longer exempt from these requirements weighed against the change in reporting requirements for all owner operators and the decrease in the overall number of device establishments that have registered since OMB approved the collection of information under control number 0910-0625.

Burden estimates are based on recent experience with the existing medical device registration and listing program and the economic analysis provided by ERG. The changes to the actual data collected are very minor, with one exception. We are assuming that it will take approximately the same amount of time to enter the data online using FURLS as it does to use the portable document format (PDF)-enabled forms that had been used for initial establishment registration prior to FURLS becoming operational in October 2007. Any additional burden associated with creating and using the Web-based system accounts (as shown in table 3 of this document under § 807.21(a)) should be offset by the elimination of the need to re-enter identifying information concerning the establishment or product every time registration or listing information is updated, which was the case when updating such information using the PDF-enabled forms.

The recurring burden for the new data collection under § 807.41 (import-related information provided by foreign companies exporting to the United States) was estimated based on the ERG memo. This report stated that foreign establishments would typically be identifying one or two importers and one or two persons who import or offer for import with readily available contact information.

The estimates for creation of new user accounts under § 807.21(a) are based on the current number of owners or operators, and experience in account creation using the existing FURLS for Food Facility Registration. The estimates for the recurring years assume a similar increase in the number of new owner or operator numbers as were created in FY 2006.

The estimate for § 807.25(d) in table 5 of this document (recordkeeping burden) reflects the requirement that owners or operators keep a list of officers, directors, and partners for each establishment. Owners or operators will need to provide this information only when requested by FDA. However, it is assumed that some effort will need to be expended to keep such lists current.

The requirements shown in table 5 for § 807.26 (renumbered from § 807.31), have not changed based on this revision to the registration and listing regulations. They reflect other recordkeeping requirements for devices listed with FDA, and the requirement to provide these records when requested by FDA. They are based on experience FDA has had with the existing regulation.

This final rule refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 807.35(b) refer to currently approved collections in 21 CFR part 607 OMB control number 0910-0052 and 21 CFR part 207 OMB control number 0910-0045. This rule will not impact the burden in 0910-0052 and 0910-0045 which are already accounted for in those information collections.

Before the effective date of this final rule, FDA will publish a notice in the Federal Register announcing OMB's decision to approve, modify, or disapprove the information collection provisions in this final rule. 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.

The Agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the Agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

The following references have been placed on display in the Division of Dockets Management (see ADDRESSES ), and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. FDA has verified the Web site addresses, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register .

Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 807 is amended as follows:

This notice announces definitions and two priorities that the Office of Special Education Programs (OSEP) intends to use for the SPDG competition in FY 2012 and possibly later years. However, nothing precludes OSEP from publishing additional priorities, requirements, definitions, or selection criteria, if needed. Furthermore, OSEP is under no obligation to make an award for these priorities. The decision to make an award will be based on the quality of applications received and available funding.

Purpose of Program: The purpose of this program is to assist SEAs in reforming and improving their systems for personnel preparation and professional development in early intervention, educational, and transition services in order to improve results for children with disabilities.

Statutory Requirements: Applicants under the SPDG program must meet the statutory requirements in sections 651 through 654 of the Individuals with Disabilities Education Act (IDEA), including the application requirements in section 653 and the use of funds requirements in section 654. Because the priorities and definitions in this notice supplement these statutory requirements, applicants should familiarize themselves with the statutory requirements they must also meet to receive funding under this program.

In addition, section 651(b) of the IDEA defines the term “personnel” as it is used in connection with the SPDG program. This definition applies to the priorities in this notice as well. “Personnel” means special education teachers, regular education teachers, principals, administrators, related services personnel, paraprofessionals, and early intervention personnel serving infants, toddlers, preschoolers, or children with disabilities, except where a particular category of personnel, such as related services personnel, is identified.

Program Authority: 20 U.S.C. 1451-1455.

We published a notice of proposed priorities and definitions for the SPDG program in the Federal Register on April 13, 2012 (77 FR 22306). That notice contained background information and our reasons for proposing these particular priorities and definitions.

Public Comment: In response to our invitation in the notice of proposed priorities and definitions, 11 parties submitted comments.

We group major issues according to subject. Generally, we do not address technical and other minor changes. In addition, we do not address comments that raised concerns not directly related to the proposed priorities and definitions.

Analysis of Comments and Changes: An analysis of the comments and of any changes in the priorities or definitions since publication of the notice of proposed priorities and definitions follows.

Comment: Two commenters recommended that we include all school personnel in both priorities. One commenter recommended that OSEP use the term “school personnel” instead of “teacher” throughout the two priorities to ensure that all school personnel, as the IDEA defines the term, have access to evidence-based professional development.

Discussion: For Priority 1, we are using the definition of “personnel” from section 651(b) of the IDEA because Priority 1 is designed broadly to focus on the effective and efficient delivery of professional development using evidence-based professional development practices. This priority would apply to all personnel defined in section 651(b) of the IDEA, not just to teachers. Priority 2, however, is limited to the specific professional development needs of general and special education teachers identified by teacher evaluation systems that take into account student growth as a significant factor in determining performance levels. Therefore, it would not be appropriate to apply the definition of “personnel” in section 651(b) of the IDEA to Priority 2.

Changes: None.

Comment: One commenter noted that rural school personnel would especially benefit from using technology to provide professional development in the form of coaching.

Discussion: OSEP agrees that the use of technology can improve the delivery of professional development in rural areas and that technology could provide a means of coaching school personnel in rural areas in using and maintaining new skills. These activities can be supported under Priority 1.

Changes: None.

Comment: One commenter recommended that OSEP add to the priorities a focus on personnel preparation.

Discussion: The primary focus of the SPDG program is to improve professional development for personnel so that they have the knowledge and skills to improve results for children with disabilities. High-quality, comprehensive professional development programs are essential to ensure that school personnel possess the skills and knowledge necessary to address the early intervention, educational, and related services needs of infants, toddlers, and children with disabilities. The Department's intent in publishing this priority is to allow States to make their systems of professional development for personnel serving children with disabilities more effective and efficient through the use of evidence-based practices. OSEP appreciates the commenter's suggestion to expand Priority 1 to include a focus on personnel preparation. However, OSEP believes that other funding opportunities can address States' personnel preparation needs, such as grants under section 662 of IDEA, and that the more limited resources under the SPDG program, 90 percent of which must be used for professional development as provided for in section 654(d)(1) of the IDEA, should be used primarily for professional development activities.

Changes: None.

Comment: Several commenters requested that Priority 1 include particular practices as areas for professional development. For example, some commenters recommended including references to universal design for learning, multi-tiered systems of support, and positive behavioral interventions and supports to the description of evidence-based professional development practices.

Discussion: The primary focus of this priority is on the use of evidence-based professional development practices that increase the implementation of evidence-based instructional practices to improve outcomes for children with disabilities. Accordingly, applicants that wish to address particular practices in their proposed projects may do so, provided they can demonstrate that these practices are evidence-based and will improve outcomes for children with disabilities.

Changes: None.

Comment: Multiple commenters supported the focus in Priority 1 on evidence-based and ongoing professional development that makes use of technology to reach school personnel. However, one commenter stated that the definition of technology is unclear and asked for clarification regarding the “newer technologies” referred to under the “Use of Technology” in the background section for Priority 1. This commenter stated that the background section refers to the use of bug-in-the ear technology for coaching and distance education technology for providing professional development to remote areas.

Discussion: OSEP appreciates commenters' support for the use of technology under Priority 1 to more efficiently and effectively provide ongoing evidence-based professional development to personnel. The discussion on the use of technology in the background section of the notice was intended to highlight the fact that the introduction of new technologies (e.g., online project management tools, wikis for communication and collaboration, and Web cast programs) has greatly enhanced the capacity to provide ongoing professional development and that applicants should consider the use of these technologies to increase the efficiency and effectiveness of their professional development. However, applicants may propose to use the technologies that best suit their needs in providing more efficient and effective professional development.

Changes: None.

Comment: One commenter requested that the Department clarify the intent of the language in the background section of the notice of proposed priorities, published at 77 FR 22306 regarding the importance of high quality professional development to improve the skills of personnel who work with infants and toddlers. The commenter was concerned that this language focused the priority on the provision of professional development for early intervention and early childhood educators.

Discussion: We believe that the language of the priority is clear and that no further clarification is needed. The purpose of Priority 1 is to ensure that personnel possess the skills and knowledge necessary to address the early intervention, educational, and related services needs of infants, toddlers, and children with disabilities and is not intended to focus only on providers of early childhood or early intervention services. In addition, it is not necessary to change the background section because it is not included in the final priority.

Changes: None.

Comment: One commenter described the importance of providing professional development that helps school personnel become culturally competent.

Discussion: OSEP agrees that providing professional development to help school personnel gain cultural competence is important. Under this priority, applicants may propose a project that helps school personnel serving children with disabilities to become culturally competent, provided the project is designed to improve professional development in this area through the use of evidence-based practices.

Changes: None.

Comment: One commenter expressed concern that using student growth data to determine professional development needs would exclude teachers whose responsibilities are not related to subjects that are part of the statewide assessment system. The commenter recommended that Priority 2 allow for the use of other types of data, such as staff surveys, supervisory conferencing, and observations, to determine professional development needs.

Discussion: The teacher evaluation systems implemented by States and LEAs use multiple measures of professional practice and student growth to determine performance levels and identify professional development needs. In particular, States and LEAs may use other measures of student learning in addition to the State's assessment data under the Elementary and Secondary Education Act of 1965, as amended (ESEA) (see the definition of “student achievement” in the Definitions section of this notice). For teachers of non-tested grades or subjects, alternative measures of student learning and performance can be used, such as student scores on pre-tests and end-of-course tests, student performance on English language proficiency assessments, and other measures of student achievement that are rigorous and comparable across schools. States and their LEAs may use other sources of data in addition to student growth data, as a part of their teacher evaluation system, to assist in determining professional development needs.

Changes: None.

Comment: One commenter approved of this priority because it encourages school personnel to analyze student performance data using objective measures to assess growth in student achievement. The commenter stated that these data could be useful at a school and district level for planning professional development and coaching. However, the commenter expressed concerns about student performance data being part of a teacher evaluation system, stating there is insufficient evidence to prove that teacher performance significantly affects student achievement.

Discussion: We appreciate the comment; however, we disagree that there is no evidence demonstrating that teacher performance has an effect on student achievement. There is a substantial body of evidence that teacher performance significantly affects student achievement. Please see Chetty, Friedman, & Rockoff, 2011; Hanushek, 2010; Hanushek, 2011; Hanushek & Rivkin, 2010; Kane & Staiger, 2008; Kane, Taylor, Tyler, & Wooten, 2010; Rockoff 2004.

Changes: None.

Comment: One commenter stated that there is no evidence that student growth can be effectively measured through an alternate assessment or testing with accommodations.

Discussion: Under section 612(a)(16)(B) of the IDEA, States must develop guidelines for the provision of appropriate accommodations for students with disabilities, and those accommodations may not operate to invalidate test results. States must ensure that teachers and other staff know how to administer assessments, including how to use appropriate accommodations, for students with the most significant cognitive disabilities. Appropriate accommodations that do not interfere with the testing construct can serve as a component of a well-designed assessment system to measure student growth. In addition, an alternate assessment that meets established technical adequacy requirements for test reliability and validity can provide data that can be included as a component of a well-designed assessment system to measure student growth.

The Department is currently funding the development of two alternate assessments for students with the most significant cognitive disabilities. The assessments will measure the knowledge and skills of those students against a common set of college- and career-ready content standards in mathematics and English language and will provide an accurate measure of student growth over a full academic year or course. These alternate assessments developed with General Supervision Enhancement Grants (GSEG) will permit the assessment of all eligible students with significant cognitive disabilities, and they will produce data (including student achievement data and student growth data) that can be used to inform (a) Determinations of school effectiveness; (b) determinations of individual principal and teacher effectiveness for purposes of evaluation; (c) determinations of principal and teacher professional development and support needs; and (d) teaching, learning, and program improvement.

Changes: None.

Comment: Multiple commenters shared concerns that their States would not be eligible for this priority because their data systems do not currently have the ability to link student performance to teacher performance.

Discussion: The Department understands that some States and their LEAs may need time to make the changes in their data systems necessary to use student growth data for decision-making purposes. Accordingly, the Department has revised Priority 2 to provide greater flexibility for States currently in the planning or initial stages of implementing teacher evaluation systems.

Revised Priority 2 will allow States to begin using the results from their teacher evaluation systems to identify the professional development needs of teachers of students with disabilities no later than the beginning of the third year of the grant's project period. To meet this priority, an applicant must include, as part of its application, a plan describing how it will use the results of teacher evaluation systems to identify the professional development needs of teachers of students with disabilities and the applicant's timeline for using the results. We believe it is important to have a competitive preference priority in this area to encourage States to build their capacity to use their evaluation systems to identify and better target the professional development needs of teachers of students with disabilities and help them to develop the knowledge and skills required to deliver evidence-based instruction.

Changes: Priority 2 has been revised to allow States to begin using their evaluation system results to identify the professional development needs of teachers of students with disabilities no later than the beginning of the third year of the grant's project period rather than at the beginning of the project period.

Comment: One commenter asked whether the teacher evaluation system must already be fully functional at the school, LEA, and State levels in order for the applicant to be eligible to receive competitive preference under this priority.

Discussion: If LEAs have teacher evaluation systems that meet State guidelines, it would be appropriate for the SPDG project to work with these LEAs. As stated in the discussion in response to the previous comment, the State must be able to use teacher evaluation systems that take into account student growth as a significant factor in determining performance levels to identify professional development needs by the beginning of the third year of the grant.

Changes: Priority 2 has been revised to allow States to begin using their evaluation system results to identify the professional development needs of teachers of students with disabilities no later than the beginning of the third year of the grant's project period rather than at the beginning of the project period.

Comment: One commenter noted the difficulty in ascribing the performance of a student with disabilities to a particular teacher because the student will likely be served by multiple professionals (i.e., a regular education teacher, a special education teacher, and a related services provider).

Discussion: While it can be difficult to ascribe the growth of students with disabilities to individual teachers, States are taking different approaches and working to ensure that their evaluation systems validly and reliably ascribe growth data to individual teachers. States and LEAs also have developed more sophisticated data systems that link teacher and student data and that are able to identify with more specificity the amount of time that teachers serve individual students.

Changes: None.

Comment: One commenter recommended that we provide in the priority that SPDG projects in States whose LEAs do not have teacher evaluation systems that take into account student growth (as defined in the notice) be allowed to establish these evaluation systems in order to determine teacher performance levels and target professional development to the specific needs of each of the teachers in participating schools or districts.

Discussion: We do not believe that SPDG funds should be used to develop or implement systems to evaluate special education teachers using student growth data. States participating in the State Fiscal Stabilization Fund (SFSF) program committed to establishing longitudinal data systems that would have the ability to link data on students and teachers. Currently, 45 States have reported they have such a system in place. The remaining five participating States have until the end of 2013 to establish their systems. Also, many States committed to measuring student growth for particular teachers and linking those data back to teacher preparation programs. While we recognize the wide variation among States in the use of longitudinal and other data on student outcomes to evaluate teacher performance, especially special education teacher performance, and there is considerable work to be done, we do not think that SPDG funds should be used to match student and teacher data or to conduct teacher evaluations.

Instead, these projects should focus on the use of teacher evaluation information to identify and address professional development needs. Under section 654(a) of the IDEA, funds could be used by projects to help LEAs to target their professional development, including identifying the type of professional development that would be most useful for their teachers. In addition, we encourage SPDG project staff to participate in State efforts to improve and expand evaluative systems to ensure their design facilitates the use of teacher performance information, which is linked to student outcome data, to identify special education teachers' professional development needs.

Under section 654(b) of the IDEA, SPDG funds can be used for purposes other than professional development, such as developing and implementing mechanisms to assist LEAs and schools in effectively recruiting and retaining highly qualified special education teachers, and could potentially be used to enhance a State's teacher evaluation system that uses student growth data for students with disabilities. However, these funds should not be used by schools or districts to gather performance information or conduct evaluations of individual teachers.

Changes: None.

Comment: Three commenters recommended that OSEP strengthen the definition of “evidence-based practices” to include causality and the demonstration of effect on student outcomes.

Discussion: The definition of “evidence-based practices” was taken from the Department's notice of final supplemental priorities and definitions for discretionary grant programs, published in the Federal Register on December 15, 2010 (75 FR 78486), and corrected on May 12, 2011 (76 FR 27637). OSEP appreciates the commenter's concerns, but the Department has developed the definition to be applicable to a broad range of programs, and it was previously the subject of public comment. Therefore, OSEP does not believe it is necessary to alter the definition in this notice.

Changes: None.

Comment: Two commenters recommended that OSEP strengthen its definition of “fidelity” and stated that fidelity to the components of a practice or program is key to improving student outcomes.

Discussion: Although we agree with the commenters that fidelity to the components of a program or practice is key to improving student outcomes, we believe that the current definition is sufficient in this regard. In the NPP, we explained that we based the proposed definition of “fidelity” on a definition that is widely accepted in the field (Gresham, MacMillan, Boebe-Frankenberger, & Bocian, 2000), and we believe this definition is sufficient for the purposes of this program.

Changes: None.

Comment: Two commenters recommended that OSEP change the definition of “student achievement” to ensure that student achievement data is comparable not only across schools but also across districts within a State.

Discussion: The definition of “student achievement” is taken from the Department's notice of final supplemental priorities and definitions for discretionary grant programs, published in the Federal Register on December 15, 2010 (75 FR 78486), and corrected on May 12, 2011 (76 FR 27637). The Department has developed this definition to be applicable to a broad range of programs, and it was previously the subject of public comment. To be consistent with the definition being used across the Department, we are using this definition without change.

Changes: None.

The Assistant Secretary for Special Education and Rehabilitative Services establishes a priority to assist SEAs in reforming and improving their systems for personnel (as that term is defined in section 651(b) of the IDEA) preparation and professional development of individuals providing early intervention, educational, and transition services in order to improve results for children with disabilities.

In order to meet this priority an applicant must demonstrate in the SPDG State Plan it submits as part of its application under section 653(a)(2) of the IDEA that its proposed project will—

(1) Use evidence-based (as defined in this notice) professional development practices that will increase implementation of evidence-based practices and result in improved outcomes for children with disabilities;

(2) Provide ongoing assistance to personnel receiving SPDG-supported professional development that supports the implementation of evidence-based practices with fidelity (as defined in this notice); and

(3) Use technology to more efficiently and effectively provide ongoing professional development to personnel, including to personnel in rural areas and to other populations, such as personnel in urban or high-need LEAs (as defined in this notice).

The Assistant Secretary establishes a priority for projects that are designed to provide professional development targeted to meet specific needs of teachers identified by teacher evaluation systems that take into account student growth (as defined in this notice) as a significant factor in determining performance levels.

To meet this priority, an applicant must include, as part of its application, a plan describing how it will use the results of teacher evaluation systems to identify the professional development needs of teachers of students with disabilities to ensure that such teachers develop the knowledge and skills required to deliver evidence-based instruction to students with disabilities. The teacher evaluation systems used to make these determinations must be based on student growth in significant part, and must include students with disabilities.

The plan must describe the applicant's timeline for using the results of evaluation systems to identify the professional development needs of teachers of students with disabilities. Under this timeline, the applicant must begin using the evaluation system results to identify the professional development needs of teachers of students with disabilities no later than the beginning of the third year of the grant's project period.

When inviting applications for a competition using one or more priorities, we designate the type of each priority as absolute, competitive preference, or invitational through a notice in the Federal Register. The effect of each type of priority follows:

Absolute priority: Under an absolute priority, we consider only applications that meet the priority (34 CFR 75.105(c)(3)).

Competitive preference priority: Under a competitive preference priority, we give competitive preference to an application by (1) awarding additional points, depending on the extent to which the application meets the priority (34 CFR 75.105(c)(2)(i)); or (2) selecting an application that meets the priority over an application of comparable merit that does not meet the priority (34 CFR 75.105(c)(2)(ii)).

Invitational priority: Under an invitational priority, we are particularly interested in applications that meet the priority. However, we do not give an application that meets the priority a preference over other applications (34 CFR 75.105(c)(1)).

The Assistant Secretary establishes the following definitions for this program. We may apply one or more of these definitions in any year in which this program is in effect.

Evidence-based refers to practices for which there is strong evidence or moderate evidence of effectiveness.

Fidelity means the delivery of instruction in the way in which it was designed to be delivered.

High-need LEA means, in accordance section 2102(3) of the Elementary and Secondary Education Act of 1965, as amended (ESEA), an LEA—

(a) That serves not fewer than 10,000 children from families with incomes below the poverty line (as that term is defined in section 9101(33) of the ESEA), or for which not less than 20 percent of the children served by the LEA are from families with incomes below the poverty line; and

(b) For which there is (1) a high percentage of teachers not teaching in the academic subjects or grade levels that the teachers were trained to teach; or (2) a high percentage of teachers with emergency, provisional, or temporary certification or licensing.

Student achievement means—

(a) For tested grades and subjects: (1) A student's score on the State's assessments under the ESEA; and, as appropriate, (2) other measures of student learning, such as those described in paragraph (b) of this definition, provided they are rigorous and comparable across schools.

(b) For non-tested grades and subjects: alternative measures of student learning and performance, such as student scores on pre-tests and end-of-course tests; student performance on English language proficiency assessments; and other measures of student achievement that are rigorous and comparable across schools.

Student growth means the change in student achievement (as defined in this notice) for an individual student between two or more points in time.

This notice does not preclude us from proposing additional priorities, requirements, definitions, or selection criteria, subject to meeting applicable rulemaking requirements.

I. Background

Throughout this document, whenever “we,” “us,” or “our” is used, we mean EPA. On March 19, 2012 (77 FR 15985), EPA published a notice of proposed rulemaking (NPR) for the State of Maryland. The NPR proposed approval of three SIP revision requests submitted by MDE, as described below.

On October 24, 2007 MDE submitted a SIP revision request to EPA which included amendments to Regulations .01-.03, repeal of existing Regulations .04 and .05, and the adoption of new Regulations .04-.09 under COMAR 26.11.17, Nonattainment Provisions for Major New Sources and Major Modifications. This SIP submittal revises the previously-approved versions of these rules as approved into the Maryland SIP on February 12, 2001 for COMAR 26.11.17 Regulations .02, .04, and .05 (66 FR 9766) and September 20, 2004 for COMAR 26.11.17 Regulations .01 and .03 (69 FR 56170). These amendments were adopted by Maryland on September 18, 2007 and became effective on October 22, 2007. The State adopted these regulations in order to meet the relevant plan requirements of Title 40 of the Code of Federal Regulations (CFR) 51.165 and the CAA. EPA is approving these amendments.

On July 31, 2009, MDE submitted a SIP revision request to EPA that consisted of the incorporation by reference of the Federal PSD requirements at 40 CFR 52.21 as codified in the July 1, 2008 edition of the CFR. The SIP revision request included amendments to the MDE Regulation .01 under COMAR 26.11.01 (General Administrative Provisions) and Regulation .14 under COMAR 26.11.06 (General Emission Standards, Prohibitions, and Restrictions). On June 23, 2011, MDE submitted a letter, retracting the part of submission #09-03 which updated the incorporation by reference date. Since originally submitting #09-03, Maryland has adopted the federal regulations as they appear in the July 1, 2009 version of the CFR (See State Submission #11-02, below). Today's action approves only that part of the submission which clarifies the definitions of “Administrator” and “reviewing authority”.

This SIP submittal revises the previously-approved versions of these rules as approved into the Maryland SIP on May 28, 2002 (67 FR 36810). These amendments were adopted by Maryland on June 11, 2009 and became effective on July 16, 2009. The State adopted these regulations in order to meet the relevant plan requirements of 40 CFR 51.166 and the CAA. EPA is approving these amendments.

On June 23, 2011, MDE submitted a SIP revision request to EPA that consisted of the incorporation by reference of the federal PSD requirements at 40 CFR 52.21 as codified in the July 1, 2009 edition of the CFR, as well as the incorporation of the revisions to 40 CFR 52.21 promulgated on May 13, 2010 in the Greenhouse Gas Tailoring Rule (75 FR 31514). The SIP revision request included amendments to the MDE Regulation .01 under COMAR 26.11.01 (General Administrative Provisions), Regulations .01 and .12 under COMAR 26.11.02 (Permits, Approvals, and Registration), and Regulation .14 under COMAR 26.11.06 (General Emission Standards, Prohibitions, and Restrictions).

This SIP submittal revises the previously-approved versions of these rules, approved as follows: COMAR 26.11.01.01 and COMAR 26.11.06.14 were adopted into the Maryland SIP on May 28, 2002 (67 FR 36810). COMAR 26.11.02.01 and .12 were adopted into the Maryland SIP on February 27, 2003 (68 FR 9012). These amendments were adopted by Maryland on April 14, 2011 and became effective on May 16, 2009. The State adopted these regulations in order to meet the relevant plan requirements of 40 CFR 51.166 and the CAA. EPA is approving these amendments.

As stated above, the SIP revisions submitted by MDE satisfy several required SIP elements: NSR Reform, NO X as a precursor to ozone, PM 2.5, and Greenhouse Gases (GHGs). Additionally, EPA is approving, as a separate action, Maryland's submittals for purposes of meeting the infrastructure requirements of the CAA which relate to Maryland's PSD permitting program and are necessary to implement, maintain, and enforce the 1997 8-hour ozone and PM 2.5 National Ambient Air Quality Standards (NAAQS) and the 2006 PM 2.5 NAAQS. Other specific requirements of MDE's SIP revisions and the rationale for EPA's proposed action are explained in the NPR and will not be restated here.

EPA received a single set of relevant comments on its March 19, 2012 (77 FR 15985) proposed action to approve revisions to the Maryland SIP. These comments, provided by Mr. Robert Ukeiley on behalf of the Sierra Club, (hereinafter referred to as “the Commenter”), raised concerns about EPA's March 19, 2012 proposed action. A full set of these comments is provided in the docket for today's final action. A summary of the comments and EPA's responses are provided below.

Generally, the Commenter raises three areas of concern. First, the Commenter asserts that the proposed revisions to Maryland's nonattainment program cannot be approved into the Maryland SIP because the “reasonable possibility” requirements are not included in the proposed regulations. Second, the Commenter asserts that “NSR Reform” cannot be approved into the Maryland SIP because EPA has failed to demonstrate that the new program “ensures equivalent or greater emissions reductions * * *” in accordance with CAA section 193. Finally, the Commenter asserts that EPA cannot approve the 2006 PM 2.5 Infrastructure SIP because Maryland's incorporation by reference of the Federal regulations is ambiguous with respect to the regulation of NO X and volatile organic compounds (VOC's) as precursors to PM 2.5 , and because the proposed SIP revision does not include the PM 2.5 increments that were promulgated by EPA on October 20, 2010 (75 FR 64864). EPA's response to these comments is provided below.

Comment 1: The commenter asserts that the proposed SIP revision cannot be approved because it does not specifically contain the “reasonable possibility” provisions of 40 CFR 51.165(a)(6).

Response 1: As we noted in the notice of proposed rulemaking, EPA promulgated the “reasonable possibility” provisions of 40 CFR 51.165(a)(6) on December 21, 2007 (72 FR 72607), after MDE submitted the revisions that are the subject of this action. However, we also noted that while the reasonable possibility provisions are a required program element, permitting authorities can meet the requirements with equivalent regulations ( See 77 FR 15988). Contrary to the assertions of the commenter, we look for equivalence of a state's provisions and do not impose a requirement that “ever[y] piece of information that is required by `reasonable possibility' requirements is required by [the State].” Maryland's robust minor NSR program contains provisions which are equivalent to 40 CFR 51.165(a)(6). The Code of Maryland Administrative Regulations (COMAR) lists the activities MDE deems to be “insignificant” and thus exempt from permitting requirements ( See, COMAR 26.11.02.10). It is highly unlikely that any facility exceeding the 50 percent significant emissions rate threshold which triggers the requirements of 40 CFR 51.165(a)(6) would escape some level (major or minor) of preconstruction review under Maryland's regulations. Once a facility is subject to preconstruction review, Maryland's record keeping and reporting regulations meet or exceed all of the reasonable possibility requirements. MDE uses the authority under the general administrative provisions of COMAR 26.11.01 to require testing and monitoring (26.11.01.04), and recordkeeping and reporting (26.11.01.05). Thus, sources in Maryland that escape major NSR are not required merely to calculate baseline and projected actual emissions and keep records of those calculations onsite. Rather, for all but the most insignificant sources, those calculations are reviewed by MDE under their minor NSR program, and the testing, monitoring, recordkeeping and reporting requirements of COMAR 26.11.01 are incorporated into their preconstruction and operating permits. Additionally, the permit application requirements of 26.11.02.11, as well as MDE's general authority under 26.11.02.06 to deny an application that has failed to demonstrate compliance with Maryland's nonattainment NSR provisions (.06B(4)) or protection of the NAAQS (.06B(5)) all support a finding that Maryland has met the statutory requirements with regard to the reasonable possibility provisions.

Comment 2: The Commenter asserts that EPA cannot approve the 2002 NSR provisions into the Maryland SIP without demonstrating that the proposed revisions insure equivalent or greater emissions reductions than the previous program, in accordance with CAA section 193. Citing to the June 16, 2011 U.S. Court of Appeals for the Seventh Circuit (Seventh Circuit) decision in NRDC v. Jackson, the Commenter further asserts that in order provide such a demonstration, EPA must analyze data from states which have already adopted the NSR Reform provisions: “EPA can start by reviewing minor source permits for major sources of pollution in Georgia, New York, and North Carolina. EPA would need to determine which of these minor source permits would have triggered NA NSR under the old rules, using the actual to potential test and the shorter look back period. If any sources would have triggered [nonattainment] NSR under the old rules but did not trigger it under the `Reform' than ( sic ) the Reform did not provide equivalent or greater emission reductions” ( See Comments at 2).

Response 2: The NSR Reform provisions at issue here have repeatedly withstood judicial review, and as we noted in our proposal, the revisions to the Maryland SIP largely mirror the Federal program. We disagree that the kind of analysis described by the Commenter is required in order to approve the revisions at issue into the SIP. We acknowledge the Seventh Circuit's admonishment against perpetual reliance on predictions over available data, as cited by the Commenter. However, as discussed below, EPA did not rely on the 2002 “Supplemental Environmental Analysis” which contained the predictions that were at issue in NRDC v. Jackson as the basis for approving these revisions into the Maryland SIP. Moreover, the number of permits that would have been required under pre-reform regulations is not determinative of whether a permitting authority has met its obligation with regard to CAA section 193: “* * * the statutes concern the quantity of emissions, not the quantity of permits” ( See NRDC v. Jackson at 6). Additionally, it should be noted that the type of analysis recommended by the commenter fails to take into consideration the emission avoidances that occur when a source obtains a federally enforceable limit on its potential to emit (PTE) in order to avoid major NSR.

The primary Reform provision with which the Commenter takes issue is the actual-to-projected actual test. Our basis for approving these revisions rests upon the fact that this applicability test can only be utilized by a fraction of sources in the permitting universe. As we noted in our proposal, only modifications to existing emission units at major stationary sources can use the baseline-to-projected actual test. The list of sources potentially affected by the revisions being proposed in this action is further shortened by the fact that electric generating units were already permitted to use this test because of the regulations arising from litigation in the Wisconsin Electric Power Company (WEPCO) case. This is commonly referred to as the “WEPCO rule” ( See, 57 FR 32314). Furthermore, any modification that did manage to avoid the requirement to obtain a major NSR permit using the test would still be subject to the preconstruction permit requirements of Maryland's minor NSR program, including any of the attendant testing, monitoring, recordkeeping and reporting requirements. Based on the limited number of potentially affected sources and the stringency of Maryland's minor NSR program, we stand behind our determination that approving the NSR Reform provisions into the SIP will have, at worst, a neutral impact on emissions in Maryland. We disagree with the Commenter's assertion that additional analysis is required.

Comment 3: The third comment relates to EPA's proposed approval of the portions of Maryland's 2006 PM 2.5 infrastructure SIP which relate to the PSD requirements of CAA section 110(a)(2). The Commenter asserts that EPA cannot approve the infrastructure SIP without: (A) clarifying the PM 2.5 precursor requirements for NO X and VOC's, and (B) including the PM 2.5 increments which were promulgated by EPA on October 20, 2010.

Response 3: EPA believes Maryland has a PSD permitting program that is sufficient to meet the requirements in section 110(a)(2)(C), (D)(i)(II) and (J) of the CAA. In this final action, EPA is approving COMAR 26.11.06.14 which incorporates by reference 40 CFR section 52.21 (2009) which includes the Federal regulations identified by the Commenter. This final action incorporates into the Maryland SIP 40 CFR 52.21(b)(50)(i)(c) (providing NO X is a precursor to PM 2.5 ) and 40 CFR 52.21(b)(50)(i)(d) (providing VOC's are presumed not to be precursors to PM 2.5 ) ( See also May 18, 2008 “Implementation of the New Source Review (NSR) Program for Particulate Matter Less than 2.5 Micrometers (PM 2.5 ),” (73 FR 28321)). With respect to the PM 2.5 increments, as the Commenter noted, states have until July 20, 2012 to submit SIP revisions which incorporate the October 20, 2011 PM 2.5 increment requirements ( See 75 FR 64864). Therefore, the Commenter's assertion is not relevant to this SIP action. EPA believes that it is unreasonable not to approve the 2006 PM 2.5 Infrastructure SIP because the State's SIP lacks requirements that EPA has not even required the State to submit yet. Instead, the EPA believes that it is appropriate for the EPA to take into consideration the timing and sequence of related SIP submissions as part of determining what it is reasonable to expect a State to have addressed in an infrastructure SIP for a NAAQS at the time when the EPA acts on such submission. Such an approach is reasonable, and to adopt a different approach by which the EPA could not act on an infrastructure SIP, or at least could not approve an infrastructure SIP, whenever there was any impending or future revision to the SIP that will be required by another collateral rulemaking action would result in regulatory gridlock. The EPA believes that such an outcome would be an unreasonable reading of the statutory process for the SIP's contemplated in section 110(a)(1) and (2). Based upon EPA's review of Maryland's PSD program, including the revisions subject to this action, Maryland has met its obligations pursuant to the portions of CAA section 110(a)(2) relating to PSD for the 1997 PM 2.5 NAAQS, the 1997 Ozone NAAQS, and the 2006 PM 2.5 NAAQS.

EPA is approving MDE's July 31, 2009 and June 23, 2011 SIP submittals as a revision to the Maryland SIP.

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

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

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

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

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

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

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

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

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

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

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

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 1, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action pertaining to preconstruction permitting requirements under Maryland's PSD and nonattainment NSR programs may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Therefore, 40 CFR part 52 is amended as follows:

EPA is determining that the Knoxville Area (comprised of Anderson, Blount, Knox, and Loudon Counties in their entireties and a portion of Roane County) has monitored attaining data for the 1997 annual and 2006 24-hour PM 2.5 NAAQS. These determinations are based upon quality-assured, quality-controlled and certified ambient air monitoring data that shows the Area has monitored attainment of the 1997 annual and 2006 24-hour PM 2.5 NAAQS based on the 2009-2011 data.

Other specific requirements of the determinations and the rationale for EPA's action are explained in the notice of proposed rulemaking (NPR) published on June 6, 2012 (77 FR 33360), and will not be restated here. The comment period closed on July 6, 2012. No comments, adverse or otherwise, were received in response to the NPR.

The determinations of attaining data, in accordance with 40 CFR 51.1004(c), suspends the requirements for this Area to submit attainment demonstrations, associated RACM, RFP plans, contingency measures, and any other planning SIPs related to attainment of either the 1997 annual or the 2006 24-hour PM 2.5 NAAQS for so long as the Area continues to attain the applicable PM 2.5 NAAQS. Finalizing these actions does not constitute a redesignation of the Knoxville Area to attainment for the 1997 annual or 2006 24-hour PM 2.5 NAAQS under section 107(d)(3) of the Clean Air Act (CAA). Further, finalizing these actions does not involve approving maintenance plans for the Area as required under section 175A of the CAA, nor does it involve a determination that the Area has met all requirements for a redesignation.

EPA is determining that the Knoxville Area has data demonstrating that it has attained the 1997 annual and 2006 24-hour PM 2.5 NAAQS. These determinations are based upon quality-assured, quality-controlled, and certified ambient air monitoring data showing that this Area has monitored attainment of the 1997 annual and 2006 24-hour PM 2.5 NAAQS during the period of 2009-2011. This final action, in accordance with 40 CFR 51.1004(c), will suspend the requirements for this Area to submit attainment demonstrations, associated RACM, RFP plans, contingency measures, and any other planning SIPs related to attainment of either the 1997 annual or the 2006 24-hour PM 2.5 NAAQS for so long as the Area continues to attain the applicable PM 2.5 NAAQS. These actions are being taken pursuant to section 179(c)(1) of the CAA and are consistent with the CAA and its implementing regulations.

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

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

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

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

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

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

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

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

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

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

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 1, 2012. Filing a petition for reconsideration by the Administrator of these final rules does not affect the finality of these actions for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. These actions, pertaining to the determination of attaining data for the 1997 annual and 2006 24-hour fine particulate matter standard for the Knoxville Area, may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2).)

40 CFR part 52 is amended as follows:

On July 18, 1997 (62 FR 36852), EPA established an annual PM 2.5 NAAQS at 15.0 micrograms per cubic meter based on a three-year average of annual mean PM 2.5 concentrations. On January 5, 2005 (70 FR 944), EPA published its air quality designations and classifications for the 1997 annual PM 2.5 NAAQS based upon air quality monitoring data for calendar years 2001-2003. These designations became effective on April 5, 2005. The bi-state Louisville Area was designated nonattainment for the 1997 annual PM 2.5 NAAQS. See 40 CFR 81.318 for Kentucky and 40 CFR 81.315 for Indiana.

Designation of an area as nonattainment starts the process for a state to develop and submit to EPA a SIP under title I, part D of the CAA. This SIP must include, among other elements, a demonstration of how the NAAQS will be attained in the nonattainment area as expeditiously as practicable, but no later than the date required by the CAA. Under CAA section 172(b), a state has up to three years after an area's designation as nonattainment to submit its SIP to EPA. For the 1997 annual PM 2.5 NAAQS, these SIPs were due April 5, 2008. See 40 CFR 51.1002(a).

On December 3, 2008, Kentucky submitted an attainment demonstration and associated reasonably available control measures (RACM), a reasonable further progress (RFP) plan, contingency measures, a 2002 base year emissions inventory and other planning SIP revisions related to attainment of the 1997 annual PM 2.5 NAAQS in the Commonwealth's portion of the bi-state Louisville Area. Subsequently, on March 9, 2011 (76 FR 12860), EPA determined that the bi-state Louisville Area attained the 1997 annual PM 2.5 NAAQS. The determination of attainment was based upon complete, quality-assured and certified ambient air monitoring data for the 2007-2009 period, showing that the Area had monitored attainment of the 1997 annual PM 2.5 NAAQS. The requirements for the Area to submit an attainment demonstration and associated RACM, RFP plan, contingency measures, and other planning SIP revisions related to attainment of the standard were suspended as a result of the determination of attainment, so long as the Area continues to attain the 1997 annual PM 2.5 NAAQS. See 40 CFR 51.1004(c).

On September 30, 2011, Kentucky withdrew the attainment demonstration submission (everything with the exception of the 2002 base year emissions inventory) for its portion of the bi-state Louisville Area as allowed by 40 CFR 51.1004(c). EPA notes that the determination of attainment does not suspend the emissions inventory requirement found in CAA section 172(c)(3), and as such, Kentucky did not withdraw this portion of its December 3, 2008, SIP revision. Section 172(c)(3) of the CAA requires submission and approval of a comprehensive, accurate, and current inventory of actual emissions.

On May 25, 2012, EPA published a proposed rulemaking to approve Kentucky's 1997 annual PM 2.5 emissions inventory for its portion of the bi-state Louisville Area. See 77 FR 31262. Comments on the proposed rulemaking were due on or before June 25, 2012. No comments, adverse or otherwise, were received on EPA's May 25, 2012, proposed rulemaking. Pursuant to section 110 of the CAA, EPA is now taking final action to approve the Kentucky's 1997 annual PM 2.5 emissions inventory as provided in EPA's May 25, 2012, proposed rulemaking. A summary of the background for today's final action is provided below. For more detail, please refer to EPA's proposed rulemaking at 77 FR 31262.

As discussed above, section 172(c)(3) of the CAA requires areas to submit a comprehensive, accurate, and current inventory of actual emissions from all sources of the relevant pollutant or pollutants in such area. Kentucky selected 2002 as the base year for the emissions inventory per 40 CFR 51.1008(b). Emissions contained in Kentucky's December 3, 2008, SIP revision cover the general source categories of point sources, non-road mobile sources, area sources, and on-road mobile sources. A detailed discussion of the emissions inventory development can be found in Appendix H of the Kentucky submittal; a summary is provided below.

The table below provides a summary of the annual 2002 emissions of nitrogen oxides (NOx), sulfur dioxide (SO 2 ), and PM 2.5 included in the Kentucky submittal.

The 172(c)(3) emissions inventory is developed by the incorporation of data from multiple sources. States were required to develop and submit to EPA a triennial emissions inventory according to the Consolidated Emissions Reporting Rule for all source categories (i.e., point, area, nonroad mobile, and on-road mobile). This inventory often forms the basis of data that are updated with more recent information and data that also are used in their attainment demonstration modeling inventory. Such was the case in the development of the 2002 base year emissions inventory that was submitted in the Commonwealth's attainment SIP for its portion of the bi-state Louisville Area. The 2002 emissions inventory was based on data developed with the Visibility Improvement State and Tribal Association of the Southeast (VISTAS) contractors and submitted by the states to the 2002 National Emissions Inventory. Several iterations of the 2002 inventories were developed for the different emissions source categories resulting from revisions and updates to the data. This resulted in the use of version G2 of the updated data to represent the point sources' emissions. Data from many databases, studies, and models (e.g., Vehicle Miles Traveled, fuel programs, the NONROAD 2002 model data for commercial marine vessels, locomotives, and Clean Air Market Division, etc.) resulted in the inventory submitted in this SIP. The data were developed according to current EPA emissions inventory guidance “Emissions Inventory Guidance for Implementation of Ozone and Particulate Matter National Ambient Air Quality Standards (NAAQS) and Regional Haze Regulations” (August 2005) and a quality assurance project plan that was developed through VISTAS and approved by EPA. EPA agrees that the process used to develop this inventory was adequate to meet the requirements of CAA section 172(c)(3) and the implementing regulations.

EPA has reviewed Kentucky's 2002 base year emissions inventory and has determined that it is adequate for the purposes of meeting section 172(c)(3) emissions inventory requirement. Further, EPA has made the determination that the emissions were developed consistent with the CAA, implementing regulations and EPA guidance for emission inventories.

EPA is taking final action to approve the 2002 base year emissions inventory portion of the attainment demonstration SIP revision submitted by the Commonwealth of Kentucky on December 3, 2008. EPA has made the determination that this action is consistent with section 110 of the CAA.

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

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

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

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

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

• Does not have Federalism implications as specified in Executive Order 13132 (64 F43255, August 10, 1999);

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

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

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

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

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 1, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

40 CFR part 52 is amended as follows:

Table of Contents I. Background II. This Action III. Final Action IV. Statutory and Executive Order Reviews I. Background

Upon promulgation of a new or revised NAAQS, sections 110(a)(1) and (2) of the CAA require states to address basic SIP requirements, including emissions inventories, monitoring, and modeling to assure attainment and maintenance for that new NAAQS. On July 18, 1997 (62 FR 36852), EPA promulgated a new annual PM 2.5 NAAQS and on October 17, 2006 (71 FR 61144), EPA promulgated a new 24-hour NAAQS. On June 11, 2012, EPA proposed to approve Tennessee's December 14, 2007, and October 19, 2009, infrastructure submissions for the 1997 annual and 2006 24-hour PM 2.5 NAAQS addressing elements 110(a)(2)(A)-(H), (J)-(M), except for section 110(a)(2)(C) nonattainment area requirements, 110(a)(2)(E)(ii)—board requirements; and section 110(a)(2)(D)(i) interstate transport requirements. See EPA's June 11, 2012, proposed rulemaking at 77 FR 34306 for more detail. On March 28, 2012, Tennessee submitted a letter of commitment to EPA to adopt specific enforceable measures related to 128(a)(1) to address current deficiencies in the Tennessee SIP. As a result of Tennessee's March 28, 2012, commitment letter, EPA signed a final rule on June 25, 2012, determining that the conditional approval is appropriate because the State has explicitly committed to address current deficiencies in the Tennessee SIP related to element 110(a)(2)(E)(ii) for the 1997 8-hour ozone NAAQS consistent with the requirements of CAA section 110(k)(4). Tennessee's March 28, 2012, commitment letter related to section 128(a)(1) is also applicable to address 110(a)(2) requirements for the 1997 annual and 2006 24-hour PM 2.5 NAAQS. In EPA's June 11, 2012, proposed rulemaking, EPA is also proposed to approve in part and conditionally approve in part Tennessee's 1997 annual and 2006 24-hour PM 2.5 infrastructure submissions with regards to section 110(a)(2)(E)(ii) based on the State's March 28, 2012, commitment letter. See 77 FR 34306. A summary of the background for today's final action is provided below.

Section 110(a) of the CAA requires states to submit SIPs to provide for the implementation, maintenance, and enforcement of a new or revised NAAQS within three years following the promulgation of such NAAQS, or within such shorter period as EPA may prescribe. Section 110(a) imposes the obligation upon states to make a SIP submission to EPA for a new or revised NAAQS, but the contents of that submission may vary depending upon the facts and circumstances. The data and analytical tools available at the time the state develops and submits the SIP for a new or revised NAAQS affects the content of the submission. The contents of such SIP submissions may also vary depending upon what provisions the state's existing SIP already contains. In the case of the 1997 annual and 2006 24-hour PM 2.5 NAAQS, states typically have met the basic program elements required in section 110(a)(2) through earlier SIP submissions in connection with previous PM NAAQS.

More specifically, section 110(a)(1) provides the procedural and timing requirements for SIPs. Section 110(a)(2) lists specific elements that states must meet for “infrastructure” SIP requirements related to a newly established or revised NAAQS. As already mentioned, these requirements include SIP infrastructure elements such as modeling, monitoring, and emissions inventories that are designed to assure attainment and maintenance of the NAAQS. The requirements that are the subject of this final rulemaking are listed below  1 and in EPA's October 2, 2007, memorandum entitled “Guidance on SIP Elements Required Under Section 110(a)(1) and (2) for the 1997 8-Hour Ozone and PM 2.5 National Ambient Air Quality Standards.”

• 110(a)(2)(A): Emission limits and other control measures.

• 110(a)(2)(B): Ambient air quality monitoring/data system.

• 110(a)(2)(C): Program for enforcement of control measures. 2

• 110(a)(2)(D): Interstate transport. 3

Throughout this document whenever “we,” “us,” or “our” is used, we mean the EPA. Information is organized as follows:

EPA is taking direct final action to approve the second 10-year CO maintenance plan for the Northern Ada County, Idaho Air Quality Maintenance Area. The Northern Ada County Area attained the CO national ambient air quality standards (NAAQS) in 2002 and has not violated the standard since 1986. The second 10-year CO maintenance plan submitted by the State is designed to keep the Northern Ada County Area in attainment for the CO standard for a second 10-year period beyond redesignation.

Under section 107(d)(1)(C) of the Act, any area designated before the date of enactment of the Clean Air Act Amendments of 1990 was to be designated upon enactment by operation of law. CO nonattainment areas that had not violated the CO standard in either year for the two-year period 1988-1989 were to be designated nonattainment and identified as “not classified” nonattainment areas. Accordingly, on November 6, 1991, the Boise-Northern Ada County Area was designated nonattainment for the CO NAAQS and identified as “not-classified” (56 FR 56746).

On January 17, 2002, the State requested EPA redesignate the Northern Ada County nonattainment area to attainment and submitted a limited maintenance plan to demonstrate maintenance of the standard for a 10-year period. EPA published approval of the redesignation request and maintenance plan on October 28, 2002 (67 FR 65713). The State submitted a second 10-year maintenance plan to EPA on February 10, 2011.

The 8-hour CO standard is attained when the daily average 8-hour CO concentration of 9.0 parts per million (ppm) is not exceeded more than once a year. Since the redesignation of the Northern Ada County Area to attainment for CO on December 27, 2002, the second highest concentration in any calendar year measured by the EPA approved monitoring network was 3.3 ppm, which is less than 9.0 ppm. Therefore the area is attaining the CO NAAQS.

In addition, areas that can demonstrate design values at or below 7.65 ppm (85 percent of exceedance levels of the CO NAAQS) for 8 consecutive quarters may use a limited maintenance plan option. The State has opted to develop a limited maintenance plan to fulfill the second 10-year maintenance plan required by the Act. The base year in the State's second 10-year maintenance plan is 2008, which has a design value of 2.9 ppm. EPA reviewed air quality monitoring data (2010-2011) and the 8-hour CO design value for the Northern Ada County Area is 1.6 ppm. Thus, the area qualifies to use the limited maintenance plan option.

Section 110(a)(2) of the Act requires that each SIP revision be adopted after reasonable notice and public hearing. This must occur prior to the revision being submitted by a State to EPA. The State of Idaho held a public hearing on January 26, 2011, in Boise, Idaho. A notice of public hearing was published in the Idaho Statesman on December 27, 2010. A notice was also published in the Valley News on January 10, 2011. This SIP revision became State effective on February 10, 2011, and was submitted by the Governor's designee to the EPA on February 10, 2011. EPA has evaluated the State's submittal and determined that the State met the requirements for reasonable notice and public hearing under section 110(a)(2) of the Act.

EPA has reviewed the Northern Ada County second 10-year CO maintenance plan and concludes that the submittal meets the requirements of section 175A(b) of the Act. The following is a summary of the requirements and EPA's evaluation of how each requirement is met.

The plan must contain an attainment year emissions inventory to identify a level of emissions in the area which is sufficient to attain the CO NAAQS. The Northern Ada County second 10-year CO maintenance plan contains an emissions inventory for the base year 2008 that is consistent with EPA's most recent guidance on maintenance plan emission inventories. The emissions inventory is a list, by source, of the air contaminants directly emitted into the Northern Ada County CO Area. The data in the emissions inventory is based on calculations and is developed using emission factors, which is a method for converting source activity levels into an estimate of emissions contributions for those sources. Because violations of the CO NAAQS are most like to occur on winter weekdays, the inventory prepared is in a “typical winter day” format. The table below shows the tons of CO emitted per winter day in 2008 by source category.

The maintenance plan demonstration requirement is considered to be satisfied for areas using the limited maintenance plan option, which are required to demonstrate design values at or below 7.65 ppm (85 percent of exceedance levels of the CO NAAQS) for 8 consecutive quarters. The State has opted to develop a limited maintenance plan to fulfill the Northern Ada County Area second 10-year maintenance plam required by the Act.

With the limited maintenance plan option, there is no requirement to project emissions of air quality over the maintenance period. EPA believes that if the area begins the maintenance period at, or below, 85 percent of the level of the CO 8-hour NAAQS, the applicability of prevention of significant deterioration requirements, the control measures already in the SIP, and Federal measures, should provide adequate assurance of maintenance over the 10-year maintenance period. The last monitored violation of the CO NAAQS in the Northern Ada County Area occurred in 1986, the last exceedance was in January 1991, and the monitored CO levels have been steadily in decline ever since. The 8-hour CO design value for Northern Ada County is 1.6 ppm based on 2010-2011 data, which is below the limited maintenance plan requirement of 7.65 ppm. Therefore, the Northern Ada County Area has adequately demonstrated that it will maintain the CO NAAQS into the future.

To verify the attainment status of the area over the maintenance period, the maintenance plan should contain provisions for continued operation of an appropriate, EPA-approved monitoring network in accordance with 40 CFR part 58. The State has an approved monitoring network that includes the Northern Ada County Area. The monitoring network was most recently approved by EPA on September 6, 2011. In the Northern Ada County second 10-year CO maintenance plan, IDEQ commits to verify continued attainment through the EPA-approved monitoring network in accordance with 40 CFR part 58.

Section 175A(d) of the Act requires that a maintenance plan include contingency provisions. The Northern Ada County second 10-year CO limited maintenance plan contains a contingency plan that would institute an oxygenated fuels program or another equivalent CO reduction measure based on the EPA's guidance and recommendations. The contingency plan is triggered either when an exceedance of the 8 hour CO standard is recorded on any monitor, or when a monitor records non-overlapping 8 hour CO concentrations of 8 ppm on 4 or more days within a single winter season within the nonattainment area. EPA finds that the contingency measures provided in the maintenance plan are adequate to ensure prompt correction of a violation.

Transportation conformity is required by section 176(c) of the Act. EPA's conformity rule requires that transportation plans, programs, and projects that are funded under 23 U.S.C. or the Federal Transit Act conform to SIPs. Conformity to a SIP means that transportation activities will not produce new air quality violations, worsen existing violations, or delay timely attainment of the NAAQS.

The transportation conformity rule (40 CFR parts 51 and 93) and the general conformity rule (40 CFR parts 51 and 93) apply to nonattainment areas and maintenance areas covered by an approved maintenance plan. Under either conformity rule, an acceptable method of demonstrating that a Federal action conforms to the applicable SIP is to demonstrate that expected emissions from the planned action are consistent with the emissions budget for the area.

While EPA's limited maintenance plan option does not exempt an area from the need to affirm conformity, it explains that the area may demonstrate conformity without submitting an emissions budget. Under the limited maintenance plan option, emissions budgets are treated as essentially not constraining for the length of the maintenance period because it is unreasonable to expect that the qualifying areas would experience so much growth in that period that a violation of the CO NAAQS would result. Similarly, Federal actions subject to the general conformity rule could be considered to satisfy the “budget test” specified in section 93.158(a)(5)(i)(A) for the same reasons that the budgets are essentially considered to be unlimited.

While areas with maintenance plans approved under the limited maintenance plan option are not subject to the budget test, the areas remain subject to other transportation conformity requirements of 40 CFR part 93, subpart A. Thus, the metropolitan planning organization (MPO) in the area or the State must document and ensure that:

a. Transportation plans and projects provide for timely implementation of SIP transportation control measures in accordance with 40 CFR 93.113;

b. Transportation plans and projects comply with the fiscal constraint element per 40 CFR 93.108;

c. The MPO's interagency consultation procedures meet applicable requirements of 40 CFR 93.105;

d. Conformity of transportation plans is determined no less frequently than every four years, and conformity of plan amendments and transportation projects is demonstrated in accordance with the timing requirements specified in 40 CFR 93.104;

e. The latest planning assumptions and emissions model are used as set forth in 40 CFR 93.110 and 40 CFR 93.111;

f. Projects do not cause or contribute to any new localized CO or particulate matter violations, in accordance with procedures specified in 40 CFR 93.123; and

g. Project sponsors and/or operators provide written commitments as specified in 40 CFR 93.125.

The lead transportation agency in Northern Ada County is the Community Planning Association of Southwest Idaho (COMPASS), the MPO. COMPASS oversees transportation conformity determinations of the Interagency Consultation Committee established in Idaho Administrative Rule IDAPA 58.01.01.567, which includes IDEQ, the Idaho Transportation Department, the Federal Highway Administration, Ada County Highway District, the City of Boise, Valley Regional Transit, and the EPA; as specified under 40 CFR part 93. Northern Ada County is currently meeting the requirements under 40 CFR part 93, subpart A.

In accordance with the requirements of the Act, EPA is approving this revision to the SIP because the State adequately demonstrates that the Northern Ada County Air Quality Maintenance Area will maintain air quality standards for CO through the year 2022. EPA is publishing this action without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision should adverse comments be filed. This rule will be effective October 1, 2012 without further notice unless the Agency receives adverse comments by September 4, 2012.

If EPA receives such comments, then EPA will publish a timely withdrawal of the direct final rule informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period on this rule. Any parties interested in commenting on this rule should do so at this time. If no such comments are received, the public is advised that this rule will be effective on October 1, 2012 and no further action will be taken on the proposed rule.

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

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

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

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

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

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

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

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

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

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

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

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 1, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

For the reasons set out in the preamble, title 40, chapter I of the Code of Federal Regulations is amended as follows:

Throughout this document, wherever “we”, “us” or “our” are used, we mean EPA. We are providing the following table of contents for ease of locating information in this proposal.

On May 25, 2012, EPA proposed to find that the Paul Spur/Douglas nonattainment area (NA)  1 is currently attaining the 24-hour PM 10 NAAQS based on certified and quality-assured data from the most recent three-year period, 2009-2011, and to suspend certain Clean Air Act (CAA) requirements related to attainment for so long as the area continues to attain the standard. See 77 FR 31268; (May 25, 2012).

To summarize our proposed rule, we described the 24-hour PM 10 NAAQS, which is 150 micrograms per cubic meter (μg/m 3 ), and reviewed the designation and classification of the Paul Spur/Douglas NA for that standard. We then discussed how EPA makes attainment determinations for PM 10 and indicated that the 24-hour PM 10 NAAQS is attained when the expected number of exceedances averaged over a three-year period is less than or equal to one at each monitoring site within the nonattainment area. See 40 CFR part 50, appendix K.

We described Arizona Department of Environmental Quality's (ADEQ's) two PM 10 monitoring sites in the Paul Spur/Douglas area. We noted that ADEQ's annual network plans have met the applicable requirements for such plans, and based on the findings of our technical system audit report, ADEQ's monitoring network meets or exceeds the applicable requirements. Finally, we noted that ADEQ has certified the data it submits to EPA's Air Quality System (AQS) database as quality-assured.

Next, we reviewed the ambient PM 10 data collected at the two PM 10 monitoring sites in the Paul Spur/Douglas area for the most recent three-year period, 2009-2011. We noted that the highest annual 24-hour average PM 10 concentrations over the past three years ranged from 46 to 85 μg/m 3 at the Paul Spur monitor and from 83 to 138 μg/m 3 at the Douglas monitor. As a result, we concluded that the area is attaining the PM 10 standard because the expected number of exceedances per year for the Paul Spur/Douglas NA was less than 1.0. For additional information on the PM 10 NAAQS, the designation and classification of the Paul Spur/Douglas NA, ADEQ's monitoring network plans and certifications, the monitoring sites in the Paul Spur/Douglas area, and the data we relied on for our clean data finding, please see 77 FR 31269-31271.

In conjunction with and based on our proposed determination that the Paul Spur/Douglas NA is currently attaining the PM 10 NAAQS, EPA proposed to determine that Arizona's obligation to submit revisions to the Arizona State Implementation Plan (SIP) to meet the following CAA requirements is not applicable for so long as the Paul Spur/Douglas NA continues to attain the PM 10 standard: The part D, subpart 4 obligation to provide an attainment demonstration pursuant to section 189(a)(1)(B); the reasonably available control measure (RACM) provisions of section 189(a)(1)(C); the reasonable further progress (RFP) provisions of section 189(c); and, the attainment demonstration, RACM, RFP and contingency measure provisions of part D, subpart 1 contained in section 172. We proposed to suspend these SIP requirements based on application of the Clean Data Policy to the Paul Spur/Douglas NA. In doing so, we noted that our application of the Clean Data Policy to the Paul Spur/Douglas NA is consistent with a number of actions we have taken for other PM 10 nonattainment areas that we also determined were attaining the NAAQS. For a detailed explanation of our Clean Data Policy and its application to the Paul Spur/Douglas NA, please see 77 FR 31271-31273.

Lastly, we noted that suspension of the State's SIP obligation would also serve to suspend EPA's obligation to promulgate a Federal Implementation Plan (FIP) to address the same attainment-related requirements. See 77 FR 31273-31274.

EPA's proposed action provided a 30-day public comment period. During this period, we received a comment from a private citizen expressing a general skepticism of the ability to regulate PM 10 in a desert environment; no general information and no Paul Spur/Douglas NA specific information was provided to support the comment. Furthermore, no information was provided to dispute either the 2009-2011 Paul Spur/Douglas ambient PM 10 data, or our proposed suspension of attainment-related SIP obligations or the related FIP obligations. Therefore, no response is necessary. We note, however, that many effective measures exist to reduce dust from anthropogenic sources in desert environments, including paving unpaved roads and other unpaved surfaces used by motor vehicles, restricting off-road vehicle use to a designated time of year and/or location where the effects can be mitigated, and stabilizing soil in areas that have been disturbed by human activity.

No comments were submitted that change EPA's assessment of the 2009-2011 ambient PM 10 data collected in the Paul Spur/Douglas NA and related finding that the area is attaining the NAAQS, or our application of the Clean Data Policy as described in our proposed action. Therefore, EPA is finalizing its determination that the Paul Spur/Douglas NA in Arizona is currently attaining the NAAQS for PM 10 .

EPA is also taking final action to determine that Arizona's obligation to make SIP submissions to meet the following CAA requirements is not applicable for as long as the Paul Spur/Douglas NA continues to attain the PM 10 NAAQS: The part D, subpart 4 obligation to provide an attainment demonstration pursuant to section 189(a)(1)(B); the reasonably available control measure (RACM) provisions of section 189(a)(1)(C); the reasonable further progress (RFP) provisions of section 189(c); and, the attainment demonstration, RACM, RFP and contingency measure provisions of part D, subpart 1 contained in section 172.

Lastly, EPA finds that our obligation to promulgate a FIP addressing the Paul Spur/Douglas NA attainment-related requirements is suspended for as long as the underlying State obligation is suspended.

This final action does not constitute a redesignation to attainment under CAA section 107(d)(3) because Arizona has not submitted a maintenance plan and EPA has not approved such a plan for the Paul Spur/Douglas NA as meeting the requirements of section 175A of the CAA, nor has EPA determined that Arizona has met the other CAA requirements for redesignation. The classification and designation status in 40 CFR part 81 remains moderate nonattainment for the Paul Spur/Douglas NA until such time as EPA determines that Arizona has met the CAA requirements for redesignating the Paul Spur/Douglas NA to attainment.

With this action, we are making a determination regarding attainment of the PM 10 NAAQS based on air quality data and, based on this determination, suspending certain Federal requirements. Therefore, this action would not impose additional requirements beyond those imposed by State law or by the CAA. For that reason, this action:

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

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

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

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

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

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

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

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

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

In addition, this action does not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP obligations discussed herein do not apply to Indian Tribes and thus will not impose substantial direct costs on Tribal governments or preempt Tribal law.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 1, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)).

On February 16, 2012, the EPA issued the National Emission Standards for Hazardous Air Pollutants from Coal- and Oil-fired Electric Utility Steam Generating Units and Standards of Performance for Fossil-Fuel-Fired Electric Utility, Industrial-Commercial-Institutional, and Small Industrial-Commercial-Institutional Steam Generating Units, generally referred to as the mercury and air toxics standards (MATS Rule), which established emissions standards for new and existing coal- and oil-fired electric utility steam generating units. The EPA received petitions, pursuant to section 307(d)(7)(B) of the Clean Air Act, from a number of interested parties requesting reconsideration of certain issues in the rule. On July 20, 2012, the EPA issued a letter, stating its intent to grant the petitions for reconsideration on certain new source issues related to the emission standards issued under Clean Air Act section 112, including measurement issues related to mercury and the data set to which the variability calculation was applied when establishing the new source standards for particulate matter and hydrochloric acid.

The Clean Air Act authorizes the EPA to stay the effectiveness of a rule if the Administrator has convened a proceeding to reconsider the rule. Under section 307(d)(7)(B) of the Act, “The effectiveness of the rule may be stayed during * * * reconsideration * * * by the Administrator or the court for a period not to exceed three months.” 42 U.S.C.7607(d)(7)(B). In its letter granting the petitions for reconsideration on certain issues relating to the Clean Air Act section 112 new source standards, the EPA stated that it intended to exercise its authority under section 307(d) to stay the effectiveness of those new source standards for 3 months.

Pursuant to section 307(d)(7)(B) of the Clean Air Act, the EPA hereby stays the effectiveness of 40 CFR 63.9984(a), 63.10005(g), 63.10030(c), Table 1 in subpart UUUUU of 40 CFR part 63, and row 2 of Table 3 in subpart UUUUU of 40 CFR part 63 for 3 months. Thus, by this action, we are staying the effectiveness of these provisions of the rule, published in the Federal Register on February 16, 2012 (77 FR 9304). Accordingly, this action also stays the effectiveness of any monitoring, recordkeeping, and reporting requirements related to the section 112(d) new source standards. This stay does not apply to any other provisions of the rule.

This stay of effectiveness will remain in place until November 2, 2012.

EPA Region 1 is publishing this direct final Notice of Partial Deletion for the Eastland Woolen Mill (Site), from the National Priorities List (NPL). This partial deletion pertains to all site media, including soil and groundwater for the following properties:

The properties proposed for deletion are shown in Figure 11 of Partial Deletion Technical Memorandum dated June 2012 and will be referred to hereafter as “the properties proposed for deletion”. All Tax Map references are based on the Town of Corinna 2004 Tax Maps and the “Survey Plan Showing Property Subject to Proposed Environmental Covenants for Maine Department of Environmental Protection, Corinna, Penobscot County, Maine” which is recorded in the Penobscot County Registry of Deeds as Plan File 2012 No. 20, dated March 29, 2012.

The NPL constitutes Appendix B of 40 CFR part 300, which is the National Oil and Hazardous Substances Pollution Contingency Plan (NCP), which EPA promulgated pursuant to Section 105 of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) of 1980, as amended. EPA maintains the NPL as the list of sites that appear to present a significant risk to public health, welfare, or the environment. Sites on the NPL may be the subject of remedial actions financed by the Hazardous Substance Superfund (Fund). This partial deletion of the Eastland Woolen Mill Superfund Site is proposed in accordance with 40 CFR 300.425(e) and is consistent with the Notice of Policy Change: Partial Deletion of Sites Listed on the National Priorities List. 60 FR 55466 (Nov. 1, 1995). As described in 300.425(e)(3) of the NCP, a portion of a site deleted from the NPL remains eligible for Fund-financed remedial action if future conditions warrant such actions.

Because EPA considers this action to be noncontroversial and routine, this action will be effective October 1, 2012 unless EPA receives adverse comments by September 4, 2012. Along with this direct final Notice of Partial Deletion, EPA is co-publishing a Notice of Intent for Partial Deletion in the “Proposed Rules” section of the Federal Register . If adverse comments are received within the 30-day public comment period on this partial deletion action, EPA will publish a timely withdrawal of this direct final Notice of Partial Deletion before the effective date of the partial deletion and the partial deletion will not take effect. EPA will, as appropriate, prepare a response to comments and continue with the deletion process on the basis of the Notice of Intent for Partial Deletion and the comments already received. There will be no additional opportunity to comment.

Section II of this document explains the criteria for deleting sites from the NPL. Section III discusses procedures that EPA is using for this action. Section IV discusses the properties proposed for deletion and demonstrates how it meets the deletion criteria. Section V discusses EPA's action to delete these Site parcels from the NPL unless adverse comments are received during the public comment period.

The NCP establishes the criteria that EPA uses to delete sites from the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted from the NPL where no further response is appropriate. In making such a determination pursuant to 40 CFR 300.425(e), EPA will consider, in consultation with the State, whether any of the following criteria have been met:

i. Responsible parties or other persons have implemented all appropriate response actions required;

ii. All appropriate Fund-financed response under CERCLA has been implemented, and no further response action by responsible parties is appropriate; or

iii. The remedial investigation has shown that the release poses no significant threat to public health or the environment and, therefore, the taking of remedial measures is not appropriate.

Pursuant to CERCLA section 121(c) and the NCP, EPA conducts five-year reviews to ensure the continued protectiveness of remedial actions where hazardous substances, pollutants, or contaminants remain at a site above levels that allow for unlimited use and unrestricted exposure. EPA conducts such five-year reviews even if a site is deleted from the NPL. EPA may initiate further action to ensure continued protectiveness at a deleted site if new information becomes available that indicates it is appropriate. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazard ranking system.

The following procedures apply to the properties proposed for deletion:

(1) EPA has consulted with the State of Maine prior to developing this direct final Notice of Partial Deletion and the Notice of Intent for Partial Deletion co-published in the “Proposed Rules” section of the Federal Register .

(2) EPA has provided the State 30 working days for review of this notice and the parallel Notice of Intent for Partial Deletion prior to their publication today, and the State, through the Maine Department of Environmental Protection, has concurred on the partial deletion of the Site from the NPL.

(3) Concurrently with the publication of this direct final Notice of Partial Deletion, a notice of the availability of the parallel Notice of Intent for Partial Deletion is being published in a major local newspaper, Bangor Daily News. The newspaper notice announces the 30-day public comment period concerning the Notice of Intent for Partial Deletion of the Site from the NPL.

(4) The EPA placed copies of documents supporting the partial deletion in the deletion docket and made these items available for public inspection and copying at the Site information repositories identified above.

(5) If adverse comments are received within the 30-day public comment period on this partial deletion action, EPA will publish a timely notice of withdrawal of this direct final Notice of Partial Deletion before its effective date and will prepare a response to comments and continue with the deletion process on the basis of the Notice of Intent for Partial Deletion and the comments already received.

Deletion of a portion of a site from the NPL does not itself create, alter, or revoke any individual's rights or obligations. Deletion of a portion of a site from the NPL does not in any way alter EPA's right to take enforcement actions, as appropriate. The NPL is designed primarily for informational purposes and to assist EPA management. Section 300.425(e)(3) of the NCP states that the deletion of a site from the NPL does not preclude eligibility for further response actions, should future conditions warrant such actions.

The following information provides EPA's rationale for deleting the properties proposed for deletion:

The Eastland Woolen Mill Superfund Site (MED980915474) (Site) is located in the center of the Town of Corinna, Penobscot County, Maine, approximately 6 miles north of Newport and 25 miles northwest of Bangor, Maine. Approximately 800 people live within one mile of the Site, and 2,500 people live within four miles.

The Town of Corinna is located within the East Branch of the Sebasticook River (EBSR) watershed, which drains to Sebasticook Lake approximately three miles south of the Town. Topography within the watershed is typified by gently rolling hills to steeply sloping ridges, varying from narrow valleys to fairly expansive low-lying floodplains. Elevations within the immediate vicinity of Corinna range from 200 to 320 feet above mean sea level (msl). The former Eastland Woolen Mill straddled the EBSR and the southern portion of the former Mill Pond.

At the time of the placement of the Eastland Woolen Mill on the EPA NPL, the Site included the former Eastland Woolen Mill property and areas where contamination has migrated or otherwise come to be located due to mill operations. The Eastland Woolen Mill property was a 21-acre parcel located on the north side of Main Street, Corinna, in central Maine. There was a 250,000 square foot Mill building, two dams, and several out buildings on site. The mill building straddled the East Branch of the Sebasticook River with one dam located under the building near Main Street; the other dam is located approximately 500 feet north of the mill and maintains the water level of Corrundel Lake, a portion of the EBSR. The two dams also created an on-site mill pond. The Site is bordered to the north by Corundel Lake and residential property, to the south by Main Street, to the east by the Dexter Road and the Methodist Church, and on the west by Route 43 and several residential properties. As a result of the data collected to support the Engineering Evaluation and Cost Analysis (EE/CA) for a non-time-critical removal action (NTCRA) and the remedial investigation (RI) program, the footprint of the Site was better defined to extend south across Main Street and downstream in the EBSR.

The Site was formerly dominated by the Eastland Woolen Mill building complex which, before its demolition in 2000, was comprised of a large manufacturing building and several ancillary structures, with a total area of 250,000 square feet. The buildings stood on both sides of and over the EBSR, a State-designated Class C water, which flows north to south through the center of Corinna. The original woolen-mill structure was built in the late 1800s or early 1900s. The property was a woolen mill as far back as 1912. Eastland Woolen Mill owned and operated the mill from 1936 to October 1996, when they closed the mill. Prior to closing in 1996, Eastland Woolen Mill was a manufacturer and finisher of wool and blended woven fabric. Fabric finishing included of the fabric to meet product or customer requirements. This dyeing operation took place in dye kettles and utilized various chemicals, including dyes and dye-aids that reportedly contained biphenyl and chlorinated benzene compounds, including 1,2-dichlorobenzene, 1,3-dichlorobenzene, 1,4-dichlorobenzene, and 1,2,4-trichlorobenzene.

Until construction of the Town of Corinna Wastewater Treatment Plant (WWTP) in 1969, liquid wastes from the mill were discharged to the ground surface beneath mill buildings, to Mill Pond Dam tailrace, and ultimately the EBSR. It was not until 1977 that all liquid waste streams were finally directed to the WWTP. As a result of these discharges, overburden soil and bedrock underlying mill buildings and river sediment and underlying soil extending several hundred feet downgradient were contaminated with chlorinated benzene compounds. Groundwater was contaminated at concentrations well above federal drinking water Maximum Contaminant Levels (MCLs) and State of Maine drinking water Maximum Exposure Guidelines (MEGs). Routine pumping of nearby residential bedrock wells spread the contamination laterally along bedrock bedding-plane fractures. Groundwater contamination was first documented in Corinna in 1983, when a MEDEP employee noticed a strange odor and taste in drinking water at the Gallison Restaurant located across the street from the Mill. Several water samples collected from the restaurant showed the presence of monochlorobenzene, dichlorobenzenes and trichlorobenzenes. Later in 1983, granular activated carbon (GAC) filters were installed on five water supply wells (residential and business) near the Mill to mitigate exposures to chlorinated benzene compounds.

Eastland Woolen Mill initiated formal environmental investigations in 1984 by performing a preliminary hydrogeologic investigation of the downtown area. The work included the completion of soil borings, installation of monitoring wells and piezometers, sampling and analysis of soil and groundwater, and a preliminary fracture-trace analysis. The investigation concluded that additional work was needed to identify a contaminant source area. By 1988, Eastland Woolen Mill had completed a study of residences and businesses at risk from the groundwater contamination and had investigated potential locations for installation of a public water supply system. It was concluded that contamination had likely spread via bedrock fractures and faults. Five additional private water supply wells were fitted with granular activated carbon filters based on results of water supply well sampling performed between 1983 and 1988.

In 1993, Eastland Woolen Mill completed Phase I of a chlorinated benzene contamination investigation in the downtown area. The report identified the tailrace beneath the Eastland Woolen Mill and the UST area where dye-aid had been stored as possible source locations.

Eastland Woolen Mill removed three underground storage tanks (USTs) from the UST Area in 1994. Chlorinated benzene compounds were detected in soil samples collected from the bottom of the excavation. Because free product was reported in the excavation and soil staining was observed, an overburden groundwater recovery well (R-1), consisting of a 30-inch-diameter corrugated metal pipe with slits in the bottom five feet and surrounded by crushed stone, was installed at the Site after removal of the USTs. In addition, a drum containing a dark oil-like substance was unearthed in the UST excavation. Recovery Well R-1 was pumped to collect chlorinated benzene-contaminated groundwater and flush contaminants from the “smear” zone between August 1994 and sometime in 1995. In conjunction with the pumping of groundwater from Well R-1, Eastland Woolen Mill instituted pumping of groundwater from the bedrock well on Lot 122, south of Main Street, now referenced as Recovery Well R-2.

In the fall of 1995, during the installation of water supply lines to serve residences affected by contamination, a dense non-aqueous-phase liquid (DNAPL) was reportedly observed within the till material beneath the gravel riverbed just downstream of the Main Street bridge. A consultant for Eastland Woolen Mill, Acheron, Inc., performed additional sampling of the sediments in the riverbed downstream of the Eastland Woolen Mill and found chlorinated benzene compounds and petroleum hydrocarbons both within the silty till layer beneath the rocky gravel riverbed and in a floodplain on the west side of the river.

After closure of the Eastland Woolen Mill in 1996, MEDEP sampled soils around the former USTs to evaluate whether residual soil contamination was present and acting as a source of groundwater contamination. This effort was supplemented in 1998 with additional analytical parameters and sampling of a background location. In 1997, MEDEP performed sediment sampling with field chemical screening to gain information on the magnitude of river bottom contamination documented by Acheron, Inc. in 1995. Additional sediment and surface water samples were collected from the river in 1998 for analysis. These investigations confirmed that high concentrations of chlorinated benzenes were present in the riverbed downstream of the Eastland Woolen Mill complex. This data was used to prepare the Hazard Ranking System scoring package that was submitted to EPA for placement of the Site on the National Priorities List (NPL).

The Site was proposed for inclusion on the NPL on April 23, 1999 (64 FR 19968). It was listed for final inclusion on the NPL on July 22, 1999 (64 FR 39878-39885).

In 1997, MEDEP performed an emergency response action to remove 54,673 pounds of various hazardous substances from process pipes, containers and vessels located within the Mill.

Future land use assumptions for the Site and surrounding areas (included the parcels proposed for deletion) are based on the Reuse Plan developed by the Town of Corinna. A large portion of the Site in the center of town has been targeted for a mix of commercial, residential and mixed-use development. The water supply system was expanded by the local water district to support future growth. The land use for properties proposed for deletion include: the Town of Corinna subdivision parcels 2, 3, 4, 5, 6, 8, 9, 10, a portion of Lot 54 on Tax Map 18, and Lot 118 on Tax Map 18, which are part of the targeted mix of commercial, residential, and mixed use development; one property owned by the Town of Corinna (Lot 53 on Tax Map 18) that will remain a public park (Winchester Park); the State of Maine Department of Conservation property which is a mixed use rail-trail that is primarily used for snowmobile travel; the Central Maine Power property that is expected to remain an electrical sub-station; and the State of Maine Department of Transportation property that is essentially right of way property related to Route 7. These land assumptions are expected to be valid for the foreseeable future.

From 1998 to 2002, USEPA performed a Remedial Investigation/Feasibility Study (RI/FS) for Operable Unit I (OUI) at the Eastland Woolen Mill site. OUI is the groundwater operable unit and includes overburden and bedrock groundwater contamination and also includes areas of deep soil contamination remaining after the NTCRA. All of the properties proposed for deletion are within the study area for OUI. The details of the OUI RI/FS can be found in the Remedial Investigation Report, Supplemental Remedial Investigation Report, Human Health Risk Assessment Report, and Baseline Ecological Risk Assessment Report that are included in the Administrative Record for the OUI Record of Decision (ROD). The RI for the OUI Study Area identified two areas where site-related contaminants exceeded federal and state drinking water criteria in overburden groundwater. One area is associated with the UST Area/Building 14 sub-area, and the other is downgradient of the former location of Buildings 1, 1A, and 3 within the Eastland Woolen Mill complex where liquid wastes were discharged. The RI also identified an area of bedrock groundwater contamination associated with the release of contamination from Buildings 1, 1A, and 3 (Area 1). The major groundwater contaminants of concern (COCs) were determined to be benzene, chlorobenzene, 1,2-dichlorobenzene, 1,3-dichlorobenzene, 1,4- dichlorobenzene, and 1,2,4 trichlorobenzene. The OUI RI and ROD also documented that three satellite areas of suspected contamination (School Street Yard, Moosehead Mill, and Bulk Fuels Storage Area) were not considered part of the Site based on the absence of contamination that would represent an unacceptable threat to human health or the environment. A fourth area, known as Lot 88, was also identified as not requiring any further action after the NTCRA removed the soil contamination from this property.

In September 2002, EPA created OUII to address the sediment and associated floodplain areas of the EBSR downstream of NTCRA excavation, as well as an area of solid and liquid waste disposal known as the old dump. During 2002 and 2003, EPA performed a series of studies to better define the potential for ecological impacts in the OUII area. Surface water, sediment, floodplain soil, and crayfish tissue samples were collected, and biological assessments of the benthic macro-invertebrate community were performed. The information from these studies was presented in a Supplemental RI Report. The information was also combined with the initial RI data to prepare a revised Baseline Ecological Risk Assessment Report that found there was no unacceptable risk to ecological receptors in the OUII area. Both reports were released in 2004 as part of the Administrative Record and were available for review during the public comment period for the OUII Proposed Plan. On September 30, 2004, EPA signed a ROD selecting No Further Action for OUII of the Site. EPA activities in the OUII Study Area are complete, and no further activities are anticipated for the OUII study area.

The RI evaluated the properties proposed for deletion. The Town of Corinna subdivision lots 8, 9, and 10, a portion of Lot 54 on Tax Map 18, along with Winchester Park were outside the footprint of the former Eastland Woolen Mill. The electrical sub-station owner by Central Maine Power was also outside of the footprint of the former Eastland Woolen Mill. Background research and Site reconnaissance activities as part of the RI and NTCRA along with the absence of groundwater contamination in the area led to the conclusion that these properties were not contaminated. Subdivision lots 8, 9 and 10 were included in the areas that were used for soil handling during the NTCRA, and cleanup confirmation work was performed at the completion of the NTCRA. The Town of Corinna subdivision lots 2, 3, 4, 5, and 6 are located in an area that was occupied by the dry processing operations at the Eastland Woolen Mill. This area was known as the “Slab Area”. As part of the OUI RI, five confirmation soil borings (SB-00-95 through SB-00-99) were completed within Slab Area (Figure 5-5 of the RI). The soil borings were spaced approximately 100 to 120 feet apart in the Slab Area (Figure 5-3 of the RI). One additional soil boring, (SB-01-106), was installed as part of the NTCRA by Weston in 2001. Table 5-3 of the RI provides a summary of volatile organic compounds (VOCs) detected in these Slab Area soil borings. Several VOCs were detected at concentrations that were below levels of concern for human contact. A monitoring well pair was installed to determine if the 1,1-dichloroethene detected in the soil was present in groundwater downgradient of the Slab area. VOCs were not detected in groundwater downgradient of the Slab, confirming that this area was not a significant source of groundwater contamination. The soil treatment facility for the NTCRA was located on the Slab Area. After the completion of the soil treatment, the Slab Area was further characterized to document that absence of significant contamination.

The State of Maine Department of Transportation, State of Maine Department of Conservation, and Town of Corinna (Lot 118 Tax Map 18) all owned property that included the contaminated sections of the EBSR. The extent of the contamination in the EBSR was documented by the NTCRA and RI investigations. In addition, State of Maine Department of Conservation also owned property within the former Eastland Woolen Mill complex near the former pump house and the State of Maine Department of Transportation owned property that was within and adjacent to the former Eastland Woolen Mill Complex. The RI and NTCRA investigation activities documented that these areas contained contaminants of concern above the Site specific cleanup levels.

There have been three major decision documents for the Eastland Woolen Mill. The 2004 Record of Decision for Operable Unit II clarified that no action was necessary for the areas within the East Branch of the Sebasticook River study area of the Site located south (downstream) from the OUI area. The 2002 Operable Unit I Record of Decision, which was amended in 2006, and the 1999 Non-Time Critical Removal Action Action Memorandum are the decision documents relevant to the partial delisting.

In January 1999, following the evaluation of data collected during an expanded site inspection, EPA signed an Approval Memorandum authorizing the preparation of an Engineering Evaluation and Cost Analysis (EE/CA) to evaluate potential response alternatives for a NTCRA at the Site. The EE/CA recommended demolishing the mill complex buildings to allow for the excavation and treatment of the contaminated soils on the Site. After completion of a public comment period and consideration of the comments, EPA signed an Action Memorandum in July 1999 to authorize a NTCRA for the Eastland Woolen Mill Superfund Site. The Action Memorandum was amended in June 2000, September 2000, May 2001, and June 2004.

The NTCRA included the removal of the mill buildings (performed during the winter of 1999/2000) and contaminated soils from four areas (performed from 2000-2001). NTCRA work areas include: Area 1: Region underlying Mill Buildings 1, 1A, and 3 (2001); Area 2: River segment down river from the mill to the abandoned railroad trestle (2000); Area 2a: River segment under the abandoned railroad trestle and overlapping Area 2 and Area 3 (2000); Area 3: River segment for a distance several hundred feet beyond the railroad trestle (2000); and Area 4: Lot 88, Building 9, UST Area, and other miscellaneous areas (2000 and 2001).

During 2000 and 2001, approximately 75,000 cubic yards (yd3) of chlorinated-benzene contaminated soils were excavated and stockpiled at the Site in lined containment structures. In 2001, pilot testing of an on-site low temperature thermal soil treatment system was performed. The results of this pilot test indicated that the treatment system could meet established treatment goals. Full-scale on-site treatment of contaminated soil began in October 2002 and was completed in October 2003. Testing of the soil after treatment documented that all of the soil that was used for on-site backfill contained residual levels of contamination below residential cleanup standards and met the NTCRA groundwater leaching criteria that were developed during the NTCRA. To support the NTCRA excavation and thermal treatment activities, a temporary groundwater extraction and treatment system (referred to as the groundwater management system) was constructed to aid in control of groundwater infiltration during excavation activities. One bedrock well and four overburden wells were connected to a temporary treatment system. The system remained operational until November 2004 to provide hydraulic control over the groundwater plume during the initial phase of the NTCRA. A detailed summary of the NTCRA source removals was presented in the November 2006 Final Overall Completion Report for the NTCRA.

Three areas of contaminated soil were not accessible to the NTCRA excavations. One area was located within Area 1 and the other two were within the Area 4 UST Area and Building 14 Area. These remaining soils are located in the saturated zone between depths of 6 to 40 ft below ground surface (bgs). The final phase of the NTCRA targeted the reduction of contamination in these source areas using in-situ chemical oxidation (ISCO).

ISCO treatment as part of the NTCRA consisted of two full-scale injections of iron-catalyzed sodium persulfate (ICP), followed by confirmatory soil borings and groundwater sampling. These injections were performed in July and October/November 2005. The NTCRA program ended in May 2006 as documented by the Final Pollution Report (POLREP) for the Eastland Woolen Mill NTCRA that was finalized in September 2006.

EPA signed a ROD in September 2002 OUI ROD to address overburden and bedrock groundwater and the remaining areas of contaminated soil/DNAPL.

Specifically, the 2002 OUI ROD includes the following major components:

• Extraction and treatment of the contaminated overburden and bedrock groundwater. The extraction system will be designed to prevent off-site migration of contaminated groundwater, prevent contaminated groundwater from having an adverse impact on the benthic community in the EBSR, and restore the aquifer to federal and state MCLs, federal non-zero MCLGs and more stringent state MEGs.

• In-situ treatment of the contaminated overburden and bedrock groundwater and remaining areas of contaminated soil and DNAPL. A chemical reagent (e.g., Fenton's Reagent or another oxidizing agent) will be added to the overburden and bedrock aquifer to reduce the mass of contaminants in the system. If the mass reduction is not sufficient to achieve cleanup levels, then enhanced flushing (using surfactants/solvents) and biological degradation (using bio-stimulants) will be attempted to further reduce the mass of contamination.

• Connection of certain residences to the water supply lines to prevent their wells from becoming contaminated, and to prevent expansion of the contamination in the groundwater.

• Implementation, monitoring and maintenance of institutional controls (i.e., deed restrictions) in the form of groundwater use restrictions (e.g., easements or restrictive covenants) to prevent ingestion of groundwater and disturbance of the groundwater extraction and treatment system.

• Long-term monitoring of groundwater, surface water and sediments to evaluate the success of the remedial action.

• Implementation of five-year reviews to assess the protectiveness of the remedy until cleanup goals have been met.

The 2002 OUI ROD was written prior to the completion of the NTCRA that commenced in 1999. Therefore, the impact of the NTCRA-related excavation and treatment of the contaminated overburden source areas was uncertain at the time of the ROD. Subsequent to the signing of the 2002 OUI ROD and the completion of the NTCRA excavation and treatment program, EPA performed assessment monitoring of the groundwater. EPA also developed an improved conceptual site model through additional hydro-geologic investigations and groundwater modeling.

Based on the information developed after the 2002 OUI ROD, EPA decided to amend the 2002 OUI ROD. The September 2006 OUI ROD Amendment eliminated the groundwater extraction and treatment system because the contaminant plume was stable and groundwater extraction was not necessary to contain the plume. The OUI ROD Amendment also eliminated the enhanced flushing component with surfactants or co-solvents because this technology was not considered viable for the fractured bedrock after further evaluation. The OUI ROD Amendment retained the emphasis on the in-situ chemical oxidation, long-term monitoring, and institutional controls.

Based on the groundwater modeling that was performed for the OUI Remedial Design, the OUI ROD Amendment revised the area where institutional controls would be necessary and defined three categories of properties within the institutional control zone. The three property categories were identified as IC Zone A (ICZ-A), IC Zone B (ICZ-B), and IC Zone C (ICZ-C).

ICZ-A identified those properties that will be subject to environmental covenants prohibiting use of groundwater over the entire property. All of the ICZ-A properties had been connected to the water line prior to the OUI ROD. Within the ICZ-A boundary, all existing bedrock and overburden water supply wells will be formally decommissioned, unless the wells are converted to monitoring wells for use in the long-term remedial action. ICZ-B identified those properties where connection to the water line and implementation of an environmental covenant prohibiting use of groundwater over the entire property was determined to be necessary as part of the OUI ROD and Remedial Design. All of these properties were connected to the water line as part of the OUI Remedial Action, moving these properties to ICZ-A; there is therefore no longer a functional application for ICZ-B.

ICZ-C identified those properties where the current well is not contaminated and does not appear to be impacting the groundwater contamination, however, the groundwater modeling suggested that a modification to the existing well to increase yield, or the installation of a new well at locations on the property closer to the Site, could have an adverse impact on the groundwater contamination by inducing migration of the groundwater contamination. The restrictions on these properties will prohibit installation of future groundwater wells in locations or at depths that differ from existing water supply wells located on these properties. ICZ-C properties may continue to use their private water wells within this zone for domestic or other uses. There are two properties included in ICZ-C.

The 2002 OUI ROD included an assessment of the potential threats to human health in the OUI study area. Based on the Human Health Risk Assessment prepared as part of the RI and the 2002 OUI ROD, the only pathways that exceeded EPA's acceptable cancer risk range and/or a hazard quotient of concern were ingestion of groundwater in the overburden and bedrock plumes by a future resident. The lifetime cancer risk estimate for a combined child and adult exposure to the bedrock plume groundwater is 6 × 10 −3 . Seventy-five percent of this risk is due to arsenic, with twenty-five percent attributable to the 1,4-DCB. EPA's hazard index of concern for non-carcinogenic risk is exceeded for children and adults for several target organs. The major contributors to these exceedances are chlorobenzene, 1,2-DCB, 1,3-DCB, 1,4-DCB, 1,2,4-TCB and arsenic. These COCs also were detected at concentrations above federal and state maximum contaminant levels (MCLs) and any more stringent state maximum exposure guidelines (MEGs). The lifetime cancer risk estimates for the overburden plume groundwater was 2 × 10 −3 . Sixty-seven percent of this risk is attributable to 1,4-DCB, with arsenic contributing to the remainder of the cancer risk. EPA's hazard index of concern for non-carcinogenic risk is exceeded for children and adults for several target organs. The major contributors to these exceedances are chlorobenzene, 1,2-DCB, 1,3-DCB, 1,4-DCB, 1,2,4-TCB and arsenic. These COCs also were detected at concentrations above federal and state MCLs and any more stringent state MEGs. The Baseline Human Health Risk Assessment concluded that the estimated risk for the soils, surface water, or sediments within the OUI area do not represent an unacceptable threat to human health. Only groundwater represents a threat to human health. Soil contamination that is causing groundwater contamination is also relevant to the cleanup action.

Based on the OUI Baseline Ecological Risk Assessment, the OUI ROD concluded that contaminant levels in surface waters, surface soils and sediments within the entire OUI area of the EBSR are not sufficiently elevated to pose a substantial risk to invertebrates, fish or wildlife. Exposure to the contaminated water at the groundwater/surface water interface, however, was identified as an unacceptable risk to those organisms dwelling in this zone. Data gathered since the 2002 OUI ROD, however, demonstrates that the concentration of contaminants in the groundwater do not exceed the levels that have the potential for an unacceptable risk to organisms dwelling in the groundwater/surface water interface. Therefore, the successful implementation of the NTCRA and OUI remedy has eliminated this risk.

Based on the successful removal of any soil contamination above the Site-specific contaminants of concern by the NTCRA, the only viable exposure pathway for the properties proposed for deletion is potential future consumption of contaminated groundwater. This would only occur upon the expansion of the groundwater contaminant plume, resulting from a pumping stress from a well that is currently outside the area of groundwater contamination but within the institutional control zone. The OUI ROD and OUI ROD Amendment both identified the need to maintain the water line connections and the implementation of institutional controls to prevent active water supply wells as critical components to protect public health.

The Remedial Action Objectives in the OUI ROD and OUI ROD Amendment were identical and are listed below:

• Prevent the ingestion of groundwater containing contaminants that exceed federal or state MCLs, federal non-zero MCL Goals (MCLGs) and more stringent state MEGs, or in their absence, an excess cancer risk of 1 × 10 −6 or a hazard quotient of 1;

• Prevent, to the extent practicable, the off-site migration of groundwater containing contaminants at a concentration above Site cleanup levels;

• Prevent, to the extent practicable, the discharge of groundwater containing contaminants at a concentration above levels that could impact ecological receptors to the East Branch of the Sebasticook River;

• Restore groundwater to meet federal or state MCLs, federal non-zero MCLGs or state MEGs (whichever is most stringent), or in their absence, an excess cancer risk of 1 × 10 −6 or a hazard quotient of 1; and

• Perform long-term monitoring of surface water, sediments and groundwater to verify that the cleanup actions at the Site are protective of human health and the environment.

The Remedial Design for the OUI Remedial Action was initiated in 2003 and completed in August 2005. The Remedial Design was implemented in close coordination with the final phase of the NTCRA ISCO program since both programs relied on ISCO to reduce the mass of contamination in the overburden soil and bedrock. As such, the NTCRA design support activities and the Remedial Design support activities are complementary. A series of additional studies and investigations were performed between 2003 and 2005 to develop the design for the NTCRA ISCO program and the in-situ treatment portion of the OUI Remedial Action.

The additional studies and investigations most relevant to the properties proposed for deletion were (1) The groundwater monitoring to update the extent of groundwater contamination remaining after the NTCRA, (2) the installation of additional bedrock monitoring wells to refine the aquifer characteristics, and (3) groundwater modeling to refine the properties that would require land use restrictions to prevent consumption of contaminated groundwater and pumping stresses that could cause the expansion of the groundwater plume.

The Remedial Design refined the institutional control zone using numerical modeling of bedrock groundwater flow and contaminant transport to evaluate the potential long-term migration of the bedrock plume under both pumping and non-pumping scenarios. This modeling, along with the groundwater monitoring data, documented that the institutional control zone will adequately protect public health.

The OUI Remedial Action has three main components. One is the connection of certain residences to the water line and the implementation of institutional controls to prevent exposure to contaminated groundwater or pumping stresses that could cause the expansion of the groundwater plume. A second is the continued treatment of the deep contamination soil and groundwater to achieve aquifer restoration. The third is the long-term monitoring, inspections, and five-year reviews to assure that the remedial action is protective of human health and the environment.

Most of the properties within the institutional control zone were connected to the local water supply line prior to the OUI Remedial Action. Based on the results of ongoing bedrock groundwater monitoring and numerical groundwater modeling performed as part of the Remedial Design, it was determined that certain residences proximal to the Site, including those identified on Map 18 as Lots 39, 43, and 52, were currently impacted by Site contaminants or had the potential to be impacted in the future. These residences were connected to the existing public water supply between September and December 2005. The land use restrictions for the properties proposed for deletion were completed in May 2012 and were recorded in the Penobscot Registry of Deeds on June 5, 2012. The land use restriction, in the form of an environmental covenant, will prevent current and future use of the contaminated groundwater or to prevent pumping stresses that could cause the groundwater contamination plume to migrate.

The RA also continued the in-situ chemical oxidation program initiated by the NTCRA. Several additional in-situ chemical oxidation injections occurred between 2006 and 2008. The Remedial Action activities were completed in 2008, as documented in the OUI Interim Remedial Action Report and the September 2008 Preliminary Closeout Report. The OUI component of the Site is now in the long-term response action component of the remedial action. The ongoing remedial action activities include: Completion of the land use restrictions; long-term monitoring of groundwater and surface water; well decommissioning; site demobilization; and completion of the in-situ chemical oxidation program. A limited soil gas program is to be implemented in 2012 to address soil vapor issues. The remedial action will be completed by 2018 when the State of Maine will take over the long term operation, maintenance, and monitoring requirements.

The parcels identified for deletion are within the NTCRA and OUI area and, therefore, share the same cleanup goals. The extent of the groundwater contamination above Site-specific cleanup goals has been reduced to an area that is within the boundaries of the Site that will remain after the partial deletion. Groundwater monitoring performed as part of the long-term groundwater monitoring program at the Site confirms that the contaminants of concern are not at concentrations above the Site specific cleanup levels on the properties proposed for deletion. Groundwater data was collected in 2006, 2007, 2009, 2010, and 2011. The data for each sampling event is contained with each annual groundwater monitoring report and is included in the record for the proposed deletion. The area of the Site that included the parcels identified for delisting was located in the dry processing and parking areas of the former Eastland Woolen Mill. The NTCRA program resulted in the excavation and on-site treatment of any soils within the area identified for delisting. The table below documents that the NTCRA successfully treated the Site soil to levels that would allow for unrestricted use.

Operation and maintenance activities for the parcels proposed for deletion include monitoring and maintenance of the institutional controls to ensure they effectively prohibit private well installation. In addition, the groundwater underlying these parcels continues to be monitored as part of the site-wide groundwater monitoring plan.

The OUI Record of Decision documented that the soil and surface water for the entire OUI area, including the properties proposed for deletion, do not represent an unacceptable threat to human health. The OUI Record of Decision identified groundwater as the only remaining threat to human health after the NTCRA. Groundwater discharge to surface water was the only ecological threat identified for the OUI. The supporting data for the characterization of the area to be delisted can be found in both the RI Report and NTCRA Documentation. In addition, long-term groundwater monitoring data documents that the properties proposed for deletion do not contain groundwater above the Site-specific cleanup goals established in the 2002 OUI ROD and 2006 OUI ROD Amendment. The properties proposed for deletion at the Eastland Woolen Mill Superfund Site do not contain soil or groundwater contamination above the Site specific cleanup levels.

The properties proposed for deletion that are identified in the Town of Corinna subdivision plan as Lots 2, 3, 4, 5, 6, 8, 9, and 10, portions of Lot 54 on Tax Map 18, the property identified as Lot 53 on Tax Map 18, and the property owned by Central Maine Power were not within the areas where substantial contamination was located. These properties contained open space, the dry processing portions of the former Eastland Woolen Mill, and office space. The concrete foundation where the dry processing of the woolen products was conducted was referred to as the “Slab Area” in the RI and NTCRA.

As part of the OUI RI, five confirmation soil borings (SB-00-95 through SB-00-99) were completed within Slab Area (see Figure 5-5 of the RI). One additional soil boring, (SB-01-106), was installed as part of the NTCRA by Weston in 2001. Table 5-3 of the RI provides a summary of volatile organic compounds (VOCs) detected in these Slab Area soil borings. Low levels of several VOCs were detected. The concentrations were below levels of concern for human contact. A monitoring well pair was installed to determine if the 1,1-dichloroethene detected in the soil was present in groundwater downgradient of the Slab area. VOCs were not detected in groundwater downgradient of the Slab, confirming that this area was not a significant source of groundwater contamination.

The Slab was not removed until after the ex-situ soil treatment phase of the NTCRA. Prior to the removal of the concrete pad, one sample was collected per 500 ft 2 using an excavator bucket to access the soil located below the concrete pad. A few areas with petroleum contamination were identified, and these soils were removed to allow for Site restoration. A total of 176 samples were collected prior to concrete pad removal. A map showing the locations of these samples is presented in Figure 17 of Appendix J in the November 2006 Final Overall Completion Report for the NTCRA, and analytical results are presented in Table 27 of this report. All of the results from these initial 176 samples collected prior to the concrete pad removal confirmed that the soil concentrations were below the Site-specific cleanup levels. An additional five locations were sampled and characterized during concrete pad and footer wall removal due to staining or suspected contamination in the soil. Samples were analyzed for VOCs, DRO, polychlorinated biphenyls and/or metals based on the type and location of the staining. A summary of analytical results is shown in Table 28 of Appendix J in the November 2006 Final Overall Completion Report for the NTCRA, and sample locations are shown in Figure 18 of this report. Three of these locations contained Diesel Range Organic contamination. The contamination was removed because the soil was in an area where grading was necessary.

In addition to the Slab Area, a portion of the properties to be deleted were used to store contaminated soil in a stockpile prior to treatment. After completion of the treatment of the contaminated soil, 22 soil samples were collected below the contaminated soil stockpile to verify that the soil did not contain the COCs at levels above the site cleanup levels. A map detailing sample locations within the stockpile footprint is shown in Figure 16 of Appendix J in the November 2006 Final Overall Completion Report for the NTCRA. The analytical results for all samples collected from the below the stockpile footprint are presented in Table 26 of this report. Sample location 21, initially sampled on 9 October 2003, showed 1,2,4-TCB at levels above the Site specifc soil excavation goal of 5,000 microgram per kilogram (μg/kg). Therefore, a 6-inch layer of soil was removed from this grid of the stockpile footprint and processed through the LTTT system. A subsequent sample of this location was collected on 10 October 2003. Results from this sample were well below Site specific cleanup levels.

In summary, the Town of Corinna subdivision lots 2, 3, 4, 5, 6, 8, 9, and 10, the portion of Subdivision Lot 1 north of the Central Maine Power property, a portion of Lot 54 on Tax Map 18, the property identified at Map 18 Lot 53 (Winchester Park) and the property owned by Central Maine Power have been evaluated during the RI and NTCRA activities. The RI documented that the area was not a substantial threat to groundwater. The NTCRA sampling further documented that these properties do not contain soil contamination above the Site specific cleanup levels.

Portions of the property owned by the State of Maine Department of Transportation, State of Maine Department of Conservation, and the Town of Corinna property described in Quitclaim Deed dated August 18, 1997 and recorded in Book 6471, Page 278, also identified as Lot 118 in Tax Map 18 dated 2004 were within the area subject to the excavation of contaminated soil and sediment as part of the NTCRA.

A portion of the State of Maine Department of Conservation property crossed the former Eastland Woolen Mill property near the area known as the pump house. The soil excavation and cleanup confirmation for this area can be found in Appendix H of the November 2006 Final Overall Completion Report for the NTCRA. Appendix H is titled: Areas 1 and 4 Soil Remediation and River Restoration Final Completion Report, Eastland Woolen Mill Superfund Site, Corinna, Maine, February 2004. Figures 2a-3b and Tables B-6 and B-7 of this report document that the cleanup was successful for those properties.

A portion of the State of Maine Department of Transportation property that is proposed for de-listing was within the Area 1 excavation area. The soil excavation and cleanup confirmation for this area can be found in Appendix H of the November 2006 Final Overall Completion Report for the NTCRA. Appendix H is titled: Areas 1 and 4 Soil Remediation and River Restoration Final Completion Report, Eastland Woolen Mill Superfund Site, Corinna, Maine, February 2004. Figures 4a-4b and Tables B-9 of this report document that the cleanup was successful for these properties.

A portion of the State of Maine Department of Transportation, State of Maine Department of Conservation, and Town of Corinna properties included the East Branch of the Sebasticook River. Appendix G in the November 2006 Final Overall Completion Report for the NTCRA documents the excavation and cleanup confirmation activities for these areas. Appendix G is titled: Areas 2, 3, 4—Lot 88, and 4—Building 4 Soil Remediation Final Completion Report, Eastland Woolen Mill Superfund Site, Corinna, Maine, June 2001. Specifically, Figures A-3A through A-4B and Tables B-7 and B-8 of Appendix G show the location and data that document that the cleanup was successful for these properties.

In summary, the property owned by the State of Maine Department of Transportation, State of Maine Department of Conservation, and the Town of Corinna property described in Quitclaim Deed dated August 18, 1997 and recorded in Book 6471, Page 278, also identified as Lot 118 in Tax Map 18 dated 2012 that are proposed for de-listing no longer contain contamination above the Site specific cleanup levels as documented by the completion report for the NTCRA.

The assessment of the first five-year review performed in 2010 found that the remedy was constructed in accordance with the requirements of the Record of Decision (ROD) issued in 2002 and amended in 2006. The LTRA remedy is functioning as designed. As a result of the response actions at the Site, there is no current exposure to contaminants at the Site. A water line provides clean water and planned ICs will ensure appropriate future use of potentially contaminated groundwater. The remedy at the Eastland Woolen Mill Superfund Site currently protects human health and the environment because the contamination accessible to ecological receptors has been removed, there is no current human exposure to contamination, the groundwater contamination is not migrating, clean water is available to all locations within the extent of the groundwater contamination, and EPA is actively treating and monitoring the groundwater as part of the on-going Long-Term Response Action. However, in order for the remedy to be protective in the long-term, the institutional controls to prevent future groundwater use need to be in place to ensure long-term protectiveness. As part of this five-year review, a preliminary assessment of the potential for vapor intrusion to present a threat at the Site was performed. There are no structures above areas of the plume that exceed vapor intrusion screening criteria, so the pathway is not complete. Further investigations regarding the vapor intrusion pathway will be completed prior to the next five-year review. Further investigation regarding the vapor intrusion pathway will be completed on properties that are not subject to the partial deletion.

Since the completion of the five-year review, the institutional controls, that are in the form of environmental covenants, have been completed for the properties that will remain within the Site and the properties that are proposed for deletion. The only institutional controls that remain to be completed are for properties that are off-site. The groundwater under these remaining properties is not contaminated but a pumping well on these properties could cause the contaminated groundwater plume to expand. In addition, the properties proposed for deletion are not in the area where the vapor intrusion evaluation is being re-evaluated. The ICs for the properties proposed for deletion and the properties that will remain within the boundaries of the Site were signed in May 2012 and recorded in June 5, 2012. The next five-year review will take place in 2015.

Throughout the EPA cleanup of the Site, community concern and involvement has been high. The local Selectboard actively sought EPA's involvement at the Site to address the contamination left behind by the closure of the mill in 1996. EPA has kept the community and other interested parties informed of Site activities through informational meetings, fact sheets, press releases and public meetings. Information about the Site is posted on EPA's Web site. EPA has met regularly with the community and Selectboard to keep them informed and to seek their input regarding Site activities. The community has also benefited from a Web site ( www.cattailpress.com ), which was developed and is maintained by a local resident. The Web site contained daily photographs of Site activities during the NTCRA demolition and excavation activities and has provided a forum for community dialogue regarding the Site. EPA's public notices and fact sheets have been posted on this Web site as well. EPA provided the community with a Technical Assistance Grant (TAG) and a Redevelopment Pilot Grant. EPA identified the potential for partial delisting of the Eastland Woolen Mill in a community update issues in 2006. EPA issues a fact sheet in 2010 to announce the performance of the Five Year Review. EPA met with the community in May 2010 to discuss the Site status and Five Year Review. All Community Involvement activities required and associated with this proposed partial deletion have been completed, including the publication of a notice in a local newspaper of general circulation regarding this proposed deletion and the availability of documents located in the Deletion Docket.

The NCP specifies that EPA may delete a site from the NPL if “all appropriate responsible parties or other persons have implemented all appropriate response actions required” or “all appropriate fund-financed response under CERCLA has been implemented, and no further response action by responsible parties is appropriate” or “the remedial investigation has shown that the release poses no significant threat to public health or the environment and, therefore, the taking of remedial measures is not appropriate”. For the partial deletion proposed at the Eastland Woolen Mill Superfund Site:

• All appropriate Fund-financed response under CERCLA has been implemented, and no further response action by responsible parties is appropriate; as required by 40 CFR 300.425(e)(1)(ii). An Interim Remedial Action Report was completed in 2008 to document the completion of the Remedial Action activities, including the area subject to de-listing.

The EPA, with concurrence of the State of Maine through the Maine Department of Environmental Protection, on June 14, 2012, has determined that all appropriate response actions under CERCLA have been completed for the properties proposed for deletion. Therefore, EPA is deleting the following properties:

Because EPA considers this action to be noncontroversial and routine, EPA is taking it without prior publication. This action will be effective October 1, 2012 unless EPA receives adverse comments by September 4, 2012. If adverse comments are received within the 30-day public comment period, EPA will publish a timely withdrawal of this direct final notice of partial deletion before the effective date of the partial deletion and it will not take effect. EPA will prepare a response to comments and continue with the deletion process on the basis of the notice of intent to partially delete and the comments already received. There will be no additional opportunity to comment.

For the reasons set out in this document, 40 CFR part 300 is amended as follows: