A proposed rule detailing the revisions was published in the Federal Register on March 23, 2011 (76 FR 16321). A 15-day comment period was provided for interested persons to respond to the proposed rule. Three comments were received from three national cotton industry organizations in support of the service and the decision to maintain the fee at the level established for the 2010 crop.

This final rule has been determined to be not significant for purposes of Executive Order 12866; and, therefore has not been reviewed by the Office of Management and Budget (OMB).

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect. There are no administrative procedures that must be exhausted prior to any judicial challenge to the provisions of this rule.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), AMS has considered the economic impact of this action on small entities and has determined that its implementation will not have a significant economic impact on a substantial number of small businesses.

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions so that small businesses will not be disproportionately burdened. There are an estimated 25,000 cotton growers in the U.S. who voluntarily use the AMS cotton classing services annually, and the majority of these cotton growers are small businesses under the criteria established by the Small Business Administration (13 CFR 121.201). Continuing the user fee at the 2010 crop level as stated will not significantly affect small businesses as defined in the RFA because:

(1) The fee represents a very small portion of the cost-per-unit currently borne by those entities utilizing the services. (The 2010 user fee for classification services was $2.20 per bale; the fee for the 2011 crop would be maintained at $2.20 per bale; the 2011 crop is estimated at 16,500,000 bales;

(2) The fee for services will not affect competition in the marketplace;

(3) The use of classification services is voluntary. For the 2010 crop, 17,611,000 bales were produced; and, almost all of these bales were voluntarily submitted by growers for the classification service; and

(4) Based on the average price paid to growers for cotton from the 2009 crop of 0.6210 cents per pound, 500 pound bales of cotton are worth an average of $311 each. The user fee for classification services, $2.20 per bale, is less than one percent of the value of an average bale of cotton.

In compliance with OMB regulations (5 CFR part 1320) which implement the Paperwork Reduction Act (PRA) (44 U.S.C. 3501), the information collection requirements contained in the provisions amended by this final rule have been previously approved by OMB and were assigned OMB control number 0581-AC43.

This final rule maintains the user fee charged to producers for cotton classification at $2.20 per bale for the 2011 cotton crop. The 2011 user fee charged to farmers was calculated using new methodology, as was required by section 14201 of the Food, Conservation, and Energy Act of 2008 (Pub. L. 110-234) (2008 Farm Bill). Prior to the changes made by the 2008 Farm Bill, the fee was determined using a user-fee formula mandated in the Uniform Cotton Classing Fees Act of 1987, as amended (Pub. L. 100-108, 728) (1987 Act). This formula used the previous year's base fee that was adjusted for inflation and economies of size (1 percent decrease/increase for every 100,000 bales above/below 12.5 million bales with maximum adjustment being ± 15 percent). The user fee was then further adjusted to comply with operating reserve constraints (between 10 and 25 percent of projected operating costs) specified by the 1987 Act.

Section 14201 of the 2008 Farm Bill provides that: (1) The Secretary shall make available cotton classification services to producers of cotton, and provide for the collection of classification fees from participating producers or agents that voluntarily agree to collect and remit the fees on behalf of the producers; (2) classification fees collected and the proceeds from the sales of samples submitted for classification shall, to the extent practicable, be used to pay the cost of the services provided, including administrative and supervisory costs; (3) the Secretary shall announce a uniform classification fee and any applicable surcharge for classification services not later than June 1 of the year in which the fee applies; and (4) in establishing the amount of fees under this section, the Secretary shall consult with representatives of the United States cotton industry. At pages 313-314, the Joint Explanatory Statement of the committee of conference for section 14201 stated the expectation that the cotton classification fee would be established in the same manner as was applied during the 1992 through 2007 fiscal years. The classification fee should continue to be a basic, uniform fee per bale fee as determined necessary to maintain cost-effective cotton classification service. Further, in consulting with the cotton industry, the Secretary should demonstrate the level of fees necessary to maintain effective cotton classification services and provide the Department of Agriculture with an adequate operating reserve, while also working to limit adjustments in the year-to-year fee.

Under the provisions of section 14201, this final rule establishes a user fee (dollars per bale classed) for the 2011 cotton crop that, when combined with other sources of revenue, will result in projected revenues sufficient to reasonably cover budgeted costs—adjusted for inflation—and allow for adequate operating reserves to be maintained. Costs considered in this method include salaries, costs of equipment and supplies, and other overhead costs, such as facility costs and costs for administration and supervision. In addition to covering expected costs, the user fee is set such that projected revenues will generate an operating reserve adequate to effectively manage uncertainties related to crop size and cash-flow timing while meeting minimum reserve requirements set by the Agricultural Marketing Service, which require maintenance of a reserve fund amount equal to four months of projected operating costs.

Extensive consultations regarding the establishment of the classification fee with U.S. cotton industry representatives were held during the period from September 2010 through March 2011 during numerous publicly held meetings. Representatives of all segments of the cotton industry, including producers, ginners, bale storage facility operators, merchants, cooperatives, and textile manufacturers were addressed in various industry-sponsored forums.

The user fee established to be charged cotton producers for cotton classification in 2011 is $2.20 per bale, which is the same fee charged for the 2010 crop. This fee is based on the pre-season projection that 16.5 million bales will be classed by the United States Department of Agriculture during the 2011 crop year.

Accordingly, § 28.909, paragraph (b) will reflect the continuation of the cotton classification fee at $2.20 per bale.

As provided for in the 1987 Act, a 5 cent per bale discount will continue to be applied to voluntary centralized billing and collecting agents as specified in § 28.909(c).

Growers or their designated agents receiving classification data will continue to incur no additional fees if classification data is requested only once. The fee for each additional retrieval of classification data in § 28.910 will remain at 5 cents per bale. The fee in § 28.910(b) for an owner receiving classification data from the National database will remain at 5 cents per bale, and the minimum charge of $5.00 for services provided per monthly billing period will remain the same. The provisions of § 28.910(c) concerning the fee for new classification memoranda issued from the National Database for the business convenience of an owner without reclassification of the cotton will remain the same at 15 cents per bale or a minimum of $5.00 per sheet.

The fee for review classification in § 28.911 will remain at $2.20 per bale.

The fee for returning samples after classification in § 28.911 will remain at 50 cents per sample.

Pursuant to 5 U.S.C. 533, good cause exists for not postponing the effective date of this final rule until 30 days after publication in the Federal Register because this rule maintains uniform user fees for 2011 crop cotton classification services as mandated by the Cotton Statistics and Estimates Act, at the same level as 2010.

For the reasons set forth in the preamble, 7 CFR part 28 is amended to read as follows:

Airworthiness Directive 2011-04-02, amendment 39-16602 (76 FR 7101, February 9, 2011), currently requires removing from service, certain part number and serial number propeller blades for Hamilton Sundstrand Propellers Model 247F Propellers.

As published, the propeller blade part number 817370-1 and ATR72-210 and ATR722-210E airplanes in the SUPPLEMENTARY INFORMATION , the Applicability, and the Compliance sections are incorrect.

No other part of the preamble or regulatory information has been changed; therefore, only the changed portion of the final rule is being published in the Federal Register .

The effective date of this AD remains March 16, 2011.

In the Federal Register of February 9, 2011, AD 2011-04-02; Amendment 39-16602 is corrected as follows:

On page 7101 in the third column, on line 26, SUPPLEMENTARY INFORMATION , change “817370-1” to “R817370-1”.

On page 7101 in the third column, on line 33, SUPPLEMENTARY INFORMATION , change “817370-1” to “R817370-1”.

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on January 5, 2011 (76 FR 480). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

Non-functioning of the RAT could result in insufficient electrical power to operate the fly-by-wire system, and subsequent loss of control of the airplane. The corrective action is repairing. You may obtain further information by examining the MCAI in the AD docket.

We gave the public the opportunity to participate in developing this AD. We considered the comment received.

Hamilton Sundstrand requested that we rephrase the Summary and Reason sections of the NPRM regarding the potential for RAT non-deployment due to freezing of the RAT mechanism. The commenter stated that the malfunction of the RAT heating system would not in itself prevent RAT deployment. The commenter stated that the heating system consists of only the RAT heater within the generator, and the potential consequence of this heater being inoperative relates primarily to freezing of the gap between the rotor and stator of the generator rotor/turbine assembly, leading to the RAT generator inability to rotate or to rotate at rated rotations per minute (RPM) for a given airspeed.

We agree to rephrase the Summary and Reason sections of the AD, as well as paragraph (e) of this AD, although the end result of the heater issue results in the identified insufficient electrical power to operate the fly-by-wire system, and subsequent loss of control of the airplane.

We reviewed the available data, including the comment received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a NOTE within the AD.

We estimate that this AD will affect 21 products of U.S. registry. We also estimate that it will take about 1 work-hour per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $1,785, or $85 per product.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect 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.

For the reasons discussed above, I certify this AD:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

On February 14, 2011, the FAA published in the Federal Register a notice of proposed rulemaking to amend controlled airspace at McCall, ID (76 FR 8324). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E Airspace designations are published in paragraph 6005 of FAA Order 7400.9U dated August 18, 2010, and effective September 15, 2010, which is incorporated by reference in 14 CFR 71.1. The Class E Airspace designations listed in this document will be published subsequently in that Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) Part 71 by amending Class E Airspace extending upward from 700 feet above the surface, at McCall Municipal Airport, for standard instrument approach procedures at the airport. Airspace reconfiguration is necessary due to the decommissioning of the McCall NDB and cancellation of the NDB approach. This also will correct the airport name from McCall Airport to McCall Municipal Airport.

The FAA has determined this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (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. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106 discusses the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends controlled airspace at McCall Municipal Airport, McCall, ID.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR Part 71 as follows:

Each year about 48 million people (1 in 6 Americans) are sickened, 128,000 are hospitalized, and 3,000 die from food borne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable.

FSMA (Pub. L. 111-353), signed into law by President Obama on January 4, 2011, enables FDA to better protect public health by helping to ensure the safety and security of the food supply. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides FDA with new enforcement authorities to help it achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur. The law also gives FDA important new tools to better ensure the safety of imported foods and directs FDA to build an integrated national food safety system in partnership with State and local authorities.

Section 207 of FSMA amends the criteria for ordering administrative detention of human or animal food in section 304(h)(1)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 334(h)(1)(A)). Under the new criteria, FDA can order administrative detention if there is reason to believe that an article of food is adulterated or misbranded. Decisions regarding whether FDA has a “reason to believe” a food is adulterated or misbranded would be made on a case by case basis because such decisions are fact specific. Section 207 also requires the Secretary of Health and Human Services to issue an interim final rule implementing this statutory change no later than 120 days following the date of enactment of FSMA and provides that the amendment made by section 207 takes effect 180 days after the date of enactment, which is July 3, 2011.

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188), was signed into law on June 12, 2002. Among other things, the Bioterrorism Act amended the FD&C Act by adding subsection (h) to section 304. This provision provided FDA the authority to order the detention of any article of food if during an inspection, examination, or investigation an FDA officer or qualified employee finds there is credible evidence or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals. The Bioterrorism Act also amended the FD&C Act by adding subsection (bb) to section 301 (21 U.S.C. 331), making it a prohibited act to move an article of food in violation of a detention order or to remove or alter any mark or label required by a detention order that identifies an article of food as detained.

In accordance with the Bioterrorism Act, FDA issued a notice of proposed rulemaking (proposed rule) in the Federal Register of May 9, 2003 (68 FR 25242), proposing procedures for the administrative detention of an article of food. In the Federal Register of June 4, 2004 (69 FR 31660), the Agency issued the final rule establishing the procedures for administrative detention, including among other provisions the criteria for ordering administrative detention. The administrative detention regulations have been codified at Title 21, Code of Federal Regulations (CFR) Part 1, Subpart K (21 CFR part 1, subpart K). This interim final rule amends those regulations. Specifically, the interim final rule is amending §§ 1.378 and 1.393(a) by replacing the existing criteria used to order administrative detention with the new criteria required by section 207 of FSMA.

FDA has examined the impacts of this interim 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). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. OMB has determined that this is a significant regulatory action as defined by the Executive Orders.

The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the additional costs per entity of this rule are negligible if any, the Agency also concludes that this 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 $135 million, using the most current (2009) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this interim final rule to result in any 1-year expenditure that would meet or exceed this amount.

In the 2003 proposed rule, FDA analyzed the economic impact of the proposed rule to provide procedures for administrative detention of food for human or animal consumption under the Bioterrorism Act (68 FR 25242 at 25250). The Economic Impact Analysis of the June 4, 2004, final rule (69 FR 31660 at 31685) revised the analysis set forth in the 2003 proposed rule. The 2004 analysis explained that any costs and/or benefits of the rule can be generated only in those circumstances in which FDA would choose to order administrative detention instead of using other enforcement tools available to the Agency, such as requesting voluntary recall, instituting a seizure action, or referring the matter to State authorities. In the 2004 analysis, FDA noted that because administrative detention was a new enforcement tool, we were not able to directly estimate how often it would be used. FDA indirectly estimated the number of potential events that would trigger an administrative detention as a subset of other existing enforcement actions at the time. The analysis assumed that FDA would be likely to choose administrative detention only if it were the most effective enforcement tool available in a particular situation.

This Economic Impact Analysis explains and further revises the analysis set forth in the 2004 final rule by addressing the economic impact of the new requirement in section 207 of FSMA.

The need for this interim final rule arises from section 207 of FSMA which changed the criteria for ordering administrative detention of human or animal food. The current criteria in section 304(h)(1)(A) of the FD&C Act provide FDA the authority to order the detention of an article of food if during an inspection, examination, or investigation, an FDA officer or qualified employee finds there is credible evidence or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals. Section 207 of FSMA changes the criteria to allow the Agency to order detention if there is reason to believe that an article of food is adulterated or misbranded. The new criteria provide FDA enhanced authority to detain articles of food that may be adulterated or misbranded for 20 calendar days with a possible 10 calendar day extension if needed to initiate legal action under section 304 or 302 of the FD&C Act (21 U.S.C. 332). This authority will further help the Agency prevent potentially harmful food from reaching U.S. consumers and thereby improve the safety of the food supply in the United States. This interim final rule implements section 207 of FSMA by amending 21 CFR part 1, subpart K, which is already in effect.

The economic impact analysis of the 2004 final rule estimated the costs of taking administrative detention actions relative to the costs of other enforcement tools already available to FDA. Using these existing tools FDA could do the following: (1) Request a voluntary recall of the suspected product; (2) move directly to seize the food; or (3) refer the matter to State authorities. The 2004 analysis explained that the estimated number of potential events that would trigger an administrative detention could also trigger the existing enforcement actions. The number of actions was estimated as a range between 0 and 223 actions per year. The upper bound (223) is the sum of 184 Class I recalls, 16 direct seizures, and 23 or 10 percent of the referrals to State authorities in fiscal year 2002. This sum (223 actions) represents the upper bound number of times FDA anticipated using administrative detention, and the lower bound of 0 suggests the possibility that FDA may not order administrative detention at all in a given year. In the analysis FDA explained that the main costs of administrative detention are from the potential loss of the value of products detained that are not in fact adulterated. Although FDA did not know the fraction of detained food products that would prove not to be adulterated, FDA used 48 percent as an upper bound. This number represents the fraction of imported foods that we detain and later release. The lower bound used was 0 percent because FDA might only administratively detain adulterated food products. The total annual costs for the 2004 final rule were estimated to be between $0, if FDA never orders administrative detention, and $50 million, if FDA orders administrative detention against food products 48 percent of which are later determined not to be adulterated.

Since the Agency has had administrative detention authority, we have never administratively detained an article of food. Under the new criteria, we believe that we are more likely to use administrative detention against articles of food in situations which include, among others, where the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. These situations are analogous to the situations for ordering Class II recalls. FDA may choose to order administrative detention in a variety of situations, including Class II situations, therefore FDA has used the number of Class II recalls to estimate the costs and benefits of this interim final rule. Chart 1 below shows the number of Class II food recall actions reported in the last 14 years ranging from 65 to 195 (annual average of 160).

To the extent that the changes made by this interim final rule provide FDA enhanced enforcement abilities in addition to other existing enforcement tools, the maximum number of times we can reasonably expect to order administrative detention in situations involving an article of food that meets the criteria for Class II recalls is bounded by the highest known number of times we have ordered a Class II recall. The highest number of Class II recall events in the last 14 years was 195 and the lowest number was 65. However, it is still possible that we may not use administrative detention in the event of a Class II recall situation. Therefore we estimate that the number of times we are likely to order administrative detention could range between 0 and 195 times per year. Although the 2004 cost estimates were based on the expectation that FDA would use administrative detention no more than 223 times per year, FDA has not used administrative detention as an enforcement tool. The upper bound cost in the 2004 analysis was over estimated and given our present knowledge, we believe it is still likely to be an overestimate. By changing the criteria under which we can order administrative detention, we further reason that FDA will be more likely to order administrative detention a number of times greater than 0 but less than 195 times during any given year. We reason that any new potential costs attributable to this interim final rule are likely to be somewhat less than the upper bound costs previously estimated in the 2004 analysis, which were $50 million.

The benefits of using administrative detention as a new enforcement tool were discussed in the Economic Impact Analysis of the 2004 final rule (68 FR 31660 at 31685) but were not definitively quantified because it was difficult to directly estimate how often FDA would order administrative detention of food. The primary benefits of administrative detention as described in the 2004 analysis are the value of the illnesses or deaths prevented because the Agency administratively detained food suspected of being adulterated. These benefits are generated if the following two conditions hold: (1) The food is in fact adulterated and (2) administrative detention prevents more illnesses or deaths than would have been prevented had we relied on our other enforcement tools. The more often these conditions hold, and the larger the amount of adulterated food administratively detained, the larger the estimated benefits of the final rule. The 2004 final rule analysis also discussed that additional benefits may be achieved in terms of deterrence to the extent that as the number of ordered administrative detentions increases so does the likelihood that adulterated products will not be shipped in the future. As described in the 2004 final rule, the expected benefits from new administrative detention authority depend upon FDA using administrative detention as an enforcement tool. Likewise, the expected benefits from this interim rule also depend on FDA using this authority. As mentioned in the cost analysis section, under the new criteria, FDA may choose to order administrative detention in a variety of situations, including Class II situations. We also reasoned that the expected number of future administrative detentions could increase as much as the number of Class II situations per year, which could be as many as 195. Either way, if FDA orders administrative detention 195 times in one year, the expected upper bound benefits are likely to be somewhat less than those described in the 2004 analysis as a result. At the same time, it is still possible that FDA will not use administrative detention as an enforcement tool in all of these situations, in which case the benefits would likely be 0 which is the same lower bound for benefits described in the 2004 analysis.

FDA examined the economic implications of this interim final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a rule has a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act requires us to analyze regulatory options that would lessen the economic effect of the rule on small entities.

The Regulatory Flexibility Act requires analyzing options for regulatory relief for small businesses. FDA finds that this interim final rule is not a significant regulatory action as defined by Executive Order 12866. In compliance with the Regulatory Flexibility Act this interim final rule will not have a significant impact on a substantial number of small businesses.

FDA concludes that the requirements of this interim final rule are not subject to review by the Office of Management and Budget because they do not constitute a “collection of information” under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3220).

The Agency has carefully considered the potential environmental effects of this action. FDA has concluded 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 requirements in this interim final rule will be in effect July 3, 2011. FDA invites public comment on this interim final rule and will consider modifications to it based on comments made during the comment period. Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 1 is amended as follows:

Each year about 48 million people (1 in 6 Americans) are sickened, 128,000 are hospitalized, and 3,000 die from food borne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable.

The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), signed into law by President Obama on January 4, 2011, enables FDA to better protect public health by helping to ensure the safety and security of the food supply. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides FDA with new enforcement authorities to help it achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur. The law also gives FDA important new tools to better ensure the safety of imported foods and directs FDA to build an integrated national food safety system in partnership with State and local authorities.

Section 304 of FSMA amends section 801(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381(m)) to require that additional information be provided in a prior notice of imported food submitted to FDA. This change requires a person submitting prior notice of imported food, including food for animals, to report, in addition to other information already required, “any country to which the article has been refused entry.” Section 304 of FSMA also requires the Secretary of Health and Human Services to issue an interim final rule implementing this statutory change no later than 120 days following the date of enactment of the legislation and provides that the amendment made by section 304 of FSMA takes effect 180 days after the date of enactment, which is July 3, 2011.

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) was signed into law on June 12, 2002. Among other things, the Bioterrorism Act amended the FD&C Act by adding section 801(m). This provision created the requirement that FDA receive certain information about imported foods before arrival in the United States. It also provided that an article of food imported or offered for import is subject to refusal of admission into the United States if adequate prior notice has not been provided to FDA. The Secretary of Health and Human Services was directed to issue implementing regulations, after consultation with the Secretary of the Treasury, by December 12, 2003, requiring prior notice of imported food.

In accordance with the Bioterrorism Act, the Department of Health and Human Services (HHS) and the Department of the Treasury jointly published a notice of proposed rulemaking (proposed rule) in the Federal Register of February 3, 2003 (68 FR 5428), proposing requirements for submission of prior notice for human and animal food that is imported or offered for import into the United States. On October 10, 2003, HHS and the Department of Homeland Security (DHS)  1 issued the prior notice interim final rule (2003 IFR) (68 FR 58974) (corrected by a technical amendment on February 2, 2004; 69 FR 4851). The 2003 IFR required that prior notice be submitted to FDA electronically using either the U.S. Customs and Border Protection (CBP) Automated Broker Interface (ABI) of the Automated Commercial System (ACS) or the FDA Prior Notice System Interface (PNSI). The 2003 IFR also set forth the timeframes within which prior notice must be submitted.

In the Federal Register of November 7, 2008 (73 FR 66294), HHS and DHS published a final rule that made a number of changes to the 2003 IFR, including changes to certain provisions containing definitions, submission timeframes, and the information that must be submitted in a prior notice. The final rule went into effect on May 6, 2009. In calendar year 2010, 10,116,018 prior notices were submitted, 8,570,497 of which were submitted through the CBP system with the remaining 1,545,521 being submitted through the FDA system.

The prior notice regulations are codified at Title 21, Code of Federal Regulations (CFR) part 1, subpart I (21 CFR 1.276 to 1.285). Section 1.281 of the regulations describes the information that must be submitted in a prior notice. This interim final rule amends those regulations as required by section 304 of FSMA. Specifically, the interim final rule is amending paragraphs (a), (b), and (c) of § 1.281 to require that the prior notice include the identity of any country to which an article of food has been refused entry.

FDA has examined the impacts of this interim final rule under Executive Orders 12866 and 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). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. OMB has determined that this is a significant regulatory action as defined by the Executive Orders.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the costs per entity of this rule are small, the Agency also concludes that this 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 (Pub. L. 104-4) 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 $135 million, using the most current (2009) 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.

The Economic Impact Analysis of the 2008 Final Rule: (1) Responded to comments received on the economic analysis of the 2003 IFR, (2) revised the analysis set forth in the 2003 IFR using new data, (3) presented an economic analysis of the leading alternative to the 2003 IFR using new data, and (4) explained the marginal benefits and costs of the final rule itself, relative to the 2003 IFR.

This Economic Impact Analysis further revises the analysis set forth in the 2008 final rule by addressing the economic impact of the new statutory requirement in FSMA.

Section 304 of FSMA requires a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry. Requiring notice of prior refusals allows FDA to better identify imported food shipments that may pose safety and security risks to U.S. consumers. This additional knowledge can further help FDA to make better informed decisions in managing the potential risks of imported food shipments into the United States. This interim final rule implements section 304 of FSMA by amending the rule that is already in effect.

In the 2003 IFR (68 FR 58974 at 59027), FDA estimated that it takes 1 hour on average to submit the prior notices for each import entry, and this estimate was not revised for the 2008 final rule. In the final rule (73 FR 66294 at 66386), FDA estimated that, on average, one import entry includes 3.6 distinct food articles or lines and thus requires 3.6 prior notices per import entry. For the final rule the estimated cost of submitting prior notice was $75 per entry assuming 3.6 lines per entry. This estimate includes 45 minutes of an administrative worker's time to gather information to initially complete the prior notice, and then 15 minutes of a manager's time to verify that the information is correct.

Additional costs associated with implementing changes in this interim final rule will be borne by all persons who submit prior notice for an article of food that is imported or offered for import into the United States. These costs are estimated as the additional time it will take for a person to gather and verify the information about whether the article was refused entry and to enter the information into an electronic system. To the extent that the information is readily available and verifiable, we reason that it could take as few as 7 seconds to as many as 108 seconds per entry to do this. In 2010, FDA received 10,116,018 prior notices. In the 2008 economic analysis, FDA estimated an average of 3.6 prior notices (lines) per entry. For purposes of this analysis we consider 3.6 to be a likely approximation of the current number of lines per entry. By dividing the number of prior notices by the 3.6 lines per entry we estimate that there are currently 2.8 million imported food entries (10,116,018 divided by 3.6). By multiplying the number of entries by the additional seconds, we estimate the additional number of hours to provide the additional information for all prior notice submitters to be an average of about 45,000 hours per year. Table 1 of this document shows the possible additional time ranges that submitters may need in order to comply with this interim final rule. The economic impact analysis of the 2008 final rule estimated that the prior notice submissions for some entries (3.6 prior notices per entry) can take more than 1 hour to complete and others may take less than 1 hour. The amount of time needed to complete the submission for an entry can reasonably vary by several minutes. As seen in table 1 of this document, the additional average time of 58 seconds required to provide this information is estimated as the average of 7 and 108 seconds per entry. Since the additional time required to provide the new information is a small fraction of the variation in time it can take to complete the prior notice for an entry, the marginal cost for the additional 58 seconds (on average) that it would take to provide the additional information would be negligible.

FDA's prior notice system provides us with enhanced knowledge of what articles of food are being imported or offered for import into the United States. Requiring prior notice of imported food shipments and defining the required data improves our ability to detect accidental and deliberate contamination of food and to deter deliberate contamination.

Before prior notice was required, FDA received almost no advance notice information about food products entering the United States from foreign sources, or the location of the food's anticipated port of arrival. With the information required by prior notice, FDA does know what articles of food are being imported or offered for import before they arrive at the port. In the event of a credible threat for a specific product or a specific manufacturer or processor, for example, FDA will be able to mobilize and assist in the detention and removal of products that may pose a serious health threat to humans or animals.

FDA's Prior Notice Center reviews prior notices and assesses the risk related to imported food shipments. FDA will be able to use the additional information from this interim final rule to better identify imported food shipments that may pose a safety or security risk to U.S. consumers. Personnel at the Prior Notice Center decide on a case-by-case basis whether the article of food needs to be held for examination upon arrival at the port. Having notice of an article of food imported or offered for import into the United States before it reaches a U.S. port allows FDA personnel to be ready at any time to respond to shipments that appear to pose a significant health risk to humans or animals.

FDA examined the economic implications of this interim final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a rule has a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act requires us to analyze regulatory options that would lessen the economic effect of the rule on small entities.

The Regulatory Flexibility Act requires analyzing options for regulatory relief for small businesses. Because the compliance costs are negligible, FDA finds that this interim final rule is not a significant regulatory action as defined by Executive Order 12866. In compliance with the Regulatory Flexibility Act this interim final rule will not have a significant impact on a substantial number of small businesses.

This interim final rule contains information collection requirements 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 these requirements are shown below with an estimate of the annual reporting 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.

FDA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Title: Information Required in Prior Notice of Imported Food.

Description: FDA is issuing regulations to require a person submitting prior notice of imported food, including food for animals, to report, in addition to other information already required, “any country to which the article has been refused entry.” Persons submitting prior notice will gather and verify information about whether the article was refused entry to any country and enter the information into an electronic system.

Description of Respondents: All persons who submit prior notice for an article of food that is imported or offered for import into the United States. FDA estimated that in 2010 there were about 129,757 prior notice submitters.

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

The number of annual responses is equivalent to the annual number of entries that are submitted. In 2010, FDA received 10,116,018 prior notices. By dividing the number of prior notices by the average number of lines per entry, we estimate 2.8 million entries. By further dividing the number of entries by the number of respondents, we estimate the average annual frequency per response to be 22. We estimate that it would take on average about 58 seconds (0.016 hours) for each respondent to submit the additional information as part of prior notice. By multiplying the number of entries by the additional 58 seconds, we estimate the total number of hours to provide the additional information to be an average of approximately 45,000 hours per year which also translates to about 20 minutes (0.35 hours) per year per respondent.

The information collection provisions for this interim final rule have been submitted to OMB for review as required by section 3507(d) of the Paperwork Reduction Act of 1995. The requirements were approved and assigned OMB control number 0910-0683. This approval expires April 30, 2014. 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.

Interested persons are requested to fax comments regarding information collection by June 6, 2011, to the Office of Information and Regulatory Affairs, OMB. To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the title, Information Required in Prior Notice of Imported Food.

The Agency has carefully considered the potential environmental effects of this action. FDA has concluded 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 requirements in this interim final rule will be in effect on July 3, 2011. FDA invites public comment on this interim final rule, and will consider modifications to it based on comments made during the comment period. Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 1 is amended as follows:

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the Coast Guard did not receive notice of the Blue Crab Festival Fireworks Display with sufficient time to publish an NPRM and to receive public comments prior to the event. Any delay in the effective date of this rule would be contrary to the public interest because immediate action is needed to minimize the potential danger to the public during the fireworks display.

For the same reason discussed above, under 5 U.S.C. 553(d)(3) the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . The Coast Guard will issue a Local Notice to Mariners and Broadcast Notice to Mariners to advise mariners of the restriction.

On May 13, 2011, The Little River Blue Crab Festival Inc., in partnership with Zambelli Fireworks Manufacturing Co., will be conducting a fireworks display in Little River, South Carolina as part of the 30th Annual Blue Crab Festival. The fireworks will explode over the waters of Little River. The fireworks display is scheduled to commence at 9:30 p.m. and conclude at 9:45 p.m. This temporary safety zone is necessary to protect the public from the hazards associated with the launching of fireworks over navigable waters of the United States.

The safety zone encompasses certain waters of Little River in Little River, South Carolina. The safety zone will be enforced from 9 p.m. until 10:30 p.m. on May 13, 2011. The safety zone will be enforced from 9 p.m., 30 minutes prior to the scheduled commencement of the fireworks display at approximately 9:30 p.m., to ensure the safety zone is clear of persons and vessels. Enforcement of the safety zone will cease at 10:30 p.m., 45 minutes after the scheduled conclusion of the fireworks display, to account for possible delays.

Persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the safety zone unless authorized by the Captain of the Port Charleston or a designated representative. Persons and vessels desiring to enter, transit through, anchor in, or remain within the safety zone may contact the Captain of the Port Charleston via telephone at 843-740-7050, or a designated representative via VHF radio on channel 16, to seek authorization. The Coast Guard will provide notice of the safety zone by Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives.

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

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.

The economic impact of this rule is not significant for the following reasons: (1) The rule will be enforced for only one and a half hours; (2) vessel traffic in the area is expected to be minimal during the enforcement period; (3) although persons and vessels will not be able to enter, transit through, anchor in, or remain within the safety zone without authorization from the Captain of the Port Charleston or a designated representative, they may operate in the surrounding area during the enforcement period; (4) persons and vessels may still enter, transit through, anchor in, or remain within the safety zone if authorized by the Captain of the Port Charleston or a designated representative; and (5) the Coast Guard will provide advance notification of the safety zone to the local maritime community by Local Notice to Mariners and Broadcast Notice to Mariners.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule may affect the following entities, some of which may be small entities: The owners or operators of vessels intending to enter, transit through, anchor in, or remain within that portion of Little River encompassed within the safety zone from 9 p.m. until 10:30 p.m. on May 13, 2011. For the reasons discussed in the Executive Order 12866 and Executive Order 13563 section above, this rule will not have a significant economic impact on a substantial number of small entities.

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

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

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

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

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

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

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

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

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

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

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

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction. This rule involves establishing a temporary safety zone to protect the public on the waters of Little River that will be enforced for a total of one and a half hours. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under ADDRESSES .

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

On November 6, 2009, we published a Notice of Proposed Rulemaking (NPRM) entitled Safety Zone; Coast Guard Use of Force Training Exercises, San Pablo Bay, CA in the Federal Register (74 FR 214). We received four comments on the proposed rule from the San Francisco Bay Conservation and Development Commission (BCDC), Audubon California, Beth Huning, and San Francisco Joint Venture. No public meetings were requested or held as part of this rulemaking.

The U.S. Coast Guard will establish a safety zone in the navigable waters of the San Pablo Bay, California that will apply to the navigable waters encompassing an area beginning at position 38°01′44″ N, 122°27′06″ W; 38°04′36″ N, 122°22′06″ W; 38°00′35″ N, 122°26′07″ W; 38°03′00″ N, 122°20′20″ W (NAD 83) and back to the starting point. U.S. Coast Guard Maritime Safety and Security Team (MSST) San Francisco, U.S. Coast Guard Air Station San Francisco, and various Coast Guard small boat stations will be conducting Use of Force training runs in the waters of San Pablo Bay. The exercises are designed to train and test Coast Guard personnel in the decision-making processes necessary to safely and effectively employ Use of Force from a small boat or helicopter during Homeland Security operations. The training will generally involve the use of several Coast Guard small boats and/or a helicopter to intercept fast-moving, evasive target vessels on the water. The small boat and helicopter crews will fire weapons at the target vessels using blank ammunition and catch bags to ensure that cartridges and other debris do not fall to the water. This safety zone is issued to establish a restricted area in San Pablo Bay around the training site.

The CG's primary missions include homeland security, search and rescue, and drug and environmental enforcement, and it is in the public interest for CG personnel to be trained and ready to serve the public at all times. Among the homeland security missions is port security training to develop the tactical qualifications and expertise necessary to fulfill this mission requirement. The small boats that conduct port security operations throughout San Francisco Bay are unable to conduct such training offshore due to conditions that often exceed the assets' operational parameters, frequent visibility restrictions, and unsuitability for the offshore environment. The San Pablo Bay safety zone provides an ideal location for the Coast Guard to conduct Use of Force training since it is at least 1.5 miles away from shore as well as a safe distance from shipping lanes, wildlife refuges, water trails and access points.

The CG conducted Use of Force training at this very same location in San Pablo Bay on average twice a month in 2009. The training went on as planned, without incidents or interference with public access, except for one occasion where the CG rescheduled one of its training sessions to avoid potential interference with a San Francisco Flyway Festival bird-watching group.

On July 29, 2009, the CG sent an email to various potentially interested parties including BCDC informing those parties of our intention to prepare a Notice of Proposed Rulemaking and a Categorical Exclusion Determination under NEPA for the establishment of a safety zone for Use of Force training in San Pablo Bay. In January 2010, in a letter to the CG, the San Francisco Bay Conservation and Development Commission raised concerns about the possible “effect on both motorized and non-motorized recreational boat traffic, and on wildlife habitat that San Francisco Bay supports, especially the habitat of both migratory and non-migratory waterfowl as well as that of the wide variety of fish species” and requested the CG prepare a Consistency Determination or Negative Determination. In December and January, the CG received comments from the San Francisco Bay Joint Venture and Audubon California that addressed possible disturbances to waterfowl and referenced a study by the USGS confirming foraging areas in San Pablo Bay are used by diving ducks. In the Consistency Determination, the USGS was contacted and determined that the proposed area is too deep to affect any shorebirds. Additionally, a response from FWS reveals that the proposed safety zone is not expected to have any impacts on any of the endangered species in the San Pablo Bay that are under the jurisdiction of the FWS.

In December 2010, the CG completed and sent the Consistency Determination to BCDC that determined the proposed safety zone and AUF training in San Pablo Bay is consistent to the maximum extent practicable with the enforceable policies of BCDC's San Francisco Bay Plan. BCDC concurred with this determination in December 2010 and determined it was “complete” and acceptable.

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

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

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

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

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

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

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

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

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

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

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

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

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

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

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction. The rule involves establishing a safety zone. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under ADDRESSES .

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

This final rule reflects the Centers for Medicare and Medicaid Services' commitment to the general principles of the President's Executive Order released January 18, 2011, entitled “Improving Regulation and Regulatory Review.” The rule revises the conditions of participation (CoPs) for both hospitals and critical access hospitals (CAHs) to: (1) Make current Federal requirements more flexible for rural and/or small hospitals and for CAHs; and (2) encourage innovative approaches to patient-service delivery.

CMS regulations currently require a hospital to have a credentialing and privileging process for all physicians and practitioners providing services to its patients. The regulations require a hospital's governing body to appoint all practitioners to its hospital medical staff and to grant privileges using the recommendations of its medical staff. In turn, the hospital medical staff must use a credentialing and privileging process, provided for in CMS regulations, to make its recommendations. CMS requirements do not take into account those practitioners providing only telemedicine services to patients. Consequently, hospitals apply the credentialing and privileging requirements as if all practitioners were onsite. This traditional and limited approach fails to embrace new methods and technologies for service delivery that may improve patient access to high quality care.

This final rule will permit hospitals and CAHs to implement a new credentialing and privileging process for physicians and practitioners providing telemedicine services. The removal of unnecessary barriers to the use of telemedicine may enable patients to receive medically necessary interventions in a more timely manner. It may enhance patient follow-up in the management of chronic disease conditions. These revisions will provide more flexibility to small hospitals and CAHs in rural areas and regions with a limited supply of primary care and specialized providers. In certain instances, telemedicine may be a cost-effective alternative to traditional service delivery approaches and, most importantly, may improve patient outcomes and satisfaction.

As noted above, the current Medicare Hospital conditions of participation (CoPs) for credentialing and privileging of medical staff at 42 CFR § 482.12(a)(2) and § 482.22(a)(2) require the governing body of the hospital to make all privileging decisions based upon the recommendations of its medical staff after the medical staff has thoroughly examined and verified the credentials of practitioners applying for privileges, and after the staff has applied specific criteria to determine whether an individual practitioner should be privileged at the hospital. The current critical access hospital (CAH) CoPs at 42 CFR 485.616(b) similarly require every CAH that is a member of a rural health network to have an agreement for review of physicians and practitioners seeking privileges at the CAH. The agreement must be with a hospital that is a member of the network, a Medicare Quality Improvement Organization (QIO), or another qualified entity identified in the State's rural health plan. In addition, the services provided by each doctor of medicine or osteopathy at the CAH must be evaluated by one of these same three types of outside parties. These requirements apply to all physicians and practitioners seeking privileges at the hospital or CAH, respectively, regardless of whether services will be provided in person and onsite at the hospital or CAH, or remotely through a telecommunications system.

While hospitals may use third-party credentialing verification organizations to compile and verify the credentials of practitioners applying for privileges, the hospital's governing body is still legally responsible for all privileging decisions. Similarly, each CAH is required to have its privileging decisions made by either its governing body or the person responsible for the CAH.

In the past, hospitals that were accredited by The Joint Commission (TJC) were deemed to have met the Medicare CoPs, including the credentialing and privileging requirements, under TJC's statutory deeming authority. Section 125 of the Medicare Improvements for Patients and Providers Act of 2008 (Pub. L. 110-275, July 15, 2008) (MIPPA), terminated the statutory recognition of TJC's hospital accreditation program, effective July 15, 2010. The law now requires TJC to secure CMS approval of its standards in order to confer Medicare deemed status on hospitals.

Under its previous statutory deeming authority, TJC has permitted “privileging by proxy,” which had allowed TJC-accredited hospitals to privilege “distant-site” (as that term is defined at section 1834(m)(4)(A) of the Social Security Act (the Act)) physicians and practitioners. TJC privileging by proxy standards allowed for one TJC-accredited facility to accept the privileging decisions of another TJC-accredited facility utilizing a streamlined independent determination process, rather than making an individualized decision based on the practitioner's credentials and record. Even though they were TJC-accredited, hospitals that have used this method to privilege distant-site medical staff technically did not meet the CMS requirements that applied to other hospitals. When we learned of specific instances of such noncompliance through on-site validation surveys by State survey agencies, the hospital was required to change its policies to come into compliance. However, the majority of Joint Commission-accredited hospitals were not routinely subjected to validation surveys of their privileging practices, and it appears that many of them were employing the practices permitted by The Joint Commission.

With the loss of statutory status for its hospital accreditation program, The Joint Commission is now required to conform its accreditation program to the Medicare requirements, including the provisions governing credentialing and privileging, and enforce it accordingly in all of its accredited hospitals.

TJC-accredited hospitals, therefore, have been concerned that they may be unable to meet the long-standing CMS privileging requirements while sustaining their current telemedicine agreements. Small hospital medical staffs, in particular, are concerned about the burden of privileging hundreds of specialty physicians and practitioners that large academic medical centers make available to them. Because of the complexity of the issues, and to minimize disruption to accredited hospitals and CAHs, we decided to allow additional time for The Joint Commission to ensure conformity to the Medicare Conditions of Participation (CoPs). Accordingly, we notified TJC that we would expect implementation of its new accreditation standards no later than the effective date of this final rule.

Upon reflection, we came to the conclusion that our present requirement is a duplicative and burdensome process for physicians, practitioners, and the hospitals involved in this process, particularly small hospitals and CAHs, which often lack adequate resources to fully carry out the traditional credentialing and privileging process for all of the physicians and practitioners that may be available to provide telemedicine services. In addition to the costs involved, small hospitals and CAHs often do not have in-house medical staff with the clinical expertise to adequately evaluate and privilege the wide range of specialty physicians that larger hospitals can provide through telemedicine services. The public comments we received on the proposed rule, which we discuss in this final rule, overwhelmingly reinforced this perception.

We published a proposed rule in the Federal Register on May 26, 2010 (75 FR 29479). In that rule, we proposed to revise both the hospital and CAH credentialing and privileging requirements to eliminate regulatory impediments and to allow for the advancement of telemedicine nationwide.

While telemedicine is included under the broader scope of telehealth, we consider telemedicine, as the term is used in the proposed rule and as we use it here in this final rule, to be the provision of clinical services to patients by practitioners from a distance via electronic communications. The distant-site telemedicine physician or practitioner provides clinical services to the hospital or CAH patient either simultaneously, as is often the case with teleICU services, for example, or non-simultaneously, as may be the case with many teleradiology services. “Simultaneously” would mean that the clinical services (for example, assessment of the patient with a clinical plan for treatment, including any medical orders needed) are provided to the patient in “real time” by the telemedicine practitioner, similar to the actions of an on-site practitioner when called in by a patient's attending physician to see the patient. Generally, payment for telehealth services under section 1834(m) of the Act, distinguished from “telemedicine services” as discussed here, requires that services be provided to a patient in real time while the patient is physically present at the originating site. “Non-simultaneously” means that while the telemedicine practitioner still provides clinical services to the patient upon a formal request from the patient's attending physician, such services may involve after-the-fact interpretation of diagnostic tests in order to provide an assessment of the patient's condition and do not necessarily require the telemedicine practitioner to directly assess the patient in “real time.” This would be similar to the services provided by an on-site radiologist who interprets a patient's x-ray or CT scan and then communicates his or her assessment to the patient's attending physician who then bases his or her diagnosis and treatment plan on these findings. In fact, the actual location (distant-site versus on-site) of the radiologist performing the readings is often the major distinguishing factor between in-house radiologists and teleradiologists. These services are not payable as “telehealth services” under section 1834(m) of the Act because in addition to not meeting the “real time” requirements, these services do not meet the telehealth patient location requirements also contained under this section of the Act and upon which the CMS telehealth payment requirements are based.

We also indicated that the proposed revisions would preserve and strengthen the core values of the credentialing and privileging process for all hospitals, provide accountability to all patients, and assure that medical staff are privileged to provide services in the hospital based on evaluation of the practitioner's medical competency.

We provided a 60-day public comment period in which we received a total of 113 timely comments from hospitals, CAHs, physicians, professional organizations, providers of teleradiology interpretation services, other specialty practitioners providing telemedicine services, and hospital systems. Overall, the majority of commenters were supportive of the proposed changes, but many also raised several separate issues. The most common comment expressed was that the proposed regulation did not go far enough in restructuring privileging and credentialing requirements for telemedicine providers. Summaries of the major issues and our responses are set forth below.

The proposed revisions to the hospital CoPs for the credentialing and privileging of telemedicine physicians and practitioners are contained within two separate CoPs: § 482.12, “Governing body,” and § 482.22, “Medical staff.”

For the Governing body CoP, we proposed to add a new paragraph, § 482.12(a)(8), which would require the hospital's governing body to ensure that, when telemedicine services are furnished to the hospital's patients through an agreement with a Medicare-participating hospital (the “distant-site” hospital as defined at section 1834(m)(4)(A) of the Act), the agreement must specify that it is the responsibility of the governing body of the distant-site hospital providing the telemedicine services to meet the existing requirements in § 482.12(a)(1) through (a)(7) with regard to its physicians and practitioners who are providing telemedicine services. These existing provisions cover the distant-site hospital's governing body responsibilities for its medical staff that all Medicare-participating hospitals must meet.

We proposed at § 482.12(a)(8) to allow the governing body of the hospital whose patients are receiving the telemedicine services to grant privileges based on its medical staff recommendations, which would rely on information provided by the distant-site hospital, as a more efficient means of privileging the individual distant-site physicians and practitioners providing the services.

This provision would be accompanied by the proposed requirement in the “Medical staff” CoP at § 482.22(a)(3), which would provide the basis on which the hospital's governing body, through its agreement as noted above, could choose to have its medical staff rely upon information furnished by the distant-site hospital when making recommendations on privileges for the individual physicians and practitioners providing such services. We specified that this option would allow the hospital's medical staff to rely upon the credentialing and privileging decisions of the distant-site hospital in lieu of the current requirements at § 482.22(a)(1) and (a)(2), which require the hospital's medical staff to conduct individual appraisals of its members and examine the credentials of each candidate in order to make a privileging recommendation to the governing body. In the proposed rule, we stated that this option would not prohibit a hospital's medical staff from continuing to perform its own periodic appraisals of telemedicine members of its staff, nor would it bar them from continuing to use the traditional credentialing and privileging process required under the current regulations. Our intent of this proposed requirement was to relieve burden for smaller hospitals by providing for a less duplicative and more efficient privileging scheme with regard to physicians and practitioners providing telemedicine services.

However, in an effort to ensure accountability to the process, we proposed within this same provision (§ 482.22(a)(3)) that the hospital, in order to choose this less burdensome option for privileging, would have to ensure that—(1) The distant-site hospital providing the telemedicine services was another Medicare-participating hospital; (2) the individual distant-site physician or practitioner was privileged at the distant-site hospital providing telemedicine services, and that this distant-site hospital provides a current list of the physician's or practitioner's privileges; (3) the individual distant-site physician or practitioner held a license issued or recognized by the State in which the hospital whose patients are receiving the telemedicine services is located; and (4) with respect to a distant-site physician or practitioner granted privileges by the hospital, the originating-site hospital had evidence of an internal review of the distant-site physician's or practitioner's performance under these telemedicine privileges and sent the distant-site hospital this information for use in its periodic appraisal of the individual distant-site physician or practitioner. We also proposed that the information sent for use in the periodic appraisal would, at a minimum, have to include all adverse events that did result or could have resulted from telemedicine services provided by the distant-site physician or practitioner to the originating hospital's patients, and all complaints the originating site hospital had received about the distant-site physician or practitioner.

Within the revisions to the hospital CoPs, we also proposed that additional language be added to the current requirement at § 482.22(c)(6), which requires that the hospital's medical staff bylaws include criteria for determining privileges and a procedure for applying the criteria to individuals requesting privileges. We proposed to add language to stipulate that in cases where distant-site physicians and practitioners were requesting privileges to furnish telemedicine services through an agreement between hospitals, the criteria for determining those privileges and the procedure for applying the criteria would be subject to the proposed requirements at § 482.12(a)(8) and § 482.22(a)(3).

Comment: We received several comments that are outside the scope of this rule. Specifically, several commenters requested that we consider establishing a central credentialing bank that would provide overall clearance for telemedicine services, possibly through regional compacts or reciprocity agreements. A number of commenters recommended that all TJC-accredited facilities (including hospitals) be able to share credentialing. A few commenters suggested that we establish a national licensing process for physicians and other practitioners in order to ease the burden associated with credentialing and privileging.

Response: We thank all commenters for their comments, but are not responding to these comments here because they are outside the scope of this rulemaking.

Comment: The majority of commenters supported the changes proposed. However, most of these commenters felt that the revisions to the CoPs did not go far enough in addressing the burdens borne by those small hospitals and CAHs that, through agreements and/or contracts, use the telemedicine services of practitioners who are not part of the medical staff of a Medicare-participating hospital. The commenters pointed out that, under the proposed requirements, small hospitals and CAHs would still be required to perform the duplicative and burdensome process of credentialing and privileging practitioners that provide telemedicine services through a distant-site telemedicine entity that is not a hospital.

Several commenters provided examples of simultaneous and non-simultaneous telemedicine services, such as teleradiology, teleICU, teleneurology, and telepathology, where distant-site physicians and practitioners provide radiology, ICU/critical care medicine, neurology, and pathology services to hospital and CAH patients under the auspices of a non-hospital entity that is nationally accredited as having met a national accreditation organization's (AO) standards for credentialing and privileging of medical staff (in addition to other standards established by the national AO). Many commenters specifically mentioned the TJC's Ambulatory Care accreditation program, which surveys and accredits nearly 2,000 ambulatory care entities (of which these non-hospital telemedicine entities, along with ambulatory surgery centers, imaging centers, and dentist offices, are included) out of approximately 30,500 ambulatory care entities nationwide. Commenters suggested that CMS include these telemedicine entities in the requirements so that small hospitals and CAHs would be able to enter into agreements with them.

Many commenters stated that including the medical staff of these distant-site telemedicine entities as part of an optional and streamlined credentialing and privileging process, as we have already proposed for distant-site Medicare-participating hospitals, would increase the overall effectiveness of this rule. They posited that if the goals of this rule were to greatly improve patient care by increasing patient access to specialty services and reduce the burdens and costs for hospitals and CAHs by removing the impediment of the traditional credentialing and privileging process, then excluding distant-site telemedicine entities would severely limit such goals. In addition, commenters stated that telemedicine practitioners are part of a growing national network that is supported by both hospitals and non-hospital telemedicine entities.

Response: We appreciate the comments supporting the rule as well as the suggestions for improving the rule. When drafting the proposed rule, we gave much thought and consideration to ideas that were similar to those that commenters have expressed regarding the inclusion of non-hospital telemedicine entities as part of these requirements. After careful consideration of the comments and the options available to us for revising the proposed rule, we have concluded that it is important that the medical staff of a distant-site telemedicine entity, which is not a Medicare-participating hospital, be included in an optional and streamlined credentialing and privileging process for those hospitals and CAHs electing to enter into agreements for telemedicine services with such entities. We believe that this inclusion would draw us significantly closer to accomplishing the stated goals of this rule, which are—(1) Increasing patient access to specialty services; and (2) reducing burden on small hospitals and CAHs.

However, this decision presented significant challenges to us as we sought to balance our desire to achieve the worthy goals noted above with the equally important mission of ensuring, through our regulatory authority and responsibility, the health and safety of all patients. As we contemplated revisions to the proposed rule that would broaden its application, the most significant challenge that we faced was reconciling inclusion of distant-site telemedicine entities into this new streamlined process without CMS having any regulatory or oversight authority over these entities. We also note that we do not have any oversight or approval process for accreditation programs (such as that of TJC) for these entities. This situation differs greatly from our proposed inclusion of other Medicare-participating hospitals, where we are assured through the State survey or Medicare-approved accreditation processes that distant-site hospitals providing telemedicine services are in compliance with our CoPs, particularly those pertaining to credentialing and privileging of medical staff.

In addition, we note that there is no statutory definition for a telemedicine entity contained in the Act. Therefore, for the purposes of this rule, we are defining a distant-site telemedicine entity as one that—(1) Provides telemedicine services; (2) is not a Medicare-participating hospital (therefore, a non-Medicare-participating hospital that provides telemedicine services would be considered a distant-site telemedicine entity also); and (3) provides contracted services in a manner that enables a hospital or CAH using its services to meet all applicable CoPs, particularly those requirements related to the credentialing and privileging of practitioners providing telemedicine services to the patients of a hospital or CAH.

Taking all of these factors into consideration, we came to the conclusion that any revisions to the regulatory language finalized here would need to hold distant-site telemedicine entities accountable to the originating-site hospital for meeting CMS practitioner credentialing and privileging standards. Likewise, hospitals and CAHs using telemedicine services will need to provide, upon request when surveyed, the most current telemedicine services agreement showing that the distant-site entities providing the services are required to comply with the CMS standards (even though CMS has no direct authority over those entities) in order for the hospital or CAH to make use of the more streamlined process when credentialing and privileging practitioners from these distant-site telemedicine entities. Similar to our regulations proposed for hospitals and CAHs using the telemedicine services of distant-site Medicare-participating hospitals, the written agreement between the hospital or CAH and the distant-site telemedicine entity will be the foundation for ensuring accountability on both sides. However, due to the differences already discussed between Medicare-participating distant-site hospitals providing telemedicine services and distant-site telemedicine entities providing similar services, there must also be differences in the way the regulations are written.

Therefore, in addition to the proposed requirements, we are also finalizing new provisions that will apply to the credentialing and privileging process and the agreements between hospitals or CAHs and distant-site telemedicine entities (§ 482.12(a)(9) and § 482.22(a)(4) for hospitals; § 485.616(c)(3) and (c)(4) for CAHs). These new provisions will require the governing body of the hospital (or the CAH's governing body or responsible individual), through its written agreement with the distant-site telemedicine entity, to ensure that the distant-site telemedicine entity, acting as a contractor of services, furnishes its services in a manner that enables the hospital (or CAH) to comply with all applicable conditions of participation and standards. For the contracted services, the applicable CoPs and standards include, but are not limited to, the credentialing and privileging requirements for distant-site physicians and practitioners providing telemedicine services.

For hospitals, we have directly linked this new requirement to an existing requirement at § 482.12(e), which requires the hospital's governing body to ensure that a contractor of services to the hospital (in this case, the distant-site telemedicine entity) furnishes services that permit the hospital to comply with all applicable conditions of participation and standards for contracted services. The applicable conditions of participation and standards would include the credentialing and privileging requirements as currently found at § 482.12(a)(1) through (a)(7) of this section and would apply (in accordance with the hospital's policy) to the telemedicine entity's physicians and practitioners that provide telemedicine services to the hospital's patients.

For CAHs, we also linked these new requirements to an existing requirement (at § 485.635(c)(4)) that, like § 482.12(e) for hospitals, pertains to contactors of services and the CAH governing body's (or responsible individual's) obligation to ensure that contracted services are furnished in a manner that enables the CAH to meet all applicable conditions of participation and standards. The standard also contains a provision, at § 485.635(c)(1), that requires the CAH to have agreements or arrangements with one or more Medicare-participating providers or suppliers in order to furnish other services to its patients. We see the “Medicare-participating” modifying provision as an impediment to the type of agreements that CAHs may now have with distant-site telemedicine entities under this final rule. Since these entities are not considered Medicare-participating providers or suppliers by CMS, we needed to make an exception to the requirement at § 485.635(c)(1). Therefore, in this final rule, we are adding a new paragraph at § 485.635(c)(5) to provide an exception to this “Medicare-participating” requirement for telemedicine entities in cases where a written agreement exists between a CAH and such entity.

We believe that the combination of the new requirements, as finalized here, and the existing requirements cited above and in the final requirements, which place responsibility on hospitals and CAHs to ensure that contracted services fully enable them to meet the CoPs, will allow hospitals and CAHs to make full use of the telemedicine services offered by non-hospital telemedicine entities without duplicating the credentialing and privileging process. This final rule will now allow hospitals and CAHs to take advantage of these streamlined credentialing and privileging options when using the telemedicine services of other Medicare-participating hospitals, non-Medicare-participating telemedicine entities, or a combination of both types of service providers. And with these new requirements dually aimed at increasing patient access to care and reducing the regulatory burden on hospitals and CAHs, CMS believes that the potential of telemedicine can be more fully realized while still maintaining essential health and safety protections.

Comment: A number of commenters stated that practitioner-to-practitioner “tele-emergency” video communications should not require credentialing and privileging of the distant-site practitioner. Another commenter requested that CMS consider that full credentialing and privileging should not be required when telemedicine services are only consultative in nature. However, the commenter did not clarify what he or she meant by “consultative” services.

Response: Any time services are provided to a patient in a hospital or CAH, the requirements regarding the credentialing and privileging of the practitioners providing the services would apply, whether such practitioners were onsite or available to the patient through telemedicine services.

Regarding “consultative” services as mentioned by the commenter, it is important to distinguish between informal consultation among practitioners (traditionally known as a “curbside consult”), and the furnishing of professional consultation services, which would include providing medical diagnosis and treatment recommendations to patients after a formal request for such services by the practitioner responsible for patient's care. The CMS privileging requirements do not apply in instances where, for example, the attending physician of record seeks informal advice from another physician(s) by whatever communications media the physicians choose to use. The physician whose advice is being sought is not providing clinical services to the patient, but is merely rendering an informal opinion on the patients' condition to the patient's attending physician, who may or may not make use of the opinion when treating the patient. Such discussions between medical professionals occur on a routine basis in hospitals across the nation and do not require that the practitioners involved be privileged at the same hospital in order for this exchange of medical opinions to take place; in fact, we believe such communications may promote safer, more effective care for patients. Only the attending physician, who is providing clinical services to the patient, would need to be privileged by the hospital or CAH to provide such services. However, a formal consult provided by a specialty or other type of practitioner, where the hospital or CAH patient receives clinical services from the specialty practitioner after the patient's attending physician requests such services be provided (either simultaneously as is often the case with teleICU services, or non-simultaneously as may be the case with many teleradiology services), would require that the practitioner is privileged to do so at the hospital or CAH where the patient is located.

Comment: One commenter stated that to further reduce burden, we should consider a “contract” approach to credentialing and privileging for telemedicine services, particularly for consultations requested by referring providers. Some commenters stated that such agreements or contracts, which essentially allow for credentialing and privileging by proxy, leave hospitals vulnerable to legal liabilities and risks and, therefore, should be prohibited under this rule. Another commenter suggested that, with regard to legal risks and liabilities, mandatory language addressing these issues should be required within the written agreements between distant-site hospitals and the hospital or CAH where the patient receives the services.

Response: The requirements, as proposed, are aimed at reducing the telemedicine credentialing and privileging burden for small hospitals and CAHs by specifically allowing for contracts or, as we refer to them, “agreements,” between a distant-site hospital or telemedicine entity providing the telemedicine services and a hospital or CAH that uses these services for the benefit of its patients. In these agreements, it is the responsibility of the hospital or CAH using the services to ensure that the specifics of the proposed requirements in this rule are explicitly laid out before entering into such an arrangement. Along these lines, we have corrected an oversight in the proposed rule and have revised the requirements in this final rule to clarify that these agreements must be “written.” It has always been the intent of this rule to allow for hospitals and CAHs to have the option of credentialing and privileging the distant-site telemedicine practitioners using the traditional process. Hospitals and CAHs electing to use the traditional credentialing and privileging process must not be compelled by a distant-site telemedicine hospital (or distant-site telemedicine entity) to enter into an agreement that requires the use of the more streamlined approach as outlined here.

Regarding the legal risks and liabilities of such agreements, the governing body of each individual hospital and CAH must weigh the risks and benefits of opting for this more streamlined process of credentialing and privileging telemedicine practitioners. We understand that there are many complex legal issues, including issues of liability, inherent to contracts and agreements between institutions. However, we believe that these issues are beyond the scope of this rule, and that any relevant legal issues must be worked out between the parties entering into the agreements in accordance with other laws and regulations governing such contracts or agreements.

Comment: One commenter cited § 482.12(b), under the “Exercise of rights” standard in the Patients Rights CoP, to state that the rule must contain language that requires the hospital or CAH to inform the patient about the use of telemedicine services for diagnostic care, so that the patient (or the patient's representative as allowed under State law) may make an informed decision about whether to accept or decline care provided in this way. The commenter believes that the patient's informed consent must be obtained by the hospital or CAH before it makes use of the telemedicine services.

Response: We respectfully disagree with the commenter. In accordance with 42 CFR 482.24(c)(2)(v), the medical staff generally specifies procedures and treatments, in addition to those required by applicable Federal or State law, that require informed consent. As long as the telemedicine practitioner is performing his or her duties within the privileges granted by the hospital or CAH, there is no difference between distant-site practitioners and in-house or on-site practitioners in this regard. If they provide treatment that, under medical staff policy, requires informed consent, then this consent must be obtained, regardless of whether the treatment is furnished using telemedicine or not. Likewise, if, as is typical, hospital medical staff or CAH professional staff policies do not require the patient's informed consent in order for an on-site radiologist to interpret an x-ray or CT scan that had been performed on the patient, then consent also would not be required when a distant-site telemedicine radiologist, who is privileged by the hospital or CAH to interpret such diagnostic radiological tests, performs the same services.

Comment: One commenter expressed concern that there is no incentive for a distant-site hospital to provide these services for independent physician groups without corporate affiliation, even if they happen to be on the distant-site hospital medical staff.

Response: While it is not clear to whom this comment is referring (“* * * independent physician groups without corporate affiliation, even if `they' happen to be on the distant-site hospital medical staff * * *”), the intent of this rule is not to provide business incentives for the provision of telemedicine services (as we believe they exist already), but to provide a more streamlined process for credentialing and privileging telemedicine practitioners that would be more efficient and less burdensome for all of the hospitals, CAHs, and distant-site hospitals involved in this process. We believe that by allowing for such an optional process, the incentives for distant-site hospitals to provide telemedicine services and for hospitals and CAHs to make use of these services will not diminish, but will greatly increase. Ultimately, we believe this will lead to even greater patient access to timely care that might not otherwise be available.

Comment: A commenter questioned the long-run sustainability of increased workload associated with telemedicine (both at the patient-site and at the distant-site facility), which, in the commenter's opinion, seems inevitable. The commenter also questioned whether our revisions would meet quality of care objectives within the commenter's facility.

Response: The goal of this proposed rule is to ensure that all patients have access to quality care in their communities. We believe that this rule provides the framework for such care. We also believe that providers and practitioners will continue to schedule patient visits and appropriately refer patients in such a manner as to not overwhelm either facility or its practitioners. We believe that this rule will increase patient access to specialty services and reduce burden on facilities and providers.

Comment: One commenter believes that CMS should assess the impact of the final rulemaking on practitioners. A few commenters stated that these requirements will increase burden on practitioners, because they will experience significant downstream reporting requirements for purposes of medical licensure renewal.

Response: It is not clear from the comments as to whom the commenters are referring with the term, “practitioners.” Assuming that the commenters means those physicians and practitioners who are providing telemedicine services, we do not believe that this rule will increase the burden of reporting requirements for license renewal any more than the traditional credentialing and privileging processes presently do.

Comment: Two commenters expressed support for the proposed regulation and requested that it be expanded to include small hospitals under 100 beds, as opposed to just rural hospitals that are participating in a State-approved telemedicine program. One commenter expressed concern that community-based facilities, which are neither hospitals nor CAHs (such as rural health clinics and federally qualified health centers), are not included in this rule as patient-site facilities. Another commenter requested that we expand the scope of the rule to all facilities regulated by Medicare.

Response: We would like to thank the commenters for their support of the proposed rule. However, we would like to clarify that this rule applies to all Medicare-participating hospitals, regardless of facility size, as well as to all Medicare-participating CAHs. Rural health clinics and federally qualified health centers are subject to separate Medicare Conditions for Coverage that do not require credentialing and privileging of their physicians and practitioners, and thus there is no basis for extending this rule to those types of facilities. However, it should be noted that many insurers, including Medicare, may place limits or restrictions on their payment for telehealth services, depending on the location of the patient who receives those services.

Comment: Two commenters stated their opposition to the proposed rule because they felt that it allowed privileging by proxy to which they are opposed. One commenter stated that the changes only invite misuse by hospital and CAH governing bodies seeking to sidestep medical staff decisions regarding credentialing and privileging and to place direct economic pressure on hospital-based practitioners (with the threat of replacing them with distant-site practitioners). The commenter further stated that the changes will effectively remove the local medical staff from any obligation that they may have in determining the qualifications of each individual applying for privileges.

Response: We respectfully disagree with the commenter. As we have stated previously, the requirements being finalized here are an option for hospitals and CAHs as they approach the credentialing and privileging process for telemedicine practitioners. Though we cannot estimate the numbers, we fully expect some hospitals and CAHs to continue credentialing and privileging telemedicine practitioners through the traditional process. Such decisions will have to be determined and agreed upon by each hospital and CAH, after the risks and benefits of each process are fully analyzed. Furthermore, since the practice of privileging by proxy has been common for TJC-accredited hospitals for several years now, there has been ample time for problems, such as the ones the commenter mentions, to come to light. We are not aware of any evidence that indicates these problems have arisen from this process.

Comment: A few commenters expressed belief that some language we used throughout the proposed rule is ambiguous and confusing and suggested that the terms “distant-site hospital” and “patient-site facility” be used consistently. Another commenter requested that we use the terms “distant site” and “originating site” to ensure consistency among CMS publications and avoid confusion. Another commenter requested that we clarify the nomenclature within the regulation so the responsibilities of each facility are explicit.

Response: In drafting the proposed rule, we gave much thought to the terms that we would use to describe, and distinguish between, the hospital that provides the telemedicine services and the hospital or CAH that receives the telemedicine services on behalf of its patients. We came to the conclusion that it would only be more confusing (for a number of reasons) to use the terms “distant site” and “originating site,” as they are contained in both the Act and the payment rules. First among these reasons is the fact that, under the Act, there are sites (for example, rural health clinics, federally qualified health centers, and physician and practitioner offices) that are defined as “originating,” but which do not apply in the context of the hospital and CAH CoPs. Additionally, the Act applies restrictions to these originating sites for specific Medicare payment purposes, which have no bearing on the hospital and CAH CoPs.

We also considered other terms, such as “patient-site facility,” but found them too vague and inappropriate as well. Upon final analysis and consideration, we decided that distant-site hospital was an appropriate term to describe those larger hospitals that provide telemedicine services to patients of smaller hospitals and CAHs.

In considering which term to use for a hospital or CAH whose patients receive telemedicine services, it became readily apparent to us that the clarity of the language in the proposed requirements was best served if we continued to use the terms used throughout the current hospital and CAH CoPs to describe the facility to which the CoPs applied and to which a survey (through either the State agencies or the national accreditation organizations) for compliance with the CoPs would be performed. Put simply, the hospital would be referred to as the “hospital” and the CAH as the “CAH.” Any qualifying language preceding these terms might change the meaning and confuse which facility these CoPs applied. In some areas, we found it necessary to use qualifying phrases such as “the distant-site hospital providing the telemedicine services” and “the hospital (or CAH) whose patients are receiving the telemedicine services.” Therefore, we are finalizing these terms as proposed.

Comment: One commenter requested that we define and distinguish the differences between telemedicine and telehealth.

Response: In drafting this rule, we reviewed a variety of existing definitions of telemedicine and telehealth. The American Telemedicine Association states that “videoconferencing, transmission of still images, e-health including patient portals, remote monitoring of vital signs, continuing medical education, and nursing call centers are all considered part of telemedicine and telehealth.” Other organizations describe telemedicine as one part of a larger category of telehealth. The Institute of Medicine of the National Academy of Science defines telemedicine as “the use of electronic information and communication technologies to provide and support health care when distance separates the participants.” According to the California Telemedicine and eHealth Center, “telehealth refers to a broader scope of services that includes telemedicine, but it also includes other services that can be provided remotely using communication technologies.” And the federal Office for the Advancement of Telehealth, describes telehealth as “including telemedicine and a variety of other services.” In addition, Section 1834(m) of the Social Security Act (the Act) addresses Medicare payment for “telehealth services.” In accordance with those statutory provisions, telehealth services are certain services provided by practitioners via a telecommunications system to patients of certain types of healthcare facilities (including hospitals and CAHs) and physician or practitioner offices that are located in rural areas.

The consensus in the telemedicine/telehealth community appears to be that telemedicine refers to the provision of clinical services to patients by practitioners from a distance via electronic communications and that it is included under the broader scope of telehealth, while the statutory Medicare telehealth payment provisions are considerably narrower. At § 1834(m) of the Act, telehealth services are defined as professional consultations, office visits, and office psychiatry services, and any additional service specified by the Secretary. Most significantly, the statute allows payment for services that are provided to patients in a variety of settings (otherwise known as “originating sites” and which include physician or practitioner offices, CAHs, rural health clinics, and hospitals), but requires that all of these originating sites must be located in one of three areas: (1) An area that is designated as a rural health professional shortage area under section 332(a)(1)(A) of the Public Health Service Act (42 U.S.C. 254e(a)(1)(A)); (2) in a county that is not included in a Metropolitan Statistical Area; or (3) from an entity that participates in a Federal telemedicine demonstration.

However, for the purposes of this rule, we see telemedicine as encompassing the overall delivery of healthcare to the patient through the practice of patient assessment, diagnosis, treatment, consultation, transfer and interpretation of medical data, and patient education all via a telemedicine link (for example, audio, video, and data telecommunications as may be utilized by distant-site physicians and practitioners), and which is not restricted to only patients in rural areas of the nation. Therefore, in order to make clear that the credentialing and privileging provisions finalized here apply to all Medicare-participating hospitals and CAHs and not to the narrower subset of services and sites eligible for Medicare telehealth payment, we chose to use the term, “telemedicine,” throughout this rule instead of “telehealth.”

Comment: Two commenters stated that they do not support using the phrase “hospital's patients.” They stated that often individuals who are not registered patients make use of a rural hospital's telemedicine facilities without being registered patients. Two other commenters encouraged us to recognize and apply the proposed credentialing and privileging model to “all types of patients.” One commenter requested clarification of the word “patient” and suggests we further define that any reference to patient applies solely to inpatient services.

Response: We are aware that individuals that are not patients sometimes make use of a rural hospital's or CAH's facilities and telemedicine equipment in order to effect what are essentially office visits with distant-site telemedicine practitioners. Since these individuals are not patients of the hospital or CAH, and the distant-site telemedicine practitioners are not seeing them as patients of the hospital or CAH, the CoPs would not apply in these situations. This speaks directly to the other comments above requesting that these requirements be applied to all types of patients and, conversely, that we clarify that these requirements apply only to inpatients. Simply stated, the hospital and CAH CoPs are intended to ensure the health and safety of those patients, inpatients as well as outpatients, who are hospital and CAH patients.

Comment: A commenter expressed concern that patient-site hospitals may not have staff with appropriate expertise that would allow them to evaluate credentialing and privileging information for specialists.

Response: The proposed and final rules address the commenter's concern. Small hospitals and CAHs that believe they lack the expertise to perform credentialing and privileging for the telemedicine services of specialized practitioners already privileged at a distant-site hospital or telemedicine entity would have the option of relying upon the distant site's privileging process instead.

Comment: A commenter questioned whether it is sufficient for a distant-site hospital to provide the information in an agreement with the partnering patient-site institution. The commenter asked if the distant-site hospital is expected to provide the patient-site hospital with detailed information that may be contained in the physician's credentialing file at the distant-site hospital.

Response: We would expect the parties engaged in the agreement to determine, within the written details of the agreement or contract, how much information would need to be included and sent for each practitioner providing telemedicine services to the hospital or CAH. At the very least, as part of its agreement with the distant-site hospital, we would expect a hospital or CAH to have access to the complete credentialing and privileging file upon request for each practitioner who is covered by the agreement.

Comment: We received a number of comments concerning the issue of State licensure and telemedicine practitioners. A few commenters stated that a telemedicine practitioner must be licensed in the State in which he or she is located as well as in any State(s) that he or she provides telemedicine services to patients. Other commenters asked for clarification on the term “recognized” as used in the proposed rule and asked if it was equivalent to the “privilege to practice” authority provided for by Nurse Licensure Compact States. A few commenters also stated that the licensure language was not clear and further stated that if it was intended that the requirements would allow for reciprocity agreements, endorsements, other compact arrangements, or situations where a State does not require local licensure, then the requirements should be amended to reflect this.

Response: We appreciate the suggestions offered by commenters. However, we believe that the proposed licensure language provides enough flexibility to hospitals and CAHs so that they may address these issues in their required agreements with distant-site telemedicine hospitals and entities. In fact, our intention was that they should address such licensure issues in accordance with their respective State laws and regulations. We neither endorse nor prohibit licensure arrangements among States, which are mentioned above. Practitioners providing telemedicine services, as well as the distant-site hospitals and entities under whose auspices they provide these services, must be aware of the licensure laws in the States where they are located in addition to the laws, compacts, and arrangements of those States in which they look to provide their services to patients.

CMS recognizes that practitioner licensure laws and regulations have traditionally been, and continue to be, the provenance of individual States, and we are not seeking to pre-empt State authority in this matter. We believe that the proposed requirements regarding State licensure leave room for the laws that exist today as well as any changes to these laws that may occur in the future, including any increase in the number of States that decide to engage in compacts, privilege to practice or reciprocity agreements, endorsements, and other arrangements regarding practitioner licensure. Therefore, we are finalizing this aspect of the requirements as proposed.

We proposed to make revisions to the CAH CoPs at § 485.616, “Agreements,” and § 485.641, “Periodic evaluation and quality assurance review.” We specified in the proposed rule that the majority of the proposed revisions, particularly those which mirror the proposed hospital revisions, are found in the “Agreements” CoP, specifically § 485.616(c). At § 485.616(c), we proposed a new standard entitled, “Agreements for credentialing and privileging of telemedicine physicians and practitioners.”

The proposed telemedicine credentialing and privileging requirements for CAHs are modeled after the hospital requirements, with almost no differences in the regulatory language. Since the only existing requirements in the CAH CoPs specific to the responsibility of the governing body to grant medical staff privileges concerns surgical privileges for practitioners, we proposed to add language that follows the language in the hospital requirements at § 482.12(a). This language delineates the responsibilities of the governing body for the professional staff privileging process.

At § 485.641(b)(4)(iv), which does not have an equivalent provision in the hospital CoPs, we proposed to make a minor change to the CAH CoPs here. We proposed to add a new provision that would allow the distant-site hospital to evaluate the quality and appropriateness of the diagnosis and treatment furnished by its own staff when providing telemedicine services to the CAH. This proposed change would add distant-site hospitals to the three other entities already allowed to perform this function under the existing regulations.

Comment: One commenter noted that we use slightly different language in the requirements for CAHs than we do for the hospital requirements, and stated that we do not discuss the reasons for the differences in the preamble to the proposed rule. The commenter noted that we state at § 485.616(c)(2) that the CAH's “governing body or responsible individual may choose to rely upon the credentialing and privileging decisions made by the governing body of the distant-site hospital regarding individual distant-site physicians or practitioners.”

Response: We thank the commenters for pointing out the discrepancy between the regulatory language for hospitals and that for CAHs in this instance. We have revised the hospital language to be consistent with that for CAHs.

Based on public comment and our own internal discussions, we are adding new provisions to this final rule that will apply to the credentialing and privileging process and the agreements between hospitals and CAHs and non-hospital, distant-site telemedicine entities that provide telemedicine services (§ 482.12(a)(9) and § 482.22(a)(4) for hospitals; § 485.616(c)(3) and § 485.616(c)(4) for CAHs). These new provisions will require the governing body of the hospital (or the CAH's governing body or responsible individual), through its written agreement with the distant-site telemedicine entity, to ensure that the distant-site telemedicine entity, acting as a contractor of services, furnishes its services in a manner that enables the hospital (or CAH) to comply with all applicable conditions of participation and standards for the contracted services, including, but not limited to, the credentialing and privileging requirements regarding its physicians and practitioners providing telemedicine services.

Essentially, the new provisions will allow for the governing body of the hospital (or the CAH's governing body or responsible individual) to rely upon the credentialing and privileging decisions made by the distant-site telemedicine entity when making its own decisions on privileges for the individual distant-site physicians and practitioners providing such services, if the hospital's governing body (or the CAH's governing body or responsible individual) ensures, through its written agreement with the distant-site telemedicine entity, that the distant-site telemedicine entity's medical staff credentialing and privileging processes and standards meet or exceed the standards at § 482.12(a)(1) through § 482.12(a)(7) and § 482.22(a)(1) through § 482.22(a)(2) for hospitals, and at § 485.616(c)(1)(i) through § 485.616(c)(1)(vii) for CAHs. Additionally, the hospital's governing body (or the CAH's governing body or responsible individual) must ensure that the distant-site telemedicine entity, through a written agreement, meets three other provisions finalized here (and similar to those proposed and finalized here for agreements between hospitals/CAHs and distant-site hospitals providing telemedicine services).

Accordingly, we have made revisions to § 482.22(c)(6) and § 485.641(b)(4) to reference these new provisions pertaining to distant-site telemedicine entities as finalized in this rule.

Additionally, we have made a revision to § 485.635(c). This standard currently requires a CAH to have agreements or arrangements with one or more Medicare-participating providers or suppliers in order to furnish other services to its patients. We saw that as an impediment to the agreements that CAHs may have with distant-site telemedicine entities under this final rule. Since these entities do not participate in Medicare, we needed to make an exception to the requirement at § 485.635(c)(1). We have added a new paragraph at § 485.635(c)(5) to provide an exception to this requirement in cases where a written agreement exists between a CAH and a distant-site telemedicine entity for the entity's distant-site physicians and practitioners to provide telemedicine services to the CAH's patients.

In this final rule, we have made two significant clarifying revisions to the language of the proposed rule.

In the requirements for both hospitals and CAHs pertaining to the agreement with a distant-site hospital providing telemedicine services, we have corrected an oversight in the proposed rule and have revised the requirements in this final rule to clarify that these agreements or contracts must be written.

We have also revised the hospital language to be more consistent with that for CAHs, where we now state that the hospital's governing body may choose to have its medical staff “rely upon the credentialing and privileging decisions made by the governing body of the distant-site hospital regarding individual distant-site physicians or practitioners.”

Finally, we have made a few minor clarifying revisions to the proposed rule in those places where we found inconsistencies in regulatory language and/or instances where we believe the language was not as clear as it should have originally been.

Under the Paperwork Reduction Act of 1995, we are required to provide 30-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues:

• The need for the information collection and its usefulness in carrying out the proper functions of our agency.

• The accuracy of our estimate of the information collection burden.

• The quality, utility, and clarity of the information to be collected.

• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.

We solicited public comment on each of these issues for the following sections of this document that contain information collection requirements (ICRs):

Section 482.12(a)(8) requires the governing body of a hospital to ensure that, when telemedicine services are furnished to the hospital's patients through an agreement with a distant-site hospital, the agreement is written and specifies that it is the responsibility of the governing body of the distant-site hospital to meet the requirements in paragraphs (1) through (7) of this section with regard to its physicians and practitioners providing telemedicine services. The burden associated with this requirement is the time and effort necessary for a hospital's governing body to develop, review, and update as necessary the agreement with a distant-site hospital. We estimate that 4,860 hospitals (not including 1,314 CAHs) must develop the aforementioned written agreement. We also estimate that the initial development of the agreement will take 1,440 minutes at an estimated cost of $1,996. Assuming at most an annual update, the review will take 360 minutes at an estimated cost of $516. The total cost associated with this requirement is $2,512.

Section 482.12(a)(9) requires the governing body of a hospital to ensure that, when telemedicine services are furnished to the hospital's patients through an agreement with a distant-site telemedicine entity, the agreement is written and specifies that the distant-site telemedicine entity is a contractor of services to the hospital and as such, in accordance with § 482.12(e), furnishes services that permit the hospital to comply with all applicable conditions of participation and standards for the contracted services, including, but not limited to, the requirements in paragraphs (a)(1) through (a)(7) of this section with regard to its physicians and practitioners providing telemedicine services. The burden associated with this requirement is the time and effort necessary for a hospital's governing body to develop, review, and update as necessary the agreement with a distant-site telemedicine entity. While this requirement is subject to the PRA, the associated burden is accounted for in our discussion of § 482.12(a)(8).

Section 482.22(a)(3) states that when telemedicine services are furnished to a hospital's patients through an agreement with a distant-site hospital, the governing body of the hospital whose patients are receiving the telemedicine services may choose to have its medical staff rely upon the credentialing and privileging decisions made by the distant-site hospital when making recommendations on privileges for the individual physicians and practitioners providing such services. To do this, a hospital's governing body must ensure that all of the provisions listed at § 482.22(a)(3)(i) through (iv) are met. Specifically, § 482.22(a)(3)(iv) contains a third-party disclosure requirement. Section 482.22(a)(3)(iv) requires that with respect to a distant-site physician or practitioner, who holds current privileges at the hospital whose patients are receiving the telemedicine services, the hospital has evidence of an internal review of the distant-site physician's or practitioner's performance of these privileges and sends the distant-site hospital such information for use in the periodic appraisal of the distant-site physician or practitioner. At a minimum, this information must include all adverse events that result from the telemedicine services provided by the distant-site physician or practitioner to the hospital's patients and all complaints the hospital has received about the distant-site physician or practitioner.

The burden associated with this third-party disclosure requirement is the time and effort necessary for a hospital to send evidence of a distant-site physician's or practitioner's performance review to the distant-site hospital with which it has an agreement for providing telemedicine services. We estimate 4,860 hospitals (not including 1,314 CAHs) must comply with this requirement. We estimate that each disclosure will take 60 minutes and that there will be approximately 32 annual disclosures. The estimated cost associated with this requirement is $1,088.

Section 482.22(a)(4) states that when telemedicine services are furnished to the hospital's patients through an agreement with a distant-site telemedicine entity, the governing body of the hospital whose patients are receiving the telemedicine services may choose, in lieu of the requirements in paragraphs (a)(1) and (a)(2) of this section, to have its medical staff rely upon the credentialing and privileging decisions made by the distant-site telemedicine entity when making recommendations on privileges for the individual distant-site physicians and practitioners providing such services, if the hospital's governing body ensures, through its written agreement with the distant-site telemedicine entity, that the distant-site telemedicine entity furnishes services that, in accordance with § 482.12(e), permit the hospital to comply with all applicable conditions of participation and standards for the contracted services. To do this, a hospital's governing body must ensure that all of the provisions listed at § 482.22(a)(4)(i) through (iv) are met. Specifically, § 482.22(a)(4)(iv) contains a third-party disclosure requirement. Section 482.22(a)(4)(iv) states that with respect to a distant-site physician or practitioner, who hold current privileges at the hospital whose patients are receiving the telemedicine services, the hospital has evidence of an internal review of the distant-site physician's or practitioner's performance and sends the distant-site telemedicine entity such information for use in the periodic appraisal of the distant-site physician or practitioner. At a minimum, this information must include all adverse events that result from the telemedicine services provided to the hospital's patients by the distant-site physician or practitioner and all complaints the hospital has received about the distant-site physician or practitioner. While this requirement is subject to the PRA, the associated burden is accounted for in our discussion of § 482.22(a)(3).

Section 485.616(c)(1) states that the governing body of the CAH must ensure that, when telemedicine services are furnished to the CAH's patients through an agreement with a distant-site hospital, the agreement is written and specifies that it is the responsibility of the governing body of the distant-site hospital to meet the requirements listed at § 485.616(c)(1)(i) through (vii) and § 485.616(c)(2). The burden associated with this requirement is the time and effort necessary for a CAH's governing body to develop, review, and update as necessary the agreement with a distant-site hospital. We estimate that 1,314 CAHs must develop and review the aforementioned written agreement. We also estimate that development of the agreement will take 1,440 minutes initially and, assuming at most an annual update, the review will take 360 minutes annually. The total cost associated with this requirement is $2,512.

Section 485.616(c)(2) states that when telemedicine services are furnished to the CAH's patients through an agreement with a distant-site hospital, the CAH's governing body or responsible individual may choose to rely upon the credentialing and privileging decisions made by the governing body of the distant-site hospital for individual distant-site physicians or practitioners, if the CAH's governing body or responsible individual ensures that all of the provisions listed at § 485.616(c)(2)(i) through (iv) are met. The burden associated with this third-party disclosure requirement at § 485.616(c)(2)(iv) is the time and effort necessary for a CAH to send evidence of a distant-site physician's or practitioner's performance review to the distant-site hospital with which it has an agreement for providing telemedicine services. We estimate 1,314 CAHs must comply with this requirement. We estimate that each disclosure will take 60 minutes and that there will be approximately 32 annual disclosures. The estimated cost associated with this requirement is $1,088.

Section 485.616(c)(3) states that the governing body of the CAH must ensure that, when telemedicine services are furnished to the CAH's patients through an agreement with a distant-site telemedicine entity, the agreement is written and specifies that the distant-site telemedicine entity is a contractor of services to the CAH and as such, in accordance with § 485.635(c)(4)(ii), furnishes services that enable the CAH to comply with all applicable conditions of participation and standards for the contracted services, including, but not limited to, the requirements in this section with regard to its physicians and practitioners providing telemedicine services.

The burden associated with this requirement is the time and effort necessary for a CAH's governing body to develop, review, and update as necessary the agreement with a distant-site telemedicine entity. We estimate that 1,314 CAHs must develop and review the aforementioned written agreement. We also estimate that development of the agreement will take 1,440 minutes (that is, 24 hours) initially and, assuming at most an annual update, the review will take 360 minutes (six hours) annually. The total cost associated with this requirement is $2,512.

Section 485.616(c)(4) states that when telemedicine services are furnished to the CAH's patients through an agreement with a distant-site telemedicine entity, the CAH's governing body or responsible individual may choose to rely upon the credentialing and privileging decisions made by the governing body of the distant-site telemedicine entity regarding individual distant-site physicians or practitioners. The CAH's governing body or responsible individual must ensure, through its written agreement with the distant-site telemedicine entity, that all of the provisions listed at § 485.616(c)(4)(i) through (iv) are met. The burden associated with this third-party disclosure requirement at § 485.616(c)(4)(iv) is the time and effort necessary for a CAH to send evidence of a distant-site physician's or practitioner's performance review to the distant-site telemedicine entity with which it has an agreement for providing telemedicine services. While this requirement is subject to the PRA, the associated burden is accounted for in our discussion of § 485.616(c)(2).

Currently, a hospital or CAH receiving telemedicine services must go through a burdensome credentialing and privileging process for each physician and practitioner who will be providing telemedicine services to its patients. In the past, under the Joint Commission's (TJC) statutory deeming authority, hospitals that were accredited by TJC were deemed to have met the CMS credentialing and privileging requirements. TJC's “privileging by proxy” standards allowed for one Joint Commission-accredited facility to accept the privileging decisions of another Joint Commission-accredited facility. TJC has been statutorily required to meet or exceed our requirements regarding credentialing and privileging since July 15, 2010.

This final rule will revise the conditions of participation (CoPs) for both hospitals and critical access hospitals (CAHs) and will implement a new credentialing and privileging process for physicians and practitioners furnishing telemedicine services. Additionally, and perhaps more significantly, failure to publish this final rule will place undue hardship and financial burden on those hospitals and CAHs who have been credentialing and privileging telemedicine practitioners under TJC's “privileging by proxy” model. These hospitals and CAHs will have to take on the burden of credentialing and privileging a significant number of telemedicine practitioners in a relatively short period of time or they will have to consider canceling their telemedicine services. Cancellation of telemedicine services by small hospitals and CAHs will drastically reduce access to needed specialty services for a great number of patients, many of whom are Medicare beneficiaries.

We have examined the impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (February 2, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)).

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This rule is not an economically significant rule and does not impose significant costs. The benefits of finalizing this rule greatly outweigh any costs imposed. Conversely, the negative impacts on overall patient health and safety as well as on the operating costs of individual hospitals and CAHs were this rule not to be finalized would be significant compared to the minimal cost imposed by finalizing it here. Accordingly, we have prepared a regulatory impact analysis, which to the best of our ability, presents the costs and benefits of the rulemaking.

A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). The RFA requires agencies to analyze options for regulatory relief of small businesses, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, we estimate that the great majority of hospitals, including CAHs, are small entities as that term is used in the RFA. Individuals and States are not included in the definition of a small entity. While we do not believe that this final rule will have a significant impact on small entities, we do believe that this rule will have a positive impact by providing immediate regulatory relief for these small entities and will negatively impact them if not finalized here. Therefore, we are voluntarily preparing a Regulatory Flexibility Analysis.

In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. This rule will not have a significant impact on small rural hospitals as it is intended to relieve the burden on hospitals, particularly on small rural hospitals and CAHs, and to reduce or eliminate the impact of the current regulatory impediments to efficient operation and patient access to essential healthcare services. Therefore, the Secretary has determined that this final rule will not have a significant negative impact on the operations of a substantial number of small rural hospitals.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2011, that threshold is approximately $136 million. This rule does not contain mandates that will impose spending costs on State, local, or tribal governments in the aggregate, or by the private sector, of $136 million.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This final rule will not have a substantial direct effect on State or local governments, preempt State laws, or otherwise have a Federalism implication.

We estimate the costs to hospitals and CAHs to implement this final rule with comment period to be minimal, particularly when weighed against the significant benefits that the rule would bring about by reducing the regulatory burden for hospitals and CAHs. The major costs are related to developing the agreement between the distant-site hospital or distant-site telemedicine entity and the hospital or CAH at which patients who receive the telemedicine services are located. Many hospitals and CAHs may already have such telemedicine service agreements in place and therefore would not incur the initial costs of developing such an agreement.

Our figures, as of March 31, 2010, indicate that there were 4,860 hospitals and 1,314 CAHs (for a total of 6,174) participating in Medicare in the United States. However, we have no way of determining an exact number on which of these hospitals provide telemedicine services and which of these hospitals and CAHs receive telemedicine services, nor can we determine how many hospitals and CAHs already have telemedicine agreements. We do not have any reliable figures on the number of non-hospital, distant-site telemedicine entities that provide telemedicine services to hospitals and CAHs. Accordingly, we have based our cost estimates on the higher costs that would be incurred if every hospital and CAH in the United States was required to develop an agreement and review and update it annually. We prepared the cost estimates for hospitals and CAHs separately. However, all sides of this equation will require the initial services of a hospital or CAH attorney at an average of $86/hour; a hospital or CAH chief of the medical/professional staff (a physician) at an average of $103/hour; and a hospital or CAH administrator at an average of $69/hour. For the third-party disclosure requirements, we also prepared the cost estimates for hospitals and CAHs separately, though both will require the annual services of a medical staff credentialing manager or a medical staff coordinator at an average of $34/hour. Our salary figures are the most recent wage estimates from the Bureau of Labor Statistics ( http://www.bls.gov/home.htm ) with 33% added to the hourly wage to account for benefits. Our estimates of time and cost for each aspect of the agreement (development and initial cost, and annual review), as well as for the third-party disclosure, is as follows:

Section 831 required DoD to mitigate the risks associated with personal services by developing guidance enabling contracting officers to better distinguish between personal services and nonpersonal services. The interim rule amended DFARS parts 211 and 237 to (1) require that statements of work or performance work statements clearly distinguish between Government employees and contractor employees and (2) ensure that procedures are adopted to prevent contracts from being awarded or administered as unauthorized personal services contracts. The interim rule included an internal requirement for a program manager, or equivalent, certification that the service contract requirement does not include an unauthorized personal services arrangement. Because of the differing missions of DoD agencies, the interim rule required agencies to adopt their own procedures.

DoD published an interim rule at 75 FR 54524 on September 8, 2010, to implement section 831 of the National Defense Authorization Act for Fiscal Year 2009 (Pub. L. 110-417, enacted October 28, 2009). The period for public comment closed on November 8, 2010. Five respondents provided public comments on the interim rule.

Comment: A respondent noted the DFARS requirement for agency-level procedures to ensure that service contract requirements are vetted and approved in a manner that will prevent them from being awarded or administered as unauthorized personal services contracts. The respondent stated its support for Defense agencies taking internal action to ensure that no unauthorized personal services contracts are requested. Another respondent expressed support for the rule and stated that it “helps create a boundary separating contractor and government employees in all workplace environments.”

Response: The respondents' support is noted. No change to the DFARS in this area was requested or made.

Comment: Two respondents specified that the DFARS should highlight and limit applicability of this rule solely to personal services contracts, not the general service contract population.

Response: No change was made in the final rule in response to this comment. It is precisely because of the potential for a migration of a “general service contract” into what is effectively a “personal services contract” that the rule is necessary. DoD, with strong encouragement from the DoD Office of Inspector General, has determined that there is a need to review all services for the purpose of ensuring the services do not become personal services.

Comment: A respondent stated that DFARS 211.106 provides no actual guidance to the agencies as to what the distinction between Government employees and contractor employees is or how an agency is to make such a determination. At a minimum, the respondent states, it may be appropriate to include in DFARS 211.106 a cross reference to the characteristics and descriptive elements in FAR 37.104. The respondent thinks the rule does not provide any actionable direction to contractors on what behaviors would be acceptable for contractor employees based on the policies and practices of the location where the contractor employee is assigned.

Response: A cross reference to FAR 37.104 and the characteristics and descriptive elements therein has been added to DFARS 211.106. However, the DFARS cannot unnecessarily repeat, paraphrase, or otherwise restate material contained in the FAR (see FAR 1.304(b)), so the DFARS addition was limited to a reference. Further, the agency-level procedures are the appropriate location for the actionable, agency-specific direction to contractors on acceptable behaviors.

Comment: A respondent noted the absence in the interim rule, in DFARS parts 237 or 242, of procedures, guidance, or information focusing on postaward contract administration to prevent actual administration of a contract as an unauthorized personal services contract. The respondent recommended (a) referencing FAR 37.104(d) in DFARS 237.503 and (b) possibly adding coverage in DFARS part 242 relating to contract administration.

Response: DoD has added a cross reference to FAR 37.104(d) at DFARS 237.503. In this final rule, no changes are made to DFARS subpart 242.

Comment: A respondent proposed several clarifying edits. The respondent suggested moving some coverage from DFARS 237.503 to DFARS 237.104 and providing additional cross references. The respondent also proposed to revise the title of the form at PGI 237.503(c).

Response: Some of these recommendations have been accommodated in the changes noted above and as follows:

• New coverage at DFARS 237.104(d) has been added to point readers to the section entitled “Agency-head responsibilities” at DFARS 237.503 to ensure awareness of the certification requirement.

• The title of the certification at PGI 237.503(c) has been changed to “Certification of Nonpersonal Services.”

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated a “significant regulatory action” although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, the rule has been reviewed by the Office of Management and Budget. This rule is not a major rule under 5 U.S.C. 804.

DoD certifies that this final rule will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., because the change solely impacts internal Government operating procedures and will therefore not have a significant cost or administrative impact on contractors, subcontractors, or offerors. An initial regulatory flexibility analysis was not performed. No comments were received from small entities on this rule.

The final rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).

Therefore, the Defense Acquisition Regulations system confirms as final the interim rule published at 75 FR 54524 on September 8, 2010, with the following changes:

DoD published a proposed rule in the Federal Register at 75 FR 60690, on October 1, 2010. This case establishes a standard method for the issuance of orders via electronic means. DoD currently has the capability to distribute orders electronically on a routine basis and can post to a Web site that any contractor can access. In order to make this possible, the DFARS needs to provide language that will make those procedures a routine part of contract order distribution. This will enable DoD to further the goals of the E-Government Act of 2002 (Pub. L. 107-347).

The public comment period closed November 30, 2010. Five respondents submitted comments to the proposed rule, which are addressed below.

Comment : One respondent opined that requiring vendors and the Government to communicate exclusively via electronic means will be the most effective way for the Government to do business in the future.

Response : Concur this could be the most effective way to communicate, however, e-mail and facsimile will continue to be permitted as a means of communication.

Comment: One respondent expressed concern that many elements of an order are not universal, and are not automatically posted to the Electronic Document Access (EDA) system from the contract writing systems ( i.e., attachments and appendices). The respondent opined that ordering officials would thus be forced to either use e-mail to get some elements of the order to the contractor or, alternatively, to manually replace the automatically uploaded documents in EDA with manually compiled complete documents. The respondent suggested that neither approach would be efficient.

Response: As a matter of policy, DoD already requires posting of the contract or order, including its attachments, to EDA. This rule merely leverages that existing requirement to codify rules for electronic issuance of orders. Use of e-mail will not be necessary.

Comment: A respondent questioned whether it is wise to take e-mail totally off the table, when FAR 52.216-18, Ordering, currently permits ordering officials to specify e-mail as an “electronic commerce method” so long as it is authorized in the schedule. The respondent recommended that the DFARS clause should explicitly permit the use of e-mail as a recognized electronic commerce method. The respondent recommended, in the alternative, that the Government permit the use of e-mail on a “by-exception basis” or at the discretion of the contracting officer.

Response: DoD considered the use of e-mail as a primary method of distribution, but rejected its use because of the lack of an audit trail. DoD was also concerned that the delivery and receipt of e-mail is subject to interruption without notice due to firewall and spam filter configurations.

Comment: A respondent suggested that the term “notice” in 252.216-70XX(c)(1), Ordering, should be defined. Another respondent stated the final rule should be clearer about who in the company will be receiving the awards to reduce the possibility for miscommunication. Another respondent stated that electronic commerce is a term specifically identified in Federal Acquisition Regulation (FAR) Part 2, and is broader than just the EDA, which is not defined in the FAR or DFARS. The respondent further stated that limiting the Government's electronic communication options to the EDA only will prevent ordering officials from using other means of electronic commerce in the event EDA is not accessible (e.g., system is down or contingency contracting where EDA may not be available), and that use of the broader term “electronic commerce” would allow for the flexibility to adopt the use of new methods of electronic communication as they arise.

Response: Contract load notification lists can be set up in EDA for a specific contract or delivery order. Each contract or delivery order requires its own notification list. Notification lists may be created for contracts that do not yet exist in EDA. When a contract loads into EDA, the notification process activates and EDA e-mails the notification to the addresses on the lists. Notification e-mail messages are sent once per day. Therefore, it is not necessary to define what constitutes a notice.

DoD has chosen EDA as its primary means of establishing an official shared copy of the contract. This case leverages that decision. This case is not intended to prohibit the use of other electronic commerce tools to transmit data about the contract, but only to address EDA as the location of the document.

Comment: A respondent suggested that DoD should allow for an alternate means of electronic communication that provides for secure transmission of files (such as deliverables, reports, financial, and Privacy Act data) back to the issuer. The respondent further stated that e-mail is a very simple, widespread, and known technology, and that many regulations require strong encryption when sending sensitive (controlled unclassified information, personally identifiable information, etc. ) data over the internet. The respondent recommended that DoD should be encrypting files before transmitting them, and that including (in the clause) the option to use e-mail would set the stage for enhanced, electronic communications between DoD and its many small contractors, via the Internet's ubiquitous direct communication tool.

Response: EDA shares data using secure hypertext transfer protocol (https), which encrypts all data in transit, and is universally used by both industry and Government to protect sensitive data. EDA fulfills DoD's requirement for the secure transmission of data.

Comment: A respondent asked whether contractor registration in EDA will eventually become mandatory like Central Contractor Registration (CCR) ( i.e., a pre-condition for receiving a contract). The respondent went on to suggest that DoD would have a difficult time getting industry (and particularly small businesses) to use EDA without a mandatory registration requirement.

Response: An implicit condition of this ordering clause is that vendors who wish to receive notice of electronic orders must create an account in EDA. In order to create an account, the vendor must know the Commercial and Government Entity (CAGE) or the Data Universal Numbering System (DUNS) number for the business unit, and specify it in their EDA registration. The electronic business point of contact for that CAGE/DUNS as identified in CCR must authorize, via e-mail, the applicant for the EDA vendor user account as someone who may access documents for that CAGE/DUNS.

Comment: A respondent noted that there is a general lag between the time when an order is released in the contract writing system, and the time when it is available in EDA, and that this is a practical downside of not permitting the use of e-mail to issue orders. Two respondents expressed concern that there may be occasions when contractors cannot readily gain access to EDA or that there may be contractors who object to registering in the EDA system.

Response: Historical data shows that, on average, actions are posted to EDA within one to two days. This average compares very favorably with the averages associated with mailing or any other distribution process. There are two EDA sites, one at http://eda.ogden.disa.mil/, and the other at http://eda.cols.disa.mil/, to ensure connectivity. These two sites allow for an overall 99.1% average system availability. EDA is a very reliable means of conducting DoD's business, and the issue of EDA nonavailability is not considered significant.

Comment: A respondent recommended striking facsimile and mail as acceptable methods of issuing orders in order to more firmly promote the use of electronic business.

Response: The objective of the case is not to eliminate paper methods but to establish a regular process for electronic methods.

DoD has considered the public comments, and has decided to make no major changes to the text that was proposed in the Federal Register at 75 FR 60690, on October 1, 2010. However, there is one small change made at 216.506(a), where the name “Ordering” was added to the clause prescription as the title for FAR 52.216-18. This final rule makes the following DFARS changes:

• Adds DFARS 216.506(a) to require a new clause 252.216-7006, Ordering, in lieu of the clause at 52.216-18, Ordering, in solicitations, and contracts when a definite-quantity contract, a requirements contract, or an indefinite-quantity contract is contemplated; and

• Add a new clause at DFARS 252.216-7006, Ordering.

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under Section 6(b) of Executive Order 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

DoD has prepared a final regulatory flexibility analysis consistent with 5 U.S.C. 604 and is summarized below. A copy of the analysis may be obtained from the point of contact specified herein.

The objective of this rule is to establish a standard method for distributing orders via electronic means. DoD currently has the capability to distribute orders electronically on a routine basis, and posts those orders to a Web site that any contractor can access.

This DFARS change will provide standard contract language that will make those order distribution procedures a routine part of contract order placement. This rule will enable DoD to further the goals of the E-Government Act of 2002.

For Fiscal Year 2009, DoD made awards to 6,097 small business unique Data Universal Numbering System (DUNS) numbers using the clause at FAR 52.216-18, Ordering. The benefit of this rule to small business is that it will make electronic distribution procedures a routine part of order issuance. This change will ultimately help improve the management, and promotion of electronic Government services and processes, and will establish a framework to improve public access to Government information, and services.

This rule was published as a proposed rule in the Federal Register at 75 FR 60690, on October 1, 2010. No comments were received from small entities on the affected DFARS subpart with regard to small businesses. We anticipate that there will be limited, if any, additional costs imposed on small businesses.

This rule does not impose any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).

Therefore, 48 CFR parts 216 and 252 are amended as follows:

DoD published a proposed rule on hexavalent chromium in the Federal Register at 75 FR 18041 on April 8, 2010. This final rule amends the DFARS to implement requirements to minimize the delivery of materials containing hexavalent chromium in DoD acquisitions. The DFARS governs only DoD procurements, therefore, this action establishes requirements that DoD personnel must follow when making acquisitions for new systems.

Hexavalent chromium is a chemical that has been used in numerous DoD weapons systems and platforms due to its corrosion protection properties. However, hexavalent chromium is recognized as an inhalation carcinogen. The National Toxicology Program's Report on Carcinogens, Eleventh Edition, lists hexavalent chromium compounds as known human carcinogens. (See http://ntp.niehs.nih.gov/ntp/roc/eleventh/known.pdf. ) The Environmental Protection Agency (EPA) classifies hexavalent chromium as a known human carcinogen by the inhalation route of exposure. (See http://www.epa.gov/iris/subst/0144.htm. )

In response to the serious human health and environmental risks associated with the use of hexavalent chromium, there has been an increase in national and international restrictions and controls. For example, in 2006, the Occupational Safety and Health Administration (OSHA) lowered the permissible exposure limit (PEL) ten-fold from 52 to 5 micrograms-per-cubic-meter, making it among the most stringently regulated materials used in manufacturing and maintenance operations. Similarly, the European Union Restriction of Hazardous Substances Directive restricts the use of hexavalent chromium in the manufacturing of certain types of electronic and electrical equipment. Finally, a number of defense-related industries are minimizing or eliminating the use of hexavalent chromium where proven substitutes are available.

Such restrictions and industry practices have decreased the availability of materials containing hexavalent chromium and have increased the regulatory burden and life cycle costs for DoD. Indeed, DoD and the industry have made substantial investments in finding suitable replacements for hexavalent chromium. To protect future access for critical applications and to implement its commitments pursuant to Executive Orders 13514 and 13423, on April 8, 2009, the Under Secretary of Defense (Acquisition, Technology and Logistics) issued a policy memorandum to minimize the use of materials containing hexavalent chromium in the acquisition of new systems throughout DoD. Among other things, the policy memorandum directed DoD personnel (specifically the Program Executive Offices in conjunction with the Military Department's Corrosion Control and Prevention Executive) to certify that “no acceptable alternative” exists before using any material containing hexavalent chromium on a new system and directed the Defense Acquisition Regulation Council to develop a clause for defense contracts that prohibits the use of materials containing hexavalent chromium in all future procurements unless specifically approved by the Government. This final rule implements those aspects of the policy memorandum. The final rule adds a new DFARS subpart and a corresponding contract clause to minimize hexavalent chromium in deliverables acquired under DoD contracts.

Eleven respondents submitted comments on the proposed rule. A discussion of those comments and the revisions made to the rule as a result of those comments is provided below. The comments are organized and presented in ten overall categories. Some comments did not pertain to the DFARS rule itself; however, they are addressed to assist in further clarifying the rule. Six of the eleven respondents supported the objective of minimizing the use of hexavalent chromium or indicated that they were already compliant. The remaining five respondents did not express support or object to the rule, but provided implications and examples of actions that will be required to minimize hexavalent chromium in deliverables. Three respondents questioned the need for the rule since DoD and industry have been working for years to develop substitutes. Despite reservations about the need for the rule, these respondents provided recommendations for improving the rule. A number of the most significant recommendations have been incorporated in the revised rule as discussed in more detail below.

Comment: Two respondents requested clarification of contractor responsibility for identifying alternatives or obtaining approvals for hexavalent chromium use.

DoD Response: A DoD solicitation for a new deliverable may contain specifications for approved hexavalent chromium substitutes. In other solicitations, or for other components in the same solicitation, DoD may provide specifications that require hexavalent chromium where its use is deemed necessary to meet performance requirements and/or where proven substitutes are not available. Consideration of substitutes will include evaluation of the factors described in the DoD policy memo including—

• Cost effectiveness of alternative materials or processes;

• Technical feasibility of alternative materials or processes;

• Environment, safety, and occupational health risks associated with the use of the hexavalent chromium or substitute materials in each specific application;

• Achieving a DoD Manufacturing Readiness Level of at least eight (8) for any qualified alternative;

• Materiel availability of hexavalent chromium and the proposed alternatives over the projected life span of the system; and

• Corrosion performance difference of alternative materials or processes as determined by agency corrosion subject matter experts.

A performance-based solicitation may not provide specifications for a substitute or pre-approval for hexavalent chromium. In such cases, the contractor is responsible for either providing a substitute that meets performance requirements or providing a request to the contracting officer for providing a deliverable containing hexavalent chromium. The contracting officer will forward the request to the authorized approving official (DFARS 223.7305(a)) for decision.

The Advanced Surface Engineering Technologies for a Sustainable Defense (ASETSDefense) Web site at http://www.assetsdefense.org has been established to provide information about hexavalent chromium substitutes. The site has a database that can be searched by type of process for substitute information. The site also contains briefings and summary reports from DoD-industry workshops on sustainable coatings and processes. The site helps reduce duplication in testing for the same or similar applications.

Comment: Two respondents requested that “legacy system” be defined, with one respondent stating that it should be any system that is past Material Development Decision, as the milestone defined in DoD Instruction 5000.02.

DoD Response: A “legacy system” means any program that has passed Milestone A, as defined in DoD Instruction 5000.02. At the Material Development Decision (MDD) stage in the acquisition process, far too little is known about a system. The MDD simply indicates that an acquisition of a system, equipment, or item will be required to satisfy a military capability. Milestone A occurs after the MDD. At Milestone A, the system concept has been refined and technology development can begin. Milestone A represents a very early stage in the acquisition process. Thus, by defining a legacy system as one that has already passed Milestone A, it provides a phase-in period for the rule to take effect. In other words, the rule affects only new systems that are pre-Milestone A. This provides a sufficient period, typically two years or more, for companies that contract with DoD to make any necessary adjustments.

Comment: Two respondents requested clarification of the term “homogeneous material.” One respondent stated that the definition proposed is overly broad and appears to be taken verbatim from the European Union Restriction of Hazardous Substances Directive. Another respondent suggested that the definition be abandoned as unusable or be clarified by naming common types of materials to be considered homogeneous and those which should be excluded from the definition.

DoD Response: The definition of “homogeneous material” was adopted from the European Union Restriction of Hazardous Substances Directive because it is widely understood by industry given the global nature of supply chains. The definition was supplemented by providing examples to assist the contracting activity and the offeror. The intent of the examples is not to be extensive or all inclusive. “Homogeneous material” means a material that cannot be mechanically disjointed into different materials and is of uniform composition throughout. This definition can be applied to any material or article in order to determine the percent by weight of hexavalent chromium in the material. Surface coatings are considered to be a separate homogeneous material from the underlying material such as aluminum. The painted aluminum article as a whole is not a homogenous material because the paint can be mechanically disjointed (sanded or grinded) from the underlying aluminum. Also, the paint and aluminum are each of separate, uniform compositions. Conversion coatings are not considered homogeneous materials because they bond with and chemically modify the underlying material and cannot be mechanically disjointed.

Comment: Two respondents requested that the prohibition of hexavalent chromium not apply to “use” but only to products that “contain” hexavalent chromium. Two respondents requested that the phrase “or use materials [that contain hexavalent chromium] in performance of this contract” in 252.223-7XXXX (b) be deleted, so that the restriction would only apply to deliverables that contain hexavalent chromium.

DoD Response: DFARS 223.7303 was revised to provide clarity that hexavalent chromium may be used in manufacturing or testing of an article, as long as it will not appear as hexavalent chromium in the final product. As an example, in chrome plating, only the metallic form of chromium remains. Thus, articles plated with the metal chromium are acceptable and the rule will have minimum affect on businesses that plate chromium. Based on an industry comment, DoD modified the rule to indicate that the “prohibition does not apply to hexavalent chromium produced as a by-product of manufacturing processes” such as hard chrome plating. This was a primary concern of one of the industry associations. The phrase “or use materials in performance of this contract” in paragraph (b) of the clause at 252.223-7XXX has been deleted.

Comment: Two respondents requested clarification of the definitions of “unapproved” and “damages” in paragraph (c) of the clause 252.223-7XXX.

DoD Response: Paragraph (c) of the clause 252.223-7XXX was deleted in its entirety (see section II.I. of this preamble addressing contractor liability).

Comment: One respondent expressed an opinion that the title of proposed DFARS Subpart 223.73 is at variance with other parts of the rule. Specifically: “The proposed subpart 223.73 is entitled `Minimizing the use of hexavalent chromium', but paragraphs 223.7302, 223-7303, and the proposed clause 252.223-7XXX use the term `prohibition.' ”

DoD Response: Review of the rule as a whole does not support a finding of a conflict and edits have been made to clarify this. While proposed DFARS 223.7302 and the proposed clause at DFARS 252.223-7XXX use the term “prohibition,” the prohibition exists only where proven substitutes are available that provide acceptable performance for the application. Consideration of cost effectiveness, technical feasibility, corrosion control performance, and other factors described in the DoD policy memo must be taken into account. Read in its entirety, proposed DFARS Subpart 223.73 and the clause at proposed DFARS 252.223-7XXX do not impose an absolute ban on the use of hexavalent chromium. Rather, DFARS Subpart 223.73 minimizes the incorporation of hexavalent chromium into deliverables to the extent practicable, considering all the factors described in the DoD policy memo.

Comment: One respondent indicated that their products are already compliant with the prohibition on hexavalent chromium in the European Union Restriction of Hazardous Substances Directive. The respondent further noted that trace amounts of hexavalent chromium remain in the products but are well below the 0.1% threshold noted in the rule.

DoD Response: No change in the rule is necessary to address this comment. The decision to allow trace amounts of hexavalent chromium of less than 0.1 percent is consistent with worldwide standards, including Europe's Restriction of Hazardous Substances; thus these products will also be compliant with the this rule.

Comment: One respondent noted that the proposal does not reference any background or guidance document for testing for hexavalent chromium percent by weight.

DoD Response: There are a number of test procedures that could be used for testing for hexavalent chromium and the choice is dependent on the material being tested. Listing test methods is beyond the scope of the rule. Providers will have flexibility to choose the test method best suited to their application. International standard IEC 62321 “Determination of levels of six regulated substances (lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers) is the most widely used and was finalized in May 2009. ISO Standard 3613 for metallic and organic coatings was updated in November 2010 and is also widely used.

Comment: Three respondents questioned the need for the rule. One respondent stated that existing environmental, safety, and health regulations provide adequate safeguards. Another stated that it considered the rule to be premature without additional study, testing, and proof of performance and since it is limited to one federal department, it should be withdrawn. Another respondent suggested that DoD should consider a phased-in approach.

DoD Response: The rule will help to facilitate DoD's compliance with the requirements established in Executive Orders 13514 and 13423 to reduce the use of toxic and hazardous substances. In addition, it allows for the codification of the policy outlined in the DoD policy memo for the acquisition community to effectively implement the guidance in contract requirements. This rule is intended for DoD program managers and contracting officers by prohibiting the use of a DoD specification or solicitation that will result in a deliverable containing hexavalent chromium unless authorized by a senior level DoD official. This addresses a key complaint from industry that DoD specifications are preventing them from eliminating hexavalent chromium despite their desire to do so.

The rule also provides incentive for industry to adopt substitutes for hexavalent chromium. The rule has been modified to provide that a “legacy system” means a program that has passed Milestone A in the defense acquisition management system, as defined in DoD Instruction 5000.02, prior to the effective date of the rule. This is an early entry point into the defense acquisition system and, as noted in section II.A. of this preamble, provides a phasing in of the mandatory requirements of the rule for new acquisitions still only in the development phases. In regard to the need for further testing, DoD and industry have spent years testing substitutes and will continue to do so. The DoD policy does not require use of substitutes unless they can meet a DoD Manufacturing Readiness Level (MRL) of at least eight. Essentially, this means that the substitute has been proven to meet performance requirements. An item at MRL eight must have detailed designs and/or specifications, proven manufacturing and quality processes, and an established and stable supply chain.

Comment: Seven respondents stated that this rule will increase costs but did not provide substantiation. In one case, the respondent indicated that “elimination of hexavalent chromium compounds * * * might result in increased level of performance risk and increased procurement costs.” Another respondent referred to an increase in life cycle costs but did not appear to account for savings in using safer chemicals or the fact that substitutes must perform as well.

DoD Response: It should be noted that cost-related comments were made before revisions in the rule that address the most significant concerns such as plating, conversion coatings, and hexavalent chromium as a by-product of manufacturing. The final rule will not affect these activities. Only one respondent provided an estimate. That estimate is instructive and is discussed further below.

Based on numerous conversations with industry and small businesses, DoD believes that the rule will have a positive impact on industry and small business profits and, at worst, be revenue neutral over time. Web sites maintained under DoD's Strategic Environmental Research and Development Program (SERDP) contain briefings describing DoD and industry efforts to develop hexavalent chromium substitutes. For example, the 2010 SERDP conference had a special session on hexavalent chromium minimization. One of the presentations by the Aerospace Industries Association described the aerospace industry's minimization strategy. (Reference: http://symposium.serdp-estcp.org/Technical-Sessions/2B ). The Web site at asetsdefense.org also contains briefings and summaries of DoD-industry conferences.

A number of small businesses have developed non-chromate processes but have been hindered in their ability to market these processes to DoD by existing DoD specifications. In one example, a small manufacturer of fasteners told DoD that they can provide non-chromate fasteners that can meet DoD performance requirements but the DoD specification calls for chromate and the requiring military office sees no reason to change it. The rule will help to remedy this problem. Subpart 223.7203 of the rule provides direction for DoD contracting officers. It prohibits contracts that include a specification or standard that results in a deliverable or construction material containing more than 0.1% hexavalent chromium by weight. In another example, a small family-run business has developed a non-chromate coating for aircraft. While the company has had success with marketing the process to commercial airlines and the Air Force, it has had limited success DoD-wide. Apparently, further motivation is needed for DoD program managers to change existing requirements for use of materials containing hexavalent chromium. The rule implements the DoD policy memo in the procurement world and will thus increase the adoption of this non-chromate coating and similar paints and coatings by small businesses DoD-wide. The rule will also help make businesses more competitive in the world market. Many large companies are requiring suppliers to provide products with a smaller “environmental footprint” by using lifecycle assessment of human health and environmental impacts. For example, over 1800 organizations are now reporting their sustainability status under the Global Reporting Initiative. (See http://www.globalreporting.org/Home. )

Non-hexavalent chromium processes should be less costly over the lifecycle of the process due to the use of less hazardous materials and related control and disposal cost. (See examples of documented cost savings in Section III.) The rule was modified so that plating and anodizing are not covered by the rule. Thus, capital costs for conversions are de minimis. For the most part, compliance with the rule will only require switching to non-chromate paints and primers.

The one respondent that provided an estimate indicated a cost of $384,000 to convert to non-hexavalent processes. The company produces lightweight shelters for the military and customers that are primarily Government agencies. The company's main processes are metal surface “cleaning and chemical conversion.” The rule, as revised, will not affect cleaning and chemical conversion (conversion coatings) and thus there will be no cost to convert related to these processes. However, the respondent's main concern was not the conversion cost but the concern that one branch of the military will require a hexavalent chromium conversion coating and other branches will require non-hexavalent conversion coatings. The DoD policy and this rule are designed to reduce this problem of maintaining dual systems because they will cause DoD-wide changes in specifications to non-hexavalent processes. While this rule does not affect the respondent's conversion coating process, DoD has other initiatives underway to eliminate inconsistent requirements by DoD program managers by modifying DoD-wide specifications where hexavalent chromium has been required and suitable substitutes are available. As an example, DoD has qualified a non-hexavalent conversion coating for wide federal use (Reference Military Standard MIL-DTL-81706).

Comment: Four respondents stated that the rule will increase lifecycle cost due to less corrosion protection.

DoD Response: The rule does not necessarily require the use of substitutes for hexavalent chromium if lifecycle costs are higher. Lifecycle costs must be considered when deciding if proven substitutes exist (see factors listed in Section II A. above).

Many often overlooked costs (e.g., costs associated with the use of restrictive protective equipment and related productivity losses, air monitoring, reporting, medical surveillance programs, collection and treatment systems, and hazardous waste disposal) can be avoided with the use of less toxic chemicals.

Comment: Three respondents stated that the rule will decrease corrosion protection thereby adversely impacting mission readiness.

DoD Response: This rule does not decrease mission readiness as this factor must be considered when determining if proven substitutes exist. To eliminate any confusion, the factors to be considered have been added to DFARS 223.7305.

Comment: One respondent inquired about the funding strategy for research and development.

DoD Response: This comment is outside of the scope of this case. DoD has a robust program for developing and testing substitutes. (See the program area “Weapons Systems and Platforms” at http://www.serdp.org. )

Comment: Two respondents recommended that DoD limit review time of the waiver to not more than 30 days.

DoD Response: DoD assumes the respondent meant “authorization” for the use of hexavalent chromium vice “waiver.” DoD program managers are establishing efficient procedures for reviewing and granting authorizations for programs they manage. Timing for reviews and authorizations will depend on the complexity of the system but program managers have an incentive to ensure that schedules are not adversely affected by the review process.

Comment: Three respondents requested clarification of the exceptions at DFARS 223.7303 (now 223.7304), regarding the repair or replacement of legacy systems.

DoD Response: The exception for legacy systems has been clarified. Legacy system is now defined and an exception has been added for sustainment related contracts (e.g., parts and services) for existing systems with hexavalent chromium. However, Section 223.7304(a) of the rule requires program managers to consider alternatives during system modifications, follow-on procurements of legacy systems, or maintenance procedure updates if it is deemed feasible and needed to achieve the objectives of the DoD policy. Consideration of alternatives will require analysis of the factors described in the DoD policy memo.

Comment: One respondent requested that DoD clarify that there is no expectation to sample and analyze legacy systems and their related parts, subsystems, and components for the sole purpose of identifying hexavalent chromium.

DoD Response: DFARS does not have a requirement that legacy systems and their related parts, subsystems, and components be sampled or analyzed for the purpose of identifying hexavalent chromium. Legacy systems are clearly excepted from the rule.

Comment: Four respondents requested clarification of the process for approval of exemptions.

DoD Response: Exemption is not a term used in the rule. The respondent evidently means the process for obtaining authorizations to provide a deliverable or construction material with hexavalent chromium as described at DFARS 223.7305. Military departments have established or are establishing internal procedures for processing authorizations for use of hexavalent chromium. These procedures are necessitated by the individual needs of the Service and/or each program office. The approval process will be provided as part of the solicitation. It is in the best interest of DoD and individual program managers to have speedy, efficient processes for handling hexavalent chromium authorizations.

Comment: One respondent noted that it would be difficult to achieve the specification requirement under MIL-DTL-38999 for circular connectors if hexavalent chromium is removed from the sealer used in manufacturing circular connectors, noting that current test data suggests that replacing hexavalent chromium with trivalent chromium is not effective for circular connectors with cadmium-free plating.

DoD Response: Given the wide range of applications and the longstanding use of hexavalent chromium, DoD recognizes that the transition to proven substitutes will take time and recognizes that it will need to make exceptions to this rule while adequate alternatives continue to be developed. This amendment to the DFARS is one component of DoD's overall strategy to minimizing the use of materials containing hexavalent chromium in Defense acquisitions. As stated in the DoD policy memo, to adequately address the environmental and health concerns associated with the use of materials containing hexavalent chromium, DoD is going beyond its established hazardous materials management processes. In fact, this change to the DFARS specifically acknowledges that there may be particular specifications, such as MIL-DTL-38999, that require case-by-case authorizations for materials that contain hexavalent chromium. Section 223.7305 allows the appropriate DoD official to authorize the use of materials that contain hexavalent chromium when necessary, and if consistent with DoD policy. Any one that seeks such an authorization should follow the procedures in the DFARS Procedures, Guidance, and Information (PGI) at 223.7305.

Furthermore, DoD appreciates the information regarding the performance of circular connectors using trivalent chromium. DoD continues to make major investments to minimize the use of hexavalent chromium in defense acquisitions. DoD has sponsored efforts that range from fundamental research through advanced development to testing and evaluation for proven substitutes. As discussed earlier, the Strategic Environmental Research and Development Program (SERDP) and the Environmental Security Technology Certification Program (ESTCP) sponsor the Advanced Surface Engineering Technologies for a Sustainable Defense (ASETSDefense), which is a database that facilitates the implementation of new, environmentally friendly technologies for surface engineering (coatings and surface treatments) by providing ready access to background information and technical data from research, development, test, and evaluation efforts as well as the status of approvals and implementations. This database is continually growing as more documents are added, concentrating on coatings that avoid the use of hexavalent chromium. DoD will continue these efforts to provide proven substitutes for an ever increasing range of applications and materials to foster the widespread implementation of alternatives to hexavalent chromium. ASETSDefense's relational database is designed with a search capability to provide access to the available information needed to make informed decisions on the use of alternatives to materials and technologies for surface engineering that pose environmental or health hazards. This information includes detailed engineering data, background documents, and information on processes and products that have been validated, authorized, or implemented. For more information and to access the database go to: http://www.assetsdefense.org/databasedescription.aspx.

Comment: One respondent requested an exception for all commercial items.

DoD Response: To provide an exception for all commercial items will jeopardize the intent of the rule and be contrary to DoD policy. It is the responsibility of the prime contractor to require suppliers to provide content information. There is currently a requirement to provide content information for articles that contain hazardous substances such as hexavalent chromium in Material Safety Data Sheets (see FAR 52.223-3, Hazardous Material Identification and Material Safety Data).

Comment: One respondent stated that paragraph (d) of the clause requires that the prohibition will always flow down to the subcontractor and does not provide for a situation where the subcontractor's items qualify for an exemption.

DoD Response: Similar to change order requests and other types of approvals, subcontractors may submit proposals for approvals of necessary hexavalent chromium use through the prime contractor for approval. Since the clause flows down, the same approval process for exemptions applies to the subcontractor as well.

Comment: One respondent asked if the liability language exempts legacy systems/or components.

DoD Response: The paragraph on liability was deleted from the final text of the clause because existing law is sufficient.

Comment: One respondent stated that data such as cost effectiveness and corrosion protection be considered in rendering exemptions.

DoD Response: The respondent is correct. The DoD policy of April 8, 2009, contains requirements for weighing hexavalent chromium versus substitutes. The following factors, at a minimum, must be considered—

• Cost effectiveness of alternative materials or processes;

• Technical feasibility of alternative materials or processes;

• Environment, safety, and occupational health risks associated with the use of the hexavalent chromium or substitute materials in each specific application;

• Achieving a DoD Manufacturing Readiness Level of at least eight (8) for any qualified alternative;

• Materiel availability of hexavalent chromium and the proposed alternatives over the projected life span of the system; and

• Corrosion performance difference of alternative materials or processes as determined by agency corrosion subject matter experts.

Section 223.7305 has been revised to include the above factors from the DoD policy memo.

Comment: One respondent inquired if another exception is required if an exception has been allowed under the original contract. Another respondent asked about exemptions for follow-on procurements, or maintenance procedures.

DoD Response: The rule has an exception for legacy systems, which are now defined. An exception has been added for sustainment related contracts (e.g., parts, services) for existing systems with hexavalent chromium approved.

Comment: One respondent requested that a dollar threshold be established for waiver of the rule.

DoD Response: Cost effectiveness will be considered in deciding whether to prohibit hexavalent chromium or authorize a deliverable containing hexavalent chromium.

Comment: One respondent stated that the rule is contrary to existing statutes such as the Resource Conservation and Recovery Act (RCRA), which sets strict requirements for manifesting and disposing of hazardous waste but does not prohibit use of materials such as hexavalent chromium.

DoD Response: The rule is not contrary to existing statutes. The rule is consistent with the 1984 Federal Hazardous and Solid Waste Amendments to RCRA that focused on waste minimization. RCRA prescribes “that the manifest required by subsection (a)(5) shall contain a certification by the generator that the generator of the hazardous waste has a program in place to reduce the volume or quantity and toxicity of such waste to the degree determined by the generator to be economically practicable.”

Comment: Two respondents stated that the rule is not consistent with national and international regulations because laws such as the Clean Water Act and the Clean Air Act, and regulations such as OSHA and the European Union's Restriction on Hazardous Substances control the release of hexavalent chromium but do not prohibit its use.

DoD Response: As with the referenced statutes and regulations, the objective of this rule is the protection of human health and the environment while balancing other considerations. Protection of human health and the environment has historically been accomplished through the reduction of releases and/or managing exposure. This rule reduces releases and exposure by minimizing the incorporation of hexavalent chromium into products acquired by DoD. The DoD approach to minimizing hexavalent chromium does consider factors such as cost effectiveness and technical feasibility as described at 223.7305. Since this rule does not address the use of hexavalent chromium in the manufacturing process or completely ban the use of hexavalent chromium in end items delivered to DoD, other statutes and regulations addressing releases and managing human exposure will complement this rule when hexavalent chromium is used in or is a byproduct of the manufacturing process or is incorporated into the end item.

Comment: One respondent stated that the rule should be applicable Governmentwide.

DoD Response: The rule is only applicable to DoD. It is based on the April 8, 2009, policy memorandum, issued by the Under Secretary of Defense (AT&L).

Comment: Two respondents requested the removal of the liability provisions of the clause because existing law is sufficient. These respondents stated that the proposed paragraph (c) of 252.223-7XXX poses an unreasonable legal and financial risk.

DoD Response: DoD agrees with the respondents. Existing law is sufficient to address any issues regarding deliverables with hexavalent chromium. Paragraph (c) of the clause was removed from the final rule.

Comment: One respondent stated that where there are “viable and effective alternatives available,” the respondent encourages the use of such alternatives. The respondent provided trivalent chromium processes as an example. Another respondent stated that the prohibition clause will “inadvertently prohibit the use of hexavalent chromium solutions that convert to trivalent chromium or other environmentally friendly compounds.”

DoD Response: The rule does not prohibit the use of trivalent chromium. The rule is designed to encourage the use of environmentally friendly alternatives as authorization is required to use hexavalent chromium.

Comment: Two respondents requested a list or matrix of preapproved hexavalent chromium products. One respondent recommended that the Government and the contractor manage a list of classes of exemptions based on the current state of the art.

DoD Response: A comprehensive list of applications that are approved for the use of hexavalent chromium is not feasible for the rule. Such a list will be outdated immediately. However, individual solicitations will contain pre-approved uses of hexavalent chromium for specific applications where its use is deemed necessary to meet performance requirements and/or proven substitutes, considering relevant factors, do not exist. DoD program managers will maintain lists of pre-approved applications based on the criteria for approving substitutes pursuant to the April 8, 2009, memorandum, while taking into consideration the current state of art.

Comment: One respondent stated that contractors may be required to incorporate Government-furnished components or equipment in the final products assembled. Therefore, the contractor should not be held liable or responsible for screening such items if the finished product contains hexavalent chromium content in the supplied items from a third party or Government.

DoD Response: If any Government-furnished component contains hexavalent chromium, the use will be authorized by the Government. With regard to components supplied by a third party to a prime contractor, it is the responsibility of the prime contractor to know what subcontractors and suppliers provide and comply with the rule. The prime contractor should require subcontractors and suppliers to provide information regarding the content of hazardous and toxic materials. In most cases, Material Safety Data Sheets can be used to provide such information.

Comment: Two respondents stated that the rule will have significant impact on small entities.

DoD Response: As mentioned above, since the rule was modified such that plating and anodizing are not covered by the rule, capital costs for conversions are de minimis. For the most part, compliance with the rule will only require switching to non-chromate paints and primers. As noted and described more thoroughly in section II.C. of this preamble, based on conversations with industry and small businesses, DoD believes that the rule will have a positive impact on industry and small business profits and at worst, be revenue neutral over time. A number of small businesses have developed non-chromate processes but have been hindered in their ability to market these processes to DoD by existing DoD specifications. The rule will also help make businesses more competitive in the world market. Non-hexavalent chromium processes should be less costly over the lifecycle of the process due to the use of less hazardous materials and related control and disposal costs.

Comment: Four respondents stated that the rule will increase lifecycle cost due to less corrosion protection.

DoD Response: The rule does not necessarily require the use of substitutes for hexavalent chromium if lifecycle costs are higher or if performance requirements for corrosion control are not met. As described in Section II.E of this preamble, the DoD policy of April 8, 2009, contains factors for considering substitutes. These factors include lifecycle costs.

Comment: Two respondents recommended that DoD should meet with industry and stakeholders prior to proceeding with proposed rule.

DoD Response: The DoD Strategic Environmental Research and Development Program (SERDP) has held and participated in several workshops with industry related to the use of hexavalent chromium and substitutes. The results of these workshops and related research are available on the SERDP Web site at http://www.serdp.org and asetsdefense.org ). In addition, DoD representatives briefed attendees at the 2010 meeting of the National Association for Surface Finishing (NASF). DoD also provided a worldwide briefing concerning the rule on a Web-cast hosted by the NASF. During the Webcast, no negative comments were received (A transcript of the Webcast is available at a cost at http://www.nasf.org/staticcontent/Dec14Recording.pdf ).

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated a “significant regulatory action” although not economically significant under section 3(f) of Executive Order 12866. Accordingly, the rule has been reviewed by the Office of Management and Budget. This rule is not a major rule under 5 U.S.C. 804.

DoD certifies that this rule will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq.

The rule has been revised to minimize effects on small businesses in particular. The rule only affects deliverables that contain greater than 0.1% hexavalent chromium, not in-plant hexavalent chromium processes or deliverables containing the metal chromium. The rule is primarily aimed at coatings. Consequently, the rule has no effect on—

• Conversion coatings;

• Hard chrome plating;

• Chromic acid anodizing;

• Most chromated metallic ceramics; and

• Chromate washes, etches, pickling, etc.

The primary coatings used by DoD affected by the rule are—

• Chromated primers (for aircraft skins);

• Chromated primers (for components);

• Aircraft fuel tank internal coatings;

• Wet install fastener sealants (used on Naval aircraft);

• Other chromated sealants (used to seal panels, covers, electronics, etc.); and

• Chromated metallic-ceramic paints used in turbine engines.

With respect to deliverables provided to DoD, the above materials are used primarily by the large aerospace companies such as—

• Airframe manufacturers;

• Engine manufacturers; and

• Missile and spacecraft manufacturers.

The suppliers to these large manufacturers will be affected primarily by the requirement to supply components painted with non-chrome primers and chrome-free sealants. Some of these suppliers are large corporations but many are small businesses. However, the substitution of non-chromated products does not require a capital investment but rather a substitution of one coating formulation for another. For the most part, the same coating application equipment can be used and, as stated earlier, the rule will be positive for many of the small businesses that have developed non-hexavalent products.

Some commercial aerospace companies have already adopted chromate-free finish systems. This is being accomplished to meet commercial client desires for more sustainable products, but it also results in a reduction in operating costs. A Boeing press release on the initial testing of non-chromate primers on commercial aircraft states:

(Reference http://www.boeing.com/apachenews/2009/issue_01/news_s7_p2.html ).

In one military example, significant cost avoidance was achieved by eliminating the extensive chromate control requirements involved in bonding attach points for wiring on the production line. Meeting the federal Permissible Exposure Level (PEL) requirements when using chromated primers requires blocking off the area during sanding operations, which interferes with all other work and reduces the efficiency of the production process.

The examples below provide evidence that in most cases, companies will achieve savings when replacing hexavalent chromium with an alternative.

At one maintenance facility, a side-by-side cost comparison was developed for a hexavalent chromium process and a non-hexavalent chromium process developed by a small business. The report shows that—

• The non-chromate process replaced three steps which dramatically reduced labor costs and also eliminated the need to purchase three other chemicals;

• The non-chromate process used 2/3 less rinse water resulting in water and wastewater cost savings and environmental benefit;

• There was a significant reduction in hazardous waste disposal costs;

• The equipment used for the non-chromate product was the same as the standard process (with hexavalent chromium); therefore there were no capital costs for the conversion; and

• Less personal protection equipment (PPE) was required when converting to the non-chromate process (e.g., full mask, hazardous materials suit, respirator cartridges, etc.).

At another facility, there was a savings of $6,000 per aircraft with $1.3 million in documented operational savings at the time of the report due to switching to a non-chromate process. The process also eliminated 500,000 gallons of wastewater per year.

A large maintenance facility in Ohio switched to a non-chromate process and significantly reduced pollutant discharges, improved worker safety, cut process time, and reported savings in excess of $200,000 just due to reduction in state and federal compliance requirements.

Another facility reported a savings of approximately $120,000 per year in water consumption and treatment costs alone and reduced production times by 4,400 man-hours per year.

Fact sheets and detailed cost and performance reports for numerous non-hexavalent chromium processes can be found by searching for “hexavalent chromium” at http://www.serdp-estcp.org .

The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).

Therefore, 48 CFR parts 223 and 252 are amended as follows:

Until 2008, a hazardous liquid pipeline operating at low-stress in a rural area was not regulated under Federal pipeline safety regulations in 49 CFR part 195 unless it crossed a commercially navigable waterway. Section 195.2 defines a “rural area” as one outside the limits of any incorporated or unincorporated city, town, village, or any other designated residential or commercial area, such as a subdivision, a business or shopping center, or community development.

The PIPES Act was signed into law on December 29, 2006, (Pub. L. 109-468). Section four of the PIPES Act (codified at 49 U.S.C. 60102(k)) required PHMSA to “issue regulations subjecting low-stress hazardous liquid pipelines to the same standards and regulations as other hazardous liquid pipelines.” The PIPES Act also stated that the new regulations could be issued in phases.

PHMSA decided to implement the PIPES Act mandate in phases, in part because PHMSA did not have complete data on the extent of rural low-stress pipelines that would be covered by the statutory mandate. Phase one, through a final rule published on June 3, 2008, (73 FR 31634), applied full Part 195 regulation to higher-risk, larger-diameter rural low-stress pipelines (i.e., those low-stress pipelines with a diameter of 8 5/8 inches or greater located in or within one-half mile of an unusually sensitive area (USA)). (These requirements are in 49 CFR 195.12.) These are the rural low-stress pipelines that have more potential to cause harm to USAs. These were also the rural low-stress pipelines on which PHMSA had the most information to prepare a regulatory cost/benefit evaluation. PHMSA planned to regulate all remaining rural low-stress pipelines (i.e., smaller-diameter—less than 8 5/8 inches diameter—rural low-stress pipelines located in or within one-half mile of a USA and all rural low-stress pipelines, of any diameter, located outside the one-half mile USA buffer) once PHMSA had more complete information on the extent of these unregulated rural low-stress pipelines. Phase one also applied reporting requirements in Subpart B of Part 195 to all rural low-stress pipelines (§ 195.48). This data was necessary for PHMSA to complete the regulatory evaluation for the extension of all safety requirements to the remaining rural low-stress pipelines in phase two.

Because PHMSA did not have adequate information on the number of operators with rural low-stress pipelines, or on the total mileage of these lines in service, we initiated the following actions:

(1) We revised the Pipeline Safety Regulations to require operators of any low-stress line (including those rural low-stress lines not brought under safety regulations) to comply with the annual reporting requirements and the incident reporting requirements of Part 195. This was part of phase one, as discussed above.

(2) On July 31, 2008, (73 FR 44800) OMB Control Number 2137-0623, PHMSA published in the Federal Register a notice of OMB-approved survey asking each operator of a rural low-stress hazardous liquid pipeline for voluntary information concerning the mileage and characteristics of these pipelines to assess the costs of subjecting rural low-stress pipeline mileage to Part 195 regulation.

(3) Based on the information received in response to the notice, PHMSA conducted two follow-up inquiries: (1) A request for information from operators who operate rural low-stress lines to determine the potential operating costs they were likely to incur to bring these unregulated lines into compliance with Part 195 regulation; and (2) a request to states with the majority of rural low-stress lines to identify any incident data the state may have collected through the years.

With the information PHMSA gathered, we moved to phase two to complete the requirement of the PIPES Act and to apply Part 195 safety requirements to all rural low-stress pipelines not included in the phase one rule. A Notice of Proposed Rulemaking (NPRM) was published in the Federal Register on June 22, 2010, (75 FR 35366) that proposed to extend Part 195 safety requirements to rural low-stress pipelines of any diameter located more than one-half mile from a USA and those less than 8 5/8 inches in diameter located in or within one-half mile of a USA.

The phase one rule established compliance deadlines for the rural low-stress pipelines that it addressed. The phase two NPRM proposed no changes to these phase one deadlines, but proposed new compliance deadlines to apply the requirements to the phase two rural low-stress pipelines proposed for regulation. In addition, PHMSA proposed to define the scope of the “could affect” buffer for application of the integrity management (IM) requirements in § 195.452 to the phase two pipelines. To codify the compliance dates and requirements, we proposed to define three “categories” of rural low-stress pipelines subject to the requirements of § 195.12. These were as follows:

• Category 1: Those rural low-stress pipelines that were covered under the phase one rule;

• Category 2: Rural low-stress pipelines of smaller diameter (less than 8 5/8 inches diameter) located in or within one-half mile of a USA (which would be subject to all Part 195 requirements including IM requirements); and

• Category 3: All other rural low-stress pipelines that were not included in phase one. Category 3 lines would fall outside the defined “could affect” buffer for application of IM requirements.

Section 195.452 addresses IM requirements for hazardous liquid pipelines. Under the requirements of that section, operators must take additional actions for each pipeline segment that could affect a high consequence area (HCA). PHMSA has defined HCAs as populated areas, commercially navigable waterways and USAs. HCAs are identified and displayed on maps available from the NPMS.

To comply with IM requirements, pipeline operators must first determine which segments of their pipeline could affect an HCA. To do this, an operator needs to compare its pipeline's location to the locations of HCAs and determine which segments of the pipeline could affect an HCA if there was a product release from the segment. These comparisons have proven to be considerably more burdensome in practice than PHMSA believed when IM rules were initially established. They involve more than just comparison of maps of pipeline location to maps of HCAs. Operators have had to consider the topography and nature of ground cover around their pipelines to estimate the direction and distance that released product might flow. Operators have also had to consider the potential transport of released product via nearby waterways, including such factors as seasonal variations in flow, the effect of stream turbulence, and their ability to respond to a release and contain further transport of spilled product.

During the phase one rulemaking for rural low-stress pipelines, PHMSA concluded it would be unnecessarily burdensome to require operators of these pipelines to perform a complete “could affect” analysis to determine which rural low-stress pipeline segments would be subject to IM requirements. Rather, PHMSA adopted a one-half mile buffer around USAs  1 as the “could affect” area (i.e., any rural low-stress pipeline segment covered by the phase one rule within the one-half mile buffer would be subject to IM requirements). PHMSA found it unlikely a “could affect” analysis on a rural low-stress pipeline would result in a larger area than the one-half mile buffer for application of IM requirements. Available data showed that the largest spill on land from a low-stress line covered two acres. An acre is 43,560 square feet. If this spill had been limited to a corridor 35 feet wide over its entire length, it still would not have traveled one-half mile. This data, coupled with the relatively lower pressure of low-stress pipelines, led PHMSA to conclude that a one-half mile buffer was more than adequate for application of IM requirements. In the NPRM, PHMSA proposed to continue to use the one-half mile buffer for phase two because PHMSA believed it would be an adequate “could affect” area that identifies the vast majority (if not all) of rural low-stress pipelines that could affect a USA.

As in phase one, PHMSA also proposed to include an option for pipeline operators to use “could affect” analyses in lieu of the one-half mile buffer to determine which of their smaller-diameter low-stress pipelines would be subject to IM requirements. PHMSA recognized that operators could use this option in circumstances where it is likely the “could affect” analysis would determine that a pipeline segment cannot affect a USA (e.g., where the USA is uphill from the pipeline). Nevertheless, PHMSA concluded it would be unreasonable to exclude this option for rural low-stress pipelines since it can identify instances in which application of IM requirements would be unnecessary.

The phase one rule allowed operators of pipelines meeting specified criteria to notify PHMSA if they would incur an excessive economic burden in complying with IM assessment requirements. The criteria were designed for rural pipelines that carry oil from a production facility (e.g., well) and where the pipeline would be abandoned or shut down as a result of the economic burden associated with IM assessments. The phase one rule provided that PHMSA would stay compliance with the IM assessment requirements while it reviews the notification. Based on the outcome of the review, PHMSA may grant the operator a special permit imposing alternative safety requirements in lieu of IM assessments.

For phase two, PHMSA considered extending the economic compliance burden provision to Category 2 pipelines—those smaller diameter rural low-stress pipelines located in or within one-half mile of a USA that would be subject to IM assessment requirements. (Category 3 low-stress pipelines would not be subject to the IM requirements under the NPRM, as described above). PHMSA concluded that this was not necessary because no Category 2 low-stress pipeline would meet the criteria in the economic burden compliance provision (§ 195.12(c)) and concerns about preserving oil production or minimizing risk of alternative transport of crude oil from wells would not apply to these pipelines. Accordingly, we did not propose to extend the economic burden compliance provision to these pipelines in the NPRM.

Section 195.1(b)(3) states that Part 195 requirements do not apply to pipelines subject to safety regulations of the United States Coast Guard (USCG). The NPRM noted that this exception had previously applied only to low-stress pipelines subject to USCG regulation and through a drafting error in the phase one final rule, was inadvertently expanded to all pipelines subject to USCG requirements. PHMSA proposed to correct this error.

PHMSA received comments from three trade associations (two of which filed joint comments), one government agency (National Transportation Safety Board, NTSB), one pipeline consultant, and one individual. None of the comments objected to the changes proposed in the NPRM. The American Petroleum Institute (API) and the Association of Oil Pipelines (AOPL), in joint comments, explicitly noted that they did not oppose application of the baseline requirements of Part 195 to all low-stress pipelines and a requirement that rural low-stress pipelines within one-half mile of a USA also be subject to the IM requirements of Part 195. NTSB supported regulating all low-stress pipelines with requirements graded according to risk. All those commenting suggested some changes, however.

Several comments addressed the scope of the proposed rule. API-AOPL requested that PHMSA clarify that the proposed rule did not apply to gathering or production pipelines or to pipelines excluded from regulation in § 195.1(b). The Independent Petroleum Association of America similarly requested clarification that the proposed requirements do not apply to gathering pipelines. NTSB suggested that the change should include all rural gathering lines and gathering lines in inlets of the Gulf of Mexico. Tracy S. Dahl, who commented on behalf of herself, suggested that the scope should include low-stress gas pipelines such as those associated with coal bed methane gas production.

With the exception of correcting a drafting error associated with low-stress pipelines subject to regulation by the USCG (discussed above), the NPRM proposed no changes to the exclusions listed in § 195.1(b). This section lists the types of pipelines excluded from the requirements of Part 195. The NPRM did not propose any new requirements for gathering pipelines, and thus no requirements applicable to those pipelines may be included in this final rule. Regulation of rural gathering pipelines is governed by § 195.11, which is not affected by this rulemaking. Further, PHMSA notes that Section 4 of the PIPES Act explicitly states, “[t]he regulations issued under this paragraph shall not apply to gathering lines.”  2 Gas pipelines were not included in the scope of the NPRM and thus no new requirements can be applied to gas pipelines as part of this rulemaking.

API-AOPL specifically requested that PHMSA clarify the exclusion in paragraph (4) of § 195.1(b) applying to “[a] low-stress pipeline that serves refining, manufacturing, or truck, rail, or vessel terminal facilities, if the pipeline is less than one mile long (measured outside facility grounds) and does not cross an offshore area or a waterway currently used for commercial navigation.” API-AOPL noted that PHMSA field personnel have recently informed certain pipeline operators that these segments are part of a larger, non-low-stress pipeline and are thus subject to Part 195, which the associations believe is contrary to the plain language of the regulation. As noted above, the exclusions of § 195.1(b) are not changed by this rulemaking, and low-stress inter-facility pipelines meeting these criteria are excluded from regulation under Part 195. However, PHMSA notes that § 195.2 and the PIPES Act both define a low-stress hazardous liquid pipeline to be one “that is operated in its entirety at a stress level of 20 percent or less of the specified minimum yield strength of the line pipe” (emphasis added). Inter-facility pipelines operating at less than 20% SMYS that is part of a larger pipeline (i.e., some of which operates at higher stress levels) would not fall under this exclusion. Such inter-facility pipelines would be subject to Part 195. Determining whether particular inter-facility piping is part of a larger pipeline depends on the characteristics of individual installations and the applicability of Part 195 requirements to specific inter-facility lines.

API-AOPL objected to the proposed change to the exception in § 195.1(b)(3) for pipelines subject to regulation by the USCG. API-AOPL contended that this was not an error because the change was included in the phase one NPRM and final rule, had been subject to notice and comment and thus cannot simply be “corrected.” PHMSA disagrees. The entire rulemaking record clearly demonstrates that this was an error in the regulatory language in the phase one rule. API-AOPL is correct that the re-write of the regulatory language of § 195.1(b) in the phase one NPRM failed to limit this exception to low-stress pipelines and that this omission was repeated in the regulatory language in the final phase one rule. The remainder of the record makes it clear, however, that this change was not intended. The NPRM for the phase one rule stated that PHMSA had

The NPRM stated elsewhere that, “[t]his proposal will not affect other exempt low-stress lines, specifically pipelines subject to the safety regulations of the USCG * * *”  4 (emphasis added). The exception applicable to lines subject to USCG regulation prior to the effective date of the phase one final rule clearly applied only to low-stress pipelines. Further, the PIPES Act required that PHMSA continue to except from part 195 those “low-stress hazardous liquid pipelines” that were subject to USCG safety regulations. Therefore, PHMSA concludes that the record demonstrates the regulatory language in the phase one final rule concerning the exemption for low-stress pipelines subject to USCG regulation was an inadvertent error and that error has been corrected in this final rule.

API-AOPL and the Independent Petroleum Association of America suggested that PHMSA exclude low-stress carbon dioxide (CO 2 ) pipelines involved in enhanced oil recovery and/or carbon capture and storage. The associations noted that these pipelines pose different risks from petroleum pipelines, that releases from low-stress CO 2 pipelines would not require the cleanup that would be associated with releases from crude oil or refined petroleum product pipelines, and that new requirements on CO 2 lines could have a chilling effect on future investment in such pipelines. PHMSA notes that these factors were not raised in comments on the phase one rule even though the phase one rule applies to rural low-stress CO 2 pipelines. PHMSA never proposed such an exclusion and also considers it inappropriate to exclude some rural low-stress CO 2 pipelines from safety regulation while regulating others (i.e., those subject to the phase one final rule), and has not incorporated the suggested exclusion in this final rule.

API-AOPL also objected to the proposed requirement that a pipeline segment subject to IM requirements must remain subject to those requirements if subsequent changes to USA boundaries result in it being more than one-half mile from a USA. They contended this requirement is inappropriate and unsupported. They stated:

PHMSA would agree if the operator of a rural low-stress pipeline were, indeed, required to analyze its pipelines to determine which segments could affect a USA. They are not. This final rule uses a one-half mile buffer as a surrogate for these expensive and complex analyses, as did the phase one rule. While PHMSA considers this a reasonable surrogate, it is possible, though unlikely, that a pipeline segment slightly less than one-half mile from a USA could not affect that USA and it is similarly possible that a pipeline segment slightly more than one-half mile distant could affect a USA. Thus, eliminating IM requirements that already apply solely because the distance to a USA has increased above one-half mile is not appropriate. Operators always have the option to perform an analysis to demonstrate that any pipeline segment could not affect a USA, in which case IM requirements need not apply regardless of the distance from a USA. Operators who experience a change in USA boundaries could exercise this option to remove a pipeline segment from IM scope. If the change in USA boundaries is significant (e.g., the USA ceases to exist), demonstrating that a segment could not affect a USA could be a simple analysis. PHMSA has retained in this final rule the requirement that a pipeline segment determined to be subject to IM requirements due to proximity to a USA must remain subject to those requirements if boundary changes result in more than one-half mile separation, absent a demonstration that the segment could not affect a USA.

Thomas Lael Services, L.P., a pipeline consultant, suggested changes to the regulatory language to improve clarity. Specifically, Lael suggested that proposed §§ 195.12(c)(2)(i) and 195.12(c)(3)(i) be modified to refer specifically to the criteria defining the pipeline segments for which identification is required. PHMSA agrees that this change would improve the clarity of the regulatory language and has revised the final rule accordingly.

Lael also suggested that the provision allowing the operator of a Category 1 rural low-stress pipeline to notify PHMSA of undue economic burden should be extended to operators of Category 2 rural low-stress pipelines. Lael noted that revenue is less for these smaller-diameter pipelines while costs are the same, increasing the importance of considering economic burden. Lael cites costs associated with patrolling the pipeline and performing pipe-to-soil potential readings as examples. These requirements, however, are outside the scope of the economic burden provision. That provision allows an operator of a Category 1 rural low-stress pipeline to notify PHMSA if the economic burden of complying with IM assessment requirements, not other provisions as cited by Lael, would be sufficient to cause the operator to shut down its pipeline. The provision is applicable only to pipelines carrying crude oil from a production facility (among other criteria). Pipelines of 8 5/8 inches or less nominal outside diameter—the size that would categorize a rural low-stress pipeline as Category 2—and that carry crude oil from a production facility are, by definition, gathering pipelines. Gathering pipelines, as noted above, are not subject to the provisions of § 195.12 and are not subject to IM requirements. Thus, PHMSA concludes that no change to the economic burden provision is needed.

Lael also suggested that the time allowed for operators to identify Category 2 and 3 rural low-stress pipelines be extended to 12 months from the proposed nine months. Lael noted that this would correct an apparent inconsistency with discussion in the NPRM preamble noting the proposed timeframes were the same as those required in phase one; therefore, 12-month timeframes were being proposed for operators of Category 2 and 3 rural low-stress pipelines in instances where 12 months was required of operators of Category 1 rural low-stress pipelines. There is no inconsistency. The NPRM preamble discussion cited by Lael clearly uses 12 months only as an example. The phase one rule required operators of Category 1 rural low-stress pipelines to identify pipeline segments meeting the criteria in the rule before nine months after the effective date of the phase 1 rule. Nine months is also required for Category 2 and 3 rural low-stress pipelines in this final rule, thus affording the consistency discussed in the NPRM.

Lael also questioned the logic of a statement in the phase two NPRM that available data showed that the largest spill on land from a low-stress pipeline traveled two acres and that this justified a one-half mile buffer as a surrogate for analyses of whether a pipeline segment could affect a USA. Lael noted that an acre is a measure of area rather than a measure of distance. PHMSA agrees that the NPRM statement was unclear about the assumptions we used to conclude that this data demonstrated a one-half mile buffer was adequate. PHMSA considered that a spill covering two acres would need to be limited to 35 feet in width over its entire length if it were to extend one-half mile from the pipeline. We concluded that it was unlikely that a spill would behave in this manner and that based on the data we could conclude that a one-half mile buffer was adequate. PHMSA has revised the discussion in the preamble of this final rule to better explain its reasoning.

API-AOPL raised a number of concerns regarding the draft regulatory analysis and regulatory flexibility (i.e., small business) analysis supporting the NPRM. These included use of data from parent companies rather than distinct operating subsidiaries in determining whether small businesses could be affected and use of inappropriate data to estimate costs. These comments have been addressed in the final regulatory analysis that is included in the rulemaking docket.

Finally, NTSB suggested that PHMSA should be given sole jurisdiction over offshore pipelines on the outer continental shelf. NTSB noted, in making this suggestion, that regulation of offshore pipelines was outside the scope of this NPRM. PHMSA agrees that changes in PHMSA jurisdiction over offshore pipelines are beyond the scope of this proceeding.

On December 3, 2010, PHMSA discussed the proposed rule with the Technical Hazardous Liquid Pipeline Safety Standards Committee (THLPSSC). The THLPSSC is a statutorily mandated advisory committee that advises PHMSA about the technical feasibility, reasonableness and cost-effectiveness of its proposed regulations. PHMSA discussed the comments received in response to the NPRM (e.g., concerns over effect on pipelines excluded from regulation and on rural gathering pipelines). These comments have been previously discussed in this document.

After careful consideration, the THLPSSC voted unanimously to find the NPRM and supporting regulatory evaluation technically feasible, reasonable, practicable, and cost effective. A transcript of the meeting is available in the docket for this rulemaking.

This final rule revises 49 CFR part 195 to cover: (1) Rural onshore low-stress pipelines with a diameter smaller than 8 5/8 inches located in or within one-half mile of a USA and (2) rural onshore low-stress pipelines of any diameter located more than one-half mile from a USA. With the publication of this final rule, and with limited exceptions, all low-stress pipelines regardless of location or size are now subject to the pipeline safety regulations. The final rule continues in place the one-half mile buffer to be used as the “could affect” area for application of IM requirements.

Our phased approach resulted in several distinct groups of rural low-stress pipelines:

• Rural low-stress pipelines that cross navigable waterways. These have historically been subject to the safety requirements of Part 195. These pipelines were not affected by phase one and are not affected by this rulemaking.

• Rural low-stress pipelines 8 5/8 inches or greater in diameter that are located in or within one-half mile of a USA. The requirements of Part 195 were made applicable to these rural pipelines in the phase one rule.

• Rural low-stress pipelines less than 8 5/8 inches in diameter that are located in or within one-half mile of a USA. These pipelines are made subject to the safety requirements of Part 195, including the IM requirements in § 195.452, by this final rule.

• Rural low-stress pipelines of any diameter that are located more than one-half mile from a USA. These pipelines are also made subject to the safety requirements of Part 195, excluding the IM requirements in § 195.452, by this final rule.

The phase one rule established a number of compliance deadlines for the rural pipelines it addressed, now referred to as Category 1 rural low-stress pipelines. These deadlines varied from relatively near term (e.g., identifying all pipeline segments subject to the phase one rule by April 3, 2009) to long term (e.g., completing baseline IM assessments by July 3, 2015). This final rule retains the compliance deadlines established in phase one for Category 1 rural low-stress pipelines. This rule subjects Category 2 rural low-stress pipelines to the same Part 195 requirements as those made applicable to Category 1 pipelines in phase one but with different compliance deadlines. Finally, this rule applies all requirements of Part 195 to Category 3 rural low-stress pipelines except for the IM requirements of § 195.452. Consistent with the phase one rule, pipeline segments will have to be identified within nine months of publication of this final rule, baseline IM assessments will have to be completed within five years of publication of the final rule, compliance with the requirements of subpart H of Part 195, Corrosion Control, will have to occur within three years and compliance with all other applicable requirements will have to occur with 12 months of publication of the final rule.

This final rule includes, as did the phase one rule, an option for operators to determine which pipeline segments are subject to IM requirements by performing analyses to determine whether pipeline segments could affect a USA in lieu of using the one-half-mile buffer.

This rule includes, as did the phase one rule, a provision addressing newly identified USAs. Such new USAs could result in additional pipeline segments meeting criteria for Category 1 or 2 rural low-stress pipelines and thus become subject to IM requirements. This final rule requires that pipeline segments identified as Category 1 or 2 continue to meet the requirements applicable to those Categories even if the boundaries of a USA are redefined so that the pipeline segment (or portion thereof) is no longer within one-half mile of the USA unless the operator determines that the segment could not affect the USA. This provision adds no additional burden because pipeline operators may simply continue to treat their pipelines as they would have without the redefinition of USA boundaries.

Section 195.1 has been revised numerous times over the years to include changes to the pipelines covered or excluded from the scope of Part 195. Section 195.1 was revised in the phase one rule to provide more clarity and to include the phase one rural low-stress pipelines within the scope of Part 195. This final rule revises Sections 195.1(a) and (b) to include the rural low-stress pipelines brought under Part 195 regulations in phase two. The changes to this section do not affect any of the other covered or excluded pipelines previously identified in § 195.1.

This final rule also corrects an inadvertent error to § 195.1 that was introduced by the changes made under the phase one rule. The error concerns the long-standing exception for low-stress pipelines subject to the regulations of the USCG. Under the phase one rule, § 195.1 was incorrectly revised to state that Part 195 does not apply to any pipeline subject to the safety regulations of the USCG. In this final rule, we are correcting § 195.1 to state again that Part 195 does not apply to any low-stress pipeline subject to the safety regulations of the USCG.

This Section is being revised to clarify that all previously unregulated low-stress pipelines in rural areas are now covered under Part 195 regulation. This Section does not apply to rural low-stress pipelines that cross a waterway used for commercial navigation because they have been regulated under Part 195 before either of the rulemakings addressing rural low-stress pipelines.

This section has been revised to define three categories of rural low-stress pipelines (Section 195.12(b)):

• Category 1 lines are those that were regulated in phase one (i.e., rural low-stress pipelines with a diameter of 8 5/8 inches or more located in or within one-half mile of a USA).

• Category 2 pipelines are those rural low-stress pipelines of smaller diameter (less than 8 5/8 inches) located in or within one-half mile of a USA.

• Category 3 are all remaining rural low-stress pipelines except for those that cross navigable waterways (which are already regulated under § 195.1 and are not addressed in § 195.12).

Section 195.12(c) also sets forth the required deadlines for compliance with various portions of Part 195. The compliance deadlines established by the phase one final rule for Category 1 rural low-stress pipelines remain unchanged. Except for the compliance deadlines for the completion of baseline IM assessments, this final rule establishes deadlines for Category 2 and Category 3 rural low-stress pipelines in the same manner as was done for Category 1 pipelines. For example, operators of Category 1 rural low-stress pipelines were required to identify these pipelines within nine months of the effective date of the phase one final rule and this final rule requires the same nine-month time frame for an operator of a Category 2 or Category 3 rural low-stress pipeline. In phase one, PHMSA adopted a compliance deadline of three and one-half years for completing 50% of baseline IM assessments and seven years for completing all baseline assessments. PHMSA concluded that it was appropriate to reduce the compliance deadlines for these requirements for the pipelines covered by this final rule considering the amount of time that has transpired since the passage of the PIPES Act and the relatively small number of miles that would be subject to these requirements. Thus, this final rule requires that operators of Category 2 pipelines complete all baseline IM assessments within five years of the effective date of the final rule and that at least 50 percent of the assessments be completed within two and one-half years.

As discussed above, PHMSA did not change the provision allowing operators of some Category 1 rural low-stress pipelines to notify PHMSA if they conclude that implementing the IM assessment requirements would pose such an economic burden that they would abandon their pipelines. This provision continues to be limited to Category 1 rural low-stress pipelines carrying crude oil from production facilities and where shutdown of the pipeline would cause loss of oil supply or a transition to truck transportation. PHMSA (with assistance from DOE, as appropriate) will review notifications and, if justified, may grant the operator a special permit to allow continued operation of the pipeline subject to alternative safety requirements.

PHMSA's reasoning for not extending the provision to Category 2 pipelines is based on the definition of “gathering line” in § 195.2. That Section defines any “pipeline 219.1 mm (8 5/8 inch) or less nominal outside diameter that transports petroleum from a production facility” as a gathering line. Gathering lines are not subject to the provisions of § 195.12. Instead, requirements applicable to regulated rural gathering lines are found in § 195.11, and do not include IM requirements. As a result, no rural low-stress pipeline of 8 5/8 inch or less nominal diameter that carries crude oil from a production facility is subject to IM requirements, and it is not necessary to provide an economic burden provision for these pipelines to ameliorate unintended impacts on production.

This Section was added in the phase one final rule. There had not previously been a scope Section in Subpart B because all pipelines subject to Part 195 were subject to all the reporting requirements in Subpart B. This Section was added in phase one because the reporting requirements of Subpart B were made applicable to all rural low-stress pipelines, even those not subject to the safety requirements of the phase one rule. Operators of those rural low-stress pipelines not subject to the technical requirements of Part 195 under phase one were not required to complete those portions of the annual report form that relate to IM requirements and inspections.

With this final rule, all rural low-stress pipelines are now subject to all requirements of Part 195, except that Category 3 pipelines are not subject to the IM requirements in § 195.452. The exclusion of portions of the annual report form related to IM has therefore been modified to apply only to operators of Category 3 pipelines.

PHMSA considers this final rule a non-significant regulatory action under Section 3(f) of Executive Order 12866 (58 FR 51735; Oct. 4, 1993). The rule is also non-significant under DOT regulatory policies and procedures (44 FR 11034: February 26, 1979). PHMSA prepared a Regulatory Evaluation, a copy of which has been placed in the docket.

This final rule affects those rural low- stress pipelines of any diameter that are more than one-half mile outside a USA and rural low-stress pipelines less than 8 5/8 inches in diameter that are located in or within one-half mile of a USA. The following table presents the estimates for the mileage affected by this rulemaking:

Four sources of mileage data that provide varying levels of detail were analyzed to derive these final mileage estimates:

• The Regulatory Analysis for the low-stress phase 1 final rule by PHMSA published in August 2006.

• A survey of operators of low-stress pipelines.

• The annual mileage data pipeline operators report to PHMSA.

• Mileage estimates reported to the NPMS.

PHMSA concluded that the estimate of 5,624 miles of rural low-stress pipeline made in the phase one regulatory analysis was a high-end estimate. The results of the survey PHMSA conducted identified 1,575 miles and the NPMS reports 1,672.9 miles, with the NPMS data excluding both intra-plant miles and lines regulated in phase one. The PHMSA annual report database includes 1,536 newly-reported low-stress rural miles. Since the data collected in the survey includes a variety of other information used in this analysis, including characteristics of the reported mileage, it was used for phase two rural low-stress pipeline mileage estimates. Distribution percentages and assumptions relating to the three phase two rural low-stress pipeline segments result in a slightly lower estimate of total miles than the original estimate that resulted from the survey data. This final estimate is approximately 1,384 miles of eligible rural low-stress pipeline.

PHMSA estimates the 30-year net present values  5 of compliance costs for this final rule to be $104.9 million. The operators of the pipelines affected by the regulatory changes included in the final rule are expected to incur costs attributable to those changes. The costs of the rulemaking will be those associated with bringing the affected pipelines into compliance with Part 195, which has the following eight Subparts:

In addition, operators of the low-stress pipelines brought under Part 195 would also need to comply with 49 CFR part 199, the alcohol and drug testing requirements.

The 30-year net present value of benefits of this final rule is $326.5 million. PHMSA expects the regulatory changes to reduce the number of incidents and the incident costs and consequences. The ability of the final rule to reduce or avoid these costs is considered to be the primary benefit of the regulation and is referred to as traditional benefits. Data on incident costs for rural low-stress pipelines are generally not available because PHMSA has not regulated these pipelines in the past. Moreover, the reduction in costs that the regulation would cause is also unknown. The final 30-year net present values of benefits of this final rule are $326.5 million.

This final rule also may produce benefits by preventing disruptions in the fuel supply caused by pipeline failures. Any interruption in the fuel supply impacts the U.S. economy by putting upward pressure on the prices paid by businesses and consumers, as incidents on Alaskan low-stress pipelines feeding major petroleum trunk lines have illustrated. Supply disruptions also have national security implications because they increase dependence on foreign sources of oil.

The Regulatory Flexibility Act of 1980, as amended, requires Federal agencies to conduct a separate analysis of the economic impact of rules on small entities. The Regulatory Flexibility Act requires that Federal agencies take small entities' concerns into account when developing, writing, publicizing, promulgating, and enforcing regulations.

This final rule covers certain rural onshore low-stress hazardous liquid pipelines. Beginning in 1991, Congress paid greater attention to the risks that hazardous liquid and natural gas pipelines pose to the environment. In the Pipeline Safety Act of 1992 (Pub. L. 102-508), Congress gave DOT greater authority to protect the environment from risks posed by pipelines. Congress continued to emphasize the need to better protect the environment from the risks pipelines pose in the Accountable Pipeline Safety and Partnership Act of 1996 (Pub. L. 104-304). With the PIPES Act of 2006 (Pub. L. 109-468), Congress went further and instructed DOT to apply all Part 195 requirements to unregulated rural low-stress pipelines.

PHMSA decided to apply Part 195 requirements to rural low-stress pipelines as a two-phase process. The phase one rulemaking covered large diameter pipe (greater than or equal to 8 5/8 inches in diameter) located in or within one-half mile of a USA. These were the higher-risk rural low-stress pipelines. This final rule addresses the remaining unregulated rural low-stress pipelines.

PHMSA is bringing the remaining rural onshore low-stress pipelines not regulated by phase one under the safety regulations of 49 CFR part 195. These lines include rural low-stress pipelines with a diameter of less than 8 5/8 inches that are within one-half mile of a USA and rural low-stress pipelines of any size diameter that are outside of the one-half mile USA buffer.

There are currently no related rules or regulations issued by other departments or agencies of the Federal Government.

In accordance with size standards published by the Small Business Administration, a pipeline transportation business with 1,500 or fewer employees is considered a small entity. 6 Depending on the products being transported, low-stress pipeline operators belong to the North American Industry Classification System Code (NAICS) 486110, Pipeline Transportation of Crude Oil, or NAICS 486910, Pipeline Transportation of Refined Petroleum Products. For both NAICS codes, a business with 1,500 or fewer employees is considered a small entity.

PHMSA made an extensive effort to identify small and other operators of rural low-stress lines. PHMSA surveyed these operators to get better information about the number of miles and compliance costs of rural hazardous liquid low-stress pipelines.

To ensure that the response rate was maximized, PHMSA publicized its plans to conduct the survey in (1) a 60-day Federal Register (FR) notice published on September 6, 2006, (71 FR 52504) and (2) a 30-day FR notice published on September 7, 2007, (72 FR 51489). No comments were submitted to either notice. PHMSA then announced the availability of the survey in a FR notice published on July 31, 2008, (73 FR 44800).

PHMSA delivered the survey and a letter explaining the importance of the study via three methods:

1. A version of the survey that allowed operators to directly input responses was posted on the PHMSA OPS Online Data Entry Web site (ODES). An e-mail announcing the survey was sent to the contact person responsible for each company's most recent annual report submission.

2. Respondents were also able to print an electronic version of the survey directly from the e-mail received and mail or fax a completed hard copy to the Volpe National Transportation Systems Center (Volpe Center).

3. Finally, in an effort to reach companies that currently operate unregulated pipelines exclusively, PHMSA and the Volpe Center worked with the American Petroleum Institute, the Association of Oil Pipelines and the Independent Petroleum Association of America to announce and distribute the survey to their members via their email newsletters.

Of the 112 operators that responded, 20 reported rural low-stress pipeline mileage. PHMSA then conducted additional follow-up discussions with these operators. Only 12 of the 20 operators were identified as actually having rural low-stress pipeline mileage that would be addressed by the phase two rulemaking. Two of the 12 relevant operators are owned by the same parent company. Therefore, there are 11 businesses that may be potentially affected by this rule.

In order assess the potential business compliance impact, information on the size of the ultimate parent companies for the potentially affected pipeline operators was collected from a compilation of Dun & Bradstreet data, online company profiles, and direct phone calls. This use of data for the ultimate parent enterprise is consistent with the Regulatory Flexibility Act which directs Federal agencies to use the U.S. Small Business Administration's (SBA) definition of a small business. The SBA's definition of a small business considers a firm's parent company and all affiliates to be a single entity. The enterprise name, number of employees, revenues, profits, compliance costs and affected mileage are listed in the following table.

The table above shows that three of the 11 enterprises employ less than 1,500 persons and are thus considered small entities. The cost estimation analysis, described in the Regulatory Analysis, concluded that the rural low- stress mileage held by two of these operators is already in compliance with Part 195. Therefore, these two small entities will not be adversely affected by the rulemaking. The other small entity, which has four miles of affected rural low- stress mileage, reports an initial compliance cost of $475,000 and recurring costs of $100,000 every five years.

The Regulatory Flexibility Act directs agencies to establish exceptions and differing compliance standards for small businesses, where it is possible to do so, and still meet the objectives of applicable regulatory statutes.

The phase two Regulatory Analysis analyzes six regulatory alternatives. They are as follows:

Alternative 1: Apply all Part 195 requirements to all eligible rural low-stress pipelines.

Alternative 2: Apply all Part 195 requirements to small diameter rural low-stress pipelines located in or within one-half mile of a USA.

Alternative 3: Apply all Part 195 requirements to rural low-stress pipelines equal to or greater than 8 5/8 inches in diameter located farther than one-half mile from a USA.

Alternative 4: Apply all Part 195 requirements to rural low-stress pipelines less than 8 5/8 inches in diameter outside one-half mile of a USA.

Alternative 5: Apply all Part 195 requirements except Subpart H (Corrosion Control) to all rural low-stress pipelines not currently regulated.

Alternative 6: Apply all Part 195 requirements except the IM Program to all rural low-stress pipelines not currently regulated.

Alternative 1 is the alternative that PHMSA has selected. This alternative not only complies with the statutory requirement but also increases the level of safety and environmental protection associated with the transportation of hazardous liquids through low-stress pipelines to a level commensurate with other pipelines that are already subject to the pipeline safety regulations.

From the information we have gathered, this final rule will have an economic impact on one known small entity. Therefore, under Section 605 of the Regulatory Flexibility Act, this final rule will not have a significant impact on a substantial number of small entities.

PHMSA has analyzed this final rule according to the principles and criteria in Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments.” Because this final rule would not significantly or uniquely affect the communities of the Indian tribal governments or impose substantial direct compliance costs, the funding and consultation requirements of Executive Order 13175 do not apply.

Pursuant to 5 CFR 1320.8(d), PHMSA used the NPRM to provide interested members of the public and affected agencies with an opportunity to comment on information collection and recordkeeping requests. PHMSA identified four information collections that would bear some impact as a result of this rulemaking. No comments were received. Upon review of the burden impacts on the identified information collection requests, PHMSA believes that the minimal impact to these information collections do not warrant revisions to the currently approved information collections.

The following information is provided for each information collection: (1) Title of the information collection; (2) OMB control number; (3) type of request; (4) abstract of the information collection activity; (5) description of affected public; (6) estimate of total annual reporting and recordkeeping burden; and (7) frequency of collection. PHMSA estimates that based on the requirements in this rule, the current information collection burden for the following information collections will remain as follows:

Title of information Collection: Transportation of Hazardous Liquids by Pipeline: Recordkeeping and Accident Reporting.

OMB Control Number: 2137-0047.

Type of Request: Revision of a currently approved information collection.

Abstract: Hazardous liquid pipeline operators must keep records to ensure that their pipelines are operated safely. Operators must also report accidents.

Type of Respondents: Hazardous Liquid Operators.

Total Annual Responses: 847.

Total Annual Burden Hours: 51,329 hours.

Frequency of Collection: On occasion.

Title of information Collection: National Pipeline Mapping Program.

OMB Control Number: 2137-0596.

Type of Request: Revision of a currently approved information collection.

Abstract: The operator of a pipeline facility (except distribution lines and gathering lines) provides information to PHMSA on the characteristics of its pipeline system. The submitted information includes updates to annual mapping information for each mile of pipeline.

Type of Respondents: Pipeline Facility Operators (except distribution lines and gathering lines).

Total Annual Responses: 894.

Total Annual Burden Hours: 16,312 hours.

Frequency of Collection: Annual.

Title of information Collection: Pipeline Integrity Management in High Consequence Areas (Operators with less than 500 Miles of Hazardous Liquid Pipelines).

OMB Control Number: 2137-0605.

Type of Request: Revision of a currently approved information collection.

Abstract: Hazardous Liquid Operators with less than 500 miles of Pipelines are required to continually assess and evaluate the integrity of their pipeline through inspection or testing. Such operators must also implement remedial, preventive, and mitigative actions on these pipelines.

Type of Respondents: Hazardous Liquid Operators (with less than 500 miles of pipelines).

Total Annual Responses: 132.

Total Annual Burden Hours: 267,960 hours.

Frequency of Collection: On occasion.

Title of information Collection: Public Awareness Program.

OMB Control Number: 2137-0622.

Type of Request: Revision of a currently approved information collection.

Abstract: Current regulations require pipeline operators to develop and implement public awareness programs. Public awareness and understanding of pipeline operations is vital to the continued safe operation of pipelines. Upon request, operators must submit their completed programs to PHMSA or, in the case of an intrastate pipeline facility operator, the appropriate state agency.

Type of Respondents: Pipeline Operators.

Total Annual Responses: 22,500.

Total Annual Burden Hours: 517,480 hours.

Frequency of Collection: On occasion.

Any questions regarding these information collections should be directed to Cameron Satterthwaite, Office of Pipeline Safety (PHP-30), Pipeline and Hazardous Materials Safety Administration (PHMSA), 2nd Floor, 1200 New Jersey Avenue, SE., Washington, DC 20590-0001, SW., Washington, DC 20590-0001, Telephone 202-366-8553.

This final rule does not impose unfunded mandates under the Unfunded Mandates Reform Act of 1995. It does not result in costs of $141.3 million or more to either state, local, or tribal governments, in the aggregate, or to the private sector, and is the least burdensome alternative that achieves the objective of the regulatory action.

The National Environmental Policy Act requires Federal agencies to integrate environmental values into their decision making processes by considering the environmental impacts of their proposed actions and reasonable alternatives to those actions. PHMSA conducted an environmental assessment of the application of phase two safety regulations to rural onshore hazardous liquid pipelines. This environmental assessment examined the environmental impacts of the requirements proposed in the NPRM, and reasonable alternatives to those actions, on the environment.

The environmental assessment found that the NPRM requirements would not significantly affect the quality of the environment. Only limited physical modification or other work that would disturb pipelines would be required, such as identifying segments of pipelines meeting the regulatory definitions, inspection and testing, installing and maintaining line markers, implementing corrosion controls, pipeline cleaning, and establishing integrity assessment programs. The environmental assessment preliminarily concluded the expected reductions in hazardous liquid spills are a minor to moderate positive environmental impact offsetting the negligible negative environmental impacts associated with implementing the rulemaking. The full final environmental assessment is available for review in the public docket. We did not receive any comment on the assessment or preliminary conclusion. Therefore, we conclude that this rulemaking will not result in any significant negative or positive environmental impacts affecting the quality of the human environment.

PHMSA has analyzed this final rule according to the principles and criteria contained in Executive Order 13132 (“Federalism”). This final rule would not (1) have substantial direct effects on the states, the relationship between the national government and the states, or the distribution of power and responsibilities among the various levels of government; (2) impose substantial direct compliance costs on state and local governments; or (3) preempt state law. Therefore, the consultation and funding requirements of Executive Order 13132 do not apply.

This final rule is not a “significant energy action” under Executive Order 13211. It is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Furthermore, this final rule has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action.

For the reasons provided in the preamble, PHMSA amends 49 CFR Part 195 as follows:

I. Background/Overview

This exception to FMCSA's hours-of-service (HOS) regulations is mandated by the RSIA of 2008. This law provides that “signal employees” who operate motor vehicles and who are regulated under 49 U.S.C. 21101, et seq., are not subject to HOS rules promulgated by any other Federal authority, including FMCSA. See 49 U.S.C. 21104(e). Thus, FMCSA amends its regulations to state that FMCSA's HOS regulations do not apply to a signal employee who is regulated under 49 U.S.C. 21101-21109. This amendment will clarify the current exception applicable to signal employees for industry and for Federal, State and local law enforcement and eliminate the potential for issuance of improper citations.

FMCSA is also amending the authority citation for 49 CFR part 395 to add appropriate statutory references and eliminate references that are either erroneous or unnecessary.

This final rule is based on FMCSA's authority to implement statutory directives enacted by several provisions of the RSIA of 2008, Public Law 110-432, 122 Stat. 4848, 49 U.S.C. 21101, et seq. Section 108 of the RSIA of 2008 substantively amends the law applicable to employees engaged in signal work for railroad operations, effective July 16, 2009. Section 108(a) amends the definition of “signal employee” to eliminate the words “employed by a railroad carrier.” See 49 U.S.C. 21101(4). As a result, employees of railroad contractors and subcontractors who are engaged in installing, repairing, or maintaining signal systems (the functions within the definition of signal employee) will also be covered by the HOS laws administered by the Federal Railroad Administration (FRA). Section 108(c) modifies the HOS restrictions applicable to covered employees. See 49 U.S.C. 21104(a)-(d).

Finally, section 108(c) provides that the HOS, duty hours, and rest periods of signal employees are governed exclusively by the HOS laws administered by FRA. It also provides that signal employees operating applicable motor vehicles are not subject to other HOS, duty hours, or rest period rules besides the FRA's requirements. See 49 U.S.C. 21104(e).

The statutory provision may be incorporated in regulations adopted by FMCSA under the authority of the Motor Carrier Act of 1935 (49 U.S.C. 31502(b)) and the Motor Carrier Safety Act of 1984 (49 U.S.C. 31136). FMCSA is authorized to implement these statutory provisions by delegation from the Secretary of Transportation in 49 CFR part 1.73.

Congress gave the Agency no discretion with respect to implementation of these RSIA of 2008 provisions. While the Administrative Procedure Act (APA) ordinarily requires the issuance of a notice of proposed rulemaking (NPRM) and opportunity for public comment, the APA provides an exception when an “agency for good cause finds * * * that notice and public procedure * * * are impracticable, unnecessary, or contrary to the public interest.” 5 U.S.C. 553(b)(B). Because this rule is technical and simply conforms FMCSA rules with current statutory provisions, the Agency deems notice and comment procedures “unnecessary” under 5 U.S.C. 553(b)(B). The promulgation of this final rule is a nondiscretionary ministerial act required by a statute. It is also contrary to the public interest to delay clarification of this requirement and FMCSA's lack of authority to enforce regulations in light of the FRA's authority of this area. Thus, the Agency finds that this rule may be adopted without issuing an NPRM and receiving public comment.

Similarly, the Agency finds the normal 30-day delayed effective date following publication of a rule does not apply. 5 U.S.C. 553(d). The APA exempts from the delayed effective date requirement “a substantive rule which grants or recognizes an exemption or relieves a restriction.” 5 U.S.C. 553(d)(1). Pursuant to the RSIA of 2008, persons covered by the statutory provision have not been subject to FMCSA's HOS requirements since the enactment of the legislation. This rule simply makes FMCSA rules consistent with the statute. Therefore, a 30-day delay in the effective date would serve no purpose as the Agency amends its rule to eliminate confusion among enforcement officials. The Agency further finds good cause for this rule to take effect upon publication under 5 U.S.C. 553(d)(3) because, given that the rule results in no substantive change in the law, there is no need for the affected industry to prepare for its implementation.

Although the RSIA of 2008 uses the term “exemption” to cover signal employees, in order to avoid confusion with the process that FMCSA uses to grant time-limited exemptions under 49 CFR part 381, today's final rule creates an “exception.” This exception, unlike an exemption, is permanent in nature, subject to our legal authority.

We implement section 108(c) of the RSIA of 2008 by adding paragraph (r) to § 395.1, exempting signal employees who operate CMVs, but who are covered by laws applicable to railroad operations, from FMCSA HOS regulations.

FMCSA has determined that this action does not meet the criteria for a “significant regulatory action” either as specified in Executive Order (E.O.) 12866 as supplemented by E.O. 13563 issued by the President on January 18, 2011 (76 FR 3821), or within the meaning of the Department of Transportation regulatory policies and procedures (44 FR 11034, Feb. 26, 1979). Therefore, this rule has not been reviewed by the Office of Management and Budget (OMB). There is no economic impact to this rule that would necessitate conducting a full regulatory evaluation. The rule simply codifies the elimination of FMCSA jurisdiction over railroad signal employees, pursuant to the RSIA of 2008. The RSIA of 2008 section 108(c) delegates the jurisdiction over the HOS, duty hours, and rest periods of signal employees exclusively to the FRA. See 49 U.S.C. 21104(a)-(e).

Under the Regulatory Flexibility Act, as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121, 110 Stat. 857), FMCSA is not required to prepare a final regulatory flexibility analysis under 5 U.S.C. 604(a) for this final rule because the Agency has not issued an NPRM prior to this action. This final rule also complies with the President's memorandum of January 18, 2011, entitled Regulatory Flexibility, Small Business, and Job Creation (76 FR 3827). As discussed above, promulgation of this final rule is a nondiscretionary ministerial act required by a statute and it creates a regulatory exception.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. However, as noted above, this is a non-discretionary action mandated by statute, and such actions do not require preparation of a statement under 2 U.S.C. 1532. In addition, FMCSA is not required to prepare a statement for this final rule because the Agency has not issued an NPRM prior to this action. 2 U.S.C. 1532.

The regulations implementing E.O. 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this action.

The rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Given FRA's authority under the RSIA of 2008 to regulate the HOS for certain carriers previously regulated by FMCSA under 49 CFR part 395, FMCSA expects the population of affected entities subject to its HOS paperwork burden may be reduced slightly. However, due to the total number of entities covered, the impact to the burden from this change is expected to be de minimis. Therefore, FMCSA has not modified its burden estimate based on this final rule. FMCSA will consider this impact during its next planned update to the associated Information Collection Request.

The Agency analyzed this final rule in accordance with all statutory and regulatory policies under the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et seq. ) and determined under FMCSA environmental procedures Order 5610.1, published March 1, 2004 (69 FR 9680), that the provision of this rule is categorically excluded (CE) based on Appendix 2, section 6(b) of the FMCSA order. This is a technical amendment needed to conform the regulations to a statutory mandate. In addition to the NEPA requirements to examine impacts on air quality, the Clean Air Act (CAA) as amended (42 U.S.C. 7401 et seq. ) also requires FMCSA to analyze the potential impact of its actions on air quality and to ensure that FMCSA actions conform to State and local air quality implementation plans. The additional contributions to air emissions from this action are expected to fall within the CAA de minimis standards and are not expected to be subject to the Environmental Protection Agency's General Conformity Rule (40 CFR parts 51 and 93).

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

FMCSA has analyzed this action under E.O. 13045, Protection of Children from Environmental Health Risks and Safety Risks. We determined that this final rule does not pose an environmental risk to health or safety that may disproportionately affect children.

This final rule does not effect a taking of private property or otherwise have taking implications under E.O. 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This action has been analyzed in accordance with the principles and criteria contained in E.O. 13132, Federalism Assessment, and it has been determined that this rulemaking does not have a substantial direct effect or sufficient federalism implications for States that would limit the policymaking discretion of the States. Nothing in this document directly preempts any State law or regulation. This final rule does not impose additional costs or burdens on the States.

FMCSA has analyzed this final rule under E.O. 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that Executive Order because it would not be likely to have an adverse effect on the supply, distribution, or use of energy.

For the reasons set forth in the preamble, the Federal Motor Carrier Safety Administration amends 49 CFR part 395 as follows:

On April 2, 2009, we, the U.S. Fish and Wildlife Service (Service), published a final rule to remove protections of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq. ), from most of the concurrently designated northern Rocky Mountain (NRM) gray wolf Distinct Population Segment (DPS) (74 FR 15123). Additional background information on the NRM gray wolf population, including previous Federal actions, can be found in our April 2, 2009, final rule. The complete text of the April 2, 2009, publication in the Federal Register can be viewed online as part of the docket for this rulemaking at http://www.regulations.gov.

Lawsuits challenging our April 2, 2009, final rule were filed in U.S. District Court for the District of Montana and U.S. District Court for the District of Wyoming. On August 5, 2010, the U.S. District Court for the District of Montana vacated and set aside our 2009 delisting rule ( Defenders of Wildlife et al. v. Salazar et al., (729 F. Supp. 2d 1207 (D. Mont.).

On April 15, 2011, President Obama signed Public Law 112-10—The Department of Defense and Full-Year Continuing Appropriations Act, 2011. Section 1713 of Public Law 112-10 requires: “Before the end of the 60-day period beginning on the date of enactment of this Act, the Secretary of the Interior shall reissue the final rule published on April 2, 2009 (74 FR 15123 et seq. ), without regard to any other provision of statute or regulation that applies to issuance of such rule. Such reissuance (including this section) shall not be subject to judicial review and shall not abrogate or otherwise have any effect on the order and judgment issued by the United States District Court for the District of Wyoming in Case Number 09-CV-118J and 09-CV-138J on November 18, 2010.”

This final rule implements that directive. The regulatory text of this final rule differs from that of the April 2, 2009, final regulation only to reflect the withdrawal of the April 2, 2009, delisting of the western Great Lakes distinct population segment of gray wolves (74 FR 15070) pursuant to terms of a settlement agreement approved by the District Court for the District of Columbia in Humane Society of the United States v. Salazar, 1:09-CV-1092-PLF (D.DC), on July 1, 2009. The preamble to the 2009 final NRM rule was explicit that the regulatory language pertaining to the western Great Lakes DPS was not attributable to the NRM rule:

Gray wolves in Montana and Idaho, as well as portions of eastern Oregon, eastern Washington, and north-central Utah, are removed from the List of Endangered and Threatened Wildlife. Gray wolves in Wyoming remain on the List of Endangered and Threatened Wildlife and continue to be subject to the provisions of our experimental population regulations codified at 50 CFR 17.84(i) and (n).

Outside Wyoming, this rule will not affect the status of the gray wolf in the NRM under State laws or suspend any other legal protections provided by State law. This rule will not affect the gray wolf's Appendix II status under the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES).

In the Proposed Rules section of today's Federal Register , we are also publishing a proposed rule that reevaluates the listing of the western Great Lakes population of gray wolves ( Canis lupus ) and proposes to revise it to conform to current statutory and policy requirements. The rule portions for 50 CFR 17.11(h) of this final rule and the proposed western Great Lakes rule are different because the final rule depicts the listing for the gray wolf as it stands today, based on the long history of rulemaking for this species, various judicial decisions, and the recent congressional action. The rule portion of the western Great Lakes rule reflects the listing for the gray wolf as we envision it should be unless public comments on the proposed rule provide information that persuades us that the listing should be presented differently.

This rule is effective upon publication in the Federal Register . Section 1713 of Public Law 112-10, directs us to reissue, within 60 days of enactment, the final NRM rule published on April 2, 2009. Section 1713 also expressly provides that such reissuance is not subject to any other statute or regulation that applies to such a rule.

This rulemaking implements section 1713 of Public Law 112-10, which expressly provides that the reissuance of this rule is not subject to any other provision of statute or regulation that applies to issuance of such a rule.

Accordingly, we amend part 17, subchapter B of chapter I, title 50 of the CFR, as set forth below:

It is our intent to discuss only those topics directly relevant to this final rule establishing a Sonoran pronghorn nonessential experimental population (NEP). For more information on the Sonoran pronghorn, refer to the February 4, 2010, proposed rule (75 FR 5732) and the 1998 Revised Sonoran Pronghorn Recovery Plan (Service 1998: http://ecos.fws.gov/docs/recovery_plan/981203.pdf ) and its amendments (Service 2002: http://ecos.fws.gov/docs/recovery_plan/031126.pdf ).

We listed the Sonoran pronghorn subspecies ( Antilocapra americana sonoriensis ) as endangered throughout its range on March 11, 1967 (32 FR 4001), under the Endangered Species Preservation Act of October 15, 1966, without critical habitat. This subspecies was included as an endangered species when the Endangered Species Act was signed into law in 1973 (Act; 16 U.S.C. 1531 et seq. ). The Act provides that species listed as endangered are afforded protection primarily through the prohibitions of section 9 and the requirements of section 7. Section 9 of the Act, among other things, prohibits the take of endangered wildlife. “Take” is defined by the Act as to harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or attempt to engage in any such conduct. Service regulations (50 CFR 17.31) generally extend the prohibitions of take to threatened wildlife. Section 7 of the Act outlines the procedures for Federal interagency cooperation to conserve federally listed species and protect designated critical habitat. It mandates that all Federal agencies use their existing authorities to further the purposes of the Act by carrying out programs for the conservation of listed species. It also states that Federal agencies will, in consultation with the Service, ensure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat. Section 7 of the Act does not affect activities undertaken on private or other non-Federal land unless they are authorized, funded, or carried out by a Federal agency.

Under section 10(j) of the Act, the Secretary of the Department of the Interior can reestablish populations outside the species' current range and designate them as “experimental.” With the experimental population designation, the relevant population is treated as threatened for purposes of section 9 of the Act, regardless of the species' designation elsewhere in its range. Threatened designation allows us discretion in devising management programs and special regulations for such a population. Section 10(j) of the Act allows us to adopt whatever regulations are necessary and advisable to provide for the conservation of a NEP. In these situations, the general regulations that extend most section 9 prohibitions to threatened species do not apply to that species, and the 10(j) rule contains the prohibitions and exemptions necessary and appropriate to conserve that species.

For the purposes of section 7 of the Act, we treat an NEP as a threatened species when the NEP is located within a National Wildlife Refuge or unit of the National Park Service, and section 7(a)(1) and the consultation requirements of section 7(a)(2) of the Act apply. Section 7(a)(1) requires all Federal agencies to use their authorities to carry out programs for the conservation of listed species. Section 7(a)(2) requires that Federal agencies, in consultation with the Service, ensure that any action authorized, funded, or carried out is not likely to jeopardize the continued existence of a listed species. When NEPs are located outside a National Wildlife Refuge or National Park Service unit, then for the purposes of section 7, we treat the population as proposed for listing, and only two provisions of section 7 apply—section 7(a)(1) and section 7(a)(4).

In these instances, NEPs provide additional flexibility because Federal agencies are not required to consult with us under section 7(a)(2). Section 7(a)(4) requires Federal agencies to confer (rather than consult) with the Service on actions that are likely to jeopardize the continued existence of a species proposed to be listed. The results of a conference are in the form of conservation recommendations that are optional as the agencies carry out, fund, or authorize activities. Because the NEP is, by definition, not essential to the continued existence of the species (see below) then the effects of proposed actions on the NEP will generally not rise to the level of jeopardizing the continued existence of the species. As a result, a formal conference will likely never be required for Sonoran pronghorn established within the NEP area. Nonetheless, some agencies (e.g., Bureau of Land Management (BLM)) voluntarily confer with the Service on actions that may affect a proposed species. Section 10(j)(2)(c)(ii) precludes the designation of critical habitat for nonessential populations. Activities that are not carried out, funded, or authorized by Federal agencies are not subject to provisions or requirements in section 7.

Based on the best scientific and commercial data available, we must determine whether the experimental population is essential or nonessential to the continued existence of the species. The regulations (50 CFR 17.80(b)) state that an experimental population is considered essential if its loss would be likely to appreciably reduce the likelihood of survival of that species in the wild. All other populations are considered nonessential. We have determined that this experimental population is not essential to the continued existence of the species in the wild (see Status of Reestablished Populations section below). Therefore, the Service is designating a nonessential experimental population for the species in this area.

Sonoran pronghorn used to establish the experimental population will come from a captive-rearing pen on Cabeza Prieta National Wildlife Refuge (NWR), as long as appropriate permits are issued in accordance with our regulations (50 CFR 17.22) prior to the animals' removal. The donor population is a captive-bred population derived primarily from wild stock at Cabeza Prieta NWR and from a wild Sonoran pronghorn population in northwestern Sonora, Mexico. The purpose of the captive population is to provide stock for augmenting existing U.S. and Mexican populations of Sonoran pronghorn, as well as supplying founder animals for establishment of an additional U.S. herd(s), in accordance with recovery actions 2.1-2.4 of the Sonoran Pronghorn Recovery Plan (Service 2002, pp. 47-48). The proposed population establishment will involve two phases: (1) Construction and operation of a captive-breeding pen at Kofa NWR, with subsequent releases to establish a new herd; and (2) relocation of excess Sonoran pronghorn from the existing breeding pen at Cabeza Prieta NWR to the eastern portion of the BMGR-E, east of Highway 85 and south of Interstate 8, with the intent of establishing another herd.

The Sonoran pronghorn was first described by Goldman (1945, pp. 3-4) and is small in terms of cranial measurements compared to the measurements of other subspecies of pronghorn (Nowak and Paradiso 1971, p. 857). Historically, the Sonoran pronghorn ranged in the United States from approximately the Santa Cruz River, Arizona, in the east, to the Gila Bend and Kofa Mountains, Arizona, to the north, and to Imperial Valley, California, to the west (Service 1998, pp. 4-6). In northwestern Sonora, Mexico, the subspecies is thought to have occurred historically as far south as Bahia Kino and east to Santa Ana and Nogales. In Baja California, Mexico, the subspecies occurred in the northeast from the United States border south to the vicinity of Punta Estrella (Phelps and Webb 1981, pp. 20-21; Service 2002, Fig. 2). Currently, three populations of the Sonoran pronghorn are extant: (1) A U.S. population in southwestern Arizona, south of Interstate 8, west of Highway 85, and east of the Copper and Cabeza Prieta mountains (80-90 wild pronghorn); (2) a population in the El Pinacate Region of northwestern Sonora (101 pronghorn); and (3) a population south and east of Mexico Highway 8 and west and north of Caborca, Sonora (381 pronghorn). The three populations are geographically isolated due to barriers such as roads and fences (Service 2002, pp. 4-10, Fig. 1). The current range of the Sonoran pronghorn in the United States is defined by the boundaries described in number (1) above. Section 10(j)(2)(A) of the Act states that, “The Secretary may authorize the release (and the related transportation) of any population (including eggs, propagules, or individuals) of an endangered species or a threatened species outside the current range of such species * * *” Consistent with years of survey data, we are confident that no Sonoran pronghorn population occurs outside of the current range (Phelps 1981, pp. 23-24; Service 2002, pp. 16 and 47).

Threats to the Sonoran pronghorn include:

(1) Highways, fences, railroads, developed areas, and irrigation canals that block access to essential forage or water resources;

(2) a variety of human activities that disturb pronghorn or degrade habitat, including livestock grazing in the United States and Mexico; military activities; recreation; poaching and hunting; clearing of desert scrub and planting of buffelgrass ( Pennisetum ciliare ), particularly in Sonora; gold mining southeast of Sonoyta, Sonora; dewatering and development along the Gila River and Río Sonoyta; and high levels of undocumented immigration and drug trafficking across the international border, and associated law enforcement response in the United States;

(3) wildfire, fueled by nonnative perennial and ephemeral plants that have increased fine fuels and allowed fire to become a much more frequent event in the Sonoran Desert;

(4) drought and associated limited food and water; and

(5) small population size and random changes in demographics.

Populations at low levels may experience random variations in sex ratios, age distributions, and birth and death rates among individuals, which can cause fluctuations in population size and possibly extinction (Service 2002, pp. 14-35; Primack 2002, pp. 196-197). In very sparse populations, males may have trouble finding females, causing an unequal sex-ratio, which may lead to a reduction in productivity (Primack 2002, pp. 310-311). In 2002, a severe drought was the primary cause of a major die off of Sonoran pronghorn. The U.S. population declined in 2002 by 83 percent, to 21 animals (Bright and Hervert 2005, p. 46). The Mexican populations declined at the same time, but not to the same degree. The population southeast of Highway 8 declined by 18 percent, while the El Pinacate population declined by 26 percent. The differences between the rates of decline north and south of the border may be due to high levels of human disturbance on the U.S. side, due primarily to heightened levels of illegal immigration, smuggling, and law enforcement response (Service 2008, p. 55).

Restoring an endangered or threatened species to the point where it is recovered is a primary goal of the endangered species program. Thus, in 1982 we published the Sonoran Pronghorn Recovery Plan (Plan) (Service 1982), which was produced by a Recovery Team comprised of representatives from the Arizona Game and Fish Department (AGFD), Cabeza Prieta NWR, BLM, and Organ Pipe Cactus National Monument (OPCNM). The Plan was subsequently revised in 1994, 1998, and 2002. Major recovery actions include:

(1) Enhance present populations of Sonoran pronghorn by providing supplemental forage and/or water;

(2) Determine habitat needs and protect present range;

(3) Investigate and address potential barriers to expansion of presently used range, and investigate, evaluate, and prioritize present and potential future reintroduction sites within the historical range;

(4) Establish and monitor a new, separate herd(s) to guard against catastrophes decimating the core population;

(5) Continue monitoring populations and maintain a protocol for a repeatable and comparable survey techniques; and

(6) Examine additional specimen evidence to assist in verification of taxonomic status (Service 1998, pp. iii-iv).

The 2002 Supplement did not include delisting criteria; however, eight short-term recovery actions were identified as necessary to downlist the species to threatened. The supplement goes on to say that accomplishing these actions would provide the information necessary to determine delisting criteria. One of the short-term recovery actions was “evaluating potential transplant locations, establishing methodology and protocols, developing interagency agreements (including with Mexico as required), acquiring funding, and initiating reestablishment projects” (Service 2002, p. 38).

After the catastrophic die off of Sonoran pronghorn in 2002, the Service and its partners embarked on a number of aggressive recovery actions to ensure the species' continued existence and to begin to rebuild populations. The cornerstone of these actions was a semi captive breeding facility, constructed in Childs Valley of Cabeza Prieta NWR in 2003, and stocked with wild Sonoran pronghorn in 2004. In 2009, as of May, 69 Sonoran pronghorn resided in the pen. To date, 44 Sonoran pronghorn have been released into the wild population. The goal of the facility is to produce at least 20 fawns each year for release to the current U.S. population, to newly established population(s) in the United States, and to augment Mexican populations.

A number of other projects are under way to increase availability of green forage and water during dry periods and seasons, offsetting to some extent the effects of drought and barriers that prevent Sonoran pronghorn from accessing greenbelts and water, such as the Gila River and Río Sonoyta. Nine emergency water sources (six on Cabeza Prieta NWR, one on OPCNM, and two on BMGR-West) have been constructed in recent years throughout the range of the U.S. population. Four forage enhancement plots, each consisting of a well, pump, pipelines, and irrigation lines, have been developed to irrigate the desert and produce forage for pronghorn. Another plot is nearing completion, and two additional plots will be installed over the next 5 years. These crucial projects, intended to pull the U.S. population back from the brink of extinction, have been cooperative efforts among the Service, AGFD, Marine Corps Air Station—Yuma, Luke Air Force Base, BLM, and OPCNM, with volunteer efforts from the Arizona Desert Bighorn Sheep Society, Arizona Antelope Foundation, and the Yuma Rod and Gun Club.

The U.S. wild population of Sonoran pronghorn has rebounded from 21 in 2002 to 80-90 in 2010; this increase has been facilitated by the collaborative recovery efforts for this species. However, at 80-90 animals currently, the U.S. population is far from being secure. We have begun to work with our Mexican partners on recovery of the Sonoran pronghorn in Sonora. Although the number of pronghorn in Sonora (482 animals) is significantly greater than in the United States, the safety net of water sources and forage plots is not in place there, and a severe drought could decimate those populations.

O'Brien et al. (2005) used landscape-level classification and modeling to assess potential Sonoran pronghorn habitat in southwestern Arizona, including current and historical range, as a means of beginning the process of identifying potential locations for establishing a second U.S. Sonoran pronghorn herd. Both models identified greater than 4,632 square miles (sq. mi) (greater than 12,000 square kilometers (sq. km)) of potential habitat (O'Brien et al. 2005, pp. 28-30). The largest blocks of potential habitat outside of the current range were the Ranegras and Harquahala plains, King Valley at Kofa NWR north of Interstate 8; Sentinel Plain and other areas to the west between Interstate 8 and the Gila River; and areas not currently occupied south of Interstate 8 and immediately west of Highway 85. The models also identified a large land area east of Highway 85 and south of Interstate 8 as potential habitat. The authors did not evaluate potential habitats in the far eastern portions of the historical range of the Sonoran pronghorn in Arizona (O'Brien et al. 2005, Figs. 3 and 4). O'Brien et al. (2005, p. 32) further explained that their models were an initial step toward identifying and evaluating potential translocation sites. They recommended soliciting public input, and reviewing predator presence and density, fencing, and the presence of preferred forage and water as additional steps in the evaluation process (O'Brien et al. 2005, p. 32).

An Interdisciplinary Team (IDT), comprising members of the Sonoran Pronghorn Recovery Team, the Tohono O'odham Nation, and representatives from land management agencies located in southwestern Arizona, was convened in 2008 to address these and other issues and considerations, and to recommend specific areas for establishing an additional U.S. herd or herds. Development of alternatives for population establishment entailed consideration of three key variables: (1) Geographical areas for establishing populations outside of the current range; (2) potential establishment techniques; and (3) legal status of established populations under the Act. Each of these three key variables had a range of options. The IDT evaluated the three key variables to arrive at the most effective combinations of geographical areas, establishment techniques, and legal status options.

The IDT conducted a mapping exercise to identify areas within the historical range of Sonoran pronghorn in the United States that were under Federal or State ownership and that contained suitable habitat for the species. The result of this exercise was identification of seven potential reestablishment areas, designated Areas A through G. The seven areas were then ranked by the IDT, using seven selection criteria, to determine the best areas for translocation. Area A (King Valley at Kofa NWR, and adjacent portions of primarily Yuma Proving Grounds and BLM lands) and Area D (primarily portions of the BMGR-E, BLM lands, and a portion of the Tohono O'odham Nation, all east of Highway 85) were ranked 1 and 2, respectively.

Public scoping for the Sonoran pronghorn population establishment project included three open houses held in November 2008 on successive evenings at Yuma, Tucson, and Phoenix, Arizona. After consideration of public input, two alternatives were carried forward in the National Environmental Policy Act (NEPA) (42 U.S.C. 4321 et seq. ) process, including establishment of Sonoran pronghorn in Areas A and D, which we will implement as per this final rule. Specific population establishment techniques are described for both areas (see Release Procedures, below), and we are establishing Sonoran pronghorn as a NEP in these areas under section 10(j) of the Act.

The NEP encompasses Areas A and D in Arizona, as well as all areas into which Sonoran pronghorn are likely to disperse. The NEP is defined as follows: An area north of Interstate 8 and south of Interstate 10, bounded by the Colorado River on the west and Interstate 10 on the east; and an area south of Interstate 8, bounded by Highway 85 on the west, Interstates 10 and 19 on the east, and the United States-Mexico border on the south.

Section 10(j) of the Act requires that an experimental population be wholly separate geographically from other wild populations of the same species. The Colorado River; Interstates 8, 10, and 19; and Highway 85, which form the boundaries of the NEP, are barriers to movement. Interstate 8 separates Area A from the current U.S. population, and Highway 85 forms a boundary between Area D and the current U.S. population. We do not expect Sonoran pronghorn to cross these barriers. Brown and Ockenfels (2007, p. 29) found that high-speed highways with right-of-way fences, such as these, were virtually Sonoran pronghorn-proof due to comprehensive fencing and high-volume traffic, and that interstate highways are effectively impassable for the species. Only once, in 1973, has a Sonoran pronghorn been known to cross Interstate 8 (Phelps 1981, p. 27). In 2008, a Sonoran pronghorn crossed Highway 85 and its associated right-of-way fences into BMGR-E (Howard 2008, pers. comm.); this is the only confirmed case of a Sonoran pronghorn crossing Highway 85 and its right-of-way fences. However, in July 2010, an unconfirmed sighting of a pronghorn doe was reported well east of Highway 85 in BMGR-E. This animal was not collared or ear-tagged, so its origins are uncertain, but it presumably crossed Highway 85 into BMGR-E from the wild population. No other documented cases of Sonoran pronghorn crossing Highway 85 and its right-of-way fences are known.

Nonetheless, in the unlikely event that a Sonoran pronghorn moves outside the NEP, the individual or individuals would not constitute a population. Our regulations define “population” as a “group of fish or wildlife * * * in common spatial arrangement that interbreed when mature” (50 CFR 17.3) and thus determine that a “geographic separation” is any area outside the area in which a particular population sustains itself. See Wyo. Farm Bureau Fed'n v. Babbitt , 199 F. 3d 1224, 1234 (10th Cir. 2000). These definitions preclude the possibility of population overlap as a result of the presence of individual dispersing Sonoran pronghorn—by definition lone dispersers do not constitute a population or even part of a population, since they are not in “common spatial arrangement” sufficient to interbreed with other members of a population. The evidence suggests that the likelihood of a lone pronghorn crossing the NEP boundary is very low, so it follows that the probability of that lone disperser encountering another Sonoran pronghorn of the opposite sex and reproducing is even more remote.

The status, as endangered or as a member of the NEP, of any dispersing Sonoran pronghorn that manages to cross Highway 85, Interstate 8, or other barriers between the NEP and the current range is defined geographically. Any Sonoran pronghorn within the NEP area is considered a member of the nonessential experimental population (including any dispersing animals from within the current range that cross into the NEP area), whereas any Sonoran pronghorn outside of the NEP is fully protected under the Act as an endangered species.

The geographical extent of the NEP designation includes areas unlikely to be used by Sonoran pronghorn, as only portions of this proposed NEP area contain suitable habitat. In the NEP area, Sonoran pronghorn habitat is limited to undeveloped areas within valleys. Mountainous areas, such as the Kofa, Castle Dome, Palomas, and Gila Bend mountains, do not provide habitat for this species; nor do developed areas within the valleys, such as agricultural areas and towns and cities. However, the NEP area represents what we believe to be the maximum geographical extent to which Sonoran pronghorn could move if released in Areas A and D. Once released into these areas, we expect the Sonoran pronghorn population(s) to grow and expand into adjacent suitable habitats, potentially moving to the boundaries of the NEP. In the unlikely event that any of the released Sonoran pronghorn, or their offspring, move across interstate highways or other barriers (e.g., rivers or mountainous areas, developed agriculture areas, or urban areas) to outside the designated NEP area (but not into the area occupied by the wild population), then the Service will evaluate the need, in the context of the 10(j) requirements, to amend the 10(j) rule to enlarge the boundaries of the NEP area to include the area of the expanded population. As discussed above, the likelihood of Sonoran pronghorn moving from the NEP area into the current range is very low.

The IDT developed the methods of release of Sonoran pronghorn into Areas A and D with the objective of maximizing the likelihood of success in establishing herds, while minimizing the impact to the source population (the animals in the captive breeding pen at Cabeza Prieta NWR) and limiting mortality or injury to translocated Sonoran pronghorn to the maximum extent possible. In King Valley, Kofa NWR (Area A), a rectangular-shaped, 0.5-square-mile (sq.-mi) (1.29-square-kilometer (sq.-km)) captive-breeding pen will be constructed. The pen will include water sources and irrigated areas to enhance forage production, as well as two observation towers from which the animals will be monitored. In December 2011/January 2012, we anticipate moving 11 Sonoran pronghorn (10 females and 1 male) to the pen from the captive-rearing pen at Cabeza Prieta NWR. These animals will be captured, either by use of a boma (a circular trap used inside the pen) or tranquilizer dart gun and moved one or two at a time by helicopter.

Prior to movement to Kofa NWR, Sonoran pronghorn will be screened for epizootic hemorrhagic disease (EHD) and bluetongue (BTV). Both diseases can infect bighorn sheep and mule deer, as well as Sonoran pronghorn. To ensure these diseases are not inadvertently moved to Kofa NWR, only Sonoran pronghorn not exhibiting clinical signs (active lesions) of EHD and BTV will be transported to the new captive breeding pen at Kofa NWR. Biennial rotation of the breeding male and death of any Sonoran pronghorn in the breeding pen at Kofa NWR would require additional flights to bring new animals from Cabeza Prieta NWR. Methods perfected at Cabeza Prieta NWR will be employed in these activities, which have been used successfully with minimal mortality of pronghorn.

Assuming successful captive-breeding at the Kofa NWR pen, up to 20 Sonoran pronghorn will be released annually into suitable habitats outside of but adjacent to the pen site at Kofa NWR, beginning as early as the winter of 2012 or 2013 and recurring each winter until 2020. Sonoran pronghorn in the pen, as well as animals released, will be closely monitored to determine success or need for adaptive management. Success criteria will be developed by the recovery team prior to the release of any animals, but the objective will be to continue releases until the population can sustain itself without augmentation. Concurrently, but only if excess animals are available from the captive-breeding pen at Cabeza Prieta NWR (not needed to augment existing herds or for the pen at Kofa NWR), these animals will be captured from the pen, transported to a holding pen in Area D, held temporarily, and then released as a group. The holding pen in Area D is located in the Midway Well area near Hat Mountain (an area locally known as BMGR-E “Area B”) in Maricopa County, Arizona. Ideally, the Sonoran pronghorn will be captured together and moved quickly to a holding pen, allowed to recover for a brief period, and released together.

Released animals in Area D will be monitored via aircraft and on-the-ground personnel to determine survival, reproduction, and other measures of success. Details of the monitoring plan will be developed prior to release and will include collection of enough data to quantitatively determine if we are meeting success criteria and, if not, what needs to be corrected to ensure success. Through adaptive management, release techniques and other management will be revised as needed to ensure success. Additional description of the release procedures and monitoring protocols can be found in the final EA (for copies of this document, see ADDRESSES above).

We have determined that these reestablished populations are nonessential, based on the following:

(a) Wild populations of the Sonoran pronghorn, totaling about 562 to 572 animals, currently exist at: (1) Cabeza Prieta NWR, OPCNM, BMGR, and adjacent BLM lands; (2) in the El Pinacate region of Sonora; and (3) south and east of Highway 8 in Sonora.

(b) A captive-breeding pen at Cabeza Prieta NWR maintains a captive population and provides stock to augment the wild populations in Arizona and Sonora. The pen has been highly successful. It was first stocked with Sonoran pronghorn in 2004; the original group of 11 animals has grown to 69 (May 2010), and another 44 Sonoran pronghorn have been released from the pen into the wild.

(c) The first priority for use of animals in the captive-breeding pen at Cabeza Prieta NWR is to augment herds within the boundaries of the current range of the species. Relocation of Sonoran pronghorn from the captive breeding pen to Kofa NWR will not appreciably inhibit the augmentation efforts for the herds within the boundaries of the current range of the species. Sonoran pronghorn produced at the Cabeza Prieta NWR pen that are not needed to augment herds within the current range or to populate the Kofa NWR pen will be used to establish a population in Area D.

(d) The possible failure of this action will not appreciably reduce the likelihood of survival of the species in the wild, because (1) the first priority for use of Sonoran pronghorn from the captive-breeding pen at Cabeza Prieta NWR is to augment the wild herd, and (2) recovery actions have been, and continue to be, implemented in the United States to reduce the effects of drought on the species (Service 2009, pp. 9, 18-19).

(e) Through programs of work endorsed by the Canada/Mexico/U.S. Trilateral Committee for Wildlife and Ecosystem Conservation and Management, the Service and AGFD coordinate with our Mexican partners on recovery actions for Sonoran pronghorn in Mexico, enhancing the likelihood of their survival and recovery.

We will ensure, through our section 10 permitting authority and the section 7 consultation process, that the use of Sonoran pronghorn from the donor population at Cabeza Prieta NWR for releases in Areas A or D is not likely to jeopardize the continued existence of the species in the wild. Establishment of additional Sonoran pronghorn populations within the species' historical range is a necessary step in recovery (Service 2002, p. 38).

The special rule that accompanies this 10(j) rule is designed to broadly exempt take of Sonoran pronghorn from the section 9 prohibitions outside of National Wildlife Refuge and National Park Service lands, as long as the take is incidental to otherwise lawful activities. We provide this exemption because we believe that incidental take of members of the NEP associated with otherwise lawful activities will not pose a substantial threat to the recovery of Sonoran pronghorn, as activities that currently occur or are anticipated in the NEP area are generally compatible with Sonoran pronghorn recovery. For example, in Area A, there are vast expanses of open valleys without major barriers to Sonoran pronghorn movement that provide suitable habitat. These valleys include King Valley at Kofa NWR, Palomas Plain, the southern end of the Ranegras Plain, and portions of the Yuma Proving Grounds. The La Posa Plain and Castle Dome Plain also provide habitat. Highway 95 runs north-south through those plains, and although it may somewhat inhibit movement to the west side of those plains, it is not a substantial barrier because it lacks right-of-way fences. In Area D, there is considerable habitat in the valleys among the Sauceda, Sand Tank, Batamote, and other mountains in that region.

There are existing military activities at Yuma Proving Grounds in Area A and BMGR-E in Area D, but pronghorn have coexisted with military activities for many years at the BMGR (deVos 1990, pp. 49-50; Krausman et al. 2004, pp. 29-33; Krausman et al. 2005, pp. 20-22); as a result, we believe they will persist with the similar activities conducted at Yuma Proving Grounds and in Area D. Although some forms of military activities could potentially result in incidental death or injury of individual pronghorn, no incidental take has ever been documented due to military activities, even before precautions were set in place as a result of section 7 consultations to minimize the likelihood of such take at the BMGR.

There is some likelihood of Sonoran pronghorn drowning in canals in Area A. Canals are present in agricultural areas on the southern, eastern, and northeastern portions of Area A; Sonoran pronghorn are known to drown in such canals (Rautenstrauch and Krausman 1986, p. 9). The major canal in Area A most likely to be accessed by Sonoran pronghorn is the Wellton Canal, located north of the Gila River and on the northern edge of the agricultural lands in the Gila Valley. It is equipped with ramps and steps designed to prevent ungulate drownings. In addition, a series of wildlife water sources exists to the north of the canal as alternative water sources. Most of the canals elsewhere in Area A are too small to result in Sonoran pronghorn entrapment, or are surrounded by agriculture or other developments and are unlikely to be accessed by Sonoran pronghorn. Other activities such as recreational hunting and camping, vehicle use, livestock grazing, and small-scale rural or agricultural development, are anticipated to either have minimal effects on Sonoran pronghorn or will be limited in extent (e.g., rural and agricultural development).

Under section 7(a)(1) of the Act, all Federal agencies are mandated to use their authorities to conserve listed species. In addition, the BLM has a policy of conferring with the Service, under section 7(a)(4), on their actions that may affect proposed species (BLM 6840 Manual). Some activities do have greater potential to compromise the success of the Sonoran pronghorn reestablishment than those described above. For instance, construction of new highways, particularly those with rights-of-way fencing, or new canals in the NEP could create barriers to movement and bisect important pronghorn habitats. There is also the potential for BLM to permit large-scale solar power plants, which would be constructed in the valleys and could eliminate up to tens of thousands of acres of habitat. Other BLM-authorized projects, such as agricultural leases, could also potentially remove large blocks of habitat and perhaps compromise the success of this project. The potential for these projects to impact the reestablishment is probably greatest on BLM lands in the valleys to the east of Kofa NWR. The Service will have the opportunity through the section 7(a)(4) conference process to work with the BLM to minimize the potential adverse effects of solar plants, agricultural leases, highways, or other projects that may compromise Sonoran pronghorn recovery.

The lands within the NEP area are managed and listed in descending order of acreage within areas A and D as follows: Area A—the Service (Kofa NWR), Department of the Army (Yuma Proving Grounds), BLM, Arizona State Lands Department, private landowners, and Colorado River Indian Tribes; Area D: Tohono O'odham Nation, BLM, Department of the Air Force (BMGR-E), private owners, and Arizona State Land Department. Outside of Areas A and D, but within the NEP, land ownership is similar, but also includes lands within the Gila River Indian Reservation, Ak-Chin Indian Reservation, Pascua Yaqui Indian Reservation, San Xavier Reservation, Buenos Aires NWR, Saguaro National Park, OPCNM, Tucson Mountain Park, and Coronado National Forest. Due to the management flexibility provided by the NEP designation and the special rule, we do not anticipate that establishment of Sonoran pronghorn in Areas A or D and subsequent dispersal of Sonoran pronghorn from the release sites will affect management on Tribal, BLM, National Forest, Department of Defense, State, or private lands.

Through section 7 consultations on NWR lands and National Park Service lands, some changes in management may occur to reduce adverse effects to Sonoran pronghorn, including minimizing the likelihood of incidental take. However, we believe few changes will be needed, because management of these lands already is broadly compatible with Sonoran pronghorn recovery. Other Federal agencies that propose actions on Kofa NWR or National Park Service lands will also be required to consult with us under section 7 of the Act, if such activities may affect Sonoran pronghorn. For instance, some activities conducted by Yuma Proving Grounds (e.g., overflights of Kofa NWR) will be subject to the consultation requirements. Some Federal agencies, such as BLM, that propose actions outside of Kofa NWR or National Park Service lands may elect to work with the Service voluntarily through the section 7(a)(4) conferring process to ensure that adverse effects of their actions on Sonoran pronghorn in the NEP area are minimized.

The Service (Cabeza Prieta NWR, Kofa NWR, and the Ecological Services office in AZ), AGFD, OPCNM, Luke Air Force Base, BLM, and other partners, in close coordination with the Sonoran Pronghorn Recovery Team, will plan and manage the establishment of new populations of Sonoran pronghorn. This group will closely coordinate on releases, monitoring, and coordination with landowners and land managers, among other tasks necessary to ensure successful population establishment. Management issues related to the Sonoran pronghorn NEP that have been considered include:

(a) Mortality: “Incidental take,” as defined by regulation at 50 CFR 17.3, is take that is incidental to, and not the purpose of, the carrying out of an otherwise lawful activity, such as agricultural activities and other rural development, ranching, military training and testing, camping, hiking, hunting, vehicle use of roads and highways, and other activities that are in accordance with Federal, Tribal, State, and local laws and regulations. With the finalization of this 10(j) rule, incidental take of Sonoran pronghorn within the NEP area outside of National Wildlife Refuge and National Park Service lands will not be prohibited, provided that the take is unintentional, not due to negligent conduct, and is in accordance with the special rule that is a part of this 10(j) rule. However, if there is evidence of intentional take, not authorized by the special rule or by a section 10 permit, of a Sonoran pronghorn within the NEP we will refer the matter to the appropriate law enforcement entities for investigation. We expect levels of incidental take to be low, because, as discussed in paragraph (d) under Status of Reestablished Populations, above, the establishment of new populations is compatible with most existing human use activities and practices for the area. In the current range of the Sonoran pronghorn in the United States, no incidental take has been documented from military activities, recreation, use of highways, and most other activities that occur both in the current range and in the NEP, the exception being canals, in which Sonoran pronghorn have drowned on several occasions. More specific information regarding take can be found in the Regulation Promulgation section of this final rule.

(b) Special handling: In accordance with 50 CFR 17.21(c)(3), “any employee or agent of the Service, any other Federal land management agency, the National Marine Fisheries Service, or a State conservation agency, who is designated by his agency for such purposes, may, when acting in the course of his official duties”, handle Sonoran pronghorn to aid sick or injured Sonoran pronghorn, or to salvage dead Sonoran pronghorn. However, other personnel and their agents, not specifically named in these regulations, will need to acquire permits from the Service for these activities.

(c) Coordination with landowners and land managers: During the NEPA scoping process, the Service and cooperators identified issues and concerns associated with the proposed Sonoran pronghorn population establishment. The population establishment was also discussed with potentially affected State agencies, tribes, and private landowners. All land owners and managers also had an opportunity to review and comment on the draft EA and proposed rule. State and Federal land management agencies either supported or did not oppose the reestablishment of a Sonoran pronghorn herd and designation as a NEP; however, at least two private landowners in the NEP expressed opposition to the proposal. U.S. Customs and Border Protection strongly encouraged limiting reestablishment to Area A. See the section Summary of Public and Peer Review Comments and Recommendations below for summaries of those comments and how we addressed any concerns.

(d) Monitoring and Adaptive Management: A monitoring and adaptive management plan for the population establishment program will be implemented by the Service, AGFD, and other partners to determine if the program is successful, and to adjust management as needed to ensure success. Success criteria have not yet been finalized, but they will include the concept that the objective of the program is to establish Sonoran pronghorn herds that are self-sustaining without augmentation via releases from captive pens or holding facilities, thereby contributing to recovery goals. The monitoring will assess all aspects of the population establishment program, from capture and movement of the animals to the captive breeding pen (Area A) or holding area (Area D), monitoring of the animals in these captive facilities, and monitoring and tracking released Sonoran pronghorn in the release areas, including Sonoran pronghorn water sources and any forage enhancement vegetation plots developed to support the established herds. Monitoring of released Sonoran pronghorn will be conducted to determine the following:

(1) Mortality and recruitment rates,

(2) causes of mortality among adult and juvenile Sonoran pronghorn,

(3) reliance on freestanding water sources,

(4) movement corridors and barriers to movements, and

(5) habitat preferences.

Each released animal will be fitted with an ear tag and radio collar. A limited number of Sonoran pronghorn will be fitted with Geographic Positioning System (GPS) platform telemetry collars. It is expected the GPS transmitters will function for up to 3 years. Telemetry flights with a fixed-wing aircraft will be conducted twice a month. Each Sonoran pronghorn will be observed from an altitude of 1,000 feet (ft.) above ground level with the aid of binoculars. Group size and composition (sex and age), habitat type, and terrain will be recorded. Additional monitoring of individual Sonoran pronghorn and herd movements will be done from the ground, particularly from high points where valley habitats of the Sonoran pronghorn can be viewed. All monitoring flights and on-the-ground surveillance will be closely coordinated with and approved by the tribal, military, and other land managers and owners where such monitoring will occur. As Sonoran pronghorn become established and breed in the establishment areas, the percentage of animals tagged or radio-collared will decline over time, and additional animals may need to be captured and radio collared to adequately monitor the herds. We will attempt to maintain radio collars on at least 10 percent of a population.

Monitoring data will be assessed regularly by the Recovery Team, and methods will be revised as needed to increase the likelihood of successful population establishment and to increase efficiency. A comprehensive review, assessment, and report of the reestablishment program by the Recovery Team will occur at a frequency of no less than once every 5 years. If at any point the program is not meeting its stated objective, or is falling short of meeting the success criteria, techniques and methods will be reviewed and revised as needed to correct problems and increase the likelihood of success. If revisions fall outside the scope of the action evaluated in the EA and FONSI, all necessary environmental compliance will be completed before those revised techniques or methods are implemented. Additional details of the monitoring and adaptive management plan, including quantifiable and measurable success criteria, will be finalized and posted on our Web site at http://www.fws.gov/southwest/es/arizona/ prior to release of Sonoran pronghorn into Areas A or D.

(e) Public awareness and cooperation: Public scoping for the Sonoran pronghorn population establishment project was conducted in the fall of 2008. Actions included an October 30, 2008, scoping letter sent to approximately 6,000 recipients, a news release to local media sources, and a series of 3 open houses held in the Arizona cities of Yuma, Tucson, and Phoenix, during November 18-20, 2008. We accepted written public scoping comments until December 12, 2008. We received 44 written responses about the project. In our EA, we discussed issues identified in the responses. The IDT and the Service used these issues to refine the proposed action and alternatives in the EA, and to identify mitigation measures to avoid or reduce potential project effects. The IDT and the Service also used the public concerns to determine which resources would be the greatest focus of the EA analysis. The comments received during the scoping process are listed in the EA, and were considered in the formulation of alternatives considered in the NEPA process. The following section describes the public outreach we conducted and the responses received during the public and peer review comment periods on the proposed rule and draft EA.

A special rule under section 4(d) of the Act is included in this establishment of an experimental population under section 10(j) of the Act. A population designated as experimental is treated for the purposes of section 9 of the Act as threatened, regardless of the species' designation elsewhere in its range. The development of protective regulations for a threatened species is an inherent part of the section 4 listing process. The Service must make this determination considering only the “best scientific and commercial data available.” A necessary part of this listing decision is also determining what protective regulations are “necessary and advisable to provide for the conservation of [the] species.” Determining what prohibitions and authorizations are necessary to conserve the species, like a listing determination of whether the species meets the definition of threatened or endangered, is not a decision that Congress intended to undergo section 7 consultation.

Actions associated with the establishment of the experimental population, such as construction of pens or the movement of wild animals, will undergo section 7(a)(2) consultation, as appropriate.

On February 4, 2010, we published our proposed rule to establish a NEP of Sonoran pronghorn in southwestern Arizona (75 FR 5732), and requested written comments from the public on the proposed rule and draft EA. We also contacted the appropriate Federal, State, and local agencies; tribes; scientific organizations; and other interested parties and invited them to comment on the proposed rule and draft EA. The initial comment period was open from February 4, 2010, to April 5, 2010. A second comment period was open from June 9, 2010, to July 9, 2010 (75 FR 32727). A public hearing was held in Gila Bend, Arizona, on February 23, 2010; however, no verbal or written comments were submitted at that hearing.

In accordance with our policy on peer review, published on July 1, 1994 (59 FR 34270), we solicited opinions from three expert biologists who are familiar with this species regarding pertinent scientific or commercial data and assumptions relating to supportive biological and ecological information for the proposed rule. Reviewers were asked to review the proposed rule for accuracy and validity of its biological information and assumptions. Two out of three peer reviewers provided comments. They were both supportive of the proposal to reestablish the Sonoran pronghorn in areas of southwestern Arizona, but suggested revisions or had some questions about the proposal. The remaining peer reviewer asked for additional information, but did not submit a final peer review. Their letter requesting additional information is counted as a response, with no position taken.

We reviewed all comments received from the peer reviewers, agencies, and the public for substantive issues and new information regarding the proposed NEP. Substantive comments received during the comment period have been addressed below and, where appropriate, incorporated directly into this final rule. The comments are grouped below as peer review and agency or public comments.

We received responses from 29 parties, comprising private individuals (15), nongovernmental organizations (4), peer reviewers (3), state agencies (2), Federal agencies (3), university (1), and anonymous (1). Some commenters clearly supported (10), opposed (4), or took no position (7) on the proposal. In addition, two supported the reestablishment, but opposed the NEP. One supported population reestablishment, but conditioned their support of the NEP on continued strong commitment by the Department of Defense to Sonoran pronghorn conservation. One conditioned their support on implementation of predator control, acknowledgement of the importance of water sources, and no impacts to hunting. Two others opposed the proposal unless predator control was conducted. One supported the Kofa NWR reestablishment but not the BMGR-E reestablishment, and one supported the BMGR-E reestablishment, but opposed the NEP and establishment of a population at Kofa NWR.

The two peer reviewers who submitted comments agreed with the following determinations: (1) The proposed establishment of experimental, nonessential populations of Sonoran pronghorn is well considered and has great potential to enhance the status of Sonoran pronghorn in the United States, and (2) proposed survey, monitoring, and capture techniques, and operation of the captive breeding pen, are within accepted practices in wildlife management. However, one commenter asked that the details of the monitoring program and success criteria be more clearly stated.

(1) Comment: Continual improvement in capture methods should be pursued on non-endangered subspecies across the range of the pronghorn to increase efficiency in capturing and maintaining captive populations.

Our Response: Consistent with Adaptive Management in the EA and the recovery plan, we will continue to evaluate new information, including publications, reports, and personal communications with others working on Sonoran pronghorn throughout its range. We will also learn from our experiences with Sonoran pronghorn to fine tune and improve capture methodologies, with the goal of minimizing stress and the possibility of injury or mortality of captured animals, while increasing efficiency of capture operations.

(2) Comment: Although habitat modeling to identify habitat suitable for reestablished populations is adequate at the landscape scale, additional work is needed to pinpoint the adequacy of habitat prior to releases. Cholla is a key forage plant that is missing or scarce north of Interstate 8. Supplemental feeding may be necessary in that area during prolonged drought.

Our Response: As discussed under “ Reestablishment Areas ” above, an IDT was tasked with identifying and ranking possible reestablishment areas within the historical range of the Sonoran pronghorn. Areas A and D ranked first and second of seven areas identified. Potential locations for a captive pen at Kofa NWR are somewhat limited by extensive wilderness designation that precludes construction and operation of that facility. Hence a block of non-wilderness, large enough to accommodate the pen, was selected in northern King Valley. This is a good location, because the pen will be located off well-traveled roads, yet it is relatively close to Highway 95, the access route from Yuma, and its location in the northern part of the valley provides an opportunity for pronghorn released directly from the pen to spread out throughout King Valley before moving off-refuge to areas of Yuma Proving Grounds or BLM lands. The IDT considered the absence of chain fruit cholla on Kofa NWR in its rankings of the seven areas. One of the seven criteria used to rank the areas was forage quality. The absence of chain fruit cholla is a concern; however, the value of that plant in the diet of the Sonoran pronghorn is primarily as a source of preformed water; it provides little nutrition (Fox 1997, pp. 76, 79). As a result, if freestanding water is available or can be provided dependably, the importance of chain fruit cholla in the diet is much reduced. Five water sources outside of the pen at Kofa NWR will be built to provide dependable water for Sonoran pronghorn. Water sources and chain fruit cholla are available on BMGR-E in Area D near where the holding pen will be constructed, and, if needed, additional water sources will be constructed; hence, water for drinking is not anticipated to be a limiting factor at BMGR-E.

(3) Comment: The movement of released Sonoran pronghorn might be underestimated, particularly as the populations grow. In particular, there is a possibility of Sonoran pronghorn moving south in Area D into Organ Pipe Cactus NM east of Highway 85, and then west into the areas occupied by the wild population.

Our Response: Some of the young male Sonoran pronghorn released from the pen in Cabeza Prieta NWR have moved extraordinary distances, and across barriers including, on at least two occasions, the right-of-way fence along Highway 85, a vehicle barrier constructed on the U.S./Mexico border, and Highways 2 and 8 in Sonora, Mexico. Released Sonoran pronghorn that wander over large areas tend to continue these long-distance movements until they find and join an existing herd or another Sonoran pronghorn. Although such movements are expected to be unusual, we agree that as Sonoran pronghorn are released and as populations grow, individuals will periodically make long-distance movements and some animals could potentially move across Highway 85 from Area D into areas occupied by the wild herd. Similarly, Sonoran pronghorn released from the pen at Cabeza Prieta NWR may occasionally move across Highway 85 into Area D.

Although these movements could occur more frequently as populations on both sides of Highway 85 increase, we do not anticipate they will ever be more than rare events for the reasons discussed in “ Reestablishment Areas ” above, hence we do not anticipate overlap of the wild population and the NEP. Lone dispersers do not constitute a population or even part of a population, because they are not in “common spatial arrangement” sufficient to interbreed with other members of a population (see discussion under “ Reestablishment Areas ”). Furthermore, the likelihood of a Sonoran pronghorn moving from the release site on BMGR-E south to the area east of Highway 85 in OPCNM is remote, because a Sonoran pronghorn would have to traverse miles of rugged terrain from the holding pen at Midway Wash through the Batamote/Coffee Pot Mountain region to reach the Hickiwan Valley or Pozo Redondo Valley, and then move south and west from there across Highway 86 and through the Gunsight Hills, then down the western bajada of the Ajo Mountains. Years of surveys have shown that Sonoran Pronghorn do not use the rugged slopes and mountainous terrain characteristic of this area (Hervert et al. 2005, p. 12).

(4) Comment: One peer reviewer expressed concern that there is a remote possibility of a Sonoran pronghorn moving through Area D south and east to Buenos Aires NWR, where a population of Mexican pronghorn ( Antilocapra americana mexicana ) currently exists.

Our Response: Buenos Aires NWR is in the southeastern portion of the NEP area, and is within the historical range of the Sonoran pronghorn (Service 2002, p. 17). The NEP area includes all regions into which Sonoran pronghorn could potentially move from release sites. Although over 90 miles southeast of the release site, we agree there is a small probability that Sonoran pronghorn could reach Buenos Aires NWR at some point in the future. The major barrier between the two areas is likely a complex of rugged terrain between the release site and Sonoran pronghorn habitat to the east and south, formed by the Batamote, Sauceda, Sand Tank, and other ranges. If a Sonoran pronghorn could get past that barrier, then potentially it could move through the valleys of the Tohono O'odham Nation, and then around the north end of the Quinlan Mountains, across Highway 86 and south through the Altar Valley to Buenos Aires NWR. Historically a more direct route probably existed south of the Baboquivari Mountains in Mexico, but a vehicle barrier and livestock fence on the United States/Mexico border now block that route.

In the unlikely event that a Sonoran pronghorn reached Buenos Aires NWR, the Service would be required to assess the effects of its actions at the refuge, including managing herds of Mexican pronghorn, and conduct intra-Service section 7 consultation if those activities may affect the Sonoran pronghorn. A decision on how to proceed would emerge from that process and would be based on the circumstances at the time.

(5) Comment: The proposed rule stated that success criteria would be developed by the recovery team prior to release of any Sonoran pronghorn into areas A or D. Success criteria drive the types of monitoring needed. Some parameter(s) of success need to be identified.

Our Response: Broadly defined, success will be measured by our ability to achieve the purpose of the program, which, as stated in the EA (p. 19) and our recovery plan (Service 2002, p. 38), is to contribute to recovery of the Sonoran pronghorn by establishing additional populations in suitable habitat within its historical range in Arizona. In accordance with 50 CFR 17.81(c)(4), a technical definition of what it means to establish a population of Sonoran pronghorn will, as the commenter notes, be forthcoming; however, it will almost certainly involve the presence of Sonoran pronghorn surviving and breeding in the wild to an extent that, at some point, release of additional animals to augment the population—either via the captive breeding pen at Kofa NWR or the holding pen in Area D— is no longer needed to sustain the population.

(6) Comment: If the reestablished populations cannot be sustained into the future without intensive management, this needs to be clearly stated.

Our Response: Some level of management will always be needed to maintain the reestablished herds. These management actions will be undertaken by the Service, in conjunction with our partners, including AGFD. The Sonoran pronghorn will need to be monitored to track their status, water sources will need to be maintained for them, and the lands they occupy must remain as habitat capable of supporting a viable herd. However, once a population is established to the degree that additional augmentation is no longer needed to sustain it, we anticipate that some intensive management actions, including the maintenance of a captive rearing pen, will no longer be necessary.

(7) Comment: Not enough information is presented to determine if the proposed monitoring will be adequate to determine whether the program is successful, and to better determine the role of water and forage enhancement plots in recovery, mortality, and recruitment rates; causes of mortality by age and sex, movements; and the role of habitat in the life history of the Sonoran pronghorn.

Our Response: The monitoring should not only allow us to determine whether the program is a success, but if it is failing to meet its objectives, the reason(s) why it is failing must emerge from the monitoring data. The latter is crucial for making appropriate changes in management to correct problems and ensure we achieve sustainable herds in Areas A and D. Although our monitoring plan is not yet complete, released animals in Area D will be monitored primarily via aircraft to determine survival, reproduction, and other measures of success. We acknowledge that all of the parameters noted by the commenter above are important in terms of tracking the status of Sonoran pronghorn populations. All of these factors will be carefully considered in the development of the monitoring program in Areas A and D.

(8) Comment: Establishment of additional herds of Sonoran pronghorn in the United States is not needed because the animals at Cabeza Prieta NWR are safe from extinction. Specifically, their continued existence is ensured because Sonoran pronghorn have been captively reared, resulting in a wild population of greater than 70 animals. An awareness of the population's precarious nature has been raised, their status will be closely watched, and animals from self-sustaining herds in Mexico can be brought to the United States if the current population crashes.

Our Response: The 1998 revision of the Sonoran Pronghorn Recovery Plan established downlisting criteria to reclassify the subspecies from endangered to threatened. Included in the downlisting criteria were stipulations that an estimated 300 adult Sonoran pronghorn occur in one U.S. population and a second separate population be established in the United States, or numbers are determined to be adequate to sustain the population through time (Service 1998, p. 37). At 80-90 wild Sonoran pronghorn, the current U.S. population is not safe from extinction. A 1996 population viability analysis concluded that at least 300 Sonoran pronghorn were needed in a population to achieve reasonable population persistence over time; however, to prevent loss of genetic diversity, 500 or more animals were needed (Defenders of Wildlife 1996, p. vii). The 2002 Supplement and Amendment to the Recovery Plan identified “evaluating potential transplant locations, establishing relocation methodology and protocols, developing interagency agreements (including with Mexico as required), acquiring funding, and initiating reestablishment projects” as one of eight priority, near-term actions needed to further recovery (Service 2002, p. 38.). In regard to bringing additional animals north from Sonora, Mexico, to augment the U.S. population, we cannot depend on the continued availability of Sonoran pronghorn from Sonora, both in terms of required international permits and the ability of Mexican populations to sustain additional harvest. In conclusion, establishing additional herds of Sonoran pronghorn in the United States is consistent with the recovery plan for the species and will further its recovery, consistent with Service mandates under section 4(f)(1) of the Act.

(9) Comment: Part of the funding for the population reestablishment is coming from the Department of Homeland Security (DHS) as mitigation for damage to Cabeza Prieta NWR, so the money should be spent at Cabeza Prieta NWR.

Our Response: Funding provided by DHS for the establishment of additional Sonoran pronghorn herds in the United States was closely negotiated, and the use of those funds was specifically defined for certain recovery actions. Mitigation funds for establishment of additional U.S. herds were secured to mitigate effects of vehicle barriers at Cabeza Prieta NWR and the BMGR, and the effects of the Ajo 1 SBInet Tower Project. The purpose of this mitigation was to offset effects to Sonoran pronghorn from these projects, not to mitigate or repair damage to resources at Cabeza Prieta NWR. Consistent with the recovery plan, one of the greatest needs for recovering the Sonoran pronghorn is to establish additional herds, off of Cabeza Prieta NWR. The Service and DHS agreed that use of the mitigation funds to establish additional Sonoran pronghorn herds outside of the current range was an appropriate offsetting measure.

(10) Comment: The proposed reestablishment will fail unless predators of Sonoran pronghorn are controlled. Specifically, commenters mentioned the need to control mountain lions at Kofa NWR and coyotes.

Our Response: Coyote, mountain lion, and bobcats are known to prey on Sonoran pronghorn (Service 2002, p. 22). Predation generally has an insignificant effect except on small populations (Lee et al. 1998, p. 61). Coyotes are the most abundant large predator sympatric with Sonoran pronghorn. In 20 mortality investigations not related to capture operations, coyotes killed at least 5 Sonoran pronghorn and are suspected in the death of another. Of 23 Sonoran pronghorn released from the captive breeding pen at Cabeza Prieta NWR in December 2009, 4 were predated by coyotes within the first 3 weeks. Since that time, one other Sonoran pronghorn found dead from the original group of 23 was probably predated, although the type of predator is unknown (Atkinson 2010, pers. comm.). Coyotes are thought to prey heavily on Sonoran pronghorn fawns as well.

Steps will be taken to deter predators from entering the captive breeding pen at Kofa NWR, including a perimeter fence constructed of woven wire 5.5 ft. (1.7 m) tall and buried 1 ft. (0.3 m) into the ground. The interior of the fence will be lined with material that will create a visual blind for predators. In addition, two layers of electric fences will be installed just outside of the woven wire fence to deter predators. Monitors will check for presence of Sonoran pronghorn predators inside the pen and holding facility daily, and if any are found, they will be removed. The holding facility at BMGR-E will be equipped with 5.5-ft (1.7-m) tall woven wire, but it will not be buried and no electric fence will be installed. However, the potential for predation will be minimized because pronghorn will not be in the facility for more than a few days, and someone will be staying with them all the time until they are released.

No predator control is proposed outside the pen at Kofa NWR and the holding facility at BMGR-E, because predation types and levels are anticipated to be similar to those at Cabeza Prieta NWR, where up to this point, predator control has not been deemed necessary to recover the Sonoran pronghorn. We anticipate that predation of released animals in Area A and D is unlikely to affect the success of the reestablishments, and mortality of released animals due to predators is expected to be similar to that experienced at Cabeza Prieta NWR. We will monitor the success of the population reestablishments, and consistent with adaptive management and recovery actions 2.411 and 2.412 in the recovery plan, we will evaluate the monitoring data and propose additional actions, if deemed necessary. Those additional actions could include predator control outside of the captive breeding pen at Kofa NWR or the holding pen at BMGR-E. However, predator control outside the pens is not covered in the EA for establishing a NEP of Sonoran pronghorn at Kofa NWR or BMGR-E. Hence, if predator control were proposed, it would be closely coordinated with land managers and AGFD, and would only proceed after all required environmental compliance was completed.

(11) Comment: Development of additional water sources, such as wildlife drinkers or tanks, should be undertaken to support the population reestablishments. In addition, an “Adopt a Game Tank” program should be implemented for interested parties to monitor, maintain, and repair water tanks for wildlife and game species.

Our Response: At Kofa NWR, we propose to develop up to seven water sources for Sonoran pronghorn, including up to two inside of the pen and five outside of the pen, but none in the Kofa Wilderness. At BMGR-E and Area D, numerous developed wildlife water sources occur in paloverde-mixed cacti-mixed scrub vegetation on the bajadas that could potentially be used by Sonoran pronghorn. As a result, no new water sources are planned for Area D; however, the need for additional wildlife water sources will be evaluated and, if needed, new water sources will be installed to support the reestablished Sonoran pronghorn. Construction of any additional water sources in Area D would be preceded by cultural resource surveys and any necessary environmental compliance. The water sources at Kofa NWR were planned in anticipation of the needs of the Sonoran pronghorn. Additional water sources at Kofa NWR, beyond those mentioned above, are not anticipated; however, consistent with proposed adaptive management and recovery actions 2.411 and 2.412 in the recovery plan, we will evaluate the monitoring data and propose additional water sources if deemed necessary to support the reestablished populations. Any additional water sources proposed at Kofa NWR would be outside the current scope of the program and supporting environmental compliance; hence additional coordination with land managers and AGFD and all necessary environmental compliance would be completed prior to construction of any additional water sources.

(12) Comment: The five water sources outside of the captive pen at Kofa NWR should have their locations generally described and mapped. Some flexibility in locations is desirable, so precise locations are unnecessary. Cultural resource surveys should be conducted prior to construction, and water sources should be built with the minimum disturbance necessary and in the least visually obtrusive manner possible.

Our Response: The approximate locations of the five water sources outside the pen at Kofa NWR have been identified and mapped in the EA (p. 36). Cultural resource surveys shall be conducted prior to any ground-disturbance activities, and the water sources will be built with the minimum disturbance necessary and in the least visually obtrusive manner possible.

(13) Comment: The efficacy of additional water sources outside of the pens is questionable based on published studies. The effects of additional water sources on other species, as well as degradation of areas around water sources as a result of increased wildlife use, need to be fully evaluated.

Our Response: The benefits and costs of water developments for wildlife in the arid southwest have been debated for many years (see reviews in Rosenstock et al. 1999 and Krausman et al. 2006). Artificial water sources in the southwest are used by a variety of wildlife species, with nongame species far outnumbering game species (O'Brien et al. 2006, pp. 544-548). Some species will use freestanding water opportunistically, whereas others require it to occupy an area (Krausman et al. 2006, pp. 565-566). Water sources can affect the distribution of wildlife species and habitat use patterns of individuals, although in some cases the effect is small (Marshal et al. 2006a, pp. 616-617). There is no evidence that water catchments elevate predation rates on wildlife (O'Brien et al. 2006, p. 589), and plant communities and forage resources in washes with water sources do not differ from washes without water, providing no evidence that water sources cause detrimental effects to Sonoran Desert plant communities via herbivory or trampling by animals attracted to the water (Marshal et al. 2006b, pp. 621-622). Construction of the five water sources outside the pen and up to two water sources inside the pen at Kofa NWR will have a disturbance footprint, but the acreage affected is small (about 0.5 acre in total), and most of the disturbance will be temporary. None of the water sources are proposed in wilderness.

Monson (1968, pp. 67-68) found there was no hard evidence that Sonoran pronghorn drink freestanding water; rather, he surmised they obtained all the water they need from the plants they consume. However, more recent work indicates they drink water, and that it is probably crucial for survival during seasonal and long-term drought periods (Fox et al. 2000; pp. 1-18; Morgart et al. 2005, pp. 57-58). Hervert et al. (2005, p. 14) found that placement of water sources in palo verde-mixed cacti associations, such as occur in King Valley of Kofa NWR, would likely functionally convert them to higher quality habitats, in some cases making them suitable for Sonoran pronghorn. This could be especially important at Kofa NWR, where chain fruit cholla is absent, but at Cabeza Prieta NWR, it is an important source of preformed or dietary water for Sonoran pronghorn (Fox et al. 2000, pp. 1-18). Currently existing developed and natural wildlife water sources within Area A are primarily located in habitats that are not likely to be used by Sonoran pronghorn or used only infrequently. For example, there are no developed wildlife water sources in potential Sonoran pronghorn habitat in King Valley. Creating new water sources for the reestablished Sonoran pronghorn herd in Area A is important to the success of the project. Sonoran pronghorn will benefit, with minimal impacts to plant communities, other wildlife, and wilderness values.

(14) Comment: One commenter suggested that if Sonoran pronghorn once inhabited the Chuckwalla Bench or East Mojave of California, then the Mojave National Preserve should be considered as a reestablishment site.

Our Response: Although the historical distribution of the Sonoran pronghorn is not entirely known, none of the reports or publications we have reviewed indicate the Sonoran pronghorn ranged into what is known today as the Mojave National Preserve in California. Phelps and Webb (1981, p. 21) show the historical distribution in California lying entirely south of Interstate 10. The 1982 version of the recovery plan (Service 1982, p. 2) adopted the distribution as interpreted by Hall and Kelson (1959, p. 1023), which did not show the subspecies occurring in California. However, Mearns (1907, p. 231) mentions observing pronghorn tracks near “Gardner's and Laguna stations” in 1894 in the Colorado Desert west of the Colorado River. Figure 2 in the 1998 recovery plan (Service 1998, p. 6) and in the 2002 revision (Service 2002, p. 17) show the historical distribution extending into California north to the vicinity of Blythe and westward into an area that includes the Chuckwalla Bench. Figure 1 of the 1998 plan extended the range north to the vicinity of Parker Dam. The southern boundary of the Mojave National Preserve is Interstate 40, which is no closer than 70 miles to Parker Dam.

We find no other reference suggesting Sonoran pronghorn occurred historically any closer to the Mojave National Preserve than Parker Dam. As a result, establishment of Sonoran pronghorn at the Preserve will be outside of its historical distribution as we understand it. Although section 10(j) of the Act does not limit experimental populations to a species' historical range, the suitability of habitats that are clearly outside of the historical range is questionable. Moreover, our analysis of potential reestablishment sites was limited to portions of the historical range in Arizona (O'Brien et al. 2005, p. 25); the suitability of the Mojave National Preserve as a potential establishment site has not been evaluated. As a result, pursuing an additional herd of Sonoran pronghorn at the Mojave National Preserve is not a desired action at this time.

(15) Comment: One commenter supported the reestablishment proposal, but believed it was inappropriate to allow hunting of Sonoran pronghorn.

Our Response: Hunting of Sonoran pronghorn is currently prohibited by section 9 of the Act. This designation of a NEP with a special rule will not change that prohibition.

(16) Comment: Designation as a NEP implies that the proposed release and subsequent establishment of an additional wild population can fail completely without adverse consequence to the continued existence of the species. This conclusion lacks scientific support; thus the population should be given full protection under the Act or designated as an experimental, essential population. Commenters also note that agency authorized take under 10(j) rules can be abused to the point of precluding recovery; a commenter cited the Mexican gray wolf NEP designation as a case in point. Another commenter offered the example of the NEP population of California condor in Arizona, which they asserted is being used as an excuse not to limit lead ammunition in the California condor recovery area.

Our Response: Because the establishment of a second Sonoran pronghorn herd is identified as a downlisting criterion in the recovery plan (Service 2002, p. 36), if such establishment failed, it would adversely affect recovery. However, we do not believe the loss of the experimental population would reduce appreciably the likelihood of the survival of the species in the wild, which is why we are designating the reestablished population as a nonessential experimental population. The Sonoran pronghorn occurs in three other populations, including two in Mexico and one in southern Arizona. Currently, the total in all three populations is approximately 562 to 572 animals in the wild. As described above under “Recovery Efforts,” a variety of aggressive management actions have been to taken to avert catastrophic declines in the U.S. population in the event of a drought. The first priority for use of animals in the captive-breeding pen at Cabeza Prieta NWR is to augment herds within the boundaries of the current range of the species in the United States and Mexico; hence, any use of animals to establish herds in Areas A or D would only be carried out after the needs of the wild populations are met. For these reasons, and for further justification for why reestablished Sonoran pronghorn herds are not essential to the continued existence of the species, refer to the section “ Status of Reestablished Populations .”

In regard to authorized take precluding recovery, the Sonoran pronghorn population reestablishments are very different from that of the Mexican gray wolf or California condor. As detailed in the special rule, only take incidental to otherwise authorized activities plus intentional take as necessary for translocation, aiding sick Sonoran pronghorn, taking biological data, salvaging dead Sonoran pronghorn, or affixing, removing, or servicing radio transmitters will be allowed. As described in the sections “ Status of the Reestablished Populations” and “Management,” we anticipate very little mortality or injury associated with military, recreational, agricultural, and other uses in the NEP that could potentially result in incidental take.

(17) Comment : The survival and growth of the NEP hinges on the good faith and stewardship of the action agencies on whose land the NEP resides. If agency commitments to conservation are not fulfilled, the Service should reconsider the NEP designation and take whatever action is necessary to ensure the recovery of Sonoran pronghorn. Conferring under Section 7 is an opportunity to ensure the actions of Federal agencies are consistent with recovery of the Sonoran pronghorn.

Our Response : The Service is dedicated to achieving the recovery of the Sonoran pronghorn, which includes using all of our authorities to achieve success in regard to reestablished Sonoran pronghorn populations in Areas A and D. As we have discussed (see Regulatory Background ), we will work with Federal action agencies through the section 7(a)(4) conference provisions of the Act in areas outside of National Park and Wildlife Refuge lands, and via the section 7(a)(2) consultation process where the NEP might be affected within Parks and Refuges. Luke Air Force Base, which manages BMGR-E lands in Area D, has been a consistent and strong partner in recovery of the Sonoran pronghorn and has contributed millions of dollars to recovery. We fully anticipate that they will continue to be a strong partner. Through the development of the NEP proposal, we were and continue to be in close contact with Yuma Proving Grounds, which manages lands in Area A and has agreed to cooperate with us on this project. The BLM has pledged its support, and furthermore has a policy of conferring with the Service on activities that may affect proposed species, including NEPs. Thus, their standard for conferring exceeds that in the regulations, which only require conferring if a Federal action is likely to jeopardize the continued existence of a proposed species or is likely to result in adverse modification or destruction of proposed critical habitat (50 CFR 402.10(a)).

Because of this support and cooperation, and as we anticipate Sonoran pronghorn recovery will be compatible with current and future activities within the NEP (see discussion under “ Management ”), we believe there will be no need to reconsider the NEP designation. However, if at any time in the future the status of the wild populations declines dramatically or other circumstances suggest that the loss of reestablished populations would be likely to appreciably reduce the likelihood of survival of the species in the wild, the Service will reevaluate the NEP designation in accordance with our policies and regulations. Furthermore, a comprehensive review, assessment, and report of the reestablishment program by the Recovery Team will occur at least every 5 years. If at any point the program is not meeting its stated objective, or is falling short of meeting the success criteria, all aspects of the program can be reevaluated and modified as needed to better meet the recovery needs of the species.

(18) Comment : Because the legal status of Sonoran pronghorn will be defined geographically (i.e., if they are in the NEP area they are part of the NEP population; if they are outside the NEP, they are fully protected under the Act), wild, endangered Sonoran pronghorn could lose the majority of their protections simply by natural movements. If it turns out that crossings by wild pronghorn into BMGR-E are occurring and/or increasing, the Service should assess and potentially reconsider the new populations' designation and requirements under section 10(j) of the Act.

Our Response: As we have earlier discussed (see discussion under “ Reestablishment Areas ”), we do not expect Sonoran pronghorn to cross over the substantial barriers that separate the NEP area from the wild herd. Only once or twice has a Sonoran pronghorn been known to cross Highway 85 and its associated right-of-way fences into BMGR-E. Released, pen-raised Sonoran pronghorn have a greater tendency to move than do wild Sonoran pronghorn. We have also seen Sonoran pronghorn make unusual movements in response to severe drought. However, the fact remains that such crossings are rare. As the wild population continues to recover and when a population becomes established in Area D, the likelihood of pronghorn crossing Highway 85, both into or out of the NEP, will probably increase. But because highways and their associated right-of-way fences are nearly impermeable barriers for Sonoran pronghorn (Brown and Ockenfels 2007, pg. 29), we do not anticipate more than occasional lone animals moving across the highway, and the occurrence of that will remain a rare event. However, if at any time in the future the wild population and the NEP begin to intermingle because of unexpected and common movement of Sonoran pronghorn across barriers between those populations, the Service will reevaluate the NEP designation in accordance with our policies and regulations.

(19) Comment : The wild and NEP populations should, at some point in the future, be allowed to intermingle in order to maximize genetic diversity and reduce possible effects from stochastic events. Linking these habits and populations may be crucial for long-term survival of the species.

Our Response : We acknowledge that allowing movement of Sonoran pronghorn among populations increases the viability of those populations and their likelihood of persistence over the long term. However, accomplishing that is problematic logistically and economically. The barriers that separate the NEP and wild populations are not temporary structures. Interstate 8, canals, and the agricultural and rural development that separate the current range from pronghorn habitat in Area A are probably insurmountable barriers. Overpasses or underpasses may be possible to allow movement of Sonoran pronghorn across Highway 85, which separates the wild population from the NEP in Area D; however, whether such a connection is feasible or likely to be sufficiently successful to affect our expectation of very infrequent intermingling is unknown at present.

(20) Comment : The assertion that U.S. Customs and Border Protection operations pose a threat to the survival and recovery of Sonoran pronghorn is inconsistent with the best scientific and commercial data.

Our Response : The proposed rule identified high levels of undocumented immigration and drug trafficking across the international border and associated law enforcement as a threat to the Sonoran pronghorn. The proposed rule went on to say that the “U.S. population declined in 2002 by 83 percent to 21 animals (Bright and Hervert 2005, p. 46). The Mexican populations declined at the same time, but not to the same degree. The population southeast of Highway 8 declined by 18 percent, while the El Pinacate population declined by 26 percent. The differences between the rates of decline north and south of the border may be due to high levels of human disturbance on the United States side primarily as a result of heightened levels of illegal immigration, smuggling, and law enforcement response (Service 2008, p. 55)” (75 FR 5735). Whether these activities pose a threat to the survival and recovery of the Sonoran pronghorn has not been thoroughly addressed. Recent analysis has shown there are about 8,000 miles of unauthorized routes on the approximately 1,000-sq.-mi refuge, mostly in designated wilderness. These are most likely attributable to both illegal cross-border traffic and associated law enforcement response by Border Patrol (McCasland 2010, pers. comm.). Furthermore, there is strong anecdotal evidence suggesting Sonoran pronghorn are avoiding areas of high cross-border traffic and law enforcement response, including the Granite forage enhancement plot and the pass near Bates Well (Service 2009, pp. 47-48). Border Patrol presence deters illegal cross-border traffic, but that deterrence has a substantial impact on its own (Milstead and Barnes 2002, pp. 87-88; Neeley 2006, p. 9; Duncan et al. 2010, pp. 123-130). However, as Border Patrol achieves operational control of the border region, we anticipate that human disturbance will be reduced over time.

(21) Comment : Kofa NWR is much more likely to support a successful reintroduction of Sonoran pronghorn than the area east of Highway 85 (Area D), which is a high-traffic area for human and narcotics smuggling. Attempting a reestablishment in Area D is inconsistent with the recovery plan, which specifies that a second, but not a third, U.S. population is needed for downlisting.

Our Response : Although not ranked as high as Area A (which includes Kofa NWR), Area D (including the area east of Highway 85) was ranked second of the seven areas evaluated by the IDT as potential release sites. The IDT believes Area D has good potential to support Sonoran pronghorn, and the subspecies existed here historically, possibly into the late 1980s (Service 1998, p. 9). Degree of disturbance, including that caused by illegal cross-border traffic and Border Patrol, were taken into account in the rankings of each area. Further, as discussed in the above comment, we anticipate that both illegal immigration and Border Patrol operations will lessen over time. The recovery plan identifies establishment of a second U.S. herd as a criterion for downlisting (Service 2002, p. 36); however, it does not suggest population reestablishments should be limited to only one. Recovery action 2 in the 1998 recovery plan is to “establish and monitor new separate herd(s)” (Service 1998, p. 40). Replication of effort in regard to population reestablishment is prudent in the event that populations in Area A or Area D are not successful. The holding pen at Area D will also serve as an outlet for excess pronghorn produced at the captive rearing pen at Cabeza Prieta NWR. Production of animals for release is expected to be more than 20 Sonoran pronghorn per year from that pen (23 were released from the pen in December 2009). Once animals are established at the pen at Kofa NWR, and as the wild herds are bolstered by releases, fewer animals will be needed, allowing releases to Area D. In addition, conditions such as drought within the current range of the Sonoran pronghorn may make release of captively propagated Sonoran pronghorn into the wild herd undesirable in some years. Area D will provide another option for use of these excess animals. Also, the ultimate goal of the Act is to delist the species, so it no longer needs the protections of the Act. Additional populations beyond what is being proposed in this action may be needed to achieve full recovery.

(22) Comment : The full effects of the rulemaking are not evaluated, because the analysis in the EA is limited to Areas A and D, but the NEP area is much larger, encompassing 10 million acres. For example, U.S. Customs and Border Protection will be required to consult on its activities at OPCNM east of Highway 85. Because of the scope and cost of the effort, along with potential effects of a wide range of activities, the proposed action appears to be a major Federal action significantly affecting the human environment. The commenter encourages the Service to limit the NEP to areas west of Highway 85.

Our Response : NEPA implementing regulations at 40 CFR 1508.9 define an EA as: “a concise public document for which a Federal agency is responsible that serves to: (1) Briefly provide sufficient evidence and analysis for determining whether to prepare an environmental impact statement or a FONSI, (2) aid an agency's compliance with the Act when no environmental impact statement is necessary, and (3) facilitate preparation of an environmental impact statement when one is necessary. The EA shall include brief discussions of the need for the proposal, of alternatives as required by section 102(2)(E) of NEPA, of the environmental impacts of the proposed action and alternatives, and a listing of agencies and persons consulted” (40 CFR 1508.9(b)).

Sonoran pronghorn pens, holding facilities, water sources, and releases will all occur in Areas A and D, and are consistent with the regulations cited above. Those are the areas on which the effects of the alternatives were focused in the EA. Over time, and as populations grow, Sonoran pronghorn could move outside of Areas A and D and potentially to the boundaries of the NEP. In the event that Sonoran pronghorn move to the boundaries of the NEP but not outside of it, the effects of Sonoran pronghorn presence in these areas would be minimal because of the NEP designation and the special rule that together broadly allow Federal actions to go forward without section 7 consultations, and private actions that may result in incidental take of the species will not require incidental take permits from the Service. In National Parks and Wildlife Refuges, for the purposes of section 7 only, the Sonoran pronghorn will be listed as a threatened species, requiring consultations for actions that may affect the species. However, we expect few if any changes would be needed in those lands to comply with the Act (see “ Management ”). Thus, based on our EA we find that in no case do the effects of the action within Areas A or D or within the NEP generally, rise to the level of significantly affecting the human environment. A “major Federal action” includes actions with effects that may be major and which are potentially subject to Federal control and responsibility (40 CFR 1508.18). Due in part to the regulatory relief provided by the NEP designation and special rule, the effects of the action are not major as documented in our FONSI.

The likelihood of Sonoran pronghorn moving into that portion of Area D east of Highway 85 on OPCNM is low. The few Sonoran pronghorn that have moved into that area have either died or not stayed there, likely because of poor habitat quality. In any case, it is probably more likely that wild Sonoran pronghorn would colonize that area from west of Highway 85 than from the release site in Area D (see our response to the third peer review comment). In that scenario, U.S. Customs and Border Protection would need to consult on their activities in that area affecting Sonoran pronghorn with or without the NEP designation.

(23) Comment : During pen construction at Kofa NWR, any desert tortoises or rosy boas found should be immediately translocated to a release site agreed upon by the AGFD, Service, and BMGR.

Our Response : In the event that State-sensitive species, such as rosy boas ( Lichanura trivirgata ) or desert tortoises ( Gopherus agassizii ) are found during any phase of construction at either the captive breeding pen at Kofa NWR or the holding pen at BMGR-E, they will be relocated no more than 0.5 mi (0.8 km) away in the direction of the most suitable and typical habitat for the species (rock outcrops or rocky hillsides, and in the case of the tortoise, dissected washes with caliche caves). If rosy boas are found during the day, they shall be held temporarily in a climate-controlled environment (e.g., a cooler) and released in the evening to prevent overheating.

(24) Comment : A commenter expressed concern that reestablishment at Kofa NWR would interfere with the hunting opportunities for bighorn sheep ( Ovis canadensis ) or other species on the refuge. In particular, the commenter questions whether areas of the refuge would be closed to public use during the Sonoran pronghorn fawning season or whether areas currently open to bighorn sheep hunting would be closed on Kofa NWR to protect Sonoran pronghorn.

Our Response : An area extending 0.25 mi (0.40 km) out from the boundaries of the captive breeding pen at Kofa NWR will be closed to the public. The pen will be in King Valley, in an area not frequented by bighorn sheep, so it will have no impact on sheep hunting. No other closures are needed or will be implemented at Kofa NWR to support the Sonoran pronghorn reestablishment.

(25) Comment: A commenter inquired how a 10(j) designation could be established on the BMGR when there are still Sonoran pronghorn in that area.

Our Response: Areas west of Highway 85 and south of Interstate 8 on the BMGR are not within the NEP. The wild herd, with the full protections of the Act, occupies this area. Only those areas of BMGR-E east of Highway 85 are in the NEP. Those areas are not currently occupied by Sonoran pronghorn. Highway 85 and its right-of-way fence provide a physical barrier to Sonoran pronghorn movement between the wild population and the NEP (see discussion in “ Reestablishment Areas ”).

(26) Comment : One commenter asked if the NEP area is clearly delineated from the area in which the wild, fully protected Sonoran pronghorn occur, and if there is a chance of confusion in areas that include both NEP and fully protected Sonoran pronghorn (e.g., BMGR). Furthermore, the commenter asked if a potential exists for incidental take of Sonoran pronghorn occurring in the current range due to its close proximity to the NEP.

Our Response : The boundaries of the NEP are clearly delineated by major highways, the Colorado River, and an international border. Where the NEP adjoins the area occupied by the wild population, the boundary between the two includes Interstate 8 (boundary with Area A) and Highway 85 (boundary with Area D). Because of those clear boundaries, the likelihood of confusing wild and NEP Sonoran pronghorn is low, because the status of each is determined geographically. Designation of the NEP adjacent to the current range alters neither the likelihood of incidental take, nor the activities that could result in incidental take of Sonoran pronghorn in the wild herd.

(27) Comment : No sufficient or verifiable evidence exists to show that Kofa NWR or any areas north of the Gila River are within the historical range of the Sonoran pronghorn. Hence, establishing a population of pronghorn at Kofa NWR is inappropriate.

Our Response : The commenter provides much supporting information that brings into question whether Sonoran pronghorn ever occupied King Valley or other portions of Kofa NWR. We acknowledge that delineating the historical range of the Sonoran pronghorn is problematic because of a lack of specimens in key areas; the anecdotal nature of sightings, of which some of the most relevant are very old; and taxonomic uncertainty—the Mexican pronghorn occurs elsewhere in southern Arizona. The uncertainty in defining historical range is reflected in the prior and current Sonoran pronghorn recovery plans. The 1982 plan, adopting the range as described by Hall and Kelson (1959, p. 1023), did not show the range of the Sonoran pronghorn north of Ajo, which is well south of the Gila River (Service 1982, p. 2). The 1998 and 2002 versions of the recovery plan adopted a more expansive view of historical range first exposed by Phelps and Webb (1981, p. 21); this later view included Kofa NWR. Phelps and Webb (1981, p. 22) provide evidence of Sonoran pronghorn on the Harquahala Plain in the 1850s, northeast of Kofa NWR, and along the Gila River in 1852, south of the Kofa NWR. As shown in the 2002 supplement and amendment to the recovery plan (Service 2002, p. 17), based on the best scientific and commercial information available, the Sonoran pronghorn recovery team and the Service believe Kofa NWR is within the historical range of the subspecies.

(28) Comment : Yuma Proving Grounds is not going to ignore their mission and cease firing if Sonoran pronghorn are in their artillery footprint. Yuma Proving Grounds could bomb herds of expensively reared Sonoran pronghorn, and military operations may alter behavior and physiology of the species. No protocols are in place at Yuma Proving Grounds to minimize death or injury of Sonoran pronghorn. This is a moral issue that must not be overlooked, as well as an additional financial loss of valuable animals.

Our Response : Specific capabilities at Yuma Proving Grounds include testing of artillery; mortars; mines; ground and aircraft weapons; target acquisition and fire control systems; wheeled and tracked vehicles; and air delivery material, equipment, and techniques. Primarily artillery and tank testing activities occur on the Kofa Range portion of Yuma Proving Grounds, which lies directly south of Kofa NWR and is the portion of Yuma Proving Grounds most likely to be colonized by Sonoran pronghorn. We acknowledge that military activities at Yuma Proving Grounds may result in some mortality and injury of Sonoran pronghorn (see discussion in “ Status of Proposed Population ”). However, similar to BMGR-E, the vast majority of the Kofa Range portion of Yuma Proving Grounds is relatively undisturbed. The likelihood of a Sonoran pronghorn being hit by an artillery shell or shrapnel, colliding with a vehicle, or encountering lethal or injurious hazards is very small. At BMGR-E, no Sonoran pronghorn have ever been documented to have been killed or injured by military activities. Luke Air Force Base implements protocols to ensure that Sonoran pronghorn are not harmed on the live fire Tactical Ranges, but even before those protocols were put in place in 1997, no Sonoran pronghorn were ever known to have been killed or injured on the BMGR as a result of military activities. There is no evidence to suggest, nor do we anticipate, that military activities at Yuma Proving Grounds will compromise the recovery efforts for the Sonoran pronghorn in Area A.

(29) Comment : One commenter questioned the timeline in the EA, which had the construction of the captive pen at Kofa NWR beginning in spring of 2010.

Our Response : Implementation of the action will not begin until after publication of this rule and the signing of the FONSI.

(30) Comment : Creating irrigated forage enhancement plots in King Valley at Kofa NWR will exacerbate nonnative, invasive plant problems. In particular, the nonnative Sahara mustard ( Brassica tournefourtii ) and Mediterranean grass ( Schismus sp.) are likely to increase.

Our Response: We acknowledge that irrigating the desert will cause increased growth of plants, including nonnative species such as Sahara mustard and Mediterranean grass. We propose irrigated areas to enhance forage within the captive pen at Kofa NWR. No forage enhancement plots are proposed outside the captive pen. Although we have not surveyed the pen site for Sahara mustard or Mediterranean grass, both almost certainly occur there. Mediterranean grass is likely ubiquitous. Sahara mustard achieves its greatest densities in fine, sandy soils, but still occurs on bajadas and in gravelly soils such as occurs at the pen site. Both species thrive in disturbed sites; hence, hoof action from Sonoran pronghorn may further enhance populations of these nonnatives. That said, these species have not increased noticeably in forage enhancement plots at Cabeza Prieta NWR, including inside the captive breeding pen. The plant communities and soils are similar between the forage plots at Cabeza Prieta and at the pen site in Kofa NWR, so we have no reason to believe these species will respond any differently at Kofa NWR. Furthermore, the fencing and visual screening on the perimeter of the pen at Kofa NWR will likely reduce spread of seed from Sahara mustard and Mediterranean grass to areas outside the pen. Consistent with our monitoring and adaptive management plan, if our actions create a nonnative invasive plant problem, we will evaluate that problem and take appropriate action to correct it.

(31) Comment: In comments provided on the Environmental Assessment, the U.S. Customs and Border Protection strongly encouraged limiting reestablishment to Area A (Kofa) due to concerns that the experimental population might impede border security operations.

Our Response: The Service and the Recovery Team believe that it is important to efforts to conserve the Sonoran pronghorn to have two population centers within the experimental area. Based on our evaluation of possible reintroduction sites, Kofa (Area A) and BMGR-East (Area D) have the best combination of size, forage availability, water availability, fragmentation, disturbance, logistics, and other factors and that is why we have chosen those two areas. Release of animals into BMGR-East would only occur after we have achieved strongly positive results from our efforts at Kofa and we have surplus animals from Cabeza Prieta and Kofa that could be placed in BMGR-East. We do not anticipate reaching that point for at least 5 years and probably longer. The Service is committed to coordinating closely with U.S. Customs and Border Protection and other partners before implementing release of Sonoran pronghorns into BMGR-East so as to limit any potentially adverse effects to operations and activities of U.S. Customs and Border Protection and our other partners. We have added language to the text of the regulation clarifying that incidental take caused by border security and enforcement carried out by Federal law enforcement officials (e.g., U.S. Customs and Border Protection) would not be prohibited.

We followed the procedures required by the Act, NEPA, and the Administrative Procedure Act during this Federal rulemaking process. Therefore, we solicited public and peer-review comments on the proposed NEP designation. As required by law, we have considered all comments received on the proposed rule and draft EA before making this final determination. Based on the above information, and using the best scientific and commercial data available (in accordance with 50 CFR 17.81), we find that creating an NEP of Sonoran pronghorn and releasing them into the NEP area in Kofa NWR of Area A and BMGR-E of Area D will further the conservation of the species.

We are making a nonsubstantive change to correct a paragraph designation error in 50 CFR 18.74(u), the nonessential experimental population rule for Rio Grande silvery minnow. In that rule, there are four subparagraphs, numbered (1) through (4). Paragraph (u)(4) is further broken down into three subparagraphs. According to the correct format for the Code of Federal Regulations, these subparagraphs should be designated as paragraphs (i) through (iii). However, they are erroneously designated as paragraphs (a) through (c). We are making this correction as part of this final rule.

The Office of Management and Budget (OMB) has determined that this rule is not significant and has not reviewed this rule under Executive Order 12866 (E.O. 12866). OMB bases its determination upon the following four criteria:

(a) Whether the rule will have an annual effect of $100 million or more on the economy or adversely affect an economic sector, productivity, jobs, the environment, or other units of the government.

(b) Whether the rule will create inconsistencies with other Federal agencies' actions.

(c) Whether the rule will materially affect entitlements, grants, user fees, loan programs, or the rights and obligations of their recipients.

(d) Whether the rule raises novel legal or policy issues.

Under the Regulatory Flexibility Act (as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996; 5 U.S.C. 601 et seq. ), whenever a Federal agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare, and make available for public comment, a regulatory flexibility analysis that describes the effect of the rule on small entities (i.e., small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of an agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule will not have a significant economic impact on a substantial number of small entities. We are certifying that this rule will not have a significant economic effect on a substantial number of small entities. The following discussion explains our rationale.

The area affected by this rule includes an area north of Interstate 8, east of the Colorado River, and west of Interstates 10 and 19; and an area south of Interstate 8, east of Highway 85, and west of Interstates 10 and 19. Because of the substantial regulatory relief provided by NEP designations, we do not expect this rule to have any significant effect on recreational, agricultural, ranching, military, or other activities within the NEP area. In addition, when NEPs are located outside a National Wildlife Refuge or unit of the National Park System, we treat the population as a species proposed for listing for the purposes of Section 7 and only two provisions apply: Section 7(a)(1) and section 7(a)(4). In these instances, NEPs provide additional flexibility because Federal agencies are not required to consult with us under section 7(a)(2). Section 7(a)(1) requires Federal agencies to use their authorities to carry out programs to further the conservation of listed species. Section 7(a)(4) requires Federal agencies to confer (rather than consult) with the Service on actions that are likely to jeopardize the continued existence of a proposed species.

The BLM has a policy (BLM 6840 Manual) of conferring on activities that may adversely affect proposed species. The results of a conference are advisory in nature and do not restrict agencies from carrying out, funding, or authorizing activities. The section 7(a)(2) requirements will apply if Sonoran pronghorn may be affected by Federal activities within National Wildlife Refuges and National Park Service units in the NEP; however, we do not anticipate any significant changes to management because these areas are already managed in a way that will promote recovery of the Sonoran pronghorn. The principal activities on private property in the NEP are agriculture, ranching, rural living, and recreation. We believe the presence of the Sonoran pronghorn will not affect the use of private or tribal lands for these purposes because there will be no new or additional economic or regulatory restrictions imposed upon States, non-Federal entities, or members of the public due to the presence of the Sonoran pronghorn.

This rule authorizes incidental take of Sonoran pronghorn within the NEP area outside of National Wildlife Refuges and National Park Service units. The regulations implementing the Act define “incidental take” as take that is incidental to, and not the purpose of, carrying out of an otherwise lawful activity such as military training, livestock grazing, recreation, and other activities that are in accordance with Federal, tribal, state, and local laws and regulations. Intentional take for purposes other than aiding sick, injured, or orphaned Sonoran pronghorn; collection of biological data; or other conservation purposes as described in the special rule at the end of this document are not authorized unless for research or educational purposes, which would require a recovery permit under section 10(a)(1)(a) of the Act.

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

a. On the basis of information contained in the “Regulatory Flexibility Act” section above, this rule will not “significantly or uniquely” affect small governments. We have determined and certify pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502 et seq., that this rulemaking will not impose a cost of $100 million or more in any given year on local or State governments or private entities. A Small Government Agency Plan is not required. As explained above, small governments will not be affected because the NEP designation will not place additional requirements on any city, county, or other local municipalities.

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

In accordance with Executive Order 12630, the rule does not have significant takings implications. When reestablished populations of federally listed species are designated as NEPs, the Act's regulatory requirements regarding the reestablished listed species within the NEP are significantly reduced. Section 10(j) of the Act and the accompanying special rule can provide regulatory relief with regard to the taking of reestablished species within an NEP area. For example, with the exception of actions on National Wildlife Refuge or National Park Service lands within the NEP, this rule allows for the taking of reestablished Sonoran pronghorn when such take is incidental to an otherwise legal activity, such as military training and testing, agriculture, rural and urban development, livestock grazing, camping, hiking, hunting, recreational vehicle use, sightseeing, nature or scientific study, rockhounding, and geocaching; or other activities that are in accordance with applicable tribal, Federal, State, and local laws and regulations. Because of the substantial regulatory relief provided by NEP designations, we do not believe the reestablishment of this species will conflict with existing or proposed human activities or hinder public use of lands within the NEP.

A takings implication assessment is not required because this rule (1) will not effectively compel a property owner to suffer a physical invasion of property and (2) will not deny all economically beneficial or productive use of the land or aquatic resources. This rule substantially advances a legitimate government interest (conservation and recovery of a listed species) and does not present a barrier to all reasonable and expected beneficial use of private property.

In accordance with Executive Order 13132, we have considered whether this rule has significant Federalism effects and have determined that a Federalism assessment is not required. This rule will not have substantial direct effects on the States, on the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government. In keeping with Department of the Interior policy, we requested information from and coordinated development of this rule with the affected resource agencies in Arizona. The AGFD has been a key participant in the recovery program for the Sonoran pronghorn, including serving on the IDP that helped develop the reestablishment proposal. Achieving the recovery goals for this species will contribute to its eventual delisting and its return to State management. No intrusion on State policy or administration is expected, roles or responsibilities of Federal or State governments will not change, and fiscal capacity will not be substantially or directly affected. The special rule operates to maintain the existing relationship between the State and the Federal Government and is being undertaken in coordination with the State of Arizona. Therefore, this rule does not have significant Federalism effects or implications to warrant the preparation of a Federalism Assessment under the provisions of Executive Order 13132.

In accordance with Executive Order 12988 (February 7, 1996; 61 FR 4729), the Office of the Solicitor has determined that this rule will not unduly burden the judicial system and will meet the requirements of sections (3)(a) and (3)(b)(2) of the Order.

In accordance with Secretarial Order 3206 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act) (June 5, 1997); the President's memorandum of April 29, 1994, Government-to-Government Relations with Native American Tribal Governments (59 FR 22951); Executive Order 13175; and the Department of the Interior's requirement at 512 DM 2, we have notified the Native American Tribes within and adjacent to the NEP area about the proposed and final rule. They have been advised through written contact, including informational mailings from the Service, and were provided an opportunity to comment on the draft EA and proposed rule. No comments were received from Tribes on these documents. If future activities resulting from this rule may affect Tribal resources, the Service will communicate and consult on a Government-to-Government basis with any affected Native American Tribes in order to find a mutually agreeable solution.

Office of Management and Budget (OMB) regulations at 5 CFR part 1320, which implement provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ), require that Federal agencies obtain approval from OMB before collecting information from the public. The Office of Management and Budget has approved our collection of information associated with reporting the taking of experimental populations and assigned control number 1018-0095. We may not collect or sponsor, and you are not required to respond to, a collection of information unless it displays a currently valid OMB control number.

We have prepared an EA and FONSI, as defined under the authority of NEPA. It is available from the Arizona Ecological Services Field Office, 2321 West Palm Royal Road, Suite 103, Phoenix, AZ 85021, or from our Web site at http://www.fws.gov/southwest/es/arizona/ or on www.regulations.gov under Docket No. FWS-R2-ES-2009-0077.

On May 18, 2001, the President issued Executive Order 13211 on regulations that significantly affect energy supply, distribution, and use. Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. This rule is not expected to significantly affect energy supplies, distribution, and use. Because this action is not a significant energy action, no Statement of Energy Effects is required.

A complete list of all references cited in this rule is available upon request from the Arizona Ecological Services Field Office (see ADDRESSES section).

The primary authors of this rule are staff of the Arizona Ecological Services Field Office (see ADDRESSES section).

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